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Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued to Embraer S.A., for a type certificate for the EMB-500 airplane. This airplane will have novel and unusual design features when compared to the state of technology envisaged in the applicable airworthiness standards. These novel and unusual design features include the installation of electronic flight instrument system (EFIS) displays, Model G1000 manufactured by Garmin, for which the applicable regulations do not contain adequate or appropriate airworthiness standards for the protection of these systems from the effects of high intensity radiated fields (HIRF). These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to the airworthiness standards applicable to these airplanes.
The effective date of these special conditions is April 16, 2008. Comments must be received on or before May 27, 2008.
Mail comments in duplicate to: Federal Aviation Administration, Regional Counsel, ACE-7, Attention: Rules Docket Clerk, Docket No. CE282, Room 506, 901 Locust, Kansas City, Missouri 64106. Mark comments: Docket No. CE282. You may inspect comments in the Rules Docket weekdays, except Federal holidays, between 7:30 a.m. and 4 p.m.
Jim Brady, Aerospace Engineer, Standards Office (ACE-111), Small Airplane Directorate, Aircraft Certification Service, Federal Aviation Administration, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone (816) 329-4132.
The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the approval design and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.
Interested persons are invited to submit such written data, views, or arguments as they may desire. Identify the regulatory docket or notice number and submit them in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. If you wish the FAA to acknowledge receipt of the comments submitted in response to this notice, include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE282.” The postcard will be date stamped and returned to the commenter.
On October 5, 2005, Embraer S.A, applied to the FAA for a new type certificate for the EMB-500 airplane. The proposed airplane incorporates a novel or unusual design feature, such as digital avionics consisting of an EFIS that is vulnerable to HIRF external to the airplane.
Under the provisions of 14 CFR part 21, § 21.17, Embraer S.A. must show that the EMB-500 aircraft meets the following provisions, or the applicable regulations in effect on the date of application for the change to the project certification basis: 14 CFR part 23 at Amendment 55; 14 CFR part 34 at Amendment 3; 14 CFR part 36 at Amendment 27; Equivalent Levels of Safety for (ELOS) issued at the time of type certification; any special conditions issued at the time of type certification, as applicable, and § 23.1301 of Amendment 23-20; §§ 23.1309, 23.1311, and 23.1321 of Amendment 23-49; and § 23.1322 of Amendment 23-43; exemptions, if any; and the special conditions adopted by this rulemaking action.
If the Administrator finds that the applicable airworthiness standards do not contain adequate or appropriate safety standards because of novel or unusual design features of an airplane, special conditions are prescribed under the provisions of § 21.16.
Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38 after public notice and become part of the type certification basis in accordance with § 21.17(a)(2).
Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.
Embraer S.A. plans to incorporate certain novel and unusual design features into an airplane for which the airworthiness standards do not contain adequate or appropriate safety standards for protection from the effects of HIRF. These features include EFIS, which are susceptible to the HIRF environment, that were not envisaged by the existing regulations for this type of airplane.
Furthermore, the HIRF environment has undergone a transformation that was not foreseen when the current requirements were developed. Higher energy levels are radiated from transmitters that are used for radar, radio, and television. Also, the number of transmitters has increased significantly. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling to cockpit-installed equipment through the cockpit window apertures is undefined.
The combined effect of the technological advances in airplane design and the changing environment has resulted in an increased level of vulnerability of electrical and electronic systems required for the continued safe flight and landing of the airplane. Effective measures against the effects of exposure to HIRF must be provided by the design and installation of these systems. The accepted maximum energy levels in which civilian airplane system installations must be capable of operating safely are based on surveys and analysis of existing radio frequency emitters. These special conditions require that the airplane be evaluated under these energy levels for the protection of the electronic system and its associated wiring harness. These external threat levels, which are lower than previous required values, are believed to represent the worst case to which an airplane would be exposed in the operating environment.
These special conditions require qualification of systems that perform critical functions, as installed in aircraft, to the defined HIRF environment in paragraph 1 or, as an option to a fixed value using laboratory tests, in paragraph 2, as follows:
(1) The applicant may demonstrate that the operation and operational capability of the installed electrical and electronic systems that perform critical functions are not adversely affected when the aircraft is exposed to the HIRF environment defined below:
(2) The applicant may demonstrate by a system test and analysis that the electrical and electronic systems that perform critical functions can withstand a minimum threat of 100 volts per meter, electrical field strength, from 10 kHz to 18 GHz. When using this test to show compliance with the HIRF requirements, no credit is given for signal attenuation due to installation.
A preliminary hazard analysis must be performed by the applicant, for approval by the FAA, to identify either electrical or electronic systems that perform critical functions. The term “critical” means those functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. The systems identified by the hazard analysis that perform critical functions are candidates for the application of HIRF requirements. A system may perform both critical and non-critical functions. Primary electronic flight display systems, and their associated components, perform critical functions such as attitude, altitude, and airspeed indication. The HIRF requirements apply only to critical functions.
Compliance with HIRF requirements may be demonstrated by tests, analysis, models, similarity with existing systems, or any combination of these. Service experience alone is not acceptable since normal flight operations may not include an exposure to the HIRF environment. Reliance on a system with similar design features for redundancy as a means of protection against the effects of external HIRF is generally insufficient since all elements of a redundant system are likely to be exposed to the fields concurrently.
As discussed above, these special conditions are applicable to the EMB-500 project. Should Embraer S.A. apply at a later date for a supplemental type certificate to modify any other model on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101.
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.
The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.
Aircraft, Aviation safety, Signs and symbols.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and 21.17; and 14 CFR 11.38 and 11.19.
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the EMB-500 airplane manufactured by Embraer S.A. to include an EFIS.
1. Protection of Electrical and Electronic Systems from High Intensity Radiated Fields (HIRF). Each system that performs critical functions must be
2. For the purpose of these special conditions, the following definition applies: Critical Functions: Functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane.
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Final rule; Treasury decision.
This Treasury decision establishes the “Swan Creek” viticultural area in Wilkes, Yadkin, and Iredell Counties, North Carolina. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
N. A. Sutton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 925 Lakeville Street, No. 158, Petaluma, CA 94952; telephone 415-271-1254.
Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels, and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the regulations promulgated under the FAA Act.
Part 4 of the TTB regulations (27 CFR part 4) allows the establishment of definitive viticultural areas and the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) contains the list of approved viticultural areas.
Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region distinguishable by geographical features, the boundaries of which have been recognized and defined in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to its geographical origin. The establishment of viticultural areas allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of a viticultural area is neither an approval nor an endorsement by TTB of the wine produced in that area.
Section 4.25(e)(2) of the TTB regulations outlines the procedure for proposing an American viticultural area and provides that any interested party may petition TTB to establish a grape-growing region as a viticultural area. Section 9.3(b) of the TTB regulations requires the petition to include—
• Evidence that the proposed viticultural area is locally and/or nationally known by the name specified in the petition;
• Historical or current evidence that supports setting the boundary of the proposed viticultural area as the petition specifies;
• Evidence relating to the geographical features, such as climate, elevation, physical features, and soils, that distinguish the proposed viticultural area from surrounding areas;
• A description of the specific boundary of the proposed viticultural area, based on features found on United States Geological Survey (USGS) maps; and
• A copy of the appropriate USGS map(s) with the proposed viticultural area's boundary prominently marked.
Raffaldini Vineyards submitted a petition to establish the 96,000-acre “Swan Creek” viticultural area on behalf of the Vineyards of Swan Creek, a trade association representing a group of vineyards and wineries in northwestern North Carolina. Three wineries and 75 acres of vineyards are located within the proposed Swan Creek viticulture area. The boundary of the proposed viticultural area incorporates portions of Wilkes, Yadkin, and Iredell Counties and includes a portion of the established Yadkin Valley viticultural area (27 CFR 9.174). We summarize below the evidence submitted in support of the petition.
The petitioner explains that the geographical name “Swan Creek” refers to a village in the approximate center of the proposed viticultural area, as well as a Yadkin River tributary creek system. As shown in the southwest portion of the provided 1:100,000-scale USGS Winston-Salem, North Carolina topographic map, Swan Creek village sits in the Brushy Mountains south of the Yadkin River. East and West Swan Creeks run north from the mountains before joining together as Swan Creek to the northwest of the village. The creek then empties into the Yadkin River approximately three miles west of Jonesville. Also, an undated State of North Carolina Department of Environment, Health, and Natural Resources document lists Swan Creek, West Swan Creek, and East Swan Creek as streams in the Yadkin-Pee Dee River Basin.
The DeLorme North Carolina Atlas and Gazetteer identifies the village as “Swancreek,” with East Swan Creek and West Swan Creek to its northwest. The petitioner explains that both names, “Swan Creek” and “Swancreek,” reference the proposed viticultural area region. However, the two-word spelling is the more common usage for businesses, roads, creeks, and historical documents, which led the petitioner to identify the proposed viticultural area as “Swan Creek.”
As further evidence of the significance of the “Swan Creek” name within the proposed area, the local Wilkes Telephone Membership Corp. telephone book, which covers the region that includes the proposed viticultural area, lists an airport, a church, and three
The petitioner relies on geographical and man-made elements identifiable on the supplied USGS maps to define and draw the boundary for the proposed viticultural area. Climate data and historic evidence that documents the breadth of the “Swan Creek” name also legitimize the proposed boundary line, according to the petitioner.
From the regional history of the Yadkin Valley, the petitioner connects the “Swan Creek” name to stories of Revolutionary War soldiers traveling along the Yadkin River, the proposed Swan Creek viticultural area's northern boundary line, while en route to the pivotal battle at King's Mountain in South Carolina. Also, during the Civil War, Union Major General George Stoneman led troops through the Swan Creek region to Virginia. Historic manuscripts maintain that frontiersman Daniel Boone homesteaded in the Swan Creek region in the 1750s.
According to the petition, farming become more prominent in the Swan Creek area after the Civil War, the Swan Creek area, and agriculture continues to characterize this rural region. Today, agriculture in the Swan Creek region includes viticulture, with 75 acres within the proposed Swan Creek viticultural area currently dedicated to grape growing.
The geology of the Swan Creek region, along with its minor climatic variation, also creates distinguishing viticultural features upon which to base the proposed Swan Creek viticultural area's boundary. The entire proposed viticultural area lies within the Yadkin River Basin. The general uniformity in the Swan Creek region's soils is attributable to the natural weathering process of the Brushy Mountains and the Brevard Shear Zone, a major fault system that also defines the Blue Ridge Escarpment in the area. The homogeneous soil within the proposed viticultural area is unlike the varied soils and rock types found in other parts of the Yadkin Valley viticultural area.
The proposed Swan Creek viticultural area boundary overlaps the established Yadkin Valley viticultural area as shown in the table below.
The northern 60 percent of the proposed Swan Creek viticultural area sits within the Yadkin Valley viticultural area, with the remaining 40 percent south of the Yadkin Valley viticultural area boundary line, according to the petition maps. The discussion below includes evidence regarding the differences between the established Yadkin Valley viticultural area and the proposed Swan Creek viticultural area, which, according to the petitioner, justifies the proposed boundary line.
Situated in the moderate elevations of the Brushy Mountains, and bordering the Yadkin River on the north, the proposed Swan Creek viticultural area's geographical location is responsible for the area's temperate climate and homogenous soil as compared to surrounding areas, according to the petitioner.
The Brushy Mountains run through the center of the Swan Creek region, with elevations in the proposed Swan Creek viticultural area varying between 1,000 feet and 2,000 feet, according to the USGS maps submitted with the petition. Within the proposed viticultural area the Brushy Mountains have elevations lower than the Blue Ridge Mountains to the west but higher than the other surrounding areas. The Blue Ridge Mountain region to the immediate west of the proposed boundary line rises to elevations of 3,000 to 5,000 feet. To the east and south of the proposed viticultural area, the elevation drops to between 500 and 1,000 feet.
Both the Yadkin River, which serves as the proposed Swan Creek viticultural area's northern boundary line, and that portion of the Brushy Mountains located within the proposed viticultural area serve as climatically moderating influences.
The Swan Creek region has an average annual high temperature of 68.9 °F and an average annual low temperature of 42.8 °F. The table below shows the contrasting temperatures in the regions beyond the proposed viticultural area's boundary line, as collected by the Southeast Regional Climate Center (SERCC) of the National Climatic Data Center.
The SERCC data shows that the Swan Creek area is generally warmer than the regions to the west and northwest, cooler than the regions to the south and east, and slightly cooler than the Yadkin Valley as a whole. Also, average January temperatures of 20° F to 25° F make the Swan Creek region less prone to Pierce's Disease, which adversely affects vineyards, than the majority of the Yadkin Valley viticultural area.
The proposed Swan Creek viticultural area averages 3,576 degree days of heat accumulation annually, which puts it in climatic region IV, according to temperature data collected by the SERCC. (As a measurement of heat accumulation during the growing season, one degree day accumulates for each degree Fahrenheit that a day's mean temperature is above 50 degrees, which is the minimum temperature required for grapevine growth. (See “General Viticulture,” by Albert J. Winkler, University of California Press, 1974.)
The surrounding areas, based on Amerine and Winkler heat summation definitions, include climatic regions IV and V to the east, region V to the south, and region I to the west-northwest.
The frost-free season of the proposed Swan Creek viticultural area extends on average from April 19 to October 17 annually, according to the “Average Last Spring Frost Dates for Selected North Carolina Locations,” horticulture information leaflets (published December 1996 and revised December 1998), by Katharine Perry, North Carolina State University. According to the petition, this frost-free season is nearly identical to Surry County, which is part of the Yadkin Valley viticultural area located immediately northeast of the proposed Swan Creek viticultural area. However, southeast of the proposed viticultural area, but also within the Yadkin Valley viticultural area, the Davidson County frost-free season runs on average from March 31 to October 31, resulting in a month less frost than in the proposed Swan Creek viticultural area. The frost-free season varies in counties outside the Yadkin Valley viticultural area and the proposed Swan Creek viticultural area, extending three weeks longer to the east and lasting four to six weeks less in regions to the west and northwest.
The growing season of the proposed Swan Creek viticultural area averages 170 to 190 days annually, according to Perry's “Average Growing Seasons for Selected North Carolina Locations,” horticulture information leaflets (published December 1996 and revised December 1998). Again, this growing season is almost identical to Surry County, located immediately northeast within the Yadkin Valley viticultural area. However, according to Perry's data, Davidson County averages a 214-day growing season annually, or between 24 and 44 more growing days than the proposed Swan Creek viticultural area. Similarly, the petition shows that Guilford County to the east has an annual growing season of between 199 and 210 days. Counties to the west and northwest of the Swan Creek region have a significantly shorter growing season, lasting an average of 139 to 162 days.
The petitioner attributes the moderate rainfall within the proposed viticultural area to the protective influence of the Brushy Mountains. Rainfall within the proposed Swan Creek viticultural area averages 48.6 inches annually, based on SERCC data, with the local grape growers surveyed by the petitioner recording less rainfall at their own weather stations. The areas to the west and northwest of the proposed viticultural area average 57 inches each year, while regions to the south and east average 44.4 inches of rain annually.
Furthermore, snowfall within the proposed Swan Creek viticultural area averages 6.3 inches annually, based on SERCC records, which is far less than the data recorded at weather stations in surrounding areas.
The documentation and evidence provided for the petition by Matthew Mayberry of the Mayberry Land Company, Elkin, North Carolina, indicate that the geology of the proposed Swan Creek viticultural area is shaped by plate tectonics and a spectrum of uplift and erosion for the entire Appalachian Mountains building cycle. The Swan Creek region is part of the larger Appalachian Mountain Range area that has gone through at least three cycles of uplift and erosion, with each cycle lasting around 300 million years. Also, the weathering and erosion cycles created the resulting Piedmont and Blue Ridge surfaces found in the proposed viticultural area today.
Mr. Mayberry explains that the four predominant rock types in the proposed viticultural area are Henderson Gneiss, Granite, Biotite Gneiss and Biotite Amphibolite Gneiss, and Sillimanite Mica Schist. These types underlay more than 90 percent of the Swan Creek area, with the latter three predominant in the southern half of the area. Along the proposed north boundary line at the Yadkin River the predominant rock types include Ashe Formation, Utramafics, and Granitic Rocks of the Crossnore Group.
The soil information in the Swan Creek viticultural area petition is compiled from the published soil surveys of Wilkes, Yadkin, and Iredell Counties in North Carolina. Roy Mathis, Soil Specialist for Correlations, Natural Resources Conservation Service, United States Department of Agriculture, provided the soil information included in the petition.
The areas surrounding the proposed Swan Creek viticultural area have soils with differing characteristics, Mr. Mathis explains. The areas to the south and east have high shrink-swell clayey soils, which are less desirable for agriculture. To the west and north are the mountainous rocks and soils of the encroaching Blue Ridge Mountains. Also, the Yadkin Valley viticultural area, which surrounds the proposed Swan Creek viticultural area to the west, north, and east, has a greater variety of soil types and temperature regimes.
The proposed Swan Creek viticultural area mesic temperature regime has soil temperatures of 47 °F to 59 °F at the depth of 20 inches, according to Mr. Mathis. In comparison, the Yadkin Valley viticultural area is in both the mesic and thermic temperature regimes, with much warmer soil temperatures at the same depth that range from 59 °F to 72 °F at the same soil depth.
Mr. Mathis explains that the soils in the proposed Swan Creek viticultural area are primarily saprolite, a soft, clay-rich soil derived from weathered felsic (acidic) metamorphic rocks of the Inner Piedmont Belt such as granites, schists, and gneisses. The region includes a small area of Sauratown Belt with the rocks being primarily metagraywacke. In contrast, the surrounding west and north areas include residuum (saprolite) weathered from felsic metamorphic rocks such as gneisses, schists, and phyllites of the Blue Ridge Geologic Belt and Smith River Allochothon. The saprolite in the surrounding area to the east is composed of weathered igneous intrusive rocks like granites, gabbros, and diorites, as well as some gneisses and schists of the Charlotte Belt.
Evard and Cowee soils, which have moderate permeability and are well-drained with a loamy surface and sub-soil layer, predominate in the Brushy Mountains. The dominant ridge top soils of the proposed Swan Creek viticultural area also include the Fairview and Clifford series. These soils have sandy clay loam or clay loam surface layers with red clayey sub-soils, and are well-drained with moderate permeability.
Rhodhiss series is the dominant soil on the steep side slopes within the proposed viticultural area boundary. This well-drained soil has a loamy surface and moderate permeability at the sub-soil level. Mr. Mathis notes that Fairview, Clifford, and Rhodhiss soils all have bedrock deeper than 60 inches.
The Yadkin River, at the northern boundary of the proposed Swan Creek
TTB published Notice No. 63 regarding the proposed Swan Creek viticultural area in the
After careful review of the petition, TTB finds that the evidence submitted supports the establishment of the proposed viticultural area. Although a portion of the proposed viticultural area falls within the boundary of the existing Yadkin Valley viticultural area, and notwithstanding the fact that the two areas share some common features, we believe that the submitted evidence regarding climate and soil type and temperature supports the conclusion that the proposed new viticultural area is sufficiently different from the rest of the Yadkin Valley viticultural area. We also believe that establishment of the new viticultural area without changing the boundary of the existing viticultural area to exclude the overlap area would best protect labels and other commercial interests of existing viticultural entities within the overlap area. Accordingly, under the authority of the Federal Alcohol Administration Act and part 4 of our regulations, we establish the “Swan Creek” American viticultural area in Wilkes, Yadkin, and Iredell Counties, North Carolina, effective 30 days from the publication date of this document.
See the narrative boundary description of the viticultural area in the regulatory text published at the end of this document.
The maps for determining the boundary of the viticultural area are listed below in the regulatory text.
Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. With the establishment of this viticultural area and its inclusion in part 9 of the TTB regulations, its name, “Swan Creek,” is recognized under 27 CFR 4.39(i)(3) as a name of viticultural significance. The text of the new regulation clarifies this point. Consequently, wine bottlers using “Swan Creek” in a brand name, including a trademark, or in another label reference as to the origin of the wine, must ensure that the product is eligible to use the viticultural area's name as an appellation of origin.
For a wine to be labeled with a viticultural area name or with a brand name that includes a viticultural area name or other term specified as having viticultural significance in part 9 of the TTB regulations, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name or other term, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible to use the viticultural area name or other term of viticultural significance as an appellation of origin and that name or other term appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the viticultural area name or other term of viticultural significance appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label.
Different rules apply if a wine has a brand name containing a viticultural area name or other term of viticultural significance that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.
We certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of a viticultural area name is the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.
This rule is not a significant regulatory action as defined by Executive Order 12866. Therefore, it requires no regulatory assessment.
N. A. Sutton of the Regulations and Rulings Division drafted this notice.
Wine.
27 U.S.C. 205.
(a)
(b)
(1) Winston-Salem, North Carolina, 1984, photoinspected 1982;
(2) Boone, North Carolina-Tennessee, 1985; and
(3) Salisbury, North Carolina, 1985, photoinspected 1983.
(c)
(1) The beginning point is on the Winston-Salem, North Carolina map at the intersection of the Yadkin River and U.S. Highway 21, along the Surry-Yadkin county line, between Elkin and Jonesville;
(2) From the beginning point, proceed 24.6 miles generally south on U.S. Highway 21, crossing onto the Salisbury, North Carolina map, to the intersection of U.S. Highway 21 with Rocky Creek at Turnersburg; then
(3) Proceed 12.3 miles generally north and west along Rocky Creek, returning to the Winston-Salem map, to the intersection of Rocky Creek with State Highway 115 at New Hope in the southwest corner of the map; then
(4) Proceed 15.5 miles generally northwest along State Highway 115, crossing onto the Boone, North Carolina-Tennessee map, to the intersection of State Highway 115 and the Yadkin River, at North Wilkesboro; and
(5) Proceed 16.7 miles generally east-northeast along the Yadkin River,
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the P.J. McArdle Bridge across the Chelsea River, mile 0.3, between Chelsea and East Boston, Massachusetts. This deviation is necessary to facilitate the annual Chelsea River Revel and 5K Road Race. This deviation allows the bridge to remain in the closed position during the running of the 5K Road Race. Vessels that can pass under the draw without a bridge opening may do so at all times.
This deviation is effective from 8 a.m. through 5 p.m. on June 14, 2008.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2008-0001 and are available online at
John McDonald, Project Officer, First Coast Guard District, at (617) 223-8364.
The owner of the bridge, the City of Boston, requested this temporary deviation. The P.J. McArdle Bridge, across the Chelsea River at mile 0.3, between Chelsea and East Boston, Massachusetts, has a vertical clearance in the closed position of 21 feet at mean high water and 30 feet at mean low water. The bridge opens on signal as required by 33 CFR 117.593. This deviation which allows the bridge to remain closed is effective from 8 a.m. through 5 p.m. on June 14, 2008. Vessels able to pass under the closed draw may do so at any time. Tankers, and tug and barge units transit Chelsea Creek under the McArdle Bridge. Waterway users were advised of the requested bridge closure period and offered no objection.
In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Direct final interpretive rule.
EPA is taking direct final action to revise an interpretive rule defining the term “substantially similar” for unleaded gasoline as that phrase is used in section 211(f) of the Clean Air Act (the Act). To meet the current definition, fuel or fuel additives must possess, at the time of manufacture, all of the physical and chemical characteristics of an unleaded gasoline as specified in ASTM Standard D 4814-88 for at least one of the Seasonal and Geographical Volatility Classes specified in the standard. EPA is amending the definition to allow some additional flexibility for the vapor/liquid ratio specification for fuel introduced into commerce in the state of Alaska in order to improve cold starting for vehicles during the winter months in Alaska.
This rule is effective on June 24, 2008 without further notice, unless EPA receives adverse comment by May 27, 2008. If EPA receives adverse comment, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2007-0071, by one of the following methods:
•
•
•
•
•
Jaimee Dong, Compliance and Innovative Strategies Division, Office of Transportation and Air Quality, Office of Air and Radiation, Environmental Protection Agency, Mail Code 6406J, 1200 Pennsylvania Avenue, Washington, DC 20460; telephone number: (202) 343-9672; fax number: (202) 343-2800; e-mail address:
EPA is publishing this rule without a prior proposed rule
If EPA receives adverse comment, we will publish a timely withdrawal in the
Entities potentially affected by this action include those involved with the production or importation of unleaded gasoline for use in Alaska. Categories and entities affected by this action include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action; however, other types of entities not listed in the table could also be affected. To determine whether your entity is affected by this action, you should examine the applicability criteria of Parts 79 and 80 of title 40 of the Code of Federal Regulations. If you have any question regarding applicability of this action to a particular entity, consult the person in the preceding
1.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
3.
Section 211(f)(1) of the Act makes it unlawful for any manufacturer of a fuel or fuel additive to first introduce into commerce, or to increase the concentration in use of, any fuel or fuel additive for use in motor vehicles manufactured after model year 1974 which is not substantially similar to any fuel or fuel additive utilized in the
Discussions with an Alaskan refiner have highlighted the need for an amendment to the definition of “substantially similar” for unleaded gasoline. Currently, manufacturers of gasoline for Alaska may not use a temperature below 41 degrees Celsius when testing the vapor-liquid (V/L) ratio of the fuel and still be within the current definition of “substantially similar.” This amendment will allow manufacturers producing unleaded gasoline for use only in Alaska during the winter months to use a minimum test temperature of 35 degrees Celsius when testing for a maximum V/L ratio of 20 instead of requiring a V/L test temperature of 41 degrees Celsius.
ASTM D 2533 is a test method that covers a procedure for measuring the volume of vapor formed at atmospheric pressure from a given volume of gasoline. The ratio of these volumes is expressed as the V/L ratio of the gasoline at the temperature of the test. The tendency of a fuel to vaporize in common automobile fuel systems is indicated by the V/L ratio of that fuel at conditions approximating those in critical parts of the fuel system. Allowing a lower test temperature means that the vapor fraction of the fuel may be higher.
The extreme cold of Alaska during the winter months increases the risk that engines using typical gasoline blends will suffer from difficulty in cold starting. A higher vapor fraction improves mixing of the fuel with air, which in turn improves cold starting. Because the automotive fuel system is closed, the lower test temperature of 35 degrees Celsius compared to 41 degrees Celsius in the winter months is unlikely to significantly increase evaporative emissions. In addition, Alaska presently does not possess ozone non-attainment areas, most likely due to the cold temperatures observed in Alaska. Therefore, in the Agency's judgment, the impact on emissions will not be significant and this increased flexibility will allow refiners to provide a fuel more suitable to the climatic conditions of Alaska.
This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.
This action does not impose an information collection burden under the provisions of the
This interpretive rule is not subject to the Regulatory Flexibility Act (RFA) which generally requires an agency to prepare a regulatory flexibility analysis for any rule that will have a significant economic impact on a substantial number of small entities. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA) or any other statute. This rule is not subject to notice and comment requirements under the APA or any other statute because it is an interpretive rule.
Although this interpretive rule is not subject to the RFA, EPA nonetheless has assessed the potential of this rule to adversely impact small entities subject to the rule. Small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. The impact of concern is any significant adverse economic impact on small entities since the primary purpose of the regulatory flexibility analysis is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604.
After considering the economic impacts of today's direct final interpretive rule on small entities, the Agency does not believe that this action is likely to have an adverse economic impact on small entities. This final action amends the “substantially similar” interpretive rule by allowing a minimum test temperature of 35 degrees Celsius for a maximum V/L ratio of 20 from September 16 to May 31 for unleaded gasoline for use only in Alaska. This change is intended to improve cold starting in automobiles during the winter months in Alaska by allowing production and sale in Alaska during the winter season of unleaded gasoline with a higher volatility. This amendment to the interpretive rule does not impose a regulatory burden on anyone, including small businesses. Instead, this final action will have a positive impact, enabling all manufacturers, including small manufacturers, to produce and market this gasoline in Alaska. We therefore believe that today's final interpretive rule should have a positive economic impact on small entities.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed
EPA has determined that this interpretive rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. This final action will amend the “substantially similar” interpretive rule by allowing a minimum test temperature of 35 degrees Celsius for a maximum V/L ratio of 20 from September 16 to May 31 for unleaded gasoline for use only in Alaska, instead of requiring a test temperature of 41 degrees Celsius. Thus, today's interpretive rule is not subject to the requirements of sections 202 and 205 of the UMRA.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
This final interpretive rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This final action will amend the “substantially similar” interpretive rule by allowing a minimum test temperature of 35 degrees Celsius for a maximum V/L ratio of 20 from September 16 to May 31 for unleaded gasoline for use only in Alaska. The requirements of this amendment will be enforced by the federal government at the national level. Thus, Executive Order 13132 does not apply to this interpretive rule.
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final interpretive rule does not have tribal implications, as specified in Executive Order 13175. This interpretive rule will apply to gasoline refiners and importers of gasoline. This final action changes the volatility standards for gasoline in Alaska, and will not impose any enforceable duties on communities of Indian tribal governments. Thus, Executive Order 13175 does not apply to this interpretive rule.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This interpretive rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This interpretive rulemaking involves technical standards. This final action will amend the “substantially similar” interpretive rule by allowing a minimum test temperature of 35 degrees Celsius for a maximum V/L ratio of 20 from September 16 to May 31 for unleaded gasoline for use only in Alaska. The test temperature of 35 degrees Celsius may be found in Table 3, Vapor Lock Protection Class 6, of ASTM D4814-04a. All technical standards included in today's amendment to the “substantially similar” interpretive rule are standards developed by ASTM, a voluntary consensus standards body, and thus raise no issues under the NTTAA. ASTM D4814-04a may be obtained from ASTM International at 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959, 610-832-9585 (phone), 610-832-9555 (fax), or
Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this final interpretive rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This direct final interpretive rule will amend the “substantially similar” interpretive rule by allowing a minimum test temperature of 35 degrees Celsius for a maximum V/L ratio of 20 from September 16 to May 31 for unleaded gasoline for use only in Alaska. This interpretive rule amendment does not relax the control measures on sources regulated by the rule and therefore will not cause emissions increases from these sources.
The Congressional Review Act, 5 U.S.C. 801
EPA will treat a fuel or fuel additive for general use in light-duty vehicles manufactured after model year 1974 as substantially similar to any fuel or fuel additive utilized in the certification of any model year 1975, or subsequent model year vehicle or engine, under section 206 of the Act, i.e., “substantially similar,” if the following criteria are met.
(1) The fuel must contain carbon, hydrogen, and oxygen, nitrogen, and/or sulfur, exclusively,
(a) Hydrocarbons;
(b) Aliphatic ethers;
(c) Aliphatic alcohols other than methanol;
(d)(i) Up to 0.3 percent methanol by volume;
(ii) Up to 2.75 percent methanol by volume with an equal volume of butanol, or higher molecular weight alcohol;
(e) A fuel additive
(2) The fuel must contain no more than 2.0 percent oxygen by weight, except fuels containing aliphatic ethers and/or alcohols (excluding methanol) must contain no more than 2.7 percent oxygen by weight.
(3) The fuel must possess, at the time of manufacture, all of the physical and chemical characteristics of an unleaded gasoline as specified in ASTM Standard D 4814-88 for at least one of the Seasonal and Geographical Volatility Classes specified in the standard, with the exception of fuel introduced into commerce in the state of Alaska. For fuel introduced into commerce in the state of Alaska, all of the requirements of this section (3) apply, with the exception of the test temperature for a maximum Vapor/Liquid Ratio (V/L) of 20, which shall be a minimum of 35 °C (95 °F) for the period from September 16 through May 31.
(4) The fuel additive must contain only carbon, hydrogen, and any one or all of the following elements: Oxygen, nitrogen, and/or sulfur.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final Rule.
This rule finalizes the interim final rule with comment period that was published on July 27, 2007, regarding extended funding for seed and operational grants for State High Risk Pools under the Public Health Service Act.
Jessica Kahn, (410) 786-9361, or John Young, (410) 786-0505.
The Trade Adjustment Assistance Reform Act of 2002 (Pub. L. 107-210) added section 2745 of the Public Health Service Act (PHS Act) to provide for two types of grants to States for the promotion of “qualified high risk pools.” These pools provide health coverage to high-risk individuals who may find private health insurance unavailable or unaffordable. Under this provision, a pool could meet the definition of a “qualified” high risk pool for purposes of section 2745 only if it met the definition of a qualified high risk pool in section 2744(c)(2) of the PHS Act. Section 2744 deals with how States can satisfy the requirement of section 2741 of the PHS Act to guarantee access to health coverage for individuals who meet the definition of an “eligible individual” under section 2741, as added by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These individuals are commonly referred to as “HIPAA-eligible” individuals.
Under section 2744(c)(2) of the PHS Act, a qualified high risk pool must provide health coverage without a pre-existing condition exclusion to “all” HIPAA-eligible individuals. This meant that State high risk pools that did not allow all HIPAA-eligible individuals into the pool without a pre-existing condition exclusion could not meet the definition of a “qualified” risk pool.
The two types of grants authorized by the legislation were “seed grants” for States that had not yet created a high risk pool, and “operational” grants to offset losses incurred by States that operate a qualified high risk pool. Under the prior law, in order for a risk pool to qualify for an operational grant, it could not charge premiums that exceeded 150 percent of the premium for applicable standard risk rates. Moreover, the amount of the grants was limited to 50 percent of the losses incurred by a State.
Section 6202 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA) and the State High Risk Pool Extension Act of 2006 (Pub. L. 109-172) (Extension Act) extended funding for seed and operational grants for State High Risk Pools and amended section 2745 of the PHS Act. The Extension Act made the following changes:
1. Expanded the definition of a “qualified high risk pool.” As noted above, section 2745(d) of the PHS Act previously defined the term to have the same meaning as in section 2744(c)(2) of the PHS Act, which required that the risk pool provide coverage to “all” HIPAA-eligible individuals (as defined in § 148.103), without any pre-existing
2. Expanded the definition of “State.” Section 2745 of the PHS Act previously defined this term to include only the 50 States and the District of Columbia, but has now been amended to include U.S. Territories.
3. Increased the amount of premiums that a risk pool can charge and still qualify for an operational grant. Section 2745 of the PHS Act previously required that the premiums charged under the pool not exceed 150 percent of the premium for applicable standard risk rates. As amended, it permits grants to States with premiums of up to 200 percent of the standard risk rates, as long as States with premiums greater than 150 percent of the standard rate use at least half of the grant funds to reduce high risk pool premiums for enrollees.
4. Removed the limitation that a State's grant not exceed 50 percent of its operating losses.
5. Changed the funding allotment formula. Previously, the grant funds were to be allotted to States under a relatively simple formula based on the number of uninsured individuals in the State. Under the new legislation, the allotment formula is more complex. Of the total appropriation for a given year—if money is appropriated—two-thirds would be available for grants to cover operational losses. Of these funds, 40 percent is to be equally divided among any of the 50 States and the District of Columbia that apply. Another 30 percent of that amount is allotted among all States that apply for grants based on the ratio of uninsured individuals in the State to uninsured individuals in all States that apply. The final 30 percent is to be allotted based on the ratio of the number of individuals enrolled in a State's risk pool to the number enrolled through the risk pools of all the qualifying States that apply. (Territories are eligible for the proportional allotments, but only up to a total of $1 million for all Territories combined.)
6. Provided authority for “bonus grants” to States (not including Territories) that qualify for operational grants. One-third of a total yearly appropriation will be used to provide grants to enable States to provide specified supplemental consumer benefits to enrollees or potential enrollees of the qualified high risk pool. (A bonus grant is not to exceed 10 percent of the total for any one State.)
This final rule updates our regulations at 45 CFR Part 148, Subpart E, Grants to States for Operation of Qualified High Risk Pools, to implement the changes made by the Deficit Reduction Act of 2005 and the State High Risk Pool Extension Act of 2006. Specific instructions about the grant solicitation and award process will be addressed in official grant announcements or other appropriate documents.
On July 27, 2007, we published in the
We amended § 148.308 (Definitions) to
• Add a definition of “bonus grants.”
• Revise the definition of “qualified high risk pool;” and
• Revise the definition of “State.”
We added the following definition for Bonus Grants—Funds that the Secretary provides from the appropriated grant funds to be used to provide supplemental consumer benefits to enrollees or potential enrollees in qualified high risk pools.
We amended the definition at § 148.308 to reflect the exception added by the Extension Act in section 2745(g)(1)(A) of the PHS Act. Specifically, a State may elect to meet the definition of a qualified high risk pool under § 148.128(a)(2)(ii)(A) by providing for enrollment of eligible individuals through an acceptable alternative mechanism (as defined for purposes of section 2744 of the PHS) that includes a high risk pool as a component.
In accordance with the Extension Act, we amended the definition to include any of the 50 States and the District of Columbia, and the U.S. Territories of Puerto Rico, the Virgin Islands, Guam, American Samoa and the Northern Mariana Islands.
This section specifies the eligibility requirements for operational grants. A State must meet all of the following requirements to be eligible for a grant:
a.
b.
In the case of a qualified high risk pool of a State that charges premiums that exceed 150 percent of the premium for applicable standard risks, the State must use at least 50 percent of the amount of the grant provided to the State to reduce premiums for enrollees. The application should demonstrate/attest that the funds will be used this way.
Two-thirds of any amounts appropriated are made available for operational grants. An eligible State may receive a grant to fund up to 100 percent of the losses incurred in the operation of its qualified high risk pool during the fiscal year for which it is applying. The grant may be less than 100 percent after the allotment limits are applied, but in no case will it be more than 100 percent.
Funds will be allocated in accordance with § 148.312 to each State that meets the eligibility requirements of § 148.310 and files an application in accordance with § 148.316. Specifically:
• Forty percent of funds made available under that section will be equally divided among any of the 50 States and the District of Columbia that meet the eligibility criteria for an operational grant;
• Thirty percent of funds made available will be divided among States
• Thirty percent will be divided among States (including territories) based on the number of people in State high risk pools during the specified year as compared to all States that apply.
In accordance with the statute, in no case will the aggregate amount allotted and made available to the U.S. Territories for a fiscal year exceed $1 million.
We will calculate the number of uninsured individuals for each eligible State by taking a 3-year average of the number of uninsured individuals in that State in the Current Population Survey (CPS) of the Census Bureau. The 3-year average will be calculated using numbers available as of March 1 of each year for the preceding 3-year period.
One-third of the total appropriation will be available for the bonus grants. These grants will be available to any one of the 50 States and the District of Columbia that receives an operational grant under § 148.310. The grants must be used to provide one or more of the following benefits:
(1) Low income premium subsidies;
(2) Reduction in premium trends, actual premium or other cost-sharing requirements;
(3) An expansion or broadening of the pool of individuals eligible for coverage, such as through eliminating waiting lists, increasing enrollment caps, or providing flexibility in enrollment rules;
(4) Less stringent rules or additional waiver authority with respect to coverage of pre-existing conditions;
(5) Increased benefits; and
(6) The establishment of disease management programs. In no case will a State receive bonus grants that exceed 10 percent of the total funds allotted for bonus grants in that fiscal year.
Funds were appropriated for Federal FY 2006 and are authorized for FY 2008 through FY 2010. Funding for FY 2008, FY 2009, and FY 2010 under the Extension Act requires subsequent enactment of appropriations authority. States will be unable to apply for grants unless and until such funding becomes available. A State that meets the eligibility requirements in § 148.310 may apply for a grant to fund losses that were incurred during the State's or pool's fiscal year ending prior to or during any federal fiscal year, 2007 through 2010 for which authorized funds are appropriated, in connection with the operation of its qualified high risk pool. Grant funding is administered on a retrospective basis (for example, pools with losses incurred in 2005 may apply for Federal FY 2006 grant funds). If a State becomes eligible for a grant in the middle of its fiscal year, a State may apply for losses incurred in a partial fiscal year if a partial year audit is done. Only losses that are incurred after it is established that a pool is eligible (that is, that it is a qualified high risk pool as defined by § 148.128(a)(2)(ii)) will qualify for a grant. An eligible State must apply for a grant no later than June 30 following the end of the State fiscal year during which it incurred losses. Each State may only be awarded one grant per fiscal year. A grant for a partial fiscal year counts as a full grant.
States that meet all of the eligibility requirements in § 148.310 and submit timely requests in accordance with paragraph (c) of § 148.314 will receive distribution of grant funds using the following methodology:
• Grant applications for losses will be on a retrospective basis. For example, grant applications for 2006 funds are based on the State's FY 2005 incurred losses.
• Grant allocations for each fiscal year will be determined by taking all grant applications received by June 30 of the Federal fiscal year and allocating grant funds in accordance with § 148.312. In no case will a State receive funds greater than 100 percent of its losses.
If any excess funds remain after the initial calculation, these excess funds will be proportionately redistributed to the States whose allocations have not exceeded 100 percent of their losses. This process will occur at the time of the initial calculation and there will be one annual allocation and distribution by September 30 of each year.
We amended § 148.316 to reflect the addition of application requirements for bonus grants. We changed the heading of § 148.316(a), “Application package,” to “Application for operational losses.” We inserted a bonus grants section by redesignating § 148.316(a)(3) as § 148.316(a)(4) and adding new paragraph (a)(3), the bonus grants requirements. The individual State applying for a bonus grant must provide:
(i) A narrative description with detailed information about each one of the following supplemental consumer benefits to be provided to enrollees and/or potential enrollees in the high risk pool:
(A) Low income premium subsidies;
(B) Reduction in premium trends, actual premium or other cost-sharing requirements;
(C) An expansion or broadening of the pool of individuals eligible for coverage, such as through eliminating waiting lists, increasing enrollment caps, or providing flexibility in enrollment;
(D) Less stringent rules, or additional waiver authority with respect to coverage of pre-existing conditions;
(E) Increased benefits; and
(F) The establishment of disease management programs.
(ii) A description of the population or subset population that will be eligible for the supplemental consumer benefits.
(iii) A projected budget for the use of bonus grant funds using the SF 424 and SF 424 A.
We revised the “Standard forms application kit” in § 148.316(b). We eliminated the text “Additional Assurances” in “Standard forms application kit,” paragraph (b)(1)(i).
We also changed the Web site URL address for the “Standard forms kit” download at paragraph (b)(1)(ii) to
There are no other changes to the content of the “Standard forms application kit.”
In § 148.316(c), “Submission of application package,” we deleted paragraphs (c)(1) and (c)(2) and replaced with text that will read: All applications should be submitted electronically via
In § 148.316(d), “Application deadlines,” we changed the applications deadlines text to read: The deadline for States to submit an application for losses incurred in a State fiscal year is June 30 of the next Federal fiscal year that begins after the end of the State fiscal year.
In § 148.316(e), “Where to submit an application,” we changed the text to read: Applications must be submitted to
We amended § 148.318, dealing with continued funding of a risk pool. The State must outline funding sources, such as assessments and State general revenues, which can cover the projected costs and are reasonably designed to ensure continued funding of losses a State incurs in connection with the operation of the qualified high risk pool after the last fiscal year for which it is applying for grant funds.
We amended this section to specify that the grantee will be required to submit quarterly progress and financial reports under part 92 of this title and in accordance with section 2745(f) of the Public Health Service Act, requiring the Secretary to make an annual report to Congress that includes information on the use of these grant funds by the States.
We did not receive any public comments on the July 27, 2007 interim final rule with comment period. Therefore, this final rule implements the provisions of the interim final rule without change.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
Section 148.316(a) requires each State to compile an application package that documents that it has met the requirements for a grant. If a risk pool entity applies on behalf of a State, it must provide documentation that it has been delegated appropriate authority by the State.
The burden associated with this requirement is subject to the PRA; however, the structure of the application collection and grant monitoring reporting requirements of the grants has not been changed from the original grants program and is currently approved under OMB control number 0938-0887 “Matching Grants to States for the Operation of High Risk Pools and Supporting Regulations at 42 CFR 148.316, 148.318, and 148.320” with a current expiration date of 01/31/2010. We are, however, revising this package to include the additional request under 148.316(a)(3) for (1) Description of Type of Consumer Benefits; (2) Description of the Eligible Population for the consumer benefits; and, (3) Projected Budget for the use of Bonus Grants. We believe the burden associated with the additional information is already captured in the currently approved OMB package (#0938-0887).
Section 148.320(a)(2)(iii) states that a grantee is required to submit quarterly progress and financial reports under part 92 of this title and in accordance with section 2745(f) of the Public Health Service Act, requiring the Secretary to make an annual report to Congress that includes information on the use of these grant funds by States.
The burden associated with this requirement is the time it would take for a grantee to submit quarterly progress and financial reports. We estimate it will take one grantee 1 hour per quarter to comply with this requirement.
If you comment on these information collection and record keeping requirements, please mail copies directly to the following:
We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. We did not prepare an analysis for the RFA because we have determined that this rule will not have a significant economic impact on a substantial number of small entities.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This rule will have no consequential effect on State, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health care Health insurance, Penalties, Reporting and recordkeeping requirements.
Secs. 2741 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg-41 through 300gg-63, 300gg-91, and 300gg-92).
This subpart implements section 2745 of the Public Health Service Act (PHS Act). It extends grants to States that have qualified high risk pools that meet the specific requirements described in § 148.310. It also provides specific instructions on how to apply for the grants and outlines the grant review and grant award processes.
The revisions read as follows:
(1) Provides to all eligible individuals health insurance coverage (or comparable coverage) that does not impose any preexisting condition exclusion with respect to such coverage for all eligible individuals, except that it may provide for enrollment of eligible individuals through an acceptable alternative mechanism (as defined for purposes of section 2744 of the PHS Act) that includes a high risk pool as a component; and
(2) Provides for premium rates and covered benefits for such coverage consistent with standards included in the NAIC Model Health Plan for Uninsurable Individuals Act that was in effect at the time of the enactment of the Health Insurance Portability and Accountability Act of 1996 (August 21, 1996) but only if the model has been revised in State regulations to meet all of the requirements of this part and title 27 of the PHS Act.
The republication, revisions, and additions read as follows:
A State must meet all of the following requirements to be eligible for a grant:
(b) The pool restricts premiums charged under the pool to no more than 200 percent of the premium for applicable standard risk rates for the State.
(d) The pool has in effect a mechanism reasonably designed to ensure continued funding of losses incurred by the State after the end of each fiscal year for which the State applies for Federal Funding in fiscal year (FY) 2005 through FY 2010 in connection with the operation of the pool.
(f) In the case of a qualified high risk pool in a State that charges premiums that exceed 150 percent of the premium for applicable standard risks, the State will use at least 50 percent of the amount of the grant provided to the State to reduce premiums for enrollees.
(g) In no case will the aggregate amount allotted and made available to the U.S. Territories for a fiscal year exceed $1,000,000 in total.
(h) Bonus grant funding must be used for one or more of the following benefits:
(1) Low income premium subsidies;
(2) Reduction in premium trends, actual premium or other cost-sharing requirements;
(3) An expansion or broadening of the pool of individuals eligible for coverage, such as through eliminating waiting lists, increasing enrollment caps, or providing flexibility in enrollment rules;
(4) Less stringent rules or additional waiver authority with respect to coverage of pre-existing conditions;
(5) Increased benefits; and
(6) The establishment of disease management programs.
The revisions read as follows:
(a) An eligible State may receive a grant to fund up to 100 percent of the losses incurred in the operation of its qualified high risk pool during the period for which it is applying or a lesser amount based on the limits of the allotment under the formula.
(b) Funds will be allocated in accordance with this paragraph to each State that meets the eligibility requirements of § 148.310 and files an application in accordance with § 148.316. The amount will be divided among the States that apply and are awarded grants according to the allotment rules that generally provide that: 40 percent will be equally divided among those States; 30 percent will be divided among States and territories based on their number of uninsured residents in the State during the specified year as compared to all States that apply; and 30 percent will be divided among States and territories based on the number of people in State high risk pools during the specified year as compared to all States that apply.
For purposes of this paragraph:
(1) The number of uninsured individuals is calculated for each eligible State by taking a 3-year average of the number of uninsured individuals in that State in the Current Population Survey (CPS) of the Census Bureau during the period for which it is applying. The 3-year average will be calculated using numbers available as of March 1 of each year.
(2) The number of individuals enrolled in health care coverage through the qualified high risk pool of the State will be determined by attestation by the State in its grant application and verified for reasonability by the Secretary through acceptable industry data sources.
(d) One-third of the total appropriation will be available for the bonus grants. In no case will a State for a fiscal year receive bonus grants that exceed 10 percent of the total allotted funds for bonus grants.
(a)
(b)
(c)
(d)
(e)
(1) In no case will a State receive funds greater than 100 percent of their losses.
(2) If any excess funds remain after the initial calculation, these excess funds will be proportionately redistributed to the States whose allocations have not exceeded 100 percent of their losses.
The revisions read as follows:
Funding for FY 2008, FY 2009, and FY 2010 under the Extension Act requires the subsequent enactment of appropriations authority. Funding was appropriated for Federal FY 2006. States will be unable to apply for FY 2008 through FY 2010 grants unless and until such funding becomes available.
(a)
(3)
(i) A narrative description of one or more of the following of the supplemental consumer benefits to be provided to enrollees and/or potential enrollees in the high risk pool:
(A) Low income premium subsidies;
(B) Reduction in premium trends, actual premium or other cost-sharing requirements;
(C) An expansion or broadening of the pool of individuals eligible for coverage, such as through eliminating waiting lists, increasing enrollment caps, or providing flexibility in enrollment;
(D) Less stringent rules, or additional waiver authority with respect to coverage of pre-existing conditions;
(E) Increased benefits; and
(F) The establishment of disease management programs.
(ii) A description of the population or subset population that will be eligible for the supplemental consumer benefits.
(iii) A projected budget for the use of bonus grant funds using the SF 424 A.
(b) Standard form application kit—(1) Forms. (i) The following standard forms must be completed with an original signature and enclosed as part of the application package:
(ii) These forms can be accessed from the following Web site:
(2)
(c)
(d)
(2)
(3)
(4)
(5)
(6)
(e)
(d) * * *
(2)
(a) * * *
(2) * * *
(iii) The grantee will be required to submit quarterly progress and financial
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification.
NMFS announces the aboriginal subsistence whaling quota it has assigned to the Alaska Eskimo Whaling Commission (AEWC) for bowhead whales, and other limitations deriving from regulations adopted at the 59
Effective April 25, 2008.
Office of International Affairs, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910.
Cheri McCarty, (301) 713-9090.
Aboriginal subsistence whaling in the United States is governed by the Whaling Convention Act (16 U.S.C. 916
At the 59
This action by the IWC thus authorized aboriginal subsistence whaling by the AEWC for bowhead whales. This aboriginal subsistence harvest is conducted in accordance with a cooperative agreement between NOAA and the AEWC.
The IWC set a 5-year block quota of 280 bowhead whales landed. For each of the years 2008 through 2012, the number of bowhead whales struck may not exceed 67, except that any unused portion of a strike quota from any year, including 15 unused strikes from the 2003 through 2007 quota, may be carried forward. No more than 15 strikes may be added to the strike quota for any one year. At the end of the 2007 harvest, there were 15 unused strikes available for carry-forward, so the combined strike quota for 2008 is 82 (67 + 15).
This arrangement ensures that the total quota of bowhead whales landed and struck in 2008 will not exceed the quotas set by the IWC. Under an arrangement between the United States and the Russian Federation, the Russian natives may use no more than seven strikes, and the Alaska Eskimos may use no more than 75 strikes.
Through its cooperative agreement with the AEWC, NOAA has assigned 75 strikes to the Alaska Eskimos. The AEWC will allocate these strikes among the 11 villages whose cultural and subsistence needs have been documented in past requests for bowhead quotas from the IWC, and will ensure that its hunters use no more than 75 strikes.
The IWC regulations, as well as the NOAA regulation at 50 CFR 230.4(c), forbid the taking of calves or any whale accompanied by a calf.
NOAA regulations (at 50 CFR 230.4) contain a number of other prohibitions relating to aboriginal subsistence whaling, some of which are summarized here. Only licensed whaling captains or crew under the control of those captains may engage in whaling. They must follow the provisions of the relevant cooperative agreement between NOAA and a Native American whaling organization. The aboriginal hunters must have adequate crew, supplies, and equipment. They may not receive money for participating in the hunt. No person may sell or offer for sale whale products from whales taken in the hunt, except for authentic articles of Native handicrafts. Captains may not continue to whale after the relevant quota is taken, after the season has been closed, or if their licenses have been suspended. They may not engage in whaling in a wasteful manner.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; tilefish Part-time permit category closure.
NMFS announces that the percentage of the tilefish annual total allowable landings (TAL) available to the tilefish Part-time permit category for the 2008 fishing year has been harvested. Therefore, commercial vessels fishing under the Part-time tilefish category may not harvest tilefish from within the Golden Tilefish Management Unit for the remainder of the 2008 fishing year (through October 31, 2008) as of April 25, 2008. Regulations governing the tilefish fishery require publication of this notification to advise the public of this closure.
Effective 0001 hrs local time, April 25, 2008, through 2400 hrs local time, October 31, 2008.
Timothy A. Cardiasmenos, Fishery Policy Analyst, at (978) 281-9204.
Regulations governing the tilefish
The TAL for tilefish for the 2008 fishing year was set at 1.995 million lb (905,172 kg) and then adjusted downward by 5 percent to 1,895,250 lb (859,671 kg) to account for incidental catch. There was no research set-aside for the 2008 fishing year. Thus, the Part-time permit category quota for the 2008 fishing year, which is equal to 19 percent of the TAL, was specified at 360,098 lb (163,338 kg). Notification of the 2008 Part-time permit category quota for the 2008 fishing year was sent in a Permit Holder Letter to all tilefish limited access permit holders on October 18, 2007.
The Administrator, Northeast Region, NMFS (Regional Administrator) monitors the commercial tilefish quota for each fishing year using dealer reports, vessel catch reports, and other available information to determine when the quota for each limited access permit category is projected to have been harvested. NMFS is required to publish notification in the
The Regional Administrator has determined, based upon dealer reports and other available information, that the 2008 tilefish TAL for the Part-time category has been harvested. Therefore, effective 0001 hr local time, April 25, 2008, further landings of tilefish harvested from within the Golden Tilefish Management Unit by tilefish vessels holding Part-time category Federal fisheries permits are prohibited through October 31, 2008. The 2009 fishing year for commercial tilefish harvest will open on November 1, 2008. Federally permitted dealers are also advised that, effective April 25, 2008, they may not purchase tilefish from Part-time category federally permitted tilefish vessels who land tilefish harvested from within the Golden Tilefish Management Unit for the remainder of the 2008 fishing year (through October 31, 2008).
The Assistant Administrator for Fisheries, NOAA (AA), finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest. If implementation of this closure were delayed to solicit prior public comment, the quota for this category would be exceeded, given the rate of harvest of tilefish for vessels in this category. This would conflict with the agency's legal obligation under section 304(e) of the Magnuson-Stevens Act to prevent overfishing and to rebuild this fishery as soon as possible. Overage of the Part-time category quota that occurs in a given fishing year is subtracted from the quota for this category in the following fishing year. Thus, allowing an overage would have a negative economic impact on owners of vessels permitted in the Part-time category, who did not contribute to the overage this year, and who would fish during the next fishing year. The AA further finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reasons stated above.
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Credit Union Administration.
Proposed rule.
The NCUA Board is proposing changes to its Freedom of Information Act (FOIA) and the Privacy Act regulations. The changes to FOIA provisions largely relate to recent amendments to the Freedom of Information Act addressing several procedural issues concerning fee practices, time limits for complying with requests, and new reporting requirements. The changes to Privacy Act provisions reflect the agency's efforts to clarify the procedures whereby individuals may obtain notification of whether an NCUA system of records contains information about the individual and access or amend a record.
Comments must be received on or before June 24, 2008.
You may submit comments by any of the following methods (please send comments by one method only):
•
•
•
•
•
•
Linda K. Dent, Staff Attorney, Office of General Counsel, at the above address or telephone (703) 518-6540.
NCUA's policy is to review regulations periodically to “update, clarify and simplify existing regulations and eliminate redundant and unnecessary provisions.” Interpretive Ruling and Policy Statement (IRPS) 87-2, Developing and Reviewing Government Regulations. NCUA notifies the public about the review, which is conducted on a rolling basis so that a third of its regulations are reviewed each year. The changes in this proposed rule are the result of NCUA review under IRPS 87-2.
The Openness Promotes Effectiveness in our National Government Act of 2007, (OPEN Government Act) was signed into law by the President on December 31, 2007. The OPEN Government Act of 2007 consists of several amendments to the Freedom of Information Act (FOIA) affecting FOIA administration. While many of the provisions are not effective until December 31, 2008, NCUA is using the opportunity of its periodic regulatory review to update its FOIA regulations to comply with the requirements of the Act. NCUA's FOIA provisions address: Types of agency records; their availability or exemption from release; procedures for requesting access to records; processing times; fees; appeals; and handling of FOIA requests involving confidential commercial information. NCUA publishes its FOIA rules at part 792, subpart A of the agency's regulations.
The Privacy Act of 1974 places requirements on federal agencies regarding the collection, maintenance, distribution, and security of an individual's personal information that is contained in an agency's systems of records. Pursuant to the Privacy Act, NCUA publishes a Notice of Systems of Records that informs the public of each system of records the agency maintains, describes the nature and routine use of records in the system, identifies the system manager responsible for the system including contact information, and provides procedures whereby individuals may determine whether a system contains a record pertaining to them, gain access to records pertaining to them, or seek to amend or correct information in a record about them. The Notice of Systems of Records is published in the
The Privacy Act also requires each federal agency to publish rules describing its Privacy Act procedures and any system of records it exempts from provisions of the Act, including the reasons for the exemption. NCUA publishes its rules at part 792, subpart E; the rules provide individuals with detailed information regarding the exercise of their rights under the Privacy Act, identifies and describes the NCUA systems of records that are exempt from provisions of the Privacy Act, and provides standards for NCUA employees regarding collecting, using, maintaining, or disseminating records.
The Board proposes several housekeeping changes to correct address information, cross-references, grammar and punctuation. More substantively, the Board proposes several changes designed to facilitate submissions of proper FOIA requests including where requests may be sent, how requests must be addressed, and what information must be included in a request. The Board also proposes to clarify the conditions and time periods for processing requests and to describe the circumstances that may halt or extend processing times.
Under the FOIA, federal agencies have a prescribed period of time to process requests for information. The Open Government Act clarifies the processing period begins on the date the request is first received by the appropriate information center, but in any event, no later than ten days after first received by any agency designated FOIA information center. The Open Government Act also clarifies the circumstances for tolling the processing time versus extending the processing
In § 792.11, paragraph (a)(6), the Board proposes to clarify two circumstances where records, typically exempt from disclosure, may be released. Generally, an individual's records are exempt from disclosure to other persons if the release would constitute an invasion of personal privacy. However, where the requester provides the subject person's written consent to the release of his or her records or proof of the subject person's death, disclosure is permissible.
The Board proposes several housekeeping changes to the regulation to correct cross-references, grammar and punctuation. The Board also proposes a change in nomenclature and additional definitions to improve understanding of rights and requirements under the regulation. For example, the term “system manager” would replace “NCUA official” to more specifically identify the person responsible for a system of records and to use nomenclature consistent with that used in the Notice of Systems of Records published in the
The Board proposes to revise language in various sections of the regulation to clarify that requests must be submitted in writing to the appropriate system manager generally, or to other staff as specified, and identifying the nature of the request on both the envelope and letter. The Board proposes to remove language which permitted individuals to submit requests via telephone because of the difficulties telephone requests present in meeting the regulation's identification requirements. These changes are intended to facilitate recordkeeping and the timely processing of Privacy Act requests. Revisions are proposed also for sections concerning medical records and the basis for exemptions of certain of NCUA's systems of records from provisions of the Privacy Act.
The NCUA Board is interested in receiving comments on the proposed amendments to subparts A and E of part 792.
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3506; 5 CFR part 1320 Appendix A.1), the Board has reviewed the proposed rule and determined it does not contain a collection of information subject to the PRA.
The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact a proposed rule may have on a substantial number of small credit unions (those under $10 million in assets). This proposed rule does not impose any requirements on federally-insured credit unions. Therefore, it will not have a significant economic impact on a substantial number of small credit unions and a regulatory flexibility analysis is not required.
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. The proposed rule would not have substantial direct effects on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined that this proposed rule does not constitute a policy that has federalism implications for purposes of the executive order.
NCUA has determined that this proposed rule would not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).
Administrative practice and procedure, Credit unions, Freedom of Information, Information, Privacy, Records, System of records.
For the reasons stated in the preamble, the National Credit Union Administration proposes to amend 12 CFR part 792 as set forth below:
1. The authority citation for part 792 continues to read as follows:
5 U.S.C. 301, 552, 552a, 552b; 12 U.S.C. 1752a(d), 1766, 1789, 1795f; E.O. 12600, 52 FR 23781, 3 CFR, 1987 Comp., p.235; E.O. 12958, 60 FR 19825, 3 CFR, 1995 Comp., p.333.
2. In § 792.3, revise the fourth sentence of the introductory text and the last sentence of paragraph (c) to read as follows:
* * * You may obtain copies of indices by making a request to the NCUA, Office of General Counsel, 1775 Duke Street, Alexandria, VA 22314-2387, Attn: FOIA Officer or as indicated on the NCUA Web site at
(c) * * * The Popular FOIA Index is available on the NCUA web site.
3. In § 792.4, revise paragraph (a) to read as follows:
(a) You may obtain copies of the records referenced in § 792.2 by obtaining the index referred to in § 792.3 and following the ordering instructions it contains, or by making a written request to NCUA, Office of General Counsel, 1775 Duke Street, Alexandria, Virginia 22314-3428, Attn: FOIA Officer or as indicated on the NCUA Web site.
4. In § 792.7, revise the first sentence of paragraph (a) and paragraph (b) to read as follows:
(a) You must send your written request to one of NCUA's Information Centers. * * *
(b) If you are seeking any NCUA record, other than those maintained by the Office of Inspector General, you should send your request to NCUA, Office of the General Counsel, 1775 Duke Street, Alexandria, Virginia 22314-3428, Attn: FOIA Officer or as indicated on the NCUA Web site at
5. In § 792.8, revise the introductory text and revise paragraph (a) to read as follows:
Until an Information Center receives your FOIA request, it is not obligated to search for responsive records, meet time deadlines, or release any records. A request will not be considered received if it does not include all of the items in paragraphs (a) through (c) of this section.
(a) Your request must be in writing and include the words “FOIA REQUEST” on both the envelope and request letter. The request letter must also include your name, address and a telephone number where you can be reached during normal business hours. If you would like us to respond to your FOIA request by electronic mail (e-mail), you should include your e-mail address.
6. In § 792.10, revise the second sentence of paragraph (a), the last sentence of paragraph (b) and the second sentence of paragraph (e) to read as follows:
(a) * * * The date of receipt for any request, including one that is addressed incorrectly or is forwarded to NCUA by another agency, is the earlier of the date the appropriate Information Center actually receives the request or 10 working days after either of NCUA's Information Centers receives the request.
(b) * * * All other requests will be handled under normal processing procedures in the order they were received.
(e) * * * If we notify you of a denial of your request, we will include the reason for the denial.
7. In § 792.11, revise paragraph (a)(6) by removing the first sentence and adding three sentences in its place to read as follows:
(a) * * *
(6) Personnel, medical, and similar files (including financial files) pertaining to another person, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy without the subject person's written consent or proof of death. Written consent consists of a written statement by the subject person, authorizing the release of the information to you, and including either the subject person's notarized signature or a declaration made under penalty of perjury that the statement is true and correct. Proof of death consists of evidence that the subject of your request is deceased—such as a death certificate, a newspaper obituary, or some comparable proof of death. * * *
8. In § 792.15, revise paragraph (a) to read as follows:
(a)(1) Where the running of such time is suspended while:
(i) The Information Center awaits additional information from the requester. A suspension of time for this purpose may occur only once during the processing period; and
(ii) The Information Center clarifies with the requester issues regarding the payment of fees pursuant to § 792.26.
(2) The Information Center's receipt of the requester's response to the request for additional information or clarification ends the tolling period;
9. Revise § 792.17 to read as follows:
If NCUA does not comply with the time limits under § 792.15, or as extended under § 792.16, you do not have to pay search fees; requesters qualifying for free search fees will not have to pay duplication fees. You also can file suit against NCUA because you will be deemed to have exhausted your administrative remedies if NCUA fails to comply with the time limit provisions of this subpart. If NCUA can show that exceptional circumstances exist and that it is exercising due diligence in responding to your request, the court may retain jurisdiction and allow NCUA to complete its review of the records. In determining whether exceptional circumstances exist, the court may consider your refusal to modify the scope of your request or arrange an alternative time frame for processing after being given the opportunity to do so by NCUA, when it notifies you of the existence of unusual circumstances as set forth in § 792.16.
10. In § 792.18, revise the first sentence of paragraph (b) to read as follows:
(b) In response to a request for expedited processing, the Information Center will notify you of the determination within ten working days of receipt of the request. * * *
11. In § 792.19, revise paragraph (c)(1) to read as follows:
(c) * * *
(1) The per-page fee for paper copy reproduction of a document is $.10;
12. In § 792.27, revise paragraphs (a)(1) through (a)(4) to read as follows:
(a) * * *
(1) Whether the subject of the requested records concerns identifiable operations or activities of the government, with a connection that is direct and clear;
(2) Whether the disclosable portions of the requested records are meaningfully informative about government operations and activities in order to be likely to contribute to an understanding of government operations or activities. Information already in the public domain, either in a duplicate or substantially identical form where nothing new would be added to the public's understanding, would not be meaningfully informative;
(3) Whether disclosure of the requested information will contribute to public understanding, meaning a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public will be considered. Representatives of the news media are presumed to satisfy this consideration; and
(4) Whether the disclosure is likely to contribute significantly to public understanding of government operations or activities. The level of public understanding before disclosure must be
13. In § 792.28, revise the first and third sentences of paragraph (a), and paragraph (c), to read as follows:
(a) Make a determination with respect to any appeal within 20 working days after the receipt of such appeal. * * * Where you do not address your appeal to the General Counsel, the time limitations stated above will be computed from the date of receipt of the appeal by the General Counsel.
(c) Address your appeal to NCUA, Office of General Counsel—FOIA APPEAL, 1775 Duke Street, Alexandria, VA 22314-3428. The words “FOIA APPEAL” should appear on the envelope and in the letter. Failure to address an appeal properly may delay commencement of the time limitation stated in paragraph (a) of this section, to take account of the time reasonably required to forward the appeal to the Office of General Counsel.
14. Amend subpart E by removing the term “NCUA official” wherever it appears and adding in its place the term “system manager.”
15. In § 792.53, add new paragraphs (g), (h) and (i) to read as follows:
(g) “Notice of Systems of Records” means the annual notice published by NCUA in the
(i) “Working day” means Monday through Friday excluding legal public holidays.
16. Revise § 792.54 to read as follows:
(a) Individuals desiring to know if a system of records contains records pertaining to them, and individuals requesting access to records in a system of records pertaining to them should submit a written request to the appropriate system manager as identified in the Notice of Systems of Records. An individual who does not have access to the
17. In § 792.55, revise paragraphs (a)(1) through (a)(3) and (c) to read as follows:
(a) * * *
(1) Individuals appearing in person, if not personally known to the system manager responding to the request, must present a single document bearing a photograph (such as a passport or identification badge) or two items of identification which do not bear a photograph but do bear both a name and address (such as a driver's license or voter registration card);
(2) Individuals submitting requests by mail may establish identity by a signature, address, date of birth, employee identification number if any, and one other identifier such as a photocopy of driver's license or other document. If inadequate identifying information is provided, the system manager responding to the request may require further identifying information before any notification or responsive disclosure.
(3) Individuals appearing in person or submitting requests by mail, who cannot provide the required documentation or identification, may provide an unsworn declaration subscribed to as true under penalty of perjury.
(c) A record may be disclosed to a representative of an individual to whom the record pertains provided the system manager receives written authorization from the individual who is the subject of the record.
18. In § 792.57, revise paragraph (b) to read as follows:
(b) Medical records may be disclosed on request to the individuals to whom they pertain unless disclosing the medical information directly to the requesting individual could have an adverse effect on the individual. Where medical information is potentially adverse to the requesting individual, the system manager responsible may advise the requesting individual that the medical records will be transmitted only to a physician designated in writing by the individual.
19. In § 792.58, revise paragraph (a) and the second sentence of paragraph (b) to read as follows:
(a) An individual may request amendment of a record concerning that individual by submitting a written request, either in person or by mail, to the system manager identified in the Notice of Systems of Records. The words “PRIVACY ACT—REQUEST TO AMEND RECORD” should be written on the letter and the envelope. The request must describe the system of records containing the record sought to be amended, indicate the particular record involved, the nature of the correction sought, and the justification for the correction or amendment. An individual who does not have access to NCUA's Notice of Systems of Records, and to whom the appropriate address is otherwise unavailable, may submit a request to the Privacy Act Officer, Office of General Counsel, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia, 22314-3428, in which case the request will then be referred to the appropriate system manager. The date of receipt of the request will be determined as of the date of receipt by the system manager.
(b) * * * The appropriate system manager will promptly (under normal circumstances, not later than 30 working days after receipt of the request) advise the individual that the record will be amended or corrected, or inform the individual of rejection of the request to amend the record, the reason for the rejection, and the procedures established by § 792.59 for the
20. In § 792.59, revise the second sentence of paragraph (a) and the first two sentences of paragraph (c) to read as follows:
(a) * * * Appeals must be addressed to the Office of General Counsel, National Credit Union Administration, 1775 Duke Street, Alexandria, VA 22314-3428 with the words “PRIVACY ACT—APPEAL” written on the letter and the envelope.* * *
(c) If an appeal under this section is denied in whole or in part, an individual may file a statement of disagreement concisely stating the reason(s) for disagreeing with the denial for amendment or correction, and clearly identifying each part of any record that is disputed. The statement must be sent within 30 working days of the date of receipt of the notice of General Counsel's refusal to authorize amendment or correction, to the General Counsel, National Credit Union Administration, 1775 Duke Street, Alexandria, VA 22314-3428.* * *
21. In § 792.60, revise paragraph (j) read as follows:
(j) To the Comptroller General, or any of his authorized representatives, in the course of the performance of the duties of the General Accountability Office;
22. In § 792.61, revise the first sentence of paragraph (a) to read as follows:
(a) Each system manager identified in the ”Notice of Systems of Records' must establish a system of accounting for all disclosures of information or records under the Privacy Act made outside NCUA.* * *
23. In § 792.63, revise paragraphs (a), (b)(1), and (b)(4), to read as follows:
(a) The system manager for each system of records is responsible for reviewing all forms developed and used to collect information from or about individuals for incorporation into the system of records.
(b) * * *
(1) To ensure that no information concerning religion, political beliefs or activities, association memberships (other than those required for a professional license), or the exercise of other First Amendment rights is required to be disclosed unless such requirement of disclosure is expressly authorized by statute or by the individual about whom the record is maintained, or unless pertinent to and within the scope of any authorized law enforcement activity;
(4) To ensure that the form or accompanying statement clearly indicates to the individual the effects on him or her, if any, of refusing to provide some or all of the requested information; and
24. In § 792.66, revise paragraphs (a) and (b)(2), add four new sentences to the end of paragraph (b)(3), and add four new sentences to the end of paragraph (b)(4) to read as follows:
(a) NCUA maintains several systems of records that are exempted from some provisions of the Privacy Act. The system number and name, description of records contained in the system, exempted provisions and reasons for exemption are as follows:
(b) * * *
(2) System NCUA-8, entitled, “Investigative Reports Involving Any Crime or Suspicious Activity Against a Credit Union, NCUA,” consists of investigatory or enforcement records about individuals suspected of involvement in violations of laws or regulations, whether criminal or administrative. These records are maintained in an overall context of general investigative information concerning crimes against credit unions. To the extent that individually identifiable information is maintained for purposes of protecting the security of any investigations by appropriate law enforcement authorities and promoting the successful prosecution of all actual criminal activity, the records in this system are exempted, pursuant to section k(2) of the Privacy Act (5 U.S.C. 552a(k)(2)), from sections (c)(3), (d), (e)(1), (e)(2), (e)(4)(G), (e)(4)(H), (f), and (g). The records in this system are also exempted pursuant to section (j)(2) of the Privacy Act, 5 U.S.C. 552a(j)(2), from sections (c)(3), (d), (e)(1), (e)(2), (e)(4)(G), (e)(4)(H), (f), and (g). Where possible, information that would identify a confidential source will be extracted or summarized in a manner that protects the source and the summary or extract will be provided to the requesting individual.
(3) * * * NCUA need not make an accounting of previous disclosures of a record in this system of records available to its subject, and NCUA need not grant access to any records in this system of records by their subject. Further, whenever individuals request records about themselves and maintained in this system of records, the NCUA will advise the individuals only that no records available to them pursuant to the Privacy Act of 1974 have been identified. However, if review of the record reveals that the information contained therein has been used or is being used to deny the individuals any right, privilege or benefit for which they are eligible or to which they would otherwise be entitled under federal law, the individuals will be advised of the existence of the information and will be provided the information, except to the extent disclosure would identify a confidential source. Where possible, information which would identify a confidential source will be extracted or summarized in a manner which protects the source and the summary or extract will be provided to the requesting individual.
(4) * * * NCUA need not make an accounting of previous disclosures of a record in this system of records available to its subject, and NCUA need not grant access to any records in this system of records by their subject. Further, whenever individuals request records about themselves and maintained in this system of records, the NCUA will advise the individuals only that no records available to them pursuant to the Privacy Act of 1974 have been identified. However, if review of the record reveals that the information contained therein has been used or is being used to deny the individuals any right, privilege or benefit for which they are eligible or to which they would otherwise be entitled under federal law, the individuals will be advised of the existence of the information and will be provided the information, except to the extent disclosure would identify a confidential source. Where possible, information that would identify a confidential source will be extracted or summarized in a manner which protects the source and the summary or extract will be provided to the requesting individual.
25. In § 792.69, revise paragraph (a) to read as follows:
(a) The Director of the Office of Human Resources, with advice from the Senior Privacy Act Officer, is
Drug Enforcement Administration (DEA), Department of Justice.
Notice of proposed rulemaking.
This Notice of Proposed Rulemaking (NPRM) proposes to classify the following three steroids as “anabolic steroids” under the Controlled Substances Act (CSA): boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione. The Drug Enforcement Administration (DEA) believes that this action is necessary in order to prevent the abuse and trafficking of these steroids. If the regulations are amended, these steroids will be listed as schedule III controlled substances subject to the regulatory control provisions of the CSA.
Written comments must be postmarked, and electronic comments must be sent on or before June 24, 2008.
To ensure proper handling of comments, please reference “Docket No. DEA-285” on all written and electronic correspondence. Written comments via regular mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be sent directly to DEA electronically by sending an electronic message to
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.
Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person, by appointment, please see the
Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 at (202) 307-7183.
On November 29, 1990, the President signed into law the Anabolic Steroids Control Act of 1990 (Title XIX of Pub. L. 101-647), which became effective February 27, 1991. This law established and regulated anabolic steroids as a class of drugs under schedule III of the Controlled Substances Act (CSA). As a result, a new anabolic steroid is not scheduled according to the procedures set out in 21 U.S.C. 811, but can be administratively classified as an anabolic steroid through the rulemaking process by adding the steroid to the regulatory definition of an anabolic steroid in 21 CFR 1300.01(b)(4).
On October 22, 2004, the President signed into law the Anabolic Steroid Control Act of 2004 (Pub. L. 108-358), which became effective on January 20, 2005. Section 2(a) of the Anabolic Steroid Control Act of 2004 amended 21 U.S.C. 802(41)(A) by replacing the existing definition of “anabolic steroid.” The Anabolic Steroid Control Act of 2004 classifies a drug or hormonal substance as an anabolic steroid if the following four criteria are met: (A) The substance is chemically related to testosterone; (B) the substance is pharmacologically related to testosterone; (C) the substance is not an estrogen, progestin, or a corticosteroid; and (D) the substance is not dehydroepiandrosterone (DHEA). Any substance that meets the criteria is considered an anabolic steroid and must be listed as a schedule III controlled substance. DEA believes that boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione meet this definition of anabolic steroid and is proposing that they be added to the list of anabolic steroids in 21 CFR 1300.01(b)(4).
Anabolic steroids are a class of drugs with a basic steroid ring structure that produces anabolic and androgenic effects. The prototypical anabolic steroid is testosterone. Anabolic effects include promoting the growth of muscle. The androgenic effects consist of promoting the development of male secondary sexual characteristics such as facial hair, deepening of the voice, and thickening of the skin.
In the United States, only a small number of anabolic steroids are approved for either human or veterinary use. Approved medical uses for anabolic steroids include treatment of androgen deficiency in hypogonadal males, adjunctive therapy to offset protein catabolism associated with prolonged administration of corticosteroids, treatment of delayed puberty in boys, treatment of metastatic breast cancer in
Adverse effects are associated with the use or abuse of anabolic steroids. These effects depend on several factors (
DEA is proposing by this NPRM to classify boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione as anabolic steroids under the definition set forth under 21 U.S.C. 802(41)(A). As noted previously, a drug or hormonal substance is classified as an anabolic steroid by meeting the following four definitional requirements: (A) The substance is chemically related to testosterone; (B) the substance is pharmacologically related to testosterone; (C) the substance is not an estrogen, progestin, or a corticosteroid; and (D) the substance is not DHEA.
To classify a substance as an anabolic steroid, a substance must be chemically related to testosterone. A Structure Activity Relationship (SAR) evaluation for each of the substances compared the chemical structure of the steroid to that of testosterone, as substances with a structure similar to that of testosterone are predicted to possess comparable pharmacological and biological activity.
Boldione is also known by the following chemical name: androsta-1,4-diene-3,17-dione. DEA has determined that the chemical structure of boldione is chemically related to that of testosterone. The chemical structure of boldione differs from testosterone by only the following two chemical groups: A ketone group at carbon 17 and a double bond between the first and second carbon. The human body would be expected to metabolize the ketone group at carbon 17 into a hydroxyl group that is present on testosterone. Furthermore, the scientific literature reports that the additional double bond at carbon 1 in boldione does not significantly decrease the anabolic activity of the substance (Vida, 1969). Boldione is an anabolic steroid precursor, being metabolized by the body into boldenone (Galletti and Gardi, 1971), which is a schedule III anabolic steroid (21 U.S.C. 801(41)(A)(vi)).
Desoxymethyltestosterone (DMT) is also known by the following names: 17α-methyl-5a-androst-2-en-17β-ol; and madol. DEA has determined that the chemical structure of desoxymethyltestosterone is chemically related to testosterone. The chemical structure of desoxymethyltestosterone differs from testosterone by the following four chemical features: The lack of a ketone group at the third carbon, a double bond between the second and third carbon, the lack of a double bond between the fourth and fifth carbon, and a methyl group at carbon 17. Each of these four chemical features is known through the scientific literature not to eliminate the anabolic and androgenic activity of the substance (Brueggemeir
19-Nor-4,9(10)-androstadienedione is also known by the following chemical names: 19-norandrosta 4,9(10)-diene-3,17-dione; and estra-4,9(10)-diene-3,17-dione. DEA has determined that the chemical structure of 19-nor-4,9(10)-androstadienedione is chemically related to testosterone. The chemical structure of 19-nor-4,9(10)-androstadienedione differs from testosterone by the following three chemical groups: A ketone group at carbon 17, the absence of a methyl group at carbon 19, and a double-bond between the ninth and tenth carbon. The human body metabolizes the ketone group at carbon 17 into a hydroxyl group that is present on testosterone. Furthermore, the scientific literature reports that both the absence of the methyl group at carbon 19 and the additional double bond in 19-nor-4,9(10)-androstadienedione increase the anabolic activity of the substance (Vida, 1969).
A substance must also be pharmacologically related to testosterone (
There are several different types of assays used to establish androgen receptor binding and efficacy. In one assay, C3H10T1/2 stem cells express androgen receptors and are used to assess steroids for their ability to bind and activate the androgen receptor (Jasuja
In January 2006, DEA reviewed the published scientific literature for pharmacological data on the anabolic and androgenic activity of boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione using the assays described above. As discussed further below, there was sufficient information on the pharmacology of desoxymethyltestosterone in the reviewed scientific literature to determine that desoxymethyltestosterone is pharmacologically related to testosterone (
Androgenic and anabolic activity assay results indicate that boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione have similar pharmacological activity as testosterone.
DEA sponsored a study
Desoxymethyltestosterone was administered subcutaneously, orally, or intramuscularly to castrated rats (Dorfman and Kincl, 1963; Kincl and Dorfman, 1964; Nutting
DEA sponsored a study
DEA has determined that boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione are unrelated to estrogens, progestins, and corticosteroids. DEA evaluated the SAR for each of the substances. The chemical structure of each substance was compared to that of estrogens, progestins, and corticosteroids because the chemical structure can be related to its pharmacological and biological activity. DEA found that the three substances lacked the necessary chemical structures to impart significant estrogenic activity (
Dehydroepiandrosterone, also known as DHEA, is exempt from control as an anabolic steroid by definition (21 U.S.C. 802(41)(A)). Boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione are not dehydroepiandrosterone and are therefore not exempted from control on this basis.
Therefore, based on the above, DEA concludes that boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione meet the CSA definition of “anabolic steroid” because each substance is: (A) Chemically related to testosterone; (B) pharmacologically related to testosterone; (C) not an estrogen, progestin, or a corticosteroid; and (D) not DHEA (21 U.S.C. 802(41)). All anabolic steroids are classified as schedule III controlled substances (21 U.S.C. 812). Once a substance is determined to be an anabolic steroid, DEA has no discretion regarding the scheduling of these substances. As discussed further below, all requirements pertaining to controlled substances in schedule III would pertain to these three substances.
If this rulemaking is finalized as proposed, DEA will classify boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione as schedule III anabolic steroids. If classified as schedule III anabolic steroids, any person who manufactures, distributes, dispenses, imports, or exports boldione, desoxymethyltestosterone, or 19-nor-4,9(10)-androstadienedione, or who engages in research or conducts instructional activities with respect to these three substances would be required to obtain a schedule III registration in accordance with the CSA and its implementing regulations. Manufacturers and importers of these three substances would be required to register with DEA and would be permitted to distribute these substances only to other DEA registrants. Only persons registered as dispensers would be allowed to dispense these three substances to end users. The CSA defines a practitioner as “a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research” (21 U.S.C. 802(21)). At present, there are no approved medical uses for these three substances. Until a manufacturer applies to the Food and Drug Administration and gains approval for products containing these substances, no person may dispense them in response to a prescription.
Manufacture, import, export, distribution, or sale of boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione, except by DEA registrants, would become a violation of the CSA that may result in imprisonment and fines (21 U.S.C. 841 and 960). Possession of these three steroids, unless legally obtained, would also become subject to criminal penalties (21 U.S.C. 844).
In addition, under the CSA, these three substances could be imported only for medical, scientific, or other legitimate uses (21 U.S.C. 952(b)) under an import declaration filed with DEA (21 CFR 1312.18). Importation of these substances would be illegal unless the person importing these substances is registered with DEA as an importer or researcher and files the required declaration for each shipment. An individual who purchases any of these substances directly from foreign companies and has them shipped to the U.S. will be considered to be importing even if the steroids are intended for personal use. Illegal importation of these substances would be a violation of the CSA that may result in imprisonment and fines (21 U.S.C. 960).
Upon consideration of public comments from this NPRM, DEA may issue a final rule classifying boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione as anabolic steroids. If classified as anabolic steroids, boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione would become subject to CSA regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importation, and exportation of a schedule III controlled substance, including the following:
If this regulation is finalized as proposed, persons who possess substances that become classified as anabolic steroids and who wish to dispose of them rather than becoming registered to handle them should contact their local DEA Diversion field office for assistance in disposing of these substances legally. DEA Diversion field office will provide the person with instructions regarding the disposal. A list of local DEA Diversion field offices may be found at
The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612). DEA is not able to determine whether this regulation will, if promulgated as a Final Rule, not have a significant economic impact on a substantial number of small entities. As of August 2007, DEA identified 22 dietary supplements promoted for building muscle and increasing strength that are purported to contain boldione, desoxymethyltestosterone, or 19-nor-4,9(10)-androstadienedione. Four dietary supplements purport to contain boldione; nine dietary supplements purport to contain desoxymethyltestosterone; and nine dietary supplements purport to contain 19-nor-4,9(10)-androstadienedione. All 22 dietary supplements are marketed and sold on the Internet.
The manufacturers and distributors of the 22 identified dietary supplements purported to contain boldione, desoxymethyltestosterone, or 19-nor-4,9(10)-androstadienedione also sell a variety of other dietary supplements. DEA has identified a substantial number of Internet distributors that sell these dietary supplements. However, these distributors also sell a variety of other nutritional products. Without information on the percentage of revenues derived from these dietary supplements, however, DEA is not able to determine the economic impact of the removal of these dietary supplements alone on the business of the firms. DEA has not been able to identify any chemical manufacturers that are currently using these substances as intermediates in their manufacturing process(es). DEA seeks comment on whether this regulation, if promulgated as a Final Rule, will have a significant economic impact on a substantial number of small entities.
As of August 2007, DEA identified 20 chemical manufacturers and distributors that sell at least one of the three substances addressed in this NPRM. Most of the companies are located in China and sell a variety of steroids. DEA notes that, as the vast majority of entities handling these substances are Internet based, it is virtually impossible to accurately quantify the number of persons handling these substances at any given time. Further, DEA has no information regarding the percentage of revenue these substances constitute for each handler.
DEA has identified one company based in the U.S. that is a DEA registrant that manufactures and distributes at least one of these substances as reference products for testing laboratories. DEA notes, upon placement into schedule III, these substances may be used for analytical purposes. This company is registered with DEA and is already in compliance with the CSA and DEA implementing regulations regarding the handling of schedule III substances.
The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with Executive Order 12866 section 1(b). It has been determined that this rule is a significant regulatory action. Therefore, this action has been reviewed by the Office of Management and Budget.
As discussed above, the effect of this rule would be to remove products containing these substances from the over-the-counter marketplace. DEA has no basis for estimating the size of the market for these products. DEA notes, however, that virtually all of the substances are imported. According to U.S. International Trade Commission data, the import value of all anabolic steroids in 2006 was $6 million. These three substances would be a subset of those imports. The value of anabolic steroid imports for the first six months of 2007 declined by 35 percent although the quantity imported increased. The total market for these products containing these substances, therefore, is probably quite small. Moreover, DEA believes that the importation of these three substances is for illegitimate purposes.
The benefit of controlling these substances is to remove from the marketplace substances that have dangerous side effects and no legitimate medical use in treatment in the United States. As discussed in detail above, these substances can produce serious health effects in adolescents and adults. If medical uses for these substances are developed and approved, the drugs would be available as schedule III controlled substances in response to a prescription issued by a medical professional for a legitimate medical purpose. Until that time, however, this action would bar the importation, exportation, and sale of these three substances except for legitimate research or industrial uses.
This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.
This rule proposes to regulate three anabolic steroids, which are neither approved for medical use in humans nor approved for administration to cattle or other non-humans. Under this proposal, only chemical manufacturers who may use these substances as chemical intermediates for the synthesis of other steroids would be required to register
This rule will not result in the expenditure by state, local, and tribal governments, in the aggregate or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Chemicals, Drug traffic control.
For the reasons set out above, 21 CFR part 1300 is proposed to be amended as follows:
1. The authority citation for part 1300 continues to read as follows:
21 U.S.C. 802, 871(b), 951, 958(f).
2. Section 1300.01 is amended in paragraph (b)(4) by:
A. Redesignating paragraphs (b)(4)(xiii) through (b)(4)(lx) as (b)(4)(xiv) through (b)(4)(lxi),
B. Adding a new paragraph (b)(4)(xiii),
C. Redesignating new paragraphs (b)(4)(xvii) through (b)(4)(lxi) as (b)(4)(xviii) through (b)(4)(lxii),
D. Adding new paragraph (b)(4)(xvii),
E. Redesignating new paragraphs (b)(4)(xlvii) through (b)(4)(lxii) as (b)(4)(xlviii) through (b)(4)(lxiii), and
F. Adding new paragraph (b)(4)(xlvii) to read as follows:
(b) * * *
(4) * * *
Internal Revenue Service (IRS), Treasury.
Correction to notice of proposed rulemaking.
This document contains corrections to a notice of proposed rulemaking (REG-104946-07) that was published in the
Lauson C. Green or Linda S. F. Marshall at (202) 622-6090 (not a toll-free number).
The correction notice that is the subject of this document is under section 411 of the Internal Revenue Code.
As published, the notice of proposed rulemaking (REG-104946-07) contains errors that may prove to be misleading and are in need of clarification.
Accordingly, the publication of the notice of proposed rulemaking (REG-104946-07), which was the subject of FR Doc. E7-25025, is corrected as follows:
1. On page 73683, column 3, in the preamble, first paragraph of the column, line 15, the language “reasonably expected to result in a larger” is corrected to read “reasonably expected to result in a smaller”.
2. On page 73685, column 1, third paragraph of the column, line 8, the language “ `capital' rule of section 411(b)(5)(b)(i)(II)” is corrected to read “ `capital' rule of section 411(b)(5)(B)(i)(II)”.
3. On page 73689, column 2, line 3 from the bottom of the fifth paragraph of the column, the language “section 411(d)(6) is available for the” is corrected to read “section 411(d)(6) relief is available for the”.
4. On page 73691, column 1, § 1.411(a)(13)-1(d)(3)(ii), line 18, the language “larger annual benefit at normal” is corrected to read “smaller annual benefit at normal”.
5. On page 73691, column 2, § 1.411(a)(13)-1(d)(3)(iii)(B), line 9, the language “reasonably expected to result in a larger” is corrected to read “reasonably expected to result in a smaller”.
6. On page 73693, column 3, § 1.411(b)(5)-1(c)(3)(ii)(A), line 17, the language “participant under the lump sum-based” is corrected to read “participant under the lump sum-based benefit”.
7. On page 73695, column 1, § 1.411(b)(5)-1(c)(5)
8. On page 73695, column 2, § 1.411(b)(5)-1(c)(5)
9. On page 73695, column 3, § 1.411(b)(5)-1(c)(5)
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations that provide guidance relating to the availability of the election to use the alternate valuation method under section 2032 of
Written or electronic comments and requests for a public hearing must be received by July 24, 2008.
Send submissions to: CC:PA:LPD:PR (REG-112196-07), Internal Revenue Service, Room 5203, PO Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-112196-07), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC 20224; or sent electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, Theresa M. Melchiorre, at (202) 622-3090; concerning submissions of comments or to request a hearing, Kelly Banks, at (202) 622-7180 (not toll-free numbers).
This document contains proposed amendments to the Estate Tax Regulations (26 CFR part 20) under section 2032 of the Code. Section 2001 imposes a tax on the transfer of the taxable estate of every decedent who is a citizen or resident of the United States. Section 2031(a) provides that the value of the decedent's gross estate includes the value at the time of decedent's death of all property, real or personal, tangible or intangible, wherever situated. Section 2032(a) provides that the value of the gross estate instead may be determined, if the executor so elects, by valuing all the property included in the gross estate as follows. Property distributed, sold, exchanged, or otherwise disposed of within 6 months after the decedent's death must be valued as of the date of distribution, sale, exchange, or other disposition. I.R.C. section 2032(a)(1). Property not distributed, sold, exchanged, or otherwise disposed of within 6 months after the decedent's death must be valued as of the date that is 6 months after the decedent's death. I.R.C. section 2032(a)(2). Any interest or estate which is affected by the mere lapse of time is included at its value as of the time of death (instead of the later date), with adjustment for any difference in its value as of the later date that is not due to the mere lapse of time. I.R.C. section 2032(a)(3).
The predecessor to section 2032 is section 302(j) of the Revenue Act of 1926, as added by section 202(a) of the Revenue Act of 1935. Revenue Act of 1935, 74 Public Law 407, 49 Stat. 1014 (1935). Section 302(j) allowed executors to elect to use a date that was one year after the date of decedent's death to value estate property. Section 302(j) contained provisions for valuing the property on the date of its sale or disposition during the alternate valuation period and for not taking into account changes in value due to a mere lapse of time. Congress enacted section 302(j) in response to “the hardships which were experienced after 1929 when market values decreased very materially between the period from the date of death and the date of distribution to the beneficiaries.” 79 Cong. Rec. 14632 (1935) (statement of Mr. Samuel B. Hill). See, also, H.R. Rep. No. 74-1681, at 9 (1935); S. Rep. No. 74-1240, part 1, at 9-10 (1935); and S. Rep. No. 74-1240, part 2, at 8-9 (1935). Section 302(j) was codified as section 811(j) in the Internal Revenue Code of 1939.
In 1941, the U.S. Supreme Court addressed whether rents, dividends, and interest received and accrued during the alternate valuation period are includible in the decedent's gross estate under section 811(j).
In 1954, section 811(j) was recodified as section 2032. Congress considered proposals to amend section 811(j) and, again, Congress stated that, “The option to value property [on the alternate valuation date] initially was provided during the Depression of the early 1930s because by the time estate taxes were paid, property values had dropped substantially, sometimes to such an extent that the proceeds of the sale would not pay the estate tax due.” H. Rep. No. 83-1337 at 90 (1954). See, also, S. Rep. No. 83-1622, at 122-123 (1954).
In 1958, § 20.2032-1 of the Estate Tax Regulations was published. This regulation restates the rule in section 2032(a)(3) and provides an example that illustrates the rule that only changes in the value of the decedent's gross estate due to market conditions, and not changes to the value due to a mere lapse of time, are to be considered in valuing the decedent's gross estate under the alternate valuation method. See example in § 20.2032-1(f)(1).
Two judicial decisions have interpreted the language of section 2032 and its legislative history differently in determining whether post-death events other than market conditions may be taken into account under the alternate valuation method. In
The district court stated that, “It seems clear that Congress intended that the character of the property be established for valuation purposes at the date of death. The option to select the alternate valuation date is merely to allow an estate to pay a lesser tax if unfavorable market conditions (as distinguished from voluntary acts changing the character of the property) result in a lessening of its fair market value.” Id. at 98.
In
The proposed regulations will amend § 20.2032-1 by restructuring paragraph (f) of this section to clarify that the election to use the alternate valuation method under section 2032 is available to estates that experience a reduction in the value of the gross estate following the date of the decedent's death due to market conditions, but not due to other post-death events. The term
The fourth sentence of § 20.2032-1(f)(2)(i) is applicable to decedents dying after May 1, 1999, subject to transition rules for certain incapacitated individuals. The fifth sentence of § 20.2032-1(f)(2)(i) is applicable to decedents dying after November 30, 1983, subject to transition rules for certain incapacitated individuals. The first, second, and third sentences of § 20.2032-1(f)(2)(i), § 20.2032-1(f)(2)(ii), and all but the last sentence in § 20.2032-1(f)(2) are applicable to decedent's dying after August 16, 1954. When adopted as final regulations, the rules contained in § 20.2032-1(f)(1), § 20.2032-1(f)(3), and the last sentence of § 20.2032-1(f)(2), will be made applicable to estates of decedents dying on or after April 25, 2008.
It has been determined that this proposed regulation is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations and, because these regulations do not impose on small entities a collection of information requirement, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Therefore, a Regulatory Flexibility Analysis is not required. Pursuant to section 7805(f) of the Internal Revenue Code, this regulation has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. The IRS and the Treasury Department also request comments on the clarity of the proposed regulations and how they may be made easier to understand. All comments will be available for public inspection and copying. A public hearing may be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the hearing will be published in the
The principal author of these proposed regulations is Theresa M. Melchiorre, Office of Associate Chief Counsel (Passthroughs and Special Industries).
Estate taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 20 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
1. Paragraph (f)(1) is redesignated as paragraph (f)(2)(i).
2. Paragraph (f)(2) is redesignated as paragraph (f)(2)(ii).
3. Paragraph (f) introductory text is redesignated as paragraph (f)(2) introductory text and the last sentence is revised.
4. New paragraphs (f)(1) and (f)(3) are added.
5. The heading for paragraph (h) is revised and four sentences are added at the end of the paragraph.
The additions and revisions read as follows.
(f)
(2)
(3)
(ii)
At D's death, D owned common stock in Corporation, a closely-held subchapter C corporation. At that time, the common stock was not subject to transfer restrictions. D's stock was valued at $50X at the date of death. Two months after D's death, D's estate participated in a tax-free
The facts are the same as in
At D's death, D owned property valued at $100X. Two months after D's death, the executor of D's estate and other family members formed four limited partnerships. The estate contributed the estate's property to the partnerships in exchange for a 25% interest in each partnership. Discounts for lack of marketability and lack of control (totaling $25X) were applied in determining the value of the estate's partnership interests, and the estate reported $75X as the total value of the estate's partnership interests on the AVD. Because the reduction in value is not attributable to market conditions, the discounts for lack of marketability and control may not be taken into account in determining the value of the partnership interests on the AVD. The result would be the same if the limited partnerships were formed prior to D's death, and the estate transferred property into the partnerships after D's death but prior to the AVD.
At D's death, D owned 100% of the units of a limited liability company (LLC). The executor elected the alternative valuation method. During the 6 months following D's death and in accordance with D's will, the executor made 6 distributions, each to a different residuary legatee on a different date and each of a 10% interest in the LLC. Pursuant to section 2032(a)(1), each distribution is valued on the distribution date. On the AVD, the estate held 40% of the units in the LLC. Pursuant to section 2032(a)(2), the 40% is valued on the AVD. In valuing the 10% interests distributed and the 40% interest held on the AVD, discounts for lack of control and lack of marketability were applied. The reduction in value of the units is not attributable to market conditions. Accordingly, the discounts for lack of marketability and control may not be taken into account in determining the value of the units distributed or held by the estate. The value of each 10% distribution is determined by taking 10% of the value on the distribution date of the units (100%) owned by the estate at D's death. The value of the units held by the estate on the AVD is determined by taking 40% of the value on the AVD of all of the units (100%) owned by the estate at D's death. If because of market conditions, the units had declined in value as of each distribution date or as of the AVD, D's estate would take such reduction in value into account.
D died owning 100% of Blackacre. D's will directs that Blackacre be divided between two trusts, 70% to Trust A for the benefit of S, D's surviving spouse, and 30% to Trust B for the benefit of C, D's surviving child. The executor of D's estate distributed a 70% interest in Blackacre to Trust A three months after D's death, and distributed a 30% interest in Blackacre to Trust B four months after D's death. On the estate tax return, the executor elected to value the estate's property under the alternate valuation method under section 2032. There was no change in the value of Blackacre during the four-month period following D's death. The 70% interest in Blackacre is to be valued as of the distribution date to Trust A, and that value is determined by taking 70% of the value of all (100%) of Blackacre as of the distribution date. The 30% interest in Blackacre is to be valued as of the distribution date to Trust B, and that value is determined by taking 30% of the value of all (100%) of Blackacre as of the distribution date. If, however, because of market conditions such as a decline in the real estate market, Blackacre's value had declined by 10% between D's date of death and the distribution date of the 30% interest, the value of the 30% interest would be determined by ascertaining 30% of the value of all (100%) of Blackacre as of the distribution date, which would equal 30% of 90% of the date of death value of Blackacre.
(h)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to amend special local regulations for annual regattas and marine parades in the Captain of the Port Detroit zone. This proposed rule is intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after regattas or marine parades. This proposed rule will establish restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after regattas or marine parades.
Comments and related materials must reach the Coast Guard on or before May 27, 2008.
You may submit comments identified by Coast Guard docket number USCG-2008-0220 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)
(2)
(3)
(4)
LT Jeff Ahlgren, Waterways Management, U.S. Coast Guard Sector Detroit, 110 Mount Elliot Ave., Detroit, MI 48207; (313) 568-9580.
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to
If you submit a comment, please include the docket number for this rulemaking (USCG-2008-0220), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name, mailing address, and an e-mail address or other contact information in the body of your document to ensure that you can be identified as the submitter. This also allows us to contact you in the event further information is needed or if there are questions. For example, if we cannot read your submission due to technical difficulties and you cannot be contacted; your submission may not be considered. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the
We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Commander, Coast Guard Sector Detroit at the address under
This proposed rule will remove the specific entries from table 1 found in 33 CFR 100.901, Great Lakes annual marine events that apply to regattas and marine parades in the Captain of the Port Detroit zone and list each regatta or marine parade as a subpart. This proposed rule will also add several regattas and marine parades not previously listed in 33 CFR part 100 and remove several events that no longer occur annually or are not regattas or marine parades.
This proposed rule is intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after regattas or marine parades. This proposed rule will establish restrictions upon and control the movement of vessels through a specified area immediately prior to, during, and immediately after regattas or marine parades.
The Captain of the Port Detroit will cause notice of enforcement of the special local regulations established by this section to be made by all appropriate means to the affected segments of the public. Such means of notification will include, but is not limited to, Broadcast Notice to Mariners and Local Notice to Mariners. The Captain of the Port Detroit will issue a Broadcast Notice to Mariners notifying the public when enforcement of the special local regulations is terminated.
This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary.
The Coast Guard's use of these special local regulations will be periodic in nature, of short duration, and designed to minimize the impact on navigable waters. These special local regulations will only be enforced immediately before and during the time the marine events are occurring. Furthermore, these special local regulations have been designed to allow vessels to transit unrestricted to portions of the waterways not affected by the special local regulations. The Coast Guard expects insignificant adverse impact to mariners from the activation of these special local regulations.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
This proposed rule would affect the following entities, some of which might be small entities: The owners of operators of vessels intending to transit or anchor in the areas designated as special local regulations in paragraphs (4) through (13) during the dates and times the special local regulations are being enforced.
These special local regulations would not have a significant economic impact on a substantial number of small entities for the following reasons. The special local regulations in this proposed rule would be in effect for short periods of time, and only once per year. The special local regulations have been designed to allow traffic to pass safely around the zone whenever possible and vessels will be allowed to pass through the zones with the permission of the Captain of the Port.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LT Jeff Ahlgren, Waterways Management, U.S. Coast Guard Sector Detroit, 110 Mount Elliot Ave., Detroit, MI 48207; (313) 568-9580. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.
This proposed rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule will not result in such expenditure, we nevertheless discuss its effects elsewhere in this preamble.
This proposed rule will not affect the taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that these safety zones and fishing rights protection need not be incompatible. We have also determined that this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this proposed rule or options for compliance are encouraged to contact the point of contact listed under
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is not likely to have a significant effect on the human environment. A preliminary “Environmental Analysis Check List” supporting this preliminary determination is available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
1. The authority citation for part 100 continues to read as follows: 33 U.S.C. 1233.
2. Amend § 100.901 Table 1 as follows:
a. Under the heading “Group Detroit, MI” remove the entries: Bay City Fireworks Display, Detroit APBA Gold Cup Race, Buick Watersports Weekend, Cleveland National Air Show, International Bay City River Roar, International Freedom Festival Fireworks, International Freedom Festival Tug Across the River, Parade of
b. Remove the heading “Group Detroit, MI”.
3. Remove and reserve § 100.902.
4. Add § 100.911 to read as follows:
(a)
(b)
(c)
5. Add § 100.912 to read as follows:
(a)
(b)
(c)
6. Add § 100.913 to read as follows:
(a)
(b)
(c)
7. Add § 100.914 to read as follows:
(a)
(b)
(c)
8. Add § 100.915 to read as follows:
(a)
(b)
(c)
9. Add § 100.916 to read as follows:
(a)
(b)
(c)
10. Add § 100.917 to read as follows:
(a)
(b)
(c)
11. Add § 100.918 to read as follows:
(a)
(b)
(c)
12. Add § 100.919 to read as follows:
(a)
(b)
(c)
13. Add § 100.920 to read as follows:
(a)
(b)
(c)
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to approve the State of California's request to revise the designation for the San Joaquin Valley (SJV) serious nonattainment area for particulate matter of ten microns or less (PM-10) (SJV nonattainment area) by splitting the area into two separate nonattainment areas: The San Joaquin Valley Air Basin serious PM-10 nonattainment area and the East Kern serious PM-10 nonattainment area. EPA is also proposing to redesignate the SJVAB nonattainment area to attainment for the PM-10 national ambient air quality standard (NAAQS) and proposing to approve the PM-10 maintenance plan, motor vehicle emissions budgets and conformity trading mechanism for the area. EPA is also proposing to exclude from use in determining that the area has attained the standard two exceedances that EPA has concluded were caused by exceptional events that occurred on July 4, 2007 and January 4, 2008. Finally, EPA is proposing to approve enforceable commitments by the Kern County Air Pollution Control District and the California Air Resources Board to install a PM-10 monitor in the East Kern nonattainment area and to address Clean Air Act requirements under section 189(d) as necessary for the area.
Any comments must arrive by
Submit comments, identified by docket number EPA-R09-OAR-2008-0306, by one of the following methods:
1.
2.
3.
Doris Lo, EPA Region IX, (415) 972-3959,
Throughout this document, “we” “us” and “our” refer to EPA.
On May 26, 2004, EPA approved the serious area PM-10 plan for the SJV nonattainment area, “2003 PM10 Plan, San Joaquin Valley Plan to Attain Federal Standards for Particulate Matter 10 Microns and Smaller” submitted by the State on August 19, 2003 and amendments to that plan submitted on December 30, 2003 (collectively, 2003 Plan). See 69 FR 30006; 40 CFR 81.305. This plan provided for, among other things, the implementation of best available control measures (BACM). In addition, since the SJV nonattainment area had failed to meet its original serious area attainment deadline of December 31, 2001, the State was required under section 189(d) of the Clean Air Act (CAA or the Act) to submit a plan that provided for an annual reduction in PM-10 or PM-10 precursors of not less than five percent until attainment. A detailed discussion of the history of PM-10 planning in the SJV nonattainment area and of EPA's approval of the 2003 Plan can be found in its proposed and final actions and the associated dockets. 69 FR 5412 (February 4, 2004); 69 FR 30006.
On October 30, 2006, EPA determined that the SJV nonattainment area had attained the 24-hour PM-10 standard
On November 16, 2007, the State submitted to EPA the “2007 PM10 Maintenance Plan and Request for Redesignation,” September 20, 2007, for the San Joaquin Valley Air Pollution Control District (SJVAPCD or the District) (2007 Plan).
On February 29, 2008, the State submitted enforceable commitments by CARB and the KCAPCD to monitor for PM-10 in the western portion of the KCAPCD and to address CAA State Implementation Plan (SIP) requirements for this area as necessary. Letter from James N. Goldstene, CARB, to Wayne Nastri, EPA, with enclosures, February 29, 2008.
Finally, on January 23, 2008, the State submitted to EPA the “Exceptional Event Documentation, PM10, Fireworks, Bakersfield, CA, July 4, 2007” and on April 15, 2008, the State submitted to EPA the “Natural Event Documentation, Bakersfield, California, January 4, 2008.”
First, EPA is proposing to grant the State's request to split the existing SJV nonattainment area into two separate nonattainment areas. EPA is then proposing to grant the State's request to redesignate the portion of the SJV nonattainment area located in the San Joaquin Valley Air Basin to attainment for the PM-10 standard and to approve the PM-10 maintenance plan, motor vehicle emissions budgets and conformity trading mechanism for the area. EPA is also proposing to exclude from use in determining that the area has attained the PM-10 standard data showing exceedances caused by exceptional events that occurred on July 4, 2007 and January 4, 2008. Finally, EPA is proposing to approve commitments by CARB and the KCAPCD to monitor for PM-10 in the western portion of the KCAPCD and to address CAA SIP requirements for the area as necessary.
As stated above, on January 31, 2008, the State submitted a request to EPA to split the existing SJV PM-10 nonattainment area into two separate nonattainment areas: (1) The San Joaquin Valley Air Basin and (2) the western portion of the KCAPCD. The State's submittal states that “[t]his change will address the inconsistency between California's adopted air basin boundary for the San Joaquin Valley and the boundary U.S. EPA is using for PM10 planning.” The State's submittal includes information about jurisdiction, geography, population and degree of urbanization, employment and traffic/commuting patterns, and emissions and air quality which supports the revised boundary designation. See Goldstene letter.
The existing SJV nonattainment area includes the entire counties of San Joaquin, Fresno, Kings, Madera, Merced, Stanislaus and Tulare and part of Kern County. The part of Kern County in the existing SJV nonattainment area is a region that straddles the Sierra Nevada and Tehachapi mountains and is located in two separate air basins: the SJV Air Basin and the Mojave Desert Air Basin (MDAB). The dividing line between
Under section 107(d)(3)(D) of the CAA, the Governor of any state may, on the Governor's own motion, submit to EPA a revised designation of any area or portion thereof within the state.
In determining whether to approve or deny a state's submittal of a request for a revised boundary designation under section 107(d)(3)(D), EPA uses the same factors Congress directed EPA to consider when the Agency initiates a revision to a designation of an area on its own motion under section 107(d)(3)(A). These factors include “air quality data, planning and control considerations, or any other air quality-related considerations the Administrator deems appropriate.” In addition, because the State's revised designation involves nonattainment areas, we also take into account CAA section 107(d)(1)(A), which provides that nonattainment areas are to include the geographic area that does not meet, or that contributes to ambient air quality in a nearby area that does not meet, the NAAQS for a given pollutant.
California has provided a compelling technical justification as to why the proposed SJVAB and East Kern nonattainment areas should be designated as separate PM-10 planning areas. A summary of the State's reasoning follows:
Based on the factors set forth above, EPA has considered the State's request in accordance with the criteria listed in CAA section 107(d)(3)(A). We find that the State has sufficiently demonstrated that the SJVAB and East Kern should be separate nonattainment areas because they lie in separate air basins, are under different local jurisdictions, have different population densities and growth levels, do not share commute patterns, have different emissions sources and have different types of air pollutants. Pursuant to CAA section 107(d)(3)(D), EPA is therefore proposing to approve the State's request to revise the boundary designation of the existing SJV PM-10 nonattainment area by splitting the area into two separate PM-10 nonattainment areas, the SJVAB and East Kern.
As explained below, we are further proposing to redesignate the SJVAB to attainment for PM-10. Pending further air quality monitoring and until such time as the East Kern nonattainment area meets the CAA requirements for redesignation, the East Kern area would be classified as a serious PM-10 nonattainment area. Thus the East Kern nonattainment area would retain the classification and nonattainment designation that applied to it when it was part of the SJV nonattainment area and would likewise retain the attainment determination applicable to that area. In order to address the serious area PM-10 statutory requirements, KCAPCD and CARB have made the enforceable commitments discussed in section V. below.
On November 16, 2007, the State submitted to EPA the 2007 Plan which addresses PM-10 maintenance plan requirements and includes a discussion of how the SJVAB (i.e., the portion of the current nonattainment area under the jurisdiction of the SJVAPCD) meets the CAA redesignation requirements.
Section 107(d)(3)(E) of the CAA states that an area can be redesignated to attainment if the following conditions are met:
(1) EPA has determined that the area has attained the NAAQS.
(2) The applicable implementation plan has been fully approved by EPA under section 110(k) of the CAA.
(3) EPA has determined that the improvement in air quality is due to permanent and enforceable reductions in emissions.
(4) The State has met all applicable requirements for the area under section 110 and Part D of the CAA.
(5) EPA has fully approved a maintenance plan, including a contingency plan, for the area under section 175A of the CAA.
These requirements are discussed in more detail in a September 4, 1992 EPA Memorandum, “Procedures for Processing Request to Redesignate Areas to Attainment, John Calcagni, Director, Air Quality Management Division” (Calcagni memo). We discuss how these requirements are met for the SJVAB in detail below.
The Calcagni memo states that there are two components involved in meeting this requirement. The first component relies on an analysis of quality-assured ambient air quality data and an ambient air monitoring network that is representative of the area of highest concentrations. For PM-10 in the SJVAB, EPA has reviewed the ambient air quality data and determined and affirmed that the PM-10 NAAQS has been attained for the years 2003 through 2006. See 71 FR 40952, 71 FR 63642, 72 FR 49046 and 73 FR 14687. These determinations also discuss the adequacy of the monitoring network for the SJVAB.
EPA has also evaluated the air quality data in EPA's Air Quality System (AQS) database for 2007 and through February 2008. This data has been included in the docket for this proposed rule. A summary of the 2005-2007 data is provided in Table 2 below.
One exceedance of the PM-10 standard was recorded at the Bakersfield-Golden FEM
Under EPA's Exceptional Events Rule, the Agency may exclude data from regulatory determinations related to exceedances or violations of the NAAQS if the state adequately demonstrates that an exceptional event caused the exceedance or violation. 40 CFR Sections 50.1, 50.14. Therefore, for the reasons set forth in the concurrence letters, EPA is proposing to exclude data showing exceedances on July 4, 2007 and January 4, 2008 in determining whether the SJVAB has continued to attain the PM-10 standard in 2007 and through February 2008. The concurrence letters explain how the State has met its burden to demonstrate that these exceedances qualify as exceptional events. Thus, EPA believes that according to the ambient air monitoring data for the SJVAB, the PM-10 NAAQS has been attained.
The second component that may be included in the showing that a PM-10 area has met the requirement that the NAAQS has been attained involves an analysis using air quality modeling. This component is addressed under the maintenance plan requirements discussion below.
The Calcagni memo states that the SIP for the area must be fully approved under section 110(k) of the CAA and must satisfy all requirements that apply to the area. Section 107(d)(3)(E)(ii). As stated above, on August 19, 2003 and December 30, 2003, the State submitted the 2003 Plan. This plan addressed all applicable requirements for the SJV serious PM-10 nonattainment area. On May 24, 2004, EPA approved all components of the 2003 Plan except for the plan's contingency measures. EPA may rely on prior SIP approvals in approving a redesignation request. See Calcagni memo, p. 3;
The Calcagni memo states that the state must be able to reasonably attribute the improvement in air quality to emission reductions which are permanent and enforceable, (CAA section 107(d)(3)(E)(iii)) and the improvement should not be a result of temporary reductions (e.g., economic downturns or shutdowns) or unusually favorable meteorology. In making this showing, the state should estimate the emission reductions from adopted and implemented Federal, State and local control measures, and consider the emission rates, production capacities, and other related information to show that the air quality improvements are the result of implemented controls.
The 2007 Plan provides a discussion and comparison of the air quality, meteorology and emissions trends since 1990. See 2007 Plan, pp. 23-28. First, the 2007 Plan discusses the significant improvements in PM-10 air quality since 1990, noting that from 1990 to 1992 there were 33 estimated exceedance days, from 1998 to 2000 there were 5.9 exceedance days and from 2002 to 2004 there were 2.9 exceedance days. Id. Next the 2007 Plan states that this improvement has occurred while air quality plans and regulations have been adopted and notes that in the late 1980's, before the adoption of plans and regulations, “* * * it was not uncommon to have 50
The 2007 Plan also states that since 1990 the Valley has experienced rapid economic growth, citing to increases in population and vehicle miles traveled (2007 Plan, p. 26, Figure 3), while at the same time the PM-10 and PM-10 precursor emissions were decreasing (2007 Plan, p. 26, Figure 4). The 2007 Plan also did not find any major sector-wide shutdowns, identifying at most “* * * about 2 tons per day of PM-10 reductions from shutdowns during the attainment period of interest.” 2007 Plan, p. 25. Thus, it does not appear that the air quality improvements were due to any economic downturns or shutdowns.
The 2007 Plan also provides an analysis of the meteorological conditions, including wind speeds, precipitation, temperature and atmospheric stability, to determine if there were any favorable meteorological conditions that may have led to the improvement in air quality during 2003-2006. 2007 Plan, p. 27 and Appendix C. The 2007 Plan found that compared to long-term averages, the period from 2003 to 2006 had: No variation in average annual wind speeds; a higher than average level of precipitation with two dry years (2003 and 2004) and two wet years (2005 and 2006); warmer than average temperatures; and a lower than average stability level. The higher than average precipitation would favor lower PM-10 levels, but it is important to note that 2003 and 2004 were in fact dry years, ranking 98th and 122nd in wetness over a period of 128 years (1878 to 2006). The higher than average temperature could have increased the potential for high PM-10 levels, but the higher stability level could have decreased the potential by providing more dispersion. The 2007 Plan concludes that these analyses indicate that there is no consistent pattern to show that there was favorable meteorology leading to the improvement in PM-10 levels during 2003 to 2006.
The 2007 Plan further states that the SJVAPCD has adopted over 500 new rules and amendments since 1992, many of which are for the purpose of reducing PM-10 or PM-10 precursor emissions. The 2007 Plan shows that all of the rules and commitments in the 2003 Plan have been adopted by the SJVAPCD and many of them have been approved by EPA and are thus federally enforceable. The SJVAPCD has adopted rules which control NO
The 2007 Plan shows decreases in the emissions inventories for the SJVAB from approximately 1000 tpd in 2000 to approximately 900 tpd in 2005 and to approximately 800 tpd in 2010. ARB Staff Report, Appendix B. As discussed further in Section E.1. below, the emissions inventories are a summary of all source categories in the SJVAB and are developed based on information about emission rates, production capacities, and other source-related information. The emissions inventories in the 2007 Plan also include reductions from adopted and implemented Federal, State and local control measures. ARB Staff Report, Appendix B.
EPA believes that the 2007 Plan has demonstrated that the improvement in PM-10 air quality for the SJVAB is a result of permanent and enforceable reductions in emissions and the improvement is not a result of temporary reductions or unusually favorable meteorology. The fact that, as discussed above, there were no economic downturns, shutdowns or meteorology impacting air quality and that the number of exceedance days and the estimated emissions have decreased over time while the population and vehicle miles traveled in the SJVAB have increased shows that the improvement in air quality can reasonably be attributed to the adoption of air quality plans and regulations during this time.
The Calcagni memo states that a state must meet those requirements of section 110 and part D of the CAA that were applicable prior to the submittal of the redesignation request. CAA section 107(d)(3)(E)(v).
The general SIP elements and requirements set forth in section 110(a)(2) include, but are not limited to, the following: Submittal of a SIP that has been adopted by the state after reasonable public notice and hearing; provisions for establishment and operation of appropriate procedures needed to monitor ambient air quality; implementation of a source permit program; provisions for the implementation of part C requirement for Prevention of Significant Deterioration (PSD); provisions for the implementation of part D requirements for New Source Review (NSR) permit programs; provisions for air pollution modeling; and provisions for public and local agency participation in planning and emission control rule development.
On numerous occasions over the past 35 years, CARB and the SJVAPCD have submitted and we have approved provisions addressing the basic CAA section 110 provisions. There are no outstanding or disapproved applicable section 110 SIP submittals with respect to the State and the SJVAPCD.
Moreover, we note that SIPs must be fully approved only with respect to applicable requirements for purposes of redesignation in accordance with CAA section 107(d)(3)(E)(ii). Thus, for example, CAA section 110(a)(2)(D) requires that SIPs contain certain measures to prevent sources in a state from significantly contributing to air quality problems in another state. However, the section 110(a)(2)(D) requirements for a state are not linked with a particular nonattainment area's designation and classification in that state. EPA believes that the requirements linked with a particular nonattainment area's designation and classifications are the relevant measures to evaluate in reviewing a redesignation request. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area in the state.
Thus, we do not believe that these requirements should be construed to be applicable requirements for purposes of redesignation. In addition, EPA believes that the other section 110 elements not connected with nonattainment plan submissions and not linked with an area's attainment status are not applicable requirements for purposes of
Subparts 1 and 4 of part D, title 1 of the CAA contain air quality planning requirements for PM-10 nonattainment areas. Subpart 1 of part D contains general requirements for areas designated as nonattainment. Subpart 4 of part D contains specific planning and scheduling requirements for particulate matter nonattainment areas. Subpart 4 of part D, section 189(a), (b) and (c) requirements apply to moderate and serious PM-10 nonattainment areas and 189(d) applies to areas which failed to attain by their serious area deadline. These requirements include: (1) An approved permit program for construction of new and modified major stationary sources; (2) provisions to ensure that reasonably available control technology (RACT) and reasonably available control measures (RACM) are implemented; (3) provisions to ensure that best available control measures (BACM) are implemented; (4) quantitative milestones to be achieved every 3 years and which demonstrate reasonable further progress (RFP) toward attainment by the applicable attainment date; (5) provisions to ensure that the control requirements applicable to major stationary sources of PM-10 also apply to major stationary sources of PM-10 precursors except where the Administrator determined that such sources do not contribute significantly to PM-10 levels which exceed the NAAQS in the area; and(6) a demonstration of attainment and an annual PM-10 or PM-10 precursor reduction of not less than five percent from the most recent emission inventory until attainment.
In addition to these specific requirements for serious PM-10 nonattainment areas, nonattainment areas must also meet the general planning requirements in subpart 1, section 172(c). These requirements include, among other things, provisions for the implementation of RACT, RFP, emissions inventories, and contingency measures.
For the SJVAB, EPA determined that these requirements were met in its approval of the 2003 Plan with the exception of the contingency measure requirement that was subsequently suspended by the determination of attainment in accordance with EPA's Clean Data Policy and the NSR permit program for construction of new and modified major stationary sources. 69 FR 30006 and 71 FR 63642.
EPA fully approved SJVAPCD NSR rules 2020 and 2201 on May 17, 2004 (69 FR 27837). Recently we proposed to: (1) Correct aspects of that approval, and (2) approve revisions to the NSR rules that explicitly exempt certain small or minor agricultural sources from permitting requirements. 73 FR 9260 (February 20, 2008). In this proposed rulemaking, we stated that “we believe that the adoption of the proposed revisions in place of the SIP as proposed to be corrected would not result in any change in emissions, any change in air quality, or any change in the area's ability to attain or maintain the NAAQS. Accordingly, we conclude that this SIP revision, if approved, will not interfere with any applicable requirements for attainment and reasonable further progress or any other applicable requirement of the CAA and is approvable under section 110(l).” 73 FR 9265.
Although the SJVAPCD NSR program has been approved, and we have proposed approval of revisions to the rule, we also note that final approval of the NSR revisions is not a necessary prerequisite to finalizing our proposed approval of the State's redesignation request. EPA has determined in past redesignations that a NSR program does not have to be approved prior to redesignation, provided that the area demonstrates maintenance of the standard without part D NSR in effect. The rationale for this position is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled “Part D NSR Requirements or Areas Requesting Redesignation to Attainment.” See the more detailed explanations in the following redesignation rulemakings: Detroit, MI (60 FR 12467-12468, March 7, 1996); Cleveland-Akron-Lorrain, OH (61 FR 20458, 20469-20470, May 7, 1996); Louisville, KY (66 FR 53665, 53669, October 23, 2001); Grand Rapids, MI (61 FR 31831, 31836-31837, June 21, 1996).
The requirements of the PSD program will apply once the area has been redesignated. Thus, new major sources with significant PM-10 emissions and major modifications of PM-10 at major sources as defined under 40 CFR 52.21 will be required to obtain a PSD permit. Currently, EPA is the PSD permitting authority in the SJVAB under a Federal implementation plan. See 40 CFR 52.270. However, the SJVAPCD can implement the Federal PSD program through a delegation agreement with EPA or, assuming that the SJVAPCD makes necessary modifications to its PSD rules, under an EPA-approved rule.
With respect to the conformity requirement, section 176(c) of the CAA requires states to establish criteria and procedures to ensure that Federally supported or funded projects “conform” to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded or approved under Title 23 U.S.C. and the Federal Transit Act (“transportation conformity”) as well as to other Federally supported or funded projects (“general conformity”). State conformity revisions must be consistent with Federal conformity regulations relating to consultation, enforcement and enforceability that the CAA required the EPA to promulgate.
EPA believes it is reasonable to interpret the conformity SIP requirements as not applying for purposes of a redesignation request under section 107(d) because state conformity rules are still required after redesignation and Federal conformity rules apply where state rules have not been approved. See
Thus, EPA concludes that the State has met all requirements applicable under section 110 and part D for the SJVAB for purposes of redesignation. CAA Section 107(d)(3)(E)(v).
Section 175A of the CAA provides the requirements for maintenance plans. These requirements are further clarified in the Calcagni memo. The provisions to be included in maintenance plans are:
(1) An attainment emissions inventory to identify the level of emissions in the area sufficient to attain the NAAQS;
(2) A demonstration of maintenance of the NAAQS for 10 years after redesignation;
(3) Verification of continued attainment through operation of an appropriate air quality monitoring network; and
(4) Contingency provisions that EPA deems necessary to assure that the State will promptly correct any violation of the NAAQS that occurs after redesignation of the area. We discuss how these requirements are met for the SJVAB below.
Section 172(c)(3) of the CAA requires all plan submittals to include a comprehensive, accurate, and current inventory of actual emissions from all sources in the nonattainment area. In demonstrating maintenance in accordance with CAA section 175A and the Calcagni memo, the state should provide an attainment emissions inventory to identify the level of emissions in the area sufficient to attain the NAAQS. Where the state has made an adequate demonstration that air quality has improved as a result of the SIP, the attainment inventory will generally be an inventory of actual emissions at the time the area attained the standard. EPA's primary guidance in evaluating these inventories is the document entitled, “PM-10 Emissions Inventory Requirements,” EPA, OAQPS, EPA-454/R-94-033 (September 1994) which can be found at:
The 2007 Plan includes detailed emissions inventories for NO
The 2007 Plan includes projected inventories for 2005, 2010 and 2020 for NO
The 2007 Plan selects the 2005 PM-10 and NO
The NO
EPA believes that the selection of 2005 for the attainment year inventory and 2020 for the maintenance year inventory is appropriate since the SJVAB was determined to have attained the PM-10 NAAQS in 2005. We have reviewed the 2007 Plan's attainment year and maintenance year emissions inventories and determined that they are accurate and comprehensive and meet the requirements of EPA guidance and the CAA.
Section 175A of the CAA requires a demonstration of maintenance of the NAAQS for 10 years after designation. A state may generally demonstrate maintenance of the NAAQS by either showing that future emissions of a pollutant or its precursors will not exceed the level of the attainment inventory, or by modeling to show that the future anticipated mix of sources and emission rates will not cause a violation of the NAAQS. Under the Act, the showing should be based on the same level of modeling used for the attainment demonstration required as part of the approved attainment plan.
Consistent with EPA's modeling guidance (The Guideline on Air Quality Models (GAQM), 40 CFR part 51, Appendix W and the PM-10 SIP Development Guideline (PMSDG), EPA 450/2-86-001, June 1987), the 2003 Plan's attainment demonstration was based on the use of two receptor models: Chemical Mass Balance (CMB) and rollback. 69 FR 5412, 5424-5425 and 69 FR 30006. The 2007 Plan also uses CMB and rollback to demonstrate maintenance of the 24-hour PM-10 standard until 2020.
In addition to the modeling for the maintenance plan, the 2007 Plan shows that total annual emissions of NO
Based on our review of the information presented in the 2007 Plan, we believe that the State has met EPA requirements for demonstrating maintenance of the PM-10 standard for the SJVAB.
In demonstrating maintenance, continued attainment of the NAAQS can be verified through operation of an appropriate air quality monitoring network. The Calcagni memo states that the maintenance plan should contain provisions for continued operation of air quality monitors that will provide such verification. The memo also states that states should ensure that they have the legal authority to implement and enforce all measures necessary to attain and to maintain the NAAQS. Finally, the memo states that the state submittal should indicate how it will track the progress of the maintenance plan (e.g., with periodic emissions inventory updates or modeling input updates) and monitor the triggers for contingency measures.
In the 2007 Plan the SJVAPCD commits to continued operation of its air quality monitoring network for verification of attainment. See 2007 Plan, pp. 12-13. The SJVAPCD's authority to continue operating after redesignation to attainment is provided for in the California Health and Safety Code sections 40150 and 40161.
Contingency provisions are required under section 175A of the CAA. These contingency measures are distinguished from those generally required for nonattainment areas under section 172(c)(9) in that they are not required to be fully adopted measures that will take effect without further action by the State in order for the maintenance plan to be approved. The Calcagni memo states that the contingency provisions of the maintenance plan should clearly identify the measures to be adopted, a schedule and procedure for adoption and implementation, and a specific time limit for action by the state. The memo also states that the contingency provisions should identify indicators or triggers which will be used to determine when the contingency measures need to be implemented. While the memo suggests inventory or monitoring indicators, it states that contingency provisions will be evaluated on a case-by-case basis. Finally, the Calcagni memo states that the contingency provisions must require the state to implement all measures contained in the part D nonattainment plan for the area prior to redesignation.
The 2007 Plan selects an action level or trigger based on an exceedance of the PM-10 NAAQS of 155 μg/m
The 2007 Plan states that if the SJVAB monitors an exceedance of 155 μg/m
If there are no reductions available from adopted measures, the District commits in the 2007 Plan to proceed with identifying control measures from feasibility studies such as those found in its 2007 Ozone Plan and Proposed 2008 PM2.5 Plan (see Table 6-2 of 2007 Ozone Plan and Table 6-5 of Proposed PM2.5 Plan) and prioritize measures most relevant for reducing PM-10 emissions. 2007 Plan, pp. 16-17. The SJVAPCD has also provided clarification that if additional control measures are necessary, the SJVAPCD will adopt and implement the control measures within the 18-month timeframe for appropriate action. Letter from Seyed Sadredin, SJVAPCD, to Deborah Jordan, EPA, April 17, 2008.
Finally, the 2007 Plan states that the State, District and local governments have adopted and implemented all measures in the 2003 Plan. 2007 Plan, p. 17 and Appendix B.
Based on the discussion above and EPA's review of the 2007 Plan, we believe the plan adequately addresses the contingency measure requirement under section 175A of the CAA.
Based on our review of the 2007 Plan, and for the reasons discussed above, we conclude that the CAA section 107(d)(3)(E) requirements for redesignation to attainment and an approvable maintenance plan for the SJVAB have been met. We are therefore proposing to approve the 2007 Plan as meeting the requirements of section 175A of the CAA and proposing to redesignate the SJVAB nonattainment area to attainment for the PM-10 NAAQS.
Under section 176(c) of the CAA, transportation plans, programs and projects in the nonattainment or maintenance areas that are funded or
The 2007 Plan provides for attainment year MVEBs for 2005 and maintenance year MVEBs for 2020.
Before an emissions budget in a submitted SIP revision may be used in a conformity determination, we must first determine that it is adequate. The criteria by which we determine whether a SIP's motor vehicle emissions budgets are adequate for transportation conformity purposes are outlined in 40 CFR 93.118(e)(4). We have described our process for determining the adequacy of submitted SIP budgets in the preamble to revisions to EPA's conformity regulations. 69 FR 40004 (July 1, 2004). Applicability of emission trading between conformity budgets for conformity purposes is described in 40 CFR 93.124(b).
CARB's mobile source emission model, EMFAC2007, was used to estimate direct PM-10 and NO
The methodology used in the 2007 Plan to estimate fugitive dust (
The 2007 Plan includes county by county subarea motor vehicle emissions budgets for 2005 and 2020 for direct PM-10 and NO
Based on our evaluation of the criteria outlined in section 93.118(e)(4) of the conformity rule, EPA proposes to find the PM-10 and NO
Transportation conformity is demonstrated for each county in the SJVAB when emissions for both PM-10 and NO
The trading mechanism specified that if, after including reductions from additional measures, the direct PM-10 budget still cannot be met, an MPO could adjust (
A subarea has demonstrated conformity if, after trading, the estimates of NO
The 2007 Plan requests that this trading mechanism remain unchanged, but available for use after 2005, the revised attainment year. Since the first analysis year, for conformity purposes, will be 2010, EPA is proposing to continue to approve use of the trading mechanism for conformity analysis years after 2005. As stated in the 2003 Plan approval (69 FR 5412, 5414-5417; 69 FR 30006), EPA continues to believe that trading mechanisms cannot be reviewed through the adequacy process, and instead need full EPA approval before they can be used.
In order to address CAA requirements for the East Kern nonattainment area, the State submitted on February 29, 2008 enforceable commitments to install a FRM/FEM in East Kern and if a violation is recorded to submit the appropriate SIP. Specifically, the State submitted a resolution approved by the Governing Board of the KCAPCD on February 27, 2008 committing to, with assistance from the State, install a FRM/FEM. Kern County Air Pollution Control Board Resolution 2008-001-02. Further, the resolution states that the KCAPCD will develop for submittal through the State to EPA, a serious nonattainment area SIP that meets the requirements of CAA section 189 in the event of a violation of the PM-10 standard. Id. On March 3, 2008, CARB's Executive Officer issued Executive Order S-08-004 approving as a SIP revision the KCAPCD commitments and committing to submit a SIP addressing section 189 in the event that the area violates the PM-10 standard. Given the low concentrations recorded at the IMPROVE monitor and the relatively minimal expected growth, we believe this is a reasonable approach for the area.
Based on our review of the State's request, EPA believes the State has addressed all the necessary requirements for a revised designation and is proposing to approve the State's request under section 107(d)(3)(D) to revise the designation for the SJV PM-10 nonattainment area by splitting the area into two separate serious PM-10 nonattainment areas, the SJVAB PM-10 nonattainment area and the East Kern PM-10 nonattainment area. Also, based on EPA's review of the 2007 Plan submitted by the State, EPA believes that the CAA requirements under section 107(d)(3)(E) for redesignations and section 175A for maintenance plans have been met for the SJVAB and EPA is therefore proposing to redesignate the newly created serious SJVAB nonattainment area to attainment for the PM-10 NAAQS and to approve the SJVAPCD's PM-10 maintenance plan, budgets and conformity trading mechanism for the area. EPA is also proposing to exclude from use in determining that the SJVAB has attained the PM-10 NAAQS two exceedances that it has concluded were caused by exceptional events on July 4, 2007 and January 4, 2008. Finally, EPA is proposing to approve commitments from KCAPCD and CARB to install a FRM/FED in the newly created East Kern serious PM-10 nonattainment area and to address section 189(d) CAA requirements for it in the event the FRM/FED records a violation of the PM-10 standard.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a ``significant regulatory action'' and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action merely proposes to approve a revised boundary designation, a redesignation to attainment for the SJVAB, a maintenance plan for the SJVAB, motor vehicle emissions budgets and conformity trading mechanism for the area and commitments for East Kern, all of which are either requested or submitted by the State, and does not impose any additional requirements. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Executive Order 13175 (65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” Seven Indian tribes have reservations located within the boundaries of the proposed SJVAB. EPA plans to consult with representatives of the seven Tribes and will continue to work with the Tribes, as provided for in Executive Order 13175. Accordingly, EPA has addressed Executive Order 13175 to the extent that it applies to this action. This proposed action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This proposed action merely proposes to approve requests or submittals from the State and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Executive Order 12898 establishes a Federal policy for incorporating environmental justice into Federal agency actions by directing agencies to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority and low-income populations. Today's action involves proposed approvals of a revised boundary designation, a redesignation to attainment for the SJVAB, a maintenance plan for the SJVAB, motor vehicle emissions budgets and conformity trading mechanism for the area and commitments for East Kern. It will not have disproportionately high and adverse effects on any communities in the area, including minority and low-income communities.
This proposed rule also is not subject to Executive Order 13045 ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because it is not economically significant. The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
Environmental protection, Air pollution control, National parks, Wilderness areas.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed interpretive rule.
EPA is proposing to revise an interpretive rule defining the term “substantially similar” for unleaded gasoline as that phrase is used in section 211(f) of the Clean Air Act (the Act). To meet the current definition, fuel or fuel additives must possess, at the time of manufacture, all of the physical and chemical characteristics of an unleaded gasoline as specified in ASTM Standard D 4814-88 for at least one of the Seasonal and Geographical Volatility Classes specified in the standard. EPA proposes to amend the definition to allow some additional flexibility for the vapor/liquid ratio specification for fuel introduced into commerce in the state of Alaska. In the “Rules and Regulations” section of this
Comments must be received by May 27, 2008.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2007-0071, by mail to Air and Radiation Docket, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the
Jaimee Dong, Compliance and Innovative Strategies Division, Office of Transportation and Air Quality, Office of Air and Radiation, Environmental Protection Agency, Mail Code 6406J, 1200 Pennsylvania Avenue, Washington, DC 20460; telephone number: (202) 343-9672; fax number: (202) 343-2800; e-mail address:
This document proposes to revise the “substantially similar” interpretive rule. EPA is not statutorily obligated to conduct notice and comment rulemaking when amending this interpretive rule.
If we receive no adverse comment, we will not take further action on this proposed rule. If we receive adverse comment, we will withdraw the direct final rule and it will not take effect. We would address all public comments in any subsequent final rule based on this proposed rule.
We do not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the information provided in the
Entities potentially affected by this action include those involved with the production or importation of unleaded gasoline for use in Alaska. Categories and entities affected by this action include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action; however, other types of entities not listed in the table could also be affected. To determine whether your entity is affected by this action, you should examine the applicability criteria of Parts 79 and 80 of title 40 of the Code of Federal Regulations. If you have any question regarding applicability of this action to a particular entity, consult the person in the preceding
1.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
3.
Section 211(f)(1) of the Act makes it unlawful for any manufacturer of a fuel or fuel additive to first introduce into commerce, or to increase the concentration in use of, any fuel or fuel additive for use in motor vehicles manufactured after model year 1974 which is not substantially similar to any fuel or fuel additive utilized in the certification of any model year 1975, or subsequent model year, vehicle or engine under section 206 of the Act. An EPA interpretive rule, published at 46 FR 38582 (July 28, 1981) and amended at 56 FR 5352 (February 11, 1991), defines the term “substantially similar” for unleaded gasoline. Under this definition, unleaded gasoline that meets several conditions, including complying with the physical and chemical specifications of ASTM Standard D 4814-88 for at least one of the Seasonal and Geographical Volatility classes specified in the standard, is considered substantially similar. Further conditions are described in the interpretive rule and its amendment.
Discussions with an Alaskan refiner have highlighted the need for an amendment to the definition of “substantially similar” for unleaded gasoline. Currently, manufacturers of gasoline for Alaska may not use a temperature below 41 degrees Celsius when testing the vapor-liquid (V/L) ratio of the fuel and still be within the current definition of “substantially similar.” This amendment would allow manufacturers producing unleaded gasoline for use only in Alaska during the winter months to use a minimum test temperature of 35 degrees Celsius when testing for a maximum V/L ratio of 20 instead of requiring a V/L test temperature of 41 degrees Celsius.
ASTM D 2533 is a test method that covers a procedure for measuring the volume of vapor formed at atmospheric pressure from a given volume of gasoline. The ratio of these volumes is expressed as the V/L ratio of the gasoline at the temperature of the test. The tendency of a fuel to vaporize in common automobile fuel systems is indicated by the V/L ratio of that fuel at conditions approximating those in critical parts of the fuel system. Allowing a lower test temperature means that the vapor fraction of the fuel may be higher.
The extreme cold of Alaska during the winter months increases the risk that engines using typical gasoline blends will suffer from difficulty in cold starting. A higher vapor fraction improves mixing of the fuel with air, which in turn improves cold starting. Because the automotive fuel system is closed, the lower test temperature of 35 degrees Celsius compared to 41 degrees Celsius in the winter months is unlikely to significantly increase evaporative emissions. In addition, Alaska presently does not possess ozone non-attainment areas, most likely due to the cold temperatures observed in Alaska. Therefore, in the Agency's judgment, the impact on emissions would not be significant and this increased flexibility will allow refiners to provide a fuel more suitable to the climatic conditions of Alaska.
EPA invites comment from all interested parties on this proposed interpretive rule revision.
See Section V in the direct final rule amending the “substantially similar” interpretive rule in the “Rules and Regulations” section of this
For the reasons set forth above, EPA proposes to amend the definition of substantially similar as follows:
EPA will treat a fuel or fuel additive for general use in light-duty vehicles manufactured after model year 1974 as substantially similar to any fuel or fuel additive utilized in the certification of any model year 1975, or subsequent model year vehicle or engine, under section 206 of the Act, i.e., “substantially similar,” if the following criteria are met.
(1) The fuel must contain carbon, hydrogen, and oxygen, nitrogen, and/or sulfur, exclusively,
(a) Hydrocarbons;
(b) Aliphatic ethers;
(c) Aliphatic alcohols other than methanol;
(d) (i) Up to 0.3 percent methanol by volume;
(ii) Up to 2.75 percent methanol by volume with an equal volume of butanol, or higher molecular weight alcohol;
(e) A fuel additive
(2) The fuel must contain no more than 2.0 percent oxygen by weight, except fuels containing aliphatic ethers and/or alcohols (excluding methanol) must contain no more than 2.7 percent oxygen by weight.
(3) The fuel must possess, at the time of manufacture, all of the physical and chemical characteristics of an unleaded gasoline as specified in ASTM Standard D 4814-88 for at least one of the Seasonal and Geographical Volatility Classes specified in the standard, with the exception of fuel introduced into commerce in the state of Alaska. For fuel introduced into commerce in the state of Alaska, all of the requirements of this section (3) apply, with the exception of the test temperature for a maximum Vapor/Liquid Ratio (V/L) of 20, which shall be a minimum of 35°C (95°F) for the period from September 16 through May 31.
(4) The fuel additive must contain only carbon, hydrogen, and any one or all of the following elements: Oxygen, nitrogen, and/or sulfur.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Qualified Products List for Water Enhancers.
Comments must be received in writing on or before June 24, 2008 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Victoria Henderson, Branch Director, Equipment and Chemicals, USDA Forest Service, National Interagency Fire Center, 3833 S. Development Avenue, Boise, Idaho 83705.
Comments also may be submitted via facsimile to (208) 387-5971 or by e-mail to:
The public may inspect comments received at the National Interagency Fire Center (NIFC), Jack Wilson Building, in Boise, Idaho, Monday through Friday between 10 a.m. to 3 p.m. Visitors are encouraged to call ahead to (208) 387-5348 to facilitate entry to the building.
Les Holsapple, Missoula Technology and Development Center (MTDC), (406) 829-6761, or Cecilia Johnson, MTDC, (406) 329-4819, or Tory Henderson, NIFC, (208) 387-5348. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.
MTDC employees consider the following to determine whether products are safe for use by Forest Service employees and Federal cooperators:
• Products must not include ingredients that create an enhanced risk in typical use to either the firefighters or the public.
• Effects are based upon acute toxicity determinations of the products and a review of lists of known and suspected carcinogens.
• The safety of the firefighters equipment, either ground-based or aircraft (i.e., uniform corrosion tests, intergrandular).
• Safety to the environment in terms of aquatic environments (fish and clean water) and terrestrial environments (wildlife and plants)—risk determinations identify products that do not enhance risk to those environments in typical use.
• Acute toxicity concerns.
• Efficiency is evaluated based upon such items as (1) the range of mix ratios of concentrate products with water appropriate for storage and handling in typical wildland fire operations to provide products that are storable and/or can be kept available on fire equipment, and (2) can be mixed and used with readily available equipment and facilities.
• Effectiveness tests for these products are based upon those products ability to reduce fire spread and intensity even after the water carrier has evaporated away.
The information submitted by manufacturers on two forms: The Confidential Disclosure Sheets and Technical Data Sheets sent to experienced staff at the MTDC, located in Missoula, Montana. These forms are available in either electronic form via e-mail or paper copies, and the manufacturers may submit them to the MTDC in either form.
This information includes listings of specific individual ingredients and the quantity of these ingredients in the formulation of the products, identification of the specific sources of supply for each ingredient, and the specific mixing and hydration requirements of gum-thickened products. If a risk analysis is determined to be necessary, the FS will request the manufacturer to send a copy of the product labeling. In these cases, a third party assesses specific levels of products or ingredients expected to occur in typical application relative to human and environmental health. Once the manufacturers (and/or their suppliers) have submitted their information and payment for the analysis and evaluation, the MTDC staff will begin to test these water enhancer products safety, efficiency, and effectiveness.
The collection of this information for each product submitted for evaluation is necessary due to the (1) length of time necessary to test the water enhancer products and perform the analysis/evaluation of those products, which takes over a year, and (2) the FS need to ensure the safety, effectiveness, and efficiency of retardant products prior to their use.
If this information is not collected and water enhancer products are not analyzed and evaluated on an on-going basis, our ability to solicit and award water enhancer contracts in a timely manner would not be possible.
Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the agency, including whether the information will have practical or scientific utility; (2) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.
Notice is hereby given that the U.S. Arctic Research Commission will hold its 86th meeting in Arlington, VA and Washington, DC on May 12-15, 2008. The Business Session, open to the public, will convene at 2 p.m. Monday, May 12, 2008 in Arlington, VA. An Executive Session will follow adjournment of the Business Session.
The Agenda items include:
(1) Call to order and approval of the Agenda.
(2) Approval of the Minutes of the 85th Meeting.
(3) Reports from Congressional Liaisons.
(4) Agency Reports.
The focus of the meeting will be reports and updates on programs and research projects affecting the Arctic.
Any person planning to attend this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and Deletion from the Procurement List.
This action adds to the Procurement List products to be furnished by nonprofit agencies employing persons who are blind or
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Kimberly M. Zeich, Telephone: (703) 603-7740, Fax: (703) 603-0655, or e-mail
On February 29, 2008, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (73 FR 11092) of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products to the Government.
2. The action will result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products proposed for addition to the Procurement List.
Accordingly, the following products are added to the Procurement List:
On February 29, 2008, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (73 FR 11092) of proposed deletions to the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action should not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the service deleted from the Procurement List.
Accordingly, the following service is deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Additions to the Procurement List.
The Committee is proposing to add to the Procurement List product and services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in the notice for each product or service will be required to procure the product and services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product and services to the Government.
2. If approved, the action will result in authorizing small entities to furnish the product and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the product and services proposed for addition to the Procurement List.
Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following product and services are proposed for addition to Procurement List for production by the nonprofit agencies listed:
Import Administration, International Trade Administration, Department of Commerce.
April 25, 2008.
Bobby Wong or Susan Pulongbarit, AD/CVD Operations, Office 9, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-0409 and (202) 482-4031, respectively.
The Department of Commerce (“the Department”) published the preliminary results of the aligned antidumping duty administrative review and new shipper review on honey from the People's Republic of China on January 16, 2008.
Pursuant to Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), and section 351.213(h)(1) of the Department's regulations, the Department shall issue the preliminary results of an administrative review within 245 days after the last day of the anniversary month of the date of publication of the order. The Act further provides that the Department shall issue the final results of review within 120 days after the date on which the notice of the preliminary results was published in the
The Department has extended the deadline for parties to submit briefs in order to address several issues raised by interested parties. As a result of these extensions and the complex issues raised in this review segment, including honey valuation, the Department has determined that it is not practicable to complete the aligned administrative review and new shipper review within the current time limit.
Section 751(a)(3)(A) of the Act and section 351.213(h) of the Department's regulations allow the Department to extend the deadline for the final results of a review to a maximum of 180 days from the date on which the notice of the preliminary results was published. For the reasons noted above, the Department is extending the time limit for the completion of these final results from the current deadline of May 15, 2008 until no later than July 14, 2008, which is 180 days from the date on which the notice of the preliminary results was published.
This notice is issued and published in accordance with sections 751(a)(3)(A) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce
On April 6, 2006, in
EFFECTIVE DATE:April 25, 2008.
FOR FURTHER INFORMATION CONTACT: Alex Villanueva, AD/CVD Operations,
Following publication of the
The Department complied with the CIT’s remand instructions and issued its
On April 6, 2006, the CIT affirmed the Department’s findings in the
On June 5, 2006, Ta Chen appealed the CIT’s decision to the CAFC. On September 21, 2006, in
Because no further appeals have been filed and there is now a final and conclusive decision in the court proceeding, we are amending the final results of administrative review of the antidumping order on certain stainless steel butt-weld pipe fittings from Taiwan for the period of June 1, 1998, through May 31, 1999. The revised weight-averaged dumping margin is as follows:
The Department will determine, and CBP shall assess, antidumping duties on all appropriate entries. In accordance with 19 CFR 351.212(b)(1), we have calculated importer-specific assessment rates. Where the importer-specific assessment rate is above de minimis on an ad valorem basis, calculated by dividing the dumping margins found on examined subject merchandise by the estimated entered value, we will instruct CBP to assess antidumping duties on that importer’s entries of subject merchandise. In accordance with 19 CFR 351.106(c)(2), we will instruct CBP to liquidate without regard to antidumping duties any entries for which the importer-specific assessment rate is
This notice is issued and published in accordance with section 751(a)(1) of the Tariff Act of 1930, as amended.
Department of Commerce, International Trade Administration.
Notice Announcing the Availability of Grant Funds.
This Notice announces the availability of grant funds in calendar year 2008 for U.S. manufacturers of certain worsted wool fabrics. The purpose of this notice is to provide the general public with a single source of program and application information related to the worsted wool grant offerings and it contains the information about the program required to be published in the
Applications by eligible U.S. producers of certain worsted wool fabrics must be received or postmarked by 5:00 p.m. Eastern Daylight Standard Time on May 27, 2008. Applications received after the closing date and time will not be considered.
Applications must be submitted to the Eastern Hemisphere, Office of Textiles and Apparel, Room 3001, U.S. Department of Commerce, Washington, DC 20230, (202) 482-4058.
Jim Bennett, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4058.
At the conclusion of the application, the applicant must attest that “all information contained in the application is complete and correct and no false claims, statements, or representations have been made.” Applicants should be aware that, generally, pursuant to 31 U.S.C. 3729, persons providing a false or fraudulent claims, and, pursuant to 18 U.S.C. 1001, persons making materially false statements or representations, are subject to civil or criminal penalties, respectively.
Information that is marked “business confidential” will be protected from disclosure to the full extent permitted by law.
This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 269, 424, 424A, 424B, SF-LLL, and CD-346 has been approved by the Office of Management and Budget (OMB) under the respective control numbers 0348-0039, 0348-0043, 0348-0044, 0348-0040, 0348-0046, and 0605-0001. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.
It has been determined that this notice is not significant for purposes of E.O. 12866.
Import Administration, International Trade Administration, Department of Commerce.
April 25, 2008.
The Department of Commerce (the “Department”) preliminary determines that raw flexible magnets (“magnets”) from the People's Republic of China (“PRC”) are being, or are likely to be, sold in the United States at less than fair value (“LTFV”), as provided in section 733 of the Tariff Act of 1930, as amended (“the Act”). The estimated dumping margins for this investigation are listed in the “Preliminary Determination Margins” section of this notice.
Melissa Blackledge or Shawn Higgins; Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-3518 or (202) 482-0679, respectively.
On September 21, 2007, the Department received a petition concerning imports of magnets from the PRC and Taiwan filed in proper form by Magnum Magnetics Corporation (“Petitioner”). On October 4, 2007, in response to a supplemental questionnaire issued by the Department on September 27, 2008, Petitioner submitted a revised version of the petition's margin calculations.
On November 1, 2007, the Department selected Polyflex Magnets Ltd. (“Polyflex”) and Qualita Magnetics Ltd. (“Qualita”), as the mandatory respondents in this investigation based upon U.S. Customs and Border Protection (“CBP”) entry data.
On November 1, 2007, the Department issued shipment questionnaires and sections A, C, and D of its antidumping duty questionnaire to the mandatory respondents. On November 9, 2007, Polyflex and Qualita submitted timely responses to the shipment questionnaires. Polyflex confirmed that it exported subject merchandise to the United States during the period of investigation (“POI”). Qualita reported that it did not export such merchandise to the United States during the POI. In November and December 2007, the Department issued shipment questionnaires to additional companies identified as large exporters by CBP entry data. The Department was able to determine through public means that four companies, Logimag Limited (“Logimag”), Marketa International, Ltd. (“Marketa”), Ningbo Magnetics Factory Ltd. (“Ningbo”), and Sinomag Technology Co., Ltd. (“Sinomag”), exported magnets. Ningbo and Sinomag reported that they did not export subject merchandise to the United States during the POI. Logimag and Marketa did not respond to the Department's original shipment letter or our second inquiries.
Polyflex submitted timely responses to sections A, C, and D of the Department's antidumping duty questionnaire during December 2007 and January 2008. The Department received comments from Petitioner and issued supplemental questionnaires to Polyflex in December 2007 and January 2008. On January 10, 2008, Polyflex submitted a timely response to the section A supplemental questionnaire. However, Polyflex did not respond to the sections C and D supplemental questionnaires.
In January 2008, the Department released to interested parties a memorandum from the Department's Office of Policy that listed potential surrogate countries and invited interested parties to comment on surrogate country and factor value selection.
On January 16, 2008, Petitioner requested a 50-day extension of the preliminary determination in this investigation. On January 31, 2008, the Department published the postponement of the preliminary determination.
On December 14, 2007, the Department received a timely separate rate application from Guangzhou Newlife Magnet Co., Ltd. (“Newlife”). The Department issued supplemental questionnaires to Newlife and received timely responses in February and March 2008.
On April 11, 2008, Petitioner submitted comments on magnetic photo pockets and the application of adverse facts available (“AFA”) in calculating dumping margins.
The POI is January 1, 2007, through June 30, 2007. This period comprises the two most recently completed fiscal
The products covered by this investigation are certain flexible magnet sheeting, strips, and profile shapes. Subject flexible magnet sheeting, strips, and profile shapes are bonded magnets composed (not necessarily exclusively) of (i) any one or combination of various flexible binders (such as polymers or co-polymers, or rubber) and (ii) a magnetic element, which may consist of a ferrite permanent magnet material (commonly, strontium or barium ferrite, or a combination of the two), a metal alloy (such as NdFeB or Alnico), any combination of the foregoing with each other or any other material, or any other material capable of being permanently magnetized. Subject flexible magnet sheeting, strips, and profile shapes are capable of being permanently magnetized, but may be imported in either magnetized or unmagnetized (including demagnetized) condition. Subject merchandise may be of any color and may or may not be laminated or bonded with paper, plastic or other material, which paper, plastic or other material may be of any composition and/or color. Subject merchandise may be uncoated or may be coated with an adhesive or any other coating or combination of coatings. Subject merchandise is within the scope of this investigation whether it is in rolls, coils, sheets, or pieces, and regardless of physical dimensions or packaging, including specialty packaging such as digital printer cartridges.
Specifically excluded from the scope of this investigation is retail printed flexible magnet sheeting, defined as flexible magnet sheeting (including individual magnets) that is laminated with paper, plastic or other material, if such paper, plastic or other material bears printed text and/or images, including but not limited to business cards, calendars, poetry, sports event schedules, business promotions, decorative motifs, and the like. This exclusion does not apply to such printed flexible magnet sheeting if the printing concerned consists of only: a trade mark or trade name; country of origin; border, stripes, or lines; any printing that is removed in the course of cutting and/or printing magnets for retail sale or other disposition from the flexible magnet sheeting; manufacturing or use instructions (
All products meeting the physical description of the subject merchandise that are not specifically excluded are included in this scope. The products subject to the investigation are currently classifiable principally under subheadings 8505.19.10 and 8505.19.20 of the Harmonized Tariff Schedule of the United States (“HTSUS”). The HTSUS subheadings are provided only for convenience and customs purposes, however, and the written description of the scope of this proceeding is dispositive.
In accordance with the Preamble to the Department's regulations (
On November 7, 2007, SH Industries, a U.S. importer of subject merchandise, argued that magnetic photo pockets, which are flexible magnets with clear plastic material fused to the magnet to form a pocket into which photographs and other items may be inserted for display, should be excluded from the scope of the antidumping and countervailing duty investigations on raw flexible magnets from the People's Republic of China and Taiwan. On November 13, 2007, the petitioner filed a response to the request by SH Industries, arguing that magnetic photo pockets are properly within the scope of the investigations. On April 11, 2008, the petitioner submitted additional arguments concerning this issue. Because we received this letter only four business days before the statutory deadline for this preliminary determination, we did not have an opportunity to consider it prior to issuance of this preliminary determination.
We invite interested parties to submit comments on the petitioner's April 11, 2008, submission and to present evidence concerning the meaning of the terms “sheeting, strips, and profiles” as those terms are used within the industry. Additionally, because the scope language also states that “subject merchandise may be of any color and may or may not be laminated or bonded with paper, plastic or other material, which paper, plastic or other material may be of any composition and/or color,” we encourage interested parties to comment on whether the plastic photo pocket fused to the flexible magnet satisfies this description.
Finally, interested parties may submit information that would be relevant in an analysis conducted pursuant to section 351.225(k)(2) of our regulations. The Department deadline for such comments will be 14 days after the publication of this notice. Rebuttal comments must be filed within five days thereafter. Comments should be addressed to Import Administration's Central Records Unit (CRU), Room 1870, U.S. Department of Commerce, 14
The Department considers the PRC to be a non-market economy (“NME”) country. In accordance with section 771(18)(c)(i) of the Act, any determination that a country is an NME country shall remain in effect until revoked by the administering authority.
In proceedings involving NME countries, the Department has a rebuttable presumption that all companies within the country are subject to government control and thus should be assessed a single antidumping duty rate. It is the Department's policy to assign all exporters of merchandise subject to investigation involving an NME country this single rate unless an exporter can demonstrate an absence of government control, both in law (
The Department's separate-rate test is not concerned, in general, with macroeconomic/border-type controls,
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from the
In this case, Polyflex has withdrawn from participating in the investigation. Since Polyflex's withdrawal has prevented the Department from asking additional supplemental questions on its separate rate status, and prevents the Department from verifying its responses, the Department has no basis upon which to grant Polyflex a separate rate. Although Polyflex remains a mandatory respondent, the Department considers Polyflex part of the PRC-wide entity because it failed to demonstrate that it qualifies for a separate rate.
Newlife submitted a timely separate rates application. In its application, Newlife stated that it is a wholly Chinese-owned company. Therefore, the Department must analyze whether this company can demonstrate the absence of both
The Department considers the following
The evidence provided by Newlife supports a preliminary finding of
The Department has determined that an analysis of
The evidence provided by Newlife supports a preliminary finding of
The evidence placed on the record of this investigation by Newlife preliminarily demonstrates an absence of
In determining what rate to assign companies receiving separate rates, the Department's normal practice is to weight-average the individually calculated margins from the mandatory respondents.
Sections 776(a)(1) and (2) of the Act provide that the Department shall apply “facts otherwise available” if,
Where the Department determines that a response to a request for information does not comply with the request, section 782(d) of the Act provides that the Department will so inform the party submitting the response and will, to the extent practicable, provide that party the opportunity to remedy or explain the deficiency. If the party fails to remedy the deficiency within the applicable time limits and, subject to section 782(e) of the Act, the Department may disregard all or part of the original and subsequent responses, as appropriate. Pursuant to section 782(e) of the Act, the Department shall not decline to consider submitted information if all of the following requirements are met: (1) The information is submitted by the established deadline; (2) the information can be verified; (3) the information is not so incomplete that it cannot serve as a reliable basis for reaching the applicable determination; (4) the interested party has demonstrated that it acted to the best of its ability; and (5) the information can be used without undue difficulties.
On February 12, 2008, counsel for Polyflex informed the Department that it would not continue participation in the instant investigation.
The Department attempted to identify additional mandatory respondents by issuing shipment letters to Marketa and Logimag on November 15, 2007, and November 29, 2007, respectively. The Department issued a second shipment questionnaire to Marketa on November 28, 2007, and to Logimag on December 12, 2007. These companies did not respond to the Department's requests for information. We have treated the non-responsive PRC producers/exporters as part of the PRC-wide entity because they did not qualify for a separate rate. Since the PRC-wide entity withheld information requested by the Department, we find that the use of facts available is appropriate to determine the PRC-wide rate, pursuant to section 776(a)(2)(A) of the Act.
Section 776(b) of the Act provides that, in selecting from among the facts otherwise available, the Department may employ an adverse inference if an interested party fails to cooperate by not acting to the best of its ability to comply with requests for information.
Section 776(b) of the Act authorizes the Department to use, as AFA, information derived from the petition, the final determination from the LTFV investigation, a previous administrative review, or any other information placed on the record. In selecting a rate for AFA, the Department selects one that is sufficiently adverse “as to effectuate the purpose of the facts available rule to induce respondents to provide the Department with complete and accurate information in a timely manner.”
Section 776(c) of the Act provides that, when the Department relies on secondary information in using the facts otherwise available, it must, to the extent practicable, corroborate that information from independent sources that are reasonably at its disposal. We have interpreted “corroborate” to mean that we will, to the extent practicable, examine the reliability and relevance of the information submitted.
To corroborate the 105.00 and 185.28 percent margins used as facts available for Newlife and as adverse facts available for the PRC-wide entity, respectively, to the extent appropriate information was available, we reviewed the adequacy and accuracy of the information in the petition during our pre-initiation analysis.
The Department has determined that the following preliminary dumping margins exist for the POI:
In accordance with 19 CFR 351.224(b), the Department will disclose to parties to this proceeding the calculations performed in reaching the preliminary results within five days after the date of publication of these preliminary results.
In accordance with section 733(d) of the Act, we will instruct U.S. Customs and Border Protection (“CBP”) to suspend liquidation of all entries of raw flexible magnets from the PRC, as described in the “Scope of Investigation” section, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
In accordance with section 733(f) of the Act, we have notified the ITC of our preliminary affirmative determination of sales at LTFV. Section 735(b)(2) of the Act requires the ITC to make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of magnets, or sales (or the likelihood of sales) for importation, of the subject merchandise within 45 days of our final determination.
19 CFR 351.301(b)(1) states that new factual information must be submitted no later than seven days before the date on which verification is to commence.
Interested parties may submit written comments (case briefs) within 30 days of publication of the preliminary results and rebuttal comments (rebuttal briefs), which must be limited to issues raised in the case briefs, within five days after the time limit for filing case briefs.
Any interested party may request a hearing within 21 days of publication of this notice.
Unless the deadline is extended pursuant to section 735(a)(2) of the Act, the Department will make its final determination within 75 days after the date of this preliminary determination, pursuant to section 735(a)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
April 25, 2008.
We preliminarily determine that imports of raw flexible magnets from Taiwan are being, or are likely to be, sold in the United States at less than fair value, as provided in section 733 of the Tariff Act of 1930, as amended. Interested parties are invited to comment on this preliminary determination. We will make our final determination within 75 days after the date of this preliminary determination.
Catherine Cartsos or Richard Rimlinger, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-1757 and (202) 482-4477, respectively.
On October 18, 2007, the Department of Commerce (the Department) published in the
On November 5, 2007, the International Trade Commission (ITC) issued its affirmative preliminary determination that there is a reasonable indication that an industry in the United States is materially injured by reason of imports of raw flexible magnets from the People's Republic of China and Taiwan. See
On December 11, 2007, we selected Kin Fong Magnets Co., Ltd. (Kin Fong), Magruba Flexible Magnets Co., Ltd. (Magruba), and JASDI Magnet Co., Ltd. (JASDI), as the mandatory respondents in this investigation. See the Memorandum form Laurie Parkhill to Stephen J. Claeys entitled “Antidumping Duty Investigation on Raw Flexible Magnets from Taiwan - Selection of Respondents,” December 11, 2007.
On March 13, 2008, the petitioner alleged that JASDI made home-market sales of raw flexible magnets at prices below the cost of production during the period of investigation. On March 26, 2008, we initiated an investigation to determine whether JASDI made home-market sales of raw flexible magnets at prices below the cost of production during the period of investigation. See Memorandum from Richard Rimlinger to Laurie Parkhill entitled “Raw Flexible Magnets from Taiwan: Request to Initiate Cost Investigation of JASDI Magnet Co., Ltd.,” dated March 26, 2008.
The period of investigation is July 1, 2006, through June 30, 2007.
The products covered by this investigation are certain flexible magnet sheeting, strips, and profile shapes. Subject flexible magnet sheeting, strips, and profile shapes are bonded magnets composed (not necessarily exclusively) of (i) any one or combination of various flexible binders (such as polymers or co-polymers, or rubber) and (ii) a magnetic element, which may consist of a ferrite permanent magnet material (commonly, strontium or barium ferrite, or a combination of the two), a metal alloy (such as NdFeB or Alnico), any combination of the foregoing with each other or any other material, or any other material capable of being permanently magnetized. Subject flexible magnet sheeting, strips, and profile shapes are capable of being permanently magnetized, but may be imported in either magnetized or unmagnetized (including demagnetized) condition. Subject merchandise may be of any color and may or may not be laminated or bonded with paper, plastic, or other material, which paper, plastic, or other material may be of any composition and/or color. Subject merchandise may be uncoated or may be coated with an adhesive or any other coating or combination of coatings. Subject merchandise is within the scope of this investigation whether it is in rolls, coils, sheets, or pieces and regardless of physical dimensions or packaging, including specialty packaging such as digital printer cartridges.
Specifically excluded from the scope of this investigation is retail printed flexible magnet sheeting, defined as flexible magnet sheeting (including individual magnets) that is laminated with paper, plastic or other material if such paper, plastic, or other material bears printed text and/or images, including but not limited to business cards, calendars, poetry, sports event schedules, business promotions, decorative motifs, and the like. This exclusion does not apply to such printed flexible magnet sheeting if the printing concerned consists of only the following: a trade mark or trade name; country of origin; border, stripes, or lines; any printing that is removed in the course of cutting and/or printing magnets for retail sale or other disposition from the flexible magnet sheeting; manufacturing or use instructions (
All products meeting the physical description of subject merchandise that are not specifically excluded are included in this scope. The products subject to the investigation are currently
On November 7, 2007, SH Industries, a U.S. importer of subject merchandise, argued that magnetic photo pockets, which are flexible magnets with clear plastic material fused to the magnet to form a pocket into which photographs and other items may be inserted for display, should be excluded from the scope of the antidumping and countervailing duty investigations on raw flexible magnets from the People's Republic of China and Taiwan. On November 13, 2007, the petitioner filed a response to the request by SH Industries, arguing that magnetic photo pockets are properly within the scope of the investigations. On April 11, 2008, the petitioner submitted additional argument concerning this issue. Because we received this letter only four business days before the statutory deadline for this preliminary determination, we did not have an opportunity to consider it prior to issuance of this preliminary determination.
We invite interested parties to submit comments on the petitioner's April 11, 2008, submission and to present evidence concerning the meaning of the terms “sheeting, strips, and profiles” as those terms are used within the industry. Additionally, because the scope language also states that “subject merchandise may be of any color and may or may not be laminated or bonded with paper, plastic or other material, which paper, plastic or other material may be of any composition and/or color,” we encourage interested parties to comment on whether the plastic photo pocket fused to the flexible magnet satisfies this description.
Finally, interested parties may submit information that would be relevant in an analysis conducted pursuant to section 351.225(k)(2) of our regulations. The deadline for such comments will be 14 days after the publication of this notice. Rebuttal comments must be filed within five days thereafter. Comments should be addressed to Import Administration's Central Records Unit (CRU), Room 1870, U.S. Department of Commerce, 14th Street and Constitution Avenue, N.W., Washington, D.C. 20230.
On December 11, 2007, we issued Sections A, B, C, D, and E
We have not received any response to our questionnaire or any other communication from Kin Fong since we issued the questionnaire to it. Magruba made attempts to respond to our January 8, 2008, letter claiming that it had not made sales during the POI as we discuss below. Although JASDI responded to Sections A, B, and C of our antidumping questionnaire initially, it did not respond to our March 11, 2008, supplemental questionnaire. Additionally, even though we informed JASDI that we had initiated an investigation to determine whether JASDI made sales of raw flexible magnets in Taiwan at prices that were below the cost of production and requested that JASDI respond to Section D of our antidumping questionnaire by April 10, 2008, JASDI did not respond to our request.
Finally, the Department rejected JASDI's request to withhold certain information from disclosure under the administrative protective order (APO). The Department requested that JASDI resubmit this information, protected under the APO. Due to timing issues, the Department also requested written authorization to share this information protected under the terms of the APO with the petitioners. JASDI did not resubmit the information as requested and did not respond to the Department's request for authorization to release the information under the APO.
For the reasons discussed below, we determine that the use of adverse facts available (AFA) is appropriate for the preliminary determination with respect to Kin Fong, Magruba, and JASDI.
Section 776(a)(2) of the Act provides that, if an interested party withholds information requested by the administering authority, fails to provide such information by the deadlines for submission of the information and in the form or manner requested, subject to subsections (c)(1) and (e) of section 782, significantly impedes a proceeding under this title, or provides such information but the information cannot be verified as provided in section 782(i), the administering authority shall use, subject to section 782(d) of the Act, facts otherwise available in reaching the applicable determination. Section 782(d) of the Act provides that, if the administering authority determines that a response to a request for information does not comply with the request, the administering authority shall promptly inform the responding party and provide an opportunity to remedy the deficient submission. Section 782(e) of the Act states further that the Department shall not decline to consider submitted information if all of the following requirements are met: (1) the information is submitted by the established deadline; (2) the information can be verified; (3) the information is not so incomplete that it cannot serve as a reliable basis for reaching the applicable determination; (4) the interested party has demonstrated that it acted to the best of its ability; and (5) the information can be used without undue difficulties.
In this case, Kin Fong, Magruba, and JASDI did not provide essential information we requested that is necessary to calculate an antidumping margin for the preliminary determination. Specifically, Kin Fong and Magruba failed to respond to all of our questionnaires, thereby withholding information that is necessary for reaching the applicable determination, pursuant to section 776(a)(2)(A) of the Act. Also, because JASDI failed to
In applying the facts otherwise available, section 776(b) of the Act provides that, if the administering authority finds that an interested party has failed to cooperate by not acting to the best of its ability to comply with a request for information from the administering authority, in reaching the applicable determination under this title, the administering authority may use an inference adverse to the interests of that party in selecting from among the facts otherwise available.
Adverse inferences are appropriate “to ensure that the party does not obtain a more favorable result by failing to cooperate than if it had cooperated fully.” See Statement of Administrative Action accompanying the Uruguay Round Agreements Act, H.R. Doc. No. 103-316, vol.1 (1994) at 870 (
With respect to Kin Fong, although the Department provided it with notice informing it of the consequences of its failure to respond adequately to the Department's questionnaire in this case pursuant to section 782(d) of the Act, Kin Fong did not respond to the questionnaire. This constitutes a failure on the part of Kin Fong to cooperate to the best of its ability to comply with a request for information by the Department within the meaning of section 776(b) of the Act. Because Kin Fong did not provide the information requested, section 782(e) of the Act is not applicable. Based on the above, the Department has preliminarily determined that Kin Fong failed to cooperate to the best of its ability and, therefore, in selecting from among the facts otherwise available, an adverse inference is warranted. See,
With respect to Magruba, although the Department provided it with notice informing it of the consequences of its failure to respond adequately to the questionnaire in this case pursuant to section 782(d) of the Act, Magruba did not file a proper response to the questionnaire.
On December 11, 2007, we sent Magruba a questionnaire. The response to Section A of our questionnaire was due on January 2, 2008. The response to sections B through D of our questionnaire was due on January 22, 2008. Because Magruba did not submit a Section A questionnaire response by the due date, we sent Magruba a follow-up letter on January 8, 2008, in which we repeated the consequences of its failure to respond adequately to our questionnaire.
On January 9, 2008, Magruba transmitted to the Department a letter in which it claimed it did not sell subject merchandise to the United States during the POI. Magruba did not file its January 9, 2008, letter in accordance to our regulations. On January 19, 2008, we sent Magruba a letter in which we identified the filing, service, and certification deficiencies of Magruba's January 9, 2008, submission. Namely, Magruba did not mail the letter to the Department of Commerce in accordance with 19 CFR 351.303(b) but faxed and e-mailed the letter, which are not acceptable methods for filing purposes. In addition, Magruba did not file the requisite number of copies in accordance with 19 CFR 351.303(c), did not provide the proper specifications on its cover letter in accordance with 19 CFR 351.303(d)(2)(v), did not include a certification that it served a copy of its submission on interested parties in accordance with 19 CFR 351.303(f), and, finally, did not include a certificate of accuracy in accordance with 19 CFR 351.303(g). Also in our January 19, 2008, letter we enclosed a copy of the pertinent regulations (19 CFR 351.303) and a copy of the public service list. Finally, in our January 19, 2008, letter we informed Magruba that we had placed a copy of its January 9, 2008, on the record but requested that Magruba refile its Janaury 9, 2008, letter in accordance with 19 CFR 351.303 by the close of business on January 22, 2008. We emphasized that, if Magruba did not file future submissions within the set deadline and in accordance with our regulations, we would reject the submission which may result in our use of adverse facts available. Magruba did not refile its January 9, 2008, letter.
On January 18, 2008, the petitioner filed comments on Magruba's Janaury 9, 2008, letter. The petitioner claimed that Magruba had in fact made sales of subject merchandise to the United States during the POI and supported its claim with import data sourced from the “PIERS” database.
On February 19, 2008, Magruba faxed and e-mailed a second letter to the Department repeating the same filing, service, and certification deficiencies of its January 9, 2008, letter. The February 19, 2008, letter had different content than the January 8, 2008, letter and thus was not an attempt to refile the Janaury 9, 2008, letter. On March 3, 2008, we sent a letter to Magruba in which we rejected its February 19, 2008, letter due to its filing deficiencies. In the letter we identified the deficiencies and again included a copy of the pertinent regulations and public service list. We allowed Magruba a chance to remedy the deficiencies and refile its February 19, 2008, letter by March 10, 2008. Magruba did not refile the letter.
Information we obtained from the U.S. Customs and Border Protection (CBP) supports the petitioner's allegation that entries of subject merchandise from Magruba entered the United States during the POI. See Memorandum from Catherine Cartsos through Richard Rimlinger to the File, Less-Than-Fair-Value Investigation On Raw Magnets from Taiwan: Customs and Border Protection Entry Data for Magruba Flexible Magnets Co., Ltd., dated April 18, 2008 (Magruba CBP Data Memorandum).
Magruba did not respond to our questionnaire. Even if Magruba believed that it did not sell merchandise covered by the scope of the investigation to the United States during the POI, Magruba still should have submitted a questionnaire response in which it
As explained above, JASDI failed to provide pertinent information we requested that is necessary to calculate an antidumping margin for the preliminary determination. Specifically, JASDI withheld information concerning its sales practices and cost-of-production information, which is necessary for reaching the applicable determination. See section 776(a)(2)(A) of the Act. These actions constitute a failure on the part of JASDI to cooperate to the best of its ability to comply with a request for information by the Department within the meaning of section 776(b) of the Act. Accordingly, the Department has preliminarily determined that JASDI failed to cooperate to the best of its ability and, therefore, in selecting from among the facts otherwise available, an adverse inference is warranted. See
Where the Department applies AFA because a respondent failed to cooperate by not acting to the best of its ability by complying with a request for information, section 776(b) of the Act authorizes the Department to rely on information derived from the petition, a final determination, a previous administrative review, or other information placed on the record. See also 19 CFR 351.308(c) and the
When using facts otherwise available, section 776(c) of the Act provides that, when the Department relies on secondary information (such as the petition) rather than on information obtained in the course of an investigation, it must corroborate, to the extent practicable, information from independent sources that are reasonably available at its disposal.
The SAA clarifies that “corroborate” means the Department will satisfy itself that the secondary information to be used has probative value. See
For the purposes of this investigation, to the extent appropriate information was available, we reviewed the adequacy and accuracy of the information in the
The petitioner calculated CEP using two price offers from the U.S. affiliated reseller of JASDI, a Taiwanese producer of raw flexible magnets. The petitioner provided an affidavit from the employee who obtained the price offers. The petitioner deducted amounts for foreign inland-freight costs, international freight costs, U.S. inland-freight costs, U.S. operating expenses (as indirect selling expenses), inventory carrying costs, and CEP profit. The petitioner used publicly available data, such as import statistics from the Bureau of Census, to estimate charges for freight expenses and marine-insurance expenses. Due to the payment terms described in the price offers, the petitioner made no adjustments for imputed credit expense. See
With respect to normal value, the petitioner calculated normal value using six price quotes, obtained by a market
Therefore, because we confirmed the accuracy and validity of the information underlying the derivation of margins in the
In making a determination as to the relevance aspect of corroboration, the Department will consider information reasonably at its disposal as to whether there are circumstances that would render a margin not relevant. Where circumstances indicate that the selected margin is not appropriate as AFA, the Department will disregard the margin and determine an appropriate margin. For example, in
In
As such, we preliminarily determine that the highest margin in the
Similar to our position in
Section 735(c)(5)(B) of the Act provides that, where the estimated weighted-averaged dumping margins established for all exporters and producers individually investigated are zero or
In accordance with section 733(d) of the Act, we are directing U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of raw flexible magnets from Taiwan that are entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
In accordance with section 733(f) of the Act, we have notified the ITC of our preliminary determination of sales at less than fair value. If our final antidumping determination is affirmative, the ITC will determine whether the imports covered by that determination are materially injuring, or threatening material injury to, the U.S. industry. The deadline for the Commission's determination would be the later of 120 days after the date of this preliminary determination or 45 days after the date of our final determination.
Case briefs for this investigation must be submitted no later than 30 days after the publication of this notice. Rebuttal briefs must be filed within five days after the deadline for submission of case briefs. A list of authorities used, a table of contents, and an executive summary of issues should accompany any briefs submitted to the Department. Executive summaries should be limited to five pages total, including footnotes.
Section 774 of the Act provides that the Department will hold a hearing to afford interested parties an opportunity to comment on arguments raised in case or rebuttal briefs, provided that such a hearing is requested by an interested
Interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request within 30 days of the publication of this notice. See 19 CFR 351.310(c). Requests should specify the number of participants and provide a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs.
We will not be conducting verifications of Kin Fong, Magruba, and JASDI because they have failed to file responses to all of our questionnaires, as discussed above in the Use of Facts Available section of this notice. Therefore, the deadline for submission of factual information in 19 CFR 351.301(b)(1) is not applicable. Thus, the deadline for submission of factual information in this investigation will be seven days after the date of publication of this notice.
We will make our final determination within 75 days after the date of this preliminary determination, pursuant to section 735(a)(1) of the Act.
This determination is issued and published pursuant to sections 733(f) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
April 25, 2008.
Karine Gziryan or Mark Manning, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-4081 and (202) 482-5253, respectively.
On May 25, 2007, the Department of Commerce (“Department”) published a notice of initiation of administrative review of the antidumping duty order on polyethylene retail carrier bags from the Peoples' Republic of China (“PRC”).
Pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“Act”), the Department shall make a preliminary determination in an administrative review of an antidumping duty order within 245 days after the last day of the anniversary month of the date of publication of the order. Section 751(a)(3)(A) of the Act further provides, however, that the Department may extend the 245-day period to 365 days if it determines it is not practicable to complete the review within the foregoing time period. The Department determines that it is not practicable to complete this administrative review within the time limits mandated by section 751(a)(3)(A) of the Act because this review involves examining a number of complex issues related to the factors of production and surrogate values. The Department requires additional time to issue and analyze supplemental questionnaires regarding these issues. Therefore, in accordance with section 751(a)(3)(A) of the Act, the Department is extending the time period for completing the preliminary results of this administrative review until August 30, 2008, which is 365 days from the last day of the anniversary month of the date of publication of the order. However, August 30, 2008, falls on a Saturday and September 1, 2008, is a federal holiday. It is the Department's long-standing practice to issue a determination the next business day when the statutory deadline falls on a weekend, federal holiday, or any other day when the Department is closed.
This extension notice is issued and published in accordance with sections 751(a)(3)(A) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with March anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews. The Department also received a request to revoke one antidumping duty order in part.
Sheila E. Forbes, Office of AD/CVD Operations, Customs Unit, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, telephone: (202) 482-4697.
The Department has received timely requests, in accordance with 19 CFR 351.213(b)(2004), for administrative reviews of various antidumping and countervailing duty orders and findings with March anniversary dates. The Department received a timely request to revoke in part the antidumping duty order on Certain Tissue Paper Products from the People's Republic of China with respect to one exporter.
In accordance with section 19 CFR 351.221(c)(1)(i), we are initiating
None.
None.
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under section 351.211 or a determination under section 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine, consistent with
Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
These initiations and this notice are in accordance with section 751(a) of the Tariff Act of 1930, as amended (19 U.S.C. 1765(a)), and 19 CFR 351.221(c)(1)(i).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that an Exempted Fishing Permit (EFP) application submitted by David Beutel and Laura Skrobe of the University of Rhode Island (URI) contains all of the required information and warrants further consideration. The EFP would enable researchers to test an experimental net that uses very large mesh panels to increase escapement of cod relative to haddock by granting exemption from the Gulf of Maine (GOM) Rolling Closure Areas II and III. The Assistant Regional Administrator has made a preliminary determination that the activities authorized under this EFP would be consistent with the goals and objectives of the Northeast (NE) Multispecies Fishery Management Plan (FMP). However, further review and consultation may be necessary before a final determination is made to issue an EFP. Therefore, NMFS announces that the Assistant Regional Administrator proposes to recommend that an EFP be issued that would allow two commercial fishing vessels to conduct fishing operations that are otherwise restricted by the regulations governing the fisheries of the Northeastern United States.
Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.
Comments must be received on or before May 12, 2008.
You may submit written comments by any of the following methods:
• Email:
• Mail: Patricia A. Kurkul, Regional Administrator, NMFS, NE Regional Office, 1 Blackburn Drive, Gloucester, MA 01930. Mark the outside of the envelope “Comments on Eliminator Trawl EFP.”
• Fax: (978) 281-9135.
Douglas Potts, Fishery Management Specialist, 978-281-9341.
A complete application for an EFP was submitted on April 2, 2008, by David Beutel and Laura Skrobe for a project entitled “Exploring Bycatch Reduction in the Haddock Fishery Through the Use of the Eliminator Trawl with Fishing Vessels in the 250 to 550 Horsepower Range” funded under the Northeast Region Cooperative Research Partnership Program. The study would conduct field testing of a new net design, referred to as the Eliminator Trawl, specifically scaled for vessels with 250 to 550 horsepower engines. This trawl net is equipped with very large mesh in selected portions of the body to increase escapement of cod and flatfish while retaining haddock. The original Eliminator Trawl, currently being considered as an additional gear in special programs in the NE multispecies fishery, is not designed to allow smaller powered vessels to utilize this net.
The EFP would exempt two vessels from the seasonal GOM Rolling Closure Areas II and III, as specified at 50 CFR 648.81(f)(1)(ii) and (iii), while conducting research trips. These closure areas are believed to provide the mix of species needed, while still being close enough to shore for the safe operation of these smaller vessels. The goal of the research is to demonstrate the efficiency of this net design to selectively target haddock. The applicants intend that, if sufficiently effective, the gear be proposed by the New England Fishery Management Council for use in existing Special Access Programs (SAPs) or for the development of a new SAP in the study area.
Research trips would be conducted within 30-minute squares 132 and 133 and the vessels would conduct side-by-side tows. One vessel would fish with the experimental trawl and the other with a standard legal groundfish trawl. The experimental trawl net employs graduated webbing starting with 5 foot (1.524 m) meshes and ending with the legal minimum 6-inch (15.24-cm) mesh size in the body and 6.5-inch (16.51-cm) mesh in the codend. Each vessel would conduct four to six 1-hour tows per day over six days between the start of the EFP and May 30, 2008, and again between April 1 and May 30, 2009. The researchers believe the best mix of haddock, Atlantic cod, and flounders would be present in this area during this period. Overall, the total expected catch from both the experimental and commercial trawls would be:
Based on other previous research conducted in the proposed area and season, the researchers estimate that the vessels would catch less that 50 lb (22.7 kg) each of other regulated groundfish species, white hake, winter flounder, witch flounder, windowpane flounder, redfish, and pollock. The vessels would be charged A days-at-sea (DAS) during the research trips and would be subject to applicable size and possession limits. Undersized, or otherwise protected fish, would not be retained or landed. Legal sized fish would be landed and sold under normal NE multispecies DAS and other applicable regulations.
The applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments
The Regional Administrator, Southwest Region, NMFS has made a preliminary determination that an application for an Exempted Fishing Permit (EFP) warrants further consideration. The application was submitted to NMFS by a California-based commercial fisherman requesting an exemption for a single vessel from the longline fishing prohibitions within the U.S. Exclusive Economic Zone (EEZ) off the West Coast during the 2008 fishing year beginning mid-September 2008, or, if administrative delays occur, during the 2009 fishing year beginning mid-September 2009. The Regional Administrator has also made a preliminary determination that the activities authorized under the EFP would be consistent with the goals and objectives of the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP). However, further review and consultation is necessary before a final determination is made to issue the EFP. Therefore, NMFS proposes to review the EFP and requests public comment on the application. The application is available for review on the NMFS Southwest Region website:
Comments must be received by May 27, 2008.
You may submit comments on this notice, identified by “RIN 0648-XH38” by any of the following methods:
• E-mail:
• Mail: Rodney R. McInnis, Regional Administrator, Southwest Region, NMFS, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213.
• Fax: (562) 980-4047.
Mark Helvey, Southwest Region, NMFS, (562) 980-4040.
An application for an EFP was submitted to the Pacific Fisheries Management Council (Council) by Peter Dupuy, a commercial fishing vessel owner, in March 2008. EFPs for fishing under the HMS FMP are governed by 50 CFR 600.745 and 660.718. The EFP would exempt a single vessel from following the gear and fishing restrictions at 50 CFR 660.712(a) implementing the HMS FMP that prohibit owners and operators of vessels registered for use of longline gear from using longline gear to fish for or target HMS within the U.S. EEZ. The applicant applied for the EFP with the intent to conduct an exploratory test fishery with a single vessel to gather information on the economic viability and environmental effects, including the potential impacts to protected species and non-target finfish interactions, of fishing for swordfish in the West Coast EEZ.
At its April 2008 meeting, the Council, with advice from its HMS Management Team and HMS Advisory Subpanel, adopted a preferred alternative for the EFP and forwarded that alternative to NMFS, recommending that the agency review the proposed EFP and, if consistent with Federal law, issue the permit. The Council recommended that the applicant be subject to a cap of one short-finned pilot whale and 12 striped marlin, and a prohibition for fishing off the State of Washington. The Council recommended that the fishery be managed through limits on the amount of incidental take of protected species that may be exposed to and adversely affected by this action. The limits will be established based upon Section 7 consultations under the Endangered Species Act by NMFS for marine mammals and sea turtles, and by the U. S. Fish and Wildlife Service for seabirds. If any one of the limits set by these consultations is reached by the fishery authorized by the EFP, the permit would be immediately revoked. The EFP would require 100 percent NMFS observer coverage. The Council's recommendations, described above, would be established as permit conditions.
If approved, the EFP would authorize a single vessel to longline fish in the EEZ off of Oregon and California. Under the proposed terms and conditions of the EFP, the vessel would target swordfish utilizing shallow-set longline gear which is set at a shallower depth (<100 m) than deep-set longline gear which is typically set in the deeper thermocline zone (~300-400 m) for tunas. The applicant would be allowed a maximum of four trips between September and December, 2008, or between September and December, 2009, and a maximum of 14 sets per trip. Fishing would neither be allowed within 50 nautical miles of the coastline nor within the Southern California Bight. The Bight is defined in general terms as coastal waters from Point Conception in the north to just past San Diego in the south, and extending offshore of San Nicolas Island (Channel Islands National Marine Sanctuary waters would be excluded from the fishing area). The mainline may not exceed 100 km and no more than 1,200 hooks may be deployed per set. The applicant would be required to use 18/0 circle hooks with a 10° offset and mackerel or mackerel-type bait (as described at 50 CFR 665.33(f) and (g), respectively). To reduce potential interactions with seabirds, gear could not be set until one hour after local sunset and must be fully deployed before local sunrise. A certain percentage of the deployed gear would be required to be outfitted with time/depth recorders to measure fishing depth; the percentage would be determined by NMFS based on the amount of data needed to extrapolate the depth of all the hooks. The applicant would be required to use a NMFS-certified shark de-hooking device to improve the post-release survivability of incidentally captured sharks.
Aside from the exemptions described above, the vessel fishing under the EFP would be subject to all other regulations implementing the HMS FMP, including measures to protect sea turtles, marine mammals, and seabirds.
The EFP application would be effective for 2008 or 2009 only. In accordance with NOAA Administrative Order 216-6, an appropriate National Environmental Policy Act document will be completed prior to the issuance of the EFP. A draft Environmental Assessment on the EFP was presented to the Council and public in April 2008. Further review and consultation is necessary before a final determination is made to issue the EFP. As required in Section 7(a)(2) of the Endangered Species Act (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that an Exempted Fishing Permit (EFP) application submitted by the Gulf of Maine Research Institute (GMRI) contains all of the required information and warrants further consideration. The Assistant Regional Administrator has made a preliminary determination that the activities authorized under this EFP would be consistent with the goals and objectives of the Monkfish Fishery Management Plan (FMP). However, further review and consultation may be necessary before a final determination is made to issue an EFP. Therefore, NMFS announces that the Assistant Regional Administrator proposes to recommend that an EFP be issued that would allow 11 commercial fishing vessels to conduct compensation fishing operations that are otherwise restricted by the regulations governing the fisheries of the Northeastern United States. This EFP, which would enable vessels to harvest monkfish granted through the Monkfish Research Set-Aside (RSA) Program, would grant exemptions from the monkfish days-at-sea (DAS) possession limits in the Southern Fishery Management Area.
Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.
Comments must be received on or before May 12, 2008.
You may submit written comments by any of the following methods:
• Email: DA8-081@noaa.gov. Include in the subject line “Comments on GMRI Monkfish EFP.”
• Mail: Patricia A. Kurkul, Regional Administrator, NMFS, NE Regional Office, 1 Blackburn Drive, Gloucester, MA 01930. Mark the outside of the envelope “Comments on GMRI monkfish EFP, DA8-081.”
• Fax: (978) 281-9135.
Emily Bryant, Fishery Management Specialist, 978-281-9244.
An application for an EFP was submitted by GMRI on March 21, 2008, for a project funded under the New England and Mid-Atlantic Fishery Management Councils' Monkfish RSA Program. The project itself will evaluate the discard of monkfish caught as bycatch on Northeast (NE) multispecies DAS and directed monkfish trips. Research trips will be covered under a separate EFP. This EFP would grant an exemption from monkfish possession limits to 11 vessels for the purpose of harvesting RSA to fund this research project (i.e. compensation fishing). Funds generated by the compensation fishing will be used to pay for vessel charters, technical and sampling equipment, as well as salaries and stipends for principal investigators and industry collaborators.
The research portion of this project will occur over the course of 1 year and will utilize boat- and port-based data collection programs to estimate and compare monkfish discards between boats trawling for NE multispecies in the DAS program and directed monkfish trips in the Gulf of Maine. The boat-based program will utilize the Study Fleet electronic logbook and independent at-sea sampling, and will be complemented with port-based sampling of retained and otherwise discarded monkfish. The research would be covered under the programmatic Study Fleet EFP. More information regarding the exemptions requested for this EFP can be found in the
Compensation fishing for this research will occur from May 2008 through April 2009. The 11 fishing industry collaborators will have access to 139 Monkfish DAS that will be awarded to the project through the Monkfish RSA Program. These vessels must be able to land at least 2,500 lb (1,134 kg) of whole monkfish (730 lb (331 kg) tail weight) per trip to achieve the goal of $3,000 per RSA DAS. In order to achieve this target catch, these fishing activities would require an exemption from monkfish DAS possession limits at § 648.94(b)(2). This exemption would provide these 11 vessels with the flexibility they need to generate sufficient income to meet projected costs, while minimizing operating expenses, of the research activity. Based on the awarded 139 DAS, this would require a total catch of 347,500 lb (157,623 kg) of whole monkfish (104,669 lb (47,477 kg) tail weight). Operating under this total landings cap, compensation fishing would continue until the required goal of 347,500 lb (157,623 kg) of whole monkfish is met, or until the awarded DAS have been fully utilized, which ever occurs first. Aside from this exemption, fishing activity will be conducted under normal commercial practices.
The applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited. If the research project is terminated for any reason prior to completion, any unused funds collected from catch sold to pay for research expenses may be refunded to NOAA.
16 U.S.C. 1801
National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of availability and request for public comment.
NOAA publishes this notice to announce the availability of the draft NOAA Hurricane Forecasting
Comments on this draft document must be submitted by 5 p.m. EDT on May 27, 2008.
The draft NOAA Hurricane Forecasting Improvement Project Plan will be available on the NOAA Research Council Web site at
The public is encouraged to submit comments electronically to
Mr. Roger Pierce, Silver Spring Metro Center Bldg. 3, Room 11314, R/PPE, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone 301-734-1062, Fax: 301-713-0158, E-mail:
NOAA is publishing this notice to announce the availability of the draft NOAA Hurricane Forecasting Improvement Project Plan for public comment. The NOAA is seeking public comment from all interested parties. The NOAA Hurricane Forecasting Improvement Project Plan draft is being issued for comment only and is not intended for interim use. Suggested changes will be incorporated where appropriate, and the final document will be posted on a NOAA Web site.
The NOAA Hurricane Forecasting Improvement Project Plan is being is being developed to reflect the evolution of NOAA's research activities and priorities. The draft NOAA Hurricane Forecasting Improvement Project Plan is consistent with the NOAA Science Advisory Board, Hurricane Intensity Research Working Group recommendations and other recent internal and external reports on hurricanes.
The draft NOAA Hurricane Forecasting Improvement Project Plan frames research in NOAA within the context of societal needs and by working with other government and academic organizations working on critical environmental challenges, particularly those associated with hurricanes, facing the United States today and in the future. This plan states NOAA's priority research areas, such as Hurricane Intensity forecast improvements, improvements in high performance computing, use of new data, for the short term and the milestones by which NOAA intends to measure progress within these areas. Significant topics addressed in the NOAA Hurricane Forecasting Improvement Project Plan include the importance of transition of research to application, the recognition of the value of transformational research, and the engagement and alignment of inter-agency and the larger scientific community efforts toward finding solutions to the challenges posed to improve hurricane forecasts.
NOAA welcomes all comments on the content of the draft NOAA Hurricane Forecasting Improvement Project Plan. We also request comments on any inconsistencies perceived within the document and possible omissions of important topics or issues. For any shortcoming noted within the draft document, please propose specific remedies.
Please follow these instructions for preparing and submitting comments. Using the format guidance described below will facilitate the processing of reviewer comments and assure that all comments are appropriately considered. Overview comments should be provided first. Comments that are specific to particular pages, paragraphs, or lines of the section should follow any overview comments and should identify the page numbers to which they apply. Please number each page of your comments.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
Notice is hereby given that NMFS, Southwest Fisheries Science Center (SWFSC) (Jeremy Rusin, Principal Investigator), Protected Resources Division, 8604 La Jolla Shores Dr., La Jolla, CA 92037 has been issued an amendment to scientific research Permit No. 774-1714-06.
The amendment and related documents are available for review upon written request or by appointment in the following offices: See
Amy Hapeman or Carrie Hubard, (301)713-2289.
On March 12, 2007, notice was published in the
Permit No. 774-1714-07 authorizes the SWFSC to conduct research on seven pinniped species, 55 cetacean species, and five sea turtle species in the Pacific, Indian, Atlantic, Arctic and Southern Oceans. The permit authorizes Level B harassment during aerial and vessel surveys for photo-identification/photogrammetry, incidental harassment, collection of sloughed skin, and salvage of carcasses and parts; Level A harassment for capture, biopsy sampling, and tagging activities; and the import/export of specimens. This amendment: (1) reorganizes the take table to reflect annual takes instead of 5-year cumulative takes; (2) increases the number of animals harassed during aerial and vessel surveys, biopsy sampled, and/or tagged for several cetacean species; (3) collapses authorized takes of six cetacean stocks to the species level; (4) adds Antarctic minke whales (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Issuance of this permit, as required by the ESA, was based on a finding that such permit: (1) was applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.
Documents may be reviewed in the following locations:
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713-2289; fax (301)427-2521;
Northwest Region, NMFS, 7600 Sand Point Way NE, BIN C15700, Bldg. 1, Seattle, WA 98115-0700; phone (206)526-6150; fax (206)526-6426;
Alaska Region, NMFS, P.O. Box 21668, Juneau, AK 99802-1668; phone (907)586-7221; fax (907)586-7249;
Southwest Region, NMFS, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213; phone (562)980-4001; fax (562)980-4018; and
Pacific Islands Region, NMFS, 1601 Kapiolani Blvd., Rm 1110, Honolulu, HI 96814-4700; phone (808)944-2200; fax (808)973-2941.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Modification of e-mail addresses published in the document entitled “South Atlantic Fishery Management Council; Public Meetings”, which published in the
The South Atlantic Fishery Management Council has modified email addresses for submitting public hearing comments for Amendment 16 to the Snapper Grouper Fishery Management Plan and for the Comprehensive Ecosystem Amendment. See
The public comment period for these amendments are open until 5 p.m., May 16, 2008.
Written comments should be sent to Bob Mahood, Executive Director, South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, North Charleston SC 29405. Copies of the public hearing documents are available from Kim Iverson, South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; telephone: (843)571-4366 or toll free at (866)SAFMC-10.
Kim Iverson, Public Information Officer, South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone (843)571-4366 or toll free 866/SAFMC-10; FAX 843/769-4520; email:
On April 17, 2008, NMFS published notification of public hearings and scoping meetings to be held from May 7 through May 15, 2008. The open period for written comments for these meetings ends at 5 p.m. on May 16, 2008. The e-mail addresses for comments regarding the Snapper Grouper Amendment 16 and the e-mail address for the Comprehensive Ecosystem Amendment were not listed correctly. The correct e-mail addresses are as follows:
For the Snapper Grouper Amendment 16, the e-mail address is
For the Comprehensive Ecosystem Amendment, the e-mail address is
All other information in the April 17, 2008, document (FR Doc. E8-8286) remains unchanged.
United States Patent and Trademark Office.
Notice and request for nominations.
On November 29, 1999, the President signed into law the Patent and Trademark Office Efficiency Act (the “Act”), Pub. L. 106-113, which, among other things, established two Public Advisory Committees to review the policies, goals, performance, budget and user fees of the United States Patent and Trademark Office (USPTO) with respect to patents, in the case of the Patent Public Advisory Committee, and with respect to trademarks, in the case of the Trademark Public Advisory Committee, and to advise the Director on these matters (now codified at 35 U.S.C. 5). The USPTO is requesting nominations for three (3) members to each Public Advisory Committee for terms of three years that begin from date of appointment.
Nominations must be postmarked or electronically transmitted on or before May 30, 2008.
Persons wishing to submit nominations should send the nominee's resumé to Chief of Staff, Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, Post Office Box 1450, Alexandria, Virginia 22313-1450; by electronic mail to:
Eleanor K. Meltzer, Chief of Staff, by facsimile transmission marked to her attention at (571) 273-0464, or by mail marked to her attention and addressed to the Office of the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, Post Office Box 1450, Alexandria, Virginia 22313-1450.
The Advisory Committees' duties include:
• Review and advise the Under Secretary of Commerce for Intellectual Property and Director of the USPTO on matters relating to policies, goals, performance, budget, and user fees of the USPTO relating to patents and trademarks, respectively; and
• Within 60 days after the end of each fiscal year: (1) Prepare an annual report on matters listed above; (2) transmit a report to the Secretary of Commerce, the President, and the Committees on the Judiciary of the Senate and the House of Representatives; and (3) publish the report in the Official Gazette of the USPTO.
Members of the Patent and Trademark Public Advisory Committees are appointed by and serve at the pleasure of the Secretary of Commerce for three (3)-year terms.
The Public Advisory Committees are each composed of nine (9) voting members who are appointed by the Secretary of Commerce (the “Secretary”). The Public Advisory Committee members must be United States citizens and represent the interests of diverse users of the USPTO, both large and small entity applicants in proportion to the number of such applications filed. The Committees must include members who have “substantial backgrounds and achievement in finance, management, labor relations, science, technology, and office automation.” 35 U.S.C. 5(b)(3). In the case of the Patent Public Advisory Committee, at least twenty-five (25) percent of the members must represent “small business concerns, independent inventors, and nonprofit organizations,” and at least one member must represent the independent inventor community. 35 U.S.C. 5(b)(2). Each of the Public Advisory Committees also includes three (3) non-voting members representing each labor organization recognized by the USPTO.
Each newly appointed member of the Patent and Trademark Public Advisory Committees will serve for a term of three years from date of appointment. As required by the Act, members of the Patent and Trademark Public Advisory Committees will receive compensation for each day while the member is attending meetings or engaged in the business of that Advisory Committee. The rate of compensation is the daily equivalent of the annual rate of basic pay in effect for level III of the Executive Schedule under section 5314 of title 5, United States Code. While away from home or regular place of business, each member will be allowed travel expenses, including per diem in lieu of subsistence, as authorized by Section 5703 of Title 5, United States Code. The USPTO will provide the necessary administrative support, including technical assistance, for the Committees.
Members of each Public Advisory Committee shall be Special Government Employees within the meaning of Section 202 of title 18, United States Code. The following additional information includes several, but not all, of the ethics rules that apply to members, and assumes that members are not engaged in Public Advisory Committee business more than sixty days during each calendar year:
• Each member will be required to file a confidential financial disclosure form within thirty (30) days of appointment. 5 CFR 2634.202(c), 2634.204, 2634.903, and 2634.904(b).
• Each member will be subject to many of the public integrity laws, including criminal bars against representing a party, 18 U.S.C. 205(c), in a particular matter that came before the member's committee and that involved at least one specific party.
• Representation of foreign interests may also raise issues. 35 U.S.C. 5(a)(1) and 18 U.S.C. 219.
Meetings of each Advisory Committee will take place at the call of the Chair to consider an agenda set by the Chair. Meetings may be conducted in person, electronically through the Internet, or by other appropriate means. The meetings of each Advisory Committee will be open to the public except each Advisory Committee may, by majority vote, meet in executive session when considering personnel, privileged, or other confidential matters. Nominees must also have the ability to participate in Committee business through the Internet.
Submit resumés for nomination for the Patent Public Advisory Committee and the Trademark Public Advisory Committee to: Chief of Staff to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, utilizing the addresses provided above.
Department of Defense; Missile Defense Agency.
Notice of cancelled meeting.
Due to the last minute unavailability of a quorum, the Missile Defense Advisory Committee meeting scheduled for Wednesday, April 2 and Thursday, April 3, 2008, from 8 a.m. to 5 p.m. was cancelled. At this date, neither the Department of Defense nor the committee's Designated Federal Officer has plans to reschedule the meeting.
Mr. Al Bready, Designated Federal Officer at
The Department of Defense announced this closed meeting in a notice that was published in the
Notice is hereby given that the Delaware River Basin Commission will hold an informal conference followed by a public hearing on Wednesday, May 14, 2008. The hearing will be part of the Commission's regular business meeting. Both the conference session and business meeting are open to the public and will be held at the Independence Seaport Museum at Penn's Landing, 211 South Columbus Boulevard and Walnut Street, Philadelphia, Pennsylvania.
The conference among the commissioners and staff will begin at 10:30 a.m. Topics of discussion will include: Update on a request for proposal for the Reassessment Study to be undertaken in accordance with the Decree Parties' Agreement of September 26, 2007; and presentation by Lori Dillard Rech, President of the Independence Seaport Museum. Because of the large number of dockets scheduled for public hearing on May 14, in a departure from the customary schedule, the portion of the business meeting consisting of the hearing on Project Review applications will be held at approximately 11:15 a.m., immediately following the morning conference session. At the conclusion of the hearing on Project Review applications, there will be a break for lunch. The business meeting will resume at 1:30 p.m.
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At the conclusion of the hearing on Project Review applications the business meeting will adjourn for lunch. The meeting will resume at 1:30 p.m. with consideration of the draft Minutes from the March 12, 2008 business meeting, announcements of upcoming events, including meetings of Commission advisory committees; a hydrologic report; a report by the Executive Director; and a report by the Commission's General Counsel.
The Commission will then consider a series of resolutions, among which the following will include public hearings: a resolution approving the 2008-2013 Water Resources Program; a resolution to amend the composition of the Monitoring Advisory Committee by the addition of a representative from the Partnership for the Delaware Estuary; a resolution authorizing the executive director to enter into contracts for the analysis of ambient water samples to characterize the nature and extent of chronic toxicity in the Delaware Estuary; a resolution authorizing the executive director to accept funds from the Pennsylvania Department of Environmental Protection for development of an integrated Water Resources Program for the Schuylkill River Watershed; a resolution authorizing the executive director to accept funds from NOAA-NWS for flood warning improvements and flood warning outreach initiatives recommended by the Interstate Flood Mitigation Task Force Report of July 2007; and a resolution providing for election of the Commission Chair, Vice Chair and Second Vice Chair for the year 2008-2009, commencing July 1, 2008.
The business meeting also will include consideration of a resolution amending the Water Quality Regulations and Comprehensive Plan to permanently designate the Lower Delaware River as a Special Protection Water and clarify certain aspects of the rule. A public hearing on this item was conducted on December 4, 2007 and the comment period closed on December 6, 2007.
Draft dockets scheduled for public hearing on May 14, 2008 will be posted on the Commission's Web site,
Individuals in need of an accommodation as provided for in the Americans with Disabilities Act who wish to attend the informational meeting, conference session or hearings should contact the commission secretary directly at 609-883-9500 ext. 203 or through the Telecommunications Relay Services (TRS) at 711, to discuss how the Commission can accommodate your needs.
Notice inviting applications for a new award for fiscal year (FY) 2008.
An applicant for assistance under this program must demonstrate in its application how it will address, in whole or in part, the needs of individuals with disabilities from minority backgrounds (34 CFR 350.40(a)). The approaches an applicant may take to meet this requirement are found in 34 CFR 350.40(b).
Additional information on the DRRP program can be found at:
These priorities are:
29 U.S.C. 762(g) and 764(a).
The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.
The maximum amount includes direct and indirect costs.
The Department is not bound by any estimates in this notice.
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You can contact ED Pubs at its Web site, also:
If you request an application from ED Pubs, be sure to identify this competition as follows: CFDA Number 84.133A-12.
Individuals with disabilities can obtain a copy of the application package in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) by contacting the person or team listed under
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• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative. Single spacing may be used for titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the recommended page limit does apply to all of the application narrative section (Part III).
The application package will provide instructions for completing all components to be included in the application. Each application must include a cover sheet (Standard Form 424); budget requirements (ED Form 524) and narrative justification; other required forms; an abstract, Human Subjects narrative, Part III narrative; resumes of staff; and other related materials, if applicable.
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Applications for grants under this program may be submitted electronically using the Grants.gov Apply site (Grants.gov), or in paper format by mail or hand delivery. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery, please refer to section IV.6.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
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To comply with the President's Management Agenda, we are participating as a partner in the Governmentwide Grants.gov Apply site. The Disability Rehabilitation Research Projects competition, CFDA number 84.133A-12, is included in this project. We request your participation in Grants.gov.
If you choose to submit your application electronically, you must use the Governmentwide Grants.gov Apply site at
You may access the electronic grant application for the Disability Rehabilitation Research Projects competition—CFDA number 84.133A-12 at
Please note the following:
• Your participation in Grants.gov is voluntary.
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system after 4:30 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov at
• To submit your application via Grants.gov, you must complete all steps in the Grants.gov registration process (see
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you submit your application in paper format.
• If you submit your application electronically, you must submit all documents electronically, including all information you typically provide on the following forms: Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications. Please note that two of these forms—the SF 424 and the Department of fEducation Supplemental Information for SF 424—have replaced the ED 424 (Application for Federal Education Assistance).
• If you submit your application electronically, you must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text), or .PDF (Portable Document) format. If you upload a file type other than the three file types specified in this paragraph or submit a password-protected file, we will not review that material.
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by e-mail. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The Department will contact you after a determination is made on whether your application will be accepted.
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
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If you submit your application in paper format by mail (through the U.S. Postal Service or a commercial carrier), you must mail the original and two copies of your application, on or before the application deadline date, to the Department at the applicable following address:
Regardless of which address you use, you must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
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If you submit your application in paper format by hand delivery, you (or a courier service) must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA number 84.133A-12), 550 12th Street, SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
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The Secretary is interested in outcomes-oriented research or development projects that use rigorous scientific methodologies. To address this interest, applicants are encouraged to articulate goals, objectives, and expected outcomes for the proposed research or development activities. Proposals should describe how results and planned outputs are expected to contribute to advances in knowledge, improvements in policy and practice, and public benefits for individuals with disabilities. Applicants should propose projects that are designed to be consistent with these goals. We encourage applicants to include in their application a description of how results will measure progress towards achievement of anticipated outcomes (including a discussion of measures of effectiveness), the mechanisms that will be used to evaluate outcomes associated with specific problems or issues, and how the proposed activities will support new intervention approaches and strategies. Submission of the information identified in this section V.2.
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If your application is not evaluated or not selected for funding, we notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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NIDRR will provide information by letter to grantees on how and when to submit the final performance report.
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• The percentage of newly-awarded NIDRR projects that are multi-site, collaborative, controlled studies of interventions and programs.
• The number of accomplishments (e.g., new or improved tools, methods, discoveries, standards, interventions, programs, or devices) developed or tested with NIDRR funding that have been judged by expert panels to be of high quality and to advance the field.
• The average number of publications per award based on NIDRR-funded research and development activities in refereed journals.
• The percentage of new grants that include studies funded by NIDRR that assess the effectiveness of interventions, programs, and devices using rigorous methods.
NIDRR uses information submitted by grantees as part of their Annual Performance Reports (APRs) in support of these performance measures.
Updates on the Government Performance and Results Act of 1993 (GPRA) indicators, revisions, and methods appear on the NIDRR Program Review Web site:
Grantees should consult this site on a regular basis to obtain details and explanations on how NIDRR programs contribute to the advancement of the Department's long-term and annual performance goals.
Donna Nangle, U.S. Department of Education, 400 Maryland Avenue, SW., Room 6029, PCP, Washington, DC 20202. Telephone: (202) 245-7462 or by e-mail:
If you use a TDD, call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
Office of Special Education and Rehabilitative Services (OSERS), Department of Education.
Notice of final priority and definitions.
The Assistant Secretary for Special Education and Rehabilitative Services, in conjunction with the Assistant Secretary for Vocational and Adult Education and the Assistant Secretary for Postsecondary Education, announces a priority and definitions for a Center on Postsecondary Education for Students With Intellectual Disabilities (Center) under the DRRP program administered by NIDRR. The Assistant Secretary may use this priority and definitions for competitions in fiscal year (FY) 2008 and later years. We take this action to focus research attention on areas of national need. We intend this priority and definitions to improve postsecondary education and other outcomes for individuals with intellectual disabilities.
Tracy Justesen, U.S. Department of Education, 400 Maryland Avenue, SW., Room 5107, Potomac Center Plaza, Washington, DC 20202-2700. Attention Donna Nangle. Telephone: (202) 245-7462 or by e-mail:
If you use a telecommunications device for the deaf (TDD), call the Federal Relay Service (FRS) at 1-800-877-8339.
Individuals with disabilities can obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the contact person listed under
The purpose of the DRRP program is to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended, by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most severe disabilities. DRRPs carry out one or more of the following types of activities, as specified and defined in 34 CFR 350.13 through 350.19: Research, training, demonstration, development, dissemination, utilization, and technical assistance. An applicant for assistance under this program must demonstrate in its application how it will address, in whole or in part, the needs of individuals with disabilities from minority backgrounds (34 CFR 350.40(a)). The approaches an applicant may take to meet this requirement are found in 34 CFR 350.40(b). In addition, NIDRR intends to require all DRRP applicants to meet the
Additional information on the DRRP program can be found at:
We published a notice of proposed priority and definitions (NPP) for NIDRR's DRRP program in the
There are differences between the NPP and this notice of final priority and definitions (NFP) as discussed in the following section.
In response to our invitation in the NPP, 11 parties submitted comments on the proposed priority and definitions. An analysis of the comments and of any changes in the priority and definitions since publication of the NPP follows.
Generally, we do not address technical and other minor changes, or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address general comments that raised concerns not directly related to the proposed priority or definitions.
With respect to descriptors of postsecondary education, while it is true that neither dataset provides information on dual enrollment programs, we believe that there are many variables or descriptors related to students with ID that are worth exploring.
Lastly, the commenters observed that some variables related to postsecondary outcomes in the NLTS-2 dataset show zero percent of cases of individuals with ID. However, the commenters did not identify any specific postsecondary variables or explain the importance of these variables to the work of the Center. The NLTS-2 has five waves of data, and only three of these waves include individuals who are old enough to be included in the postsecondary sample, particularly because many students with ID attend secondary school to the maximum age (21 years old or older). We believe that the number of variables lacking relevant cases should decline as individuals age in the postsecondary category.
This notice does not solicit applications. In any year in which we choose to use this priority and definitions, we invite applications through a notice in the
This NFP is in concert with President George W. Bush's New Freedom Initiative (NFI) and NIDRR's Final Long-Range Plan for FY 2005-2009 (Plan). The NFI can be accessed on the Internet at the following site:
The Plan, which was published in the
Through the implementation of the NFI and the Plan, NIDRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of expertise, information, and training to facilitate the advancement of knowledge and understanding of the unique needs of traditionally underserved populations; (3) determine best strategies and programs to improve rehabilitation outcomes for underserved populations; (4) identify research gaps; (5) identify mechanisms of integrating research and practice; and, (6) disseminate findings.
The Assistant Secretary for Special Education and Rehabilitative Services, the Assistant Secretary for Vocational and Adult Education, and the Assistant Secretary for Postsecondary Education jointly announce a priority for a DRRP—the Center on Postsecondary Education for Students with Intellectual Disabilities (Center). In order to meet this priority, the Center must—
(a) Identify key characteristics and promising practices of postsecondary education programs at community colleges, vocational-technical schools, and four-year colleges that currently serve students with intellectual disabilities (ID), including specialized programs that are intended to promote independence and improve employment outcomes for students with ID such as dual enrollment programs for students with ID who are still enrolled in high school and receiving special education services. This includes collecting information on—
(1) How students with ID are recruited and retained in these programs;
(2) The extent to which students with ID are enrolled in academic courses as part of these programs; and
(3) The types and extent of accommodations provided to students with ID in order to ensure their active participation in these programs;
(b) Conduct scientifically based research (as defined in 20 U.S.C. 7801(37) and included in the
The NLTS-2 and the Florida K-20 Education Data Warehouse are only examples of existing datasets that may be used for purposes of conducting secondary analysis. Reports of study findings and data tables containing frequency counts for some variables can be accessed at:
(c) Compile existing technical assistance materials and develop new materials, as needed, including information on promising practices that can be replicated, for postsecondary education institutions that are developing new programs or expanding existing programs to provide activities for students with ID. Technical assistance materials must be informed by knowledge acquired through the Center's research program, as the knowledge becomes available;
(d) Partner with existing training and technical assistance providers for the purpose of disseminating technical assistance materials to postsecondary education programs interested in developing new programs or expanding existing programs for students with ID. To the extent possible, technical assistance and other informational materials should be disseminated to interested students with ID and their families;
(e) Provide technical assistance information and materials to appropriate NIDRR research and dissemination centers, including the National Center for the Dissemination of Disability Research and the Research Utilization Support and Help (RUSH) Project at the Southwest Educational Development Laboratory, and the Center for International Rehabilitation Research Information and Exchange at the State University of New York at Buffalo;
(f) Establish an advisory committee of researchers, vocational rehabilitation providers, transition planners, secondary and postsecondary educators, individuals with ID, and parents of individuals with ID to provide the Center, on an ongoing basis, with guidance on the Center's research and technical assistance activities;
(g) Conduct a formative evaluation of the Center's activities, using clear performance objectives to ensure continuous improvement in the operation of the Center, including objective measures of progress in implementing the project and ensuring the quality of research and technical assistance; and
(h) To the extent possible, consult with the sponsors of activities that are similar or related to the Center's activities, especially, existing training and technical assistance resources that have been established by relevant offices within the U.S. Department of Education, including the Rehabilitation Services Administration's Rehabilitation Continuing Education Programs; the Office of Special Education Programs'
The Assistant Secretary for Special Education and Rehabilitative Services, the Assistant Secretary for Vocational and Adult Education, and the Assistant Secretary for Postsecondary Education jointly establish the following definitions for the purpose of the
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(a) Employs systematic, empirical methods that draw on observation or experiment;
(b) Involves rigorous data analyses that are adequate to test the stated hypotheses and justify the general conclusions drawn;
(c) Relies on measurements or observational methods that provide reliable and valid data across evaluators and observers, across multiple measurements and observations, and across studies by the same or different investigators;
(d) Is evaluated using experimental or quasi-experimental designs in which individual entities, programs, or activities are assigned to different conditions and with appropriate controls to evaluate the effects of the condition of interest, with a preference for random-assignment experiments, or other designs to the extent that those designs contain within-condition or across-condition controls;
(e) Ensures that experimental studies are presented in sufficient detail and clarity to allow for replication or, at a minimum, offer the opportunity to build systematically on their findings; and
(f) Has been accepted by a peer-reviewed journal or approved by a panel of independent experts through a comparably rigorous, objective, and scientific review.
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(a) Individuals ages 13 through 26 whose intellectual functioning levels require significant changes in instructional methods and modifications to the curriculum in order to participate in postsecondary education programs;
(b) Individuals who have significant limitations in adaptive skill areas as expressed in conceptual, social, and practical adaptive skills; and
(c) Individuals whose disabilities originated before the age of 18.
This NFP has been reviewed in accordance with Executive Order 12866. Under the terms of the order, we have assessed the potential costs and benefits of this regulatory action.
The potential costs associated with this NFP are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.
In assessing the potential costs and benefits—both quantitative and qualitative—of this NFP, we have determined that the benefits of the final priority and definitions justify the costs.
The benefits of the DRRP programs have been well established over the years in that other DRRP projects have been completed successfully. The priority and definitions announced in this notice will generate new knowledge through research, dissemination, utilization, and technical assistance.
Another benefit of the final priority and definitions is that establishing a new DRRP will support the President's NFI and improve the lives of individuals with disabilities. The new DRRP will generate, disseminate, and promote the use of new information that will improve the options for individuals with intellectual disabilities to achieve improved education, employment, and independent living outcomes.
You may view this document, as well as all other Department of Education documents published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
29 U.S.C. 762(g) and 764(a).
Institute of Education Sciences, Department of Education.
Notice of a new system of records.
In accordance with the Privacy Act of 1974, as amended (Privacy Act), the Department of Education (Department) publishes this notice of a new system of records entitled “Adult English as a Second Language (ESL) Literacy Impact Study” (18-13-19). The National Center for Education Evaluation and Regional Assistance at the Department's Institute of Education Sciences (IES) commissioned this evaluation. It will be conducted under a contract that IES awarded in September 2004.
The study will address the following questions:
(1) How effective is instruction based on a literacy workbook in improving the English reading and speaking skills of low-literate adult ESL learners?
(2) Is instruction based upon the workbook more effective for certain groups of students (e.g., native Spanish speakers)?
(3) How well do instructors implement the instruction based upon the workbook?
The system will contain information about approximately 40 adult ESL teachers and two cohorts of approximately 900 adult learners per cohort. Within each cohort, approximately 450 learners will participate in classes in which instruction based upon the literacy workbook is implemented and approximately 450 learners will participate in classes in which instruction that is not based upon the literacy workbook is implemented. The first cohort of learners will be enrolled in adult education classes during the Fall semester of 2008. The second cohort of learners will be enrolled in adult education classes during the Spring semester of 2009.
The system of records will include information about the adult learners participating in the evaluation, including names and addresses; demographic information such as race, ethnicity, gender, age, and educational background; and scores on literacy assessments. The system of records will also include information about the teachers participating in the evaluation, including names; demographic information such as race, ethnicity, gender, and educational background; and teaching experience.
The Department seeks comment on the new system of records described in this notice, in accordance with the requirements of the Privacy Act. We must receive your comments on the proposed routine uses for the system of records referenced in this notice on or before May 27, 2008.
The Department filed a report describing the new system of records covered by this notice with the Chair of the Senate Committee on Homeland Security and Governmental Affairs, the Chair of the House Committee on Oversight and Government Reform, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on April 22, 2008. This system of records will become effective at the later date of—(1) the expiration of the 40-day period for OMB review on June 2, 2008 or (2) May 27, 2008, unless the system of records needs to be changed as a result of public comment or OMB review.
Address all comments about the proposed routine uses to Dr. Ricky Takai, Director, Evaluation Division, National Center for Education Evaluation and Regional Assistance, Institute of Education Sciences, U.S. Department of Education, 555 New Jersey Avenue, NW., room 502D, Washington, DC 20208-0001. Telephone: (202) 208-7083. If you prefer to send comments through the Internet, use the following address:
You must include the term “Adult ESL Literacy Impact Study” in the subject line of the electronic message.
During and after the comment period, you may inspect all comments about this notice at the U.S. Department of Education in room 502D, 555 New Jersey Avenue, NW., Washington, DC, between the hours of 8 a.m. and 4:30 p.m., Eastern time, Monday through Friday of each week except Federal holidays.
On request, we supply an appropriate aid, such as a reader or print magnifier, to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of aid, please contact the person listed under
Dr. Ricky Takai. Telephone: (202) 208-7083. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1-800-877-8339.
Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the contact person listed in this paragraph.
The Privacy Act (5 U.S.C. 552a) requires the Department to publish in the
The Privacy Act applies to information about individuals that contains individually identifying information and that is retrieved by a unique identifier associated with each individual, such as a name or social security number. The information about each individual is called a “record,” and the system, whether manual or computer-based, is called a “system of records.”
The Privacy Act requires each agency to publish a notice of a system of records in the
You may view this document, as well as all other documents of this Department published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
For the reasons discussed in the preamble, the Director of the Institute of Education Sciences, U.S. Department of Education, publishes a notice of a new system of records to read as follows:
Adult English as a Second Language (ESL) Literacy Impact Study.
None.
(1) Evaluation Division, National Center for Education Evaluation and Regional Assistance, Institute of Education Sciences (IES), U.S. Department of Education, 555 New Jersey Avenue, NW., room 502D, Washington, DC 20208-0001.
(2) American Institutes for Research, 1000 Thomas Jefferson Street, Washington, DC 20007-3839.
(3) Berkeley Policy Associates, 440 Grand Avenue, Suite 500, Oakland, CA 94610-5012.
(4) Mathematica Policy Associates, 600 Alexander Park, Princeton, NJ 08540-6346.
This system contains records on adult ESL students and teachers who are participating in an evaluation of the effectiveness of a literacy workbook and teacher training in improving the English reading and speaking skills of adult ESL learners who have low levels of literacy in their native language. Teachers and adult ESL learners at recruited sites will volunteer to participate in the study.
The system will contain information about 40 adult ESL teachers and two cohorts of approximately 900 adult ESL learners per cohort. The system of records will include information about the adult learners participating in the evaluation, including the learners' names; addresses; demographic information such as race/ethnicity, gender, age, educational background; and scores on literacy assessments. The system of records will also include information about the teachers participating in the evaluation, including the teachers' names; demographic information such as race/ethnicity, gender, educational background; and teaching experience.
The evaluation being conducted is authorized under section 243 of the Adult Education and Family Literacy Act (20 U.S.C. 9253), as well as sections 171(b) and 173 of the Education Sciences Reform Act of 2002 (ESRA) (20 U.S.C. 9561(b) and 9563).
The information in this system is used for the following purpose: To study the effectiveness of a literacy workbook and teacher training in improving the English reading and speaking skills of adult ESL learners who have low levels of literacy skills in their native language.
The Department of Education (Department) may disclose information contained in a record in this system of records under the routine uses listed in this system of records without the consent of the individual if the disclosure is compatible with the purposes for which the record was collected. These disclosures may be made on a case-by-case basis or, if the Department has complied with the computer matching requirements of the Privacy Act, under a computer matching agreement. Any disclosure of individually identifiable information from a record in this system must also comply with the requirements of section 183 of the ESRA (20 U.S.C. 9573) providing for confidentiality standards that apply to all collections, reporting, and publication of data by IES.
Not applicable to this system notice.
The Department maintains records on CD-ROM, and the contractor (American Institutes for Research) and subcontractors (Berkeley Policy Associates and Mathematica Policy Associates) maintain data for this system on computers and in hard copy.
Records in this system are indexed and retrieved by a number assigned to each individual that is cross-referenced by the individual's name on a separate list.
All physical access to the Department's site and to the sites of the Department's contractor and subcontractors, where this system of records is maintained, is controlled and monitored by security personnel. The computer system employed by the Department offers a high degree of resistance to tampering and circumvention. This security system limits data access to Department and contract staff on a need-to-know basis, and controls individual users' ability to access and alter records within the system. The contractor and subcontractors will establish similar sets of procedures at their sites to ensure confidentiality of data. Their systems are required to ensure that information identifying individuals is in files physically separated from other research data. The contractor and subcontractors will maintain security of the complete set of all master data files and documentation. Access to individually identifying data will be strictly controlled. At each site all data will be kept in locked file cabinets during nonworking hours, and work on hardcopy data will take place in a single room, except for data entry. Physical security of electronic data will also be maintained. Security features that protect project data include: Password-protected accounts that authorize users to use the contractor's and subcontractors' systems but to access only specific network directories and network software; user rights and directory and file attributes that limit those who can use particular directories and files and determine how they can use them; and additional security features that the network administrators will establish for projects as needed. The contractor and subcontractor employees who “maintain” (collect, maintain, use, or disseminate) data in this system shall comply with the requirements of the confidentiality standards in section 183 of the ESRA (20 U.S.C. 9573).
Records are maintained and disposed of in accordance with the Department's Records Disposition Schedules (ED/RDS, Part 3, Item 2b and Part 3, Item 5a).
Director, Evaluation Division, National Center for Education Evaluation and Regional Assistance, Institute of Education Sciences, U.S. Department of Education, 555 New Jersey Avenue, NW., room 502D, Washington, DC 20208.
If you wish to determine whether a record exists regarding you in the system of records, contact the systems manager. Your request must meet the requirements of regulations at 34 CFR 5b.5, including proof of identity.
If you wish to gain access to your record in the system of records, contact the system manager. Your request must meet the requirements of regulations at 34 CFR 5b.5, including proof of identity.
If you wish to contest the content of a record regarding you in the system of records, contact the system manager. Your request must meet the requirements of the regulations at 34 CFR 5b.7, including proof of identity.
The system of records will include information collected from adult
None.
Department of Energy; Office of Science.
Notice of open meeting.
This notice announces a meeting of the Biological and Environmental Research Advisory Committee. Federal Advisory Committee Act (Pub. L. No. 92-463, as amended) requires that public notice of these meetings be announced in the
Monday, May 19, 2008, 9 a.m. to 5:30 p.m.; and Tuesday, May 20, 2008, 9 a.m. to 12:30, E.D.T.
Hilton Hotel, 620 Perry Parkway, Gaithersburg, MD 20877.
Dr. David Thomassen (301-903-9817;
• Report on the Environmental Remediation Sciences Division Committee of Visitors.
• Report on the Low Dose Radiation Research Program BERAC Review.
• Science Talk.
• Update on BER Program for Ecosystems Research.
• Workshop Report—Next Generation of Climatic Change Ecosystem Experiments After the FACE Studies, Follow-on to October 2006, BERAC Report.
• Genomics: GTL Data Sharing Policy.
• Update on Joint ASCAC-BERAC GTL Charge
• Report on BER Carbon Cycling and Carbon Sequestration Workshop
• Comments and Discussion, Anna Palmisano, Associate Director of Science for Biological and Environmental Research.
• News from the Life and Medical Sciences, Climate Change Research, and Environmental Remediation Sciences Divisions.
• New business.
• Public Comment.
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Monday, May 19, 2008, 1 p.m.-5 p.m., Tuesday, May 20, 2008, 8:30 a.m.-4 p.m.
DoubleTree Hotel, 411 West Bay Street, Savannah, GA 31401.
Gerri Flemming, Office of External Affairs, Department of Energy, Savannah River Operations Office, P.O. Box A, Aiken, SC 29802; Phone: (803) 952-7886.
If needed, time will be allotted after public comments for items added to the agenda and administrative details. A final agenda will be available at the meeting Monday, May 19, 2008.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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j. This application is not ready for environmental analysis at this time.
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m. You may also register online at
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o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the applications for licenses for Alcoa Power Generating, Inc.'s 210-megawatt Yadkin Hydroelectric Project (Project No. 2197) and Progress Energy Carolina's 108.6-MW Yadkin-Pee Dee River Hydroelectric Project (Project No. 2206), located on the Yadkin and Pee Dee rivers in the counties of Davidson, Davie, Montgomery, Rowan, Stanly, Anson, and Richmond, near Charlotte, North Carolina. Based upon this review,
The final EIS contains staff's evaluation of the applicant's proposal and alternatives for relicensing the Yadkin and Yadkin-Pee Dee River Projects. The final EIS documents the views of governmental agencies, non-governmental organizations, affected Indian tribes, the public, the license applicants, and Commission staff.
A copy of the final EIS is available for review in the Commission's Public Reference Branch, Room 2A, located at 888 First Street, NE., Washington, DC 20426. The final EIS also may be viewed on the Commission's Web site at
You may also register online at
For further information, contact Stephen Bowler at (202) 502-6861 or
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) of the natural gas pipeline facilities proposed by the Transcontinental Gas Pipe Line Corporation (Transco) in the above-referenced docket.
The EA was prepared to satisfy the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The EA assesses the environmental impacts of constructing and operating the proposed Sentinel Expansion Project (Project). The purpose of the proposed Project is to provide approximately 142,000 dekatherms per day (Dt/d) of natural gas delivery capacity to the northeastern United States through the replacement of existing facilities and the addition of looping and compression facilities along Transco's existing natural gas delivery system.
The EA has been placed in the public files of the FERC. A limited number of copies of the EA are available for distribution and public inspection at: Federal Energy Regulatory Commission, Public Reference Room, 888 First Street, NE., Room 2A, Washington, DC 20426, (202) 502-8371.
Copies of the EA have been mailed to federal, state, and local agencies, public interest groups, interested individuals, newspapers, and parties to this proceeding.
Any person wishing to comment on the EA may do so. To ensure consideration prior to a Commission decision on the proposal, it is important that we receive your comments before the date specified below.
Please note that the Commission strongly encourages the electronic filing of any comments or interventions or protests to this proceeding, see 18 Code of Federal Regulations 385.2001(a)(1)(iii) and the instructions on the Commission's Internet Web site at
If you are filing written comments, please carefully follow these instructions to ensure that your comments are received in time and properly recorded:
• Send an original and two copies of your comments to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First St., NE., Room 1A, Washington, DC 20426;
• Reference Docket No. CP08-31-000;
• Label one copy of the comments for the attention of the Gas Branch 2, PJ-11.2; and
• Mail your comments so that they will be received in Washington, DC on or before May 19, 2008.
Comments will be considered by the Commission but will not serve to make the commentor a party to the proceeding. Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Affected landowners and parties with environmental concerns may be granted intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which would not be adequately represented by any other parties. You do not need intervenor status to have your comments considered.
Additional information about the project is available from the Commission's Office of External Affairs, at 1-866-208-FERC or on the FERC Internet Web site (
In addition, the Commission now offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching
On February 21, 2008, the Commission issued a “Notice of Application Accepted for Filing, Soliciting Motions to Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Fishway Prescriptions” with a comment date of April 21, 2008, and a reply comment date of June 5, 2008.
On April 16, 2008, Exelon Corporation and PPL Holtwood, LLC, jointly requested the comment date be extended an additional two weeks. The comment date will be extended to May 5, 2008, and the reply comment date will be extended until June 19, 2008.
Take notice that on April 16, 2008, Polytop Corporation tendered for filing a Petition for Acceptance of Initial Tariff, Waivers and Blanket Authority.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
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j. Hydro Matrix Limited Partnership filed its request to use the Traditional Licensing Process on December 27, 2007. Hydro Matrix Limited Partnership filed public notice of its request on January 15, 2008. In a letter dated February 13, 2008, the Director of the Office of Energy Projects approved Hydro Matrix Limited Partnership's request to use the Traditional Licensing Process.
k. With this notice, we are initiating informal consultation with: (a) The U.S. Fish and Wildlife Service under section 7 of the Endangered Species Act; and (b) the Virginia State Historic Preservation Officer, as required by section 106, National Historical Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. Hydro Matrix Limited Partnership filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
m. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (
Register online at
Tiger Natural Gas, Inc. (Tiger) filed an application for market-based rate authority, with an accompanying rate schedule. The proposed market-based rate schedule provides for the sale of energy and capacity at market-based rates. Tiger also requested waivers of various Commission regulations. In particular, Tiger requested that the Commission grant blanket approval under 18 CFR part 34 of all future issuances of securities and assumptions of liability by Tiger.
On April 17, 2008, pursuant to delegated authority, the Director, Division of Tariffs and Market Development-West, granted the requests for blanket approval under part 34 (Director's Order). The Director's Order also stated that the Commission would publish a separate notice in the
Notice is hereby given that the deadline for filing protests is May 19, 2008.
Absent a request to be heard in opposition to such blanket approvals by the deadline above, Tiger is authorized to issue securities and assume obligations or liabilities as a guarantor, indorser, surety, or otherwise in respect of any security of another person; provided that such issuance or assumption is for some lawful object within the corporate purposes of Tiger, compatible with the public interest, and is reasonably necessary or appropriate for such purposes.
The Commission reserves the right to require a further showing that neither public nor private interests will be adversely affected by continued approvals of Tiger's issuance of securities or assumptions of liability.
Copies of the full text of the Director's Order are available from the Commission's Public Reference Room, 888 First Street, NE., Washington, DC 20426. The Order may also be viewed on the Commission's Web site at
Environmental Protection Agency.
Notice of the correction of the description of an equivalent method for monitoring ambient air quality.
Notice is hereby given that the Environmental Protection Agency (EPA) designated on March 12, 2008, in accordance with 40 CFR part 53, one new equivalent method for measuring concentrations of particulate matter as PM
Elizabeth Hunike, Human Exposure and Atmospheric Sciences Division (MD-D205-03), National Exposure Research Laboratory, U.S. EPA, Research Triangle Park, North Carolina 27711. Phone: (919) 541-3737, e-mail:
In accordance with regulations at 40 CFR Part 53, the EPA evaluates various methods for monitoring the concentrations of those ambient air pollutants for which EPA has established National Ambient Air Quality Standards (NAAQSs) as set forth in 40 CFR Part 50. Monitoring methods that are determined to meet specific requirements for adequacy are designated by the EPA as either reference methods or equivalent methods (as applicable), thereby permitting their use under 40 CFR Part 58 by States and other agencies for determining attainment of the NAAQSs.
The EPA hereby announced the designation of one new equivalent method for measuring concentrations of particulate matter as PM
The new equivalent method for PM
An application for an equivalent method determination for the candidate method was received by the EPA on September 19, 2007. The sampler is commercially available from the applicant, Met One Instruments, Inc., 1600 Washington Boulevard, Grants Pass, Oregon 07526 (
A test analyzer representative of this method has been tested in accordance with the applicable test procedures specified in 40 CFR part 53 (as amended
As a designated equivalent method, this method is acceptable for use by states and other air monitoring agencies under the requirements of 40 CFR part 58, Ambient Air Quality Surveillance. For such purposes, the method must be used in strict accordance with the operation or instruction manual associated with the method and subject to any specifications and limitations (
Use of the method should also be in general accordance with the guidance and recommendations of applicable sections of the “Quality Assurance Handbook for Air Pollution Measurement Systems, Volume I,” EPA/600/R-94/038a and “Quality Assurance Handbook for Air Pollution Measurement Systems, Volume II, Part 1,” EPA-454/R-98-004 (available at
In general, a method designation applies to any sampler or analyzer which is identical to the sampler or analyzer described in the application for designation. In some cases, similar samplers or analyzers manufactured prior to the designation may be upgraded or converted (
Part 53 requires that sellers of designated reference or equivalent method analyzers or samplers comply with certain conditions. These conditions are specified in 40 CFR 53.9 and are summarized below:
(a) A copy of the approved operation or instruction manual must accompany the sampler or analyzer when it is delivered to the ultimate purchaser.
(b) The sampler or analyzer must not generate any unreasonable hazard to operators or to the environment.
(c) The sampler or analyzer must function within the limits of the applicable performance specifications given in 40 CFR Parts 50 and 53 for at least one year after delivery when maintained and operated in accordance with the operation or instruction manual.
(d) Any sampler or analyzer offered for sale as part of a reference or equivalent method must bear a label or sticker indicating that it has been designated as part of a reference or equivalent method in accordance with Part 53 and showing its designated method identification number.
(e) If such an analyzer has two or more selectable ranges, the label or sticker must be placed in close proximity to the range selector and indicate which range or ranges have been included in the reference or equivalent method designation.
(f) An applicant who offers samplers or analyzers for sale as part of a reference or equivalent method is required to maintain a list of ultimate purchasers of such samplers or analyzers and to notify them within 30 days if a reference or equivalent method designation applicable to the method has been canceled or if adjustment of the sampler or analyzer is necessary under 40 CFR 53.11(b) to avoid a cancellation.
(g) An applicant who modifies a sampler or analyzer previously designated as part of a reference or equivalent method is not permitted to sell the sampler or analyzer (as modified) as part of a reference or equivalent method (although it may be sold without such representation), nor to attach a designation label or sticker to the sampler or analyzer (as modified) under the provisions described above, until the applicant has received notice under 40 CFR Part 53.14(c) that the original designation or a new designation applies to the method as modified, or until the applicant has applied for and received notice under 40 CFR 53.8(b) of a new reference or equivalent method determination for the sampler or analyzer as modified.
Aside from occasional breakdowns or malfunctions, consistent or repeated noncompliance with any of these conditions should be reported to: Director, Human Exposure and Atmospheric Sciences Division (MD-E205-01), National Exposure Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711.
Designation of this new equivalent method is intended to assist the States in establishing and operating their air quality surveillance systems under 40 CFR Part 58. Questions concerning the commercial availability or technical aspects of the method should be directed to the applicant.
Environmental Protection Agency (EPA).
Notice of extension of comment period.
The EPA is announcing an extension of the public comment period on the Draft Risk and Exposure Assessment Reports for Nitrogen Dioxide (NO
Comments on the above reports must be received on or before May 30, 2008.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2006-0922, by one of the following methods:
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Dr. Scott Jenkins, Office of Air Quality Planning and Standards (Mailcode C504-06), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; e-mail:
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
Under section 108(a) of the Clean Air Act (CAA), the Administrator identifies and lists certain pollutants which “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare.” The EPA then issues air quality criteria for listed pollutants, which are commonly referred to as “criteria pollutants.” The air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air, in varying quantities.” Under section 109 of the CAA, EPA establishes NAAQS for each listed pollutant, with the NAAQS based on the air quality criteria. Section 109(d) of the CAA requires periodic review and, if appropriate, revision of existing air quality criteria. The revised air quality criteria reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. The EPA is also required to periodically review and revise the NAAQS, if appropriate, based on the revised criteria.
Air quality criteria have been established for the nitrogen oxides (NO
The draft documents convey the approach taken to assess exposures to ambient NO
The EPA is soliciting advice and recommendations from the CASAC by means of a review on the draft documents at an upcoming public meeting of the CASAC. A
Revision of FR Notice Published 02/29/2008: Extending Comment Period from 04/29/2008 to 06/13/2008.
Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and Section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167.
An explanation of the ratings assigned to draft environmental impact statements (EISs) was published in FR dated April 11, 2008 (73 FR 19833).
Environmental Protection Agency.
Notice; Announcement of availability of literature searches for IRIS assessments; request for information.
The U.S. Environmental Protection Agency (EPA) is announcing the availability of literature searches for three IRIS assessments, manganese (CAS No. 7439-9), 1,2,4 trimethylbenzene (CAS No. 95-63-6), and 1,3,5-trimethylhenzene (CAS No. 108-67-8) that may be started in 2008, and requesting scientific information on health effects that may result from exposure to these chemical substances. The Integrated Risk Information System (IRIS) is an EPA database that contains information on human health effects that may result from chronic exposure to chemical substances in the environment.
EPA will accept information related to the specific substances included herein as well as any other compounds being assessed by the IRIS Program. Please submit any information in accordance with the instructions provided below.
Please submit relevant scientific information, identified by docket ID number EPA-HQ-ORD-2007-0664, online at
For information on the IRIS program, contact Dr. Abdel-Razak Kadry, IRIS Program Director, National Center for Environmental Assessment, (Mail Code: 8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: (703) 347-8545; facsimile: (703) 347-8689; or e-mail:
For general questions about access to IRIS, or the content of IRIS, please call the IRIS Hotline at (202) 566-1676 or send electronic mail inquiries to
IRIS is a database of human health effects that may result from chronic exposure to various chemical substances found in the environment. (EPA notes that information in the IRIS database has no preclusive effect and does not predetermine the outcome of any rulemaking. When EPA uses such information to support a rulemaking, the scientific basis for, and the application of that information are subject to comment.) IRIS currently provides information on the chronic health effects—both cancer and non-cancer—associated with more than 500 chemical substances.
The database includes chemical-specific summaries of qualitative and quantitative health information in support of the first two steps of the risk assessment process,
The 2008 IRIS agenda was announced in a
EPA is soliciting public involvement in assessments on the IRIS agenda, including new assessments starting in 2008. While EPA conducts a thorough literature search for each chemical substance, there may be unpublished studies or other primary technical sources that are not available through the open literature. EPA would appreciate receiving scientific information from the public during the information gathering stage for the assessments listed in this notice or any other assessments on the IRIS agenda. Interested persons should provide scientific analyses, studies, and other pertinent scientific information. While EPA is primarily soliciting information on new assessments starting in 2008. the
This notice provides: (1) A list of new IRIS assessments that may start in 2008 for which literature searches have recently become available; and (2) instructions to the public for submitting scientific information to EPA pertinent to the development of these assessments. EPA is also announcing the availability of additional literature searches on the IRIS Web site (
Literature searches are now available for manganese (CAS No. 7439-9), 1,2,4 trimethylbenzene (CAS No. 95-63-6), and 1,3,5-trimethylbenzene (CAS No. 108-67-8) at
As of Monday, November 28, 2005, EPA's EDOCKET was replaced by the Federal Docket Management System (FDMS), the new federal government-wide system. FDMS was created to provide a single point of access to all federal rulemaking activities. All materials previously found in EDOCKET are now available on the Internet at
EPA has established an official public docket for this action under Docket ID No. EPA HQ-ORD-2007-0664. The official public docket is the collection of materials that is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through EPA's electronic public docket and comment system. EPA Dockets at
It is important to note that EPA's policy is that public submissions, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the submission contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute are not included in the official public docket or in EPA's electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.
Information on chemical substances listed in this notice may be submitted as provided in the
EPA's preferred method for receiving submissions is via EPA's electronic public docket. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your submission. In contrast to EPA's electronic public docket, EPA's electronic mail (e-mail) system is not an “anonymous access” system. If you send e-mail directly to the docket without going through EPA's electronic public docket, your e-mail address is automatically captured and included as part of the submission that is placed in the official public docket and made available in EPA's electronic public docket.
Environmental Protection Agency (EPA).
Notice of meeting.
Under the Federal Advisory Committee Act, Public Law 92463, EPA gives notice of a meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology, and management issues. The Council is a panel of individuals who represent diverse interests from academia, industry, non-governmental organizations, and local, state, and tribal governments. The purpose of this meeting is to discuss biofuels, environmental technology, and sustainable water infrastructure. The Council will also be discussing potential projects on environmental information and integrated modeling for integrated environmental decision making, among other issues. A copy of the agenda for the meeting will be posted at
NACEPT will hold a two day open meeting on Wednesday, May 14, 2008, from 8:30 a.m. to 12:30 p.m. and Thursday, May 15, 2008, from 12 p.m. to 2 p.m.
The meeting will be held at the U.S. EPA's Potomac Yards Conference Center, 2777 Crystal Drive, Arlington, VA 22202. The meeting is open to the public, with limited seating on a first-come, first-served basis.
Sonia Altieri, Designated Federal Officer,
Requests to make oral comments or to provide written comments to the Council should be sent to Sonia Altieri, Designated Federal Officer, at the contact information above. All requests must be submitted no later than May 8, 2008.
Environmental Protection Agency (EPA).
Notice.
This notice announces that EPA has received a petition under section 21 of the Toxic Substances Control Act (TSCA), and requests comments on issues raised by the petition. The petition was received from Michael J. Dochniak on March 6, 2008, and asks EPA “to establish regulations prohibiting the use and distribution in commerce of
Comments must be received on or before May 12, 2008.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2008-0273, by one of the following methods:
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You may be potentially affected by an action in response to this petition if you manufacture, process, import, or distribute in commerce
• NAICS code 325520, Adhesive Manufacturing.
• NAICS code 424690, Other Chemical and Allied Products Merchant Wholesalers.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities that may potentially be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the TSCA section 21 petition on
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
Section 21 of TSCA allows citizens to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth facts that the petitioner believes establish the need for the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, EPA must promptly commence an appropriate proceeding. If EPA denies the petition, EPA must publish its reasons for the denial in the
On March 6, 2008, Michael J. Dochniak petitioned EPA under TSCA section 21. The petitioner is concerned about risks to human health and the environment from exposure to
Under TSCA section 21, EPA must either grant or deny a petition within 90 days. Because the 90 day response date is June 3, 2008, EPA will allow the public until May 12, 2008 to reply with any additional information relevant to the issues identified in the petition, a copy of which can be obtained from the public docket (see
In assessing the usability of any data or information that may be submitted, EPA plans to follow the guidelines in EPA’s “A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information” (EPA 100B-03/001), referred to as the “Assessment Factors Document.” The Assessment Factors Document was published in the
Environmental protection, antigenic proteins, Asperger syndrome, Autism,
Environmental Protection Agency (EPA).
Notice.
This notice announces that EPA has received a petition under section 21 of the Toxic Substances Control Act (TSCA), and requests comments on issues raised by the petition. The petition was received on March 24, 2008, from 25 organizations and approximately 5,000 individuals. The petitioners are concerned about risks to human health and the environment from exposure to formaldehyde in composite wood products, including hardwood plywood, particle board, and medium density
Comments must be received on or before May 12, 2008.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2008-0267, by one of the following methods:
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You may be potentially affected by an action in response to this petition, if you manufacture, process, import, or distribute in commerce composite wood products, including hardwood plywood, particle board, and medium density fiberboard. Potentially affected entities may include, but are not limited to:
• Veneer, plywood, and engineered wood product manufacturing (NAICS code 3212).
• Manufactured home (mobile home) manufacturing (NAICS code 321991).
• Prefabricated wood building manufacturing (NAICS code 321992).
• All other basic organic chemical manufacturing (NAICS code 325199), e.g., formaldehyde manufacturing.
• Furniture and related product manufacturing (NAICS code 337).
• Furniture merchant wholesalers (NAICS code 42321).
• Lumber, plywood, millwork, and wood panel merchant wholesalers (NAICS code 42331).
• Other construction material merchant wholesalers (NAICS code 423390), e.g., merchant wholesale distributors of manufactured homes (i.e., mobile homes) and/or prefabricated buildings.
• Furniture stores (NAICS code 4421).
• Building material and supplies dealers (NAICS code 4441).
• Manufactured (mobile) home dealers (NAICS code 45393).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities that may potentially be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the TSCA section 21 petition. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
Section 21 of TSCA allows citizens to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth facts that the petitioner believes establish the need for the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, EPA must promptly commence an appropriate proceeding. If EPA denies the petition, EPA must publish its reasons for the denial in the
On March 24, 2008, the Sierra Club, National Center for Healthy Housing, National Coalition to End Childhood Lead Poisoning, Alliance for Healthy Homes, National Housing Institute, Healthy Building Network, Gulf Coast Environmental Restoration Task Force of Sierra Club, Next Generation Choices Foundation, Improving Kids’ Environment, EarthRose Institute, Grassroots Environmental Education, Healthy Homes of Louisiana, Lower Mississippi Riverkeeper, Women's Community Cancer Project, Gulf Coast D'Iberville Volunteers Foundation, Advocates for Environmental Human Rights, Environmental Health Watch, North Gulfport Community Land Trust, Louisiana Environmental Action Network, Allergy and Environmental Health Assoc., Aspen River Construction, DeVany Industrial Consultant, Protect Sacred Sites “Indigenous People, One Nation,” United People of the Cherokee Nation, Clean Air Athens, and approximately 5,000 individuals petitioned EPA under TSCA section 21. The petitioners are concerned about risks to human health and the environment from exposure to formaldehyde emitted from composite wood products, including hardwood plywood, particle board, and medium density fiberboard. They are petitioning EPA to assess and reduce these risks by exercising its authority under TSCA section 6(a) to:
1. Adopt and apply nationally the formaldehyde emissions regulation for composite wood products, including hardwood plywood, particle board, and medium density fiberboard, recently adopted by the California Air Resources Board.
2. Extend the regulation to include composite wood products used in manufactured homes.
Under TSCA section 21, EPA must either grant or deny a petition within 90 days. Because the 90-day response date is June 21, 2008, EPA will allow the public until May 12, 2008 to reply with any additional information relevant to the issues identified in the petition, a copy of which can be obtained from the public docket (see
While EPA is interested in any information relevant to the issues identified in the petition, EPA is particularly interested in comments that address any of the following questions:
1
2.
ii. How is this likely to vary by region of the country, as compared to the national market?
3.
ii. What percentage of the composite wood market uses them?
iii. What percentage of the national composite wood market, exclusive of California, is expected to use them after 2012 (when California’s Phase 2 emission limits have become effective)?
4.
i. What percentage of the composite wood market is used in manufactured housing?
ii. How are the composite wood products used in manufactured housing different from composite wood products subject to the California regulation?
iii. What is the annual volume of composite wood products used in manufactured housing?
iv. What percentage of composite wood products (by volume of product) is used in manufactured housing and is therefore not subject to the California regulations?
v. What percentage of composite wood products used for manufactured housing and not subject to California’s regulations nonetheless meets the California emission limits?
In assessing the usability of any data or information that may be submitted,
Environmental protection, Composite wood products, Formaldehyde, Housing, Toxic Substance Control Act (TSCA).
Environmental Protection Agency (EPA).
Notice of settlement.
Under Section 122(h)(1) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency has entered into a settlement for reimbursement of past response costs concerning the Smalley-Piper Superfund Site located in Collierville, Shelby County, Tennessee for publication.
The Agency will consider public comments on the settlement until May 27, 2008. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate.
Copies of the settlement are available from Ms. Paula V. Batchelor. Submit your comments, identified by Docket ID No. EPA-RO4-SFUND-2008-0305 or Site name Smalley-Piper Superfund Site by one of the following methods:
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Written comments may be submitted to Ms. Batchelor within 30 calendar days of the date of this publication.
Paula V. Batchelor at 404-562-8887.
Environmental Protection Agency (EPA).
Notice of public comment period.
The EPA is announcing a public comment period for the external review draft document entitled, “Toxicological Review of Ethylene Glycol mono-Butyl Ether (EGBE): In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-08/006A). EPA intends to consider comments and recommendations from the public and the expert panel meeting, which will be scheduled at a later date and announced in the
EPA is releasing this draft document solely for the purpose of pre-dissemination public review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be
The draft document is available via the Internet on NCEA's home page under the Recent Additions and the Data and Publications menus at
The public comment period begins April 25, 2008, and ends June 24, 2008. Technical comments should be in writing and must be received by EPA by June 24, 2008. EPA intends to submit comments from the public received by this date for consideration by the external peer-review panel.
The draft “Toxicological Review of Ethylene Glycol mono-Butyl Ether (EGBE): In Support of the Summary Information on the Integrated Risk Information System (IRIS)” is available via the Internet on the National Center for Environmental Assessment's (NCEA) home page under the Recent Additions and the Data and Publications menus at
Comments may be submitted electronically via
For information on the public comment period, contact the Office of Environmental Information Docket; telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail:
If you have questions about the document, contact, Angela Howard, Chemical Manager, National Center for Environmental Assessment; telephone: (919) 541-5133; facsimile: (919) 541-0248; e-mail:
IRIS is a database that contains potential adverse human health effects information that may result from chronic (or lifetime) exposure to specific chemical substances found in the environment. The database (available on the Internet at
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2008-0245 by one of the following methods:
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If you provide comments by mail or hand delivery, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 22, 2008.
Board of Governors of the Federal Reserve System, April 22, 2008.
U.S. General Services Administration (GSA).
Correction.
In the meeting notice that published in the issue of Wednesday, April 16, 2008 (73 FR 20675), the telephone number for Ms. Pat Brooks in
Information on the Panel meetings, agendas, and other information can be obtained at
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to
Excluded Parties List System (EPLS).
The General Services Administration's (GSA) Office of the Chief Acquisition Officer (OCAO) is the owner of the system. The system of records is maintained by a contractor. Contact the system manager for additional information.
a. Individuals excluded or disqualified under a Federal agency's codification of the Common Rules on Nonprocurement suspension and debarment, or otherwise declared ineligible from receiving certain Federal assistance and/or benefits.
b. Individuals debarred, suspended, proposed for debarment, or otherwise declared ineligible from participating in Federal procurement programs.
c. Individuals barred or suspended from acting as sureties for bid and performance bond activity in procurement programs.
d. Individuals barred from entering the United States.
e. Individuals that may be subject to sanctions pursuant to 31 CFR Parts 500-599 and subparts there under.
Information entered by Federal agencies that identifies excluded individuals and the applicable authority, in the form of cause and treatment (CT) codes, under which the exclusion was made.
The authorities for maintaining the system are the Federal Acquisition Regulation Subparts 9.4 and 28.2; Executive Order 12549 (February 18, 1986); Executive Order 12689 (August 16, 1989); and 31 U.S.C. Sec. 6101, note.
To maintain a Governmentwide system of records that identifies individuals who have been excluded from participating in Federal procurement and nonprocurement (financial or non-financial assistance and benefits programs), throughout the Federal government. In some instances a record may demonstrate that an exclusion applies only to the agency taking the action, and therefore, does not have Governmentwide effect. The purpose of these exclusions is to protect the Government from nonresponsible contractors and individuals, ensure proper management throughout the Federal government, and protect the integrity of Federal activities.
a. To contracting officers and other Federal, State, and local government employees involved in procuring goods and services with Federal funds or administering Federal financial assistance programs or benefits to determine a party's eligibility status to participate in Federal procurement and nonprocurement programs.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order where the records clearly indicate, or when seen with other records indicate, a violation of civil or criminal law or regulation, when the information is needed to perform a Federal duty or to decide the issues.
c. To a Federal, State or local agency, financial institution or a healthcare or industry provider that administers Federal financial or non-financial assistance programs or benefits, when the information is needed to determine eligibility.
d. To an expert, consultant, contractor, Federal, State or local agency, or financial institution, when the information is needed to perform a Federal duty.
e. To an appeal, grievance, or formal complaints examiner, an equal employment opportunity investigator, an arbitrator, a union representative, or other official engaged in investigating or settling a grievance, complaint, or appeal filed by an employee, when the information is needed to decide the issues.
f. To a requesting Federal, State or local agency, financial institution, or a healthcare or industry provider in connection with hiring or retaining an employee, issuing a security clearance, investigating an employee, clarifying a job, letting a contract, or issuing a license, grant, or other benefit by the requesting agency where the information is needed to decide on a Federal financial or non-financial assistance program or benefit.
g. To a member of Congress or to a congressional staff member in response to a request from the person who is the subject of the record, when the information is needed to perform a Federal duty.
h. To the Department of Justice when an agency, an agency employee, or the United States is a party to or has an interest in litigation, and the records are needed to pursue the litigation.
i. To a court or judicial body when an agency, an agency employee, or the United States is a party to or has an interest in litigation, and the records are needed to pursue the litigation.
j. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office (GAO) or the Interagency Suspension and Debarment Committee (ISDC) when the information is required for program evaluation purposes.
k. To the National Archives and Records Administration (NARA) for records management purposes.
l. To appropriate agencies, entities, and persons when (1) The Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Electronic records are stored on readily accessible servers and backed up to tape media. Paper records are stored in file folders.
Electronic records are retrieved by Exact Name, Partial Name, Action Dates, Termination Dates, Create Dates, Data Universal Numbering System (DUNS), Classification, Exclusion Type, CT Code, Agency, U.S. State, Country, Cage Code, verification of Name with the
System records are safeguarded in accordance with the requirements of the Privacy Act of 1974, as amended, the Computer Security Enhancement Act of 1997, and the EPLS Security Plan. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data that is stored, processed, and transmitted. Paper records are stored in locked filing cabinets when not in use or are kept in secured rooms, accessible to authorized users only. The Debar Maintenance and Administration portals are ID and password protected. The public portal does not require ID and passwords because privacy protected information is not available on the public site.
Electronic records of past exclusions are maintained permanently in the archive list for historical reference. Federal agencies reporting exclusion information in the EPLS should follow their agency's guidance and policies for disposition of paper records.
Integrated Acquisition Environment Program Manager, Office of the Chief Acquisition Officer, General Services Administration, 2011 Crystal Drive, Suite 911, Arlington, VA 22202.
Individuals receive prior notification that their names will be contained in the EPLS from the Agency that takes the action to exclude them from Federal procurement and nonprocurement programs. An individual may retrieve system records by accessing the EPLS public portal, which displays publicly available information only.
Requests from individuals to determine the specifics of a record included in the EPLS should be addressed to the Agency Point of Contact (POC) identified in the record.
The procedures for contesting the content of a record and appealing an initial decision may be found in 41 CFR Part 105-64. Individuals should contact the Agency Point of Contact (POC) identified in the record to commence a record contest or appeal.
Federal agencies are the source for entering record information in the EPLS.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
GSA SmartPay Purchase Charge Card Program.
System records are located at the Federal agency for which an individual is authorized to perform purchase charge card transactions. Records necessary for a contractor to perform under a Federal agency contract are located at the contractor's facility. Contact the System Manager for additional information.
Individuals covered by the system are Federal employees, contractors, and other individuals who apply for and/or use Government-assigned purchase charge cards.
The system provides control over expenditure of funds through the use of Federal Government purchase cards. System records include:
a. Personal information on individuals who apply for and use Federal Government charge cards, including name, Social Security Number, agency of employment, business address (including city, state, country, and zip code), title or position, business telephone, business fax number, and e-mail address.
b. Account processing and management information, including purchase authorizations and vouchers, charge card applications, charge card receipts, terms and conditions for card use, charge card transactions, contractor monthly reports showing charges to individual account numbers, account balances, and other data needed to authorize, account for, and pay authorized purchase card expenses.
E.O. 9397; E.O. 12931; 40 U.S.C. Sec. 501-502.
To establish and maintain a system for operating, controlling, and managing a purchase charge card program involving commercial purchases by authorized Federal Government employees and contractors.
System information may be accessed and used by authorized Federal agency employees or contractors to conduct official duties associated with the management and operation of the purchase charge card program. Information from this system also may be disclosed as a routine use:
a. To a Federal, State, local, or foreign agency responsible for investigating,
b. To an appeal, grievance, or formal complaints examiner; equal employment opportunity investigator; arbitrator; or other official engaged in investigating, or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To officials of labor organizations recognized under Public Law 95-454, when necessary to their duties of exclusive representation on personnel policies, practices, and matters affecting working conditions.
d. To another Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; clarifying a job; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
e. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office (GAO) or other Federal agency when the information is required for program evaluation purposes.
f. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To an expert, consultant, or contractor in the performance of a Federal duty to which the information is relevant, including issuance of charge cards.
i. To GSA in the form of listings, reports, and records of all transportation related transactions, including refunds and adjustments, by the contractor to enable audits of transportation related charges to the Government.
j. To GSA contract agents assigned to participating agencies for billing of purchase expenses.
k. To agency finance offices for debt collection purposes.
l. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Information may be collected on paper or electronically and may be stored on paper or on electronic media, as appropriate.
Records may be retrieved by name, Social Security Number, credit card number, and/or other personal identifier or appropriate type of designation.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A-130. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms. Electronic records are protected by passwords and other appropriate security measures.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the handbook, GSA Records Maintenance and Disposition System (OAD P 1820.2A and CIO P 1820.1), authorized GSA records schedules, and by individual agencies.
Director, Office of Commercial Acquisition (FC), General Services Administration, 1901 South Bell Street, Arlington VA 22202. Also, officials responsible for individual agency purchase card programs using the SmartPay system.
Individuals may obtain information about their records from the purchase charge card program manager of the agency for which they transact purchases.
Requests from individuals for access to their records should be addressed to their agency's purchase charge card program manager or to the finance office of the agency for which the individual transacts purchases.
Individuals may access their records, contest the contents, and appeal determinations according to their agency's rules.
Information is obtained from individuals submitting charge card applications, monthly contractor reports, purchase records, managers, other agencies, non-Federal sources such as private firms, and other agency systems containing information pertaining to the purchase charge card program.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: Telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system
Personal Identity Verification Identity Management System (PIV IDMS).
Sensitive but unclassified.
Records covered by this system are maintained by a contractor at the contractor's site.
The PIV IDMS records will cover all participating agency employees, contractors and their employees, consultants, and volunteers who require routine, long-term access to federal facilities, information technology systems, and networks. The system also includes individuals authorized to perform or use services provided in agency facilities (e.g., Credit Union, Fitness Center, etc.).
At their discretion, participating Federal agencies may include short-term employees and contractors in the PIV program and, therefore, inclusion in the PIV IDMS. Federal agencies shall make risk-based decisions to determine whether to issue PIV cards and require prerequisite background checks for short-term employees and contractors. The system does not apply to occasional visitors or short-term guests. GSA and participating agencies will issue temporary identification and credentials for this purpose.
Enrollment records maintained in the PIV IDMS on individuals applying for the PIV program and a PIV credential through the GSA HSPD-12 managed service include the following data fields: Full name; Social Security Number; Applicant ID number, date of birth; current address; digital color photograph; fingerprints; biometric template (two fingerprints); organization/office of assignment; employee affiliation; work e-mail address; work telephone number(s); office address; copies of identity source documents; employee status; military status; foreign national status; federal emergency response official status; law enforcement official status; results of background check; Government agency code; and PIV card issuance location. Records in the PIV IDMS needed for credential management for enrolled individuals in the PIV program include: PIV card serial number; digital certificate(s) serial number; PIV card issuance and expiration dates; PIV card PIN; Cardholder Unique Identifier (CHUID); and card management keys. Agencies may also choose to collect the following data at PIV enrollment which would also be maintained in the PIV IDMS: Physical characteristics (e.g., height, weight, and eye and hair color). Individuals enrolled in the PIV managed service will be issued a PIV card. The PIV card contains the following mandatory visual personally identifiable information: Name, photograph, employee affiliation, organizational affiliation, PIV card expiration date, agency card serial number, and color-coding for employee affiliation. Agencies may choose to have the following optional personally identifiable information printed on the card: Cardholder physical characteristics (height, weight, and eye and hair color). The card also contains an integrated circuit chip which is encoded with the following mandatory data elements which comprise the standard data model for PIV logical credentials: PIV card PIN, cardholder unique identifier (CHUID), PIV authentication digital certificate, and two fingerprint biometric templates. The PIV data model may be optionally extended by agencies to include the following logical credentials: Digital certificate for digital signature, digital certificate for key management, card authentication keys, and card management system keys. All PIV logical credentials can only be read by machine.
5 U.S.C. 301; Federal Information Security Management Act (Pub. L. 107-296, Sec. 3544); E-Government Act (Pub. L. 107-347, Sec. 203); Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et al.) and Government Paperwork Elimination Act (Pub. L. 105-277, 44 U.S.C. 3504); Homeland Security Presidential Directive 12 (HSPD-12), Policy for a Common Identification Standard for Federal Employees and Contractors, August 27, 2004; Federal Property and Administrative Services Act of 1949, as amended.
The primary purposes of the system are: To ensure the safety and security of Federal facilities, systems, or information, and of facility occupants and users; to provide for interoperability and trust in allowing physical access to individuals entering Federal facilities; and to allow logical access to Federal information systems, networks, and resources on a government-wide basis.
In addition to those disclosures generally permitted under 5 U.S.C. Section 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside GSA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
a. To the Department of Justice (DOJ) when: (1) The agency or any component thereof; or (2) any employee of the agency in his or her official capacity; (3) any employee of the agency in his or her individual capacity where agency or the Department of Justice has agreed to represent the employee; or (4) the United States Government is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records by DOJ and is therefore deemed by the agency to be for a purpose compatible with the purpose for which the agency collected the records.
b. To a court or adjudicative body in a proceeding when: (1) The agency or any component thereof; (2) any employee of the agency in his or her official capacity; (3) any employee of the agency in his or her individual capacity where the agency or the Department of Justice has agreed to represent the employee; or (4) the United States Government is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records and is therefore deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records.
c. Except as noted on Forms SF 85, SF 85-P, and SF 86, when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate public authority, whether Federal, foreign, State, local, or tribal, or otherwise,
d. To a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained.
e. To the National Archives and Records Administration (NARA) or to the General Services Administration for records management inspections conducted under 44 U.S.C. 2904 and 2906.
f. To agency contractors, grantees, or volunteers who have been engaged to assist the agency in the performance of a contract service, grant, cooperative agreement, or other activity related to this system of records and who need to have access to the records in order to perform their activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Federal Information Security Management Act (Pub. L. 107-296), and associated OMB policies, standards and guidance from the National Institute of Standards and Technology, and the General Services Administration.
g. To a Federal agency, State, local, foreign, or tribal or other public authority, on request, in connection with the hiring or retention of an employee, the issuance or retention of a security clearance, the letting of a contract, or the issuance or retention of a license, grant, or other benefit, to the extent that the information is relevant and necessary to the requesting agency's decision.
h. To the Office of Management and Budget (OMB) when necessary to the review of private relief legislation pursuant to OMB Circular No. A-19.
i. To a Federal, State, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947, as amended; the CIA Act of 1949, as amended; Executive Order 12333 or any successor order; and applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders, or Directives.
j. To designated agency personnel for controlled access to specific records for the purposes of performing authorized audit or authorized oversight and administrative functions. All access is controlled systematically through authentication using PIV credentials based on access and authorization rules for specific audit and administrative functions.
k. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office (GAO), or other Federal agency in accordance with the agency's responsibility for evaluation of Federal personnel management.
l. To the Federal Bureau of Investigation for the FBI National Criminal History check.
m. To a Federal, State, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947 as amended; the CIA Act of 1949 as amended; Executive Order 12333 or any successor order; and applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders or directives.
n. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Records are stored in electronic media and in paper files.
Records may be retrieved by name of the individual, Cardholder Unique Identification Number, Applicant ID, Social Security Number, and/or by any other unique individual identifier.
Consistent with the requirements of the Federal Information Security Management Act (Pub. L. 107-296), and associated OMB policies, standards and guidance from the National Institute of Standards and Technology, and the General Services Administration, the GSA HSPD-12 managed service office protects all records from unauthorized access through appropriate administrative, physical, and technical safeguards. Access is restricted on a “need to know” basis, utilization of PIV Card access, secure VPN for Web access, and locks on doors and approved storage containers. Buildings have security guards and secured doors. All entrances are monitored through electronic surveillance equipment. The hosting facility is supported by 24/7 onsite hosting and network monitoring by trained technical staff. Physical security controls include: Indoor and outdoor security monitoring and surveillance; badge and picture ID access screening; biometric access screening. Personally identifiable information is safeguarded and protected in conformance with all Federal statutory and OMB guidance requirements. All access has role-based restrictions, and individuals with access privileges have undergone vetting and suitability screening. All data is encrypted in transit. While it is not contemplated, any system records stored on mobile computers or mobile devices will be encrypted. GSA maintains an audit trail and performs random periodic reviews to identify unauthorized access. Persons given roles in the PIV process must be approved by the Government and complete training specific to their roles to ensure they are knowledgeable about how to protect personally identifiable information.
Disposition of records will be according to NARA disposition authority N1-269-06-1 (pending).
Director, HSPD-12 Managed Service Office, Federal Acquisition Service (FAS), General Services Administration, Suite 911, 2011 Crystal Drive, Arlington, VA 22202.
A request for access to records in this system may be made by writing to the System Manager. When requesting
Same as Notification Procedure above.
Same as Notification Procedure above. State clearly and concisely the information being contested, the reasons for contesting it, and the proposed amendment to the information sought.
Employee, contractor, or applicant; sponsoring agency; former sponsoring agency; other Federal agencies; contract employer; former employer.
None.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Access Certificates for Electronic Services (ACES).
System records are maintained for the General Services Administration (GSA) by contractors at various physical locations. A complete list of locations is available from: Administrative Contracting Officer, FEDCAC, Federal Technology Service, General Services Administration, 7th and D Streets, SW., Room 5060, Washington, DC 20407; telephone (202) 708-6099.
Individuals covered are persons who have applied for the issuance of a digital signature certificate under the ACES program; have had their certificates amended, renewed, replaced, suspended, revoked, or denied; have used their certificates to electronically make contact with, retrieve information from, or submit information to an automated information system of a participating agency; have requested access to ACES records under the Freedom of Information Act (FOIA) or Privacy Act; and have corresponded with GSA or its ACES contractors concerning ACES services.
The system contains information needed to establish and verify the identity of ACES users, to maintain the system, and to establish accountability and audit controls. System records include:
a. Applications for the issuance, amendment, renewal, replacement, or revocation of digital signature certificates under the ACES program, including evidence provided by applicants or proof of identity and authority, and sources used to verify an applicant's identify and authority.
b. Certificates issued.
c. Certificates denied, suspended, and revoked, including reasons for denial, suspension, and revocation.
d. A list of currently valid certificates.
e. A list of currently invalid certificates.
f. A file of individuals requesting access and those granted access to ACES information under FOIA or the Privacy Act.
g. A file of individuals requesting access and those granted access for reasons other than FOIA or the Privacy Act.
h. A record of validation transactions attempted on digital signature certificates issued by the system.
i. A record of validation transactions completed on digital signature certificates issued by the system.
Section 5124(b) of the Clinger-Cohen Act of 1996, 40 U.S.C. 1424, which provides authority for GSA to develop and facilitate governmentwide electronic commerce resources and services, and the Paperwork Reduction Act, 44 U.S.C. 3501,
To establish and maintain an electronic system to facilitate secure, on-line communication between Federal automated information systems and the public, using digital signature technologies to authenticate and verify identity.
Information from this system may be disclosed as a routine use:
a. To GSA ACES program contractors to compile and maintain documentation on applicants for proofing applicants' identity and their authority to access information system applications of participating agencies.
b. To GSA ACES program contractors to establish and maintain documentation on information sources for verifying applicants' identities.
c. To Federal agencies participating in the ACES program to determine the validity of applicants' digital signature certificates in an on-line, near real time environment.
d. To GSA, participating Federal agencies, and ACES contractors, for ensuring proper management, ensuring data accuracy, and evaluation of the system.
e. To Federal, State, local or foreign agencies responsible for investigating,
f. To a member of Congress or to a congressional staff member in response to a request from the person who is the subject of the record.
g. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
h. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
i. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
j. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
k. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
l. To the National Archives and Records Administration (NARA) for records management purposes.
All records are stored by GSA ACES contractors or by GSA as hard copy documents and/or on electronic media.
Records are retrievable by a personal identifier or by other appropriate type of designation approved by GSA and made available to ACES participants at the time of their application for ACES services.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A-130, Appendices I and III. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. The ACES System Security Plan, approved by GSA for each ACES contractor, provides for inspections, testing, continuity of operations, and technical certification of security safeguards. GSA accredits and annually re-accredits each contractor system prior to its operation.
System records are retained and disposed of according to GSA records maintenance and disposition schedules and the requirements of the National Archives and Records Administration.
Administrative Contracting Officer, FEDCAC, Federal Technology Service, General Services Administration, Room 5060, 7th and D Streets, SW., Washington, DC 20407.
Inquiries from individuals should be addressed to the system manager. Applicants for digital signature certificates will be notified by the GSA ACES contractor which facilitates individual access to the relevant Federal agency database as follows:
a. Each applicant will be provided, on a Government-approved form that can be retained by the individual applicant, the principal purposes of the ACES program; the authority for collecting the information; the fact that participation is voluntary; the fact that identity and authority information must be provided and verified before a certificate will be issued; the fact that the information provided is covered by the Privacy Act and the Computer Security Act; the routine uses that will be made of the information being provided; the limitations on the uses of the information being provided; the procedures to be followed for requesting access to the individual's own records; and the possible consequences of failing to provide all or part of the required information or intentionally providing false information.
b. Written notification in response to an individual's request to be advised if the system contains a record pertaining to him/her.
c. Written notification to an individual when any record on the individual is made available to any person under compulsory legal process when such process becomes a matter of public record.
d. Written notification of the right to appeal to GSA by any individual on any dispute concerning the accuracy of his/her record.
GSA ACES contractors will provide notification of, access to, review of, or copies of an individual's record upon his/her request as required by the Privacy Act.
GSA ACES contractors will amend an individual's record upon his/her written request, as required by the Privacy Act and GSA's implementing regulations, 41 CFR part 105-64. If the ACES contractor determines that an amendment is inappropriate, the contractor shall submit the request to the System Manager for a determination by GSA whether to grant or deny the request for amendment and direct response to the requester.
The sources for information in the system are the individuals who apply for digital signature certificates, GSA ACES contractors using independent sources to verify identities, and internal system transactions designed to gather and maintain data needed to manage and evaluate the ACES program.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer:
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
GSA/HRO-4.
Labor-Management Relations Files.
The system is in the Office of Human Resources Services at GSA (CPL) at 18th & F Streets, NW., Washington, DC 20405, and service and staff offices throughout GSA. The Offices are as follows:
Central Office, Central Office Human Resources Division (CPL), General Services Administration, 1800 F Street, NW., Washington, DC 20405. (202) 501-0040.
National Capital Region, Human Resources Office (WCP), General Services Administration, 7th and D Streets, SW., Washington, DC 20407. (202) 708-5335.
New England Region, Human Resources Office (1CP), General Services Administration, 10 Causeway Street, Boston, MA 02222. (617) 565-6634.
Northeast and Caribbean Region, Human Resources Office (2AR), General Services Administration, 26 Federal Plaza, New York, NY 10278. (212) 264-8138.
Mid-Atlantic Region, Human Resources Office (3CP), General Services Administration, The Strawbridge Building, 20 North Eighth Street, Philadelphia, PA 19107-3191. (215) 446-4951.
Southeast Sunbelt Region, Office of Human Resources (4AH), General Services Administration, 77 Forsyth Street, Suite 650, Atlanta, GA 30303. (404) 331-3186.
Great Lakes Region, Human Resources Office (5CP), General Services Administration, 230 South Dearborn Street, Chicago, IL 60604. (312) 353-5550.
The Heartland Region, Human Resources Office (6CP), General Services Administration, 1500 East Bannister Road, Kansas City, MO 64131. (816) 926-7206.
Greater Southwest Region, Human Resources Office (7CP), General Services Administration, 819 Taylor Street, Room 9A00, Forth Worth, TX 76102. (817) 978-3190.
Region 8 Human Resource Office (7CP-8), W. 6th Avenue & Kipling Street, Room: 210, Lakewood, CO 80225-0000.
Pacific Rim Region, Human Resources Office (9CP), General Services Administration, 450 Golden Gate Avenue, San Francisco, CA 94100. (415) 744-5185.
Auburn On-Site Support Group (9CPA), 400 15th Street, SW., Room: 1008, Auburn, WA 98001.
GSA employees who are union officials or who are in an exclusively recognized union. It includes GSA employees who file a grievance under the negotiated grievance procedure.
Records include:
1. List of employees who are elected or appointed as National union officers or officials.
2. National arbitration awards based on an employee or union grievance.
Authority for maintaining the system comes from 5 U.S.C. Chapter 71.
a. To identify and record employees who are included in an exclusively recognized union, are under dues withholding, are elected or appointed as union officers, whose grievances have been resolved by arbitration, and who use official time for representing employees.
b. To the Department of Labor in carrying out its functions regarding labor-management relations in the Federal service.
c. To officials of labor organizations recognized under Pub. L. 95-454, when needed for their duties of exclusive representation concerning personnel policies, practices, and matters affecting working conditions.
d. In any legal proceeding, where pertinent, to which GSA is a party before a court our administrative body.
e. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
f. By the Office of Personnel Management in producing descriptive statistics to support the function for which the records are collected and maintained or for related work force studies. While published statistics and studies do not identify individuals, in some instances data elements in a study may be structured so as to allow an individual to be identified by inference.
g. To disclose information to the Office of Management and Budget in reviewing private relief legislation at any stage of the clearance process.
h. To disclose information to officials of the Merit System Protection Board, including the Office of Special Counsel; the Federal Labor Relations Authority and its General Counsel; or the Equal Employment Opportunity Commission when requested in performing official duties.
i. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
j. To a Member of Congress or staff on behalf of and at the requests of the individual who is the subject of the record.
k. To the extent that official personnel records in the custody of GSA are covered within systems of records published by the Office of Personnel Management as Government-wide system, they are considered part of the Government-wide system. Other official personnel records covered by notices published by GSA and considered to be separate systems of records may be transferred to the Office of Personnel Management under official personnel programs and activities as a routine use.
l. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
m. To the National Archives and Records Administration (NARA) for records management purposes.
n. To appropriate agencies, entities, and persons when (1) The Agency suspects or has confirmed that the
Paper records and/or system generated inquiries are stored in file cabinets.
The records are filed numerically and/or alphabetically by name.
When not in use by an authorized person, the records are stored in locked metal file cabinets or in secured rooms.
The Office of Human Resources Services disposes of the records as scheduled in the HB, GSA Records Maintenance and Disposition System (OAD P 1820.2A).
Director, Labor Relations Division (CPL), Office of Human Resources Services, 1800 F Street, NW., Washington, DC 20405.
Current employees may obtain information about whether they are a part of the system by contacting the designated office where the action was processed.
Requests from current employees to review information about themselves should be directed to the designated office where the action was processed. For the identification required, see 41 CFR part 105-64.
GSA rules for reviewing a record, contesting the content, and appealing an initial decision are 41 CFR part 105-64.
Officials who manage records pertaining to employees who are union officials or in an exclusively recognized union and employees who have filed a grievance under the negotiated grievance procedure.
General Services Administration.
Notice.
The General Services Administration (GSA) reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: Telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Internal Evaluation Case Files.
This system is located in the GSA Office of Inspector General, 1800 F Street, NW., Washington, DC 20405. The database for this system is on a local area network in the GS Building and is operated by the System Development and Support Division of the Office of Inspector General.
Individuals covered by the system are employees and former employees of the GSA Office of Inspector General. The system also includes any person who was the source of a complaint or allegation; a witness who has information or evidence on any aspect of an investigation; and any possible or actual suspect in a civil, criminal, or administrative action.
Investigative files containing information such as name, date and place of birth, experience, and investigative material that is used as a basis for taking civil, criminal, and administrative actions.
5 U.S.C. App. 3., Section 2
The system serves as a basis for issuing subpoenas and taking civil, criminal, and administrative actions.
Records are used by GSA officials and representatives of other Government agencies on a need-to-know basis in the performance of their official duties under the authorities set forth above and for the following routine uses.
a. A record of any case in which there is an indication of a violation of law, whether civil, criminal, or regulatory in nature, may be disseminated to the appropriate Federal, State, local, or foreign agency charged with the responsibility for investigating or prosecuting such a violation or charged with enforcing or implementing the law.
b. A record may be disclosed to a Federal, State, local, or foreign agency or to an individual organization in the course of investigating a potential or actual violation of any law, whether civil, criminal, or regulatory in nature,
c. A record relating to a case or matter may be disclosed in an appropriate Federal, State, local, or foreign court or grand jury proceeding in accordance with established constitutional, substantive, or procedural law or practice, even when the agency is not a party to the litigation.
d. A record relating to a case or matter may be disclosed to an actual or potential party or to his or her attorney for the purpose of negotiation or discussion on matters such as settlement of the case or matter, plea-bargaining, or informal discovery proceedings.
e. A record relating to a case or matter that has been referred by an agency for investigation, prosecution, or enforcement or that involves a case or matter within the jurisdiction of any agency may be disclosed to the agency to notify it of the status of the case or matter or of any decision or determination that has been made or to make such other inquiries and reports as are necessary during the processing of the case or matter.
f. A record relating to a case or matter may be disclosed to a foreign country pursuant to an international treaty or convention entered into and ratified by the United States, or to an Executive agreement.
g. A record may be disclosed to a Federal, State, local, foreign, or international law enforcement agency to assist in crime prevention and detection or to provide leads for investigation.
h. A record may be disclosed to a Federal, State, local, foreign, tribal or other public authority in response to its request in connection with the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuing of a license, grant, or other benefit by the requesting agency, to the extent that the information relates to the requesting agency's decision on the matter.
i. A record may be disclosed to the public, news media, trade associations, or organized groups when the purpose is educational or informational, such as describing crime trends or distinctive or unique modus operandi, provided that the record does not identify a specific individual.
j. A record may be disclosed to an appeal or grievance examiner, formal complaints examiner, equal opportunity investigator, arbitrator, or other authorized official engaged in investigation or settlement of a grievance, complaint, or appeal filed by an employee. This includes matters and investigations involving the Merit Systems Protection Board or the Office of Special Counsel. A record also may be disclosed to the United States Office of Personnel Management (OPM) in accordance with the agency's responsibility for evaluating Federal personnel management.
k. A record may be disclosed as a routine use to a Member of Congress or to a congressional staff member in response to an inquiry of the congressional office made at the request of the person who is the subject of the record.
l. Information may be disclosed at any stage of the legislative coordination and clearance process to the Office of Management and Budget (OMB) for reviewing private relief legislation as set forth in OMB Circular No. A-19. A record may be disclosed:
(a) To an expert, a consultant, or contractor of GSA engaged in a duty related to an agency function to the extent necessary to perform the function; and
(b) To a physician to conduct a fitness-for-duty examination of a GSA officer or employee.
m. A record may be disclosed to any official charged with the responsibility to conduct qualitative assessment reviews of internal safeguards and management procedures employed in investigative operations. This disclosure category includes members of the President's Council on Integrity and Efficiency and officials and administrative staff within their investigative chain of command, as well as authorized officials of the Department of Justice and the Federal Bureau of Investigation.
n. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
o. To the National Archives and Records Administration (NARA) for records management purposes.
Paper records are kept in files and file folders. Electronic records are stored on hard drive or CD-ROM.
Both paper records and electronic records are retrievable by name or assignment number.
Paper records are stored in locked rooms with access limited to authorized personnel. Computer based records are available only to authorized users with a need to know and are protected by a network logon password, user password, and restricted right of access to the software, system, file, data element, and report.
Records are disposed of by shredding or burning, as scheduled in GSA Handbook, GSA Maintenance and Disposition System (OAD P 1820.2A).
Internal Evaluation Staff (JE) of the Office of Inspector General, General Services Administration, 1800 F Street, NW., Washington, DC 20405.
An individual who wishes to be notified whether the system contains a record concerning him or her should address a request to the Office of Counsel to Inspector General (JC), General Services Administration, Room 5324, 1800 F Street, NW., Washington, DC 20405.
An individual seeking access to a record should put his or her request in writing and address it to the Office of Counsel to the Inspector General (JC), including full name (maiden name if appropriate), address, and date and place of birth. General inquiries may be made by telephone: (202) 501-1932.
GSA rules for contesting the content of a record or appealing a denial of a request to amend a record are in 41 CFR Part 105-64.
The sources are individuals themselves, employees, informants, law enforcement agencies, other Government agencies, employers, references, co-workers, neighbors, educational institutions, and intelligence sources.
In accordance with 5 U.S.C. 552a(j), this system of records is exempt from all provisions of the Privacy Act of 1974 with the exception of subsections (b); (c)(1) and (2); (e)(4)(A) through (F); (e)(6), (7), (9), (10), and (11); and (i) of the Act, to the extent that information in the system pertains to the enforcement of criminal laws, including police efforts to prevent, control, or reduce crime or to apprehend criminals; to the activities of prosecutors, courts, and correctional, probation, pardon, or parole authorities; and to (1) information compiled for the purpose of identifying individual criminal offenders and alleged offenders and consisting only of identifying data and notations of arrests, the nature and disposition of criminal charges, sentencing, confinement, release, and parole and probation status; (2) information compiled for the purpose of a criminal investigation, including reports of informants and investigators, that is associated with an identifiable individual; or (3) reports of enforcement of the criminal laws, from arrest or indictment through release from supervision. This system is exempted to maintain the efficacy and integrity of the Office of Inspector General's law enforcement function.
In accordance with 5 U.S.C. 552a(k), this system of records is exempt from subsections (c)(3); (d); (e)(1); (e)(4) (G), (H), and (I); and (f) of the Privacy Act of 1974. The system is exempt:
a. To the extent that the system consists of investigatory material compiled for law enforcement purposes. However, if any individual is denied any right, privilege, or benefit for which the individual would otherwise be eligible as a result of the maintenance of such material, such material shall be provided to such individual, except to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express promise that the identity of the source would be held in confidence, or, prior to the effective date of the Act, under an implied promise that the identity of the source would be held in confidence; and
b. To the extent the system consists of investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for Federal civilian employment, military service, Federal contracts, or access to classified information, but only to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express promise that the identity of the source would be held in confidence, or, prior to the effective date of the Act, under an implied promise that the identity of the source would be held in confidence.
This system has been exempted to maintain the efficacy and integrity of lawful investigations conducted pursuant to the Office of Inspector General's law enforcement responsibilities and responsibilities in the areas of Federal employment, Government contracts, and access to security classified information.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Personal Property Sales Program.
System records are maintained by the General Services Administration (GSA) at several locations. A complete list of the locations is available from the System Manager.
The system will include those individuals who request to be added to GSA bidders' mailing lists, register to bid on GSA sales, and enter into contracts to buy Federal personal property at sales conducted by GSA.
The system contains information needed to identify potential and actual bidders and awardees, and transaction information involving personal property sales. System records include:
a. Personal information provided by bidders and buyers, including names, phone numbers, addresses, Social Security Numbers, and credit card numbers or other banking information; and
b. Contract information on Federal personal property sales, including whether payment was received, the form of the payment, notices of default, and contract claim information.
40 U.S.C. 121(c) and 40 U.S.C. 541, et seq.
To establish and maintain a system of records for conducting public sales of Federal personal property by GSA.
System information may be accessed and used by authorized GSA employees or contractors to prepare for and conduct personal property sales, administer sales contracts, perform
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the GSA Office of Finance for debt collection purposes (see GSA/PPFM-7).
h. To the National Archives and Records Administration (NARA) for records management purposes.
i. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Information may be collected on paper or electronically and may be stored on paper or on electronic media, as appropriate.
Records are retrievable by a personal identifier or by other appropriate type of designation approved by GSA.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A-130. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms. Electronic records are protected by passwords and other appropriate security measures.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the handbook, GSA Records Maintenance and Disposition System (OAD P 1820.2), and authorized GSA records schedules.
Director, Property Management Division (FBP), Federal Supply Service, General Services Administration, 2200 Crystal Drive, Crystal Plaza 4, Arlington, VA 22202.
Individuals may submit a request on whether a system contains records about them to the system manager at the above address.
Requests from individuals for access to their records should be addressed to the system manager.
GSA rules for access to systems of records, contesting the contents of systems of records, and appealing initial determinations are published in the
Information is provided by individuals who wish to participate in the GSA personal property sales program, and system transactions designed to gather and maintain data and to manage and evaluate the Federal personal property disposal program.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
FedBizOpps (FBO).
Records are maintained in electronic form in the GSA Federal Supply Service
a. Interested individuals. Individuals who request information from the FedBizOpps system. The contact is voluntary. The individual's e-mail address is used to respond to requests and inquiries.
b. Interested vendors. Contact information provided by vendors and/or individuals who are sole proprietors. Vendors may voluntarily establish a Vendor Notification Profile in FedBizOpps, within the secure production portion of the system. The vendor is notified by the system when selected FedBizOpps postings occur that are of interest to that vendor based on the profile.
The system maintains an inventory of Federal solicitations and related documents, and vendor contact information. System information includes:
a. Organizational, contact, and access control information on Federal contracting officials authorized to access and use the FedBizOpps system services for the management, administration, and posting of Federal solicitation information and related documents.
b. Contact information in the form of an e-mail address, provided voluntarily by vendors and other individuals who wish to use FedBizOpps to be kept informed of Federal procurements and/or specific solicitations of interest. Vendors also may choose to be included on the Interested Vendors Listing (IVL) to further eCommerce opportunities. A vendor may provide any or all of the data in the Interested Vendor Listing, which consists of Company Name, Address, Phone Number(s), E-mail address(es), Name of Point of Contact, and Business Type.
15 U.S.C. 637 and 41 U.S.C. 416.
To establish and maintain a system for posting, finding, and retrieving Federal solicitation information for procurements valued over $25,000; and to disseminate Federal solicitations to interested public individuals and businesses.
System information may be accessed and used by authorized Federal contracting officials to post Federal solicitation information and related documents in the conduct of official Federal business or by Federal contractors, vendors, and/or interested individuals to search, monitor, find, and/or respond to Federal solicitations of interest. Information from this system also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.
c. To duly authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To the Office of Personnel Management (OPM) and the Government Accountability Office (GAO) when the information is required for evaluation of the program.
e. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Information is collected electronically and is stored on readily accessible hard drives, backed up to tape media.
Federal government electronic solicitation records and related documents are readily retrievable by the general public using the search and retrieval and/or drill-down select and retrieval capabilities of FedBizOpps. The Federal buyer and interested individual (vendor) contact information described in the Categories of Records in the System paragraph is accessible only to authorized Federal officials and to the FedBizOpps system services that use the information for its intended purposes.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and the FedBizOpps System Security Plan. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data that is stored, processed, and transmitted, including password protection and other appropriate security measures.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the GSA Records Maintenance and Disposition System handbooks OAD P 1820.2A and CIO P 1820.1, and authorized GSA records schedules.
FBO Program Manager, FedBizOpps Program Office, General Services Administration, Federal Supply Service (GSA/FIB), Crystal Mall Four, Room 804 (CM4-804), 1901 South Bell Street, Arlington, VA 22202-4502.
An individual may obtain information on whether the system contains his or her record by addressing a request to the FedBizOpps (FBO) Program Manager at the above address.
Requests from individuals for access to their records should be addressed to the FedBizOpps (FBO) Program Manager at the above address.
GSA rules for access to systems of records, for contesting the contents of
Information is obtained from individuals who are Federal contracting officials authorized to use the FedBizOpps system for official Federal business or who are individuals voluntarily providing contact information using FedBizOpps vendor services in order to be notified of solicitations of interest.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Federal Procurement Data System—Next Generation (FPDS-NG).
Electronic records are maintained by the FPDS-NG contractor in a secure computer facility. Contact the system manager for additional information.
FPDS-NG includes information on individuals who are sole proprietors who have or had contracts with the Federal Government.
The system collects, processes, and maintains official statistical data on Federal contracting, including:
a. Information on individual federal contractors that may include name, DUNS (Data Universal Numbering System) number, and Social Security Number as the Taxpayer Identification Number (TIN).
b. Contracts that are unclassified but may be considered sensitive due to insight they may provide into federal government activities in conjunction with data from other federal contracts.
Public Law 93-400 Office of Federal Procurement Policy Act, as amended; 41 U.S.C. 405, 417.
To establish and maintain a system for assembling, organizing, and presenting contract procurement data for the federal government and the public sector.
Information in this system may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.
c. To an authorized appeal or grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator, or other duly authorized official engaged in investigation or settlement of a grievance, complaint, or appeal filed by an individual to whom the information pertains.
d. To the Office of Management and Budget (OMB) and the Government Accountability Office (GAO) in accordance with their responsibilities for evaluating Federal programs.
e. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
f. To authorized officials of the agency that provided the information for inclusion in the system.
g. To an expert, consultant, or contractor in the performance of a Federal duty to which the information is relevant.
h. To provide recurring or special reports to the President, Congress, the Government Accountability Office, Federal Executive agencies, and the general public.
i. As a means of measuring and assessing the impact of Federal contracting on the nation's economy and the extent to which small, veteran-owned small, service-disabled veteran-owned small, HUBZone small, small disadvantaged and woman-owned small business concerns are sharing in Federal contracts.
j. To provide information for policy and management control purposes.
k. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Information may be collected electronically and may be stored on electronic media, as appropriate. Electronic records are kept on server
Records are retrievable by a variety of fields, the key for individual records being the unique Procurement Instrument Identifier (PIID).
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and the FPDS-NG System Security Plan. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data that is stored, processed, and transmitted. Electronic records are protected by passwords and other appropriate security measures.
Data entry is limited to authorized users whose names and levels of access are maintained by federal agencies and the information is securely stored online. Unclassified but sensitive contract data in the system is restricted to those who have access within the federal agency. Agencies determine when their contract information may be made available for viewing by other agencies and the public.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the GSA Records Maintenance and Disposition System handbooks OAD P 1820.2A and CIO P 1820.1, and authorized GSA records schedules.
Federal Procurement Data Center Program Manager, Integrated Acquisition Environment (GSA/IAE/VSI), Office of The Chief Acquisition Officer, Suite 911, Crystal Park I, 2011 Crystal Drive, Arlington, VA 22202.
An individual may obtain information on whether the system contains his or her record by registering with FPDS-NG as a public user and using one or more of the various search capabilities to search for the record, or by addressing the inquiry to the system manager. Requests for system information that is releasable under the Freedom of Information Act (FOIA) may be directed to the Federal Procurement Data Center Program Manager through the FOIA Requestor Service Center, 1800 F St., NW., Room 7126, Washington, DC 20405.
Any individual may register with FPDS-NG as a public user and use one or more of the various search capabilities to search for federal contracts after they have been awarded and entered into FPDS-NG. Individuals also may request access to their information from the system manager. The public may obtain releasable information by submitting a FOIA request to the Federal Procurement Data Center Program Manager through the FOIA Requestor Service Center.
GSA establishes the rules for access to federal contracts. Individuals may contest the contents of a contract by contacting the contracting office in the department or agency that awarded the contract.
Information is obtained from federal agencies who report federal contracts after award according to the reporting requirements included in the Federal Acquisition Regulation Subpart 4.6—Contract Reporting. These records may contain the names of individuals, their DUNS number, and Taxpayer Identification Number (TIN).
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Electronic Acquisition System (EAS).
The system records and documents are maintained at the Enterprise Service Center of the GSA Public Buildings Service (PBS). Contact the EAS System Manager for additional information.
The system maintains information on individuals, as well as businesses, who have made an offer or provided a quote in response to a PBS solicitation or who have entered into a contract with PBS.
The system maintains information required throughout the lifecycle of a PBS contract action including information about contracts, proposals and bids, and vendors. The Central Contractor Registry, a federal government computer system maintained by the Department of Defense, is the sole source for vendor information in EAS. All information received from CCR is originally submitted by the vendor to CCR. In addition to business contact and identification information (address, telephone number, and Taxpayer Identification Number (TIN)), the system includes personal information on individuals who use personal contact and identification information (home address, telephone, e-mail, and fax numbers, and Social Security Number) for business purposes as sole proprietors.
Office of Federal Procurement Policy Act of 1974 (Pub. L. 93-400), as
To provide and maintain a system supporting PBS acquisition contract preparation, workflow activities, tracking, and reporting. The system ensures that the PBS staff prepares, assembles, and maintains information necessary for compliance with FAR and GSAM contracting requirements.
System information may be accessed and used by authorized GSA employees and contractors to conduct official duties associated with federal acquisition. Information from this system may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.
c. To duly authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office (GAO) or other Federal agency when the information is required for program evaluation purposes.
e. To another Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; clarifying a job; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
f. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
g. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
h. To the National Archives and Records Administration (NARA) for records management purposes.
i. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
System records and documents are electronically stored on servers, tape backups, and/or compact discs.
Records may be retrieved by name and/or other personal identifier or appropriate type of designation.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and the EAS System Security Plan. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the data. Security measures include password protections, assigned roles, and transaction tracking.
Disposition of records will be according to the National Archives and Records Administration (NARA) guidelines, set forth in the GSA Records Maintenance and Disposition System (OAD P 1820.2A) handbook.
EAS Program Manager, Systems Development and Maintenance Division (PGAB), Office of the PBS Chief Information Officer, General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Individuals may obtain information about their records from the EAS Program Manager at the above address.
Requests from individuals for access to their records should be addressed to the EAS Program Manager. GSA rules for individuals requesting access to their records are published in 41 CFR part 105-64.
Individuals must contest their record's source data and appeal determinations for correction at the Central Contractor Registry according to CCR rules. Individuals may contest their GSA records' contents and appeal determinations according to GSA rules published in 41 CFR part 105-64.
Information is obtained from the Central Contractor Registry for registered and matched vendors who are offerors or winners of GSA PBS contract actions.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: Telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system
Records of Defunct Agencies.
The system of records is located in the GSA regional office building, 7th & D Streets, SW., Washington, DC 20407, and at the GSA National Payroll Center, 6BCY, 1500 E. Bannister Road, Kansas City, MO 64131-3088.
Employees of defunct agencies, including but not limited to, presidential commissions, committees, small agencies, and boards, whose records the GSA services under a reimbursable agreement.
Payroll and financial records, including but not limited to, time and attendance cards, payment vouchers, employee health benefit records, requests for deductions, tax forms, including W-2 forms, overtime requests, leave data, retirement records, and vendor register and payment tapes.
5 U.S.C. Part III, Subparts D and E, 26 U.S.C. Chapter 24 and 3501, E.O. 9397, and 31 U.S.C. 1531.
To notify the public of the routine use and storage of payroll, personnel and financial records stored by GSA for defunct agencies that are sensitive in nature.
The GSA uses the records for concluding the administrative operations of the defunct agency. Routine uses include providing a copy of an employee's Department of the Treasury Form W-2, and Wage and Tax Statement, to the State, city, or other local jurisdiction that has authority to tax the employee's pay. The agency also provides a record under a withholding agreement between a State, city, or other jurisdiction and the Department of the Treasury under 5 U.S.C. 5516, 5517, and 5520, or in response to the written request of an authorized official of the taxing jurisdiction to the Director, GSA National Payroll Center (6BCY), 1500 East Bannister Road, Kansas City, MO 64131-3088. The request must include a copy of the statute or ordinance showing the authority of the jurisdiction to tax the employee based on place of residence, place of employment, or both.
Under a withholding agreement between a city and the Department of the Treasury (5 U.S.C. 5520), the GSA furnishes copies of executed city tax withholding certificates to the city in response to a written request from the proper city official to the GSA official named in the paragraph above. Records are also released to the Government Accountability Office for audits and to the Internal Revenue Service for use in investigations. Additional routine uses are:
a. To disclose a record to the appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, or regulation, or order, where the GSA becomes aware of an indication of a violation, or potential violation of a civil or criminal law or regulation.
b. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
c. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
e. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant and a physician to conduct a fitness-for-duty examination of a GSA officer or employee.
g. To disclose a record to the OPM concerning pay, benefits, retirement deductions, and other information needed under that agency's responsibility to evaluate Federal personnel management.
h. To the National Archives and Records Administration (NARA) for records management purposes.
i. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
To the extent that official personnel records in the GSA's custody are covered within systems of records published by the OPM as Government-wide records, the records are considered part of the Government-wide system. Other personnel records covered by notices published by the GSA and considered to be separate systems of records may be transferred to the OPM under personnel programs as a routine use.
Paper records are in file folders and card files. Microfiche records on microfiche sheets are stored in cabinets. CD-ROMs and floppy disks are stored in file cabinets.
Payroll records are retrievable by Social Security Number and other records by name.
When not in use by an authorized person, the records are stored in locked metal containers or in secured rooms.
The Division Director of the Agency Liaison Division and the National Payroll Center disposes of the records as scheduled in the handbook, GSA Records Maintenance and Disposition System (OAD P 1820.2).
The system managers are the Director, Agency Liaison Division (WB-E),
Requests to review or receive a copy of a record should be sent to the system manager named above.
See 41 CFR part 105-64, published in the
See 41 CFR part 105-64.
When it shuts down, the agency that the GSA services publishes a notice in the
General Services Administration.
Notice.
The General Services Administration (GSA) reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Transportation Benefits Records.
System records are maintained by the Office of the Chief Human Capital Officer (C), 1800 F Street, NW., Washington, DC 20405; and by each of GSA's regional offices.
Employees applying for transit subsidies for use of public transportation and vanpools to and from the workplace.
Record categories may include name, home address, Social Security Number, work organization and location, mode of transportation, and commuting costs.
E.O. 13150; 26 U.S.C. 132(f); and Federal Employees Clean Air Incentives Act (section 2(a) of Public Law 103-172, found at 5 U.S.C. 7905), as amended.
To establish and maintain systems for providing transportation fringe benefits to employees who use mass transportation to commute to and from work.
System information is used to determine the eligibility of applicants for transportation benefits and to disburse benefits to eligible employees through the Department of Transportation. Information also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
System records are stored electronically and on paper.
Records may be retrieved by name, Social Security Number, or other identifier in the system.
Records are safeguarded in accordance with the Privacy Act and the Computer Security Act. Technical,
Applications will be maintained for as long as the applicant is an eligible participant in the subsidy program. System records are retained and disposed of according to GSA records maintenance and disposition schedules and the requirements of the National Archives and Records Administration (NARA).
Office of the Chief Human Capital Officer (C), Office of Human Capital Management (CH), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Inquiries should be directed to the system manager at the above address.
Requests for access to records should be directed to the system manager. GSA rules for accessing records under the Privacy Act are provided in 41 CFR part 105-64.
Requests to correct records should be directed to the system manager. GSA rules for contesting record contents and for appealing determinations are provided in 41 CFR part 105-64.
Sources for information in the system are: Employees submitting applications for transit subsidies.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street NW., Washington, DC 20405.
GSA undertook and completed an agency wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Grievance Records.
The records are located in the Office of Human Resources Services at GSA or office in GSA in which grievances were filed. The offices are as follows:
Central Office, Central Office Human Resources Division (CHP), General Services Administration, 1800 F Street NW., Washington, DC 20405, (202) 501-0040.
National Capital Region, Human Resources Office (WCP), General
Services Administration, 7th and D Streets SW., Washington, DC 20407, (202) 708-5335.
New England Region, Human Resources Office (1CP), General Services Administration, 10 Causeway Street, Boston, MA 02222, (617) 565-6634.
Northeast and Caribbean Region, Human Resources Office (2AR), General Services Administration, 26 Federal Plaza, New York, NY 10278, (212) 264-8138.
Mid-Atlantic Region, Human Resources Office (3CP), General Services Administration, The Strawbridge Building, 20 North Eighth Street, Philadelphia, PA 19107-3191, (215) 446-4951.
Southeast Sunbelt Region, Office of Human Resources (4AH), General Services Administration, 77 Forsyth Street, Suite 650, Atlanta, GA 30303, (404) 331-3186.
Great Lakes Region, Human Resources Office (5CP), General Services Administration, 230 South Dearborn Street, Chicago, IL 60604, (312) 353-5550.
The Heartland Region, Human Resources Office (6CP), General Services Administration, 1500 East Bannister Road, Kansas City, MO 64131, (816) 926-7206.
Greater Southwest Region, Human Resources Office (7CP), General Services Administration, 819 Taylor Street, Room 9A00, Forth Worth, TX 76102, (817) 978-3190.
Pacific Rim Region, Human Resources Office (9CP), General Services Administration, 450 Golden Gate Avenue, San Francisco, CA 94100, (415) 744-5185.
Current or former employees who have filed grievances with GSA under part 771 of the Office of Personnel Management (OPM) Regulations (5 CFR part 771) or a negotiated procedure.
The system contains grievances filed by agency employees under part 771 of OPM regulations. It also includes files of internal grievance and arbitration systems that are established through negotiations with recognized labor unions.
5 U.S.C. Chapter 75; E.O. 10577, as amended; E.O. 11491, as amended.
To maintain an information system documenting employee grievances, including statements of witnesses, reports of interviews and hearings, examiner's findings and recommendations, a copy of the original and final decision, and related correspondence and exhibits.
System information may be accessed and used by authorized Federal agency employees or contractors to conduct official duties. Information from this system also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To disclose information to any source from which additional
c. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
e. By GSA or the Office of Personnel Management in the production of summary description statistics and analytical studies in support of the function for which the records are collected and maintained, or for related work force studies. While published statistics do not contain individual identifiers, in some instances the selection of elements of data included in the study may be structured in such a way as to make the data individually identifiable by inference.
f. To officials of the Merit Systems Protection Board, including the Office of Special Counsel; the Federal Labor Relations Authority and its General Counsel, or Equal Employment Opportunity Commission when requested in performance of their authorized duties.
g. In response to a request for a discovery or for appearance of a witness, information that is relevant to the subject matter involved in a pending judicial or administrative proceeding.
h. To provide information to officials of labor organizations reorganized under the Civil Service Reform Act when relevant and necessary to their duties of exclusive representation concerning personnel policies, practices, and matters affecting working conditions.
i. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
j. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
k. To the National Archives and Records Administration (NARA) for records management purposes.
l. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
The records are maintained in file folders.
Records reside where the grievance action is processed. The records are filed numerically and/or alphabetically by name.
These records are maintained in lockable metal filing cabinets to which only authorized personnel have access.
These records are disposed of 3 years after closing of the case. Disposal is by shredding or burning.
The Director of Human Capital Policy and Program Management Division (CHP), Office of Human Capital Management (CH), 1800 F Street, NW., Washington, DC 20405.
Current employees may obtain information about whether they are a part of the system by contacting the designated office where the action was processed.
Requests from current employees to review information about themselves should be directed to the designated office where the action was processed. For the identification required, see 41 CFR part 105-64.
Review of a request from an individual seeking to amend a grievance record that has been the subject of a judicial or quasi-judicial process is limited in scope. Review of this type of request is restricted to determining if the record accurately documents GSA's ruling on the case and does not include a review of the merits of an action, determination, or finding. An individual who wishes to amend his or her record to correct factual errors should contact the GSA Office of Human Resources Services (CHP) or the office where the grievance was processed. The individual must also follow the GSA Privacy Act procedures on amending records (CPO 1878.1).
Officials who manage records pertaining to employees who have filed grievances with GSA under part 771 of the Office of Personnel Management (OPM) Regulations (5 CFR part 771) or a negotiated procedure.
Under 5 U.S.C. 552a(k)(2), this system of records is exempt from subsections (c)(3); (d); (e)(1); (e)(4)(G), (e)(4)(H), (e)(4)(I); and (f) of the Act when the records are complied for a law enforcement purpose and the record will not be used to deny a right, benefit, or privilege from the subject of the record.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions,
Occupational Health and Injury Files.
The system of records is used in the General Services Administration's Office of Human Resources Services; the Safety and Environmental Management Division, Office of Real Property Management and Safety, Public Building Service; and in the offices of supervisors of any employee who has had an occupational health problem or who was injured on the job. The data base is in computers at the Heartland Regional Office, Kansas City MO.
The Human Resources Services Offices are as follows:
Central Office, Central Office Human Resources Division (CPS), General Services Administration, 1800 F Street NW., Washington, DC 20405, (202) 501-0040.
National Capital Region, Human Resources Office (WCP), General Services Administration, 7th and D Streets SW., Washington, DC 20407, (202) 708-5335.
New England Region, Human Resources Office (1CP), General Services Administration, 10 Causeway Street, Boston, MA 02222, (617) 565-6634.
Northeast and Caribbean Region, Human Resources Office (2AR), General Services Administration, 26 Federal Plaza, New York, NY 10278, (212) 264-8138.
Mid-Atlantic Region, Human Resources Office (3CP), General Services Administration, The Strawbridge Building, 20 North Eighth Street, Philadelphia, PA 19107-3191, (215) 446-4951.
Southeast Sunbelt Region, Office of Human Resources (4AH), General Services Administration, 77 Forsyth Street, Suite 650, Atlanta, GA 30303, (404) 331-3186.
Great Lakes Region, Human Resources Office (5CP), General Services Administration, 230 South Dearborn Street, Chicago, IL 60604, (312) 353-5550.
The Heartland Region, Human Resources Office (6CP), General Services Administration, 1500 East Bannister Road, Kansas City, MO 64131, (816) 926-7206.
Greater Southwest Region, Human Resources Office (7CP), General Services Administration, 819 Taylor Street, Room 9A00, Forth Worth, TX 76102, (817) 978-3190.
Pacific Rim Region, Human Resources Office (9CP), General Services Administration, 450 Golden Gate Avenue, San Francisco, CA 94100, (415) 744-5185.
GSA employees who were injured or who have an occupational health problem.
The system includes:
• Accident reports (including CA 1 and 2: Federal Employee's Notice of Injury or Occupational Disease);
• Claims for Compensation for Injury or Occupational Disease (CA 4 replaced with CA-2);
• Claims for Continuance of Compensation on Account of Disability (CA 8 replaced with CA-7); and
• Lists of employees receiving medical services, and health records. The automated information system contains statistics such as occupation and sex of employees, age group, cost per injury, days lost, cause and severity of injuries, and part(s) injured.
5 U.S.C. ch. 81 and 5 U.S.C. 7203 and 7901.
To maintain information for accident and occupational health reports, gather data for statistical reports, and record any employee who is injured or has an occupational health problem.
System information may be accessed and used by authorized Federal agency employees or contractors to conduct official duties. Information from this system also may be disclosed as a routine use:
a. To a Federal, State, or local public health agency on any employee who has a specific communicable disease or condition. The purpose is to prevent the spread of the disease or condition.
b. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
c. To the Office of Worker's Compensation Programs on a claim for benefits filed by an employee.
d. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
e. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
f. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
g. To the Occupational Safety and Health Administration, as required by section 19 of the Occupational Safety and Health Act.
h. To Central Office and regional office managers and supervisors to identify trends in injuries and better manage the program.
i. To the Department of Labor to verify payments to an injured employee.
j. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
k. To the National Archives and Records Administration (NARA) for records management purposes.
l. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are kept in file folders. Magnetic tapes and disks are stored in libraries. Electronic records are stored in computers and attached equipment.
Records are filed and retrieved by Social Security Number or claim number.
Records are stored in locked file cabinets or in secured rooms. Computer records are protected by a password system.
The Office of Human Resources Services disposes of the records as scheduled in the handbook, GSA Records Maintenance and Disposition system (OAD P 1820.2A).
Chief, Employee Relations Branch, (CPSE), Office of Human Resources Services (CP), General Services Administration (CP), 18th and F Streets, NW., Washington, DC 20405.
Current employees should address requests to their supervisor or to the Human Resources Services officer. Former employees should address requests to the Human Resources Services officer.
Current employees should address requests to their supervisor or to the Human Resources Services officer. Former employees should address requests to the Human Resources Services officer. For the identification required, see 41 CFR part 105-64.
GSA rules for contesting the content and appealing an initial decision are in 41 CFR part 105-64.
The employee and the personnel specialist who prepared a claim.
General Services Administration.
Notice.
The General Services Administration (GSA) reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Purchase Card Program.
System records are maintained by the Office of Finance, General Services Administration (GSA), at 1800 F Street, NW., Washington, DC 20405, and by designated purchase card coordinators' offices in GSA regions. Contact the System Manager for additional information.
The system includes employees of GSA, and of independent offices and commissions serviced by GSA, who qualify to use Federal Government charge cards for making authorized purchases for official business.
The system provides control over expenditure of funds through the use of Federal Government purchase cards. System records include:
a. Personal information on charge card users, including names, home or business telephone numbers and addresses, Social Security Numbers, date of birth, employment information, or commercial and agency investigative reports showing debtors' asset, liabilities, income, expenses, bankruptcy petitions, history of wage garnishments, repossessed property, tax liens, legal judgments on debts owed, and financial delinquencies; and
b. Account processing and management information, including charge card transactions, contractor monthly reports showing charges to individual account numbers, account balances, and other data needed to authorize, account for, and pay authorized purchase card expenses.
41 U.S.C. 252a, 252b, 427, 428; E.O. 12931, and Section 639 of the Consolidated Appropriations Act, 2005 (Pub. L. 108-447).
To establish and maintain a system for operating, controlling, and managing the purchase card program involving commercial purchases by authorized Government employees.
System information may be accessed and used by authorized GSA employees or contractors to conduct official duties associated with the management and operation of the purchase card program. Information from this system also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To the GSA Office of Finance for debt collection purposes (see GSA/PPFM-7).
i. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Information may be collected on paper or electronically and may be stored on paper or on electronic media, as appropriate.
Records are retrievable by a personal identifier or by other appropriate type of designation approved by GSA.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A-130. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms. Electronic records are protected by passwords and other appropriate security measures.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the handbook, GSA Records Maintenance and Disposition System (CIO P 1820.1), and authorized GSA records schedules.
Director, Financial Initiative Division (BCD), Office of Financial Policy and Operations, Office of the Chief Financial Officer, General Services Administration, 1800 F Street, NW., Washington, DC 20405.
A Privacy Act Statement on the purchase card data collection form notifies individuals of the purpose and uses of the information they provide. Employees may obtain information about whether they are a part of this system of records from the system manager at the above address.
Requests from individuals for access to their records should be addressed to the system manager.
GSA rules for access to systems of records, contesting the contents of systems of records, and appealing initial determinations are published at 41 CFR part 105-64.
Information is obtained from individuals submitting charge card applications, monthly contractor reports, purchase records, managers, other agencies, non-Federal sources such as private firms, and other agency systems containing information pertaining to the purchase card program.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Pegasys.
Pegasys records and files are maintained in the Phoenix Data Center (PDC), with records also stored in the Washington, DC Central Office, Ft. Worth regional office, and Kansas City regional office.
Individuals covered by Pegasys include GSA vendors and Federal employees.
Pegasys contains records and files pertaining to financial information; therefore, these files and records contain the following privacy data:
• Social Security Number (SSN);
• Employee address;
• Banking information;
• Credit Card number.
The Chief Financial Officers (CFO) Act of 1990 (Public Law 101-576) as amended.
Pegasys is the GSA core financial management system of records to make payments and record accounting transactions. This includes funds management (budget execution and purchasing), credit cards, accounts payable, disbursements, standard general ledger, and reporting. It is part of a shared-services financial operation providing a commercial-off-the-shelf (COTS) financial system (in a private-vendor hosted environment), financial transaction processing, and financial analysis for its main business lines of Federal supplies and technology, public buildings, and general management and administration offices. GSA also utilizes this shared-service operation to cross service multiple external client agencies.
System information accessed by Pegasys may be used by designated finance center employees and their supervisors, along with designated analysts and managers. System information also may be used:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To conduct investigations, by authorized officials, that are investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
f. To the National Archives and Records Administration (NARA) for records management purposes.
g. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
All records and files in Pegasys are stored electronically in a password-protected database format.
Information on individuals contained in Pegasys records and files are retrievable by name or vendor number.
Pegasys records and files are safeguarded in accordance with the requirements of the Privacy Act. Access is limited to authorized individuals with passwords, and the database is maintained behind a certified firewall. Information on individuals is released only to authorized persons on a need-to-know basis and in accordance with the provisions of routine use. This system undergoes frequent testing and is certified and accredited for operation. Periodic Privacy Act Impact Assessments are performed as well to ensure the adequacy of security controls to protect personally identifiable information.
Pegasys records and files are retained and disposed of according to GSA records maintenance and disposition schedules and the requirements of the National Archives and Records Administration (NARA).
Director, Financial Systems Development Division (BDD), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Individuals wishing to inquire if the system contains information about them should contact the Pegasys system manager.
Requests for access may be directed to the Pegasys system manager.
GSA rules for accessing records, for contesting the contents, and appealing initial decisions are in 41 CFR part 105-64, published in the
The sources for information in Pegasys are the individuals for whom the records are maintained, the supervisors of those individuals, and existing agency systems.
General Services Administration.
Notice.
The General Services Administration (GSA) reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: Telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new
Payroll Accounting and Reporting (PAR) System.
The system is located in the Office of the Chief Financial Officer, General Services Administration (GSA) in Kansas City, Missouri; in commissions, committees and small agencies serviced by GSA; and in administrative offices throughout GSA.
Those covered are present and former employees of GSA and of commissions, committees, and small agencies serviced by GSA; and persons in intern, youth employment, and work/study programs.
PAR provides complete functionality for an employee's entire service life from initial hire through final payment and submission of retirement records to the Office of Personnel Management (OPM). The system holds payroll records, and includes information received by operating officials as well as personnel and finance officials administering their program areas, including information regarding nonsupport of dependent children. The system also contains data needed to perform detailed accounting distributions, provide for tasks such as mailing checks and bonds, and preparing and mailing tax returns and reports. The record system may contain:
a. Employee's name, Social Security Number, date of birth, sex, work schedule, and type of appointment.
b. Service computation date for assigning leave, occupational series, position, grade, step, salary, award amounts, and accounting distribution.
c. Time, attendance, and leave; Federal, State, and local tax; allotments; savings bonds; and other pay allowances and deductions.
d. Tables of data for editing, reporting, and processing personnel and pay actions, which include nature-of-action code, organization table, and salary table.
e. Information regarding court-ordered payments to support dependent children, including amounts in arrears.
5 U.S.C. Part III, Subparts D and E, 26 U.S.C. Chapter 24 and 2501, and E.O. 9397.
To maintain automated information system to support the day-to-day operating needs of the payroll program. The system can provide payroll statistics for all types of Government organizations, and allows many uses for each data element entered. The system has a number of outputs: For the payroll office, outputs include comprehensive payroll reports; accounting distribution of costs; leave data summary reports; each employee's statement of earnings, deductions, and leave every payday; State, city, and local unemployment compensation reports; Federal, State, and local tax reports; Forms W-2, Wage and Tax Statement; and reports of withholding and contributions.
For the Office of Human Resources Services, outputs include data for reports of Federal civilian employment. The system also provides data to GSA staff and administrative offices to use for management purposes.
a. To disclose information to a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order, where the agency becomes aware of a violation or potential violation of civil or criminal law or regulation.
b. To disclose requested information to a court or other authorized agency regarding payment or nonpayment of court-ordered support for a dependent child.
c. To disclose information to Congressional staff in response to a request from the person who is the subject of the record.
d. To disclose information to a manager, expert, consultant, or contractor of the agency for performing a Federal duty.
e. To disclose information to a Federal, State, or local agency maintaining civil, criminal, enforcement, or other information to obtain information needed to make a decision on hiring or retaining an employee; issuing a security clearance; letting a contract; or issuing a license, grant, or other benefit.
f. To disclose requested information to a Federal agency in connection with hiring or retaining an employee; issuing a security clearance; reporting an employee investigation; or clarifying a job.
g. To disclose information to an appeal, grievance, or formal complaints examiner; equal employment opportunity investigator; arbitrator; union official or other official engaged in investigating or settling a grievance, complaint, or appeal filed by an employee.
h. To disclose information to the Office of Management and Budget for reviewing private relief legislation at any stage of the clearance process.
i. To provide a copy of the Department of the Treasury Form W-2, Wage and Tax Statement, to the State, city, or other local jurisdiction that is authorized to tax the employee's compensation. The record is provided by a withholding agreement between the State, city, or other local jurisdiction and the Department of the Treasury under 5 U.S.C. 5516, 5517, and 5520.
j. To disclose information to the Office of Human Resources Services in reporting civilian employment.
k. To disclose information to agency administrative offices who may restructure the data for management purposes.
l. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are kept in file folders, within locked power files; microfiches in cabinets; and computer records within a computer and attached equipment. All paper records are secured with the National Payroll Center (NPC), which is a secured area at the GSA NPC in Kansas City, Missouri.
Records are filed by name or Social Security Number at each location.
Records are stored in locked power files, within the NPC in Kansas City, when not in use by an authorized person. Electronic records are protected by a password system and other appropriate security measures. The NPC is a secured access facility.
The Heartland Finance Center disposes of the records by shredding or burning, as scheduled in the handbook GSA Records Maintenance and Disposition System (CIO P 1820.1).
Deputy Chief Financial Officer, Office of Financial Policy and Operations, General Services Administration, 1800 F Street, NW., Washington, DC 20405.
An individual inquiry should be addressed to the system manager.
An individual request should be addressed to the system manager. Furnish full name, Social Security Number, address, telephone number, approximate dates and places of employment, and nature of the request.
GSA rules for contesting the content of a record and appealing an initial decision are in 41 CFR 105-64.
The sources are the individuals themselves, other employees, supervisors, officials of other agencies, State governments, record systems GSA/ HRO-37, OPM/GOVT-1, EEOC/GOVT-1, and private firms.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
System for Tracking and Administering Real-property (STAR).
Electronic records are maintained at the GSA Public Buildings Service (PBS) Enterprise Service Center site. Paper records are located in PBS regional and field offices. Contact the system manager for additional information.
STAR includes information on individuals who are sole proprietors who lease property to the Federal Government. In addition to sole proprietors, individuals who might be designated to receive lease payments are included. Information on these individuals includes their name, contact information, and their Taxpayer Identification Number (TIN).
The system maintains an inventory of government owned and leased property and includes:
a. Personal information of property owners, including sole proprietors who are designated as Lessors, or the sole proprietor's designee who is authorized to receive payments for the lease, designated as Lease Payee. b. Internal communications that reference the Lessors and Lease Payees.
40 U.S.C. Chapters 5, 31, and 33.
To establish and maintain a system for tracking and administering leased property.
System information may be accessed and used by authorized GSA employees or contractors in the conduct of official duties associated with the tracking and administration of leased property. The information may be shared with the GSA real property management systems Rent Estimate, Business Information Solution, Occupancy Agreement Tool, and Data Gateway. Information from this system also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.
c. To duly authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To the Office of Personnel Management (OPM) and the Government Accountability Office (GAO) when the information is required for evaluation of the program.
e. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To appropriate agencies, entities, and persons when (1) The Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has
Information may be collected on paper or electronically and may be stored on paper or on electronic media, as appropriate. Electronic records are kept on server hard drives and/or CD-ROM.
Records are retrievable by a lessor's or designee's name and/or TIN.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and the STAR System Security Plan. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data that is stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms. Electronic records are protected by passwords and other appropriate security measures.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the GSA Records Maintenance and Disposition System handbooks OAD P 1820.2A and CIO P 1820.1, and authorized GSA records schedules.
STAR Program Manager, Systems Development Division (PGAB), Office of Technology Capital Asset Management, Room 5217, General Services Administration, 1800 F Street, NW., Washington, DC 20405-0001.
An individual may obtain information on whether the system contains his or her record by addressing a request to the STAR Program Manager at the above address.
Requests from individuals for access to their records should be addressed to the STAR Program Manager at the above address.
GSA rules for access to systems of records, for contesting the contents of systems of records, and for appealing initial determinations are published in the
Information is obtained from individuals who are sole proprietor property owners or individuals who are designated to receive lease payments.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Travel Charge Card Program.
This system of records is located in the finance office of the local installation of the Federal agency for which an individual has traveled. Records necessary for a contractor to perform under a contract are located at the contractor's facility.
Individuals covered by the system are current Federal employees who have their own government assigned charge card and all other Federal employees and authorized individuals who use a Federal account number for travel purposes.
Records include name, address, Social Security Number, date of birth, employment information, telephone numbers, information needed for identification verification, travel authorizations and vouchers, charge card applications, charge card receipts, terms and conditions for use of charge cards, and monthly reports from contractor(s) showing charges to individual account numbers, balances, and other types of account analyses.
5 U.S.C. 5707 and implementing Federal Travel Regulation, 41 CFR 300-304; 5 U.S.C. 5738; E.O. 11609; 36 CFR 13747 (1971); 31 U.S.C. 1348; Public Law 107-56 Sec. 326.
To assemble in one system information to provide government agencies with: (1) Necessary information on the commercial travel and transportation payment and expense control system, which provides travelers charge cards and the agency an account number for official travel and related travel expenses on a worldwide basis; (2) attendant operational and control support; and (3) management
a. To disclose information to a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, implementing, or carrying out a statute, rule, regulation, or order, where an agency becomes aware of a violation or potential violation of civil or criminal law or regulation.
b. To disclose information to a Member of Congress or a congressional staff member in response to an inquiry made at the request of the individual who is the subject of the record.
c. To disclose information to the contractor in providing necessary information for issuing credit cards.
d. To disclose information to a requesting Federal agency in connection with hiring or retaining an employee; issuing a security clearance; reporting an employee investigation; clarifying a job; letting a contract; or issuing a license, grant, or other benefit by the requesting agency where the information is relevant and necessary for a decision.
e. To disclose information to an appeal, grievance, or formal complaints examiner; equal employment opportunity investigator; arbitrator; exclusive representative; or other official engaged in investigating, or settling a grievance, complaint, or appeal filed by an employee.
f. To disclose information to officials of labor organizations recognized under Pub. L. 95-454, when necessary to their duties of exclusive representation on personnel policies, practices, and matters affecting working conditions.
g. To disclose information to a Federal agency for accumulating reporting data and monitoring the system.
h. To disclose information in the form of listings, reports, and records of all common carrier transactions including refunds and adjustments to an agency by the contractor to enable audits of carrier charges to the Federal government.
i. To appropriate agencies, entities, and persons when (1) The Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
j. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
k. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
l. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
m. To the National Archives and Records Administration (NARA) for records management purposes.
Paper records are stored in file folders. Electronic records are stored within a computer and associated equipment.
Records are filed by name, Social Security Number, and/or credit card number.
Paper records are stored in lockable file cabinets or secured rooms. Electronic records are protected by passwords, access codes, and entry logs. There is restricted access to credit card account numbers, and information is released only to authorized users and officials on a need-to-know basis.
Records are kept for 3 years and then destroyed, as required by the General Records Retention Schedules issued by the National Archives and Records Administration (NARA).
Assistant Commissioner, Office of Acquisition (FC), Federal Supply Service, General Services Administration, Crystal Mall Building 4, 1941 Jefferson Davis Highway, Arlington, VA 22202.
Inquiries by individuals should be addressed to the Finance Officer of the agency for which they traveled.
Requests from individuals should be addressed to the Finance Officer of the agency for which they traveled. Individuals must furnish their full name and the authorizing agency and its component to facilitate the location and identification of their records.
Individuals wishing to request amendment of their records should contact the Finance Officer of the agency for which they traveled. Individuals must furnish their full name and the authorizing agency and component for which they traveled.
Charge card applications, monthly reports from the contractor, travel authorizations and vouchers, credit card companies, and data interchanged between agencies.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for
Contracted Travel Services Program.
System records are located at the service providers under contract with a Federal agency and at the Federal agencies using the contracts.
Individuals covered by the system are Federal employees authorized to perform official travel, and individuals being provided travel by the Federal government.
System records include a traveler's profile containing: Name of individual; Social Security Number; employee identification number; home and office telephones; home address; home and office e-mail addresses; emergency contact name and telephone number; agency name, address, and telephone number; air travel preference; rental car identification number and car preference; hotel preference; current passport and/or visa number(s); credit card numbers and related information; bank account information needed for electronic funds transfer; frequent traveler account information (e.g., frequent flyer account numbers); trip information (e.g., destinations, reservation information); travel authorization information; travel claim information; monthly reports from travel agent(s) showing charges to individuals, balances, and other types of account analyses; and other official travel related information.
31 U.S.C. 3511, 3512, and 3523; 5 U.S.C. Chapter 57; and implementing Federal Travel Regulations (41 CFR parts 300-304).
To establish a comprehensive beginning-to-end travel services system containing information to enable travel service providers under contract to the Federal government to authorize, issue, and account for travel and travel reimbursements provided to individuals on official Federal government business.
a. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order, where agencies become aware of a violation or potential violation of civil or criminal law or regulation.
b. To another Federal agency or a court when the Federal government is party to a judicial proceeding.
c. To a Member of Congress or staff on behalf and at the requests of the individual who is the subject of the record.
d. To a Federal agency employee, expert, consultant, or contractor in performing a Federal duty for purposes of authorizing, arranging, and/or claiming reimbursement for official travel, including, but not limited to, traveler profile information.
e. To a credit card company for billing purposes, including collection of past due amounts.
f. To an expert, consultant, or contractor in the performance of a Federal duty to which the information is relevant.
g. To a Federal agency by the contractor in the form of itemized statements or invoices, and reports of all transactions, including refunds and adjustments to enable audits of charges to the Federal government.
h. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
i. To an authorized appeal or grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator, or other duly authorized official engaged in investigation or settlement of a grievance, complaint, or appeal filed by an employee to whom the information pertains.
j. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
k. To officials of labor organizations recognized under 5 U.S.C. chapter 71 when relevant and necessary to their duties of exclusive representation concerning personnel policies, practices, and matters affecting working conditions.
l. To a travel services provider for billing and refund purposes.
m. To a carrier or an insurer for settlement of an employee claim for loss of or damage to personal property incident to service under 31 U.S.C. Sec. 3721, or to a party involved in a tort claim against the Federal government resulting from an accident involving a traveler.
n. To a credit reporting agency or credit bureau, as allowed and authorized by law, for the purpose of adding to a credit history file when it has been determined that an individual's account with a creditor with input to the system is delinquent.
o. Summary or statistical data from the system with no reference to an identifiable individual may be released publicly.
p. To the National Archives and Records Administration (NARA) for records management purposes.
q. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are stored in file cabinets. Electronic records are maintained within a computer (e.g., PC, server, etc.) and attached equipment.
Paper records are filed by a traveler's name and/or Social Security Number/
Paper records are stored in lockable file cabinets or secured rooms. Electronic records are protected by a password system and a FIPS 140-2 compliant encrypted Internet connection. Information is released only to authorized users and officials on a need-to-know basis.
Records kept by a Federal agency are maintained in accordance with the General Records Retention Schedules issued by the National Archives and Records Administration (NARA).
Assistant Commissioner, Office of Transportation and Property Management (FB), Federal Acquisition Service, General Services Administration, Room 300, 2200 Crystal Drive, Arlington, VA 20406.
Inquiries from individuals should be addressed to the appropriate administrative office for the agency that is authorizing and/or reimbursing their travel.
Requests from individuals should be addressed to the appropriate administrative office for the agency that is authorizing and/or reimbursing their travel. Individuals must furnish their full name and/or Social Security Number to the authorizing agency for their records to be located and identified.
Individuals wishing to request amendment of their records should contact the appropriate administrative office for the agency that authorized and/or reimbursed their travel. Individuals must furnish their full name and/or Social Security Number along with the name of the authorizing agency, including duty station where they were employed at the time travel was performed.
The sources are the individuals themselves, employees, travel authorizations, credit card companies, and travel service providers.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review, GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Child Care Subsidy.
This system of records is maintained by the Office of the Chief Human Capital Officer (C), 1800 F Street, NW., Washington, DC.
The individuals in the system are employees of the General Services Administration who voluntarily apply for child care subsidies.
Application forms for child care subsidy containing personal information, including employee (parent) name, Social Security Number, grade, home and work numbers, addresses, telephone numbers, total income, number of dependent children, and number of children on whose behalf the parent is applying for a subsidy; information on child care providers used, including name, address, provider license number and State where issued, tuition cost, and provider tax identification number; and copies of IRS Forms 1040 and 1040A for verification purposes.
Public Law 106-58 and E.O. 9397.
To establish and verify GSA employees' eligibility for child care subsidies in order for GSA to provide monetary assistance to its employees.
Information from this system may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; of the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To appropriate agencies, entities, and persons when (1) the Agency
Information may be collected on paper or electronically and may be stored as paper forms or on computers.
By name; may also be cross-referenced to Social Security Number.
When not in use by an authorized person, paper records are stored in lockable metal file cabinets or secured rooms. Electronic records are protected by the use of passwords.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the handbook, GSA Records Maintenance and Disposition System (OAD P 1820.2) and authorized GSA records schedules.
Office of the Chief Human Capital Officer (C), Office of Human Capital Management (CH), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Individuals may submit a request on whether a system contains records about them to: Office of the Chief People Officer (C), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Requests from individuals for access to their records should be addressed to the system manager.
GSA rules for access to systems of records, contesting the contents of systems of records, and appealing initial determinations are published in the
Information is provided by GSA employees who apply for child care subsidies. Furnishing of the information is voluntary.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Credit Data on Individual Debtors.
Records are located at the following GSA Central Office and Regional addresses of the GSA Office of Finance:
• GSA Building, 1800 F Street, NW., Washington, DC 20405.
• Bannister Complex, 1500 East Bannister Road, Kansas City, MO 64131.
• Fritz G. Lanham Federal Building, 819 Taylor Street, Fort Worth, TX 76102.
Individuals covered include employees, former employees, and other individuals who are indebted to GSA or any other agency or department of the United States; a State, territory or commonwealth of the United States, or the District of Columbia (hereinafter collectively referred to as “States”); or individuals that may become indebted to GSA or another agency or department of the United States as the result of a privately owned vehicle (POV) being involved in an accident with a GSA Fleet vehicle.
The records may contain information from commercial and agency investigative reports showing debtors' assets, liabilities, income, and expenses; identifying information, such as names and taxpayer identification numbers (TINs) (i.e., Social Security Numbers or employer identification numbers); debtor contact information, such as work and home address, and work and home telephone numbers; and name of employer and employer address. The records for claims against nongovernmental individuals (i.e., claims arising from vehicle accidents) may contain information on privately owned vehicles (POVs), including, but not limited to: (a) The owner, year, make, model, tag number and State of the vehicle; and (b) the driver's or owner's insurance company information, including name, address, telephone number and policy number. Debts include unpaid taxes, loans, assessments, fines, fees, penalties, overpayments, advances, extensions of credit from sales of goods or services, third-party claims, and other amounts of money or property owed to, or collected by, GSA, any other Federal entity or a State, including past-due support that is
5 U.S.C. 5514, 31 U.S.C. 3701 and 3702, 31 U.S.C. 3711
The purpose of the system is to assemble and maintain information on individuals who are indebted to GSA, other Federal entities, and States for the purpose of effecting enforced collections from the debtors, including past-due support enforced by States. The information contained in the records is maintained for the purpose of taking action to facilitate collection and resolution of debts using various methods, including, but not limited to, requesting repayment of debt by telephone or in writing, pursuing offset, levy, administrative wage garnishment, centralized salary offset, referral to collection agencies or litigation, and using other collection or resolution methods authorized or required by law. The information is also maintained for the purpose of providing collection information about the debt to other Federal entities or States collecting the debt, providing statistical information on debt collection operations, and testing and developing enhancements to computer systems containing the records.
In addition to the disclosures permitted under subsection (b) of the Privacy Act, 5 U.S.C. 552a(b), GSA may disclose information contained in this system of records without the consent of the subject individual if the disclosure is compatible with the purpose for which the record was collected under the following routine uses:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To any Federal agency where the debtor is employed or receiving some form of remuneration for the purpose of enabling that agency to collect a debt owed the Federal government on GSA's behalf. GSA may negotiate with the debtor for voluntary repayment or may initiate administrative or salary offset procedures or other authorized debt collection methods under the provisions of the Debt Collection Act of 1982, 5 U.S.C. 5514, or the Debt Collection Improvement Act of 1996, 31 U.S.C. 3701
e. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
f. To any Federal, State or local agency, U.S. Territory or commonwealth, or the District of Columbia, or their agents or contractors, including private collection agencies (consumer and commercial):
(1) To facilitate the collection of debts through the use of any combination of various debt collection methods required or authorized by law, including, but not limited to: Requests for repayment by telephone or in writing; negotiation of voluntary repayment or compromise agreements; offsets of Federal payments, which may include the disclosure of information contained in the records for the purpose of providing the debtor with appropriate pre-offset notice and to otherwise comply with offset prerequisites, to facilitate voluntary repayment in lieu of offset, and to otherwise effectuate the offset process; referral of debts to private collection agencies, to Treasury-designated debt collection centers, or for litigation; obtaining administrative and court-ordered wage garnishment; conducting debt sales; publishing names and identities of delinquent debtors in the media or other appropriate places; creating a Centralized Salary Offset program; and pursuing any other debt collection method authorized by law.
(2) To conduct computerized comparisons to locate Federal payments to be made to debtors.
(3) To conduct authorized computer matching programs in compliance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a, to identify and locate individuals receiving Federal payments (including but not limited to salaries, wages and benefits), which may include the disclosure of information contained in the records for the purpose of requesting voluntary repayment or implementing Federal employee salary offset or other offset procedures.
(4) To collect a debt owed to GSA, another Federal entity, or State through the offset of payments made by States, territories, commonwealths, or the District of Columbia.
(5) To account for or report on the status of debts for which such entity has a financial or other legitimate need for the information in the performance of official duties.
(6) To deny Federal financial assistance in the form of loans or loan guarantees to an individual who owes a delinquent debt to GSA or another Federal entity or who owes delinquent child support that has been referred to GSA for collection by administrative offset.
(7) To develop, enhance, and/or test databases, matching communications, or other computerized systems that facilitate debt collection processes.
(8) To provide assistance with any other appropriate debt collection purpose.
g. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
h. To any individual or entity:
(1) To facilitate the collection of debts through the use of any combination of various debt collection methods required or authorized by law, including, but not limited to: pursuing administrative or court-ordered wage garnishment; reporting information to commercial credit bureaus; conducting asset searches; publishing the names and identities of delinquent debtors in the media or other appropriate places; conducting debt sales; or initiating Centralized Salary Offsets.
(2) To deny Federal financial assistance in the form of loans or loan guarantees to an individual who owes a delinquent debt to the United States or delinquent child support that has been referred to GSA for collection by administrative offset.
(3) To pursue any other appropriate debt collection purpose, such as to credit reporting agencies or credit bureaus for the purpose of adding to a credit history file or obtaining a credit history file or comparable credit information for use in debt collection. As authorized by the Debt Collection Improvement Act of 1996, 31 U.S.C. 3701
i. To the Internal Revenue Service and applicable State and local governments for tax reporting purposes. Under the provisions of the Debt Collection Improvement Act of 1996, 31 U.S.C. 3701
j. To banks enrolled in the Treasury Credit Card Network to collect a payment or debt when the individual has given his or her credit card number for this purpose.
k. To the Department of Treasury or other Federal agency with whom GSA has entered into an agreement establishing the terms and conditions for debt collection cross servicing operations on behalf of GSA to satisfy, in whole or in part, debts owed to the United States. Cross servicing includes the possible use of all debt collections tools such as administrative offset, referral to debt collection contractors, and referral to the Department of Justice.
l. To the Department of Treasury, government corporations, State or local agencies, or other Federal agencies to conduct computer matching programs for the purpose of identifying and locating individuals who are receiving Federal salaries or benefit payments and are delinquent in their repayment of debts owed to the United States under certain programs administered by the GSA in order to collect the debts under the provisions of the Debt Collection Act of 1982, as amended, 5 U.S.C. 5514, or the Debt Collection Improvement Act of 1996, 31 U.S.C. 3701
m. To the National Archives and Records Administration (NARA) for records management purposes.
n. To or from the Department of Treasury for the purpose of allowing the GSA National Payroll Center (NPC) to participate in the Centralized Salary Offset (CSO) program, or similar offset program. Agencies must notify the Department of Treasury of all delinquent debts over 180 days past due so that recovery may be made by centralized administrative offset. This includes debts that GSA seeks to recover from the pay account of an employee of another agency by salary offset, or by another agency seeking recovery from a GSA employee, including client agency employees, by salary offset.
o. To or from another agency or department of the United States when a GSA Fleet vehicle has been involved in an accident with an individual or commercial POV. Disclosure to consumer reporting agencies: Disclosures pursuant to 5 U.S.C. 552a(b)(12) may be made from this system to consumer reporting agencies as defined in the Fair Credit Reporting Act, 15 U.S.C. 1681a(f), or the Federal Claims Collection Act of 1966, as amended, 31 U.S.C. 3701(a)(3) and 3711(e).
p. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
q. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are maintained in file folders and/or boxes and stored in lockable filing cabinets or file room until archived at NARA, or in electronic form in computers or other electronic media.
Records are maintained by name and claim number and are cross-referenced with the Social Security Number (when available).
Records are stored in guarded buildings and/or in areas controlled by authorized personnel. Computer files are protected by the use of passwords and other appropriate security measures.
Records for files submitted to the Financial Management Service for cross servicing per the Debt Collection Act of 1996 are maintained on site for the time period at FMS (up to 10 years). Records for closed files are sent to the National Archives and Records Administration and are retained for 6 years and 3 months.
Deputy Chief Financial Officer, Office of Financial Policy and Operations, General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Inquiries by individuals under the Privacy Act of 1974, as amended (5 U.S.C. 552a) regarding claims pertaining to themselves should be addressed to the system manager. All individuals making inquiries should provide as much descriptive information as possible to identify the particular record desired. The system manager will advise as to whether GSA maintains the records requested by the individual.
Requests from individuals for access to records should be addressed to the system manager and should include the individual's name and address.
GSA rules for contesting the contents of the records and for appealing initial determinations are promulgated in 41 CFR 105.64.
Information in this system is obtained from individual debtors; credit bureaus;
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Employee Credit Reports.
The system is located in the General Services Administration, Heartland Finance Center, Financial Information Control Division, 1500 East Bannister Road, Kansas City, MO 64131.
Present and former employees and/or contractors who have refused to abide by the terms of their training agreement or other employment-related contracts, and thereby have incurred a liability to the Government. When appropriate, similar information is gathered on their spouses.
Information that may be stored includes but is not limited to, name and address, age, number of dependents, name of employer, nature of business, position held/time held, full or part-time employment, net worth and what it consists of, annual earned income, other income, reputation, credit record, financial records, and personal history. The records are used in GSA to investigate employees who default on employment-related contracts.
31 U.S.C. 3711(e).
To assemble and maintain information on individuals who are indebted to GSA and other Federal entities for the purpose of effecting enforced collections from the debtors. The information contained in the records is maintained for the purpose of taking action to facilitate collection and resolution of debts using various methods, including, but not limited to, requesting repayment of debt by telephone or in writing, pursuing offset, administrative wage garnishment, centralized salary offset, referral to collection agencies or litigation, and using other collection or resolution methods authorized or required by law. The information is also maintained for the purpose of providing collection information about the debt to other Federal entities collecting the debt, and providing statistical information on debt collection operations.
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To appropriate agencies, entities, and persons with (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
The paper records are maintained in file folders and/or boxes and stored in filing cabinets or file room until archived at NARA, or in electronic form in computers or other electronic media.
Records are retrieved by name or by identifying number.
Records are stored in guarded buildings and/or in areas controlled by authorized personnel. Computer files are protected by the use of passwords and other appropriate security measures. Only persons given authority to do so handle this information.
The records are disposed of as scheduled in the handbook GSA Records Maintenance and Disposition System (CIO P 1820.1).
Director, Financial Information Control Division (6BCD), Heartland Finance Center, 1500 East Bannister Road, Kansas City, MO 64131.
Obtain this information from the office named above.
See 41 CFR, part 105-64 for the procedures.
Credit companies, individuals, employers/supervisors, former employers, banks, and GSA credit investigators.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: Telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Federal Acquisition Institute (FAI) Online University.
The system is managed by the Federal Acquisition Institute, located at 9820 Belvoir Road, Fort Belvoir VA 22060-5565. Contact the system manager for additional information.
Individuals, public or private, who use the FAI Online University resources and who register for or take the online courses.
The system maintains a record of an individual and his/her course progress while attending online courses. Required information consists of name and e-mail. Additional information is voluntarily provided and may include: a. Contact data (home or business address including city, state, zip code, and country; and home or business telephone and fax number). b. Work-related information, including affiliated organization, business telephone, business fax number, and manager's e-mail. c. Training records, including course type selection, course progress, and course start/completion dates.
40 U.S.C. Chapters 5, 31, and 33; Title 5 U.S.C. 4101,
To maintain a system for providing acquisition and procurement training in order to promote the development of a professional Federal acquisition workforce, ensure availability of exceptional training, and improve Federal acquisition workforce management.
System information may be accessed and used by authorized FAI employees, System Administrators, and contractors in the conduct of their official duties associated with tracking and administering training record and for system management purposes. In addition, information from this system may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of a civil or criminal law or regulation.
c. To duly authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To the Office of Personnel Management (OPM) and the Government Accountability Office (GAO) when the information is required for evaluation of the program.
e. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure
Information is electronically collected and stored on hard drives.
Records are retrievable by name.
System records are safeguarded in accordance with the requirements of the Privacy Act and the Computer Security Act. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data that is stored, processed, and transmitted. Records are protected by passwords and other appropriate security measures.
Disposition of records is according to the National Archives and Records Administration (NARA) guidelines, as set forth in the GSA Records Maintenance and Disposition System handbooks OAD P 1820.2A and CIO P 1820.1, and authorized GSA records schedules.
Director, Federal Acquisition Institute, c/o Defense Acquisition University, 9820 Belvoir Road, Fort Belvoir, VA 22060-5565.
An individual may obtain information on whether the system contains his or her record by sending the request to Director, Federal Acquisition Institute, c/o Defense Acquisition University, 9820 Belvoir Road, Fort Belvoir, VA 22060-5565.
Individuals may access their own records using their own password. Requests from individuals for access to their records also may be requested from FAI by writing to the above address.
GSA rules for access to systems of records, for contesting the contents of systems of records, and for appealing initial determinations are published in the
Information is obtained from individuals who register with FAI Online University.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: Telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Travel System.
The system of records is located in the General Services Administration (GSA) Central Office, service and staff offices and administrative offices throughout GSA.
GSA current and former employees and travelers of commissions, committees, and small agencies serviced by GSA, including persons other than full-time employees authorized to travel on Government business.
The system provides control over the expenditure of funds for travel, relocation, and related expenses. Therefore, provisions are made to authorize travel and relocation, provide and account for advances, and to pay for travel and relocation costs. The system contains records that may include, but are not limited to, name, Social Security Number, date of birth, residence address, dependents' names and ages, duty stations, itinerary and credit data in the form of credit scores (examples of credit scores are FICO, an acronym for Fair Isaac Corporation, a Beacon score, etc.) or commercial and agency investigative reports showing debtors' assets, liabilities, income, expenses, bankruptcy petitions, history of wage garnishments, repossessed property, tax liens, legal judgments on debts owed, and financial delinquencies.
5 U.S.C. 5701-5709, 5 U.S.C. 5721-5739, and Section 639 of the Consolidated Appropriations Act, 2005 (Pub. L. 108-447).
To assemble in one system information supporting the day-to-day operating needs associated with managing the GSA travel and relocation programs. The system includes an automated information system and supporting documents.
System information may be accessed and used by authorized GSA employees or contractors to conduct official duties associated with the management and operation of the travel and relocation program. Information from this system also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance,
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To the Office of Management and Budget in connection with reviewing private relief legislation at any stage of the coordination and clearance process.
i. To banking institutions so that travelers may receive travel reimbursements by electronic funds transfer (EFT).
j. To the Department of the Treasury regarding overseas travel allowances that are excluded from taxable income, so that reports can be compiled and submitted to the Congress.
k. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are stored in file folders and/or boxes and stored in cabinets or file room until archived at NARA; magnetic tapes and cards are stored in cabinets and storage libraries; and computer records are stored within computers and attached equipment or other electronic media.
Paper records are filed by name or by identifying number.
Electronic records are retrievable by name, vendor number (an identifier assigned by GSA to all payees, including companies and individuals), or Social Security Number.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A130. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms. Electronic records are protected by passwords and other appropriate security measures.
The agency disposes of the records as described in the HB, GSA Records Maintenance and Disposition System (CIO P 1820.1).
Director, Financial Initiative Division (BCD), Office of Financial Policy and Operations, Office of the Chief Financial Officer, General Services Administration, 1800 F Street, NW., Washington DC, 20405.
Employees may obtain information about whether they are a part of this system of records from the system manager at the above address.
Requests from individuals for access to their records should be addressed to the system manager.
GSA rules for access to systems of records, contesting the contents of systems of records, and appealing initial determinations are published at 41 CFR Part 105-64.
The sources are individuals, other employees, supervisors, other agencies, management officials, and non-Federal sources such as private firms.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Disbursement and Accounts Payable Files.
System records are located in GSA's finance centers and other locations as follows:
• Heartland Finance Center, 1500 East Bannister Road, Kansas City, MO 64131.
• Greater Southwest Finance Center, 819 Taylor Street, Fort Worth, TX 76102.
• Office of the Chief Financial Officer, 1800 F Street, NW., Washington, DC 20405.
• Service and Staff Offices throughout GSA.
GSA employees; contractors and contractual or appointed experts and consultants.
The system provides for reporting each account's status. Records may include but are not limited to name, address, telephone number, vendor identification number, banking information and Social Security number.
31 U.S.C. 3501
To assemble in one system disbursement and accounts payable records to GSA employees, contractors and other experts and consultants procured by contract or by appointment.
To the extent necessary, the records are available outside GSA to monitor and document adverse action proceedings and to advise on credit inquiries. The following routine uses also apply:
a. In a legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
c. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
e. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
f. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
g. To the National Archives and Records Administration (NARA) for records management purposes.
h. To the Office of Management and Budget in connection with reviewing private relief legislation at any stage of the coordination and clearance process.
i. To the Department of Treasury and/or banking institutions so that payments may be made by electronic funds transfer (EFT).
j. To the Department of Treasury so claims can be collected through cross servicing, Treasury Offset Program or the Centralized Salary Offset Program.
k. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's effort to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are maintained in file folders and/or boxes and stored in filing cabinets or file room until archived at NARA, or in electronic form in computers.
Records are retrieved by name or by identifying number.
Records are stored in guarded buildings and/or in areas controlled by authorized personnel. Computer files are protected by the use of passwords and other appropriate security measures.
Disposition of records is in accordance with the Handbook, GSA Records Maintenance and Disposition System (CIO P 1820.1).
Deputy Chief Financial Officer, Office of Financial Policy and Operations, General Services Administration, 1800 F Street, NW., Washington, DC 20405.
Individuals may obtain information about whether they are part of this system of records from the system manager at the above address.
Requests to access records should be directed to the system manager at the above address. Inquiries should provide, as appropriate, full name, Social Security number, vendor number, address, telephone number, and the dates and transactions giving rise to the record. For identification requirements, refer to the agency regulations in 41 CFR part 105-64.
GSA rules for access to records, and for contesting the contents and appealing initial determinations are provided in 41 CFR part 105-64.
The individuals themselves, employees, other agencies, management officials, and non-Federal sources such as private firms.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration,
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Employee Drug Abuse/Alcoholism Files.
The system is located in the office of the private sector organizations or providers for the Employee Assistance Program (EAP) who have contracted with the Office of Human Resources Services at GSA.
The EAP office contacts are as follows:
Central Office, Federal Occupational Health, (800) 222-0364.
National Capital Region, Federal Occupational Health, (800) 222-0364.
Northeast and Caribbean Region, Cooperative Administrative Support Program Consortia, Long Island and Queens: (516) 222-1221, New Jersey: (201) 402-1015, Puerto Rico and the Virgin Islands: (809) 763-6701 or (800) 981-5070, New York City: (212) 264-4673, New England: (617) 565-6533 or (800) 869-8867.
Mid-Atlantic Region, Federal Occupational Health, (800) 222-0364.
Southeast Sunbelt Region, Davine Sparks, LCSW, (800) 222-0364 or (404) 730-3237.
Great Lakes Region, Federal Occupational Health, (800) 222-0364.
The Heartland Region, Federal Occupational Health, (800) 222-0364.
Greater Southwest Region, Federal Occupational Health, (800) 222-0364 or (888) 262-7848.
Pacific Rim Region, North of Bakersfield: Linda Boone or Jean Taylor (415) 436-7448, South of Bakersfield: Joan Sexton (213) 894-0160 or Sandy Freed (213) 894-0153.
New England Region, Services provided by a Consortia—Individual providers, (617) 565-6533 or (800) 869-8867.
Rocky Mountain Region, Federal Occupational Health (800) 222-0364 or (888) 262-7848 (TTY).
1. Counseling and rehabilitation referrals.
2. Records of counseling and rehabilitation.
Public Law 92-255 and 5 U.S.C. 7904.
To maintain an information system on employees suspected of abusing or known to abuse alcohol or another drug and for self-initiated referrals.
Disclosing information related to anyone with a history of alcohol or drug abuse is restricted by Alcohol and Drug Abuse Patient Records regulations, 42 CFR part 2. System information may be accessed and used by authorized Federal agency employees or contractors to conduct official duties. Information from this system also may be disclosed as a routine use:
a. Documenting that the supervisor deals properly with an employee whose work is affected by alcohol abuse or other drug abuse.
b. Communicating information to those who use it in performing their duties, such as a counselor, medical or health worker, an alcohol or other drug abuse program administrator, or a qualified service organization.
c. Disclosing information to the Department of Justice or another Federal agency in defending a claim against the United States, when the claim is based on a person's mental or physical condition and is allegedly caused by GSA activities affecting the person.
d. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
e. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
f. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
g. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
h. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
i. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
j. To the National Archives and Records Administration (NARA) for records management purposes.
k. To appropriate agencies, entities, and persons when (1) The Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records are kept in a file cabinet or in a drawer.
The records are filed alphabetically by name.
When not in use by an authorized person, the records are stored in a locked metal file cabinet or in a secured room.
The records are kept for a year after the employee's last contact with a counselor or until the employee separates or transfers, whichever occurs first. If there is an EEO case, MSPB appeal, or arbitration, the records are kept for 3 years after the case is
The Director, Human Capital Policy and Program Management Division (CHP), Office of Human Capital Management (CH), 1800 F Street, NW., Washington, DC 20405.
An employee may obtain information as to whether he or she is part of the system of records from the immediate supervisor or the Director of Human Capital Policy and Program Management Division at the address above, whichever is appropriate.
A request to review a record related to you should be directed to the immediate supervisor or Director of Human Capital Policy and Program Management Division at the address above, whichever is appropriate. For the identification required, see 41 CFR part 105-64 published in the
GSA rules to review the content of a record and appeal an initial decision are in 41 CFR part 105-64 published in the
The supervisor(s), counselors, personnel specialists, and individual employee.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
eLease.
The system records and documents are maintained at the Enterprise Service Center of the GSA Public Buildings Service (PBS). Contact the System Manager for additional information.
The system maintains information on individuals, as well as businesses, who have made an offer on a PBS lease solicitation or who have entered into a contract with PBS regarding a building lease.
The system maintains information required throughout the lifecycle of a PBS building lease including information about leases, offerors, and lessors. In addition to business contact and identification information (address, telephone number, and Taxpayer Identification Number (TIN)), the system includes personal information on individuals who use personal contact and identification information (home address, telephone, e-mail, and fax numbers, and Social Security Number) for business purposes as sole proprietors.
Federal Property and Administrative Services Act, as amended (40 U.S.C. Sec. 585).
To establish and maintain a system for operating, controlling, and managing the Federal property leasing program; tracking leasing projects and workflow activities; and managing associated documents.
System information may be accessed and used by authorized GSA employees and contractors to conduct official duties associated with Federal government building leases. Information from this system may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.
c. To duly authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office (GAO) or other Federal agency when the information is required for program evaluation purposes.
e. To another Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; clarifying a job; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
f. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
g. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
h. To the National Archives and Records Administration (NARA) for records management purposes.
i. To appropriate agencies, entities, and persons when (1) The Agency suspects or has confirmed that the security or confidentiality of
System records and documents are electronically stored on servers and/or compact discs.
Records may be retrieved by name and/or other personal identifier or appropriate type of designation.
System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and the eLease System Security Plan. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the data. Security measures include password protections, assigned roles, and transaction tracking.
Disposition of records will be according to the National Archives and Records Administration (NARA) guidelines, set forth in the GSA Records Maintenance and Disposition System (OAD P 1820.2A) handbook.
eLease Program Manager, Systems Development Division (PGAB), Office of the PBS Chief Information Officer, General Services Administration, 1800 F Street, NW., Washington DC 20405.
Individuals may obtain information about their records from the eLease Program Manager at the above address.
Requests from individuals for access to their records should be addressed to the eLease Program Manager. GSA rules for individuals requesting access to their records are published in 41 CFR part 105-64.
Individuals may contest their records' contents and appeal determinations according to GSA rules published in 41 CFR part 105-64.
Information is obtained from individuals who are offerors or lessors of GSA PBS building leases.
General Services Administration.
Notice.
GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and in response to OMB M-07-16. This notice is a compilation of updated Privacy Act system of record notices.
Effective May 27, 2008.
Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail
GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405.
GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review GSA is publishing updated Privacy Act systems of records notices. Rather than make numerous piecemeal revisions, GSA is republishing updated notices for one of its systems. Nothing in the revised system notices indicates a change in authorities or practices regarding the collection and maintenance of information. Nor do the changes impact individuals' rights to access or amend their records in the systems of records. The updated system notices also include the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach.
Personnel Security files.
Some records in the system are classified under Executive Order 12958 as amended.
Personnel security files are maintained with other appropriate records in the Personnel Security Requirements Division (CPR), GSA Building, 1800 F Street NW., Washington, DC 20405.
Employees, applicants for employment, former employees of GSA and of commissions, committees, small agencies serviced by GSA, contractors, students, interns, volunteers, individuals authorized to perform or use services provided in GSA facilities (e.g. Credit Union or Fitness Center) and individuals formerly in any of these positions that require regular, ongoing access to federal facilities, information technology systems or information classified in the interest of national security. Included are historical researchers, experts or consultants, and employees of contractors performing services for GSA.
Personnel security files contain information such as name, former names, date and place of birth, home address, phone numbers, height, weight, hair color, eye color, sex, passport information, military information, civil court information, employment history, residential history, Social Security Number, occupation, experience, and investigative material, education and degrees earned, names of associates and references and their contact information, citizenship, names of relatives, citizenship of relatives, names of relatives who work for the federal government, criminal history, mental health history, drug use, financial information, fingerprints, summary report of investigation, results of suitability decisions, level of security clearance, date of issuance of security clearance, requests for appeals, witness statements, investiga tor's notes, tax return information, credit reports, security violations, circumstances of violation, and agency action taken.
Depending upon the type of investigation, GSA is authorized to ask for this information under Executive Orders 10450 as amended, 10865 as amended, 12968 as amended, and 12958 as amended; sections 3301 and 9101 of title 5, U.S. Code; sections 2165 and 2201 of title 42, U.S. Code; parts 5, 731, 732, and 736 of title 5, Code of Federal Regulations; and Homeland Security Presidential Directive 12.
To assemble in one system information pertaining to issuing security clearances and public trust certifications, suitability decisions, fitness for service of applicants for federal employment and contract positions, and administrative actions. Information security files also are used for recommending administrative action against employees found to be violating GSA classified national security information regulations.
a. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body.
b. To the Department of Justice when: (a) The agency or any component thereof; or (b) any employee of the agency in his or her official capacity; (c) any employee of the agency in his or her individual capacity where agency or the Department of Justice has agreed to represent the employee; or (d) the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records by DOJ is therefore deemed by the agency to be for a purpose compatible with the purpose for which the agency collected the records.
c. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record.
d. Except as noted on Forms SF-85, 85-P, and 86, when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate public authority, whether Federal, foreign, State, local or tribal, or otherwise, responsible for enforcing, investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative or prosecutorial responsibility of the receiving entity.
e. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
f. To agency contractors or volunteers who have been engaged to assist the agency in the performance of a contract service, cooperative agreement, or other activity related to this system of records and who need to have access to the records in order to perform their activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
g. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office (GAO) when the information is required for program evaluation purposes.
h. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record.
i. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
j. To the National Archives and Records Administration (NARA) for records management purposes.
k. To a federal, state, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947 as amended, the CIA Act of 1949 as amended, Executive Order 12333 or any successor order, applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders, or directives.
l. To the Office of Management and Budget when necessary to the review of private relief legislation pursuant to OMB Circular No. A-19.
m. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Records are maintained on paper and electronically in secure locations. Records are maintained in the system of records Comprehensive Human Resources Integrated System (GSA/PPFM-8) in the personnel security module and associated equipment.
Records are retrieved by name and Social Security Number.
Personnel security file records are stored in a secured office in cabinets with access limited to authorized employees. A password system protects access to computer records. Access to the records is limited to those employees who have a need for them in the performance of their official duties.
These records are retained and disposed of in accordance with General Records Schedule 18, item 22, approved by the National Archives and Records Administration (NARA). Records are destroyed by burning, pulping, or shredding, as scheduled in the HB GSA Records Maintenance and Disposition System (OAD P 1820.2A).
Director, Personnel Security Requirements Division (CPR), 1800 F Street, NW., Washington, DC 20405.
Inquiries by individuals as to whether the system contains a record pertaining to themselves should be addressed to the system manager.
Requests from individuals for access to records should be addressed to the system manager and should include full name (maiden name where appropriate), address, and date and place of birth. General inquiries may be made by telephone.
GSA rules for accessing records, contesting their content, and appealing initial decisions appear in 41 CFR part 105-64.
Individuals, employees, informants, law enforcement agencies, courts, other Government agencies, employees' references, co-workers, neighbors, rental/lease, educational institutions, and intelligence sources. Security violation information is obtained from a variety of sources, such as security guard's reports, security inspections, witnesses, supervisor's reports, and audit reports.
Under 5 U.S.C. 552a(k)(5), the personnel security case files in the system of records are exempt from subsections (c)(3); (d); (e)(1); (e)(4)(G), (H), and (I); and (f) of the act. Information will be withheld to the extent it identifies witnesses promised confidentiality as a condition of providing information during the course of the background investigation.
Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office on Women's Health.
Notice.
The U.S. Department of Health and Human Services (HHS), Office of Public Health and Science (OPHS), Office on Women's Health (OWH) announces the development of a National Lupus Awareness campaign with the Advertising Council and invites public and private sector lupus and women's health related organizations to participate as collaborating partners to provide advice on the development and dissemination of the campaign materials.
Representatives of lupus and women's health organizations should submit expressions of interest by May 18, 2008.
Expressions of interest, comments, and questions may be submitted by electronic mail to
Frances E. Ashe-Goins RN, MPH, Office on Women's Health, Office of Public Health and Science, Department of Health and Human Services, 200 Independence Avenue, SW., Room 728E, Washington, DC 20201, (202) 690-6373 (telephone), (202) 401-4005 (fax).
The OWH was established in 1991 to improve the health of American women by advancing and coordinating a comprehensive women's health agenda throughout HHS. This program has two goals: Development and implementation of model programs on women's health; and leading education, collaboration and coordination on women's health. The program fulfills its mission through competitive contracts and grants to an array of community, academic and other organizations at the national and community levels. National educational campaigns provide information about the important steps women can take to improve and maintain their health.
OWH has worked on community based lupus awareness projects over the years and those activities, though successful, have not met the overwhelming critical national need for lupus education.
Lupus is a chronic (life-long) autoimmune disease that for unknown reasons causes the immune system to mistakenly attack the body's own healthy cells and tissue as though they were foreign invaders. The resulting inflammation causes symptoms of disease. Without intervention, the inflammation leads to tissue damage, organ failure, disability, and in many cases, premature death.
Public recognition of lupus is low. A recent survey of 1,000 U.S. adults (18+) conducted for the Lupus Foundation of America (LFA) revealed that 39 percent knew nothing about lupus, and 22 percent had never heard of the disease. When probed, only 20 percent could reflect even basic information about the disease. An earlier survey showed that only 4 out of 10 young adults (18-24) claimed to be familiar with lupus. Lack of awareness of lupus symptoms is the underlying reason for late diagnosis and increased morbidity.
A report by the Centers for Disease Control and Prevention in 2002 revealed that over a 10-year period, deaths attributed to lupus increased 60 percent overall; among older African-American women, the increase was nearly 70 percent. This report suggests that increased awareness of lupus and proactive diagnosis of the disease will reduce the number of deaths due to lupus. It is estimated that
OWH has contracted with the Advertising Council to plan, develop, implement, and evaluate a national lupus marketing campaign to increase the awareness of symptoms of lupus, its health effects and provide information to individuals who may be at risk for lupus to help them decide whether to seek medical evaluation. The National Lupus Awareness Campaign is intended to generate public attention for lupus and raise recognition of the disease as a significant national public health problem that disproportionately affects young women of color.
In order to develop and implement the National Lupus Awareness Campaign, OWH is interested in establishing partnerships with private and public lupus and women's health related organizations. As partners with HHS, these health organizations can bring their ideas and expertise, administrative capabilities, and resources, which are consistent with the goals of the National Lupus Awareness Campaign.
Given the National Lupus Awareness Campaign's objectives, entities which have similar goals and consistent interests, appropriate expertise and resources, and which would like to pursue lupus awareness activities in collaboration with OWH are encouraged to reply to this notice. Working together, these partnerships will provide innovative opportunities to promote an increased national awareness of lupus, with the end goal of earlier lupus detection and diagnosis and decreased morbidity.
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency's function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
1.
2.
3.
Telephone survey data from Medicare beneficiary's interviews are to be completed during Phase II of the Evaluation of the Medical Adult Day-Care Services Demonstration. The survey was developed based on collection of data from face-to-face interviews with beneficiaries from Phase I of the Demonstration evaluation.
4.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at
To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on
OMB Human Resources and Housing Branch, Attention: Carolyn Raffaelli, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395-6974.
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
1.
2.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at
In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by
1.
2.
Centers for Medicare and Medicaid Services, HHS.
Proposed Notice.
This proposed notice with comment period acknowledges the receipt of a deeming application from Det Norske Veritas Healthcare (DNV) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on May 27, 2008.
In commenting, please refer to file code CMS-2895-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates, please):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Under the Medicare program, eligible beneficiaries may receive covered services in a hospital provided certain requirements are met. Section 1861(e) of the Social Security Act (the Act), establishes distinct criteria for facilities seeking designation as a hospital. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 482 specify the conditions that a hospital must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for hospitals.
Generally, in order to enter into an agreement, a hospital must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 482 of our CMS regulations. Thereafter, the hospital is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative, however, to surveys by State agencies.
Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the
Section 1865(b)(2) of the Act and our regulations at § 488.8(a) require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's: Requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.
Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of DNV's request for deeming authority for hospitals. This notice also solicits public comment on whether DNV's requirements meet or exceed the Medicare conditions of participation for hospitals.
DNV submitted all the necessary materials to enable us to make a determination concerning its request for approval as a deeming organization for hospitals. This application was determined to be complete on March 12, 2008. Under Section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accrediting organizations), our review and evaluation of DNV will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of DNV's standards for a hospital as compared with Medicare's hospital conditions of participation.
• DNV's survey process to determine the following:
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).
In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this proposed notice.
In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments.
Section 1865 of the Social Security Act (42 U.S.C. 1395bb).
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Kelly Buchanan, DFO, (410) 786-6132, or e-mail
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Secretary is mandated by section 1868(a)(1) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and manual instructions related to physician services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the Council's consultation must occur before
The Council consists of 15 physicians, including the Chair. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists, and chiropractors. Members serve for overlapping 4-year terms.
Section 1868(a)(2) of the Act provides that the Council meet quarterly to discuss certain proposed changes in regulations and manual issuances that relate to physicians' services, identified by the Secretary. Section 1868(a)(3) of the Act provides for payment of expenses and per diem for Council members in the same manner as members of other advisory committees appointed by the Secretary. In addition to making these payments, the Department of Health and Human Services and CMS provide management and support services to the Council. The Secretary will appoint new members to the Council from among those candidates determined to have the expertise required to meet specific agency needs in a manner to ensure appropriate balance of the Council's membership.
The Council held its first meeting on May 11, 1992. The current members are: Vincent J. Bufalino, M.D., Chairperson; M. Leroy Sprang, M.D.; Karen S. Williams, M.D.; Jonathon E. Siff, M.D., MBA; John E. Arradondo, M.D., MPH; Tye J. Ouzounian, M.D.; Arthur D. Snow, Jr., M.D.; Gregory J. Przybylski, M.D.; Jeffrey A. Ross, DPM, M.D.; and Roger L. Jordan, O.D. Four new members to be sworn on May 19th include: Joseph Giaimo, D.O; Pamela Howard, M.D.; Fredrica Smith, M.D.; and Christopher Standaert, M.D.
The meeting will commence with the Council's Executive Director providing a status report, and the CMS responses to the recommendations made by the Council at the March 3, 2008 meeting, as well as prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics:
• Recovery Audit Contractors (RAC) Update.
• National Provider Indentifier (NPI) Update.
• CMS Quality Agenda, which includes the following:
• 9th Scope of Work.
• Physician Quality Reporting Initiative (PQRI) Update.
• Quality Measures: Hospital Compare; Nursing Home Compare.
For additional information and clarification on these topics, contact the DFO as provided in the
The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the
Since this meeting will be held in a Federal Government Building, the Hubert H. Humphrey Building, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to accommodate security procedures. In order to gain access to the building, participants will be required to show a government-issued photo identification (for example, driver's license or passport), and must be listed on an approved security list before persons are permitted entrance. Persons not registered in advance will not be permitted into the Hubert H. Humphrey Building and will not be permitted to attend the Council meeting.
All persons entering the building are subject to inspection via metal detector or other means applicable. In addition, all items brought to the Hubert H. Humphrey Building, whether personal or for the purpose of presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any
Individuals requiring sign language interpretation or other special accommodation must contact the DFO via the contact information specified in the
(Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)).)
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by May 27, 2008.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to
Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the statement is truthful and not misleading. The draft guidance document entitled “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” (November 9,
In the
Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they chose to place a claim on their product's label. Gathering evidence on their product's claim is a one time burden; they collect the necessary substantiating information for their product as required by section 403(r)(6) of the act.
The standard discussed in the draft guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health-related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature.
The time it takes to assemble the necessary scientific information to support their claims depends on the product and the claimed benefits. If the product is one of several on the market making a particular claim for which there is adequate publicly available and widely established evidence supporting the claim, then the time to gather supporting data will be minimal; if the product is the first of its kind to make a particular claim or the evidence supporting the claim is less publicly available or not widely established, then gathering the appropriate scientific evidence to substantiate the claim will be more time consuming.
FDA assumes that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established. We increased this estimated burden from 1 hour per claim to 44 hours per claim based on information received from industry, as noted in our June 7, 2007, document in response to comment 1 (72 FR 31583 and 31584). FDA believes it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals and in foreign languages or in the older, classical literature where it is not available on computerized literature databases or in the major scientific reference databases, such as the National Library of Medicine's literature database, all of which increases the time of obtaining substantiation.
In the
There are no capital costs or operating and maintenance costs associated with this information collection.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Notice is hereby given of a change in the meeting of the Neurotoxicology and Alcohol Study Section, June 3, 2008, 8 a.m. to June 4, 2008, 5 p.m., Sir Francis Drake Hotel, 450 Powell Street, San Francisco, CA 94102, which was published in the
The meeting will be held one day only June 3, 2008. The meeting time and location remain the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, May 15, 2008, 10 a.m., to May 16, 2008, 8 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the
The meeting will be held one day only, May 16, 2008, from 11 a.m. to 4 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Hematopoiesis Study Section, June 5, 2008, 8 a.m. to June 6, 2008, 11 a.m., Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD, 20814, which was published in the
The meeting will be held one day only June 5, 2008, from 8 a.m. to 7 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Muscular Dystrophy Coordinating Committee (MDCC).
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Notice is hereby given of a change in the meeting of the National Advisory Council for Biomedical Imaging and Bioengineering, May 16, 2008, 9 a.m. to 5 p.m., Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, Maryland 20817, which was published in the
The meeting start time has been changed from 9 a.m. to 8:30 a.m. The meeting location remains the same.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of meetings of the National Diabetes and Digestive and Kidney Diseases Advisory Council.
The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, DHS.
Notice of public meeting.
The Coast Guard will hold a public meeting for citizens to provide oral comments relating to the alteration of the Naheola Railroad Bridge near Pennington, Alabama. The meeting will allow interested persons to present comments and information about the bridge being unreasonably obstructive to navigation. The meeting will be open to the public.
The meeting will be held on May 21, 2008, from 1 p.m. to 5 p.m. If you would like to submit written materials as part of the meeting record or request to make an oral presentation at the meeting please provide your information to the District Bridge Administrator no later than May 16, 2008. If you wish to add comments directly to the Docket, they must reach the Coast Guard no later than May 16, 2008.
The meeting will be held at the Alabama's Delta Resource Center, 30945 Five Rivers Boulevard, Spanish Fort, Alabama 36527. Send written material, requests to make oral presentation or comments to Commander (dwb), Eighth Coast Guard District, Bridge Branch, 1222 Spruce Street, Room 2.107F, Saint Louis, Missouri 63103.
All other comments and materials may be submitted under the Coast Guard docket number USCG-2008-0224 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)
(2)
(3)
(4) Fax: 202-493-2251.
If you have questions regarding this notice call Mr. Roger K. Wiebusch, Bridge Administrator, telephone (314) 269-2378. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.
We encourage you to participate in this action by submitting comments and related materials. All comments received will be posted, without change, to
If you submit a comment, please include the docket number for this notice (USCG-2008-0224), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name and a mailing address, an e-mail address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under
To view comments, as well as documents mentioned in this notice as being available in the docket, go to
Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the
Complaints have been received alleging that the bridge is unreasonably obstructive to navigation. Information available to the Coast Guard indicates numerous bridge allisions have occurred between 1995 and 2007. The navigation opening of the bridge is 150 feet and causes significant delays to commercial water traffic. Mariners transit the bridge under a non-navigation span when possible. During periods of high water mariners often double trip the bridge, which adds many hours to the bridge transit. Based on the comments received at the public meeting, the bridge may be found to be unreasonably obstructive to navigation. Such a finding may require relocating and increasing the horizontal clearance of the railroad bridge to meet the reasonable needs of navigation.
The hearing is open to the public. Attendees at the meeting, who wish to present testimony and have not previously made a request to do so, will follow those having submitted a request, as time permits. If a large number of persons wish to speak, the presiding officer may limit the time allotted to each speaker. Conversely, the public meeting may end early if all present wishing to speak have done so.
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the individual listed in the
Federal Law Enforcement Training Center (FLETC), DHS.
Committee Management; Notice of Federal Advisory Committee Meeting.
On April 9, 2008, the Federal Law Enforcement Training Center announced in the
The State and Local Advisory Committee meeting met on April 17, 2008, from 8 a.m. to 3 p.m.
The meeting was held at the Jekyll Island Club Hotel, 371 Riverview Drive, Jekyll Island, Georgia.
Reba Fischer, Designated Federal Officer, Federal Law Enforcement Training Center, Department of Homeland Security, 1131 Chapel Crossing Road, Townhouse 396, Glynco, GA 31524; (912) 267-2343;
Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). The mission of the Advisory Committee to the Office of State and Local Training is to advise and make recommendations on matters relating to the selection, development, content and delivery of training services by the OSL/FLETC to its State, local, campus, and tribal law enforcement customers.
The State and Local Advisory Committee met for the purpose of discussing strategic planning; training needs of state, local, campus, and tribal law enforcement officers; validation of training; and training initiatives. The meeting was open to the public.
The Federal Advisory Committee Act requires that notices of meetings of advisory committees be announced in the
Transportation Security Administration; United States Coast Guard; DHS.
Notice.
The Department of Homeland Security (DHS) through the Transportation Security Administration (TSA) issues this notice of the date for the beginning of the initial enrollment for the Transportation Worker Identification Credential (TWIC) for the Port of Hueneme, CA.
TWIC enrollment begins in Hueneme on May 1, 2008.
You may view published documents and comments concerning the TWIC Final Rule, identified by the docket numbers of this notice, using any one of the following methods.
(1) Searching the Federal Docket Management System (FDMS) Web page at
(2) Accessing the Government Printing Office's Web page at
(3) Visiting TSA's Security Regulations Web page at
James Orgill, TSA-19, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202-4220. Transportation Threat Assessment and Credentialing (TTAC), TWIC Program, (571) 227-4545; e-mail:
The Department of Homeland Security (DHS), through the United States Coast Guard and the Transportation Security Administration (TSA), issued a joint final rule (72 FR 3492; January 25, 2007) pursuant to the Maritime Transportation Security Act (MTSA), Pub. L. 107-295, 116 Stat. 2064 (November 25, 2002), and the Security and Accountability for Every Port Act of 2006 (SAFE Port Act), Pub. L. 109-347 (October 13, 2006). This rule requires all credentialed merchant mariners and individuals with unescorted access to secure areas of a regulated facility or vessel to obtain a TWIC. In this final rule, on page 3510, TSA and Coast Guard stated that a phased enrollment approach based upon risk assessment and cost/benefit would be used to implement the program nationwide, and that TSA would publish a notice in the
This notice provides the start date for TWIC initial enrollment at the Port of Hueneme, CA, on May 1, 2008. The Coast Guard will publish a separate notice in the
To obtain information on the pre-enrollment and enrollment process, and enrollment locations, visit TSA's TWIC Web site at
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of approval of Intertek USA, Inc., as a commercial gauger.
Notice is hereby given that, pursuant to 19 CFR 151.13, Intertek USA, Inc., 139 Castle Coakley Suite #8, St. Croix, VI 00820, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.13. Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquires regarding the specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
The approval of Intertek USA, Inc., as commercial gauger became effective on January 15, 2008. The next triennial inspection date will be scheduled for January 2011.
Randall Breaux, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Suite 1500N, Washington, DC 20229, 202-344-1060.
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (Fish and Wildlife Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on June 30, 2008. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
You must submit comments on or before June 24, 2008.
Send your comments on the IC to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail);
To request additional information about this IC, contact Hope Grey by mail, fax, or e-mail (see
The number of light geese (lesser snow and Ross' geese) in the mid-continent region has nearly quadrupled during the past several decades due to a decline in adult mortality and an increase in winter survival. Lesser snow and Ross' geese are referred to as light geese because of their light coloration as opposed to dark geese such as white-fronted or Canada Geese. Because of their feeding activity, light geese have become seriously injurious to their habitat as well as to habitat important to other migratory birds. This poses a serious threat to the short- and long-term health and status of some migratory bird populations. We believe that the number of light geese in the mid-continent region has exceeded long-term sustainable levels for their arctic and subarctic breeding habitats and that the populations must be reduced. 50 CFR 21 provides authority for the management of overabundant mid-continent light geese.
Light geese in the mid-continent region are separated into two different populations for management purposes. Lesser snow and Ross' geese that primarily migrate through North Dakota, South Dakota, Nebraska, Kansas, Iowa, and Missouri, and winter in Arkansas, Louisiana, Mississippi, and eastern, central, and southern Texas and other Gulf States are referred to as the mid-continent population of light geese. Lesser snow and Ross' geese that primarily migrate through Montana, Wyoming, and Colorado and winter in New Mexico, northwestern Texas, and Chihuahua, Mexico, are referred to as Western Central Flyway population of light geese.
States that participate in the light geese conservation order must inform and brief all participants on the requirements in 50 CFR 21.60 and conservation order conditions that apply to the implementation of light geese control measures. Participating States must collect information on the number of birds taken during control efforts, the methods by which they were taken, and the date on which they were taken. We use this information to administer the conservation order and, particularly, to monitor the effectiveness of control strategies and to protect migratory birds. Each participating State must submit an annual report summarizing the activities it conducted.
We invite comments concerning this IC on:
(1) whether or not the collection of information is necessary, including whether or not the information will have practical utility;
(2) the accuracy of our estimate of the burden for this collection of information;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents.
Comments that you submit in response to this notice are a matter of public record. We will include and/or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (Fish and Wildlife Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on June 30, 2008. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
You must submit comments on or before June 24, 2008.
Send your comments on the IC to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail);
To request additional information about this IC, contact Hope Grey by mail, fax, or e-mail (see
The Fish and Wildlife Service National Conservation Training Center (NCTC) in Shepherdstown, West Virginia, provides natural resource and other professional training for Service employees, employees of other Federal agencies, and other affiliations. While most training is for Service employees, NCTC offers student slots to State agencies, private individuals, not-for-profit organizations, and university personnel.
NCTC designed FWS Form 3-2193 (Training Application) as a quick and easy method for prospective students to request training. We encourage applicants to use FWS Form 3-2193 and to submit their requests electronically. However, we do not require applicants to complete both a training form required by their agency and FWS Form 3-2193. NCTC will accept any single training request as long as each
NCTC uses data from the form to generate class rosters, class transcripts, and statistics, and as a budgeting tool for projecting training requirements. It is also used to track attendance, mandatory requirements, tuition, and invoicing for all NCTC-sponsored courses both on- and off-site.
We invite comments concerning this IC on:
(1) whether or not the collection of information is necessary, including whether or not the information will have practical utility;
(2) the accuracy of our estimate of the burden for this collection of information;
(3) ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information on respondents.
Comments that you submit in response to this notice are a matter of public record. We will include and/or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
U.S. International Trade Commission.
Institution of investigation pursuant to 19 U.S.C. 1337.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on March 24, 2008, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Magotteaux International S/A of Belgium and Magotteaux, Inc. of Franklin, Tennessee. A letter supplementing the complaint was filed on April 11, 2008. The complaint as supplemented alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain composite wear components and products containing the same that infringe all of the claims of U.S. Patent No. RE 39,998. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainants request that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
Anne Goalwin, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2574.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2007).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain composite wear components and products containing the same that infringe one or more of claims 1-22 of U.S. Patent No. RE 39,998, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainants are—
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Commission investigative attorney, party to this investigation, is Anne Goalwin, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Room 401B, Washington, DC 20436; and
(4) For the investigation so instituted, the Honorable Theodore R. Essex is designated as the presiding administrative law judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondent in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of the respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
The Department of Labor (DOL) hereby announces the submission of the following public information collection requests (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). A copy of each ICR, with applicable supporting documentation, including among other things a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at
Interested parties are encouraged to send comments to the Office of Information and Regulatory Affairs, Attn: Bridget Dooling, OMB Desk Officer for the Employment Standards Administration (ESA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202-395-7316/Fax: 202-395-6974 (these are not toll-free numbers), E-mail:
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
By application dated April 11, 2008, a petitioner requested administrative reconsideration of the negative determination regarding workers' eligibility to apply for Trade Adjustment Assistance (TAA) and Alternative Trade Adjustment Assistance (ATAA) applicable to workers and former workers of the subject firm. The determination was issued on March 13, 2008. The Notice of determination was published in the
The determination was based on the Department's findings that workers separations at the subject firm were due to a shift in production of automated X-ray inspection system prototypes (including software code and hardware design functions) to Malaysia, a country that is not a party to a free trade agreement nor a beneficiary country with the United States. The subject firm did not import automated X-ray inspection system prototypes following the shift in production to a foreign source.
The request for reconsideration alleges that Agilent Technologies might be in fact an importer of X-ray inspection systems and software. The petitioner also alleges that the customers of the subject firm also import X-ray inspection systems and software purchased directly from a production facility of Agilent Technologies in Malaysia.
The Department has carefully reviewed the request for reconsideration and will further investigate whether imports of like or directly competitive
After careful review of the application, I conclude that the claim is of sufficient weight to justify reconsideration of the U.S. Department of Labor's prior decision. The application is, therefore, granted.
By application dated April 11, 2008, a petitioner requested administrative reconsideration of the negative determination regarding workers' eligibility to apply for Trade Adjustment Assistance (TAA) and Alternative Trade Adjustment Assistance (ATAA) applicable to workers and former workers of the subject firm. The determination was issued on March 19, 2008. The Notice of determination will soon be published in the
The initial investigation resulted in a negative determination based on the finding that imports of brass rod, wire, and low melt alloys did not contribute importantly to worker separations at the subject firm and no shift of production to a foreign source occurred.
In the request for reconsideration, the petitioner provided additional information regarding the subject firm's customers and requested the Department of Labor conduct further investigation to determine whether workers of the subject firm are eligible for TAA on the basis of the secondary impact.
The Department has carefully reviewed the requests for reconsideration and the existing record and has determined that the Department will conduct further investigation to determine if the workers meet the eligibility requirements of the Trade Act of 1974.
After careful review of the application, I conclude that the claim is of sufficient weight to justify reconsideration of the U.S. Department of Labor's prior decision. The application is, therefore, granted.
In accordance with section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on January 15, 2008, applicable to workers of Faurecia Exhaust Systems, Granger, Indiana. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers are engaged in the production of automotive exhaust systems.
New information shows that leased workers of Industrial Distribution Group—Midwest Division were employed on-site at the Granger, Indiana location of Faurecia Exhaust Systems. The Department has determined that these workers were sufficiently under the control of the subject firm to be considered leased workers.
Based on these findings, the Department is amending this certification to include leased workers of Industrial Distribution Group—Midwest Division working on-site at the Granger, Indiana location of the subject firm.
The intent of the Department's certification is to include all workers employed at Faurecia Exhaust Systems, Granger, Indiana who were adversely affected by a shift in production of automotive exhaust systems to Mexico.
The amended notice applicable to TA-W-62,633 is hereby issued as follows:
All workers of Faurecia Exhaust Systems, including on-site leased workers from Industrial Distribution Group—Midwest Division, Granger, Indiana, who became totally or partially separated from employment on or after January 2, 2007, through January 15, 2010, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on February 9, 2007 to workers of Fedders North America, Effingham, Illinois. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers are engaged in the production of air conditioners, both room and central.
New information shows that Airwell North America purchased the name, distributor list, some inventory and parts of the Effingham, Illinois location of Fedders North America, Inc. Some former workers of the subject firm are
Based on these findings, the Department is amending this certification to include all workers of Airwell North America, working on-site at the Effingham, Illinois location of the subject firm.
The intent of the Department's certification is to include all workers employed at Fedders North America, Inc., Effingham, Illinois who were adversely-impacted by increased company imports of air conditioners, both room and central.
The amended notice applicable to TA-W-60,804 is hereby issued as follows:
All workers of Fedders North America, Inc., including on-site workers from Airwell North America, Effingham, Illinois, who became totally or partially separated from employment on or after December 28, 2006, through February 9, 2009, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.
In accordance with section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification Regarding Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on January 14, 2008, applicable to workers of Fantech, Inc., Sarasota, Florida. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers are engaged in the production of residential ventilation systems and premium bath fans.
New information shows that RB Kanalflakt, Inc. is the parent firm of Fantech, Inc. and that some of the workers wages at the subject firm are being reported under three Unemployment Insurance (UI) tax accounts: Fantech, Inc., RB Kanalflakt, Inc. and Kanalflakt, Inc.
Accordingly, the Department is amending this certification to properly reflect this matter.
The intent of the Department's certification is to include all workers of Fantech, Inc. who were adversely affected by a shift in production of residential ventilation systems and premium bath fans to Canada.
The amended notice applicable to TA-W-62,606 is hereby issued as follows:
All workers of Fantech, Inc., RB Kanalflakt, Inc., and Kanalflakt, Inc., Sarasota, Florida, who became totally or partially separated from employment on or after December 20, 2006, through January 14, 2010, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on March 14, 2008, applicable to workers of Manosh Hardwoods LLC, Sawmill, including on-site leased workers of Westaff, Inc., Morrisville, Vermont. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The workers were engaged in the production of rough hardwood lumber for floors, furniture, etc.
New information shows that H.A. Manosh Corporation is the parent firm of Manosh Hardwoods LLC, Sawmill. Some workers at the subject firm are involved in the closing of the business, selling off inventory and property, and have their wages reported under a separate unemployment insurance (UI) tax account for H.A. Manosh.
Accordingly, the Department is amending the certification to properly reflect this matter.
The intent of the Department's certification is to include all workers of Manosh Hardwoods LLC, Sawmill who were adversely affected by increased customer imports.
The amended notice applicable to TA-W-62,796 is hereby issued as follows:
All workers of Manosh Hardwoods LLC, Sawmill, including on-site leased workers of Westaff, Inc., including workers whose wages were paid by H.A. Manosh Corporation, Morrisville, Vermont, who became totally or partially separated from employment on or after January 23, 2007, through March 14, 2010, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.
Employment and Training Administration, Labor.
Notice of Determination of Lower Living Standard Income Level.
Under Title I of the Workforce Investment Act (WIA) of 1998 (Pub. L. 105-220), the Secretary of Labor annually determines the Lower Living Standard Income level (LLSIL) for uses
Send written comments to: Mr. Evan Rosenberg, Department of Labor, Employment and Training Administration, 200 Constitution Ave., NW., Room N-4464, Washington, DC 20210.
Please contact Mr. Evan Rosenberg, telephone 202-693-3593; fax 202-693-3532 (these are not toll-free numbers).
It is the purpose of the Workforce Investment Act of 1998 “to provide workforce investment activities, through statewide and local workforce investment systems, that increase the employment, retention, and earnings of participants, and increase occupational skill attainment by participants, and as a result, improve the quality of the workforce, reduce welfare dependency, and enhance the productivity and competitiveness of the Nation.”
The LLSIL is used for several purposes under WIA. Specifically, WIA section 101(25) defines the term “low income individual” for eligibility purposes, and sections 127(b)(2)(C) and 132(b)(1)(B)(v)(IV) define the terms “disadvantaged youth” and “disadvantaged adult” in terms of the poverty line or LLSIL for state formula allotments. The Governor and state/local workforce investment boards (WIBs) use the LLSIL for determining eligibility for youth, eligibility for employed adult workers for certain services and for the Work Opportunity Tax Credit (WOTC). We encourage the Governors and state/local WIBs to consult WIA regulations and the preamble to the WIA Final Rule (published at 65 FR 49294 August 11, 2000) for more specific guidance in applying the LLSIL to program requirements. The Department of Health and Human Services (HHS) published the annual 2008 update of the poverty-level guidelines in the
WIA section 101(24) defines the LLSIL as “that income level (adjusted for regional, metropolitan, urban and rural differences and family size) determined annually by the Secretary [of Labor] based on the most recent lower living family budget issued by the Secretary.” The most recent lower living family budget was issued by the Secretary in the fall of 1981. The four-person urban family budget estimates, previously published by the Bureau of Labor Statistics (BLS), provided the basis for the Secretary to determine the LLSIL. BLS terminated the four-person family budget series in 1982, after publication of the fall 1981 estimates. Currently, BLS provides data to ETA through which ETA develops the LLSIL tables, as provided in the Appendices.
ETA published the 2007 updates to the LLSIL in the
Jurisdictions included in the various regions, based generally on Census Divisions of the U.S. Department of Commerce, are as follows:
Additionally, separate figures have been provided for Alaska, Hawaii, and Guam as indicated in Appendix B, Table 2.
For Alaska, Hawaii, and Guam, the year 2007 figures were updated from the June 4, 2007, “State Index” based on the ratio of the urban change in the State (using Anchorage for Alaska and Honolulu for Hawaii and Guam) compared to the West regional metropolitan change, and then applying that index to the West regional metropolitan change.
Data on 23 selected MSAs are also available. These are based on semiannual CPI-U changes for a 12-month period ending in December 2007. The updated LLSIL figures for these MSAs and 70 percent of the LLSIL are reported in Appendix C, Table 3.
Appendix D, Table 4 lists each of the various figures at 70 percent of the updated 2008 LLSIL for family sizes of one to six persons. Because tables 1-3 only list the LLSIL for a family of four, table 4 can be used to determine the LLSIL for families of one to six persons. For families larger than six persons, an amount equal to the difference between
Governors should designate the appropriate LLSILs for use within the State from Appendices A, B, and C, containing Tables 1 through 3. Appendices D and E, which contain Tables 4 and 5, may be used with any LLSIL designated. The Governor's designation may be provided by disseminating information on MSAs and metropolitan and non-metropolitan areas within the State or it may involve further calculations. For example, the State of New Jersey may have four or more LLSIL figures for Northeast metropolitan, Northeast non-metropolitan, portions of the State in the New York City MSA, and those in the Philadelphia MSA. If a workforce investment area includes areas that would be covered by more than one figure, the Governor may determine which is to be used.
Under 20 CFR 661.110, a State's policies and measures for the workforce investment system shall be accepted by the Secretary to the extent that they are consistent with the WIA and the WIA regulations.
It should be noted, the publication of these figures is only for the purpose of meeting the requirements specified by WIA as defined in the law and regulations. BLS has not revised the lower living family budget since 1981, and has no plans to do so. The four-person urban family budget estimates series has been terminated. The CPI-U adjustments used to update the LLSIL for this publication are not precisely comparable, most notably because certain tax items were included in the 1981 LLSIL, but are not in the CPI-U. Thus, these figures should not be used for any statistical purposes, and are valid only for those purposes under WIA as defined in the law and regulations.
Under Title I of the Workforce Investment Act of 1998 (Pub. L. 105—220), the Secretary of Labor annually determines the Lower Living Standard Income Level (LLSIL). This Notice announces the LLSIL Tables for 2008. WIA requires the Department of Labor to update and publish the LLSIL tables annually. The LLSIL tables are used for several purposes under WIA, including determining eligibility for youth and for the Work Opportunity Tax Credit.
To use the 70 percent LLSIL value, where it is stipulated for WIA programs, begin by locating the region or metropolitan area where they reside. These are listed in Tables 1, 2 and 3. After locating the appropriate region or metropolitan statistical area, find the 70 percent LLSIL amount for that location. The 70 percent LLSIL figures are listed in the last column to the right on each of the three tables. These figures apply to a family of four. Larger and smaller family eligibility is based on a percentage of the family of four. To determine eligibility for other size families consult table 4 and the instructions below.
To use Table 4, locate the 70 percent LLSIL value that applies to the individual's region or metropolitan area from Tables 1, 2 or 3. Find the same number in the “family of four” column of Table 4. Move left or right across that row to the size that corresponds to the individual's family unit. That figure is the maximum household income the individual is permitted in order to qualify as economically disadvantaged under WIA.
Where the HHS poverty level for a particular family size is greater than the corresponding LLSIL figure, the LLSIL figure appears in a shaded block. Individuals from these size families may consult the 2008 HHS poverty guidelines found in the
To use the LLSIL to determine the minimum level for establishing self-sufficiency criteria at the State or local level, begin by locating the metropolitan area or region from Table 1, 2 or 3. Then locate the appropriate region or metropolitan statistical area and then find the 2008 Adjusted LLSIL amount for that location. These figures apply to a family of four. Locate the correspon55ding number in the family of four in the column below. Move left or right across that row to the size that corresponds to the individual's family unit. That figure is the minimum figure States must set for determining whether employment leads to self-sufficiency under WIA programs.
Occupational Safety and Health Administration (OSHA), Labor.
Maritime Advisory Committee for Occupational Safety and Health; notice of meeting.
The Maritime Advisory Committee for Occupational Safety and Health (“MACOSH” or “Committee”) was established to advise the Assistant Secretary of Labor for OSHA on issues relating to occupational safety and health in the maritime industries. The purpose of this
The workgroups will meet on May 20, 2008, and MACOSH will meet on May 21, 2008.
The Committee and workgroups will meet at the Wyndham Jacksonville Riverwalk Hotel, 1515 Prudential Drive, Jacksonville, FL 32207. The Longshoring workgroup will meet in the Rope Room of the hotel; the other workgroups will meet in the Tug Room of the hotel. MACOSH will meet in the hotel's Port Room. Mail comments, views, or statements in response to this notice to Vanessa L. Welch, Office of Maritime, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210; phone (202) 693-2086; Fax: (202) 693-1663.
For general information about MACOSH and this meeting, contact: Joseph V. Daddura, Director, Office of Maritime, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210; phone: (202) 693-2086. Individuals with disabilities wishing to attend the meeting should contact Vanessa L. Welch at (202) 693-2086 no later than May 5, 2008, to obtain appropriate accommodations.
All MACOSH meetings and workgroup meetings are open to the public. All interested persons are invited to attend the MACOSH and workgroup meetings at the times and places listed below.
MACOSH will meet from 8 a.m. until approximately 5 p.m. on Wednesday, May 21, 2008, in the hotel's Port Room.
The Shipyards workgroup will meet on Tuesday, May 20, 2008, from 8 a.m. until 10 a.m. in the Tug Room.
The Longshoring workgroup will meet on Tuesday, May 20, 2008, from 8 a.m. until 10 a.m. in the Rope Room.
The Cranes and Falls workgroup will meet on Tuesday, May 20, 2008, from 10 a.m. until 12 p.m. in the Tug Room.
The Outreach and Safety Culture workgroup will meet on Tuesday, May 20, 2008, from 1 p.m. until 3 p.m. in the Tug Room.
The Health workgroup will meet on Tuesday, May 20, 2008, from 3 p.m. until 4 p.m. in the Tug Room.
The meeting times for each workgroup are approximate and subject to change without advance notice.
Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice under the authority granted by sections 6(b)(1) and 7(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655, 656), the Federal Advisory Committee Act (5 U.S.C. App. 2), Secretary of Labor's Order 5-2007 (72 FR 31159), and 29 CFR parts 1911 and 1912.
10 a.m., Friday, May 2, 2008.
The Richard V. Backley Hearing Room, 9th Floor, 601 New Jersey Avenue, NW., Washington, DC.
Open.
The Commission will hear oral argument in the matter
Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Jean Ellen (202) 434-9950/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of an amendment to Facility Operating License No. DPR-37 issued to Virginia Electric and Power Company for operation of the Surry Power Station, Unit No. 2 located in Surry County, Virginia.
The proposed amendment would allow a one-cycle revision to Surry Power Station, Unit No. 2 Technical Specifications (TSs). Specifically, TS 6.4.Q, “Steam Generator (SG) Program,” and TS 6.6.3, “Steam Generator Tube Inspection Report,” will be revised to incorporate an interim alternate repair criterion (IARC) into the provisions for SG tube repair for use during the Surry Power Station, Unit No. 2, 2008 spring refueling outage and the subsequent operating cycle. This amendment application requests approval of an IARC that requires full-length inspection of the tubes within the tubesheet but does not require plugging tubes if any circumferential cracking observed in the region greater than 17 inches from the top of the tubesheet (TTS) is less than a value sufficient to permit the remaining circumferential ligament to transmit the limiting axial loads. This amendment application is required to preclude unnecessary SG tube plugging while still maintaining tube structural and leakage integrity. This amendment application includes SUNSI (proprietary information). Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.
The Commission has made a proposed determination that the amendment request involves no significant hazards consideration. Under the Commission's regulations in Title 10 of the CODE OF FEDERAL REGULATIONS (10 CFR), Section 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:
(1) Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Of the various accidents previously evaluated, the proposed changes only affect the steam generator tube rupture (SGTR) event evaluation and the postulated steam line break (SLB), and locked rotor evaluations. Loss-of-coolant accident (LOCA) conditions cause a compressive axial load to act on the tube. Therefore, since the LOCA tends to force the tube into the tubesheet rather than pull it out, it is not a factor in this amendment request. Another faulted load consideration is a safe shutdown earthquake (SSE); however, the seismic analysis of Model F steam generators has shown that axial loading of the tubes is negligible during an SSE.
At normal operating pressures, leakage from PWSCC below 17 inches from the TTS is limited by both the tube-to-tubesheet crevice and the limited crack opening permitted by the tubesheet constraint. Consequently, negligible normal operating leakage is expected from cracks within the tubesheet region.
For the SGTR event, the required structural margins of the steam generator tubes is maintained by limiting the allowable ligament size for a circumferential crack to remain in service to 203 degrees below 17 inches from the TTS for the subsequent operating cycle. Tube rupture is precluded for cracks in the hydraulic expansion region due to the constraint provided by the tubesheet. The potential for tube pullout is mitigated by limiting the allowable crack size to 203 degrees subsequent operating cycle. These allowable crack sizes take into account eddy current uncertainty and crack growth rate. It has been shown that a circumferential crack with an azimuthal extent of 203 degrees for the 18-month SG tubing eddy current inspection interval meets the performance criteria of NEI 97-06, Rev. 2, “Steam Generator Program Guidelines” and Draft Regulatory Guide (RG) 1.121, “Bases for Plugging Degraded PWR Steam Generator Tubes.” Therefore, the margin against tube burst/pullout is maintained during normal and postulated accident conditions and the proposed change does not result in a significant increase in the probability or consequence of a SGTR.
The probability of a SLB is unaffected by the potential failure of a SG tube as the failure of a tube is not an initiator for a SLB event. SLB leakage is limited by leakage flow restrictions resulting from the leakage path above potential cracks through the tube-to-tubesheet crevice. The leak rate during postulated accident conditions (including locked rotor) has been shown to remain within the accident analysis assumptions for all axial or circumferentially oriented cracks occurring 17 inches below the top of the tubesheet. Since normal operating leakage is limited to 150 gpd, the attendant accident condition leak rate, assuming all leakage to be from indications below 17 inches from the top of the tubesheet would be bounded by 470 gpd. This value is within the accident analysis assumptions for the limiting design basis accident for Surry, which is the postulated SLB event.
Based on the above, the performance criteria of NEI-97-06, Rev. 2 and Draft Regulatory Guide (RG) 1.121 continue to be met and the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
(2) Does the proposed change create the possibility of a new or different accident from any accident previously evaluated?
The proposed change does not introduce any changes or mechanisms that create the possibility of a new or different kind of accident. Tube bundle integrity is expected to be maintained for all plant conditions upon implementation of the interim alternate repair criteria. The proposed change does not introduce any new equipment or any change to existing equipment. No new effects on existing equipment are created nor are any new malfunctions introduced.
Therefore, based on the above evaluation, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
Does the proposed change involve a significant reduction in a margin of safety?
The proposed change maintains the required structural margins of the steam generator tubes for both normal and accident conditions. NEI 97-06, Rev. 2 and RG 1.121 are used as the basis in the development of the limited tubesheet inspection depth methodology for determining that steam generator tube integrity considerations are maintained within acceptable limits. RG 1.121 describes a method acceptable to the NRC staff for meeting GDC 14, 15, 31, and 32 by reducing the probability and consequences of an SGTR. RG 1.121 concludes that by determining the limiting safe conditions of tube wall degradation beyond which tubes with unacceptable cracking, as established by inservice inspection, should be removed from service or repaired, the probability and consequences of a SGTR are reduced. This RG uses safety factors on loads for tube burst that are consistent with the requirements of Section III of the ASME Code.
For axially oriented cracking located within the tubesheet, tube burst is precluded due to the presence of the tubesheet. For circumferentially oriented cracking in a tube or the tube-to-tubesheet weld, Reference 6 defines a length of remaining tube ligament that provides the necessary resistance to tube pullout due to the pressure induced forces (with applicable safety factors applied). Additionally, it is shown that application of the limited tubesheet inspection depth
Based on the above, it is concluded that the proposed changes do not result in any reduction of margin with respect to plant safety as defined in the Updated Final Safety Analysis Report or bases of the plant Technical Specifications.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Written comments may be submitted by mail to the Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this
The filing of requests for hearing and petitions for leave to intervene is discussed below.
Within 60 days after the date of publication of this notice, the person(s) may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person(s) whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request via electronic submission through the NRC E-filing system for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area O1F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated on August 28, 2007 (72 FR 49139). The E-Filing process requires participants to submit and serve documents over the internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in
To comply with the procedural requirements of E-Filing, at least five (5) days prior to the filing deadline, the petitioner/requestor must contact the Office of the Secretary by e-mail at
A person filing electronically may seek assistance through the “Contact Us” link located on the NRC Web site at
Non-timely requests and/or petitions and contentions will not be entertained absent a determination by the Commission, the presiding officer, or the Atomic Safety and Licensing Board that the petition and/or request should be granted and/or the contentions should be admitted, based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii). To be timely, filings must be submitted no later than 11:59 p.m. Eastern Time on the due date.
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
For further details with respect to this license amendment application, see the application for amendment dated April 14, 2008, which is available for public inspection at the Commission's PDR, located at One White Flint North, File Public Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
1. This order contains instructions regarding how potential parties to this proceeding may request access to documents containing sensitive unclassified information (including SUNSI and SGI).
2. Within ten (10) days after publication of this notice of opportunity for hearing, any potential party as defined in 10 CFR 2.4 who believes access to SUNSI or SGI is necessary for a response to the notice may request access to SUNSI or SGI. A “potential party” is any person who intends or may intend to participate as a party by demonstrating standing and the filing of an admissible contention under 10 CFR 2.309. Requests submitted later than ten (10) days will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
3. The requester shall submit a letter requesting permission to access SUNSI and/or SGI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, MD 20852. The e-mail address for the Office
a. A description of the licensing action with a citation to this
b. The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the licensing action identified in (a) if the licensing action is not sustained;
c. If the request is for SUNSI, the identity of the individual requesting access to SUNSI and the requester's need for the information in order to meaningfully participate in this adjudicatory proceeding, particularly why publicly available versions of the application would not be sufficient to provide the basis and specificity for a proffered contention;
d. If the request is for SGI, the identity of the individual requesting access to SGI and the identity of any expert, consultant or assistant who will aid the requester in evaluating the SGI, and information that shows:
(i) Why the information is indispensable to meaningful participation in this licensing proceeding; and
(ii) The technical competence (demonstrable knowledge, skill, experience, training or education) of the requester to understand and use (or evaluate) the requested information to provide the basis and specificity for a proffered contention. The technical competence of a potential party or its counsel may be shown by reliance on a qualified expert, consultant or assistant who demonstrates technical competence as well as trustworthiness and reliability, and who agrees to sign a non-disclosure affidavit and be bound by the terms of a protective order; and
e. If the request is for SGI, Form SF-85, “Questionnaire for Non-Sensitive Positions,” Form FD-248 (fingerprint card), and a credit check release form completed by the individual who seeks access to SGI and each individual who will aid the requester in evaluating the SGI. For security reasons, Form SF-85 can only be submitted electronically, through a restricted-access database. To obtain online access to the form, the requester should contact the NRC's Office of Administration at 301-415-0320.
These forms will be used to initiate the background check, which includes fingerprinting as part of a criminal history records check. Note: Copies of these forms do
4. To avoid delays in processing requests for access to SGI, all forms should be reviewed for completeness and accuracy (including legibility) before submitting them to the NRC. Incomplete packages will be returned to the sender and will not be processed.
5. Based on an evaluation of the information submitted under items 2 and 3.a through 3.d, above, the NRC staff will determine within ten days of receipt of the written access request whether (1) there is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding, and (2) there is a legitimate need for access to SUNSI or need to know the SGI requested. For SGI, the need to know determination is made based on whether the information requested is necessary (
6. If standing and need to know SGI are shown, the NRC staff will further determine based upon completion of the background check whether the proposed recipient is trustworthy and reliable. The NRC staff will conduct (as necessary) an inspection to confirm that the recipient's information protection systems are sufficient to protect SGI from inadvertent release or disclosure. Recipients may opt to view SGI at the NRC's facility rather than establish their own SGI protection program to meet SGI protection requirements.
7. A request for access to SUNSI or SGI will be granted if:
a. The request has demonstrated that there is a reasonable basis to believe that a potential party is likely to establish standing to intervene or to otherwise participate as a party in this proceeding;
b. The proposed recipient of the information has demonstrated a need for SUNSI or a need to know for SGI, and that the proposed recipient of SGI is trustworthy and reliable;
c. The proposed recipient of the information has executed a Non-Disclosure Agreement or Affidavit and agrees to be bound by the terms of a Protective Order setting forth terms and conditions to prevent the unauthorized or inadvertent disclosure of SUNSI and/or SGI; and
d. The presiding officer has issued a protective order concerning the information or documents requested.
8. If the request for access to SUNSI or SGI is granted, the terms and conditions for access to sensitive unclassified information will be set forth in a draft protective order and affidavit of non-disclosure appended to a joint motion by the NRC staff, any other affected parties to this proceeding,
9. If the request for access to SUNSI is denied by the NRC staff or a request for access to SGI is denied by NRC staff either after a determination on standing and need to know or, later, after a determination on trustworthiness and reliability, the NRC staff shall briefly state the reasons for the denial. Before the Office of Administration makes an adverse determination regarding access, the proposed recipient must be provided an opportunity to correct or explain information. The requester may challenge the NRC staff's adverse determination with respect to access to SUNSI or with respect to standing or need to know for SGI by filing a challenge within five (5) days of receipt of that determination with (a) the presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an administrative law judge with jurisdiction pursuant to § 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer. In the same manner, an SGI requester may challenge an adverse determination on trustworthiness and reliability by filing a challenge within fifteen (15) days of receipt of that determination.
In the same manner, a party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed within five (5) days of the notification by the NRC staff of its grant of such a request. If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
10. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI and/or SGI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those [intervenors/petitioners] who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. Attachment 1 to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
For the Nuclear Regulatory Commission.
Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC, Commission) has published a draft plant-specific supplement to the Generic Environmental Impact Statement for License Renewal of Nuclear Plants (GEIS), NUREG-1437, regarding the renewal of operating licenses NPF-068 and NPF-081 for an additional 20 years of operation for Vogtle Electric Generating Plant, Units 1 and 2 (VEGP). VEGP is located in Burke County, Georgia, approximately 15 miles east-northeast of Waynesboro, GA, and 26 miles southeast of Augusta, GA. Possible alternatives to the proposed action (license renewal) include no action and reasonable alternative energy sources.
The draft Supplement 34 to the GEIS is publicly available at the NRC Public Document Room (PDR), located at One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, or from the NRC's Agencywide Documents Access and Management System (ADAMS). The ADAMS Public Electronic Reading Room is accessible at
Any interested party may submit comments on the draft supplement to the GEIS for consideration by the NRC staff. To be considered, comments on the draft supplement to the GEIS and the proposed action must be received by July 16, 2008; the NRC staff is able to assure consideration only for comments received on or before this date. Comments received after the due date will be considered only if it is practical to do so. Written comments on the draft supplement to the GEIS should be sent to: Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, Mailstop T-6D59, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Comments may be hand-delivered to the NRC at 11545 Rockville Pike, Room T-6D59, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Electronic comments may be submitted to the NRC by e-mail at
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission seeks comments from the public on a study of a postal rule that allows certain fundraising mailings to be sent at reduced rates. The comments will assist the Commission in preparing a statutorily-required report and recommendations.
Initial comments due June 24, 2008; reply comments due July 24, 2008.
Submit comments electronically via the Commission's Filing Online system at
Stephen L. Sharfman, General Counsel, 202-789-6820 and
The Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3218 (2006), directs the Commission to prepare several reports on special topics. One directive requires the Commission to examine an exception to the cooperative mail rule to determine whether this change in eligibility for reduced postage contains adequate safeguards to protect against abuses of rates for nonprofit mail and deception of consumers. The Commission is to report the results of this examination to the Postal Service, along with any recommendations it deems appropriate. If the Postal Service fails to act thereon, the Commission may take such action it deems necessary to prevent abuse of rates or deception of consumers.
The Commission establishes Docket No. PI2008-4 to facilitate compliance with the directive in section 711 and seeks comments from the public on the scope and nature of the examination, report, and potential recommendations. 39 U.S.C. 505 requires the designation of an officer of the Commission in all public proceedings to represent the interests of the general public. The Commission designates Katja M. Eichinger to serve as the Public Representative. Pursuant to this designation, Ms. Eichinger will direct the activities of Commission personnel assigned to assist her and, upon request, will provide their names for the record. Neither she nor any of the assigned personnel will participate in or provide advice on any Commission decision in this proceeding.
The cooperative mail rule is a longstanding provision in the DMM. It traditionally has controlled access to reduced postage rates by limiting the ability of an entity that is eligible for reduced rates to “cooperate” or partner with another entity in a mailing and still retain its reduced rate eligibility for the mailing in question. The rule generally accomplishes this, in brief, by requiring that each cooperating entity independently qualify for nonprofit rates at the post office of mailing; by requiring that the mail matter being sent be that of the eligible entity; and by prohibiting “sharing” a permit with an entity not authorized to mail at reduced rates. These restrictions effectively foreclose a nonprofit from cooperating with a for-profit entity if the mailing is to be sent at nonprofit rates, unless the cooperation involves a legitimate principal-agent relationship in a fee-for-service arrangement.
The traditional rationale for imposing limits on cooperative mailings has been that access to reduced rates is a privilege—initially subsidized by taxpayers, but more recently by other mailers—and that the limits help prevent abuse of this privilege. The extent of the benefit has varied in the years since its introduction, but eligible cooperative mailings currently pay 60 percent of the Regular Standard Mail rate.
In 2003, the Postal Service initiated an administrative rulemaking to address a revision to the cooperative mail rule. The rulemaking resulted in a revision, effective November 13, 2003, widely referred to as the Fundraising Exception. In practical effect, this revision expands eligibility in a limited respect by exempting fundraising mailings seeking only monetary donations from application of the DMM's conditions for an eligible cooperative mailing.
The Postal Service notice of proposed rulemaking included a discussion of the history of the cooperative mail rule and its application to fundraising mailings; the traditional role of Congress with respect to eligibility for nonprofit Standard Mail rates; recent concerns about the impact of the cooperative mail rule on fundraising mailings; and proposed legislation to exempt certain fundraising mail from the rule. It noted, with respect to the impact of the rule on fundraising mailings, that over the last several years, some nonprofit organizations have made the Postal Service aware of concerns that the application of the cooperative mail rule
In many cases, the arrangements between the professional fundraiser and the nonprofit are cooperative under the longstanding application of the cooperative mail rule. Indeed, the Postal Service understands that some states require contractual terms between nonprofits and some (but not all) types of professional fundraisers to contain elements that would cause the resultant fundraising mailings to violate the cooperative mail rule.
The Postal Service said it was sensitive to the plight of these nonprofit organizations, but was reluctant to propose an administrative solution because expanding or reducing eligibility to mail at nonprofit or other preferred status traditionally has been a legislative function; discriminating between its customers is prohibited by statute, except where authorized by law; and expanding eligibility for nonprofit rates could create a significant competitive advantage for a newly-eligible mailer, relative to those still mailing at the commercial rate.
The Postal Service acknowledged the seriousness of the issues raised by the nonprofits, but characterized them as appearing primarily to raise consumer protection concerns, rather than postal concerns. It therefore considered them a type of social policy concern best addressed elsewhere, such as through Federal legislation or the state officials who regulate the relationship between professional fundraisers and nonprofit organizations.
* * * only exempts fundraising mailings seeking monetary donations. Mailings that include solicitations for products or services, whether through sale, lease, or other arrangements, will not be exempt from application of the cooperative mail rule. If there is a cooperative arrangement involving such goods or services, the mailpiece will not be eligible for Nonprofit Standard mail rates.
Second, the Postal Service said the exemption was only from application of the cooperative mail rule, and that affected mailings would continue to be subject to all other applicable postal standards.
The next point was that the rule, if adopted, would be a change of postal policy rather than a clarification of existing standards, and thus would be prospective only, effective on the date of adoption. It would not form the basis for a request for a refund.
In our discussions with nonprofit representatives and Congressional representatives, no consensus was reached on an effective and administratively feasible method to accomplish this goal. However, this rulemaking does not prevent other interested federal or state agencies from regulating such practices. Moreover, it is also hoped that the nonprofit sector may undertake educational efforts to inform potential targets of such practices.
The Postal Service's final point was that it would be alert to the consequences of the new standard, should it be adopted, and might revisit the exception and consider a further rulemaking or other appropriate administrative measures if it resulted in the types of abuses that had been discussed or any other unintended consequences.
In the explanation accompanying the final rule, the Postal Service characterized the 67 comments it had received as diverse in terms of types of entities represented and broad as to the range of views.
In response to the comments, the Postal Service modified the proposed rule in several respects. It added a condition related to donor lists by providing that the fundraising exemption applies only where the nonprofit organization is either given a list of the donors, their contact information, and the amount of their donations, or waives, in writing, the receipt of such list.
The Postal Service discussed, but did not accept, commenters' suggestions that would have resulted in a regulation that:
The preceding summary makes clear that the Fundraising Exception expands eligibility for nonprofit Standard Mail rates for certain types of mailings, but does so in a relatively limited way. It also makes clear that the Fundraising Exception, as adopted, did not include many of the checks, or safeguards, some commenters believed should be included to ward off abuse of nonprofit rates and consumer deception. The Commission invites comments from the general public to facilitate its examination of whether the Fundraising Exception contains adequate safeguards to protect against abuse of nonprofit rates and consumer protection, and preparation of the related report and recommendations. Comments may address any relevant topic; however, the Commission also presents the following questions to help focus the discussion.
The directive in section 711 speaks to abuse of nonprofit rates, rather than fraud. In connection with the scope and extent of abuse that may occur under the Fundraising Exemption, the Commission is especially interested in the following matters:
1. The 2003 rulemaking acknowledged that commenters had raised concerns about several types of abusive fundraising practices, including predatory credit arrangements. To what extent have these practices occurred, since the 2003 revision, in connection with mailings sent under the Fundraising Exemption?
2. Have there been any material changes in fundraising practices since the Postal Service's 2003 rulemaking that give rise to new concerns about abuse in connection with the Fundraising Exception?
3. To what extent has the nonprofit sector engaged in education efforts designed to inform nonprofits, especially those considered especially vulnerable to overreaching or predatory partners, about the scope of the Fundraising Exception and potential abuses? Also, are there reliable means of measuring or assessing the success of these efforts?
4. To what extent has the Postal Service (including any organizational division) engaged in education efforts specifically directed at the Fundraising Exception and potential abuses? Are there reliable means of measuring or assessing the success of these efforts?
5. What information and data are available about the extent to which the Fundraising Exception has been used by mailers eligible for nonprofit rates since adoption in 2003, in terms of features such as number and type of entities using the Fundraising Exception, volume, and total postage involved?
The directive in section 711 also extends to deception of consumers. The Commission is interested in commenters' views on all relevant aspects of consumer deception, including:
1. The 2003 rulemaking mentioned that there were a growing number of State laws on charitable fundraising that created a potential for conflict with cooperative mail as then formulated. Has there been an increase in the number of States proposing or adopting such laws? What safeguards or protections are included in these laws? Do these laws pose any conflicts with the 2003 Fundraising Exception or did this Exception satisfactorily resolve relevant concerns?
2. To what extent has the Postal Service undertaken efforts to educate consumers (in the capacity of a donor or potential donor responding to a mailed solicitation) about abuses or potential fundraising abuses?
3. To what extent have individual States engaged in efforts to educate consumers (in the capacity of a donor or potential donor responding to a mailed solicitation) about abuses or potential fundraising abuses?
4. To what extent has deception of potential donors been reported or documented by the Postal Service, nonprofit mailer organizations, State or local consumer protection agencies, or others?
1. The Commission establishes Docket No. PI2008-4, Inquiry into Cooperative Mail Rule Exception, to facilitate compliance with section 711 of the Postal Accountability and Enhancement Act.
2. The Commission designates Katja M. Eichinger as the Public Representative representing the interests of the general public in this proceeding.
3. Comments on issues related to the directive in section 711 of the PAEA are due June 24, 2008.
4. Reply comments are due July 24, 2008.
5. The Secretary shall arrange for publication of this Notice in the
By the Commission.
By telephone vote on April 14, 2008, the Board of Governors of the United States Postal Service voted unanimously to close to public observation its meeting held via teleconference. The Board determined that prior public notice was not possible.
1. Strategic Planning.
2. Personnel Matters and Compensation Issues.
The General Counsel of the United States Postal Service has certified that the meeting was properly closed under the Government in the Sunshine Act.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Tuesday, April 29, 2008 at 2 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters may also be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3) (5), (7), (9)(B), and (10) and 17 CFR 200.402(a)(3), (5), (7), (9)(ii) and (10), permit consideration of the scheduled matters at the Closed Meeting.
Commissioner Casey, as duty officer, voted to consider the items listed for the Closed Meeting in closed session.
The subject matter of the Closed Meeting scheduled for April 29, 2008 will be:
Formal orders of investigation;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an enforcement nature;
Adjudicatory matters; and
A matter related to an enforcement proceeding.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact:
The Office of the Secretary at (202) 551-5400.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change would clarify the jurisdictional status of options and security futures on streetTRACKS Gold Shares by adding an interpretation following the definition of “fund share” in Article I, section 1 of OCC's By-Laws.
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to clarify the jurisdictional status of options and security futures on streetTRACKS Gold Shares by adding an interpretation following the definition of “fund share” in Article I, section 1 of OCC's By-Laws. Under the proposed interpretation, OCC would clear and treat as securities options any option contracts on streetTRACKS Gold Shares that are traded on securities exchanges. Similarly, OCC would clear and treat as security futures any futures contracts on streetTRACKS Gold Shares.
In its capacity as a “derivatives clearing organization” registered with the Commodity Futures Trading Commission (“CFTC”), OCC filed this proposed rule change for prior approval by the CFTC pursuant to provisions of the Commodity Exchange Act (“CEA”) in order to foreclose any potential liability under the CEA based on an argument that the clearing by OCC of options on streetTRACKS Gold Shares as securities options or the clearing of futures on that product as security futures constitutes a violation of the CEA. This rule change was filed with the CFTC as an amendment to SR-OCC-2008-04, which is pending approval at the CFTC.
The proposed rule change is consistent with the purposes and requirements of section 17A of the Act because it is designed to promote the prompt and accurate clearance and settlement of transactions in securities options and security futures, to foster cooperation and coordination with persons engaged in the clearance and settlement of such transactions, to remove impediments to and perfect the mechanism of a national system for the prompt and accurate clearance and settlement of such transactions, and, in general, to protect investors and the public interest. It accomplishes this purpose by reducing the likelihood of a dispute as to the Commission's jurisdiction or shared jurisdiction in the case of security futures over derivatives based on streetTRACKS Gold Shares. The proposed rule change is not inconsistent with the By-Laws and Rules of OCC, including any proposed to be amended.
OCC does not believe that the proposed rule change would impose any burden on competition.
Written comments were not and are not intended to be solicited with respect to the proposed rule change, and none have been received.
Within thirty-five days of the date of publication of this notice in the
(A) By order approve the proposed rule change or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act.
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-OCC-2007-07 and should be submitted on or before May 12, 2008.
For the Commission by the Division of Trading and Markets, pursuant to delegated authority.
The Committee will meet in open session from 1:30 p.m. through 3 p.m. on Monday, June 2, 2008, in the Department of State, 2201 “C” Street, NW., Washington, DC, in Conference Room 1205, to discuss declassification and transfer of Department of State records to the National Archives and Records Administration and the status of the
Questions concerning the meeting should be directed to Marc J. Susser, Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State, Office of the Historian, Washington, DC, 20520, telephone (202) 663-1123, (e-mail
A meeting of the Advisory Committee on Democracy Promotion will be held on Monday, May 12, 2008 in Room 1107, U.S. Department of State, 2201 C Street, NW., Washington, DC. The meeting will be open to the public from 10 a.m.-12 p.m., up to the capacity of the meeting room. The Committee members will discuss various issues relating to strategies to promote democratic governance, with Secretary Rice leading the discussion from 10:30-11 a.m. Pursuant to section 10(d) of the Federal Advisory Committee Act, 5 U.S.C. App. 10(d) and 5 U.S.C. 552b(c)6, it has been determined that the meeting will be closed to the public from 12 to 2 p.m. because the Committee will be discussing sensitive information about the personal situation of human rights dissidents, disclosure of which would likely jeopardize the safety and welfare of these individuals and constitute a clearly unwarranted invasion of their personal privacy.
Entry to the main State Department building is controlled and will require advance arrangements. Members of the public wishing to attend this meeting should, by Thursday, May 8, 2008, notify Karen Chen in the Bureau of Democracy, Human Rights and Labor—telephone: 202-647-4648—of their name, date of birth, valid government-issued ID number (see below), and citizenship, in order to arrange admittance. This includes admittance for government employees as well as others.
All attendees must use the “C” Street entrance of the Department, after being screened through the exterior screening facilities, and arrive by 9:30 a.m. One of the following valid IDs will be required for admittance: Any U.S. driver's license with photo, a passport, or a U.S. Government agency ID. Because an escort is required at all times, attendees should expect to remain in the meeting throughout the open portion.
For more information, contact Anne Carson, Special Assistant to the Under Secretary for Democracy and Global Affairs, Department of State, Washington, DC 20520, telephone: (202) 647-8703.
Federal Aviation Administration (FAA), DOT.
Notice of public meeting.
This notice announces a public meeting (teleconference) of the FAA's Aviation Rulemaking Advisory Committee (ARAC) to discuss transport airplane and engine (TAE) issues.
The meeting is scheduled for Tuesday, May 20, 2008 starting at 10:30 a.m. Eastern Daylight Time. Arrange for oral presentations by May 6, 2008.
Federal Aviation Administration, 800 Independence Ave., SW., Room 810, Washington, DC 20591.
Nicanor Davidson, Office of Rulemaking, ARM-207, FAA, 800 Independence Avenue, SW., Washington, DC 20591, Telephone (202) 267-5174, FAX (202) 267-5075, or e-mail at
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. app. III), notice is given of an ARAC meeting to be held via teleconference on May 20, 2008. This ad hoc meeting is being held to review and vote on the Task 3 report (Specific Risk) from the Airplane Level Safety Analysis Working Group (ASAWG).
The agenda for the meeting is as follows:
• Opening Remarks;
• ASAWG Task 3 Report and Vote.
Attendance is open to the public, but will be limited to the availability of phone lines. Please confirm your attendance with the person listed in the
For persons participating, the call-in number is (202) 493-4180; the Passcode is “5507.” To insure that sufficient telephone lines are available, please notify the person listed in the
If you need meeting documents, please contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice of RTCA Government/Industry Air Traffic Management Advisory Committee.
The FAA is issuing this notice to advise the public of a meeting of RTCA Government/Industry Air Traffic Management Advisory Committee.
The meeting will be held July 17, 2008, from 1 p.m. to 4 p.m.
The meeting will be held at FAA Headquarters, 800 Independence Avenue, SW., Bessie Coleman Conference Center (2nd Floor), Washington, DC 20591.
RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC 20036; telephone (202) 833-9339; fax (202) 833-9434; Web site
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice is hereby given for the Air Traffic Management Advisory Committee meeting.
Non-Government attendees to the meeting must go through security and be escorted to and from the conference room. Attendees with laptops will be required to register them at the security desk upon arrival and departure. Agenda items will be posted on
Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice of RTCA Special Committee 217/EUROCAE Working Group 44 meeting.
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 217/EUROCAE Working Group 44: Airport Mapping Databases.
The meeting will be held May 14-16, 2008, from 9 a.m.-5 p.m.
The meeting will be held at EUROCONTROL, Rue de la Fusee, 96, B-1130 Brussels, Belgium.
(1) RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC, 20036 telephone (202) 833-9339: fax (202) 833-9434; Web site
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463. 5 U.S.C., Appendix 2), notice is
• May 14:
• Open Plenary (Chairmen's Remarks and Introductions, Review and Approve Meeting Agenda, Discussion).
• Schedule—Completion in no more than three meetings.
• Schedule for this week.
• Schedule for next meetings.
• Presentations:
• Gap Analysis—ARINC 816 and RTCAIEUROCAE documents;
• Gap Analysis—ATXM and RTCA/EUROCAE documents.
• Begin effort to revise documents.
• May 15:
• Plenary Session.
• May 16:
• Plenary Session.
• Other Business.
• Determine and agree on action plan.
• Meeting Plans and Dates.
Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice of petitions for exemption received.
This notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.
Comments on petitions received must identify the petition docket number involved and must be received on or before May 15, 2008.
You may send comments identified by Docket Number FAA-2008-0394 using any of the following methods:
•
•
•
•
•
We will post all comments we receive, without change, to
Tyneka Thomas (202) 267-7626 or Frances Shaver (202) 267-9681, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by FHWA.
This notice announces actions taken by the FHWA that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, the SR 519 Intermodal Access Project—Phase 2: Atlantic Corridor, in the State of Washington. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before October 22, 2008. If the Federal law that authorizes judicial review of a claim provides a time period of less than 180 days for filing such claim, then that shorter time period still applies.
Stephen Boch, Major Project Oversight Manager, Federal Highway Administration, Jackson Federal Building, 915 2nd Avenue, Room 3142, Seattle, Washington, 98174; telephone: (206) 220-7356; and e-mail:
Notice is hereby given that the FHWA has taken final agency actions by issuing licenses, permits, and approvals for the following highway project: SR 519 Intermodal Access Project—Phase 2: Atlantic Corridor. The purpose of the project is
The actions by the FHWA on this project, and the laws under which such actions were taken, are described in the February 2008 Environmental Assessment (EA), April 2008 Finding of No Significant Impact (FONSI), and in other documents in the FHWA administrative record for the project. The EA, FONSI and other documents in the FHWA administrative record are available by contacting the FHWA or the Washington State Department of Transportation at the addresses provided above.
The EA can be viewed and downloaded from the project Web site at
This notice applies to all Federal agency decisions on the project as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1.
2.
3.
4.
5.
6.
7.
8.
9.
23 U.S.C. 139(l)(1).
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt fifty-six individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will enable these individuals to operate CMVs in interstate commerce.
The exemptions are effective
Dr. Mary D. Gunnels, Director, Medical Programs, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On March 5, 2008, FMCSA published a notice of receipt of Federal diabetes exemption applications from fifty-six
FMCSA has evaluated the eligibility of the fifty-six applicants and determined that granting the exemptions to these individuals would achieve a level of safety equivalent to, or greater than, the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(3).
The Agency established the current standard for diabetes in 1970 because several risk studies indicated that diabetic drivers had a higher rate of crash involvement than the general population. The diabetes rule provides that “A person is physically qualified to drive a commercial motor vehicle if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control” (49 CFR 391.41(b)(3)).
FMCSA established its diabetes exemption program, based on the Agency's July 2000 study entitled “A Report to Congress on the Feasibility of a Program to Qualify Individuals with Insulin-Treated Diabetes Mellitus to Operate in Interstate Commerce as Directed by the Transportation Act for the 21st Century.” The report concluded that a safe and practicable protocol to allow some drivers with ITDM to operate CMVs is feasible. The 2003 notice in conjunction with the November 8, 2005 (70 FR 67777)
These fifty-six applicants have had ITDM over a range of 1 to 38 years. These applicants report no hypoglycemic reaction that resulted in loss of consciousness or seizure, that required the assistance of another person, or resulted in impaired cognitive function without warning symptoms in the past 5 years (with one year of stability following any such episode). In each case, an endocrinologist has verified that the driver has demonstrated willingness to properly monitor and manage their diabetes, received education related to diabetes management, and is on a stable insulin regimen. These drivers report no other disqualifying conditions, including diabetes-related complications. Each meets the vision standard at 49 CFR 391.41(b)(10).
The qualifications and medical condition of each applicant were stated and discussed in detail in the March 5, 2008,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows the applicants to operate CMVs in interstate commerce.
To evaluate the effect of these exemptions on safety, FMCSA considered medical reports about the applicants' ITDM and vision, and reviewed the treating endocrinologist's medical opinion related to the ability of the driver to safely operate a CMV while using insulin.
Consequently, FMCSA finds that exempting these applicants from the diabetes standard in 49 CFR 391.41(b)(3) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption will be provided to the applicants in the exemption document and they include the following: (1) That each individual submit a quarterly monitoring checklist completed by the treating endocrinologist as well as an annual checklist with a comprehensive medical evaluation; (2) that each individual reports within 2 business days of occurrence, all episodes of severe hypoglycemia, significant complications, or inability to manage diabetes; also, any involvement in an accident or any other adverse event in a CMV or personal vehicle, whether or not they are related to an episode of hypoglycemia; (3) that each individual provide a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (4) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the certification when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
FMCSA received no comments in this proceeding.
After considering the comments to the docket, and based upon its evaluation of the fifty-six exemption applications, FMCSA exempts Ryan N. Adams, Clay B. Anderson, Michael B. Bessinger, Douglas D. Brown, Kenneth T. Clark, Joseph F. Colbert, Daniel E. Coufal, Stuart A. Dietz, John J. Durrence, Michael B. Elzey, Candy C. Eubank, Thomas S. Faucette, Jr., Earl S. Fibish, Stanley R. Folkerts, Timothy L. Gahring, Donald W. Giesbrecht, Todd W. Gillespie, Stephen W. Golden, Richard E. Grunden, Jack L. Guffey, Mark Hall, Teresa M. Hansen, Jason A. Henry, Michael B. Heuett, John M. Hickey, Joe Ibarra, Anthony L. Lambert, Paul F. Lanich, Ronald M. Lavallee, Eric R. Ledvina, Kenneth L. Lefeld, Steven J. Leite, Daryl G. Lewis, George A. Lucietto, Robert A. Manning, Ottis N. McCoy, Joseph G. McDonald, Richard L. McDonald, David D. Millard, Jr., Raymond E. Miller, Victor E. Millwood, Walter G. Minshall, Alan J. Mitchell, Raymond P. Mora, Sr., John M. Murray, John R. Pile, Forest T. Porter, John Rubillo, Jason E. Saunders, Christopher D. Singleton, Brian Slover, Steven T. Slowey, Jacob A. Small, Richard S. Synakowski, Sabrina F. Thomas, and Scott D. Wimer from the ITDM standard in 49 CFR 391.41(b)(3), subject to the conditions listed under “Conditions and Requirements” above.
In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will be valid for two years unless revoked earlier by FMCSA. The exemption will be revoked if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the exemption is still effective at the end of the 2-year period, the person may apply to FMCSA for a renewal under procedures in effect at that time.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA previously announced its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 8 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has reviewed the comments submitted in response to the previous announcement and concluded that granting these exemptions will provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Dr. Mary D. Gunnels, Director, Medical Programs, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. The comment period ended on March 20, 2008.
FMCSA received one comment in this proceeding. The comment was considered and discussed below.
Advocates for Highway and Auto Safety (Advocates) expressed opposition to FMCSA's policy to grant exemptions from the FMCSR, including the driver qualification standards. Specifically, Advocates: (1) Objects to the manner in which FMCSA presents driver information to the public and makes safety determinations; (2) objects to the Agency's reliance on conclusions drawn from the vision waiver program; (3) claims the Agency has misinterpreted statutory language on the granting of exemptions (49 U.S.C. 31136(e) and 31315); and finally (4) suggests that a 1999 Supreme Court decision affects the legal validity of vision exemptions.
The issues raised by Advocates were addressed at length in 64 FR 51568 (September 23, 1999), 64 FR 66962 (November 30, 1999), 64 FR 69586 (December 13, 1999), 65 FR 159 (January 3, 2000), 65 FR 57230 (September 21, 2000), and 66 FR 13825 (March 7, 2001). We will not address these points again here, but refer interested parties to those earlier discussions.
The Agency has not received any adverse evidence on any of these drivers that indicates that safety is being compromised. Based upon its evaluation of the 8 renewal applications, FMCSA renews the Federal vision exemptions for John R. Alger, Gene Bartlett, Jr., Marland L. Brassfield, Billy R. Jeffries, John P. Rodrigues, Robert V. Sloan, Gary N. Wilson, and William B. Wilson.
In accordance with 49 U.S.C. 31136(e) and 31315, each renewal exemption will be valid for 2 years unless revoked earlier by FMCSA. The exemption will be revoked if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Transit Administration, DOT.
Notice of request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to extend the following currently approved information collection: Reporting of Technical Activities by FTA Grant Recipients. The
Comments must be submitted before May 27, 2008. A comment to OMB is most effective if OMB receives it within 30 days of publication.
LaStar Matthews, Office of Administration, Office of Management Planning, (202) 366-2295 or e-mail:
The information collected is used to report annually to Congress, the Secretary, and to the Federal Transit Administrator on how grantees are responding to national emphasis areas and congressional direction, and allows FTA to track grantees' use of federal planning funds.
All written comments must refer to the docket number that appears at the top of this document and be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503, Attention: FTA Desk Officer.
General Motors Corporation (GM) has determined that certain model year 2005, 2006 and 2007 Cadillac STS passenger cars equipped with sunroofs do not fully comply with paragraph S4(e) of 49 CFR 571.118, Federal Motor Vehicle Safety Standard (FMVSS) No. 118,
Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule implementing those provisions at 49 CFR Part 556, GM has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety. Notice of receipt of the petition was published, with a 30-day public comment period, on December 10, 2007 in the
For further information on this decision, contact Mr. Stuart Seigel, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5287, facsimile (202) 493-0073.
GM certified these vehicles to paragraph S4(e) of 49 CFR 571.118, which requires in pertinent part:
S4. Operating requirements. * * * power operated window, partition, or roof panel systems may be closed only in the following circumstances: * * *
(e) During the interval between the time the locking device which controls the activation of the vehicle's engine is turned off and the opening of either of a two-door vehicle's doors or, in the case of a vehicle with more than two doors, the opening of either of its front doors;
GM explains that for 60 seconds after the vehicles are started, if the engine is turned off and a front door is opened, the sunroof module software allows the sunroof to be closed if someone in the vehicle activates the control switch. If more than 60 seconds elapses from the starting of the vehicle, this condition will not occur.
GM stated that it is not aware of any incidents or injury related to the subject condition.
GM included an analysis of the risk associated with the subject condition and a detailed explanation of the reasons why it believes the noncompliance to be inconsequential to motor vehicle safety.
In summary, GM states that for all of the subject vehicles:
• The subject condition affects only the sunroof, not the power windows.
• The subject condition requires multiple actions that must occur within a 60 second time period. First, the following sequence of actions must occur: driver starts engine, driver turns off engine, and driver or front passenger opens a front door. After this sequence of actions and still within the 60 second time frame, occupants must take additional actions: Push the sunroof close switch and position an occupant to create the risk of sunroof entrapment. All of these actions must occur within one 60 second time frame.
• If the sunroof switch is pushed steadily and then released, the sunroof promptly stops moving.
• The sunroof incorporates an auto-reverse system. This system will activate whenever the sunroof is closing in the express close mode. Therefore, sunroof entrapment requires the completion of the initial sequence of engine start/engine stop/front door open actions, and also requires an occupant to press and hold the sunroof closure switch and position an occupant within the sunroof—all within the 60 second window and in such a manner that the auto-reverse is not effective in preventing sunroof entrapment.
• The Agency has granted similar petitions in the past.
• GM is not aware of any injures or incidents related to the subject condition.
GM states that it believes that because the noncompliance is inconsequential to motor vehicle safety that no further corrective action is warranted. GM has also informed NHTSA that it has corrected the problem that caused these errors so that they will not be repeated in future production.
The following explains our rationale.
The purpose of paragraph S4 of FMVSS No. 118 is to minimize the likelihood of death or injury to occupants from accidental operation of power windows, partitions, and roof panels. We believe that this noncompliance is inconsequential to motor vehicle safety for a number of reasons. It is very unlikely that the entire sequence of events—starting the engine, turning the engine off, opening a front door, a person becoming positioned in the sunroof opening, and pushing the sunroof close button—will occur in less than 60 seconds. We also believe that the risk exposure time is likely further reduced as the sunroof, normally closed at the time of engine start, would have to first be opened then closed, with the opening time subtracted from the 60 second interval.
The noncompliant situation does not involve power windows, where entrapment is rare but a realistic possibility. Power window openings are physically more accessible to occupants than the sunroof opening and thus present a higher risk of entrapment to persons in the vehicle, especially unattended occupants (normally children).
The subject vehicle sunroof can be closed either by continuous actuation of the sunroof switch, or by a momentary touch and release of the same switch which initiates an express-close mode. In the first mode, the sunroof ceases movement upon release of the switch. This allows immediate operator sunroof closure control minimizing the entrapment risk. During the express-close mode, the vehicle incorporates an auto-reverse feature that is designed to reverse sunroof motion before it can exert a force of 100N (22.5lbf.) or more on a foreign object or person. We believe this added feature will further minimize the risk of entrapment to an occupant (normally a child).
Lastly, GM indicates that it is not aware of any injuries, owner complaints
Based on the above, NHTSA has decided that GM has met its burden of persuasion that the sunroof noncompliance described is inconsequential to motor vehicle safety. Accordingly, GM's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the noncompliances under 49 U.S.C. 30118 and 30120.
49 U.S.C. 30118, 30120; delegations of authority at 49 CFR 1.50 and 501.8.
Automobili Lamborghini SpA (Lamborghini), has determined that certain vehicles that it manufactured during the period June 8, 2007 to December 18, 2007, did not fully comply with paragraph S5.5 of 49 CFR 571.205 Federal Motor Vehicle Safety Standards (FMVSS) No. 205
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Lamborghini has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
This notice of receipt of Lamborghini's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
Affected are approximately 152 model year 2008 Lamborghini Gallardo Superleggera coupe passenger cars produced during the period June 8, 2007 to December 18, 2007. Paragraph S5.5 of 49 CFR 571.205 requires in pertinent part that:
S5.5 Item 4A Glazing. Item 4A glazing may be used in all areas in which Item 4 safety glazing may be used, and also for side windows rearward of the “C” pillar. I.e., Item 4A glazing may be used under Item 4A paragraph (b) of ANSI/SAE Z26.1-1996 only in side windows rearward of the “C” pillar.
Lamborghini explained that due to a configuration mistake on the production line an incorrect component made of polycarbonate (item 4A glazing) was used in the rear windows of certain U.S. version coupes (hardtops). Lamborghini further explained that based on the requirements of paragraph S5.5 of FMVSS No. 205 item 4A glazing is permitted in European specification vehicle rear windows and in U.S. convertible rear windows, but not in U.S. coupe (hardtop) rear windows.
Lamborghini stated its belief that the reason why FMVSS No. 205 excludes item 4A from the rear windows of coupe (hardtop) vehicles is twofold:
(1) The breaking of rigid plastic windows in a crash could leave sharp, pointed shards in the window frame which could easily be contacted by an occupant's head. There is also concern about occupant injury resulting from large shards of rigid plastic glazing being propelled inward by vehicle impacts with trees, poles, or other vehicles.
(2) Second, The reduction in visibility through rear windows using plastic glazing due to abrasion and weathering creates significant safety concerns because a driver may have insufficient visibility to avoid a crash in the first place.
Lamborghini also stated that it believes the noncompliance is inconsequential to motor vehicle safety in the case of the Superleggera because neither of the safety concerns discussed above is present because:
(1) The use of polycarbonate glazing creates no greater danger because FMVSS No. 201 conformance testing has shown that a passenger head cannot physically contact the rear window given its small size and location. Also, the rear window is so small and located in a protected position between the “buttresses” of the vehicle's roof such that impacts with trees, poles, or other vehicles, would not create the danger of posed by large shards.
(2) Reduction in visibility due to abrasion and weathering is not an issue with the Superleggera. In this vehicle, the driver's rear visibility is based on the twin rear side mirrors. Even with no abrasion or weathering, the design of the vehicle (and in particular the “buttresses” of the roof) precludes a large degree of rearward visibility. Lamborghini additionally states that it believes that this situation is common for performance sports cars.
Lamborghini further explains that in its opinion NHTSA has previously given other reasons that a noncompliance similar to the instant one are inconsequential to motor vehicle safety including:
(1) Such a noncompliance is “expected to be imperceptible, or nearly so, to vehicle occupants or approaching drivers.”
(2) Under FMVSS No. 205, item 4A glazing is permitted in the rear window of a “convertible”, including hardtop convertibles.
(3) NHTSA previously held that as regards an exotic vehicle, a noncompliance is inconsequential because the vehicle at issue was not an ordinary passenger automobile designed for daily use, not designed to be used as a family's primary passenger vehicle, and more of a collector's piece, produced in very low numbers and driven a low number of miles.
Lamborghini additionally states that no customer complaints related to this noncompliance have been received.
Lamborghini requested that NHTSA consider its petition and grant an exemption from the notification and recall requirements of the National Traffic and Motor Vehicle Safety Act on the basis that the noncompliance described above is inconsequential as it relates to motor vehicle safety.
Lamborghini also states that it has corrected the problem that caused these errors so that they will not be repeated in future production.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited at the beginning of this notice and be submitted by any of the following methods:
a.
b.
c.
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
Documents submitted to a docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated below will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
(49 U.S.C. 30118, 30120: delegations of authority at CFR 1.50 and 501.8)
The Department of the Treasury will submit the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13 on or after the date of publication of this notice. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, and 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Clearance Officer: Glenn P. Kirkland (202) 622-3428, Internal Revenue Service, Room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224.
Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.
Notice and request for comments.
As part of our continuing effort to reduce paperwork and respondent burden, and as required by the Paperwork Reduction Act of 1995, we invite comments on the proposed or continuing information collections listed below in this notice.
We must receive your written comments on or before June 24, 2008.
You may send comments to Mary A. Wood, Alcohol and Tobacco Tax and Trade Bureau, at any of these addresses:
• P.O. Box 14412, Washington, DC 20044-4412;
• 202-927-8525 (facsimile); or
•
Please send separate comments for each specific information collection listed below. You must reference the information collection's title, form, or recordkeeping requirement number, and OMB number (if any) in your comment. If you submit your comment via facsimile, send no more than five 8.5 x 11 inch pages in order to ensure electronic access to our equipment.
To obtain additional information, copies of the information collection and its instructions, or copies of any comments received, contact Mary A. Wood, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412; or telephone 202-927-8210.
The Department of the Treasury and its Alcohol and Tobacco Tax and Trade Bureau, as part of their continuing effort to reduce paperwork and respondent burden, invite the general public and other Federal agencies to comment on the proposed or continuing information collections listed below in this notice, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of the relevant information collection. All comments are part of the public record and subject to disclosure. Please not do include any confidential or inappropriate material in your comments.
We invite comments on: (a) Whether this information collection is necessary for the proper performance of the agency's functions, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the information collection's burden; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the information collection's burden on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide the requested information.
Currently, we are seeking comments on the following records and forms:
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 4684, Casualties and Thefts.
Written comments should be received on or before June 24, 2008 to be assured of consideration.
Direct all written comments to R. Joseph Durbala, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Carolyn N. Brown, (202) 622-6688, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224 or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 1042, Annual Withholding Tax Return for U.S. Source Income of Foreign Persons, Form 1042-S, Foreign Person's U.S. Source Income Subject to Withholding, and Form 1042-T, Annual Summary and Transmittal of Forms 1042-S.
Written comments should be received on or before June 24, 2008 to be assured of consideration.
Direct all written comments to R. Joseph Durbala, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Carolyn N. Brown, at (202) 622-6688, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Office of Thrift Supervision (OTS), Treasury.
Notice and request for comment.
The proposed information collection request (ICR) described below has been submitted to the Office of Management and Budget (OMB) for review and approval, as required by the Paperwork Reduction Act of 1995. OTS is soliciting public comments on the proposal.
Submit written comments on or before May 27, 2008. A copy of this ICR, with applicable supporting documentation, can be obtained from RegInfo.gov at
Send comments, referring to the collection by title of the proposal or by OMB approval number, to OMB and OTS at these addresses: Office of Information and Regulatory Affairs, Attention: Desk Officer for OTS, U.S. Office of Management and Budget, 725 17th Street, NW., Room 10235, Washington, DC 20503, or by fax to (202) 395-6974; and Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552, by fax to (202) 906-6518, or by e-mail to
For further information or to obtain a copy of the submission to OMB, please contact Ira L. Mills at,
OTS may not conduct or sponsor an information collection, and respondents are not required to respond to an information collection, unless the information collection displays a currently valid OMB control number. As part of the
Such applications or notices must be in a form prescribed by OTS. OTS's Applications for Permission to Establish a Branch Office and Change of Location of an Office are designed to provide the minimum amount of information necessary to determine whether the request meets OTS's criteria for approval of these activities.
Pursuant to 12 CFR 516.80, the applicant must publish a notice in a newspaper printed in the English language. If the OTS determines that the primary language of a significant number of adult residents of the community is a language other than English, the OTS may require that the applicant simultaneously publish additional notice(s) in the community in the appropriate language.
Section 228 of the Federal Deposit Insurance Corporation Improvement Act of 1991 requires each insured depository institution to give 90 days prior written notice of any branch closing to its primary federal regulator and to branch customers. The notice to the regulator must include a detailed statement of the reasons for the decision to close the branch and information in support of those reasons.
Office of Thrift Supervision (OTS), Treasury.
Notice and request for comment.
The proposed information collection request (ICR) described below has been submitted to the Office of Management and Budget (OMB) for review and approval, as required by the Paperwork Reduction Act of 1995. OTS is soliciting public comments on the proposal.
Submit written comments on or before May 27, 2008. A copy of this ICR, with applicable supporting documentation, can be obtained from RegInfo.gov at
Send comments, referring to the collection by title of the proposal or by OMB approval number, to OMB and OTS at these addresses: Office of Information and Regulatory Affairs, Attention: Desk Officer for OTS, U.S. Office of Management and Budget, 725 17th Street, NW., Room 10235, Washington, DC 20503, or by fax to (202) 395-6974; and Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552, by fax to (202) 906-6518, or by e-mail to
For further information or to obtain a copy of the submission to OMB, please contact Ira L. Mills at,
OTS may not conduct or sponsor an information collection, and respondents are not required to respond to an information collection, unless the information collection displays a currently valid OMB control number. As part of the approval process, we invite comments on the following information collection.
OTS uses the information in connection with a model to advise savings associations in OTS's supervision of their activities related to interest rate risk.
Office of Thrift Supervision (OTS), Treasury.
Notice and request for comment.
The proposed information collection request (ICR) described below
Submit written comments on or before May 27, 2008. A copy of this ICR, with applicable supporting documentation, can be obtained from RegInfo.gov at
Send comments, referring to the collection by title of the proposal or by OMB approval number, to OMB and OTS at these addresses: Office of Information and Regulatory Affairs, Attention: Desk Officer for OTS, U.S. Office of Management and Budget, 725 17th Street, NW., Room 10235, Washington, DC 20503, or by fax to (202) 395-6974; and Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552, by fax to (202) 906-6518, or by e-mail to
For further information or to obtain a copy of the submission to OMB, please contact Ira L. Mills at,
OTS may not conduct or sponsor an information collection, and respondents are not required to respond to an information collection, unless the information collection displays a currently valid OMB control number. As part of the approval process, we invite comments on the following information collection.
The Department of Veterans Affairs (VA) gives notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Veterans' Advisory Committee on Rehabilitation will be held on May 21-22, 2008, at the Department of Veterans Affairs, 811 Vermont Avenue, Washington, DC. The meeting sessions will be held in the Kenneth Eaton Room 819, from 8 a.m. to 4:30 p.m. on May 21 and 8 a.m. to 1 p.m. on May 22. The meeting is open to the public.
The purpose of the Committee is to provide recommendations to the Secretary of Veterans Affairs on the rehabilitation needs of veterans with disabilities and on the administration of VA's rehabilitation programs.
During the meeting, committee members will be briefed on various VA rehabilitation-related initiatives. The Committee will also be discussing research on rehabilitation needs of veterans with disabilities.
No time will be allocated at this meeting for oral presentations from the public. Any member of the public wishing to attend the meeting is requested to contact Mr. Joseph Tucker, Designated Federal Officer, at (202) 461-9637. The Committee will accept written comments. Comments can be addressed to Mr. Tucker at the Department of Veterans Affairs, Veterans Benefits Administration (28), 810 Vermont Avenue, NW., Washington, DC 20420. In communication with the Committee, writers must identify themselves and state the organizations, associations, or person(s) they represent.
By Direction of the Secretary.
U.S. Election Assistance Commission (EAC).
Notice.
Pursuant to sections 254(a)(11)(A) and 255(b) of the Help America Vote Act (HAVA), Public Law 107-252, the U.S. Election Assistance Commission (EAC) hereby causes to be published in the
This notice is effective upon publication in the
Bryan Whitener, Telephone 202-566-3100 or 1-866-747-1471 (toll-free).
On March 24, 2004, the U.S. Election Assistance Commission published in the
The revised State plans from Florida, New Jersey, Oregon, South Dakota, Nevada, and Alaska address material changes in the respective budgets of the previously submitted State plans. South Dakota and New Jersey submitted certifications under HAVA section 251(b)(2) allowing the State to use requirements payments for activities other than meeting the requirements of Title III. Minnesota and Oregon have provided updates to how the states plan to meet the Title III requirements, including implementation of the HAVA section 301 voting system standards and the HAVA section 303 statewide voter registration list.
In accordance with HAVA section 254(a)(12), all the State plans submitted for publication provide information on how the respective State succeeded in carrying out its previous State plan. The States all confirm that these material changes to their respective State plans were developed and submitted to public comment in accordance with HAVA sections 254(a)(11), 255, and 256.
Upon the expiration of thirty days from April 25, 2008, the States are eligible to implement the material changes addressed in the plans that are published herein, in accordance with HAVA section 254(a)(11)(C).
EAC wishes to acknowledge the effort that went into revising this State plan and encourages further public comment, in writing, to the State election official listed below.
Thank you for your interest in improving the voting process in America.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Kathy Ezzell, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7266, Washington, DC 20410; telephone (202) 708-1234; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to John Hicks, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2009 (for discharges occurring on or after October 1, 2008 and on or before September 30, 2009) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the
We are proposing to revise existing policies regarding the PPS within the authority granted under section 1886(j) of the Act.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 20, 2008.
In commenting, please refer to file code CMS-1554-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201 (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Susanne Seagrave, (410) 786-0044, for information regarding the payment policies. Jeanette Kranacs, (410) 786-9385, for information regarding the wage index.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Because of the many terms to which we refer by acronym in this proposed rule, we are listing the acronyms used and their corresponding terms in alphabetical order below.
Section 4421 of the Balanced Budget Act of 1997 (BBA, Pub. L. 105-33), as amended by section 125 of the Medicare, Medicaid, and SCHIP (State Children's Health Insurance Program) Balanced Budget Refinement Act of 1999 (BBRA, Pub. L. 106-113), and by section 305 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA, Pub. L. 106-554), provides for the implementation of a per discharge prospective payment system (PPS) under section 1886(j) of the Social Security Act (the Act) for inpatient rehabilitation hospitals and inpatient rehabilitation units of a hospital (hereinafter referred to as IRFs).
Payments under the IRF PPS encompass inpatient operating and capital costs of furnishing covered rehabilitation services (that is, routine, ancillary, and capital costs) but not direct graduate medical education costs, costs of approved nursing and allied health education activities, bad debts, and other services or items outside the scope of the IRF PPS. Although a complete discussion of the IRF PPS provisions appears in the original, FY 2002 IRF PPS final rule (66 FR 41316) as revised in the FY 2006 IRF PPS final rule (70 FR 47880), we are providing below a general description of the IRF PPS for fiscal years (FYs) 2002 through 2005.
Under the IRF PPS from FY 2002 through FY 2005, as described in the FY 2002 IRF PPS final rule (66 FR 41316), the Federal prospective payment rates were computed across 100 distinct case-mix groups (CMGs). We constructed 95 CMGs using rehabilitation impairment categories (RICs), functional status (both motor and cognitive), and age (in some cases, cognitive status and age may not be a factor in defining a CMG). In addition, we constructed five special CMGs to account for very short stays and for patients who expire in the IRF.
For each of the CMGs, we developed relative weighting factors to account for a patient's clinical characteristics and expected resource needs. Thus, the weighting factors accounted for the relative difference in resource use across all CMGs. Within each CMG, we created tiers based on the estimated effects that certain comorbidities would have on resource use.
We established the Federal PPS rates using a standardized payment conversion factor (formerly referred to as the budget neutral conversion factor). For a detailed discussion of the budget neutral conversion factor, please refer to our FY 2004 IRF PPS final rule (68 FR 45684 through 45685). In the FY 2006 IRF PPS final rule (70 FR 47880), we discussed in detail the methodology for determining the standard payment conversion factor.
We applied the relative weighting factors to the standard payment conversion factor to compute the unadjusted Federal prospective payment rates under the IRF PPS from FYs 2002 through 2005. We then applied adjustments for geographic variations in wages (wage index), the percentage of low-income patients, and location in a rural area (if applicable) to the IRF's unadjusted Federal prospective payment rates. In addition, we made adjustments to account for short-stay transfer cases, interrupted stays, and high cost outliers.
For cost reporting periods that began on or after January 1, 2002 and before October 1, 2002, we determined the final prospective payment amounts using the transition methodology prescribed in section 1886(j)(1) of the Act. Under this provision, IRFs transitioning into the PPS were paid a blend of the Federal IRF PPS rate and the payment that the IRF would have received had the IRF PPS not been implemented. This provision also allowed IRFs to elect to bypass this blended payment and immediately be paid 100 percent of the Federal IRF PPS rate. The transition methodology expired as of cost reporting periods beginning on or after October 1, 2002 (FY 2003), and payments for all IRFs now consist of 100 percent of the Federal IRF PPS rate.
We established a CMS Web site as a primary information resource for the IRF PPS. The Web site URL is
Section 1886(j) of the Act confers broad statutory authority upon the Secretary to propose refinements to the IRF PPS. In the FY 2006 IRF PPS final rule (70 FR 47880) and in correcting amendments to the FY 2006 IRF PPS final rule (70 FR 57166) that we published on September 30, 2005, we finalized a number of refinements to the IRF PPS case-mix classification system (the CMGs and the corresponding relative weights) and the case-level and facility-level adjustments. Any reference to the FY 2006 IRF PPS final rule in this proposed rule also includes the provisions effective in the correcting amendments. For a detailed discussion of the final key policy changes for FY 2006, please refer to the FY 2006 IRF PPS final rule (70 FR 47880 and 70 FR 57166).
In the FY 2007 IRF PPS final rule (71 FR 48354), we further refined the IRF PPS case-mix classification system (the CMG relative weights) and the case-level adjustments, to ensure that IRF PPS payments continue to reflect as accurately as possible the costs of care. For a detailed discussion of the FY 2007 policy revisions, please refer to the FY 2007 IRF PPS final rule (71 FR 48354).
In the FY 2008 IRF PPS final rule (72 FR 44284), we updated the Federal prospective payment rates and the outlier threshold, revised the IRF wage index policy, and clarified how we determine high-cost outlier payments for transfer cases. For more information on the policy changes implemented for FY 2008, please refer to the FY 2008 IRF PPS final rule (72 FR 44284), in which we published the final FY 2008 IRF Federal prospective payment rates.
After publication of the FY 2008 IRF PPS final rule (72 FR 44284), section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007, Public Law 110-173, amended section 1886(j)(3)(C) of the Act to apply a zero percent increase factor for FYs 2008 and 2009, effective for IRF discharges occurring on or after April 1, 2008. Section 1886(j)(3)(C) of the Act requires the Secretary to develop an increase factor to update the IRF Federal prospective payment rates for each FY. Based on the legislative change to the increase factor, we revised the FY 2008 Federal prospective payment rates for IRF discharges occurring on or after April 1, 2008. Thus, the final FY 2008 IRF Federal prospective payment rates that were published in the FY 2008 IRF PPS final rule (72 FR 44284) were effective for discharges occurring on or after October 1, 2007 and on or before March 31, 2008; and the revised FY 2008 IRF Federal prospective payment rates will be effective for discharges occurring on or after April 1, 2008 and on or before September 30, 2008. The revised FY 2008 Federal prospective payment rates are available on the CMS Web site at
As described in the FY 2002 IRF PPS final rule, upon the admission and discharge of a Medicare Part A fee-for-service patient, the IRF is required to complete the appropriate sections of a patient assessment instrument, the Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI). All required data must be electronically encoded into the IRF-PAI software product. Generally, the software product includes patient grouping programming called the GROUPER software. The GROUPER software uses specific IRF-PAI data elements to classify (or group) patients into distinct CMGs and account for the existence of any relevant comorbidities.
The GROUPER software produces a five-digit CMG number. The first digit is an alpha-character that indicates the comorbidity tier. The last four digits represent the distinct CMG number. Free downloads of the Inpatient Rehabilitation Validation and Entry (IRVEN) software product, including the GROUPER software, are available on the CMS Web site at
Once a patient is discharged, the IRF submits a Medicare claim (a Health Insurance Portability and Accountability Act (HIPAA, Pub. L. 104-191) compliant electronic claim or, if the Administrative Compliance Act (ASCA, Pub. L. 107-105,) permits a paper claim, a UB-04 or a CMS-1450, as appropriate) using the five-digit CMG number and sends it to the appropriate Medicare fiscal intermediary (FI) or Medicare Administrative Contractor (MAC). Claims submitted to Medicare must comply with both ASCA and HIPAA. Section 3 of the ASCA amends section 1862(a) of the Act by adding paragraph (22) which requires the Medicare program, subject to section 1862(h) of the Act, to deny payment under Part A or Part B for any expenses for items or services “for which a claim is submitted other than in an electronic form specified by the Secretary.” Section 1862(h) of the Act, in turn, provides that the Secretary shall waive such denial in situations in which there is no method available for the submission of claims in an electronic form or the entity submitting the claim is a small provider.
In addition, the Secretary also has the authority to waive such denial “in such unusual cases as the Secretary finds appropriate.” See also the final rule, “Medicare Program; Electronic Submission of Medicare Claims” (70 FR 71008, November 25, 2005). Section 3 of the ASCA operates in the context of the administrative simplification provisions of HIPAA, which include, among others, the requirements for transaction standards and code sets codified in 45 CFR, parts 160 and 162, subparts A and I through R (generally known as the Transactions Rule). The Transactions Rule requires covered entities, including covered healthcare providers, to conduct covered electronic transactions according to the applicable transaction standards. (See the program claim memoranda issued and published by CMS at:
The Medicare FI or MAC processes the claim through its software system. This software system includes pricing programming called the “PRICER” software. The PRICER software uses the CMG number, along with other specific claim data elements and provider-specific data, to adjust the IRF's prospective payment for interrupted stays, transfers, short stays, and deaths, and then applies the applicable adjustments to account for the IRF's wage index, percentage of low-income patients, rural location, and outlier payments. For discharges occurring on or after October 1, 2005, the IRF PPS payment also reflects the new teaching status adjustment that became effective as of FY 2006, as discussed in the FY 2006 IRF PPS final rule (70 FR 47880).
In this proposed rule, we are proposing to make the following updates to the IRF PPS:
• Update the FY 2009 IRF PPS relative weights and average length of stay values using the most current and complete Medicare claims and cost report data, as discussed in section II.
• Update the FY 2009 IRF PPS payment rates by the proposed wage index and labor related share in a budget neutral manner, as discussed in sections III.A and B.
• Update the outlier threshold amount for FY 2009, as discussed in section IV.A.
• Update the cost-to-charge ratio ceiling and the national average urban and rural cost-to-charge ratios for purposes of determining outlier payments under the IRF PPS, as discussed in section IV.B.
As specified in 42 CFR 412.620(b)(1), we calculate a relative weight for each CMG that is proportional to the resources needed by an average inpatient rehabilitation case in that CMG. For example, cases in a CMG with a relative weight of 2, on average, will cost twice as much as cases in a CMG with a relative weight of 1. Relative weights account for the variance in cost per discharge due to the variance in resource utilization among the payment groups, and their use helps to ensure that IRF PPS payments support beneficiary access to care as well as provider efficiency.
In this proposed rule, we propose to update the CMG relative weights and average length of stay values using the most recent available data (FY 2006). We propose to do this using the same methodology, with one change, that was described in the original, FY 2002 IRF PPS final rule (66 FR 41316) and the FY 2006 IRF PPS final rule (70 FR 47880, 47887 through 47888). The proposed change to the methodology involves using new, more detailed cost-to-charge ratio (CCR) data from the cost reports of IRF subprovider units of primary acute care hospitals, instead of CCR data from the associated primary acute care
In calculating the CMG relative weights, we use a hospital-specific relative value method to estimate operating (routine and ancillary services) and capital costs of IRFs. To estimate these costs for FY 2009, we propose to use the CCRs from the IRF subprovider units of primary acute care hospitals, except for the freestanding IRFs (for which we will continue to use the data from the cost report of the primary hospital, as discussed above). For FY 2009, we propose to use the same methodology we used to compute the CMG relative weights for FYs 2002 through 2008, with the one change described above, to update the CMG relative weights to reflect the most recent available data (FY 2006). The process used to calculate the CMG relative weights for this proposed rule follows below:
Consistent with the way we implemented changes to the IRF classification system in the FY 2006 IRF PPS final rule (70 FR 47880 and 70 FR 57166) and the FY 2007 IRF PPS final rule (71 FR 48354), we are proposing to make the revisions to the CMG relative weights for FY 2009 in such a way that total estimated aggregate payments to IRFs for FY 2009 are the same with or without the proposed changes (that is, in a budget neutral manner) by applying a budget neutrality factor to the standard payment amount. To calculate the appropriate proposed budget neutrality factor to apply to the standard payment amount, we propose to use the following steps:
In section III.C of this proposed rule, we discuss the proposed methodology for calculating the standard payment conversion factor for FY 2009.
Table 1 below, “Proposed Relative Weights and Average Lengths of Stay for Case-Mix Groups,” presents the CMGs, the comorbidity tiers, the proposed corresponding relative weights, and the proposed average length of stay values for each CMG and tier for FY 2009. The average length of stay for each CMG is used to determine when an IRF discharge meets the definition of a short-stay transfer, which results in a per diem case level adjustment. The proposed relative weights and average length of stay values shown in Table 1 are subject to change for the final rule based on analysis of updated data.
Generally, updates to the CMG relative weights result in some increases and some decreases to the CMG relative weight values. Table 2 shows, overall, how the proposed revisions in this proposed rule would affect particular CMG relative weight values, which affect the overall distribution of payments within CMGs and tiers. Note that, because we propose to implement the CMG relative weight revisions in a budget neutral manner, total estimated aggregate payments to IRFs for FY 2009 would not be affected. However, the proposed revisions would affect the distribution of payments within CMGs and tiers.
As Table 2 shows, over 96 percent of all IRF cases are in CMGs and tiers that would experience less than a 5 percent change (either increase or decrease) in the CMG relative weight value as a result of the proposed revisions. The most significant increase in the proposed CMG relative weight values, in terms of the largest number of cases affected, would be a 3.3 percent increase in the CMG relative weight value for CMG A0802—Replacement of lower extremity joint, motor score greater than 37.05 and motor score less than 49.55—in the “no-comorbidity” tier. In the FY 2006 data, 25,822 IRF discharges were classified into this CMG and tier. We believe that the higher costs reported in this CMG and tier in FY 2006, compared with those reported for this CMG and tier in FY 2003, may reflect recent IRF case mix changes caused, at least in part, by the phase-in of the “75 percent” rule and increased medical review of IRF discharges. These changes to the system have likely increased the complexity of patients being admitted to IRFs, especially among the lower-extremity joint replacement cases with no comorbidities, which do not meet the 75 percent rule criteria and have been the focus of a lot of the medical review activities.
These same trends explain the most significant decrease in the proposed CMG relative weight values, in terms of the largest number of cases affected. The proposed revisions would reduce the CMG relative weight value for CMG 5001—Short-stay cases, length of stay is 3 days or fewer—by 31.7 percent. This decrease is associated with a substantial decrease in the number of cases classified into this extremely short-stay CMG, from 10,222 IRF discharges in FY 2003 to 2,376 IRF discharges in FY 2006. We believe that increases in the complexity of IRF patients resulting from the “75 percent” rule and the IRF medical review activities may mean that fewer IRF patients can effectively be treated in IRFs for 3 days or fewer.
The changes in the proposed average length of stay values in this proposed rule, compared with the current (FY 2008) average length of stay values, are small and primarily distributional. Some values increase and some decrease, compared with the FY 2008 values. The only notable changes are in 3 of the CMGs for traumatic spinal cord injuries, B0403, B0404, and B0405 (all in tier 1), for which the proposed average length of stay values increased by 8.55 days, 14.92 days, and 9.72 days, respectively. This may, again, be due to increases in the complexity of IRF patients resulting from the “75 percent” rule and the IRF medical review activities. The overall average length of stay in IRFs also increased from 12.8 days in FY 2003 to 13.9 days in FY 2006, which may be attributable to increases in IRFs' case mix over this period.
Given the recent changes in IRFs' case mix, we believe that it is especially important to update the CMG relative weights and average length of stay values at this time to reflect these changes.
Section 1886(j)(3)(C) of the Act requires the Secretary to establish an increase factor that reflects changes over time in the prices of an appropriate mix
We continue to use the methodology described in the FY 2006 IRF PPS final rule to update the labor-related share for FY 2009. In FY 2004, we updated the 1992 market basket data to 1997 based on the methodology described in the FY 2004 IRF PPS final rule (68 FR 45688 through 45689). As discussed in the FY 2006 IRF PPS final rule (70 FR 47915 through 47917), we rebased and revised the market basket for FY 2006 using the 2002-based cost structures for IRFs, inpatient psychiatric facilities (IPFs), and long-term care hospitals (LTCHs) to determine the FY 2006 labor-related share. For FYs 2007 and 2008, we used the same methodology discussed in the FY 2006 IRF PPS final rule (70 FR at 47908 through 47917) to determine the IRF labor-related share. For FY 2009, we continue to use the same methodology discussed in the FY 2006 IRF PPS final rule. The labor-related share for FY 2009 is the sum of the FY 2009 relative importance of each labor-related cost category, and reflects the different rates of price change for these cost categories between the base year (FY 2002) and FY 2009. For this proposed rule, the labor-related share reflects Global Insight's first quarter 2008 forecast. As shown in Table 3, the total FY 2009 Rehabilitation, Psychiatric, and Long-Term Care Hospital Market Basket (RPL) labor-related share in this proposed rule is 75.691 percent. We propose to update the labor-related share with the most recent available data for the final rule.
Section 1886(j)(6) of the Act requires the Secretary to adjust the proportion (as estimated by the Secretary from time to time) of rehabilitation facilities' costs attributable to wages and wage-related costs by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the rehabilitation facility compared to the national average wage level for those facilities. The Secretary is required to update the IRF PPS wage index on the basis of information available to the Secretary on the wages and wage-related costs to furnish rehabilitation services. Any adjustments or updates made under section 1886(j)(6) of the Act for a FY are made in a budget neutral manner.
In the FY 2008 IRF PPS final rule (72 FR 44299), we maintained the methodology described in the FY 2006 IRF PPS final rule to determine the wage index, labor market area definitions, and hold harmless policy consistent with the rationale outlined in the FY 2006 IRF PPS final rule (70 FR 47917 through 47933).
For FY 2009, we propose to maintain the policies and methodologies described in the FY 2008 IRF PPS final rule relating to the labor market area definitions and the wage index methodology for areas with wage data. Therefore, this proposed rule continues to use the Core-Based Statistical Area (CBSA) labor market area definitions and the pre-reclassification and pre-floor hospital wage index data based on 2004 cost report data.
When adopting new labor market designations made by the Office of Management and Budget (OMB), we identified some geographic areas where there were no hospitals and, thus, no hospital wage index data on which to base the calculation of the IRF PPS wage index. We continue to use the same methodology discussed in the FY 2008 IRF PPS final rule (72 FR 44299) to address those geographic areas where there are no hospitals and, thus, no hospital wage index data on which to base the calculation of the FY 2009 IRF PPS wage index.
Additionally, this proposed rule incorporates the CBSA changes published in the most recent OMB bulletin that applies to the hospital wage data used to determine the current IRF PPS wage index. The changes were nomenclature and did not represent substantive changes to the CBSA-based designations. Specifically, OMB added or deleted certain CBSA numbers and revised certain titles. The OMB bulletins are available online at
Finally, as discussed in the FY 2008 IRF PPS final rule (72 FR 44298), FY 2008 was the third and final year of the 3-year phase-out of the budget neutral hold harmless policy. For FY 2008 and beyond, we no longer apply an adjustment for IRFs that meet the criteria described in the FY 2006 final rule (70 FR 47923 through 47926).
We are taking this opportunity to address the change in the treatment of “New England deemed counties” (that is, those counties in New England listed in § 412.64(b)(1)(ii)(B) that were deemed
In the FY 2008 IPPS final rule with comment period, (72 FR 47337 through 47338), § 412.64(b)(1)(ii)(B) was revised that the two “New England deemed counties” that are still considered rural under the OMB definitions (Litchfield County, CT and Merrimack County, NH), are no longer considered urban, effective for discharges occurring on or after October 1, 2007, and, therefore, are considered rural in accordance with § 412.64(b)(1)(ii)(C). However, for purposes of payment under the IPPS, acute care hospitals located within those areas are treated as being reclassified to their deemed urban area effective for discharges occurring on or after October 1, 2007 (see 72 FR 47337 through 47338). We note that the IRF PPS does not provide for geographic reclassification. Also, in the FY 2008 IPPS final rule with comment period (72 FR 47338), we explained that we limited this policy change for the “New England deemed counties” only to IPPS hospitals, and any change to non-IPPS provider wage indexes would be addressed in the respective payment system rules.
Accordingly, as stated above, we are taking this opportunity to clarify the treatment of “New England deemed counties” under the IRF PPS in this proposed rule.
As discussed above, the IRF PPS has consistently used the IPPS definition of “urban” and “rural” with regard to the wage index used in the IRF PPS. Under existing § 412.602, an IRF's wage index is determined based on the location of the IRF in an urban or rural area as defined in §§ 412.64(b)(1)(ii)(A) through (C).
Historical changes to the labor market area/geographic classifications and annual updates to the wage index values under the IRF PPS are made effective October 1 each year. When we established the most recent IRF PPS payment rate update, effective for discharges occurring on or after October 1, 2007 through September 30, 2008, we considered the “New England deemed counties” (including Litchfield County, CT and Merrimack County, NH) as urban for FY 2008, as evidenced by the inclusion of Litchfield County, CT as one of the constituent counties of urban CBSA 25540 (Hartford-West Hartford-East Hartford, CT), and the inclusion of Merrimack County, NH as one of the constituent counties of urban CBSA 31700 (Manchester-Nashua, NH).
As noted above, § 412.602 indicates that the terms “rural” and “urban” are defined according to the definitions of those terms in §§ 412.64(b)(1)(ii)(A) through (C). Applying the IPPS definitions, Litchfield County, CT and Merrimack County, NH are not considered “urban” under §§ 412.64(b)(1)(ii)(A) and (B) as revised under the FY 2008 IPPS final rule and, therefore, are considered “rural” under § 412.64(b)(1)(ii)(C). Accordingly, reflecting our policy to use the IPPS definitions of “urban” and “rural”, these two counties would be considered “rural” under the IRF PPS effective with the next update of the IRF PPS payment rates, October 1, 2008, and would no longer be included in urban CBSA 25540 (Hartford-West Hartford-East Hartford, CT) and urban CBSA 31700 (Manchester-Nashua, NH), respectively. We note that this policy is consistent with our policy of not taking into account IPPS geographic reclassifications in determining payments under the IRF PPS. We do not need to make any changes to our regulations to effectuate this change.
There is one IRF (in Merrimack County, NH) that greatly benefits from treating these counties as rural. This IRF would begin to receive a higher wage index value and the 21.3 percent adjustment that is applied to IRF PPS payments for rural facilities. Currently, there are no IRFs in the following areas: Litchfield County, CT; rural Connecticut; or rural New Hampshire.
In the FY 2008 IRF PPS final rule (72 FR 44284, August 7, 2007), we established IRF PPS wage index values for FY 2008 calculated from the same data (collected from cost reports submitted by hospitals for cost reporting periods beginning during FY 2003) used to compute the FY 2007 acute care hospital inpatient wage index, without taking into account geographic reclassification under sections 1886(d)(8) and (d)(10) of the Act. The IRF PPS wage index values applicable for discharges occurring on or after October 1, 2007 through September 30, 2008 are shown in Table 1 (for urban areas) and Table 2 (for rural areas) in the addendum to the FY 2008 IRF PPS final rule (72 FR 44312 through 44335).
We are continuing to use IPPS wage data for the FY 2009 IRF PPS Wage Index, because we believe that using the hospital inpatient wage data is appropriate and reasonable for the IRF PPS. We note that the IPPS wage data used to determine the FY 2009 IRF wage index values reflect our policy that was adopted under the IPPS beginning in FY 2008, which apportions the wage data for multi-campus hospitals located in different labor market areas (CBSAs) to each CBSA where the campuses are located (see the FY 2008 IPPS final rule with comment period (72 FR 47317 through 47320)). We computed the FY 2009 IRF PPS wage index values presented in this notice consistent with our pre-reclassified IPPS wage index policy (that is, our historical policy of not taking into account IPPS geographic reclassifications in determining payments under the IRF PPS).
For the FY 2009 IRF PPS, we computed the wage index from IPPS wage data (submitted by hospitals for cost reporting periods beginning in FY 2004 and used in the FY 2008 IPPS wage index), which allocated salaries and hours to the campuses of two multi-campus hospitals with campuses that are located in different labor areas, one in Massachusetts and another in Illinois. Thus, the proposed FY 2009 IRF PPS wage index values for the following CBSAs are affected by this policy: Boston-Quincy, MA (CBSA 14484), Providence-New Bedford-Falls River, RI-MA (CBSA 39300), Chicago-Naperville-Joliet, IL (CBSA 16974) and Lake County-Kenosha County, IL-WI (CBSA 29404) (please refer to Table 1 in the addendum of this proposed rule).
To calculate the wage-adjusted facility payment for the payment rates set forth in this proposed rule, we multiply the unadjusted Federal prospective payment by the proposed FY 2009 RPL labor-related share (75.691 percent) to determine the labor-related portion of
Adjustments or updates to the IRF wage index made under section 1886(j)(6) of the Act must be made in a budget neutral manner; therefore, we calculated a budget neutral wage adjustment factor as established in the FY 2004 IRF PPS final rule and codified at § 412.624(e)(1), and described in the steps below. We propose to use the following steps to ensure that the FY 2009 IRF standard payment conversion factor reflects the update to the proposed wage indexes (based on the FY 2004 pre-reclassified and pre-floor hospital wage data) and the proposed labor-related share in a budget neutral manner:
To calculate the proposed standard payment conversion factor for FY 2009, as illustrated in Table 5 below, we begin with the standard payment conversion factor for FY 2008. To explain how we determined the standard payment conversion factor for FY 2008, we include Table 4 below. The final FY 2008 IRF standard payment conversion factor that we show in Tables 4 and 5 below is different than the IRF standard payment conversion factor that we finalized in the FY 2008 IRF PPS final rule (72 FR 44284) because we adjusted the IRF standard payment conversion factor for IRF discharges occurring on or after April 1, 2008 to reflect the changes codified in section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173). Section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 amended section 1886(j)(3)(C) of the Act to require the Secretary to apply a zero percent increase factor for FYs 2008 and 2009, effective for discharges occurring on or after April 1, 2008. Section 1886(j)(3)(C) of the Act requires the Secretary to develop an increase factor to update the IRF Federal prospective payment rates for each FY. For a discussion of the increase factor the Secretary typically uses to update the IRF Federal prospective payment rates, see the FY 2008 IRF PPS final rule (72 FR 44284). In the FY 2008 IRF PPS final rule, we used the RPL market basket estimate described in that final rule (3.2 percent) to update the IRF standard payment conversion factor. As shown in Table 3 of the FY 2008 IRF PPS final rule, applying this market basket estimate to the standard payment amount resulted in a final standard payment conversion factor for FY 2008 of $13,451.
However, section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 had the effect of changing the increase factor for FY 2008 from 3.2 percent to zero percent for discharges occurring on or after April 1, 2008. This, in turn, had the effect of decreasing the IRF standard payment conversion factor for discharges occurring on or after April 1, 2008.
As shown in Table 4, to develop the FY 2008 standard payment conversion factor for discharges beginning on or after April 1, 2008, we started with the FY 2007 standard payment conversion factor that was finalized in the FY 2007 IRF PPS final rule (71 FR 48354). We then multiplied this by the zero percent increase factor, as described above. Then, we applied the same FY 2008 budget neutrality factor (1.0041) for the Wage Index, Labor-Related Share, and the Hold Harmless Provision that was published in the FY 2008 IRF PPS Final Rule (72 FR 44284). This resulted in the final FY 2008 standard payment conversion factor, effective for discharges occurring on or after April 1, 2008, of $13,034.
As a result, the IRF standard payment conversion factor changed from $13,451 for discharges occurring on or after October 1, 2007 to $13,034 for discharges occurring on or after April 1, 2008.
Further, as required by section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007, we apply an increase factor of zero percent to the standard payment conversion factor for FY 2009, meaning that it does not change from the current value of $13,034. Next, we apply the proposed combined budget neutrality factor for the FY 2009 wage index and labor related share of 1.0004, which would result in a standard payment amount of $13,039. Finally, we apply the proposed budget neutrality factor for the revised CMG relative weights of 0.9969, which would result in the proposed FY 2009 standard payment conversion factor of $12,999.
After the application of the CMG relative weights described in section II of this proposed rule, the resulting proposed unadjusted IRF prospective payment rates for FY 2009 are shown below in Table 6, “Proposed FY 2009 Payment Rates.”
Table 7 illustrates the proposed methodology for adjusting the Federal prospective payments (as described in sections III.A through III.C of this proposed rule). The examples below are based on two hypothetical Medicare beneficiaries, both classified into CMG 0110 (without comorbidities). The unadjusted Federal prospective payment rate for CMG 0110 (without comorbidities) appears in Table 6 above.
One beneficiary is in Facility A, an IRF located in rural Spencer County, Indiana, and another beneficiary is in Facility B, an IRF located in urban Harrison County, Indiana. Facility A, a non-teaching hospital, has a disproportionate share hospital (DSH) percentage of 5 percent (which results in a low-income percentage (LIP) adjustment of 1.0309), a wage index of 0.8576, and an applicable rural adjustment of 21.3 percent. Facility B, a teaching hospital, has a DSH percentage of 15 percent (which results in a LIP adjustment of 1.0910), a wage index of 0.9065, and an applicable teaching status adjustment of 0.109.
To calculate each IRF's labor and non-labor portion of the Federal prospective payment, we begin by taking the unadjusted Federal prospective payment rate for CMG 0110 (without comorbidities) from Table 6 above. Then, we multiply the estimated labor-related share (75.691) described in section III.A by the unadjusted Federal prospective payment rate. To determine the non-labor portion of the Federal prospective payment rate, we subtract the labor portion of the Federal payment from the unadjusted Federal prospective payment.
To compute the wage-adjusted Federal prospective payment, we multiply the result of the labor portion of the Federal payment by the appropriate wage index found in the addendum in Tables 1 and 2, which would result in the wage-adjusted amount. Next, we compute the wage-adjusted Federal payment by adding the wage-adjusted amount to the non-labor portion.
Adjusting the Federal prospective payment by the facility-level adjustments involves several steps. First, we take the wage-adjusted Federal prospective payment and multiply it by the appropriate rural and LIP adjustments (if applicable). Second, to determine the appropriate amount of additional payment for the teaching status adjustment (if applicable), we multiply the teaching status adjustment (0.109, in this example) by the wage-adjusted and rural-adjusted amount (if applicable). Finally, we add the additional teaching status payments (if applicable) to the wage, rural, and LIP-adjusted Federal prospective payment rates. Table 7 illustrates the components of the proposed adjusted payment calculation.
Thus, the proposed adjusted payment for Facility A would be $31,454.07 and the proposed adjusted payment for Facility B would be $31,436.44.
Section 1886(j)(4) of the Act provides the Secretary with the authority to make payments in addition to the basic IRF prospective payments for cases incurring extraordinarily high costs. A case qualifies for an outlier payment if the estimated cost of the case exceeds the adjusted outlier threshold. We calculate the adjusted outlier threshold by adding the IRF PPS payment for the case (that is, the CMG payment adjusted by all of the relevant facility-level adjustments) and the adjusted threshold amount (also adjusted by all of the relevant facility-level adjustments). Then, we calculate the estimated cost of a case by multiplying the IRF's overall CCR by the Medicare allowable covered charge. If the estimated cost of the case is higher than the adjusted outlier threshold, we make an outlier payment for the case equal to 80 percent of the difference between the estimated cost of the case and the outlier threshold.
In the FY 2002 IRF PPS final rule (66 FR 41316, 41362 through 41363), we discussed our rationale for setting the outlier threshold amount for the IRF PPS so that estimated outlier payments would equal 3 percent of total estimated payments. Subsequently, we updated the IRF outlier threshold amount in the FYs 2006, 2007, and 2008 IRF PPS final rules (70 FR 47880, 70 FR 57166, 71 FR 48354, and 72 FR 44284) to maintain estimated outlier payments at 3 percent of total estimated payments, and we also stated that we would continue to analyze the estimated outlier payments for subsequent years and adjust the outlier threshold amount as appropriate to maintain the 3 percent target.
For this proposed rule, we performed an updated analysis of FY 2006 claims and IRF-PAI data using the same methodology that we used to set the initial outlier threshold amount when we first implemented the IRF PPS in the FY 2002 IRF PPS final rule (66 FR 41316), which is also the same methodology we used to update the outlier threshold amounts for FYs 2006, 2007, and 2008. (Note that the methodology that we use to calculate the appropriate outlier threshold amount for each FY requires us to simulate Medicare payments for that FY, which requires the use of IRF-PAI data. The CMGs and tiers in effect for FY 2009 would be slightly different than those that were in effect for FY 2006, due to revisions that were implemented in the FY 2007 IRF PPS final rule (71 FR 48354). Thus, we use the IRF-PAI data rather than the IRF claims data to classify the FY 2006 patients into the appropriate CMGs and tiers for FY 2009 to simulate payments and thereby calculate the appropriate outlier threshold amount.) We did not update the outlier threshold amounts for FYs 2003, 2004, and 2005 because data from the FYs immediately after we implemented the IRF PPS were not yet available to perform the analysis of the outlier threshold amount for these FYs.
For FY 2009, based on an analysis of updated FY 2006 claims and IRF-PAI data, we estimate that IRF outlier payments as a percentage of total estimated payments would be 3.7 percent without the proposed change to the outlier threshold amount. The reason for this change is discussed below.
In the FY 2008 IRF PPS final rule (72 FR 44284), we established an outlier threshold amount for FY 2008 that would maintain estimated IRF outlier payments equal to 3 percent of total estimated IRF payments. However, the estimate of the outlier threshold amount for a given FY is dependent upon the estimated total IRF PPS payments for that FY. If estimated total IRF PPS payments for a FY decrease, then the outlier threshold amount must increase to maintain estimated outlier payments at 3 percent of total estimated payments.
Further, we use the IRF market basket estimate to project IRF cost increases for each FY. If we project IRF cost increases for a given FY that are larger than the projected increase in IRF PPS payments in that FY, then the outlier threshold amount must increase for that FY to maintain estimated outlier payments at 3 percent of total estimated payments.
As discussed previously in this proposed rule, section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173), which amended section 1886(j)(3)(C) of the Social Security Act, required the Secretary to apply a zero percent increase factor for FYs 2008 and 2009, effective for discharges occurring on or after April 1, 2008. The effect of this change was to decrease projected IRF PPS payments after we implemented what would have been the appropriate outlier threshold amount for FY 2008 if the increase factor had not been adjusted mid-year. We estimate that total IRF PPS payments for FY 2008 decreased from approximately $6.5 billion to approximately $6.4 billion as a result of the changes codified in section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173). This reduction in estimated total payments for FY 2008, and lack of
In addition, we estimate that IRF costs would increase by 3.0 percent (the FY 2009 IRF market basket estimate) between FY 2008 and FY 2009. The combined effect of the estimated decrease in IRF PPS payments for FY 2008, the lack of increase to IRF PPS payments for FY 2009 that is an effect of the legislative adjustment to the increase factor for FY 2009 (described above), and the projected 3.0 percent increase in IRF costs for FY 2009 is to increase estimated IRF outlier payments to 3.7 percent of total estimated payments for FY 2009. This increase in estimated IRF outlier payments as a percentage of total estimated payments for FY 2009 results in a larger than anticipated increase in the outlier threshold amount for FY 2009 to maintain estimated outlier payments at 3 percent of total estimated payments.
Based on the updated analysis of FY 2006 claims and IRF-PAI data and the revised estimates of total IRF PPS payments for FYs 2008 and 2009 (as discussed above), we propose to update the outlier threshold amount to $9,191 to maintain estimated outlier payments at 3 percent of total estimated aggregate IRF payments for FY 2009.
The outlier threshold amount for FY 2009 is subject to change in the final rule based on analysis of updated data.
In accordance with the methodology stated in the FY 2004 IRF PPS final rule (68 FR 45692 through 45694), we apply a ceiling to IRFs' CCRs. Using the methodology described in that final rule, we propose to update the national urban and rural CCRs for IRFs. We apply the national urban and rural CCRs in the following situations:
• New IRFs that have not yet submitted their first Medicare cost report.
• IRFs whose overall CCR is in excess of the proposed national CCR ceiling for FY 2009, as discussed below.
• Other IRFs accurate data which to calculate an overall CCR are not available.
Specifically, for FY 2009, we estimate a proposed national average CCR of 0.616 for rural IRFs, which we calculate by taking an average of the CCRs for all rural IRFs for which we have sufficient cost report data. Similarly, we estimate a proposed national CCR of 0.486 for urban IRFs, which we calculate by taking an average of the CCRs for all urban IRFs for which we have sufficient cost report data. We weight both of these averages by the IRFs' estimated costs, meaning that the CCRs of IRFs with higher costs factor more heavily into the averages than the CCRs of IRFs with lower costs. For new IRFs, we use these national CCRs until the facility's actual CCR can be computed using the first settled cost report (either tentative or final, whichever is earlier).
In addition, we propose to set the national CCR ceiling at 1.58 for FY 2009. This means that, if an individual IRF's CCR exceeds this ceiling of 1.58 for FY 2009, we would replace the IRF's CCR with the appropriate national average CCR (either rural or urban, depending on the geographic location of the IRF). We estimate the national CCR ceiling by:
Step 3. Multiplying the standard deviation of the national average CCR computed in step 2 by a factor of 3; and
We note that the proposed national average rural and urban CCRs and our estimate of the national CCR ceiling in this section are subject to change in the final rule based on analysis of updated data.
Section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) amended section 5005 of the Deficit Reduction Act of 2005 (DRA, Pub. L. 109-171) to revise the following elements of the 75 percent rule that are used to classify IRFs:
• The compliance rate that IRFs must meet to be excluded from the IPPS and to be paid under the IRF PPS shall be no greater than the 60 percent compliance rate that became effective for cost reporting periods beginning on or after July 1, 2006.
• Patient comorbidities that satisfy the criteria specified in 42 CFR 412.23(b)(2)(i) shall be included in the calculations used to determine whether an IRF meets the 60 percent compliance percentage for cost reporting periods beginning on or after July 1, 2007.
Although section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) grants the Secretary broad discretion to implement compliance criteria up to 60 percent, we are setting the compliance rate at 60 percent, the highest level possible within current statutory authority, for the reasons discussed below. In addition, we will monitor the impact of the new compliance criteria to ensure that IRFs predominantly treat patients who benefit most from this level of care.
We believe that a 60 percent compliance rate implements the provisions of the statute with minimal disruption to IRF operations. The 60 percent compliance rate has been in effect for cost reporting periods beginning on or after July 1, 2005, and the overwhelming majority of IRFs have already adjusted operations to meet or exceed the 60 percent compliance rate. Fewer than 20 IRFs out of approximately 1,250 IRFs nationwide have been declassified since the May 7, 2004 final rule (69 FR 25752) became effective. Thus, a conservative estimate is that over 98 percent of IRFs have been able to meet or exceed the 60 percent compliance rate.
Maintaining the 60 percent compliance rate also allows us to more effectively analyze changes in IRF operations and admissions patterns that would be needed to comply with the current statutory requirement to analyze IRF utilization and issue a report to Congress.
Finally, we believe that setting the compliance rate at 60 percent, the highest level possible within current statutory authority, will help to ensure that IRFs predominantly treat patients who benefit most from this level of care. Prior to the implementation of section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173), the Medicare regulations in 42 CFR § 412.23(b)(2) specified that a 75 percent compliance rate would become effective, and that comorbidities would no longer be used to determine whether an IRF met the 75 percent rule requirements, for cost reporting periods beginning on or after July 1, 2008.
We note that the FY 2009 President's budget proposes a repeal of the provisions in section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) that require that the compliance rate be
For these reasons, we propose the following revisions to the regulation text in § 412.23(b). Specifically, we propose to remove the following phrases from the first sentence of § 412.23(b)(2)(i):
• “and before July 1, 2007;” and
• “and for cost reporting periods beginning on or after July 1, 2007 and before July 1, 2008, the hospital has served an inpatient population of whom at least 65 percent,”
We also propose to remove § 412.23(b)(2)(ii) in its entirety, redesignate the existing § 412.23(b)(2)(iii) to § 412.23(b)(2)(ii), and revise all references to the previously numbered § 412.23(b)(2)(iii) accordingly.
As noted above, we will continue to monitor trends in IRF utilization and spending to ensure that IRFs are treating the types of patients who benefit most from the intensive rehabilitation therapies provided in IRFs. In this regard, we will also continue to work with the Medicare contractors to review the medical necessity of IRF claims. With the IRF compliance rate set below 75 percent, it is particularly important for the Medicare contractors to review the medical necessity of IRF stays, regardless of whether the primary reason for admission is 1 or more of the 13 conditions listed in § 412.23(b)(2)(iii) (which is being redesignated as § 412.23(b)(2)(ii) in this proposed rule). We also believe that it is important for us to work with stakeholders to review the IRF medical necessity criteria to ensure that they reflect the current practice of medicine, and that they are consistently interpreted and applied by the stakeholders.
Under current law, Medicare covers post-acute care (PAC) services in various care settings, including skilled nursing facilities (SNFs), home health agencies (HHAs), long-term care hospitals (LTCHs), and IRFs. Each of the PAC sites has a separate payment system that relies on different patient assessment instruments, although there is no mandated assessment instrument for LTCHs. The current model is based on provider-oriented “silos” with significant payment differentials existing between provider types that treat similar patients and provide similar services.
In the FY 2007 IRF PPS proposed rule (71 FR at 28134), we described our plans to explore refinements to the existing PAC payment methodologies to create a more seamless system for the delivery and payment of PAC services under Medicare. The new model will focus on beneficiary needs rather than provider type and will be characterized by more consistent payments for the same type of care across different sites of service, quality driven pay-for-performance incentives, and collection of uniform clinical assessment information to support quality and discharge planning functions.
We also noted in the FY 2007 IRF PPS proposed rule (71 FR at 28134) that section 5008 of the Deficit Reduction Act (DRA) of 2005 mandates a PAC payment reform demonstration for purposes of understanding costs and outcomes across different PAC sites. To meet this mandate, CMS implemented the PAC Payment Reform Demonstration (PAC-PRD) to examine differences in costs and outcomes for PAC patients of similar case mix who use different types of PAC providers and to develop a standardized patient assessment tool for use at acute care hospital discharge and at PAC admission and discharge. This tool, the Continuity Assessment Record and Evaluation (CARE) tool, will measure the health and functional status of Medicare acute discharges. During the demonstration, CARE will be completed upon a patient's discharge from the acute care hospital and upon admission and discharge from a PAC setting. The CARE instrument consists of a core set of assessment items that are common to all patients and care settings and are organized under several major domains: Medical, Functional, Cognitive, Social, and Continuity of Care, in addition to supplemental items for specific conditions and care settings.
Additional information on the PAC-PRD is available at:
We are interested in receiving public comments on the CARE instrument, and specifically invite comments on how CARE might advance the use of Health Information Technology (HIT) in automating the process for collecting and submitting quality data. The CARE tool is available at
In addition, we wish to take this opportunity to discuss recent developments in the related area of value-based purchasing (VBP). VBP ties payment to performance through the use of incentives based on measures of quality and cost of care. The implementation of VBP is rapidly transforming CMS from being a passive payer of claims to an active purchaser of higher quality, more efficient health care for Medicare beneficiaries. Our VBP initiatives include hospital pay for reporting (the Reporting Hospital Quality Data for the Annual Payment Update Program), physician pay for reporting (the Physician Quality Reporting Initiative), home health pay for reporting, the Hospital VBP Plan Report to Congress, and various VBP demonstration programs across payment settings, including the Premier Hospital Quality Incentive Demonstration and the Physician Group Practice Demonstration.
The preventable hospital-acquired conditions (HAC) payment provision for IPPS hospitals is another of CMS' value-based purchasing initiatives. Section 1886(d)(4)(D) of the Act required the Secretary to select for the HAC IPPS payment provision conditions that: (a) Are high cost, high volume, or both; (b) are assigned to a higher-paying diagnosis-related group (DRG) when present as a secondary diagnosis; and (c) could reasonably have been prevented through the application of evidence-based guidelines. Beginning October 1, 2008, Medicare can no longer assign an inpatient hospital discharge to a higher-paying MS-DRG if a selected HAC condition was not present on admission. That is, the case will be paid as though the preventable condition that becomes a secondary diagnosis were not present. (Medicare will continue to assign a discharge to a higher-paying MS-DRG in those instances where the selected condition was, in fact, present on admission).
The broad principle articulated in the HAC payment provision for IPPS hospitals—of Medicare not paying for these types of preventable conditions—could potentially be applied to other Medicare payment systems for similar conditions that occur in settings other than IPPS hospitals. Other possible
A related application of the broad principle behind the HAC payment provision for IPPS hospitals could be considered through Medicare secondary payer policy by requiring the provider that failed to prevent the occurrence of a preventable condition in one setting to pay for all or part of the necessary follow-up care in a second setting. This would help shield the Medicare program from inappropriately paying for the downstream effects of a preventable condition acquired in the first setting but treated in the second setting.
We note that we are not proposing new Medicare policy in this discussion of the possible application of HACs payment policy for IPPS hospitals to other settings, as some of these approaches may require new statutory authority. Rather, we are seeking public comment on the application of the preventable HACs payment provision for IPPS hospitals to other Medicare payment systems and settings. We look forward to working with stakeholders in the fight against these preventable conditions.
We are proposing to make revisions to the regulation text in response to section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173). Specifically, we are proposing to revise 42 CFR part 412. We discuss these proposed revisions and others in detail below.
As discussed in section V of this proposed rule, we propose to revise the regulation text in paragraph (b)(2)(i) and remove paragraph (b)(2)(ii) in response to section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007. To summarize, for cost reporting periods—
(1) Beginning on or after July 1, 2005, the hospital has served an inpatient population of whom at least 60 percent require intensive rehabilitation services for treatment of one or more of the conditions specified at paragraph (b)(2)(ii) of this section.
(2) A comorbidity that meets the criteria as specified in § 412.23(b)(2)(i) (as amended by removing former (b)(2)(ii) and redesignating former (b)(2)(iii) as the new (b)(2)(ii)) may continue to be used to determine the compliance threshold.
• Update the FY 2009 IRF PPS relative weights and average length of stay values using the most current and complete Medicare claims and cost report data, as discussed in section II.
• Update the FY 2009 IRF PPS payment rates by the proposed wage index and labor related share in a budget neutral manner, as discussed in section III.A and B.
• Update the outlier threshold amount for FY 2009, as discussed in section IV.A.
• Update the cost-to-charge ratio ceiling and the national average urban and rural cost-to-charge ratios for purposes of determining outlier payments under the IRF PPS, as discussed in section IV.B.
This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
Because of the large number of public comments we normally receive on
We have examined the impact of this proposed rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA, September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any one year). This proposed rule does not reach the $100 million economic threshold and thus is not considered a major rule. We estimate that the total impact of the proposed changes in this proposed rule would be a decrease of approximately $20 million (this reflects a $20 million decrease due to the proposed update to the outlier threshold amount to decrease estimated outlier payments from approximately 3.3 percent in FY 2008 to 3 percent in FY 2009).
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most IRFs and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any one year. (For details, see the Small Business Administration's final rule that set forth size standards for health care industries, at 65 FR 69432, November 17, 2000.) Because we lack data on individual hospital receipts, we cannot determine the number of small proprietary IRFs or the proportion of IRFs' revenue that is derived from Medicare payments. Therefore, we assume that all IRFs (an approximate total of 1,200 IRFs, of which approximately 60 percent are nonprofit facilities) are considered small entities and that Medicare payment constitutes the majority of their revenues. The Department of Health and Human Services generally uses a revenue impact of 3 to 5 percent as a significance threshold under the RFA. Medicare fiscal intermediaries and carriers are not considered to be small entities. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $130 million. This proposed rule would not mandate any requirements for State, local, or tribal governments, nor would it affect private sector costs.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. As stated above, this proposed rule would not have a substantial effect on State and local governments.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as follows:
1. The authority citation for part 412 continues to read as follows:
Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
2. Section 412.23 is amended by—
A. Revising paragraph (b)(2)(i).
B. Removing paragraph (b)(2)(ii).
C. Redesignating paragraph (b)(2)(iii) as (b)(2)(ii).
The revision reads as follows:
(b) * * *
(2) * * *
(i) For cost reporting periods beginning on or after July 1, 2004 and before July 1, 2005, the hospital has served an inpatient population of whom at least 50 percent, and for cost reporting periods beginning on or after July 1, 2005, the hospital has served an inpatient population of whom at least 60 percent required intensive rehabilitation services for treatment of one or more of the conditions specified at paragraph (b)(2)(ii) of this section. A patient with a comorbidity, as defined at § 412.602, may be included in the inpatient population that counts toward the required applicable percentage if—
(A) The patient is admitted for inpatient rehabilitation for a condition that is not one of the conditions specified in paragraph (b)(2)(ii) of this section;
(B) The patient has a comorbidity that falls in one of the conditions specified in paragraph (b)(2)(ii) of this section; and
Environmental Protection Agency (EPA).
Notice.
EPA is making available a final White Paper that reviews data on the level in the human food supply of Cry9C protein from StarLink
Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8715; fax number: (703) 308-7026; e-mail address:
You may be potentially affected by this action if you are an agricultural producer or food manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
EPA is making available a final White Paper that reviews data on the level in the human food supply of Cry9C protein from StarLink
The Agency notified the public regarding the availability of a draft version of the White Paper in the October 17, 2007
The final White Paper concludes that the Cry9C protein has been sufficiently removed from the human food supply to render the level of risk low enough that continued testing for the protein in yellow corn at dry mills and masa production facilities provides no added public heath protection. The final White Paper therefore recommends that FDA withdraw its guidance recommending testing yellow corn grain at dry mills and masa production facilities. A full copy of the final EPA White Paper is available in docket EPA-HQ-OPP-2007-0832.
Environmental protection, Agricultural commodities, Pesticides and pests.
Food and Drug Administration, HHS.
Notice; withdrawal.
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance document entitled “FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues.” FDA is withdrawing its guidance in response to the release by the Environmental Protection Agency (EPA) of its final “White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated With Such Exposure,” the availability of which is announced elsewhere in this issue of the
April 25, 2008.
Lauren Posnick Robin or Samir Assar, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1639 or 301-436-1636, respectively.
In the
In the
In response to the EPA recommendation that FDA withdraw its guidance on the sampling and testing of yellow corn grain for Cry9C at dry mills and masa production facilities (72 FR 58978), FDA announced that it was seeking comment on whether to withdraw its guidance document entitled “FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues” (72 FR 58980, October 17, 2007). FDA received five comments, all from trade associations, that supported withdrawal of the guidance document.
In its final “White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated With Such Exposure,” EPA continues to recommend, as reflected elsewhere in this issue of the
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. These materials include the following: The entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSE-positive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15 percent insoluble impurities; and mechanically separated beef that is derived from the materials prohibited by this rule. These measures will further strengthen existing safeguards against BSE.
This final rule is effective April 27, 2009. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication in new 21 CFR 589.2001 effective April 27, 2009.
Burt Pritchett, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6860, e-mail:
BSE is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. However, the distribution of infectivity in the body of the animal and mode of transmission differ according to the species and TSE agent. In addition to BSE, TSEs include, among other diseases, scrapie in sheep and goats, chronic wasting disease in deer and elk, and Creutzfeldt-Jakob disease in humans.
The agent that causes BSE has yet to be fully characterized. The theory that is most accepted in the international scientific community is that the agent is an abnormal form of a normal protein known as cellular prion protein. The BSE agent does not evoke a traditional immune response or inflammatory reaction in host animals. BSE is confirmed by post-mortem microscopic examination of an animal's brain tissue or by detection of the abnormal form of the prion protein in an animal's brain tissues. The pathogenic form of the protein is both less soluble and more resistant to degradation than the normal form. The BSE agent is resistant to heat and to normal sterilization processes.
BSE is not a contagious disease, and therefore is not spread through casual contact between animals. The possibility of maternal transmission (i.e., from a bovine dam directly to her offspring) was suggested by a 1997 study conducted in the United Kingdom. However, subsequent studies have shown that it is unlikely that maternal transmission of BSE occurs at any epidemiologically significant level, if it occurs at all. Scientists believe that the primary route of transmission requires that cattle ingest feed that has been contaminated with a sufficient amount of meat and bone meal (MBM) from an infected animal. This route of transmission can be prevented by excluding potentially contaminated materials from ruminant feed.
Scientific and epidemiological studies have linked variant Creutzfeldt-Jakob disease (vCJD) in humans to exposure to the BSE agent, most likely through human consumption of beef products contaminated with the agent. As of February 2007, 165 probable and confirmed cases of vCJD have been reported in the United Kingdom. It is believed that in the United States, where measures to prevent the introduction and spread of BSE have been in place for some time, there is far less potential for human exposure to the BSE agent. The Centers for Disease Control and Prevention (CDC) leads a surveillance system for vCJD in the United States. As of November 2006, CDC had detected two vCJD cases involving United States residents who were born and raised in the United Kingdom. A third case was confirmed by CDC in November 2006 and involved a United States resident living in Virginia who was born and raised in Saudi Arabia and had lived in the United States since 2005. This individual did not live in Europe at any time, and CDC has determined that this person was most likely infected from contaminated cattle products consumed as a child when living in Saudi Arabia.
On December 23, 2003, the U.S. Department of Agriculture (USDA) diagnosed BSE in an adult cow in the United States that had been imported from Canada. Since then, USDA has confirmed two other cases of BSE in adult cows in the United States. One cow, which was diagnosed on June 24, 2005, was born and raised in Texas. The other cow, which was diagnosed on March 15, 2006, had been on a farm in Alabama for less than a year. The Texas cow was 12 years old and the Alabama cow was determined to be more than 10 years old. Therefore, both cows were born before FDA's 1997 ruminant feed rule (62 FR 30936, June 5, 1997) was in place.
Under USDA's enhanced BSE surveillance program, 787,711 cattle were tested between June 1, 2004, and September 20, 2006. As previously noted, only two animals tested positive for BSE, one in Texas and one in Alabama. In September 2006, USDA transitioned to an ongoing surveillance plan under which approximately 40,000 cattle are tested per year.
In the October 6, 2005, issue of the
The preamble to the proposed rule contained information regarding BSE, including a summary of the current animal feed safeguards in the United States and the risk of BSE in North America, other options FDA considered for strengthening animal feed protections, and the reasons for proposing to exclude certain cattle-derived risk materials from all animal food and feed. Also discussed in the preamble to the proposed rule was the Harvard Risk Assessment (referred to in the preamble to the proposed rule as the “Harvard-Tuskegee Study”), completed for USDA in 2001. The authors released a revised risk assessment in 2003. Among other things, the Harvard-Tuskegee Study identified pathways or practices that, if addressed, could further decrease the already low risk of the spread of BSE if it were introduced into this country.
In mid-July 2006, USDA's Food Safety and Inspection Service (FSIS) released a further revised Harvard Risk Assessment. Conducted in 2005, the risk assessment used an updated model to simulate the impact of measures adopted by USDA and considered by FDA in response to the detection of a BSE-positive cow in Washington State in December 2003. The 2005 study confirmed the original findings in the 2001 Harvard-Tuskegee Study and noted that, with the protective measures in place in the United States in 2003, the introduction of BSE would result in limited spread, and the disease would be eliminated over time. Of the additional feed-related mitigation measures evaluated, the revised model predicted that removal of specified risk materials (SRMs) from all animal feed would result in a substantial reduction of any residual BSE disease agent not eliminated by the 1997 feed ban, because doing so eliminates transmissions resulting from cross-contamination and on-farm misfeeding.
The current U.S. ruminant feed regulation (§ 589.2000 (21 CFR 589.2000)) prohibits the use of certain mammalian-origin proteins in ruminant feed, but allows the use of these materials in feed for non-ruminant animals. While the prevalence of BSE in the United States is very much lower than in European countries with BSE, evidence from the European experience has demonstrated that, in countries with a high level of circulating BSE infectivity, measures on only ruminant feed were not sufficient to eliminate all transmission of BSE; new cases continued to be found in cattle born in the United Kingdom after implementation of a ruminant-to-ruminant feed ban. As stated in the proposed rule, these new cases were attributed to either cross-contamination during feed manufacture and transport, or to intentional or unintentional misfeeding on the farm. FDA believes that the presence of certain cattle-derived risk materials in the non-ruminant feed supply presents a potential source of exposure in the United States. Although in the United States, compliance with the 1997 ruminant feed rule by the U.S. animal feed industry, i.e., renderers, protein blenders, and feed mills, has been very high, inspections of feed manufacturing firms have identified some instances of inadequate cleanout procedures, mislabeling, and recordkeeping deficiencies.
As discussed in the preamble to the proposed rule, data from both naturally infected and experimentally infected cattle indicate that roughly 90 percent of BSE infectivity is contained in the brain and spinal cord, and only about 10 percent of BSE infectivity is present in the retina, dorsal root and trigeminal ganglia, and the distal ileum (Ref. 1). The agency continues to believe that the 1997 ruminant feed rule provides a strong primary line of defense against BSE transmission by prohibiting the use in ruminant feed of all materials with potential BSE infectivity. The additional measures taken in this final rule will further reinforce the existing rule by removing certain cattle-derived risk materials from all animal feed. This action greatly minimizes the residual BSE risks not eliminated by the 1997 feed ban if cross-contamination of ruminant feed with non-ruminant feed, or diversion of non-ruminant feeds to ruminants, were to occur.
As discussed in greater detail in section II of this document, FDA received numerous comments on its proposed rule. Based on these comments, the agency has made some modifications to this final rule. Specifically, a statement has been added setting forth the purpose of the new section, i.e., to prohibit the use of certain cattle origin materials in the food or feed of all animals to further reduce the risk of the spread of BSE within the United States. This change was made to clarify that the cattle materials prohibited by this rule are being prohibited from use in all animal food or feed because of their risk for transmitting BSE. This rule, however, should not be construed to mean that it is legal to use any portion of an animal that is adulterated under the Federal Food, Drug, and Cosmetic Act (the act) in animal food or feed.
Under section 402(a)(5) of the act (21 U.S.C. 342(a)(5)), animal feed and feed ingredients containing material derived from a BSE-positive animal are adulterated because they are in whole or in part the product of a diseased animal. The definition of cattle materials prohibited in animal feed (CMPAF) has been revised to include the entire carcass of BSE-positive cattle. This change was made to be consistent with the agency's previous guidance entitled “Use of Material from BSE-Positive Cattle in Animal Feed,” for which a notice of availability was published in the
Additional changes have also been made in this final rule to the definition of CMPAF. As defined in the proposed rule, CMPAF included the brains and spinal cords from cattle of any age not inspected and passed for human consumption (or the entire carcass, if brain and spinal cord were not removed). FDA explained in the preamble to the proposed rule its rationale for applying these requirements to cattle of any age. This rationale cited surveillance data showing that cattle not inspected and passed for human consumption were included in the population of cattle at highest risk of BSE, and noted that inspection programs were not in place in the rendering industry for verifying the age of dead cattle. However, given the challenges of removing the brain and spinal cord from this class of cattle, FDA specifically requested comment on this issue.
FDA has revised the definition of CMPAF in the final rule (proposed § 589.2001(a)(iii) and new section 589.2001(b)(iii)) to prohibit the use of the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brain and spinal cord have not been effectively removed or otherwise effectively excluded from animal feed. As a result, the rule now prohibits the use of the entire carcass of cattle not inspected and passed for human consumption unless: (1) The cattle are shown to be less than 30 months of age, or (2) the brains and spinal cords were effectively removed or effectively excluded from animal feed use. The final rule was further revised to require renderers to develop and maintain written procedures for determining the age of and/or removing the brain and spinal cord from, dead cattle, and to make the written procedures available for FDA inspection. FDA notes that, for cattle not inspected and passed that are diseased or that died otherwise than by slaughter, the entire carcass of such animals is adulterated under section 402(a)(5) of the act. FDA has traditionally exercised enforcement discretion with regard to the use of such animals in animal feed. For example, see Compliance Policy Guide 675.400. FDA intends to continue exercising such discretion for the use in animal feed of: (1) The remaining material from cattle that are diseased or that die otherwise than by slaughter when the brain and spinal cord are effectively removed or effectively excluded from animal feed use and (2) the entire carcass from cattle that are diseased or that die otherwise than by slaughter if such cattle are shown to be less than 30 months of age.
FDA made these revisions based on comments indicating that it is feasible to put processes in place to age such cattle and that very little risk reduction is gained by excluding material from such cattle. FDA also received many comments that raised concerns about the environmental impacts of disposing of these animals by means other than rendering them for animal feed use.
FDA noted in the preamble to the October 2005 proposed rule (70 FR 58570) that European surveillance data suggest that cattle not inspected and passed for human consumption are more likely to test positive for BSE than healthy cattle that have been inspected and passed. However, FDA considered the level of risk reduction that might potentially be achieved by prohibiting materials from cattle that are not inspected and passed for human consumption and that are less than 30 months of age. FDA also considered the following: (1) Surveillance data indicate the current risk of BSE to U.S. cattle is very low, (2) the existing ruminant feed regulation provides strong protection against BSE, and (3) the new measures established by the final rule represent a secondary level of protection to address failures in compliance that may occur with the existing ruminant feed rule. After considering all of the previously mentioned factors, FDA determined that the proposed measure to prohibit materials from cattle that are not inspected and passed for human consumption and that are less than 30 months of age is not necessary.
Based on comments received, FDA has added a provision to this rule so that the agency may designate a country as not subject to the new requirements in this rule. As explained elsewhere in this document, a country seeking such a designation must submit a written request and include information about the country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other relevant information.
Lastly, for renderers handling cattle materials, this final rule provides, as did the proposed rule, that such renderers must establish and maintain records sufficient to demonstrate that material rendered for animal feed was not manufactured from, processed with, or does not otherwise contain CMPAF. Based on comments received regarding verification of CMPAF segregation in slaughter facilities, this final rule has been revised to clarify that the renderer's records must also include documentation that establishments supplying cattle materials to the renderers have adequate procedures in place to effectively exclude CMPAF. These supplier-related records must include either certification or other documentation from the supplier that material supplied to the renderer does not include CMPAF
FDA received more than 840 comments on the proposed rule. They came from a wide variety of organizations, such as cattlemen, renderers, feed manufacturers, Federal agencies, State agriculture departments, trade associations, professional organizations, universities and research institutions, consumer organizations, and individuals. Many comments questioned the need for additional controls in light of the high compliance with FDA's 1997 feed rule by the U.S. animal feed industry, coupled with the low prevalence of BSE in this country. Some comments took the opposing view, stating that more aggressive steps should be taken by FDA and that all ruminant-derived material should be prohibited in all animal feed. Some comments urged that all exemptions (e.g., plate waste and poultry litter) be removed from the regulations. Other comments asserted that the proposed rule was not scientifically based and should not be finalized.
Many comments from industry raised concerns about the increased burden—financial and otherwise—if the proposed rule is finalized. Some comments discussed the difficulty of ensuring complete removal of brain and spinal cord from dead cattle. Other comments expressed concerns about the increased volume of materials that would have to be disposed of through incineration, landfills, or other means. Potentially adverse environmental effects—and resultant adverse animal and public health consequences—from the increased volume of disposal materials were mentioned by several comments. Comments also expressed concerns about registration, certification, verification of segregation of CMPAF at slaughter establishments, recordkeeping, and record retention time.
A description of the comments and FDA's responses follows.
(Comment 1) Many comments, in addressing the proposed rule generally, said that the current BSE feed regulation does not need to be strengthened. Reasons given for this position were the low prevalence of BSE in this country as shown by USDA's surveillance results, the conclusion of the original Harvard Risk Assessment that the United States is resistant to BSE, and the effectiveness of the current ruminant feed rule (§ 589.2000) as evidenced by the high rate of industry compliance and the absence of BSE cases in cattle born after the 1997 ruminant feed rule. One comment said that FDA should develop a more accurate estimation of BSE risk to U.S. cattle by entering USDA's most recent prevalence data into the Harvard Risk Assessment model.
(Response) FDA agrees that the prevalence of BSE in the United States is very low, and that compliance with the current feed ban by the U.S. animal feed industry is at a high level. Though the situations are not directly
(Comment 2) One comment said that, because the cow found in Texas in June 2005 did not test positive as a typical case of BSE, this case does not support the need for additional regulation.
(Response) FDA is aware that the PrP
(Comment 3) Several comments said that the proposed rule was not based on the BSE situation in the United States, but rather on the situation in Europe where the incidence of BSE was 500-fold greater and control measures were instituted after BSE cases were identified. One comment also thought FDA might have developed its proposal based on the BSE situation in Japan.
(Response) While the data from Europe and Japan on BSE provided the agency with important information to help develop our response to BSE, the agency based its decision on the BSE situation in the United States and believes that these measures are appropriate to the United States situation. The agency believes, however, that the early firewalls (prohibition on imports of animals and ruminant feed from countries with BSE and the ruminant feed ban) put in place in the United States makes it possible and appropriate to strengthen feed controls with measures that are still less expansive than those that would be appropriate in countries with higher BSE prevalence such as in European countries and Japan. The measures being implemented are commensurate with the BSE prevalence in the United States.
(Comment 4) Several comments declared that the recommendations in the International Review Team's (IRT) February 2005 report are not relevant to the development of this rule because they were not based on science, they do not reflect the difference in BSE risk between Europe and the United States, and they do not present an accurate understanding of the U.S. industry's compliance with the existing BSE feed regulation.
(Response) FDA agrees that not all of the IRT recommendations are appropriate for the U.S. situation. However, FDA is adopting the IRT recommendation to require the removal of certain cattle-derived risk materials from all animal feed. FDA believes that the level of compliance with the current ruminant feed rule by the U.S. animal feed industry is high, but believes that the additional measures provide a secondary level of protection to address failures in compliance that may occur with the existing ruminant feed rule.
(Comment 5) One comment said that cross-contamination is not a problem because the BSE prevalence is so low in the United States. Another comment asked for the data the agency is relying on to show that cross-contamination and feeding errors need to be controlled, especially since the agency's own statistics show the industry is in high compliance with the 1997 ruminant feed rule.
(Response) FDA agrees that overall compliance with the 1997 ruminant feed rule by the U.S. animal feed industry has been high, but there have been instances of noncompliance with the rule that could have resulted in cattle being exposed to prohibited material through cross-contamination, mislabeling, or intentional or unintentional misfeeding. Information describing these instances of noncompliance was set forth in the preamble to the October 2005 proposed rule (70 FR 58570 at 58577). An updated summary of compliance information is provided in the References section of this document (Ref. 2).
(Comment 6) A few comments asked FDA to recognize that the USDA 18-month surveillance snapshot may not be an accurate indication of BSE prevalence in the United States. Specifically, because the BSE cases to date are likely clustered in time and location, USDA's surveillance results may underestimate the true risk.
(Response) FDA stated in the preamble to the proposed rule that the detection of one BSE case in over 418,000 samples analyzed under USDA's enhanced surveillance program at the time of the publication of the proposed rule indicates that the prevalence of BSE is very low in the U.S. cattle population. FDA notes that USDA has conducted surveillance for BSE since 1990. A July 20, 2006, USDA report entitled “An Estimate of the Prevalence of BSE in the United States” supports FDA's qualitative statement of a very low prevalence of BSE in the United States (Ref. 3). According to the report, a model developed in Europe was used to calculate U.S. BSE prevalence from two BSE cases detected in 735,213 samples collected over a 7-year period ending in March 2006. Results of this analysis support a conclusion that the prevalence of BSE in the U.S. cattle population is less than one infected animal per million adult cattle.
FDA remains confident in the two models used by USDA. The most likely values calculated by these models for the estimated number of cases were 4 or 7 infected animals out of 42 million adult cattle. USDA's analysis was submitted to the scrutiny of a peer review process, and the expert panel agreed with the appropriateness of USDA's assumptions and the factors it considered, as well as with the estimate of BSE prevalence.
(Comment 7) One comment noted that the effectiveness of the feed ban, especially at the farm level, is not known.
(Response) Inspection results indicate that compliance by U.S. animal feed industry is high. However, FDA agrees that it is very difficult to assess compliance with the ruminant feed rule at the farm level. FDA believes excluding certain cattle-derived risk materials from all animal feed channels will minimize any residual risks from on-farm misfeeding.
(Comment 8) Two comments indicated that the agency's feed control measures for ensuring compliance with the 1997 ruminant feed rule have been inadequate, citing a Government Accountability Office (GAO) study as evidence.
(Response) FDA disagrees with these comments. FDA believes its enforcement activities are adequate for ensuring industry compliance with the 1997 ruminant feed rule. The agency's response to the GAO's study can be found in Appendix VI of the GAO's report (Ref. 4).
(Comment 9) One comment speculated that, in some species, atypical BSE might be more pathogenic than typical BSE.
(Response) FDA is not aware of any scientific evidence that atypical BSE is
(Comment 10) Several comments said the proposed rule will hamper BSE surveillance by reducing the number of cattle available for sampling.
(Response) FDA has conferred with USDA on the development of this rule. Further, USDA's transition from enhanced BSE surveillance to ongoing BSE surveillance places greater importance on collecting samples where clinical histories on sampled animals are more likely to be available, such as on farms and at diagnostic laboratories, and less importance on sampling at rendering plants where clinical histories are usually not available (Ref. 5).
A number of comments recommended ways to strengthen feed controls that they believed would provide better protection than the measures proposed by FDA.
(Comment 11) Several comments stated that the proposed rule does not go far enough, that it still allows materials derived from ruminant species to be fed to other species, and that it does not include any of the actions announced on January 26, 2004. Several comments suggested that no animal or mammalian products be allowed in cattle feed or in feed for any other food-producing animal species. One comment noted that, although the proposed rule is a small step in the right direction, it is inadequate to close the existing loopholes. Two comments stated that the proposal ignores some of the recommendations made by the IRT and other BSE experts. Several comments stated that the proposed rule would leave 10 percent of the potential infectivity in the feeding system. One comment stated that the 10-percent infectivity may represent 780 ID
(Response) The agency does not believe it is necessary, given the low prevalence of BSE in the United States, to prohibit all ruminant material from animal feed, nor is it necessary to prohibit all animal or all mammalian products in cattle feed. Our reasoning for deciding against the measures under consideration by FDA that were announced on January 26, 2004, and choosing instead to focus on certain cattle-derived risk materials was fully explained in the preamble to the October 2005 proposed rule (70 FR 58570 at 58578). In deciding to prohibit brain and spinal cord only from cattle 30 months of age or older, rather than the full list of SRMs, FDA considered the following: (1) Surveillance data indicate the current risk of BSE to U.S. cattle is very low, (2) the existing ruminant feed regulation provides strong protection against BSE, and (3) the new measures in this rule represent a secondary level of protection to address potential failures in compliance that may occur with the existing ruminant feed rule. FDA believes that the existing ruminant feed rule provides a strong line of defense by prohibiting the use in ruminant feed of protein derived from mammalian tissues. The additional measures in this final rule will further reinforce existing ruminant feed protection measures by removing the highest risk cattle-derived materials from all animal feed.
(Comment 12) One comment stated that the agency's proposal was too broad and asked that the rule be limited to removal of brain and spinal cord from dead and antemortem condemned cattle 30 months of age or older. The comment said this would have captured the two BSE cases in Washington and Texas.
(Response) FDA believes that the rule should apply to cattle slaughtered for human consumption as well as to cattle not inspected and passed for human consumption at antemortem inspection. Infected cattle that are over 30 months of age and in the preclinical stage of disease could pass antemortem inspection, yet still harbor significant levels of BSE infectivity in the brain and spinal cord.
(Comment 13) Numerous comments suggested that FDA prohibit the use of blood in animal feed. Reasons mentioned were that blood has been shown to contain TSE infectivity in several species, that vCJD has been found to be transmitted through blood, and that emboli created by stunning could carry infectivity. One comment said that, with more sensitive detection methods, BSE infectivity may be confirmed in blood. In contrast, numerous comments said FDA should continue to allow the use of blood in animal feed because there is no scientific basis for prohibiting blood in cattle feed and because calf health is dependent on colostrum supplements, which include blood products. One comment said that the chair of the IRT committee stated that blood does not transmit BSE.
(Response) As explained in the preamble to the proposed rule, FDA is not prohibiting the use of blood and blood products in animal feed because we believe such a prohibition would do very little to reduce the risk of BSE transmission. Although TSE infectivity has been demonstrated experimentally in the blood (Ref. 6) of sheep and rodents (Ref. 7), species differences in the involvement of the lymphoreticular system in TSE diseases suggest that these findings cannot necessarily be extrapolated to cattle (Ref. 8). Studies using mouse and cattle bioassays have so far failed to detect BSE infectivity in bovine blood (Ref. 9). While FDA agrees that more sensitive detection methods might some day demonstrate BSE infectivity in bovine blood, the agency believes that it is highly unlikely that the BSE agent is present in blood of infected cattle at levels sufficient to transmit disease through oral administration of processed blood products. This conclusion is based on the inefficiency of the oral route of transmission relative to the intracerebral route, which was used in unsuccessful attempts to detect BSE infectivity in bovine blood. FDA believes that the prohibitions in this final rule make it unnecessary to also preclude the use of blood in animal feed.
(Comment 14) A number of comments requested that poultry litter not be permitted to be fed to cattle, citing several reasons. One comment asked that FDA determine actual risk before deciding that poultry litter is not a risk factor. One comment stated that feces were infectious in rodents orally challenged with scrapie. Another comment noted that, in the United Kingdom, when cattle are orally challenged, the feces must be treated as medical waste for 1 month post-challenge. Another comment stated that TSE agents may be present in the porcine/poultry intestinal content, while still another comment stated that the 2001 World Health Organization/Food and Agriculture Organization of the United Nations/World Organisation for Animal Health (OIE) Technical
(Response) In the preamble to the October 2005 proposed rule, FDA provided calculations submitted in comments to the advance notice of proposed rulemaking (ANPRM) that published in the
(Comment 15) Several comments disagreed with the need for prohibiting poultry litter in cattle feed if FDA finalizes the proposed measures. Two comments said that there is no scientific basis for prohibiting poultry material in ruminant rations. Another comment pointed out that banning poultry litter would create significant disposal issues.
(Response) As discussed in the response to the previous comment, because the rule prohibits the use of the highest risk cattle-derived materials in all animal feed, FDA agrees that it is not necessary to prohibit poultry litter from being fed to cattle.
(Comment 16) Several comments recommended that dedicated facilities and equipment be required in order to prevent cross-contamination. One comment disagreed, stating that requiring dedicated facilities would force some renderers to discontinue operations.
(Response) As explained in the preamble to the October 2005 proposed rule (70 FR 58570 at 58584), FDA fully expects this final rule to reduce substantially the remaining risk associated with cross-contamination, and therefore does not believe that the rule needs to also require dedicated facilities and equipment.
(Comment 17) One comment suggested a “systems approach” as a substitute for the measures presented in the proposed rule. This approach, according to the comment, would prohibit the entire carcass (except skeletal muscle) of mature dead cattle and the brain and spinal cord of mature slaughter cattle from all animal feed. It would also prohibit the use of hypobaric (vacuum) rendering for processing inedible ruminant material. The commenter submitted modeling data obtained using the Harvard Risk Assessment model, which showed that this approach is as protective of animal and public health as a complete SRMs ban, while creating a much smaller disposal challenge. According to the modeling results, the “systems approach” and the full SRMs approach would reduce cases of BSE by 97 percent and 99 percent, respectively. FDA's proposed measures would reduce new cases by 40 percent to 63 percent, depending on the effectiveness of brain and spinal cord removal. The comment acknowledged that the “systems approach” would initially create disposal challenges, especially in the dairy sector, but that cost-effective carcass disposal methods could be implemented.
(Response) The difference between the comment's “systems approach” and the approach in this final rule is that the “systems approach” would exclude the entire carcass of dead cattle 30 months of age or older rather than only the brain and spinal cord. As the comment acknowledges, eliminating the rendering option (other than disposal rendering) for disposal of all dead cattle 30 months of age or older may create major disposal challenges in some regions of the country (see “Environmental Assessment” for this final rule, Docket No. 2002N-0273). Modeling results submitted by the same commenter in response to the ANPRM showed that eliminating vacuum rendering contributed very little to the effectiveness of the “systems approach.” The agency believes that excluding brain and spinal cord from all cattle 30 months of age or older, and not the complete list of SRMs, is the most appropriate course of action for the United States where the BSE prevalence is low and strong feed controls are already in place.
(Comment 18) Citing the link of BSE cases in Alberta to hypobaric (or vacuum) rendering, one comment recommended that the use of hypobaric rendering be prohibited because it provides no TSE inactivation.
(Response) FDA agrees that the cluster of BSE cases associated with a vacuum renderer in Alberta underscores the concern about the ability of this process to inactivate BSE infectivity. A major advantage of the measures in this final rule over other options considered is that they prevent the highest risk cattle-derived materials from all animal feed, thereby reducing concerns about vacuum rendering.
(Comment 19) One comment said that FDA should prohibit the use of mammalian protein in feed for food producing animals, and cited the following recent research to support this position:
• Infectious dose may be smaller than previously thought: Attack rate studies in the United Kingdom have demonstrated transmission at a 0.001 gram (g) dose (no reference), 10 times lower than the 0.01 g dose described by FDA in the proposal.
• Repeated low dose exposure: A study in which scrapie was injected into mice (Jacquemot 2005) showed that repeated low doses caused scrapie when a single dose of the same size did not. A second study in which scrapie was administered orally to hamsters (Diringer 1998) showed a higher incidence of scrapie in hamsters receiving repeated doses than in hamsters receiving a single dose.
• Additional organs may be infectious: Disease-specific prion protein (PrP
• Interspecies barrier may be smaller than previously thought: Some studies have shown interspecies inoculation produced subclinical disease but not clinical disease, suggesting that previously assumed species barriers were not complete (Hill 2000).
(Response) FDA is aware that BSE transmission has been demonstrated at a 0.001 g dose. FDA is also aware of the other recent scientific findings and considered this information as we were developing the final rule. The agency believes that the risks associated with repeated low dose exposure, infectivity in inflamed organs, and unapparent carriers of BSE infectivity are very low. The agency believes the risks of BSE infection are adequately addressed by the 1997 ruminant feed rule and this final rule, and that it is not necessary to prohibit all mammalian protein in feed for food-producing animals.
(Comment 20) One comment noted that species which appear to be resistant may in fact be unapparent carriers and over time could become sources of the BSE agent. Another comment added that failure to detect infectivity in tissues of experimentally infected pigs and chickens might be due to insufficiently sensitive bioassay techniques. Another
(Response) These concerns were first addressed in the 1997 ruminant feed rule (62 FR 30936 at 30939). The agency has received no new information that would lead us to conclude that the additional measures suggested by these comments are needed to protect against BSE at this time.
(Comment 21) Several comments said that FDA should remove the exemptions in the current feed rule, with the possible exception of the exemption for milk.
(Response) As discussed in the preamble to the October 2005 proposed rule (70 FR 58570 at 58573), the agency considered eliminating certain of the current exemptions in the 1997 ruminant feed rule. However, as further discussed in that preamble, given low levels of BSE prevalence and high compliance with the 1997 ruminant feed ban, the agency determined that prohibiting the highest risk cattle-derived materials from all animal feed would be the most appropriate measure in the United States to further reduce the remaining risk of BSE infection not already addressed by the 1997 feed ban. Other responses to comments in the preamble to this final rule also discuss the agency's reasons for not eliminating certain exemptions in the 1997 ruminant feed rule.
(Comment 22) Numerous comments suggested that the plate waste exemption be eliminated. Reasons cited were that plate waste could contain highly infectious material, FDA has not specified the reheating requirements sufficient to inactivate the agent, it could be a factor in the spread of scrapie, and it confounds feed testing. In contrast, one comment advised against eliminating the exemption, noting that potential infectivity in high risk material has already been removed from meat by USDA regulations.
(Response) The exemption in the 1997 ruminant feed rule is specifically for “inspected meat products which have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings)” (§ 589.2000(a)(1)). FDA disagrees that it is necessary to eliminate the plate waste exemption because, since 2004, human food has been required to be free of SRMs by USDA and FDA (69 FR 1862, January 12, 2004 (affirmation of interim rule 72 FR 38699, July 13, 2007), and 69 FR 42256, July 14, 2004, respectively).
The agency received a number of comments about trade, particularly about international standards related to feed controls for the prevention of BSE.
(Comment 23) One comment stated that FDA should not place more importance on trade considerations than on animal health, while another comment asserted that the proposed rule does not meet international standards, and therefore export markets may remain closed to U.S. products. In contrast, another comment stated that the proposed rule would satisfy trading partners and should help to reopen export markets.
(Response) FDA's mission is to promote and protect public health. The agency's regulations are issued to achieve this mission. FDA is also aware of the international trade obligations of the United States and considers these obligations in rulemaking. FDA believes that this final rule, while based on its mission to promote and protect the public health, is consistent with international trade obligations.
(Comment 24) One comment stated that the OIE recommends that feed and certain other commodities from controlled risk countries should not be traded if they contain protein from brains, eyes, spinal cord, skull, or vertebral column from cattle 30 months of age or older, or contain protein from the distal ileum or tonsils from cattle of any age. The comment added that if these commodities should not be traded internationally, then they should not be used domestically.
(Response) The OIE guidelines described in the comment apply to meat products for human consumption and ruminant feed. They do not apply to all animal feed. FDA also notes that these risk materials are already prohibited from all ruminant feed. As discussed throughout the preamble to this final rule, FDA believes further prohibiting brain and spinal cord from cattle 30 months of age and older in all animal food or feed is appropriate for the U.S. situation.
(Comment 25) Several comments stated that FDA should harmonize its new BSE feed regulations with those proposed by Canada. One comment provided a recommendation on how the United States and Canadian feed regulations should be harmonized, suggesting that both countries prohibit dead and downer cattle and require the removal of brain and spinal cord from cattle 30 months of age and older at slaughter. In contrast, another comment stated that trade with Canada should be restricted because of inadequate feed controls and inadequate surveillance in Canada.
(Response) The governments of the United States and Canada discussed the differences between their proposed regulations and considered options for aligning the two regulations. This led to a better understanding of each country's situation. Having considered the circumstances related to each of the BSE-positive cows and the control systems in place in Canada and the United States, FDA has concluded that measures in the 1997 ruminant feed rule and in this final rule are the most appropriate for the situation in the United States.
(Comment 26) Australia and New Zealand commented that they should not have to meet the proposed FDA requirements for exporting feed products to the United States because both countries have BSE-free status. Further, they stated that such requirements are contrary to World Trade Organization obligations under the Sanitary and Phytosanitary Agreement.
(Response) As stated previously, FDA is aware of the international trade obligations of the United States and has considered these obligations throughout the rulemaking process for this regulation. In the preamble to FDA's interim final rule on prohibiting the use of certain cattle materials in human food and cosmetics (69 FR 42256, July 14, 2004), FDA requested comment on standards to apply when determining another country's BSE status, providing an exemption for “BSE-free” countries, and how to determine that countries meet any standards that might be developed. On July 13, 2007, USDA's FSIS published a final rule “
FDA received numerous comments addressing the definition of “cattle materials prohibited in animal food or feed” (CMPAF) as set forth in proposed § 589.2001(a). While some urged that all deads and downers, regardless of age, be included in the definition, others suggested that younger cattle be excluded from the definition because of science showing a lower infectivity risk in this group.
(Comment 27) Numerous comments suggested that FDA exclude all deads and downers, regardless of their age, from the feed chain because they contain the highest level of infectivity and because the Harvard-Tuskegee Study showed reduction of the risk of BSE transmission when these two categories of animals were eliminated from the feed stream. Several comments said that infectivity could be present in tissues other than brain and spinal cord. Specifically mentioned was new research showing infectivity in peripheral nerves, both in one cow using a new bioassay technique (Buschmann and Groschup, 2005 (Ref. 10)), and in a 94-month-old BSE infected cow in Japan using a western blot method. One comment said that subclinical infection could be present in cattle younger than 30 months of age.
(Response) FDA disagrees that it is necessary to prohibit all cattle not inspected and passed for human consumption from all animal feed to prevent BSE infection. BSE has a long incubation period. Epidemiological data from the United Kingdom epidemic have demonstrated that, on average, cattle develop clinical signs 4 to 6 years after infection (Bradley 1991; Anderson 1996 (Ref. 11)), though the incubation period can be longer or shorter than 4 to 6 years. With BSE, as with other TSEs, the total amount of infectivity in an animal increases throughout the incubation period, reaching the highest load at the end, very close to the death of the animal. Infectivity is considered to increase exponentially after exposure, reaching 4.5 logs less than clinical cases by 50 percent of the incubation period, and 3 logs less than a clinical case at 70 percent of the incubation period (Comer and Huntly, 2003 (Ref. 12)). Therefore, FDA assumes that the benefit shown in the Harvard-Tuskegee Study of excluding animals that die on the farm from the animal feed chain (77 percent reduction in mean number of new cases) is primarily attributable to excluding older deadstock.
FDA does not believe that studies showing BSE infectivity in peripheral nerves are sufficient to justify prohibiting all cattle not inspected and passed from use in all animal feed to prevent BSE infection. In the Buschmann and Groschup study, the experimental mice used were approximately 10 times more sensitive than cattle to the BSE agent, and the donor cow was showing severe signs of late-stage clinical BSE. Furthermore, based on end-point titration, incubation time, and transmission rate, the infectivity levels in peripheral nerves are extremely low compared to levels in brain and spinal cord. The mice were injected both intracerebrally and intraperitoneally, which is much more efficient than the oral route of administration. Therefore, the agency believes that very little BSE risk reduction would be realized if this final rule prohibited all cattle not inspected and passed for human consumption from use in all animal feed.
(Comment 28) Several comments suggested that deads and downers under 30 months of age be allowed in non-ruminant feed without brain and spinal cord removal, pointing out that no risk reduction is achieved by this requirement, and that age of deadstock could be verified by dentition, records, animal identification systems, or an onsite inspection. One comment said that FDA should provide guidance to renderers for procedures to verify age of cattle.
(Response). FDA agrees that very little BSE risk reduction would be realized by prohibiting from animal feed all cattle less than 30 months of age that were not inspected and passed for human consumption and from which brain and spinal cord had not been removed. In the preamble to the October 2005 proposed rule, the agency explained the rationale for the 30-month age criterion and stated that it should be applied in the animal feed context. However, the agency also explained that the decision to prohibit all cattle not inspected and passed for human consumption from which the brain and spinal cord were not removed from animal feed was based on the fact that procedures were currently not in place at rendering facilities to verify that firms were determining the age of cattle effectively (70 FR 58570 at 58578). Several comments suggested methods to determine the age of dead cattle, including animal identification systems, dairy herd records, dentition, body weight, or feed lot origin.
Based on the limited scientific basis with regard to BSE risk reduction for prohibiting cattle not inspected and passed for human consumption less than 30 months of age and the comments suggesting ways to determine the age of such cattle, FDA has revised the definition of CMPAF in the final rule. The revised definition of CMPAF includes the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not effectively removed or otherwise effectively excluded from animal feed. The final rule requires renderers to maintain written procedures if they remove brain and spinal cord from such cattle, or separate such animals based on whether or not they are 30 months of age or older. As suggested by one comment, FDA will issue separate guidance for industry on methods for determining the age of cattle. FDA will work with USDA to develop methods consistent with those of USDA.
As FDA noted previously (70 FR 58570 at 58579), section 402(a)(5) of the act states that a food shall be deemed to be adulterated if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter. Since the category of cattle defined in this final rule as “cattle not inspected and passed for human consumption” are animals that already fall within the category of animals referred to in section 402(a)(5) of the act as “diseased animals or animals which died otherwise than by slaughter,” any animal feed derived from such animals would be considered adulterated. However, FDA has traditionally exercised enforcement discretion with regard to the use of such animals in animal feed. For example, see Compliance Policy Guide 675.400. With the implementation of this final rule, FDA will no longer exercise enforcement discretion over those materials prohibited by this regulation (i.e., CMPAF) that are derived from cattle not inspected and passed for
(Comment 29) One comment asked that downer cattle not be allowed in animal feed.
(Response) Under the final rule, to prevent BSE, cattle not inspected and passed for human consumption are prohibited from use in animal feed unless they are shown to be less than 30 months of age or the brain and spinal cord are effectively removed or effectively excluded from animal feed. FDA originally included cattle of any age that were not inspected and passed for human consumption in the definition of CMPAF because: (1) European surveillance data suggested that cattle not inspected and passed for human consumption posed a higher risk for BSE and (2) we believed that processes were currently not established in the rendering industry for verifying the age of such cattle through inspection. However, FDA received comments on the feasibility of aging such cattle and on the relatively low risk reduction achieved by excluding such cattle if they were less than 30 months of age. FDA considered these comments, surveillance data indicating the current risk of BSE to U.S. cattle is very low, the strong feed protection provided by the existing ruminant feed rule, and the added secondary level of protection provided by the other provisions of this final rule. Based on these factors, FDA concluded that it was not necessary to include in the definition of CMPAF cattle not inspected and passed for human consumption that are under 30 months of age.
(Comment 30) One comment requested that striated muscle from cattle that died otherwise than by slaughter be allowed to be harvested for use in non-ruminant feed.
(Response) This final rule does not prohibit the use of cattle not inspected and passed for human consumption in animal feed if they are shown to be less than 30 months of age or if the brain and spinal cord are effectively removed or otherwise effectively excluded from animal feed. 4-D operations (plants that harvest skeletal muscle from dead, dying, diseased, or disabled cattle) that harvest skeletal muscle for such use as pet and mink food fall within the final rule's definition of renderer and must have written procedures in place describing the aging methods and specifying how brain and spinal cord, or parts of carcasses containing brain and spinal cord, will be effectively removed or effectively excluded from animal feed. As discussed in more detail in the response to Comment 28, FDA notes that the use in animal feed of materials from cattle not inspected and passed for human consumption that are diseased or that die otherwise than by slaughter is the subject of enforcement discretion.
(Comment 31) One comment from a foreign country requested that FDA clarify whether beef recovered by Advanced Meat Recovery (AMR) systems from vertebral column, from which spinal cord has been removed, is permissible in animal feed.
(Response) This final rule does not prohibit in animal feed an AMR product derived from the vertebral column of cattle from which spinal cord has been removed prior to the AMR process, provided that the other requirements of the final rule are also met.
(Comment 32) Several comments stated that cattle carcasses and parts condemned on post-mortem inspection should not be considered CMPAF because some parts of the condemned carcass may have already been commingled with normal slaughter byproducts. The comments suggested that the definition “cattle not inspected and passed for human consumption” be changed to “cattle that do not pass ante-mortem inspection.”
(Response) The agency did not intend for the purposes of this regulation that the carcasses of cattle condemned on post-mortem inspection be included in the definition of cattle not inspected and passed for human consumption. The agency intended this category of cattle to include cattle that had been presented to a slaughter establishment and rejected (did not pass ante-mortem inspection) as well as cattle that had not been presented to a slaughter establishment and, hence, were not subject to inspection by an appropriate regulatory authority. To clarify this, FDA is modifying the definition of “cattle not inspected and passed for human consumption” in this final rule to mean “cattle that did not pass ante-mortem inspection by the appropriate regulatory authority.
(Comment 33) One comment stated that the proposal is unclear as to whether the 0.15-percent insoluble impurity standard applies to all tallow or only to tallow derived from CMPAF. The comment requested that the tallow standard only apply to CMPAF-derived tallow.
(Response) The final rule defines tallow as CMPAF if it is derived from: (1) BSE-positive cattle or (2) from other CMPAF material and contains insoluble impurities greater than 0.15 percent. The existing § 589.2000 has been changed to clarify that protein derived from mammalian tissues does not include tallow containing 0.15 percent or less insoluble impurities. The result of these changes is that tallow usage is more restrictive in ruminant feed than in feed for non-ruminants. All tallow that contains more than 0.15 percent insoluble impurities is prohibited in ruminant feed, but only tallow that contains more than 0.15 percent insoluble impurities and that is made from CMPAF is prohibited in the food or feed of all animals.
(Comment 34) Five comments stated that tallow should be prohibited in animal feed. Two comments said that tallow should be entirely free of protein impurities. In contrast, another comment said that tallow from animals inspected and passed for human consumption with SRM removed should be allowed in animal feed without the 0.15 percent restriction.
(Response) The agency disagrees that all tallow should be prohibited in animal feed or that tallow should be free of impurities to be used in animal feed. The OIE considers tallow with less than 0.15 percent insoluble impurities to be protein-free. Further, OIE guidelines recommend that tallow meeting this standard is safe for use in animal feed, regardless of the exporting country's BSE status. As explained in the proposed rule, the agency is concerned about protein impurities that may be present in tallow particularly now that an attack rate study in the United Kingdom has found that oral administration of a very low dose (1 milligram (mg)) of BSE-infected brain produced disease in 1 of 15 calves receiving the dose. The agency sought comment on its proposed action, but no comments were received that provided a scientific basis for the agency to modify its position. Therefore, FDA has decided to prohibit all tallow containing more than 0.15 percent insoluble impurities from use in ruminant feed, but prohibit only tallow that contains more than 0.15 percent insoluble
(Comment 35) Two comments said that, because no BSE risk is associated with the dirt, bone, and sand that comprise the impurities in tallow, the agency does not need to prohibit tallow containing more than 0.15 percent impurities.
(Response) These comments imply that protein is not a component of tallow impurities. A 2001 report from a European Scientific Steering Committee stated that analysis of impurities in six tallow samples found that crude protein levels ranged from 5 percent to 16 percent, assuming that all nitrogen in the impurities was of protein origin (Ref. 13). Since protein may be a component of tallow impurities, FDA believes that limiting tallow impurities to the OIE recommended level of 0.15 percent is appropriate.
(Comment 36) Many comments stated that brain and spinal cord cannot be removed completely from some dead cattle, and that the feasibility of removal depends on such things as condition of the carcass, size of the animal, worker skill, weather conditions, and distance between the production site and the rendering facility. Some comments submitted estimates of the percentage of dead animals from which brain and spinal cord could feasibly be removed. Those estimates ranged from as low as 15 percent to as high as 54 percent.
(Response) FDA acknowledges that removing brain and spinal cord from dead cattle may be difficult for the reasons mentioned, and that the agency may have overestimated the number of independent renderers that would choose to remove brain and spinal cord from dead cattle. However, FDA believes that, unless cattle not inspected and passed for human consumption are shown to be less than 30 months of age, the brain and spinal cord must be removed prior to use in animal food or feed to prevent BSE. As discussed in more detail in the response to Comment 28, FDA notes that the use in animal feed of materials from cattle not inspected and passed that are diseased or that die otherwise than by slaughter is the subject of enforcement discretion.
(Comment 37) FDA was asked to define what constitutes an “acceptable” level of brain/spinal cord removal. Another comment recommended that renderers maintain written procedures for processes used to remove brain and spinal cord and verify that such processes meet FDA standards for removal.
(Response) During an inspection, FDA will review the adequacy of a firm's written procedures for removal of brain and spinal cord and will verify that the firm is following its procedures and effectively removing all the brain and spinal cord or otherwise excluding it from animal feed use.
(Comment 38) One comment said that custom-slaughter plants (not federally or State inspected) will need to remove the brain and spinal cord of all cattle, regardless of the animal's age.
(Response) Meat from cattle slaughtered under the custom-slaughter exemption is exclusively for the use by the owner of the animal, members of his or her household, and nonpaying guests and employees (Federal Meat Inspection Act, section 623(a)). Because such cattle are slaughtered without inspection by an appropriate regulatory authority, these animals would be considered cattle not inspected and passed for human consumption. The rule prohibits their use in animal feed if they are not shown to be less than 30 months of age or the brain and spinal cord are not effectively removed or effectively excluded from animal feed.
(Comment 39) One comment stated that FDA should require firms that intend to render deadstock for use in animal feed to obtain a special permit and demonstrate to FDA's satisfaction that they have implemented a system that is consistently effective in removing brain and spinal cord.
(Response) This final rule requires that rendering firms maintain written procedures specifying how brain and spinal cord are effectively removed. The agency does not believe that requiring such firms to obtain a permit is necessary at this time. FDA believes that following its current approach of working collaboratively with its State counterparts to ensure compliance with BSE regulations will continue to be effective.
(Comment 40) Two comments stated that dentition will not work for the process of determining the age of cattle and that an animal identification system is needed.
(Response) The final rule has been revised to emphasize that firms are responsible for having processes in place to ensure cattle not inspected and passed for human consumption from which brain and spinal cord are not removed are shown to be less than 30 months of age. If a firm is unable to determine the age of an animal, the brain and spinal cord must be removed in order for the remaining carcass to be used for animal feed and not violate the prohibitions in this final rule. As discussed in more detail in the response to Comment 28, FDA notes that the use in animal feed of materials from cattle not inspected and passed that are diseased or that die otherwise than by slaughter is the subject of enforcement discretion.
Cattle under 30 months of age may be adequately identified through dentition. Veterinary texts and academic articles indicate that the second set of permanent incisors erupt when cattle are between 24 and 30 months of age. Thus, cattle would be considered to be 30 months of age and older if at least one of the second set of permanent incisors has erupted. However, environmental or operational conditions could make aging by dentition difficult. Therefore, firms' written procedures may need to include other means of age determination or adopt the default assumption that the animal is over 30 months.
A significant number of comments were submitted pertaining to disposal problems that could be created if the proposed rule is finalized. These problems ranged from the financial burden created by collection fees to State and local regulations that restrict non-feed disposal of prohibited materials.
(Comment 41) Numerous comments said that FDA underestimated the volume of material that will require alternative disposal when FDA's proposed measures force renderers to increase collection fees or discontinue deadstock pickup. One comment said that as a result of the new regulation, pig, horse, and deer mortalities will no longer be picked up on discontinued routes. Another comment stated that farmers and dairymen will probably bury, compost, landfill, or dump carcasses to avoid the increased collection fee that renderers will charge.
(Response) FDA agrees that renderers who continue to collect deadstock will likely increase collection fees to cover the costs of complying with the new requirements, and that we may have underestimated the impact that higher fees will have on deadstock collection. In the October 2005 proposed rule (70 FR 585701 at 58592), we estimated that the 17 percent of dead cattle currently being collected would decrease by 3.5 percent, and did not assume a decrease in the collection of dead animals of other species. The revised economic
(Comment 42) Some comments stated that rendering is the best disposal option and that burial, composting, and incineration are undesirable alternatives. One comment said that if SRMs and deadstock are diverted from animal feed use, FDA will no longer have control over this material. Another comment pointed out that it takes 14 months to properly compost a 1500-pound (lb) cow.
(Response) FDA believes this final rule appropriately controls materials to be rendered for animal feed. FDA intends to work with relevant local, State, and other Federal agencies concerning disposal issues.
(Comment 43) Some comments stated that an infrastructure is not in place to provide alternative disposal in all areas of the country. Several comments said the rule will create a disposal crisis. One comment said that landfill operators and solid waste regulators are not prepared to deal with the magnitude of the disposal problem, and that some landfills will not accept dead animals or slaughter byproducts. Another comment said that they found no incinerators in their service area that would accept dead animals. One comment said that disposal rendering is feasible, but may not be locally available or that collection fees may be prohibitive. The last comment also said that alkaline hydrolysis digesters are not feasible, strict air pollution measures might preclude the use of incinerators, composting is prohibited in some areas, and land for burial is unavailable in densely populated areas.
(Response) FDA recognizes that no single method of disposal is available or suitable in all regions of the country and acknowledges that the transition from rendering to other forms of disposal will be challenging in some parts of the country. The regulation will not become effective until 12 months after publication of this final rule, so that livestock producers, meat packers, renderers, and regulators have sufficient time to arrange for disposal of CMPAF using one or more of the alternatives mentioned or any other legal alternative.
(Comment 44) A number of comments stated that, due to disposal restrictions at the State and local levels, a comprehensive disposal plan is needed before the proposed rule is implemented. Several comments said that FDA should consult with Federal, State, and local agencies, and with the affected industries, on environmentally safe disposal of deadstock. One comment said that neither FDA nor USDA has jurisdiction over on-farm disposal. Another comment said that USDA should use its broad animal health authority to lead a Federal agency task force on disposal.
(Response) Non-feed disposal of carcasses and slaughter byproducts is primarily regulated by State and local agencies. Under certain circumstances, Federal agencies, such as the Environmental Protection Agency (EPA), may use their authorities to regulate disposal of this material. FDA consulted with EPA and participated in an industry sponsored roundtable in July 2006 to discuss practical solutions for non-feed disposal throughout the United States. FDA is ready to work with industry and other governmental agencies in identifying appropriate ways to dispose of CMPAF.
(Comment 45) Some comments pointed out that Europe avoided massive disposal problems through government subsidies to the rendering industry for picking up and rendering prohibited material. Subsidies would help with disposal problems in the United States.
(Response) FDA does not have authority to subsidize alternative disposal of CMPAF.
(Comment 46) Several comments urged FDA to explore alternative ways to use CMPAF, such as in the production of biofuel.
(Response) FDA welcomes innovative ways of disposing of animal byproducts, such as using them for the production of biofuels. The agency has participated in industry/government workshops that explored ideas for using deadstock and animal byproducts for the production of energy. The agency encourages environmentally sound, commercial uses of these materials so that the disposal burden is minimized.
(Comment 47) One comment indicated that FDA should not expect a disposal-only rendering industry to develop if the proposed rule is implemented.
(Response) FDA acknowledges that many factors, including the implementation of this final rule, play a role in determining whether facilities dedicated to disposal rendering may emerge in the marketplace.
(Comment 48) One comment stated that prohibited brain and spinal cord material should not be diverted for use as fertilizer because the infectious agent can survive in soil and be recycled to cattle through crops.
(Response) FDA is not aware of any data showing that BSE can be transmitted by this route.
(Comment 49) One comment asked that the U.S. Government focus on research and on supporting the rendering industry's development of alternative uses for animal byproducts.
(Response) FDA agrees that alternative uses for animal byproducts need to be encouraged and studied further.
(Comment 50) Several comments addressed certification/registration of facilities handling cattle materials. One comment suggested that FDA should require annual certification to ensure that every facility handling cattle materials is in compliance with the rule. Another comment suggested registration of entities that handle prohibited cattle material, including renderers, farms that feed or mix feed for ruminants, and other parties that handle prohibited material, except where government inspection is already present (packer-associated renderers).
(Response) The agency does not believe that requiring certification or registration of firms is necessary at this time. FDA believes that continuing its current approach of working collaboratively with its State counterparts to ensure compliance with BSE regulations will continue to be effective.
(Comment 51) One comment asked whether written statements from slaughter and processing establishments would be acceptable to FDA as evidence that offal is free of prohibited material. One comment said that, due to liability concerns, renderers will be reluctant to accept material from plants that are not federally inspected. Two comments said that slaughter plants should be required to verify that raw materials sent for rendering into animal feed are free of prohibited cattle materials.
(Response) The proposed rule provided that renderers that handle cattle materials must establish and maintain records sufficient to demonstrate that materials rendered for animal feed are not manufactured from, processed with, or does not otherwise contain CMPAF. The final rule has been revised to further clarify that renderers' records must also include certification or other documentation from each supplier, or other documentation acceptable to FDA, that CMPAF has been excluded from materials to be
(Comment 52) One comment asked that FDA clarify whether separate lines of equipment (barrels, room storage, pick-up vehicles) are required for handling SRM material. Another comment said the proposal's requirement that facilities be dedicated may cause renderers to discontinue processing CMPAF. A third comment stated that equipment for processing and transportation of prohibited cattle materials should be specifically designated for such purposes only. A fourth comment suggested that renderers and slaughter plants should have verifiable separation and identification procedures in place.
(Response) Under the final rule, renderers that provide a service to a slaughter plant by disposing of CMPAF must ensure that there is no cross-contamination, either through direct contact or via equipment surfaces, between CMPAF and animal feed or feed ingredients. In addition, CMPAF material is required to be marked and labeled “Do not feed to animals.” Renderers are responsible for ensuring that firms collecting such material on their behalf meet these requirements.
FDA received many comments that addressed enforcement issues. Specifically, concerns were raised about an increased inspection burden, prohibited materials being illegally transported and dumped, and the need for agency guidance on recordkeeping.
(Comment 53) Several comments said that additional resources will be needed to effectively enforce the new measures. One comment said that additional inspectors may be needed to ensure proper removal and disposal of the CMPAF. Two other comments said that increased inspectional presence will be necessary to ensure that firms comply with aging and brain and spinal cord removal requirements.
(Response) FDA agrees that successful enforcement of the new measures will require an increased inspectional presence at firms that render cattle materials. Any reallocation of inspections needed to enforce this new rule should not affect the inspections of high-risk firms that are already being conducted to enforce the current ruminant feed rule.
(Comment 54) One comment said the proposed rule creates too much of an inspectional burden with an over reliance on the examination of records. Another comment, in contrast, said that visual inspection by investigators ultimately cannot determine the presence or absence of the BSE agent.
(Response) The agency considers both onsite observations of firms' operations and examination of records to be important and valuable components for ensuring compliance with the new rule. Inspections are not intended to detect the presence of the BSE agent, but rather are intended to ensure that CMPAF are not used in animal feed. Records examination is intended to verify that firms maintain and follow written procedures and to facilitate tracking the receipt, processing, and distribution of CMPAF.
(Comment 55) One comment stated that increases in renderer pick-up fees will result in illegal transportation and dumping of deads, downers, and CMPAF.
(Response) FDA intends to vigorously enforce this new rule to ensure that CMPAF is not used in animal feed. FDA believes this final rule appropriately controls materials to be rendered for animal feed. FDA intends to work with relevant local, State, and other Federal agencies concerning disposal issues.
(Comment 56) One comment said the proposal may cause independent renderers to stop accepting offal from red meat slaughter and processing establishments unless assurances are received that prohibited materials have been removed. Another comment cited a statement from a USDA OIG report saying that slaughter establishments are not adequately removing SRMs under current USDA regulations (Ref.14). The comment expressed concern that assurance cannot be provided for the removal of CMPAF from slaughter cattle under the proposed FDA regulation.
(Response) As stated in the proposed rule, this final rule requires renderers to establish and maintain records sufficient to demonstrate that raw materials to be rendered for animal feed are free of CMPAF. The agency expects that, as a condition of collection, renderers will require beef slaughter establishments to provide sufficient documentation to enable the renderers to meet their obligation for establishing and maintaining records demonstrating CMPAF removal. As discussed above, this final rule clarifies that renderers' records must include documentation, such as certification or other documentation from the supplier that material supplied to the renderer does not include CMPAF, or documentation of another method acceptable to FDA to verify that CMPAF has been segregated from slaughter byproducts that are to be rendered for animal feed use.
(Comment 57) Several comments stated that renderers might not collect offal from 4-D plants and custom slaughter establishments because there is not routine government inspection of these operations to ensure removal of CMPAF. Several comments suggested that FDA require written certification of CMPAF removal.
(Response) Because 4-D plants meet the definition of renderer, these firms are subject to the requirements of this rule. The final rule requires that renderers maintain written procedures for how they will remove brain and spinal cord from cattle not inspected and passed for human consumption and, if such cattle are to be rendered without brain and spinal cord removal, written procedures for how they will verify that such cattle are less than 30 months of age. Rendering firms that collect material from a 4-D operation would have the responsibility of showing that CMPAF had been removed by the 4-D plant prior to collection, or that any CMPAF-containing material collected is not introduced into animal feed.
With respect to custom slaughter, the final rule defines CMPAF to include certain cattle not inspected and passed for human consumption by the appropriate regulatory authority. Since the slaughter and processing of cattle in custom slaughter operations are not subject to inspection, the cattle handled by custom slaughter facilities would be considered not inspected and passed for human consumption. Therefore, cattle materials from custom slaughter establishments cannot be rendered for use in animal feed if the brain and spinal cord are not effectively removed from cattle that are 30 months of age or older. It is the renderer's responsibility to establish and maintain records sufficient to demonstrate that material rendered for use in animal feed does not contain CMPAF. The final rule clarifies that these records must include certification or other documentation from the supplier demonstrating that adequate segregation procedures are in place at slaughter establishments, including custom slaughter
If renderers receive CMPAF for disposal, they are responsible for ensuring that it is excluded from animal feed. As discussed in more detail in the response to Comment 29, FDA notes that the use in animal feed of materials from cattle not inspected and passed for human consumption that are diseased or that die otherwise than by slaughter is the subject of enforcement discretion.
(Comment 58) Numerous comments asked that FDA provide guidance on several aspects of the rule, such as proper recordkeeping, acceptable processes for removing brain and spinal cord from cattle not inspected and passed for human consumption, and separation and dedication of processing areas.
(Response) FDA has specified in the final rule the recordkeeping requirement for renderers receiving raw materials from slaughter facilities. FDA will provide guidance as needed for meeting other requirements of the new rule.
(Comment 59) One comment suggested that FDA require firms handling prohibited material to be registered.
(Response) Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA. The agency does not believe that requiring additional registration of all firms handling prohibited material is necessary at this time. FDA believes that following its current approach of working collaboratively with its State counterparts to ensure compliance with BSE regulations will continue to be effective.
(Comment 60) One comment suggested that FDA license firms handling prohibited cattle material just as it licenses feed mills that use Category II drugs as Type A medicated articles.
(Response) The agency does not believe that requiring that firms be licensed is necessary at this time. FDA believes that continuing its current approach of working collaboratively with its state counterparts to ensure compliance with BSE regulations will continue to be effective.
(Comment 61) Two comments questioned whether FDA has jurisdiction to inspect slaughter establishments to verify proper segregation of CMPAF. Another comment said it strongly opposes new FSIS inspectional activity to oversee CMPAF removal from animal feed. In addition, two comments said that the proposed rule amounts to an unfunded mandate requiring States to conduct additional inspections at slaughter establishments to ensure proper removal of CMPAF.
(Response) Under this final rule, it is the responsibility of the renderer to ensure that material rendered for use in animal feed is free of CMPAF. FDA acknowledges that it does not conduct inspections in USDA-regulated slaughter establishments. Nevertheless, the agency believes that ensuring the segregation of CMPAF from other slaughter byproducts is pivotal to enhancing the safety of all animal feed. During inspections at rendering facilities, FDA intends to verify that renderers maintain records sufficient to demonstrate that material rendered for use in animal feed does not contain CMPAF. In response to comments regarding recordkeeping and the need for verification of the raw materials, the final rule has been revised to clarify that a renderer's records must either include certification or other documentation from the supplier that material supplied to the renderer does not include CMPAF, or documentation of another method acceptable to FDA, such as third party certification, for verifying that suppliers have effectively excluded CMPAF.
(Comment 62) Two comments stated that distribution records should be sufficiently detailed to allow for conducting trace forward and trace back investigations of prohibited cattle materials.
(Response) As finalized herein, § 589.2001(c)(2)(vi) (21 CFR 589.2001(c)(2)(vi)) requires renderers that handle CMPAF to establish and maintain records sufficient to track CMPAF to ensure such material is not introduced into animal feed, and make the records available for inspection and copying by FDA. And under § 589.2001(c)(3)(i), renderers that handle any cattle materials must establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, CMPAF, and make the copies available for inspection and copying by FDA. FDA expects to provide guidance, as needed.
(Comment 63) One comment stated that renderers should maintain records on how they dispose of prohibited cattle material.
(Response) The final rule requires renderers to maintain records sufficient to track CMPAF to ensure that the material was not introduced into animal feed.
(Comment 64) Several comments suggested that instead of requiring that records be kept for 1 year, FDA should require that records be maintained for a longer time period. Suggestions ranged from 3 to 12 years.
(Response) FDA does not consider it necessary to extend the recordkeeping requirement. As discussed in greater detail in the preamble to the October 2005 proposed rule (70 FR 58570 at 58582), FDA believes 1 year is appropriate, considering the amount of time the products will be in the animal feed production and distribution systems.
(Comment 65) Several comments pointed out that time may be needed for implementation of the rule. Two comments suggested that it would take more than a year for renderers to develop dedicated rendering facilities or other types of disposal in California. Two other comments suggested a staged approach.
(Response) FDA received numerous comments regarding the impacts of the proposed new requirements, particularly with respect to the separation and appropriate disposal of CMPAF. The analysis of economic impacts completed for this final rule estimates that slaughter and rendering facilities will incur substantial one-time capital costs in order to comply with the new requirements. Furthermore, this analysis indicates that a substantial component of the total cost of this rule is associated with the disposal of CMPAF. Based on comments received on the proposed rule and on FDA's impact analysis completed for this final rule, FDA agrees that sufficient time will be needed to effectively implement the new requirements of this final rule including the development of alternate methods for disposing of CMPAF. FDA believes that 12 months should be a sufficient amount of time for the U.S. animal feed industry to come into compliance with this final rule.
(Comment 66) Several comments said that instead of implementing new measures, FDA should provide additional resources to support compliance and enforcement of the current ban. Two comments stated that implementation of the new rule should not lessen enforcement of the current rule.
(Response) The basis for the measures in this final rule was discussed in the preamble to the October 2005 proposed rule (70 FR 58570 at 58578). Implementation of this new rule should not diminish inspection and enforcement of the 1997 ruminant feed
(Comment 67) One comment said that rendering plants will need time to modify equipment and procedures before the rule is implemented.
(Response) FDA understands that rendering plants will have to make a variety of modifications to comply with the final rule. For this reason, FDA has made the new rule effective 12 months from the date of publication.
The final rule amends § 589.2000 to exclude from the definition of “protein derived from mammalian tissues” tallow containing no more than 0.15 percent insoluble impurities and tallow derivatives as specified in § 589.2001(b)(6). FDA also received several comments related to other requirements in § 589.2000.
(Comment 68) Three comments stated that salvaged pet foods, including distressed pet food, should be prohibited in cattle feed.
(Response) Pet food containing prohibited mammalian protein is prohibited from use in ruminant feed by the 1997 ruminant feed rule. Pet food products sold or intended for sale as distressed or salvage items must be labeled with the statement “Do not feed to cattle or other ruminants” if they contain or may contain prohibited mammalian protein (see § 589.2000(d)(4)). This final rule further reduces the risk that cattle could be exposed to the BSE agent through pet food because it requires the removal of certain cattle-derived risk materials from all animal feed.
(Comment 69) Two comments requested that the current feed rule be revised to exempt firms that handle retail pet food from recordkeeping requirements.
(Response) The 1997 ruminant feed rule requires firms to maintain records sufficient to track products containing prohibited mammalian protein. Exempting retail pet food distributors from recordkeeping requirements would diminish the ability of the agency to trace feed or feed ingredients that are adulterated under the 1997 ruminant feed rule. The agency intends to issue guidance that addresses what constitutes records sufficient to track prohibited protein associated with the sale of retail pet food.
(Comment 70) One comment suggested that the current rule be revised to require feed labels that clearly, concisely, and accurately inform users about the source of animal protein ingredients in feeds. The comment said that requiring new feed ingredient definitions such as “non-ruminant derived animal proteins,” “ruminant derived animal proteins,” and “non-mammalian derived animal proteins” would be helpful.
(Response) Section 589.2000 requires that feed products that contain or may contain prohibited mammalian protein be labeled with the caution statement “Do not feed to cattle or other ruminants.” Part 501 (21 CFR part 501) contains most of the labeling requirements for animal feed. Under § 501.4, ingredients must be listed on the product label by their common or usual name. Section 501.110 provides for the use of collective terms, such as “animal protein products,” in lieu of listing each ingredient by its common or usual name. For FDA recommendations regarding the common or usual names for animal feed ingredients, see Compliance Policy Guide 7126.08. In response to the FDA Amendments Act of 2007, FDA intends to develop new regulations on processing and ingredient standards and ingredient definitions for all animal feed, and updated labeling standards for pet food.
Section 589.2001(a)(1) is being added to the final rule, and it sets forth the purpose of new § 589.2001, which is to prohibit the use of certain cattle origin materials in the food or feed of all animals to further reduce the risk of the spread of BSE within the United States.
To address the BSE risk, § 589.2001(b)(1) defines cattle materials prohibited in animal feed (CMPAF) to include the following: (1) The entire carcass of BSE-positive cattle; (2) the brains and spinal cords of cattle 30 months of age and older; (3) the entire carcass of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not effectively removed or otherwise effectively excluded from animal feed; and (4) mechanically separated beef and certain tallow that is derived from materials prohibited by this rule. The definition of CMPAF does not include tallow derivatives or certain tallow that contains no more than 0.15 percent insoluble impurities. This definition differs from the proposed rule in that the entire carcass from BSE-positive cattle has been added to the definition. This was done to clarify that all materials from such animals are prohibited from use in animal feed. Further, the regulations were revised to exclude from the definition of CMPAF certain cattle that have not been inspected and passed for human consumption. Under the proposed rule, cattle that were not inspected and passed for human consumption were excluded from the definition of CMPAF if their brains and spinal cords were removed. The final rule was revised to indicate that such cattle are not considered CMPAF if the animals were shown to be less than 30 months of age, regardless of whether the brain and spinal cord have been removed. The regulations have also been revised to exclude from the definition of CMPAF certain cattle materials that originate from a country that has been designated by FDA as exempt from the requirements of this rule based on its BSE risk status. This exclusion is being added in response to comments and because the agency has determined that it is not necessary for all BSE-related restrictions to apply to animal feed regardless of a country's BSE status. Epidemiological evidence indicates that the BSE epidemic in the United Kingdom (U.K.) was a result of consumption of animal feed contaminated by the BSE agent. The spread of BSE outside the U.K. has been attributed to the export of BSE-contaminated feed from the U.K. to other countries prior to the realization of the role of feed in transmitting the disease and the subsequent restrictions on such trade. FDA acknowledges that a country may not have engaged in commercial trade in animal feed with the U.K. or other affected countries, and it may have had preventive measures in place for a length of time adequate to make remote the chance that BSE is present in that country.
Such a country may be able to demonstrate to FDA that its BSE case history, risk factors, and measures to prevent the introduction and transmission of BSE make certain BSE-related restrictions unnecessary with respect to cattle materials from that country. Allowing cattle materials from such a country to be used in non-ruminant animal feed manufactured from, processed with, or otherwise containing CMPAF is consistent with OIE's recommendation that other prohibited materials from negligible risk countries not be restricted. The process for seeking designation to be covered by this exclusion is set forth in § 589.2001(f).
In its application, the requesting country will be expected to provide information to FDA on its BSE case history, including whether cattle in that
• Possible presence of BSE in indigenous and/or imported cattle;
• Geographic origin of imported cattle;
• Materials used in the production of ruminant feed and feed ingredients; and
• Importation of ruminant feed and feed ingredients.
FDA will consider information relating to the possible presence of BSE in indigenous and imported cattle in the requesting country as well as the requesting country's production and importation of ruminant feed and feed ingredients. With respect to imported cattle, relevant information includes the identification of any countries where imported cattle were born or raised and the dates any cattle were imported. With regard to ruminant feed, FDA will consider, among other things, how ruminant feed was produced in the requesting country, including what animal origin materials were allowed to be included. FDA will also consider whether ruminant feed and feed ingredients were imported, and if so, the source countries and dates of import.
In addition to reviewing risk factors such as those identified previously, FDA will assess how the requesting country has addressed and managed any identified BSE risks through the implementation of appropriate measures to prevent the introduction and transmission of BSE. FDA will consider how long such preventive measures have been in place and whether they have been effectively carried out. Examples of preventive measures include the following:
• A prohibition on the use of ruminant feed that might carry a risk of transmitting the BSE agent;
• A prohibition on the import of cattle and cattle-derived products that might carry a risk of transmitting the BSE agent;
• Surveillance systems for BSE in cattle populations with appropriate examination of brain or other tissues collected for surveillance in approved laboratories;
• Mandatory notification and examination of all cattle showing signs consistent with BSE; and
• Protocols or other written procedures for investigating potential cases of BSE, including ability to trace former herdmates of BSE-positive animals.
As part of its evaluation of a requesting country's feed restrictions, FDA will consider factors including whether appropriate feed restrictions are in place and the adequacy of enforcement of those restrictions (e.g., the frequency of facility inspections and level of compliance). FDA also will consider a requesting country's import controls for cattle material. Such consideration will include whether the country effectively monitors and controls potential pathways of cattle materials and other potentially infective materials into its country from other countries for which such controls are necessary.
In addition, FDA will consider the requesting country's surveillance and monitoring efforts with respect to BSE. For example, FDA will evaluate the level at which the country performs surveillance and monitoring, whether tissue samples are collected and examined at approved laboratories, and whether recognized diagnostic procedures and methods are used, such as those procedures and methods provided in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Ref. 15).
FDA also will consider whether the requesting country has an ongoing program for notification and investigation of all cattle showing signs consistent with BSE. In evaluating such a program, FDA will consider, among other factors, whether notification and investigation is mandated, whether veterinarians, producers, and others involved in cattle production have been provided sufficient information about BSE, such as through an awareness program, and whether there are additional measures in place to stimulate reporting of suspect cattle, such as compensation or penalties.
FDA also will consider a requesting country's written procedures for investigating potential cases of BSE. Such a consideration will include whether the country has written procedures for the investigation of suspect animals and whether the country has the investigative capability to follow up positive findings by tracing former herdmates of animals determined to be BSE positive. Finally, FDA also will consider any other information relevant to determining whether the country should be designated under § 589.2001(f).
FDA and the USDA agencies, APHIS and FSIS, have different regulatory responsibilities with respect to preventing BSE and ensuring food safety. Therefore, FDA cannot rely on the evaluations of APHIS and FSIS in making a determination on country designations. FDA will, however, consult with APHIS and FSIS as part of its evaluation process. In addition, FDA will take into consideration available risk assessments of other competent authorities in conducting its evaluation. Although it is not required, a previous BSE evaluation by USDA, OIE, or by another government or another competent authority, will be helpful to FDA in its review and may decrease the time needed for FDA to make a determination.
Upon completion of its review, FDA will provide written notification of its decision to the requesting country, including the basis for the decision. FDA may impose conditions in granting a request for designation. Further, any designation granted under § 589.2001(f) will be subject to future review by FDA to ensure that the designation remains appropriate. As part of this process, FDA may ask designated countries to confirm that their BSE situation and the information submitted by them in support of their original application remain unchanged. Further, FDA may revoke a country's designation if FDA determines that it is no longer appropriate.
FDA will provide further information on its evaluation process, the scope of the review, and the types of supporting information that it would find helpful in reviewing a country's submission at the time of the request.
Section 589.2001(b)(2) defines cattle not inspected and passed for human consumption as cattle that did not pass antemortem inspection by the appropriate regulatory authority. This term includes nonambulatory disabled cattle. Nonambulatory disabled cattle are cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions. The definition of cattle not inspected and passed for human consumption was revised to add the word “ante-mortem” to clarify that cattle referred to in this definition are those that did not pass (or were not subjected to) antemortem inspection.
Section 589.2001(b)(3) defines mechanically separated beef as a finely comminuted meat food product, resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of cattle carcasses and parts of carcasses.
Section 589.2001(b)(4) defines renderer to mean any firm or individual that processes slaughter byproducts, animals unfit for human consumption, or meat scraps. The term includes
Section 589.2001(b)(5) defines tallow to mean the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues.
Section 589.2001(b)(6) defines tallow derivative to mean any product obtained through initial hydrolysis, saponification, or transesterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or transesterification may be applied to obtain the desired product.
The definitions in § 589.2001(b)(3), (b)(4), (b)(5), and (b)(6) are unchanged from the proposed rule.
Section 589.2001(c)(1) provides that no animal food or feed ingredient shall be manufactured from, processed with, or otherwise contain CMPAF. Section 589.2001(c)(2) provides new requirements for renderers that handle CMPAF. Section 589.2001(c)(3) provides new requirements for renderers that handle any cattle material.
Section 589.2001(c)(2) of the final rule has been revised to include requirements for renderers that intend to render for use in animal feed cattle not inspected and passed for human consumption. If such cattle are to be rendered for animal feed, the renderer must ensure that the brain and spinal cord are effectively removed or otherwise effectively excluded from material rendered for use in animal feed. If such cattle are to be rendered without brain and spinal cord removal, the renderer must ensure that such animals are less than 30 months of age. In addition, written procedures must be maintained specifying the procedures used to ensure compliance with these requirements.
As provided in the proposed rule, § 589.2001(c)(2) of the final rule also requires that renderers that handle CMPAF use separate equipment or containers to handle such material once it has been separated from other cattle materials. This requirement is intended to ensure that equipment used to manufacture, process, blend, store, or transport CMPAF or products that contain or may contain CMPAF do not serve as a source of cross-contamination.
In addition, § 589.2001(c)(2) requires renderers that handle CMPAF or products that contain or may contain CMPAF to: (1) Label the prohibited materials in a conspicuous manner with the statement “Do not feed to animals”; (2) mark the prohibited material with an agent that can be readily detected on visual inspection, and (3) establish and maintain records sufficient to track the prohibited materials to ensure such material is not introduced into animal feed, and make the records available for inspection and copying by FDA. These requirements are intended to ensure that CMPAF do not enter the animal feed chain and thus have no opportunity for inclusion in animal food or feed. FDA believes that such material must be both labeled and marked to ensure that it does not enter the feed channels, since without such measures this material would be indistinguishable from other cattle materials. Marking the material will provide a readily detectable method on visual examination by which all persons in the animal feed chain can be made aware that the product is prohibited material or contains prohibited material. Marking also will serve as a way to make the status of the material known if, for some reason, the label “Do not feed to animals” is separated from the product.
Section 589.2001(c)(3) requires that renderers that handle any cattle materials shall: (1) Establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, CMPAF; (2) make copies of records available for inspection and copying by FDA; and (3) be in compliance with requirements under § 589.2000 regarding animal proteins prohibited in ruminant feed. These requirements are unchanged from the proposed rule.
Section 589.2001(c)(2)(v) requires that renderers that receive, manufacture, process, blend, or distribute CMPAF establish and maintain records sufficient to demonstrate that such material was not introduced into animal feed and make them available to FDA for inspection and copying. Furthermore, § 589.2001(c)(3) requires that renderers that receive, manufacture, process, blend, or distribute any cattle materials establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain CMPAF. Such records shall be considered sufficient to meet this requirement if they include documentation that establishments supplying cattle materials to the renderers have adequate procedures in place to effectively exclude cattle materials prohibited in animal feed. The exclusion of CMPAF by establishments supplying cattle materials to renderers must be demonstrated either by certification or other documentation provided by the supplier or by another method acceptable to FDA such as third-party certification. Certification or other documentation provided by the supplier is acceptable provided such records include a description of the supplier's segregation procedures, documentation that the supplier confirms that such procedures are in place prior to supplying any cattle material to the renderer, and records of the renderer's periodic review of its suppliers' certification or other documentation. Copies of all records established and maintained by renderers must be made available for inspection and copying by FDA.
In the preamble to the October 2005 proposed rule (70 FR 58570 at 58581), FDA explained that these recordkeeping requirements were intended to ensure that no CMPAF would enter the feed channel. At that time, the agency explained that it did not believe it was necessary for persons other than renderers that are involved in the manufacture or processing of feed or feed ingredients to maintain records documenting the exclusion of CMPAF. The agency went on to state its belief that requiring the maintenance of such records at all manufacturing and processing points downstream would be redundant and provide little additional information of value. FDA, however, sought comments on the need to require that records be maintained by persons other than renderers. The agency did not receive any comments on this point. Therefore, FDA is requiring that such records be established and maintained by renderers for the reasons explained in the preamble to the proposed rule.
FDA also sought specific comments on what types of records would be appropriate for satisfying the recordkeeping requirements and whether further detail would be needed
Section 589.2001(e) provides that the records required by this final rule be maintained for a minimum of 1 year. The 1-year record retention period is consistent with the existing requirements for ruminant feeds in § 589.2000(h). We believe that, for the purposes of the recordkeeping requirements, 1 year is appropriate in light of the time that the products will be in the animal feed production and distribution systems. Extending the record retention period would have little practical value in determining the source of BSE in an animal. In reaching this conclusion, the agency considered the potentially long time period from ingestion of the BSE agent in feed to manifestation of clinical signs and lesions and the lack of a reliable estimate for the latency period.
Section 589.2000(a)(1) has been amended to add language that excludes, from the definition of protein derived from mammalian tissues, tallow containing no more than 0.15 percent insoluble impurities and tallow derivatives as specified in § 589.2001(b)(1)(v). As discussed in the preamble to the proposed rule, § 589.2000 previously did not include tallow in the definition of protein derived from mammalian tissues. However, in light of concerns about protein impurities present in tallow, FDA has included tallow in the definition of protein derived from mammalian tissues unless it contains no more than 0.15 percent insoluble impurities.
FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts, and equity). The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before finalizing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current (2005) Implicit Price Deflator for the Gross Domestic Product.
FDA finds that the final rule constitutes an economically significant regulatory action as defined in section 3(f)(1) of Executive Order 12866 because the sum of the recurring costs and capital costs that could be incurred in 1 year rounds to $100 million. We base this conclusion on both a study of the impacts on industry of the final rule (conducted for FDA by the Eastern Research Group (ERG), a private consulting firm (Ref. 16)) and the discussion in the remainder of this section. Under the requirements of the Regulatory Flexibility Act (RFA), the agency has determined that the regulation will have a significant impact on a substantial number of small entities. Therefore, the agency has prepared a final regulatory flexibility analysis in accordance with the RFA (5 U.S.C. 604). The analysis can be located in section IV.H of this document. This final rule imposes no mandates on government entities, and does not require the expenditure of over $122 million in any 1 year by the private sector. As such, further analysis of anticipated costs and benefits is not required by the Unfunded Mandates Reform Act.
The existing rule, which provides the baseline for this analysis, prohibits the use of certain protein derived from mammalian tissues in ruminant feeds. This final rule expands this restriction to prohibit certain cattle-derived risk materials in all animal feeds. The final rule, which is very similar to the proposed rule, would define those CMPAF to include the brain and spinal cord of all cattle 30 months of age or older slaughtered for human consumption, as well as the brain and spinal cord of cattle not inspected and passed for human consumption 30 months of age or older, the entire carcass of cattle not inspected and passed for human consumption 30 months of age or older unless the brain and spinal cord have been effectively removed or effectively excluded from animal feed, as well as other materials. The final rule makes a notable change from the proposed rule by not defining as CMPAF the brain and spinal cord from cattle under 30 months of age that are not inspected and passed for human consumption. FDA has also revised the final rule to clarify that the records established and maintained by renderers that receive cattle materials to be rendered for use in animal feed must include certification or other documentation from the supplier, or other documentation acceptable to FDA, that material supplied to the renderer does not include CMPAF. For the purposes of this final rule, the term “cattle not inspected and passed for human consumption” includes non-ambulatory disabled cattle. The final rule prohibits tallow derived from BSE-positive cattle from use in animal feed and prohibits tallow derived from other CMPAF from use in animal feed unless it contains no more than 0.15 percent insoluble impurities. The final rule also prohibits mechanically separated (MS) beef derived from any of the CMPAF from use in animal feed. Additional provisions of the final rule would require renderers that handle CMPAF to use separate equipment or containers to handle this material once it has been separated from other cattle materials. Such renderers would also be required to follow certain procedures for labeling and marking CMPAF and recordkeeping and records access.
The benefits of the final rule include the elimination of the vast majority of the risk not addressed by the 1997 ruminant feed ban of spreading BSE to other cattle from intentional or unintentional use of non-ruminant feed for ruminants or cross-contamination of
This final rule that prohibits the use of these materials in animal food or feed would impose four types of costs: Disposal costs, the opportunity cost of the MBM and tallow not produced, direct costs of new equipment and re-allocated labor, and feed substitution costs. Total compliance costs of the final rule are estimated to range from about $64.4 to $80.9 million per year annualized over 10 years assuming a 7-percent discount rate; at a 3-percent discount rate, total compliance costs are estimated at $64.0 to $80.5 million per year.
Compliance costs include those imposed by the rule's prohibition on the use of certain tissues from cattle 30 months of age or older slaughtered for human food and cattle 30 months of age and older not inspected and passed for human consumption in any animal feed as well as the cost to substitute other feed ingredients for those foregone from further processing of CMPAF. First, we discuss the brain and spinal cord ban as direct costs to the affected firms (including disposal costs, where applicable) and the social cost of the ban on the raw materials used in feed product inputs. Then, we discuss the feed substitution costs. Table 1 of this document shows a summary of these costs.
The ban on the use of certain cattle materials in all animal feed from cattle 30 months of age and older slaughtered for human consumption and cattle 30 months of age and older not inspected and passed for human consumption would require renderers that process either materials from cattle 30 months of age and older slaughtered for human consumption or cattle not inspected and passed for human consumption 30 months of age and older to separate the CMPAF from the remaining offal. Renderers may require slaughter facilities to separate such materials as a condition of collection. We estimate the one-time capital costs of such a requirement for slaughterers at about $2.1 million (Table 1, line 2) (or $299,000 annualized at 7 percent over 10 years and $246,000 annualized at 3 percent over 10 years). We estimate that the annual cost of the additional labor to separate this CMPAF from other cattle offal at about $972,000 (Table 1, line 3) (including maintenance on new equipment). Although compliance costs of these activities will be borne initially by slaughterers, a portion of the costs are likely to be passed along to cattle producers and consumers. For renderers, average annualized capital investment and labor costs for CMPAF separation and segregation are estimated at about $7.0 million (Table 1, lines 9 and 10).
Our analysis does not project a specific disposal route for CMPAF due to the variability of State and municipal laws for disposal of organic wastes. As it did for the proposed rule, our analysis of the final rule estimates a $12 per 100 lbs (hundredweight (cwt)) of CMPAF disposal cost (including any transportation costs) from slaughter and rendering establishments. We estimate annual disposal costs for CMPAF from independent renderers at about $11.3 million (Table 1, line 11) and from slaughterers at about $3.4 million (Table 1, line 23). We expect that the disposal costs for slaughter CMPAF are immediately passed on to animal producers as lower prices for animals delivered to slaughter. Additional disposal costs to animal producers for other animals that would no longer be rendered as a result of this rule will range from $24.7 million to $35.7 (Table 1, line 22) million annually. We estimate the social cost of the loss of MBM sales to range from $0.8 to $1.0 (Table 1, lines 4 and 14) million and the social cost from lost tallow sales to range from $0.7 to $0.8 million (Table 1, lines 5 and 15). These costs include the lost value from CMPAF from cattle 30 months of age and older slaughtered for human consumption, cattle not inspected and passed for human consumption 30 months of age and older, as well as calves, cattle under 30 months not inspected and passed for human consumption and other species that would no longer be rendered as a result of this rule. We judge the social cost of the loss of hide value resulting from this rule to range from $9.2 million to $13.7 million (Table 1, line 12) annually. The estimated cost of both creating and executing procedures for the aging of animals at greater or less than 30 months of age is $2.4 million (Table 1, lines 6 and 13) annually. To the extent some slaughter establishments already have aging procedures in place to comply with FSIS' SRM rule, this amount may be an overestimate.
The final rule, as in the proposed rule, requires that tallow derived from certain CMPAF contain no more than 0.15 percent insoluble impurities. Even though the estimate of CMPAF is much larger in the final rule, because the amount handled directly by independent renderers would remain relatively small, we concluded that it would not be economical for renderers or tallow manufacturers to further process into tallow the brains and spinal cords from all cattle that have their brains and spinal cords removed while complying with the additional equipment separation and tallow testing and purification requirements. We therefore did not include any additional cost for this provision.
Compared with the final rule, we do not offer any alternative that would impose greatly lower costs. The only feasible lower-cost alternative that would reduce the risk of cross contamination would be to require separate facilities or equipment to produce ruminant and non-ruminant feed.
This alternative would strengthen FDA's 1997 feed rule by preventing cross contamination of feed ingredients for ruminants with mammalian proteins currently prohibited from ruminant feed. To prevent cross contamination, this alternative would require dedicated equipment in those facilities producing or handling feed or feed ingredients for ruminants and mammalian proteins currently prohibited from ruminant feed. In the analysis of the alternatives to the proposed rule, ERG estimated that only independent renderers and feed mills would incur compliance costs for this dedicated facilities or equipment (70 FR 58593). It should be noted, however, that this requirement for dedicated facilities and equipment differs from the dedicated equipment requirement of the SRM ban (Alternative 3 in this document). Since the dedicated facilities and equipment option is analyzed here as a separate alternative (i.e. not as part of the SRM ban), the tonnage of rendered ruminants would not be reduced (without the SRM ban), and the resulting transportation costs would be larger than had the SRM ban been included as part of this alternative.
To dedicate facilities, independent renderers would invest about $8 million in one-time costs and feed mills would invest about $43.2 million in one-time costs. Annualized over 10 years at 7 percent, capital investment for dedicated facilities would equal about $7.3 million, or about $1.1 million for independent renderers and about $6.2 million for feed mills. ERG forecast that this alternative would have little effect on MBM production, but would force firms to spend more to transport MBM because they could no longer backhaul ruminant feed in trucks used to transport feed containing mammalian proteins currently prohibited in ruminant feed (70 FR 58593 to 58594). In the analysis for the proposed rule, ERG estimated that dedicated equipment would increase transportation costs by $8 million to $16 million for renderers and $14.2 million to $28.4 million for feed mills (70 FR 58594). Accounting for ERG's revised fuel costs (Ref. 16), the estimated costs for dedicated transportation equipment range from $14.6 million to $29.3 million annually for renderers and from $22.5 million to $45.0 million annually for feed mills. The total estimated annualized compliance costs of this alternative range from $44.4 million to $81.6 million.
This alternative addresses the problem of animal feed being cross-contaminated with prohibited mammalian protein in firms that manufacture animal feeds and also handle prohibited mammalian protein by requiring such firms to have dedicated facilities or equipment for animal feeds. The compliance costs of this alternative are similar to the costs of the final rule. In contrast to the final rule, however, this alternative would allow CMPAF with the highest BSE infectivity to remain in the animal feed supply, allowing potential exposure to BSE infectivity when cattle consume feed intended for other species through cross-contamination or misfeeding. We conclude, therefore, that the final rule more effectively reduces the risk from cross-contamination and misfeeding than this alternative to require dedicated facilities or equipment. Given the general similarity in compliance costs, we therefore judge this alternative to be less cost-effective than the final rule.
The proposed rule would require that the brain and spinal cord from all cattle 30 months of age or older slaughtered for human consumption, and from all cattle not inspected and passed for human consumption of any age to be defined as CMPAF. The main difference between the proposed rule and the final rule is that the proposed rule would also define as CMPAF the brain and spinal cord of cattle under 30 months of age that were not inspected and passed for human consumption. Compared with the final rule, this alternative produces more tissue for disposal by deadstock renderers, increasing the compliance costs for independent renderers.
Although this regulatory action would prohibit more material from animal feed than would the final rule, it would only add the brain and spinal cord of cattle not inspected and passed for human consumption under 30 months of age to the list of prohibited cattle material. Scientific evidence indicates that the probability that the brain and spinal cord from cattle under 30 months of age contains BSE infectivity is extremely low (Ref. 18). Consequently, this alternative is less cost-effective than the final rule because it cost $9.2 to $14.8 million more without a commensurate reduction of risk.
The third alternative we considered would prohibit the use of the full list of specified risk material (SRM) from animal feed and require the use of dedicated equipment by renderers. The scope of this alternative is similar to Canada's 2006 enhanced feed rule and is the most restrictive regulatory action we considered.
In practice, some tissues that are not defined as SRM would be difficult to separate and are treated as SRM. Canada made a similar distinction in its enhanced feed rule. Thus, in addition to the material prohibited in the final rule, this alternative would prohibit from all animal feed: The skull, eyes, trigeminal ganglia, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of all cattle.
As shown in Table 3 of this document, the estimated annualized costs of this alternative range from $332.0 million to $344.7 million. Slaughterers would incur annualized costs of about $19.5 million in lost revenues and increased labor and capital costs. Independent renderers would incur from $42.9 million to $55.6 million in annualized costs of lost revenues and increased labor and capital costs. Animal producers would incur about $12.7 million annually in feed substitution costs. Disposal costs for animals that would no longer be rendered as a result of the SRM ban and the disposal costs for slaughter SRM would account for the majority of the estimated annualized costs and equal about $257 million. Because most slaughterers can immediately pass disposal costs back to cattle producers by adjusting the prices they pay for slaughter animals, cattle producers would likely incur the entire cost of SRM disposal in the short run. ERG estimated that over time, markets would adjust to the impacts of an SRM ban and about 50 percent of the total incremental costs of this alternative would be passed on to consumers as higher beef prices, 38 percent of the total incremental costs would be passed back to cattle producers as lower cattle prices and 12 percent of the total incremental costs would be incurred by processors.
Although this option would increase the material removed from animal feed when compared with the first alternative, the incremental reduction in the potential risk would not be commensurate with the costs as shown in Table 3 of this document. Thus, this regulatory alternative would be much less cost-effective than either the final rule or the proposed rule.
Table 4 of this document shows the annualized and incremental costs of each regulatory alternative considered. The safeguards put in place by the 1997 ruminant feed rule have substantially reduced the potential risk that tissues infected with the agent that causes BSE could get into ruminant feed. The final rule further reduces the possible risk of cross contamination of ruminant feed with prohibited material. As explained previously, we have determined that the final rule is the most cost-effective action for reducing the potential risk that animal feed or feed ingredients intended for ruminants could contain the agent that causes BSE.
Executive Order 12866 directs agencies to assess the need for any significant regulatory action and to provide an explanation of how the regulation will meet that need. Comments on the October 2005 proposed rule did not address the accuracy of the theoretical argument FDA put forth in the preamble to the October 2005 proposed rule related to private incentives and market failure (70 FR 58570 at 58587). Therefore, FDA retains this argument here in the final rule. In this instance, FDA concludes that private incentive systems for both suppliers and purchasers in markets for cattle, rendering, and ruminant feed may inadequately address the risk of BSE. This market failure is a result of inadequate information being available to buyers of potentially infective animal feed. Because of the risk of cross contamination during feed production and the risk of inadvertently feeding non-ruminant feed to ruminants on an integrated farm, buyers of ruminant and non-ruminant feed would likely value a decrease in risk of BSE transmission if the market were able to provide it. Buyers, however, have little information about the BSE infectivity of feed because the costs to them of ascertaining infectivity are very high and higher than the costs to the feed producers. As a result, buyers may unknowingly buy feed contaminated with BSE because of the presence of CMPAF.
The potential market failures created by the continued use of materials that this final rule would eliminate are the same as described in the 1997 ruminant feed rule. If feed purchasers could easily identify the risk of the infective agent associated with products from specific suppliers, they could more easily reduce these risks by refusing to buy feed products derived from ruminants known to have consumed processed CMPAF. Feed purchasers, however, are unlikely to obtain the information they need due to the long incubation period for BSE, which could lead to a suboptimal level of risk prevention by purchasers during the incubation period. Moreover, ruminant producers have no way of knowing whether a particular batch of feed or feed ingredients intended for ruminants is free of potentially infective proteins due to the possibility of CMPAF being introduced through cross-contamination with feed or feed ingredients intended for non-ruminants.
FDA received few comments on the proposed rule that focused on the benefits section. One comment stated that the proposal was unnecessary because it addressed only a very small risk. FDA agrees that the risk is low but reiterates, as in the proposed rule, that by requiring removal of the highest risk cattle-derived materials from use in any animal feed, the final rule further reduces BSE risks not already addressed by the 1997 feed ban.
The purpose of the final rule is to further strengthen existing safeguards against BSE in the United States. Reduced risk of BSE among cattle also reduces human risk of vCJD, which is believed to be caused by consumption
FDA estimates that banning CMPAF from use in any animal feed would effectively remove about 90 percent of any remaining potential infectivity from possible spread through the feed system. To derive this estimate of the risk reduction from the ban on CMPAF, we assume that the number of new BSE cases is proportional to the amount of all infectious material included in feed. Given this assumption, we estimate the percentage reduction in the risk of new BSE cases as the percentage reduction in infectious material. A 1999 report by the Scientific Steering Committee of the European Union suggests that the brain and spinal cord constitute 89.7 percent of the total infective load in a case of BSE. This rule would prohibit use in all animal feed of these tissues from all cattle 30 months of age or older. Brain and spinal cord taken from cattle under 30 months of age would not be defined as CMPAF, however, because the probability is extremely low that tissues from cattle of this age would contain BSE infectivity. Thus, banning CMPAF from animal feed would effectively remove about 90 percent of total infectivity from animal feed. The absolute level of animal health risk reduced by this rule would depend on the number of infected animals in the United States and the extent to which cattle are exposed to infected material.
The potential human exposure to infectious materials from consuming beef is already small, because USDA and FDA prohibit the use of certain cattle materials, including SRMs, from human food. The 2005 Harvard Risk Assessment that USDA's Food Safety and Inspection Service made available to the public in July 2006 estimates that interim measures implemented by FSIS on January 12, 2004, and finalized on July 13, 2007, reduce potential human exposure to BSE infectivity by 99.6 percent (see 69 FR 1862 and 72 FR 38700).
Assessing the public health implications from estimates of the human exposure to the BSE agent is difficult because there is no agreed-upon relationship between human exposure to cattle ID
A second major category of benefits largely accrues to U.S. cattle producers and reflects the potential for increased exports of U.S. beef and beef products to countries that have acted to curtail exports since the discovery of the infected cow in Washington State in December 2003. USDA assessed this category of benefits in the FSIS SRM interim final rule that it issued in January 2004. In its assessment, USDA concluded that “the 2004 beef export demand forecast has been reduced by 90 percent” (Ref. 21). Foreign trade data shows that from 2003 to 2004, the quantity of beef, veal, and beef variety meat exported by the United States decreased by about 75 percent, whereas the value of these exports declined by about 80 percent (Ref. 22). According to USDA data, total U.S. exports of beef, veal, and variety meats amounted to $3.9 billion in sales in 2003, and exports of live cattle resulted in an additional $63 million. USDA reports that the value of total beef and veal exports for 2006 amounted to $2 billion. In 2006 prices, the decline in export value comes to $2.2 billion (= ($3.85 billion * 1.09 [price adjustment]) − $2 billion). The quantity exported fell from 1,274,110 metric tons in 2003 to 653,205 metric tons in 2006. Some export markets disappeared almost overnight: Exports of U.S. beef to Japan fell from 375,452 metric tons in 2003 to 517 metric tons in 2004; exports to South Korea fell from 246,595 metric tons in 2003 to 144 metric tons in 2004. Exports have increased since 2006 but remain below 2003 levels.
Numerous foreign governments have cited perceived weaknesses in the 1997 feed ban as a justification for not fully opening their markets to U.S. beef and beef products. The preventive measures contained in this final rule may increase the likelihood that foreign governments ease some restrictions on imports of U.S. beef products and cattle.
We cannot estimate the trade benefits of this final rule. We can estimate the net effect on social surplus of the continuing restrictions on beef exports, as well as the potential gain from removing those restrictions. To do so, we use a standard economic model of the effects of export restrictions on consumer and producer surplus. The closing of export markets, all else being the same, leads to a fall in exports and a rise in domestic consumption as more beef is sold on the domestic market (Ref. 23). The forced sale to U.S. consumers increases consumer surplus and decreases producer surplus. Over time, the quantity produced in the domestic economy falls as well, as producers respond to the restrictions. If the trade restrictions on U.S. beef are removed, beef exports will increase, domestic consumption will decrease, and domestic production will increase. Once all adjustments are made to the withdrawal of the restrictions, we estimate the gain in social surplus to be about $105 million per year, with a range of $80 million to $120 million.
We estimate the effects of the export restrictions using changes in beef prices and exports. Price changes in the U.S. market, however, are dominated by seasonal and trend effects, fluctuations in feed costs, and a host of other factors. These complications make it difficult to use actual beef price changes to estimate the effect of diminished exports on price. As an alternative to direct estimates of price changes, we impute the price effect by estimating the decline in domestic price needed to clear the market if beef intended for export is instead sold on the domestic market. Again, we do not estimate the actual change in price but the imputed contribution of the increased quantity of beef on average price. Our imputed price change draws on the price elasticity of demand for beef, which is the percentage change in the quantity of beef demanded divided by the percentage change in price. The estimates in the literature show the mean price elasticity of demand for beef is about −1.086, although the variance of the estimates is high (Ref. 24).
To estimate the continued effect of the export restrictions and the potential gains from their removal, we assume that in their absence, the proportion of U.S. production exported would return to the 2003 level, 9.6 percent (Ref. 25). In 2006, the shortfall in beef exports compared with 2003 accounted for
The rise in social surplus can be approximated using the rise in price and the average value of exports in 2003 and 2006. We estimate this gain to be about $105 million (=
The estimated gain in social surplus is highly sensitive to the assumptions made about the responses of domestic beef consumers and producers to the removal of export restrictions. Our base estimate of the gain in social surplus assumes that in the long-run, the changes in consumption are about twice as large as the change in production (the price elasticity of supply is about half as large as the price elasticity of demand in absolute value). If increased U.S. beef production accounts for one-half of the response to the removal of trade restrictions (the price elasticity of supply is about the same as the price elasticity of demand in absolute value), the gain in social surplus is about $80 million per year. By contrast, if reduced consumption of beef in the United States accounts for three-fourths of the response to the removal of trade restrictions (the price elasticity of supply is about one-third the price elasticity of demand in absolute value), the gain in social surplus is about $120 million per year.
The estimates we present here are all based on a simplified model of the effects of trade restrictions. The estimates represent the gains from removing all remaining restrictions on beef exports, which will increase the world demand for U.S. beef. The estimates do not represent the gains from this final rule. The gains from this final rule would be estimated based on any relaxation of trade restrictions resulting from the rule. If other public and private policies reduce trade restrictions, then the potential gains from this rule would be correspondingly reduced. New safety events, such as more BSE cases, would also reduce the potential effects of this final rule on trade. We also expect that as time passes, the effects measured here will dissipate to be dominated by other changes in the world and domestic markets for beef. The social surplus estimated here would only be the short-term benefit of this final rule if publication of this rule leads directly to the return of U.S. beef to its status in world markets before the discovery of the infected cow in Washington State in December 2003, assuming that no other policies or events intervene.
FDA has examined the numerous public comments that addressed the analysis of impacts section published with the proposed rule. Furthermore, FDA contracted with ERG to update the analysis it prepared for the proposed rule, taking into account the comments and data provided during the public comment period, as well as any other new or amended provisions that FDA made to the final rule. This section summarizes the ERG report on the final rule, responds to comments on the costs of the proposed rule, and describes the composition, size, and scale of economic activity for the various affected industry sectors that would be impacted by the final rule.
The feasible regulatory alternatives to the final rule include the following: (1) Separate facilities and equipment for renderers and feed mills; (2) the proposed rule, which would prohibit the use of brain and spinal cord from cattle 30 months of age and older slaughtered for human consumption as well as from all cattle not inspected and passed for human consumption from animal feed; and (3) a full SRM ban in animal feed and separate facilities and equipment for renderers. The ERG report also includes estimates of impacts on small entities in the sectors that are impacted to a significant degree to fulfill requirements of a regulatory flexibility analysis.
In the development of its final report on the brain and spinal cord prohibition, ERG reviewed the public comments to the rule that concerned the economic impacts of the proposed rule, focusing closely on the data and analysis included in a report prepared for and submitted by the National Renderers Association. ERG utilized the services of industry consultants and other contractors for their technical expertise, including contracting with an agricultural engineering firm to generate capital cost estimates for independent rendering operations. Additionally, ERG prepared and administered a small survey to independent renderers with additional questions about their operations, including logistics of animal pick-up services, days of operation, decomposition of deadstock, and their ability to comply with the rule.
One of the most comprehensive comments to the proposed rule was prepared by Informa Economics for the National Renderers Association entitled “Economic Impacts of Proposed Changes to Livestock Feed Regulations” (Ref. 26). It concluded that the economic impact on renderers would far exceed the impacts that FDA estimated in the proposed rule, resulting in a significant economic burden of $127.7 million annually in direct economic impacts. Many of the individual comments or criticisms of our analysis of the proposed rule contained in the Informa report reflected other public comments from other individuals, companies, associations, and State governments. We have assembled similar comments together and will address them throughout the summary of the latest ERG analysis.
Approximately $113 million of the $127.7 million (about 88 percent) of the direct costs in the 2005 Informa report represent the estimated deadstock collection fees that would be paid by livestock producers for picking up those deadstock that would still be rendered under the proposed rule. The Informa analysis assumes that the average individual pick-up fees that would be charged across the four cattle categories represent the costs that renderers would incur to remove the CMPAF from cattle not inspected and passed for human consumption, as well as costs to handle, process, and dispose of the material. The assumption, however, leads to an estimate of costs that represents not the expected marginal fee increases from the proposed rule, but rather the total pick-up fee that the animal producer would pay. Using only the marginal pick-up fee per cwt that would be imposed by this rule reduces the total cost from $112.7 million to $62.9 million. The remainder of the original $112.7 million in fees ($49.8 million) represents costs that are currently incurred by the animal producers and are therefore not compliance costs of this rule. Further, the other 12 percent of the total direct costs represent the market value of the tallow and MBM that would be foregone due to this rule. Accounting for only the social costs of these lost revenues, estimated at the renderer's net income rate of 5.65 percent (use of net income as social cost is explained later in this document), reduces the $15.7 million to only about $0.89 million, a reduction of about $14.81 million.
This adjustment in estimated pick-up fee and MBM and tallow social cost losses reduces Informa's total direct costs to about $63.1 million. This figure is actually below our final rule estimate of $64 million to $81 million, which includes a cost reduction from the exemption from the definition of CMPAF for cattle under 30 months not inspected and passed for human consumption. If, however, we were to include the upper end of the range of marginal fee increases from the Informa report (Informa's $112.7 million cost represents only the lower bound of the data it presented), the range of the total direct costs from the Informa report (after accounting for the changes mentioned previously) would be $63.1 million to $113.53 million.
The Informa report also concludes that additional indirect costs for slaughter facilities to handle and dispose of CMPAF (which is not calculated separately in the report) and capital investments made by renderers to handle, process and dispose of CMPAF would likely result in a total cost exceeding $150 million annually. We agree that slaughtering facilities will incur additional capital costs, and ERG has increased its estimate from $676,000 in the proposal to about $1.27 million annually in the final rule. The capital investments for renderers that are detailed in the Informa report (amounting to an annualized total of $11.3 million) are based on an assumption that 26 renderers would actually install additional equipment to render the CMPAF for disposal, which is 50 percent of the number that replied that they might consider installing such equipment. Those 26 rendering operations in question, however, would also have been included in the survey's question on the expected increase in pick-up fees. The increase in pick-up fees, therefore, would account for these additional capital costs if they were indeed anticipated. The previously mentioned modifications to Informa's calculations result in a significantly lower total cost for the final rule. Additionally, we disagree with Informa's conclusion that, due to State and local prohibitions against its disposal in landfills, there is a high likelihood that all CMPAF would need to be rendered prior to disposal, although we agree that there is some uncertainty about the disposal methods that will be used throughout the United States.
Various other comments focused on the general subject of increased costs to slaughterers and other meat processors for disposal of byproducts, the reduction in the value of the slaughtered animals, and the reduction in the profitability of renderers. Although almost none of these comments contained additional data to support these conclusions, ERG performed additional analyses of the relevant industries that largely support the main concerns expressed in these comments.
Other comments stated that increased costs would be passed on to farmers. We agree that some compliance costs will be immediately passed on to farmers; ERG therefore concluded that animal producers would incur $28.1 million to $39.1 million in annual costs for alternative disposal of CMPAF from cattle slaughtered for human consumption and cattle not inspected and passed for human consumption (Table 1, lines 21 and 22). Other comments requested that we offer other economic incentives or remuneration in order to compensate renderers for converting operations to alternative disposal methods or for the cost of disposal, as has occurred in Europe. We did not consider subsidies as a policy option because FDA does not have this authority. Furthermore, the use of subsidies would not change the total social costs of the final rule, but rather transfer the costs to others. Likewise, the social cost does not change, as one comment suggested, if the number of cattle available for USDA's BSE testing program decreases because the renderer refuses to waive pick-up fees. In this case, the social cost is transferred to the general public.
We also received some comments that made claims about costs to individual States, such as the claim that the proposed rule would impose $10 million in costs on California dairy farmers, feedlots, and beef cattle producers. While we cannot verify this estimate without additional data necessary to support such claims, we agree that the costs of this final rule will be proportionally heavier in states with large populations of affected cattle.
One comment stated that removal of brain and spinal cord would reduce processing ability by 40 percent to 50 percent, without providing supporting information. Another comment stated that FDA should focus on removal of SRMs from 4D and antemortem condemned animals greater than 30 months, the cost of which would be from $64 million to $76 million, according to some industry estimates that were not disclosed. Without supporting information, we cannot respond directly to these comments. The ERG report, however, takes into account a number of public comments and changed many of its assumptions due to these public comments.
In general, this final rule, which prohibits certain cattle-derived risk materials from all animal food or feed, would impose four types of costs: Disposal costs, lost revenue measuring the value of the MBM and tallow not produced, direct costs of new equipment and re-allocated labor, and feed substitution costs.
For the proposed rule, ERG identified and discussed five options for disposal of CMPAF. These included landfilling of the CMPAF without rendering, rendering for disposal, disposal through alkaline hydrolysis digesters, incineration, and composting. The analysis concluded that landfilling would likely be one of the methods used to dispose of CMPAF, and that rendering for disposal would be unlikely due to the relatively small amount of CMPAF. The disposal cost estimate of the proposal was set at $12/cwt, based on discussions with industry members and ERG's other report on alternative regulatory options, including a full SRM prohibition. ERG concluded that the per cwt disposal cost would be higher than the full SRM prohibition disposal cost due to the lower volume of CMPAF for the brain and spinal cord prohibition as well as the uncertainty in disposal methods and unfamiliarity with some of the disposal methods in the industry. At this $12/cwt rate, disposal costs of the proposed rule for CMPAF from slaughter and render facilities were estimated at $7.72 million.
ERG also calculated the disposal costs of cattle not inspected and passed for human consumption that would no longer be rendered as a result of the proposed rule. This ban was expected to result in an increase in the number of on-farm disposals. For its analysis of the proposed rule, ERG estimated that 17 percent of cattle not inspected and passed for human consumption were currently rendered. In addition, ERG had predicted that an additional 0.6 percent of all cattle not inspected and passed for human consumption (or 3.5 percent of all cattle not inspected and passed for human consumption that are currently rendered) would no longer be rendered due to the proposed rule. These animals were estimated to result in an increase in capital and labor costs for on-farm burial of about $1.02 million.
We received numerous public comments concerning the estimates on the rendering of cattle not inspected and passed for human consumption. Some were more specific than others, but the prevailing theme was that we had
In its analysis of the final rule, the ERG report uses the Informa survey data of renderers (conducted for its November 2005 report) and USDA data, which show that about 45 percent of cattle not inspected and passed for human consumption are currently rendered. We therefore base our cost estimates for the final rule solely on the 45 percent figure, and do not include those based on the former range of 17 percent to 42 percent.
We also received many comments concerning the ERG estimate that about 26,000 cattle not inspected and passed for human consumption (or 0.6 percent of all cattle not inspected and passed for human consumption) would no longer be rendered as a result of the rule. Informa's 2005 results showed that renderers replied that, in total, about 67 percent of cattle not inspected and passed for human consumption that are currently rendered would no longer be rendered due to the proposed rule. That is, 45 percent times 67 percent = 30 percent of all cattle not inspected and passed for human consumption due to either renderer refusal to accept the animal or the producer's refusal to pay a higher pick-up fee, would no longer be rendered. The final ERG report, relying on estimates it received from deadstock renderers and estimated price elasticities of deadstock to renderers, projects that pick-up charge increases would range from 25 percent to 50 percent for all cattle under 30 months and 100 percent to 150 percent for cattle 30 months of age or older. We note that one comment stated that California renderers would increase their pick-up fees by 50 percent. These higher pick-up fees, coupled with expected closures of rendering plants handling about 10 percent of these cattle, support ERG's revised estimate that 29.4 percent to 44.8 percent of currently rendered cattle not inspected and passed for human consumption will no longer be rendered as a result of this rule. We accept this estimate as well and include it in this analysis. The Informa estimate of 67 percent may overstate the probability of an animal no longer being rendered because some of the carcasses that one renderer says will no longer be picked up by his company may still be picked up by another renderer. As a result of this and other changes in the final report, we estimate that the total amount of CMPAF would range from 610 million to 733 million lbs, a significant increase from the 64 million lbs estimated in the proposed rule.
Due to many public comments that FDA underestimated disposal costs in the proposed rule, ERG re-analyzed its methodology and assumptions concerning disposal in its report for the final rule. It reviewed various disposal technologies and a range of estimated costs for each based on literature compiled by researchers at Kansas State University, National Agricultural Biosecurity Center Consortium. The Kansas State University report presents a most likely representative estimate of costs, although it was derived from a graphic figure in the source document and thus contains some uncertainty. It also identified another disposal method that ERG had not considered in the proposed rule, namely that cattle would be left to decompose in the field or range without any additional treatment of the carcass. Some comments reflected the overall conclusions of the Kansas State University report, stating that incineration and composting are currently prohibitively expensive or complicated. One comment stated that burying CMPAF could be very expensive if a minimum of 4 hours rent for a backhoe is required, giving further support to the conclusion that when possible, these cattle would likely be left to decompose in the field. Several other comments questioned the availability of landfills for disposal of CMPAF. Another comment asked that we consult cost data in the 2004 publication on carcass disposal technologies by the National Agricultural Biosecurity Center Consortium. Table 7 in that publication shows disposal costs per ton for various carcass disposal methods. For both burial and landfilling, it presents cost estimates that are below the estimates ERG uses in its analysis of this final rule (Ref. 27).
Although many other comments questioned what they perceived to be low total disposal costs published in the proposed rule, the 2005 Informa survey reported an average disposal cost estimate of $11.51/cwt among those firms that indicated they would accept the CMPAF. Additionally, the Kansas State study reported 7 disposal options greater than $12/cwt and 4 options lower than $12/cwt. Accordingly, ERG has retained the overall average of $12/cwt disposal cost for CMPAF (from brain and spinal cord removal) from independent rendering operations for the final rule. Some comments questioned the economic feasibility of using dedicated trucks to transport CMPAF to disposal or for further processing. We have in fact included these costs in our totals because in its analyses of disposal costs, ERG included the transportation costs in the $12 per cwt estimate. Further, the Informa survey of renderers (reporting that renderers expect disposal costs would average $11.51 per cwt.) based its questions on CMPAF as defined by the proposed rule, which would require separate transportation trucks or compartments. Based on this $12/cwt rate, we estimate that CMPAF disposal costs of the final rule for slaughter facilities will be $3.4 million (Table 1, line 22).
Disposal costs for CMPAF removed at independent renderers are estimated using the same $12/cwt estimate used in the proposal (we explained the $12/cwt figure and public comments in detail earlier in the document). The Informa report and many other comments remarked that much more than just the brain and spinal cord would need to be removed from those cattle not inspected and passed for human consumption that were not too decomposed to undergo separation. Furthermore, comments stated that a significant number of them would be too decomposed to separate the brain and spinal cord. For both the proposed and final rule, ERG judged that from 1.3 lbs to 53.0 lbs of CMPAF would be removed from cattle 30 months of age or older, but for the final rule it also included an allowance for the number of cattle 30 months of age or older not inspected and passed for human consumption that are picked up but that are too decomposed to undergo tissue separation. The Informa claim
For the disposal of the additional cattle not inspected and passed for human consumption that are no longer picked up for rendering, ERG adjusted the $12/cwt disposal cost for those carcasses that are likely to be buried on the farm. For on-farm burial, the most likely representative cost listed in the Kansas State University report was $6/cwt. ERG increased this to an estimated $8/cwt to account for those farms where burial is less economical or less viable due to the absence of available land. The cattle carcasses were then distributed among the following four types: Calves, feedlot, cattle 30 months of age or older, and cattle under 30 months. For its disposal cost calculations, ERG used only the incremental social cost, which is the difference between the disposal method and the existing charge for renderer pick-up cost (per cwt) as developed in the Informa report. For cattle 30 months of age or older not inspected and passed for human consumption, ERG calculated the incremental cost per cwt at $4.65 ($8.00/cwt minus the current $3.35/cwt); for cattle under 30 months ERG calculated the incremental cost at $5.49 ($8.00/cwt minus the current $2.51/cwt). For feedlot cattle, whose full disposal cost remains at $12/cwt because it is unlikely they would be buried at the producer site, ERG calculated the incremental cost at $10.24/cwt ($12.00/cwt minus the current $1.76/cwt). For calves, ERG assumed current pick-up charges to increase by $4.00/cwt, noting that their current reported pick-up fee exceeds $12/cwt. As a result, we estimate total disposal costs for the additional cattle not inspected and passed for human consumption to range from $22.0 million to $33.0 million annually.
To account for the additional tonnage of non-cattle species that died at the animal producer establishment and would no longer be rendered as a result of this rule as suggested by some comments, ERG added an additional 10 percent of the cost of the midpoint in the range of total disposal costs for the combined calves, feedlot, cattle 30 months of age or older, and cattle under 30 months ($2.7 million) (Table 1, line 21 adds $2.7 million to the disposal cost range of $22.0 to $33.0 million). We acknowledge additional uncertainty in this 10-percent estimate as we lack the data to present a more robust estimate. In sum, we find that the total disposal costs for slaughter establishments ($3.4 million), renderers ($11.3 million), cattle not inspected and passed for human consumption that would no longer be picked up by renderers ($22.0 million to $33.0 million), and other non-cattle species ($2.7 million) will range from $39.4 million to $50.4 million.
For the proposed rule, ERG had calculated that the 64 million lbs. of CMPAF from both slaughter operations and from those cattle not inspected and passed for human consumption that would no longer be rendered would have yielded about 10,800 lbs. of MBM and 4,400 lbs. of tallow. Using historical byproduct prices, ERG had estimated the value of the MBM and tallow at $1.0 million and $0.8 million. Accepting the 2004 Informa estimate of a larger number of cattle currently rendered, we had included in the proposed rule an upper estimate of lost revenues of MBM at $1.7 million and tallow at $1.2 million.
The final rule differs from the proposed rule in that it exempts certain cattle-derived risk materials (brain and spinal cord from cattle under 30 months not inspected and passed for human consumption) from the definition of CMPAF. The final rule continues to prohibit the use of CMPAF in all animal feeds to prevent BSE.
Both ERG's 2004 report (relied upon for our analysis of the proposed rule) and the Informa report included the foregone revenues from MBM and tallow that would have been produced from the CMPAF as costs of the rule. This approach, however, overstates the true social cost of the rule because it includes value added from the use of capital and labor at rendering facilities that would not be used if the CMPAF goes to disposal without further rendering. A better estimate of social cost would include only the lost value attributable to the now-prohibited raw materials, or the difference in total cost between final products made with MBM or tallow from the CMPAF and the total cost of final products made with alternative raw materials. A more accurate estimate of the social cost of the rule would be the net income that would otherwise have been generated from the processing of CMPAF into MBM and tallow. For the final rule, ERG has estimated renderer average net income for both MBM and tallow at 5.65 percent of their foregone sales, based on 2002 Census of Manufacturers data. Marginal net income may be more appropriate because it takes into account the existence of fixed costs. The lack of detailed revenue and cost data for those independent renderers affected by the rule, however, prevents us from estimating the cost functions necessary for a measure of marginal net income. The significance of the difference between marginal and average net income is not likely to be large in this case, since the supplies of raw materials are highly elastic and the amount affected is a small fraction of all ingredients. Industry data show that 18 percent of cattle 30 months of age or older are slaughtered for human consumption, thus requiring CMPAF removal. Consequently, ERG estimated the CMPAF removed at slaughterhouses to be about 28 million lbs. Using industry data on byproduct yields as well as historical averages prices for MBM and tallow of $180/ton and $360/ton, ERG estimated the value of this foregone MBM at $0.6 million and tallow at $0.5 million. Using a 5.65 percent net income rate, ERG estimated the social cost of the foregone MBM and tallow from slaughtered cattle at $64,000 per year (Table 1, lines 4 and 5).
Additionally, ERG estimated the value of the MBM and tallow foregone from the carcasses of the cattle not inspected and passed for human consumption that would no longer be collected by renderers as a result of this rule (and would likely be disposed of on the farm or elsewhere). This reduction in rendering would include those cattle not rendered due to the reduced quantity demanded for rendering services of cattle not inspected and passed for human consumption caused by the substantial expected increase in pick-up charges. In addition, fewer cattle will be rendered due to a number of rendering plant closures. Using various price elasticities of demand, ERG's calculations forecast a 29.4 percent to 44.8 percent reduction in the number of cattle not inspected and passed for human consumption that are picked up for rendering. Using industry averages of animal weights for cattle of different ages, ERG calculated the total weight of animals that would no longer be picked up for rendering at 489 million lbs to 719 million lbs. Applying the yield rates of MBM and tallow for whole carcasses (25 percent for MBM, 10 percent for tallow) results in MBM revenue losses ranging from $11.0 million to $16.2 million, and tallow
ERG also calculated the social cost of the hides that would be lost due to an increase in the number of cattle not inspected and passed for human consumption that would no longer be rendered as a result of this rule. The same assumptions and calculations that form the basis for the 29.4-percent to 44.8-percent increase in cattle not inspected and passed for human consumption that would no longer be rendered as a result of this rule apply to loss of cattle hide value as well. ERG has taken the reduction in each of the four individual cattle categories (the total reduction ranges from 29.4 percent to 44.8 percent over all calves, feedlot, cattle 30 months of age or older, and cattle under 30 months), and applied the average market value of the hide for each to estimate the total hide value lost due to this rule at $9.16 million to $13.69 million. In this case, ERG concludes that the social cost would include almost the entire market value of the hide because the only value added to the process is a very small amount of labor required for hide removal. Because this value was not calculated and subtracted from the average market values, the previously mentioned total may slightly overestimate the social costs.
In the proposed rule we reported five categories of direct costs, including: (1) Capital and labor costs for slaughtering and rendering, (2) the tallow restriction, (3) MS beef restriction, (4) marking costs, and (5) labeling and recordkeeping costs. For the final rule, we address these same costs as well as the cost of (6) creating procedures for training on, and actual administration of, the age determination process for cattle.
a.
For the proposed rule, we relied on the previous ERG report to project that slaughterers would incur annualized capital and labor costs that totaled $676,000 ($597,000 in annual labor costs plus $555,000 in capital costs annualized at 7 percent over 10 years). These costs included the additional offal bins that all slaughterers were expected to require, the modified procedures and processes for the larger slaughterers, and additional labor to segregate the CMPAF. Comments on the proposed rule did not offer specific costs for slaughterers but generally maintained that slaughterers would be affected.
For the final rule, ERG revised its estimated number of USDA-inspected plants upward to 1,545 from 689, but revised the estimated number of cattle having CMPAF removed at slaughterers down from 100 percent to about 18 percent due to the change in approach whereby only cattle 30 months of age or older would have CMPAF removed at slaughter. ERG estimated the resulting one-time capital expenditures of the final rule at $2.10 million (or $299,000 annualized at 7 percent over 10 years). With the addition of maintenance costs of about $315,000 and labor costs of $656,000, ERG estimated the total annualized slaughter costs for capital and labor at about $1.27 million (Table 1, lines 2 and 3), representing a small increase from the proposed rule.
In the proposed rule, we concluded that renderers would also incur additional capital and labor costs to handle CMPAF segregation from cattle not inspected and passed for human consumption. ERG projected equipment purchases and installation at a one-time cost of $3.1 million (or $442,000 at 7 percent over 10 years), as well as additional labor costs of $1.4 million annually. We used this cost as the low end of the range of costs, and used a figure 2.46 times greater as the upper end based on the 2004 Informa assertion that 42 percent of cattle not inspected and passed for human consumption were currently rendered, compared with ERG's previous finding of this number at 17 percent. The proposed rule's estimate for both renderer capital and labor costs was $1.9 million to $4.6 million annually. Numerous public comments addressed the capital and labor costs to renderers. In general, the comments stated that FDA greatly underestimated the cost to renderers of removing brain and spinal cord from cattle not inspected and passed for human consumption.
For the final rule, ERG reassessed the conclusions in its analysis of the proposed rule using the information provided in the 2005 Informa Economics report and presents final rule estimates that are substantially larger. ERG now estimates that there are 70 deadstock renderers, including 25 very small renderers that were likely not included in the Informa survey's result of 45 deadstock renderers. The estimated number is, however, a decrease from the proposed rule's estimate of 141 independent renderers because it is now accepted that deadstock renderers are a small subset of independent renderers, and non-deadstock renderers would not incur these additional capital and labor costs.
ERG contracted with an engineering firm to estimate the renovation of deadstock rendering facilities in order to remove CMPAF. The engineering firm created a detailed capital cost estimate for a deadstock renderer handling 150 animals per day at about $600,000. ERG used this estimate as well as results of its discussions with other deadstock renderers to produce capital cost estimates across the range of deadstock renderers by size. The capital costs on a per plant basis have increased substantially for this final rule, most notably to account for the planning and construction of a separate structure for the removal of CMPAF. Whereas ERG had estimated one-time costs for capital improvements for renderers at $3.1 million for the proposed rule (or $442,000 annualized at 7 percent over 10 years), it estimated if all renderers initiated such renovations, the one-time costs for capital improvements for the final rule would be $32.2 million (or $4.6 million annualized at 7 percent over 10 years). The engineering estimates did not include a specific cost for construction permits, as one comment suggested would be needed, but the cost of construction permits would likely amount to a small part of the separate contingency costs that were included at $54,000 per rendering facility.
ERG also increased its estimate of deadstock renderer labor costs on a per plant basis, due to further discussions with rendering facility managers. Whereas ERG estimated the additional
Public comments and industry discussions with ERG indicate that many facilities would not undertake the capital improvements and additional labor necessary to renovate facilities and change their operating procedures. In its analysis of the final rule, ERG adjusted the total costs to account for the number of deadstock renderers that would not undergo these renovations, assuming that the expected decline in the percentage of renderers would equal the percentage reduction in material sent to rendering. To do this, ERG relied on renderers' predictions (through direct discussions with renderers as well as in public comments) that they would require very large increases in pick-up fees. Some predicted that the pick-up fees would more than double. As a result, ERG estimated that the increase in fees would range from 100 percent to 150 percent for cattle 30 months of age or older, and 25 percent to 50 percent for all other cattle. Using estimated price elasticities ranging from 0.25 for feedlot cattle to 0.6 for calves (Informa also suggests an inelastic demand for rendering services by many livestock producers), ERG calculated the total reduction in raw material going to rendering at 29.4 percent to 44.8 percent, including an additional 10 percent reduction for facilities that abandon deadstock rendering. The 29.4 percent reduction in raw material going to rendering represent a decrease of 549,000 from the current total number of 1,870,000 cattle rendered (549,000/1,870,000 = 29.4 percent). This decrease is the combined decrease in numbers of calves, feedlot cattle, cattle 30 months or older, and cattle under 30 months. The number of calves going to rendering will decrease by 216,000, or 25 percent from the current number, 865,000 calves (865,000 times 25 percent = 216,000). The 25 percent decrease includes a 15 percent decrease due to increased pick-up fees (0.6 elasticity times 25 percent increased pick-up fees) plus a 10 percent further reduction in non-cattle rendering due to plant closures. The number of feedlot cattle going to rendering will decrease by 27,000, or 6.3 percent from the current number, 424,000 feedlot cattle (424,000 times 6.3 percent = 27,000). The 6.3 percent is the result of a 0.25 elasticity times a 25 percent increase in pick-up fees. The number of cattle 30 months of age or older going to rendering will decrease by 281,000, or 60 percent from the current number, 469,000 cattle 30 months of age or older (469,000 times 60 percent = 281,000). The 60 percent decrease includes a 50 percent decrease due to increased pick-up fees (0.5 elasticity times 100 percent increased pick-up fees) plus a 10 percent further reduction in non-cattle rendering due to plant closures. The number of cattle under 30 months of age going to rendering will decrease by 25,000, or 22.5 percent from the current number, 111,000 cattle under 30 months of age (111,000 times 22.5 percent = 25,000). The 22.5 percent decrease includes a 12.5 percent decrease due to increased pick-up fees (0.5 elasticity times 25 percent increased pick-up fees) plus a 10 percent further reduction in non-cattle rendering due to plant closures.
The total reduction in cattle equals 29.4 percent of the currently rendered number of cattle (549,000/1,870,000 = 29.4 percent). The upper end of the range (44.8 percent) was calculated by the same method using the upper end range of factors. Using the midpoint of this 29.4-percent to 44.8-percent range, ERG predicted that about 37.1 percent of the renderers will not undergo these necessary capital renovations, thereby reducing the $32.2 million one-time cost to $20.25 million and the $11.2 million in annualized capital, maintenance, and labor costs to $7.0 million (Table 1, lines 9 and 10). Additionally, the number of cattle 30 months of age or older going to rendering would be reduced by 60 percent to 85 percent, thereby reducing the disposal costs to $11.3 million. Without the adjustment for these two factors, the annualized capital, operating, maintenance, and disposal costs for deadstock operators would be estimated at $52.4 million, not $18.4 million.
b.
c.
The ERG report maintains that all or almost all 4D plants already remove the brain and spinal cord. To the extent that a small percentage of 4D plants might not remove these materials, we agree that there could be some additional compliance costs to this final rule but believe them to be small due to the small number of establishments. As such, we have slightly revised our previous conclusion that there would not be additional compliance costs as a
d.
For the final rule, ERG used the same assumptions to calculate its estimate of marking costs, resulting in the same marking ranging from $0.11 to $0.78 per ton of CMPAF. In this case, though, ERG included as an upper bound estimate of marking costs the tonnage of MBM and tallow from cattle not inspected and passed for human consumption that would not be rendered for non-ruminant feed as a result of this rule. In effect, ERG has allowed for the possibility that the additional cattle that would not be rendered for feed as a result of this rule would be rendered for disposal instead. Taking this possibility into account provides for a worst-case scenario for marking costs. We now estimate the final rule marking costs to range from $18,000 to $64,000 annually, a relatively large increase from those of the proposal but a very small part of total compliance costs.
e.
For the final rule, ERG increased the hours needed for label design, production, and review, but did not revise hourly estimates for recordkeeping modification and review. In total, we estimate this labeling and recordkeeping provision to cost industry about $90,000 annually (a $165,000 one-time cost annualized at 7 percent over 10 years plus $67,000 in annual costs). Additionally, the final rule has been revised to clarify that a renderer's records must either include (1) certification or other documentation from the supplier that material supplied to the renderer does not include CMPAF, provided that it includes a description of the segregation procedures used, documentation that the supplier confirms that its segregation procedures are in place prior to supplying any cattle material to the renderer, and records of the renderer's periodic review of the suppliers' certification or other documentation; or (2) documentation of another method, acceptable to FDA, such as third party certification, for verifying that suppliers have effectively excluded CMPAF.
Based on the levels of effort estimated for the 2007 dietary supplement cGMP final rule (72 FR 34752) requiring certification of procedures, FDA projects that the initial certification or other documentation of the suppliers' procedures will require a 20-hour effort by a management level employee of an independent renderer. The Bureau of Labor Statistics (BLS) provides data on employee costs for management occupations classified within the North American Industrial Classification System (NAICS) code 311600—the animal slaughtering and processing industry (BLS data on individual occupations within NAICS code 311613—rendering and meat product processing, is not available). We have adjusted the BLS wage data, including a 40 percent increase for benefits and adjusting for inflation in employment costs. FDA estimates the initial certification or other documentation of suppliers to an independent renderer to cost about $1,030 (annualized at $250 per year over 10 years at a 7 percent discount rate). FDA estimates that the periodic review of the certification or other documentation to take 8 hours annually, resulting in a $412 annual cost. FDA expects daily recordkeeping to amount to 5 minutes per day for an administrative support employee. Using the BLS data, this recordkeeping cost is estimated at about $460 annually. Total annualized certification or other documentation costs per independent renderer establishment are estimated at about $1,125.
FDA projects that the initial certification or other documentation of the internal system of a packer/renderer will require 6 hours for a management level employee. An additional 3 hours is expected to be expended each year for periodic review of the internal certification or other documentation. Packer/renderers will also be expected to incur recordkeeping costs estimated at about 5 minutes per day. Using the same BLS wage data as above, FDA projects annualized certification or other documentation costs per packer/renderer establishment to be about $690. The total annualized costs of the new recordkeeping costs associated with the certification or other documentation of suppliers (slaughterers) for the estimated 125 independent renderers and 50 packer/renderers handling CMPAF is estimated at about $175,000.
f.
The ERG report concludes that, in the absence of a national cattle identification system, deadstock renderers will need to make the judgments regarding age on an animal-by-animal basis. Compliance costs for such a system would include administrative costs for the creation of procedures for employees to judge the age of animals, and training costs for educating employees on these procedures, as well as annual labor costs for the employees that administer the age determination process.
ERG assumed that the cost of procedure development, normally a
For the age determinations, ERG judged that the rendering truck drivers would make the actual age determinations at the animal producer site by reviewing the paperwork or using the dentition method. ERG judged that this procedure would not add to the total time an employee spends at each pick-up site. It therefore did not include additional compliance costs for the rendering truck driver. Review of these determinations and paperwork would be made at the rendering facility by supervisory personnel. ERG estimated total annual labor costs for the in-plant reviews of the age determination at about $790,000. Total annual costs for renderer age determination efforts are estimated at $1.28 million ($491,000 plus $790,000).
For the proposed rule, we included in the compliance costs the incremental cost for the feed ingredients that would be needed to replace the MBM in non-ruminant animal feeds. Animal feed producers would be expected to substitute more costly protein sources for the MBM that was previously manufactured from CMPAF. In the analysis of the 1997 final rule prohibiting the use of mammalian proteins (with exceptions) from use in ruminant feeds, we calculated the cost to substitute MBM in a typical cattle ration. Assuming a $20 per ton price difference between MBM and a substitute feed ingredient, in this case soybean meal, we estimated that the reformulated cattle ration would cost an additional $31.76 per ton (including other ingredients). However, the prices of MBM and equivalent substitutes vary constantly based on weather, global markets, slaughter rates, and other factors. We have no other information on the types of rations or feed formulations that will be affected by this final rule. Consequently, we accept the cattle ration example as a conservative estimate of the long-term cost of feed substitution.
Accordingly, for the October 2005 proposed rule, we inflated the unit cost from $31.76 per ton to $38.33 per ton to account for inflation through 2005 and determined the tonnage of MBM that would no longer be processed from the CMPAF. Multiplying this total, 15.6 million lbs, by $38.33 per ton resulted in about $300,000 in feed substitution costs for the proposed rule. Accounting for the high end of the range of animals currently rendered (as noted in the 2004 Informa report) led to an upper end cost of about $450,000.
We received one comment that the removal of ruminant proteins from non-ruminant feed may increase the price of other protein sources, but it did not address the method used to account for feed substitution costs. We received many comments concerning the total amount of cattle byproducts that would no longer be made available for further processing for use in non-ruminant feeds. As noted previously in the section on disposal costs, ERG concluded that a much larger amount of cattle byproducts would no longer be available for this use. In total, the ERG calculations imply that the amount of MBM foregone from slaughterer and renderer CMPAF, as well as MBM that could have been produced from cattle not inspected and passed for human consumption that will no longer be rendered due to this rule, will range from 76,100 tons to 91,500 tons; a significant increase from the 7,800 tons estimated for the proposed rule. Based on the incremental feed substitution cost of $38.33 per ton of MBM, we estimate that long-term total feed substitution costs for the final rule will range from $2.92 million to $3.51 million annually.
For the proposed rule, we concluded that there may be an increase in Federal fund expenditures for inspection activities, but did not expect it to be significant. The total number of establishments inspected was not expected to change substantially, as all establishments that would be inspected for compliance under § 589.2001 are already subject to § 589.2000 or other Federal rules. The additional materials that would be included as CMPAF may result in an increase in the number of inspections or the length of time necessary to inspect an establishment. We did not estimate the additional costs that would be required because we judged that the additional resources would not be substantial. ERG judged that no new rendering facilities would be constructed or dedicated to rendering for disposal due to the proposed rule, and thus our inspection activities would not noticeably increase.
The final rule contains a provision that was not included in the proposed rule. This provision exempts CMPAF from designated countries from the prohibition on its use in animal feed. A foreign country seeking this designation will submit a written request to FDA that includes (1) information about the country's BSE case history, (2) risk factors, (3) measures to prevent the introduction and transmission of BSE, and (4) any other information relevant to determine how cattle materials from the country will be defined under 21 CFR 589.2001(b)(1). FDA will respond to a country's request in writing and may specify certain conditions when granting a request. Country designations will be subject to future review by FDA and can be revoked if a review shows that BSE-related restrictions are necessary.
a.
In addition to the countries recognized by OIE, a country exporting a large quantity of cattle products into the United States may submit a request for country designation to FDA. Table 1 presents data from USDA's Foreign Agricultural Service showing countries
b.
Countries that successfully request to be designated as exempt from CMPAF restrictions applicable to animal feed will be subject to annual review by FDA to ensure that their designation remains appropriate. As part of this process, FDA may ask designated countries to confirm that both their BSE status and the information submitted by them in support of their original application remain unchanged. FDA may revoke a country's designation if FDA determines that it is no longer appropriate.
FDA has not yet determined the method by which the agency will conduct these annual reviews. One possible method would be for FDA to send a letter to designated countries asking whether there has been a change in their status or circumstances relative to their BSE history, surveillance, import activities, or other relevant criteria, and then compare any changed information with the information in the original submission. The OIE requires that countries whose BSE status has been officially recognized “should annually confirm during the month of November whether their status and the criteria by which their status was recognized have remained unchanged.” In some cases, the FDA reviewer might rely on this information, if available, in conducting a future review of the country's designation.
For this analysis, we assume it will take FDA and the designated country about one-third the time and effort as the original request for country designation. Thus, if the total cost to submit the request and have it reviewed by FDA was $12,480, the annual review of the country designation by FDA and the submitting country will cost about $4,200 (see Table 7).
It is likely that those countries that currently export to the United States a significant amount of cattle-derived material that contains CMPAF will be most interested in submitting a request for country designation. It is also possible that new markets for cattle-derived products containing CMPAF could develop, providing an incentive for other countries to submit a request to FDA to be designated as exempt from CMPAF restrictions in animal feed. For this analysis, we do not attempt to forecast either new markets for cattle-derived products containing CMPAF or the frequency and costs of future requests for country designations.
For the proposed rule, we presented alternative ranges of costs that could be expected due to the uncertainty in certain cost factors. Specifically, we showed that total compliance costs would increase substantially (from a range of $14 million to $24 million to a range of $20 million to $36 million) if the number of cattle not inspected and passed for human consumption that would no longer be rendered as a result of this rule (or 3.4 percent of all cattle not inspected and passed for human consumption) increased to about 11.6 percent of all cattle not inspected and passed for human consumption. This increase would be due to the much greater weight of the entire cattle carcass that would be disposed of compared with the weight of CMPAF from an
Public comments on the method used by both ERG and FDA have previously been presented. The common perception in comments, summarized here again, is that the analysis of the proposed rule considerably underestimated the number of cattle not inspected and passed for human consumption that would no longer be rendered. We have also previously shown that additional data, public comments, and discussion with industry and association members have led to an updated analysis that presents a significantly greater number of those animals that would no longer be rendered due to this final rule. The sensitivity analysis included in the ERG report on the final rule attempts to identify the most influential factors of the analysis, and the range of costs associated with varying the key assumptions. ERG finds the disposal cost rate for CMPAF to be particularly influential because it represents a large fraction of total costs. Specifically, its analysis shows that a 33-percent increase or decrease in the disposal cost per cwt of CMPAF results in a respective $18.1 million increase or decrease in the lower bound of total costs and a $23.7 million increase or decrease in the upper bound of total costs. The price of MBM and tallow does not have much effect on total costs. Similarly, the level of renderer capital costs do not appear to be significant because the amortization over 10 years results in a small annual cost compared to disposal costs. The elasticity estimates appear to have a more significant effect on total costs. A reduction in price elasticity of 50 percent from the low estimate for each ruminant category would reduce the lower bound of total compliance costs by about 22 percent, while an increase in elasticity by 50 percent from the high estimate for each ruminant category would result in a 15 percent increase in the upper bound of total compliance costs.
The Regulatory Flexibility Act requires an agency to prepare a regulatory flexibility analysis if a rule is expected to have a significant impact on a substantial number of small entities. The discussion in this section of the final rule, as well as data and analysis contained in this rule's regulatory impact analysis, and section three of the ERG report, constitutes our final regulatory impact analysis in compliance with section 604 of the Regulatory Flexibility Act.
The Regulatory Flexibility Act requires that we present a succinct statement of a rule's objectives. As stated previously in this analysis and unchanged from the proposed rule, the intent of this rule is to strengthen the safeguards designed to prevent the spread of BSE in U.S. cattle, as well as to reduce further any risk posed to humans from the agent that causes BSE.
Other requirements of the Regulatory Flexibility Act are a description of the small entities that would be impacted by the final rule, an estimate of the number of small entities to which the rule would apply, a description of the projected reporting, recordkeeping (see Section VI. Paperwork Reduction Act of 1995) and other compliance costs of the rule and the reason why any other significant alternatives considered by the agency were rejected.
The ERG analysis concentrates on the effects of the rule on small renderers and small slaughterers, and to a lesser extent on small dairy farms. Slaughterers are classified in the North American Industrial Classification System (NAICS) under code 311611—Animal (Except Poultry) Slaughtering, and renderers are classified under NAICS code 311613—Rendering and Meat Byproduct Processing (see Table 8). The Small Business Administration (SBA) classifies both slaughterers and renderers with less than 500 employees as small businesses.
The number of cattle slaughtering and rendering establishments expected to be impacted by the CMPAF ban is 1,545 and 231, respectively. The majority of the impacts on renderers are expected to be incurred by the 70 deadstock renderers. Using both Census and USDA data, ERG distributed the slaughtering establishments across the size classes of establishments using the same proportions as those presented in the total number of establishments. This distribution shows that almost 99 percent of slaughtering establishments would qualify as small businesses.
According to SBA data, over 97 percent of all slaughtering firms would be considered small businesses, which would take into account multi-establishment firms. The SBA data also reports that 83 percent of all rendering firms would be considered small businesses. ERG concluded that it is likely that all 70 deadstock renderers have less than 500 employees and thus are considered small businesses. In summary, the number of affected small businesses in both sectors would be substantial.
As in its analysis of the proposed rule, ERG used its Small Business Impact Model (SBIM) to predict net income and closure impacts on both slaughtering and rendering firms (Appendix A of the ERG report contains a technical explanation of the SBIM). The model, which assumes a partial cost pass-through of costs for slaughterers (animal producers would incur the disposal costs), predicts modest impacts on cattle slaughtering due to the small minority of cattle slaughtered for human consumption that are 30 months of age or older. The model predicts costs for the small slaughterers to range from under $100 for the smallest establishments slaughtering less than 1,000 animals per year to about $7,100 per establishment for those slaughtering 300,000 to 500,000 cattle annually. Compliance costs as a percent of net income would range from less than 0.1 percent to 2.1 percent for the small slaughter businesses. For all slaughterers, regardless of size, costs are expected to be significantly below 1 percent of revenues.
Costs for the deadstock renderers were estimated through the SBIM with two separate scenarios: One in which disposal costs are included and one in which they are not included. Disposal costs are not included under one scenario to reflect the likelihood that increased pick-up charges to animal producers will mostly offset the additional disposal costs. In this case, compliance costs for the smallest establishment ranged from an estimate of $97,000 to $122,000 ($153,000 to $180,000 including disposal costs). Compliance costs for the larger establishments ranged from $2.01 million to $2.57 million ($3.23 million to $3.79 million including disposal costs). Compliance costs as a percent of net income ranged from 41 percent to 81 percent across all deadstock renderer sizes (from 65 percent to 100 percent including disposal costs). The total number of rendering establishments expected to close (assuming only disposal costs are transferred to animal producers), using a net income assumption of 5.65 percent, ranged from 12 to 16 facilities. If these disposal costs are not transferred, the model forecasts 23 to 28 closures. Although all renderers contacted by ERG that were contemplating investing in capital to remove brain and spinal cord expected to charge substantially more in pick-up fees to recover these costs, some rendering plant closures are likely to result from this rule (Ref. 16, Section 3.3).
Small farms will incur compliance costs for the disposal of those animals that are no longer rendered due to either the increase in renderer pick-up fees or the termination of deadstock rendering services. ERG prepared a baseline enterprise dairy budget to demonstrate the relative size of the impacts of the final rule on a small (120-cow) dairy farm with about $300,000 in revenues. The SBA defines small dairy and beef cattle producers as those with revenues under $750,000, and USDA data shows the average dairy farm has about 110 dairy cows (Ref. 28). The expected incremental compliance costs (from the ERG model) for disposal of the annual number of dead dairy cows and calves (assumed to be disposed of off-site at $12/cwt and $4/cwt, respectively) on an operation of this size is about $700, using the individual disposal rates for over 30-month cattle and calves. Compliance costs of an operation of this size are estimated at 0.25 percent of revenues and 2.63 percent of net income.
The effect of the annual feed substitution costs on small non-ruminant animal operations is also expected to be minimal. The $2.9 to $3.5 million in additional costs would not be significant when spread over the thousands of non-ruminant animal producers that currently use ruminant protein in animal feeds.
The Regulatory Flexibility Act requires agencies to analyze regulatory alternatives that would minimize any significant impact of a rule on small entities. For an analysis of the regulatory alternatives to this final rule, see section IV.B of this document.
SBREFA (Pub. L. 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with SBREFA, OMB has determined that this final rule is a major rule for the purpose of congressional review.
This final rule contains information collection provisions that were submitted to OMB for review under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The title, description, and the respondent description of the information collection provisions are shown below with an estimate of the annual recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
As discussed in section I of this document, FDA has revised the final rule to include a statement of purpose for the rule, specifically, to prohibit the use of certain cattle origin materials in the food or feed of all animals to help prevent the spread of BSE in U.S. cattle. The final rule was also revised to require renderers to establish and maintain written procedures on aging animals to ensure that such animals are less than 30 months old if they are to be rendered for use in animal feed without brain and spinal cord removal.
FDA believes that it has maximized the practical utility of this collection of information by not prohibiting certain cattle materials in animal food or feed, as long as the agency can be assured, through the establishment of written procedures, that brain and spinal cord were effectively removed or effectively excluded from animal feed or that the material was from cattle less than 30 months of age. FDA believes it has minimized the burden to the rendering industry by not specifying the procedures to be followed so as to provide the latitude to establish procedures that can most efficiently be incorporated into rendering operations.
The estimated recordkeeping burden is derived from agency resources and discussions with affected industry. As discussed in the Paperwork Reduction Act section of the October 2005 proposed rule (70 FR 58570 at 58598), the recordkeeping requirement in § 589.2001(c)(2)(vi) will apply to the limited number of renderers that will handle CMPAF. FDA estimates that no more than 50 of the approximately 175 (based on current data) total independent rendering firms will be involved in the handling of this material. Although the agency may consider the distribution records needed to comply with this regulation “usual and customary” and thus not subject to the PRA, FDA believes there will be a burden associated with setting up a system to ensure such records are sufficient to address the recordkeeping requirement. Likewise, although FDA may consider the records necessary to comply with § 589.2001(c)(3)(i) as “usual and customary” and not subject to PRA burden accounting, FDA is including a burden estimate to cover establishment of a system to ensure that existing receipt, manufacturing, and certification records adequately address this requirement. FDA estimates that the recordkeeping burden associated with § 589.2001(c)(3)(i) would apply to the balance of the rendering firms not handling CMPAF. FDA solicited public comment on the estimated recordkeeping burden associated with § 589.2001(b)(2)(iv) (§ 589.2001(c)(2)(vi) in the final rule) and § 589.2001(b)(3)(i) (§ 589.2001(c)(3)(i) in the final rule) of the proposed rule, but no comments were received. It was estimated that the operation and maintenance cost per renderer for complying with the records requirements of either of these sections would be $340.
As discussed previously, FDA has revised the final rule to require the maintenance of certain written procedures if cattle not inspected and passed for human consumption are to be rendered for use in animal feed. The recordkeeping burden associated with the requirement to maintain written procedures (§ 589.2001(c)(2)(ii)) will apply to only those renderers that choose to render for use in animal feed cattle not inspected and passed for human consumption. Based on the expertise of FDA's compliance staff who are knowledgeable about industry practices, FDA estimates that no more than 50 of the approximately 175 total independent rendering firms will be involved in the handling of this material. Furthermore, FDA estimates that the recordkeeping burden for this new requirement is similar to the burden that was previously estimated for § 589.2001(c)(2)(vi) and § 589.2001(c)(3)(i). Therefore, FDA estimates that the cost per renderer for compliance with the new requirement for establishing and maintaining written procedures will be $340 per renderer, hence the new figure of $17,000 as shown in Table 9 of this document. Table 9 also reflects the estimated 26 hours each renderer will need to satisfy the requirement under which renderers must maintain records from their supplier, certifying that materials provided were free of CMPAF.
There will be a one-time burden to countries that apply to FDA seeking to be designated as not subject to restrictions applicable to CMPAF. We estimate that each country that applies for an exclusion will spend 80 hours putting information together to submit to FDA. Table 10 row 1 of this document presents the one-time burden expected for countries that apply for the exclusion.
Countries that successfully petition FDA to be designated as exempt from certain BSE-related restrictions applicable to animal feed will be subject to future review by FDA to ensure that their designation remains appropriate. As part of this process, FDA may ask designated countries from time-to-time to confirm that their BSE situation and the information submitted by them in support of their original application remains unchanged. We assume it will take FDA and the designated country undergoing a review in the future about one third the time and effort it did when the information was submitted. Table 10 row 2 of this document presents the expected recurring burden.
The information collection provisions of this final rule have been submitted to OMB for review. Prior to the effective date of this final rule, FDA will publish a notice in the
In the “Environmental Impact” section of the preamble to the October 6, 2005, proposed rule (70 FR 58570), FDA stated that it had carefully considered the potential environmental impact of this action and had determined that the proposed action would not have a significant impact on the human environment and that an environmental impact statement was not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, were placed on display in the public docket (Docket No. 2002N-0273).
As discussed in section IV of the preamble to this final rule, the agency received many comments to the proposed rule that addressed the environmental effects of the proposed action, noting that the volume of material that would not be allowed in animal feed was much larger than originally estimated. As a result, FDA decided to perform a new environmental assessment that took into account the new information submitted in response to the proposed rule. Following a review of this new assessment, FDA again has made a finding of no significant impact. The evidence supporting that finding, contained in the new environmental assessment, may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. For ease of reference, the “Summary of Environmental Consequences” is reproduced below:
“The EA has examined the environmental consequences of prohibiting the use in animal feed of brain and spinal cord from cattle over 30 months of age, and the carcasses of dead stock cattle that were either not age verified or from which brain and spinal cord were not removed. Our assessment indicates that, under this final rule, approximately 670 million pounds of cattle byproducts that would normally be recycled in animal feed will be diverted to other forms of disposal. In most areas of the country, this change in disposal patterns is not expected to have a large impact on the environment. In some areas of the country, however, adverse environmental impacts could be expected unless new disposal capacity is developed. To allow time for development of new methods of disposal, the agency is delaying implementation of this regulation for 12 months. We assume that disposal of the materials prohibited in animal feed by the final rule will be disposed of in accordance with local, State, and Federal laws and regulations.”
FDA received several comments on the proposed rule that addressed environmental concerns surrounding the residual effects of disposal of cattle byproducts. The comments and the agency's responses are set forth in the following paragraphs.
(Comment 71) Several comments said that FDA did not conduct an adequate environmental impact analysis for the proposed rule and improperly made a finding of no significant impact. Another comment said that the environmental assessment failed to consider alternative methods of disposal other than landfilling and rendering. A number of comments said that FDA underestimated the environmental impact resulting from improper composting and landfilling.
(Response) In comments to the proposed rule, FDA received new information indicating that some of the assumptions used in the economic analysis may have been incorrect, especially those assumptions related to disposal of deadstock. The agency modified the assumptions based on this new information and considered all other relevant comments in completing a re-analysis of both the economic and environmental impacts of the proposed rule. After completing a new environmental assessment, the agency still concludes that the environmental
(Comment 72) Several comments said that animal and human health risks from non-feed disposal of deadstock are greater than the risks reduced by the proposed regulation. In contrast, one comment stated that, since the majority of cattle mortalities today are disposed of by means other than rendering and since this disposal does not appear to be causing disease outbreaks, the comment questioned the assertion by some that on-farm and alternative disposal will degrade public and animal health. Another comment stated that health concerns resulting from the proposed rule are being exaggerated for the purpose of preventing the rule from being finalized.
(Response) The agency received no data in support of either position on the effects of non-feed disposal of CMPAF on animal or human health.
(Comment 73) Several comments asked why FDA is not concerned about environmental exposure to the BSE agent through indiscriminant disposal of deadstock if the BSE infectious dose is really 10 mg or less and the agent remains infectious in soil.
(Response) The agency believes that, based on the extremely low prevalence of BSE in this country and the absence of evidence that BSE is transmitted through soil and water, the risk of BSE transmission through exposure to the BSE agent in the environment is very low.
(Comment 74) Several comments said that landfilling and burial will create problems of odor control, ground and surface water contamination, and disease caused by conventional pathogens. Other comments stated that the soil and geologic conditions in certain states are particularly unsuitable for carcass burial.
(Response) FDA believes that odors and pathogens should not be significant problems when carcasses are properly buried, and in particular, when carcasses are landfilled. The agency acknowledges, however, that soil or geologic conditions in some parts of the country may not permit carcasses to be properly buried. In such areas, alternative disposal methods should be identified. The agency intends to allow sufficient time before the rule becomes effective to allow for the arrangement of disposal methods that are appropriate for local conditions.
FDA has analyzed this final rule in accordance with the principles in Executive Order 13132. FDA has determined that the final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web site addresses after this document publishes in the
Animal feeds, Animal foods, Food additives, Incorporation by reference.
21 U.S.C. 321, 342, 343, 348, 371.
(a) * * *
(1)
(c) * * *
(4) Renderers shall comply with all applicable requirements under § 589.2001.
(e) * * *
(3) Renderers shall comply with all applicable requirements under § 589.2001.
(a)
(b)
(i) The entire carcass of BSE-positive cattle;
(ii) The brains and spinal cords of cattle 30 months of age and older;
(iii) The entire carcass of cattle not inspected and passed for human consumption as defined in paragraph (b)(2) of this section that are 30 months of age or older from which brains and spinal cords were not effectively removed or otherwise effectively excluded from animal feed;
(iv) Mechanically separated beef as defined in paragraph (b)(3) of this section that is derived from materials specified in paragraphs (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this section; and
(v) Tallow as defined in paragraph (b)(5) of this section that is derived from materials specified in paragraphs (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this section.
(vi) Cattle materials prohibited in animal feed do not include:
(A) Tallow derivatives as defined in paragraph (b)(6) of this section;
(B) Tallow as defined in paragraph (b)(5) of this section that is derived from materials specified in paragraphs (b)(1)(ii) and (b)(1)(iii) of this section and that contains no more than 0.15 percent insoluble impurities. Insoluble impurities must be measured by the method entitled “Insoluble Impurities” (AOCS Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from the AOCS (
(C) Materials as defined in paragraphs (b)(1)(ii), (b)(1)(iii), (b)(1)(iv) (other than mechanically separated beef from the carcass of a BSE-positive cattle), and (b)(1)(v) of this section from cattle from a country that has been designated under paragraph (f) of this section.
(2)
(3)
(4)
(5)
(6)
(c)
(2) Renderers that receive, manufacture, process, blend, or distribute cattle materials prohibited in animal feed as defined in paragraph (b)(1) of this section, or products that contain or may contain cattle materials prohibited in animal feed, shall take the following measures to ensure that materials prohibited as defined in paragraph (b)(1) of this section are not introduced into animal feed:
(i) Exclude from use in animal feed the entire carcass of cattle not inspected and passed for human consumption as defined in paragraph (b)(2) of this section if:
(A) The brain and spinal cord are not effectively removed from such cattle or the brain and spinal cord from such cattle are not otherwise effectively excluded from animal feed; and
(B) Such cattle are 30 months of age or older.
(ii) If renderers remove brain and spinal cord from cattle not inspected and passed for human consumption, or separate such animals based on whether or not they are 30 months of age or older, renderers must maintain adequate written procedures specifying how these processes are carried out.
(iii) Once cattle materials prohibited in animal feed have been separated from other cattle materials, provide for measures to avoid cross-contamination;
(A) Use separate equipment while handling cattle materials prohibited in animal feed; or
(B) Use separate containers that adequately prevent contact with animal feed, animal feed ingredients, or equipment surfaces;
(iv) Label the cattle materials prohibited in animal feed and products that contain or may contain cattle materials prohibited in animal feed in a conspicuous manner as follows: “Do not feed to animals”;
(v) Mark the cattle materials prohibited in animal feed and products that contain or may contain cattle materials prohibited in animal feed with an agent that can be readily detected on visual inspection; and
(vi) Establish and maintain records sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into animal feed, and make the records available for inspection and copying by the Food and Drug Administration.
(3) Renderers that receive, manufacture, process, blend, or distribute any cattle materials shall take the following measures to ensure that materials prohibited as defined in paragraph (b)(1) of this section are not used in animal feed:
(i) Establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, cattle materials prohibited in animal feed and make copies of all records available for inspection and copying by the Food and Drug Administration. With respect to cattle materials obtained from establishments which have segregated cattle materials prohibited in animal feed, such records must demonstrate that establishments supplying cattle materials to the renderers have adequate procedures in place to effectively exclude cattle materials prohibited in animal feed; and these records shall be considered sufficient to meet this requirement if they include either:
(A) Certification or other documentation from the supplier that material supplied to the renderer does not include cattle materials prohibited in animal feed; such certification or documentation is acceptable, provided that it includes a description of the segregation procedures used, documentation that the supplier confirms that its segregation procedures are in place prior to supplying any cattle material to the renderer, and records of the renderer's periodic review of the suppliers' certification or other documentation; or
(B) Documentation of another method acceptable to FDA, such as third-party certification, for verifying that suppliers have effectively excluded cattle materials prohibited in animal feed.
(ii) Comply with all applicable requirements under § 589.2000 regarding animal proteins prohibited in ruminant feed.
(d)
(2) Animal feed or feed ingredients that are not in compliance with paragraph (c)(1) of this section are adulterated under section 402(a)(2), 402(a)(3), or 402(a)(5) of the act.
(3) Animal feed or feed ingredients that are not in compliance with the labeling requirements of paragraph (c)(2)(iv) of this section are misbranded under section 403(a)(1) or 403(f) of the act.
(4) Failure of a renderer to comply with the requirements in paragraph (e) of this section will render the animal feed or feed ingredients adulterated under section 402(a)(4) of the act.
(e)
(f)
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice of funding availability (NOFA).
Purpose of Program: This funding opportunity is available for a demonstration program to provide assistance for intergenerational dwelling units for intergenerational families in connection with the supportive housing program under Section 202 of the Housing Act of 1959 (12 U.S.C. 1701q). The purpose of the program is to expand the supply of intergenerational dwelling units for very low-income grandparent(s) or relative(s) heads of household 62 years of age or older raising a child.
1. Purpose of the Program. The purpose of this program is to provide assistance for a demonstration program to expand the supply of intergenerational dwelling units for very low-income grandparent(s) or relative(s) heads of households 62 years of age or older raising a child who is not more than 18 years of age or not more than 19 years of age and also attending school. The family must meet the age requirements to be eligible for an intergenerational dwelling unit.
2. Available Funds. Funding is available for $3.96 million to develop housing for intergenerational families.
3. Types of Funds. Capital Advance funding is available under this NOFA to cover the cost of expanding the supply of intergenerational housing. In addition, Project Rental Assistance Contract (PRAC) funds are available for Section 202 Capital Advance projects that are funded under this program to cover the difference between the HUD-approved operating costs of the project and the tenants' contribution toward rent (30 percent of their adjusted monthly income). PRAC funds are available to cover the difference between the HUD-approved operating costs of the project and the tenants' contribution toward rent (30 percent of their adjusted monthly income) for private nonprofit owners of Section 202/8 projects for intergenerational dwelling units provided:
a. Through development of buildings or projects comprised solely of intergenerational units; or
b. Through the development of an annex or addition to an existing project assisted under Section 202 of the Housing Act of 1959 (12 U.S.C. 1701q), that contains intergenerational dwelling units, including through the development of elder cottage housing opportunity units that are small, freestanding, barrier free, energy efficient, removable dwelling units located adjacent to a larger project or dwelling. (Converted units that already receive either Section 8 or PRAC will not be eligible for PRAC assistance under this NOFA).
4. Eligible Applicants. Only private nonprofit owners of a Section 202 project interested in applying for funding under this program should carefully review the detailed information listed in this NOFA.
5. Eligible Activities. This program provides funding to private nonprofit owners of a Section 202 project to use only for expanding the supply of intergenerational dwelling units.
6. Match Requirements. None required.
For those projects eligible to receive PRAC funds, the funds are used to cover the difference between the tenants' contribution toward rent (30 percent of adjusted income) and the HUD-approved cost to operate the project. The PRAC funds may also be used to provide supportive services and to hire a service coordinator in those projects selected for assistance. The supportive services must be appropriate to the category or categories of residents to be served.
1. Demonstration Program Funds. The reservation for funds is based on a formula that takes the development cost limit for the appropriate building type (elevator, non-elevator, and unit size), multiplies it by the number of units of each size (including a unit for a resident manager, if applicable), then multiplies the result by the high-cost factor for the geographical area. For retrofitting existing units, the funds will be available for the costs of physical conversion of the units and related community and service space. The development cost limits can be found in this NOFA.
2. PRAC Funds. The initial PRAC award covers 3 years. The amount awarded is determined by multiplying the number of revenue units for intergenerational families by the appropriate operating cost standard times three.
1. Covered Family. A family that:
a. includes a child; and
b. has a head of household who is 62 years of age or older who is:
(1) A grandparent of the child who is raising the child; or
(2) a relative of the child who is raising the child.
2. Elderly Person. The term “elderly person” is defined as a household composed of one or more persons, at least one of whom is 62 years of age or older at the time of initial occupancy.
3. Intergenerational family. A covered family that has a head of household who is an elderly person, as defined above.
4. Intergenerational dwelling unit. A qualified dwelling unit that is reserved for occupancy only by an intergenerational family.
5. Child. An individual who is not older than 18 years of age or not older than 19 years of age and also attending school.
6. Grandparent. With respect to a child, an individual who is a grandparent or step-grandparent of the child by blood or marriage, regardless of the age of such individual. In the case of a child who was adopted, the term includes an individual who, by blood or marriage, is a grandparent or step-grandparent of the child as adopted.
7. Relative. With respect to a child, an individual who is not a parent of the child by blood or marriage and is a “relative” of the child by blood or marriage regardless of the age of the individual. In the case of a child who was adopted, the term “relative” includes an individual who, by blood or marriage, is a relative of the family who adopted the child.
8. Raising a child. With respect to an individual, the individual:
a. Resides with the child; and
b. Is the primary caregiver for the child: (1) Because the biological or adoptive parents of the child do not reside with the child or are unable or unwilling to serve as the primary caregiver of the child; and (2) regardless of whether the grandparent or other relative has a legal relationship to the child (such as guardianship or legal custody) or is caring for the child informally and has no such legal relationship with the child.
9. General Section. HUD's Fiscal Year 2008 Notice of Funding Availability (NOFA); Policy Requirements and General Section to the FY2008 SuperNOFA for HUD's Discretionary Programs; Notice, published March 19, 2008 (73 FR 14882).
The owner makes a commitment by signing form HUD-92041, Sponsor's Conflict of Interest Resolution. The Sponsor will make a commitment by signing form HUD-92042, Sponsor's Resolution for Commitment to the Project.
a. Funds are available only to private nonprofit owners of Section 202 projects to use in expanding the supply of intergenerational dwelling units. These units must be provided:
(1) By designating and retrofitting, for use as intergenerational dwelling units, existing dwelling units that are located within a project assisted under Section 202 of the Housing Act of 1959 (12 U.S.C. 1701q);
(2) Through development of buildings or projects comprised solely of intergenerational dwelling units; or
(3) Through the development of an annex or addition to an existing project assisted under Section 202 of the Housing Act of 1959 (12 U.S.C. 1701q), that contains intergenerational dwelling units, including through the development of elder cottage housing opportunity units that are small, freestanding, barrier free, energy efficient, removable dwelling units located adjacent to a larger project or dwelling.
b. For those projects eligible to receive PRAC funds, the funds will be available to cover the difference between the HUD-approved operating costs and the amount the residents pay (each resident pays 30 percent of adjusted income), as well as the HUD-approved cost to operate the project.
c. A portion of the PRAC funds (not to exceed $15 per unit/per month) may be used to cover some of the cost of any supportive services for residents. The balance of the cost for services must be
2. Threshold Requirements for Funding Consideration. In addition to the threshold criteria outlined in the General Section, the following threshold requirements must be met. (See Section V.B.2. of this NOFA and Section III.C.2. and 3 of HUD's Fiscal Year 2008 Notice of Funding Availability (NOFA); Policy Requirements and General Section to the FY2008 SuperNOFA for HUD's Discretionary Programs; Notice.)
a. Nonresponsive Application. Your application will be considered nonresponsive to this NOFA and will not be accepted for processing if the following threshold requirements are not met:
(1) You must be an eligible applicant.
(2) You must have a DUN and Bradstreet Universal Data Numbering System (DUNS) number. The DUNS number must be included in the data entry field labeled “organizational DUNS” on the form SF-424. Instructions for obtaining a DUNS number can be found at either
(3) To have qualified dwelling units for purposes of this notice, each unit:
(a) Shall not have fewer than two separate bedrooms but no more than four separate bedrooms;
(b) Be equipped with design features appropriate to meet the special physical needs of elderly persons, as needed; and
(c) Be equipped with design features appropriate to meet the special physical needs of young children, as needed.
(4) You request less than the minimum of 5 units.
(5) You submit a substantially deficient application. (A majority of the required exhibits are not submitted with your application, particularly, but not limited to, those exhibits which are not curable.)
(6) You request more than $2 million in funding.
(7) You request assistance for an ineligible activity as defined in this program NOFA. (Please refer to Part IV.E.2.)
(8) You submit paper copies of the application, and you have not received approval from HUD for a waiver of the electronic submission requirements or you submit less than the required number of paper copies indicated in your waiver notification.
b. Other Criteria.
(1) You must have the experience to develop and operate intergenerational dwelling units.
(2) You must have sufficient funds available to reach initial closing and complete the project.
(3) Your application must contain acceptable evidence of the following:
(a) Evidence of Site Control. You must provide evidence of site control as described in section IV.B.2.c.(1)(iv)(d)(i) of this NOFA.
(b) Historic Preservation. You are required to send to the State/Tribal Historic Preservation Officer (SHPO/THPO) a letter that attempts to initiate consultation with that officer and requests the officer's review of your determinations and findings with respect to the historical significance of your proposed project. A sample letter to the SHPO/THPO that you may adapt for your use, if you so choose, is available on HUD's Web site at
(c) Contamination. HUD must determine if a proposed site contains contamination, such as hazardous waste, petroleum, or petroleum products, and, if so, HUD must be satisfied that it is eliminated to the extent necessary to meet nonsite-specific federal, state, or local health standards. You must assist HUD by doing the following:
(i) Phase I Environmental Site Assessment (ESA). You must undertake and submit a Phase I ESA, prepared in accordance with the ASTM Standard E 1527-05, as amended, using the table of contents and report format specified at Appendix X4 thereto, completed or updated as specified at Section 4.6 thereto no earlier than 180 days prior to the application deadline date. The Phase I ESA must be completed and submitted with the application. Therefore, it is important that you start the Phase I ESA process as soon after publication of this NOFA as possible.
A Phase I ESA that is not properly updated, does not use the report format specified at Appendix X4 of ASTM Standard E 1527-05, or that is prepared in accordance with an older version of ASTM E 1527 will result in a technical rejection of your application.
To help you choose an environmentally safe site, HUD invites you to review the documents “Choosing an Environmentally Safe Site” and “Supplemental Guidance, Environmental Information,” which are available on the HUD Web site at
(ii) Phase II ESA. If the Phase I ESA indicates the possible presence of contamination and/or hazards, you must decide whether to continue with this site or choose another site. Should you choose another site, the same Phase I ESA process identified above must be followed for the new site. However, if you choose to continue with the original site on which the Phase I ESA indicated contamination or hazards, you must undertake a detailed Phase II ESA by an appropriate professional. In order for your application to be considered for review under this funding competition, the Phase II must be received by Aretha Williams, Director, Grant Policy and Management Division, U.S. Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410, on or before August 1, 2008.
(iii) Clean-up. If the Phase II ESA reveals site contamination, the extent of the contamination and a plan for clean-up of the site must be submitted to HUD Headquarters. The plan for clean-up must include a contract for remediation of the problem(s) and an approval letter from the applicable federal, state, and/or local agency with jurisdiction over the site. In order for your application to be considered for review under this funding competition, this information must be received by Aretha Williams, Director, Grant Policy and Management Division, U.S. Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410 on or before August 1, 2008. If the above information is not received by that date, the application will be rejected.
Clean-up could be an expensive undertaking. You must pay for the cost of any clean-up and/or remediation with sources other than the demonstration program funds. If the application is approved, clean-up must be completed prior to initial closing. Completion of clean-up means that HUD must be satisfied that the contamination has been eliminated to the extent necessary to meet nonsite-specific federal, state, or local health standards, with no active or passive remediation still taking place, no capping over of any contamination, and no monitoring wells. However, it is acceptable if contamination remains solely in groundwater that is at least 25 feet below the surface.
(d) Asbestos. Asbestos is a hazardous substance commonly used in building products until the late 1970s. Therefore,
(i) If there are no pre-1978 structures on the site or if there are pre-1978 structures that most recently consisted solely of four or fewer units of single-family housing, including appurtenant structures thereto, a statement to this effect, or
(ii) If there are pre-1978 structures on the site, other than for a site that most recently consisted of solely four or fewer units of single-family housing, including appurtenant structures thereto, a comprehensive building asbestos survey that is based on a thorough inspection to identify the location and condition of asbestos throughout any structures. In those cases where suspect asbestos is found, it would either be assumed to be asbestos or would require confirmatory testing. If the asbestos survey indicates the presence of asbestos or the presence of asbestos is assumed, and if the application is approved, HUD will condition the approval on an appropriate mix of asbestos abatement and an asbestos Operations and Maintenance Plan.
(e) Lead-Based Paint. You must comply with the requirements of the Lead-Based Paint Poisoning Prevention Act (42 U.S.C. 4821-4846), the Residential Lead-Based Paint Hazard Reduction Act (42 U.S.C. 4851
(4) There must be a market need for the number of units proposed in the area of the project location. You must provide a copy of a written assessment of the intergenerational families' housing needs in the relevant community. For the assessment, you should engage the help of local child welfare agencies, caregiver support groups, Area Agencies on Aging, and other supportive service providers working with the families.
(5) You must provide a copy of a feasibility study on the proposed project.
(6) You must provide commitment and support letters from the appropriate organizations, agencies, and businesses. The commitment and support letter(s) from the appropriate groups should:
(a) be submitted by the application submission date as part of your application for financial assistance;
(b) indicate that the intergenerational dwelling units, facilities, and supportive services to be provided are designed to meet the needs of the residents who will reside in the intergenerational dwelling units as defined in this NOFA.
(7) You are required to include a Supportive Services Plan that describes the supportive services proposed to be provided to the anticipated occupants, including a description of the public or private funds that are expected to fund the proposed services and the manner in which the services will be provided to the proposed residents. You must not require residents to accept any supportive services as a condition of occupancy or admission.
(8) Delinquent Federal Debt. Refer to the General Section for information regarding delinquent federal debt.
3. Program Requirements. By signing the Demonstration Program application, you are certifying that you will comply with all program requirements listed in the General Section, as well as the following requirements:
a. Statutory and Regulatory Requirements. In addition to the statutory, regulatory, threshold, and public policy requirements listed in the General Section, you must comply with all statutory and regulatory requirements listed in this NOFA.
b. Existing Section 202 Developments. If you are designating and retrofitting units within an existing Section 202 project or are building an annex or addition to an existing Section 202 project:
(1) Your project must meet HUD's Uniform Physical Conditions Standards at 24 CFR part 5, subpart G;
(2) The project's most recent management review rating must be rated as satisfactory or above;
(3) The project's most recent Real Estate Assessment Center (REAC) physical inspection report for the project must be 60 or above;
(4) The project must be well maintained;
(5) The project must not have a recent history of mortgage defaults; and
(6) The project owner must not have any material adverse financial or managerial actions or omissions with regard to any project that is federally assisted and/or financed with a loan or capital advance from or any mortgage insured by an agency of the federal government.
c. Supportive Services Plan. HUD believes that a strong Supportive Services component is crucial to the success of your project over the next 20 years. It is critical that you develop and maintain solid relationships and partnerships with the supportive service providers in the community to ensure the provision of services for the intergenerational families. In addition, due to the amount of funds available under this NOFA for supportive services, it is vital that additional resources are found.
For purposes of this NOFA, you must develop and submit a Supportive Services Plan for the services that will be offered on-site and/or off-site. You must submit one copy of your Supportive Services Plan to each appropriate state or local service funding organization well in advance of the application deadline, for appropriate review. The state or local funding organization(s) should return the Supportive Services Plan to you with appropriate comments and an indication of any funding commitment, which you will then include with the application you submit to HUD.
d. Prohibition Against Lobbying Activities. The Byrd Amendment prohibits recipients of federal contracts, grants, or loans from using those funds for lobbying activities.
e. Economic Opportunities for Low- and Very Low-Income Persons (Section 3). You must comply with Section 3 of the Housing and Urban Development Act of 1968, 12 U.S.C. 1701u (Economic Opportunities for Low- and Very Low-Income Persons), and implementing regulations at 24 CFR part 135. You must ensure that training, employment, and other economic opportunities shall, to the greatest extent feasible, be directed toward low- and very low-income persons, particularly those who are recipients of government assistance for housing and to business concerns that provide economic opportunities to low- and very low-income persons, including people with disabilities.
f. Minimum Project Size. The minimum number of units that can be applied for in one application is five units.
g. Accessibility. Your project must meet accessibility requirements published at 24 CFR 891.120, 24 CFR 891.210, and Section 504 of the Rehabilitation Act of 1973 and its implementing regulations at 24 CFR part 8, and, if your new project is new construction, the design and construction requirements of the Fair Housing Act and HUD's implementing regulations at 24 CFR part 100. In addition, 24 CFR 8.4(b)(5) prohibits the selection of a site or location that has the purpose or effect of excluding persons with disabilities from the federally assisted program or activity. Refer to Section V.A. below and the General Section for information regarding the policy-priority of encouraging accessible design.
h. Conducting Business in Accordance with HUD Core Values and Ethical Standards. You are not subject to the requirements of 24 CFR parts 84 and 85, as outlined in the General Section, except that the disposition of real
i. Fair Housing. You must comply with the requirements of the Fair Housing Act; Executive Order 11063; Title VI of the Civil Rights Act; the Age Discrimination Act of 1975; the affirmative fair housing marketing requirements of 24 CFR part 200, subpart M; and the implementing regulations at 24 CFR part 108, which require that the project be marketed to those least likely to apply. You must also comply with any other applicable federal, state, and local laws prohibiting discrimination and promoting equal opportunity, including affirmatively furthering fair housing, and other certifications listed in this application. You must comply with the Uniform Federal Accessibility Standards (24 CFR 40.7), section 504 of the Rehabilitation Act of 1973, HUD's implementing regulations at 24 CFR part 8, and the Americans with Disabilities Act of 1990.
Refer to the General Section for additional Information on Fair Housing Requirements.
j. Davis Bacon. You must comply with the Davis-Bacon requirements (12 U.S.C. 1701q(j)(5)) and the Contract Work Hours and Safety Standards Act, in accordance with 24 CFR 891.155(d).
k. Ensure the Participation of Small Businesses, Small Disadvantaged Businesses, and Woman-Owned Businesses. HUD is committed to ensuring that small businesses, small disadvantaged businesses, and woman-owned businesses participate fully in HUD's direct contracting and in contracting opportunities generated by HUD's financial assistance.
l. Executive Order 13166, Improving Access to Persons with Limited English Proficiency (LEP). Successful applicants are required to take reasonable steps to ensure meaningful access to their programs and activities by LEP persons. For further guidance on serving persons with limited English proficiency in HUD assisted programs, see “Final Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons” (72 FR 2732, January 22, 2007). Applicants must seek to improve access to persons with limited English proficiency by providing materials and information in languages other than English. Make applications and other materials available in languages other than English that are common in the community, if speakers of these languages are found in significant numbers and are members of intergenerational families. For further guidance on serving persons with limited English proficiency in HUD-assisted programs, see the recent HUD LEP guidance, “Notice of Guidance to Federal Assistance Recipients Regarding—Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons,” 68 FR 70968 (December 19, 2003).
m. Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. HUD has undertaken a review of all policies and regulations that have implications for faith-based and community organizations, and has established a policy priority to provide full and equal access to grassroots faith-based and other community-based organizations.
n. Accessible Technology. The Rehabilitation Act Amendments of 1998 apply to all electronic information technology (EIT) used by a grant recipient for transmitting, receiving, using, or storing information to carry out the responsibilities of these awards.
o. Participation in HUD-Sponsored Program Evaluation. As a condition of the receipt of funds under this NOFA, recipients are required to cooperate with all HUD staff or contractors performing HUD-funded research and evaluation studies.
p. Executive Order 13202. Comply with Executive Order 13202, Preservation of Open Competition and Government Neutrality toward Government Contractors' Labor Relations on Federal and Federally Funded Construction Projects.
q. OMB Circulars and Governmentwide Regulations Applicable to Financial Assistance. Applicants are subject to the Administrative Requirements of OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations; OMB Circular A-122, Cost Principles for Non-Profit Institutions; the administrative requirements of 24 CFR part 84; and the procurement requirements of 24 CFR 84.44.
r. National Environmental Policy Act. Your application is subject to the National Environmental Policy Act of 1969 and the applicable related federal environmental authorities (See 24 CFR part 50, as applicable). An environmental review will be completed by HUD before awarding any assistance under this program.
s. Design and Cost Standards. You must comply with HUD's Section 202 design and cost standards (24 CFR 891.120 and 891.210), the Uniform Federal Accessibility Standards (24 CFR 40.7), Section 504 of the Rehabilitation Act of 1973, and HUD's implementing regulations at 24 CFR part 8, and, for covered multifamily dwellings designed and constructed for first occupancy after March 13, 1991, the design and construction requirements of the Fair Housing Act and HUD's implementing regulations at 24 CFR part 100, and, where applicable, the Americans with Disabilities Act of 1990.
t. Ownership of Section 202 projects. Owners of a Section 202 project can apply for funding under this NOFA. The present single-purpose regulatory limitation on Section 202 owner provisions of the regulations, which restricts ownership of more than one project, is waived for applicants applying for funding under this NOFA. This waiver will apply only if your proposal for developing intergenerational dwelling units is through designating and retrofitting existing units in a Section 202 project or through building an annex or addition to an existing Section 202 project. If your proposal is for the development of buildings or projects solely of intergenerational dwelling units, you must form an Owner entity (in accordance with 24 CFR 891.205) after issuance of the demonstration program fund reservation and must cause the Owner entity to file a request for determination of eligibility and a request for demonstration program funds, and must provide sufficient resources to the Owner entity to ensure the development and long-term operation of the project, including capitalizing the Owner entity at firm commitment processing in an amount sufficient to meet its obligations in connection with the project over and above the demonstration program assistance amount.
HUD has adopted a wide-ranging energy action plan for improving energy efficiency in all HUD program areas. As a first step in implementing the energy plan, HUD, the Environmental Protection Agency, and the Department of Energy have signed a joint partnership to promote energy efficiency in HUD's affordable housing efforts and programs. The purpose of the Energy Star partnership is not only to promote energy efficiency of the affordable housing stock, but also to help protect the environment.
Although it is not a requirement, you are encouraged to promote energy efficiency in the design and operation of your proposed project. Your application will receive one point if you describe your plans for doing so in the proposed project. You are urged especially to purchase and use Energy Star-labeled products. For further information about Energy Star, see
Applicants are required to submit an electronic application, unless they receive a waiver of the requirement in accordance with the procedures in Section IV.C. of this NOFA. See the General Section for information on electronic application submission and timely submission and receipt requirements.
You may request general information and copies of the General Section and NOFA (including related documents) from the NOFA Information Center (800-HUD-8929 or 800-483-8929) Monday through Friday, except on federal holidays. Persons with hearing and speech impairments may access the above number via TTY by calling the toll-free Federal Information Relay Service at 800-877-8339. When requesting information, please refer to the name of the program in which you are interested.
Before the application deadline date, HUD staff is available to provide you with general guidance and technical assistance. For technical support for obtaining or submitting the application, call Aretha Williams at (202) 708-3000 or Claire Trivedi at (202) 402-6634 (these are not toll-free numbers). HUD staff is not permitted to assist in preparing your application.
Section 1001 of Title 18 of the United States Code (Criminal Code and Criminal Procedure, 72 Stat. 967) applies to all information supplied in the application submission. Among other things, 18 U.S.C. 1001 provides that whoever knowingly and willfully makes or uses a document or writing containing any false, fictitious, fraudulent statement or entry, in any matter within the jurisdiction of any department or agency of the United States, shall be fined not more than $10,000 or imprisoned for not more than 5 years, or both.
The application consists of four parts with a total of eight exhibits. Included with the eight exhibits are prescribed forms, certifications, and resolutions. The components of the application are:
• Part 1—(Exhibit 1), Application Form for Demonstration Program for Elderly Housing for Intergenerational Families;
• Part 2—Your Ability to Develop and Operate the Proposed Project (Exhibits 2 and 3);
• Part 3—The Need for Intergenerational Housing in the Area to be Served, Site Control and Suitability of Site (including security), and Adequacy of the Provisions of Supportive Services and of the Proposed Project (Exhibits 4 and 5);
• Part 4—General Application Requirements, Certifications, and Resolutions (Exhibits 6 through 8).
The following additional information, which may assist you in preparing your application, is available on HUD's Web site at
• Letter Requesting SHPO/THPO Review;
• Choosing an Environmentally Safe Site;
• Supplement to Choosing an Environmentally Safe Site; and
• Affordable Housing for Intergenerational Families Satellite Broadcast Training May 30, 2007.
Your application must include all of the information, materials, forms, and exhibits listed below (unless you were selected for a Section 202 fund reservation within the last three funding cycles). If you qualify for this exception, you are not required to submit the information described in Exhibits 2(a), (b), and (c), which are the articles of incorporation (or other organizational documents), bylaws, and the Internal Revenue Service tax exemption, respectively. If there has been a change in any of these documents since your previous HUD approval, you must submit the updated information in your application. Headquarters will verify your previous HUD approval by checking the project number and approval status with the appropriate local HUD office based on the information submitted.
Please submit your application using the following format provided in this NOFA. For applications to be submitted electronically, in which you have created files to be attached to the electronic application, you should number the pages of the attached file and include a header that identifies the exhibit that it relates to. Please be sure to follow the file labeling and file format in the General Section.
For applicants that have received a waiver of the electronic application submission, you must number the pages of each file, narratives, and other attached files. Include the name of your organization, your DUNS number, and the exhibit number that you are responding to on the header of each document.
(1) Exhibit 1—Application Form for Demonstration Program for Elderly Housing for Intergenerational Families. A copy of the form HUD-92910 is available in the instructions download at
(1) Exhibit 2—Evidence of your legal status (
(a) Articles of Incorporation, constitution, or other organizational documents;
(b) Bylaws;
(c) IRS tax exemption ruling (this must be submitted by all Sponsors, including churches).
If you received a Section 202 fund reservation within the last three funding cycles, you are not required to submit the documents described in (a), (b), and (c) above. Instead, submit the project number of the latest application and the local HUD office to which it was submitted. If there have been any modifications or additions to the subject documents, indicate such, and submit the new material.
(2) Exhibit 3—Your purpose, community ties, and experience.
(a) A description of your purpose(s), current activities, including your ability to enlist volunteers and raise private and local funds, and how long you have been in existence.
(b) A description of your community support:
(i) Your ties to the community at large, including minority and elderly communities, and to the community of intergenerational families, in particular; and
(ii) Your efforts to involve the elderly and youth in intergenerational families in:
(A) Developing the application;
(B) Participating on the project's planning committee;
(C) Developing the project's operating philosophy;
(D) Reviewing the application prior to submission to HUD; and
(E) Your intent to involve them in the operation of the project.
(c) The extent that the jurisdiction in which your project will be located has undertaken efforts to remove regulatory barriers to affordable housing and how you have supported these efforts. This is an optional requirement, but to obtain up to 2 points for this policy priority you must complete the form HUD-27300, Questionnaire for HUD's Initiative on Removal of Regulatory Barriers and provide the required documentation. See Rating Factor 3 in Section V.A. below for more details.
(d) A comprehensive sources and uses statement that details all funds for development and supportive services for the proposed project, including a description of other funding sources for the project (financial assistance, donation of land, provision of services, etc.).
(e) Include all financial commitment letters with specific dollar amounts from appropriate organizations. If $100,000 or more in funding has been secured, you will receive 5 points, provided a letter from each lender or donor confirming the funding is included with the application.
Given the amount of the funds available under this NOFA, the need to collaborate and obtain funding from other sources is critical.
(f) Address how training, employment, and economic opportunities shall, to the greatest extent feasible, be directed toward low- and very low-income persons, particularly those who are recipients of government assistance for housing and to business concerns that provide economic opportunities to low- and very low-income persons.
(g) Letters of support from agencies, organizations, businesses, and/or any other groups that will partner with you to provide on-site and/or off-site supportive services. The letters of support should indicate that the intergenerational units, facilities, and supportive services to be provided are designed to meet the needs of the residents who will reside in the intergenerational dwelling units. Their experience with intergenerational families must be described in the letters.
(h) A description of your relevant experience with intergenerational families and their housing and supportive service needs. The description should include any rental housing projects and/or supportive services facilities that you sponsored, own and/or operate; your past or current involvement in any programs other than housing that demonstrates your management capabilities (including financial management) and experience; your experience in serving the target population (elderly, children, and intergenerational families including minorities); and the reasons for receiving any increases in fund reservations for developing and/or operating previously funded Section 202 or Section 811 projects. The description should include data on the facilities and services provided; the racial/ethnic composition of the populations served, if available; and information and testimonials from residents or community leaders on the quality of the activities. Examples of activities that could be described include housing counseling, nutrition and food services, special housing referrals, screening, and information projects.
(i) A description of the practical solutions you will implement that will enable residents of your project to meet the terms and conditions of the lease. In addition, describe the educational opportunities you will provide for the residents and how you will provide them. This description should include any activities that will enhance the quality of life for the residents. And finally, describe how your proposed project will be an improved living environment for the residents in comparison to their previous place of residence.
(j) Describe how you will ensure that your proposed project will remain viable as housing, with the availability of supportive services for the target population. This description should address the measures you would take should any of the following occur:
(i) Funding for any of the needed supportive services becomes depleted:
(ii) If, for any State-funded services for your project, the State changes its policy regarding the provision of supportive services to projects such as the one you propose; or
(iii) If the need for housing for the population you will be serving wanes over time, causing vacancies in your project.
(k) Describe your plan for completing the proposed project. Include a project development timeline that lists the major development stages for the project with associated dates that must be met in order to get the project to initial closing and start of construction within the 18-month fund reservation period, as well as the full completion of the project, including final closing. Completion of the Program Outcome Logic Model (HUD-96010) will assist you in completing your response to this Exhibit.
(l) Describe the extent to which your past performance evidences that the proposed project will result in timely development of the project.
(1) Exhibit 4—Need and Project Information.
(a) Evidence of Need.
(i) A brief narrative summarizing the findings from the written assessment of the intergenerational families' housing needs in the relevant community. A copy of the assessment must be included with the application. See Section III.C.2.b.(4) above. Also, a description of how information in the community's or (where applicable) the State's Consolidated Plan, Analysis of Impediments to Fair Housing Choice (AI), or other planning document that analyzes fair housing issues was used in documenting the need for the project.
(ii) Identification of the target population and their demographic characteristics and the extent of their housing needs. The target population must be surveyed and asked about their following preferences and needs:
(A) If new construction, type of building(s),
(B) The number of bedrooms—at least two—for each dwelling unit;
(C) Design features;
(D) Indoor community space;
(E) Outdoor space;
(F) Types of supportive services;
(iii) A description of how the proposed project will benefit the target population and the community in which it will be located.
(b) A brief narrative summarizing the findings from the feasibility study for the proposed project. A copy of the feasibility study must be included with the application. See III.C.2.b.(5). The study must include, but is not limited to information concerning:
(i) Site selection;
(ii) Condition of the project;
(iii) Neighborhood/location issues;
(iv) Existing residents and relocation requirements;
(v) Development design;
(vi) Preliminary building plans or plans to designate and retrofit;
(vii) Neighborhood receptivity to the proposed project;
(viii) Needs and receptivity of the target population;
(ix) Program policies and procedures;
(x) Staffing patterns;
(xi) Implementation Plan;
(c) These intergenerational dwelling units must include design features and public space that accommodate all ages being served. Each unit must have at least two separate bedrooms and be equipped with design features appropriate to meet the special physical needs of elderly persons and young children, as needed. Features in existing intergenerational housing include electrical outlet protections, handrails in the bathrooms and hallways, shower thermostats that keep the water from getting too hot, and secure outside play areas visible from the dwelling units.
The proposed design of the housing should include adequate, flexible community space that can accommodate varying uses, multiple ages being served, and the changing needs of the residents. For the comfort of all residents, the proximity of the community space to the housing units and soundproofing should be considered as part of the proposed building design. If private, individual, outside space is available, such as private porches or terraces, it should be evenly distributed among each of the units.
You must provide a description of the physical construction aspects of the intergenerational dwelling units, including the following:
(i) Narrative description of the building design, including a description of the number of units with bedroom distribution; any special design features, including any features that incorporate visitability standards and universal design, amenities, and/or commercial and community spaces; and how this design will facilitate the delivery of services in an economical fashion and accommodate the changing needs of the residents over the next 10 to 20 years.
If the community spaces, amenities, or features exceed the project design and cost standards of 24 CFR 891.120(a) and (c), the special standards of 24 CFR 891.210, and the limitation on bedroom unit sizes as required
(ii) A short narrative describing how security for the project will be designed and incorporated in your proposed project. Security may include, but is not limited to, a 24-hour front desk, cameras, and emergency buzzer systems in each dwelling unit. Twenty-four-hour security for the units is essential, as are enforcement policies for security violations.
(iii) Describe how the project will promote energy efficiency (in accordance with the requirements set forth in Section III.C.4. of this NOFA), including any plans to incorporate energy-efficiency features in the operation of the project through the use of Energy Star-labeled products and appliances and, if applicable, innovative construction or rehabilitation methods or technologies to be used that will promote efficient construction. This piece will serve as an assurance that the project will promote energy efficiency.
(iv) A description of the project must address how the units will conform to the accessibility requirements described in the Uniform Federal Accessibility Standards (UFAS).
(d) Evidence of site control and permissive zoning.
(i) Acceptable evidence of site control is limited to any one of the following:
(A) Deed or long-term leasehold that evidences that you have title to or a leasehold interest in the site. If a leasehold, the term of the lease must be at least 50 years with renewable provisions for 25 years, except for sites on Indian trust land, in which case the term of the lease must be at least 50 years with no requirement for extensions;
(B) Contract of sale for the site that is free of any limitations affecting the ability of the seller to deliver ownership to you after you receive and accept a notice of Demonstration Program funds. (The only condition for closing on the sale can be your receipt and acceptance of the demonstration program funds.) The contract of sale cannot require closing earlier than the Demonstration Program closing;
(C) Option to purchase or for a long-term leasehold, which must remain in effect for 6 months from the date on which the applications are due, must state a firm price binding on the seller, and be renewable at the end of the 6-month period. The only condition on which the option may be terminated is if you are not awarded a fund reservation;
(D) If the site is covered by a mortgage under a HUD program (
(E) For sites to be acquired from a public body, evidence is needed that the public body possesses clear title to the site and has entered into a legally binding agreement to lease or convey the site to you after you receive and accept a notice of Demonstration Program funds. Where HUD determines that time constraints of the funding round will not permit you to obtain all of the required official actions (
(ii) Under HUD's regulations and requirements, whether you have title to the site, a contract of sale, an option to purchase, or are acquiring a site from a public body, you must provide evidence (a current title policy or other acceptable evidence) that the site is free of any limitations, restrictions, or reverters that could adversely affect the use of the site for the proposed project for the term of the mortgage (
A proposed project site may not be acquired or optioned from a general contractor (or its affiliate) that will construct the Demonstration Program project or from any other development team member.
(iii) Evidence that the project, as proposed, is permissible under applicable zoning ordinances or regulations or a statement of the proposed action required to make the proposed project permissible AND the basis for the belief that the proposed action will be completed successfully before the submission of the firm commitment application (
(iv) Evidence of compliance with the URA requirement (49 CFR part 24, and 24 CFR 891.155(e)) that the seller has been provided, in writing, with the required information regarding a voluntary, arm's length purchase transaction (
A certification for this requirement is not sufficient. Therefore, evidence must be submitted to meet this requirement. This information should have been provided before making the purchase offer. However, in those cases where there is an existing option or contract, the seller must be provided the opportunity to withdraw from the agreement or transaction, without penalty, after this information is provided.
(v) Narrative describing topographical and demographical aspects of the site, the suitability of the site and area (as well as a description of the characteristics of the neighborhood), how use of the site will promote greater housing opportunities for minority intergenerational families and intergenerational families with persons with disabilities (if applicable), and how
You can best demonstrate your commitment to affirmatively furthering fair housing by describing how your proposed activities will assist the jurisdiction in overcoming impediments to fair housing choice identified in the applicable jurisdiction's Analysis of Impediments (AI) to Fair Housing Choice, which is a component of the jurisdiction's Consolidated Plan, or any other planning document that addresses fair housing issues. The applicable Consolidated Plan and AI may be that of the community, county, or state to which input should have been provided by local community organizations, agencies in the community, and residents of the community. Alternatively, a document that addresses fair housing issues and remedies to barriers to fair housing in the community, which was previously prepared by a local planning or similar organization, may be used. Applicable impediments could include the need for improved housing quality and services for minority intergenerational families, lack of affirmative marketing and outreach to minority intergenerational families, and the need for quality elder-care services within areas of minority concentration, when compared with the type and quality of similar services and housing in nonminority areas.
(vi) A map showing the location of the site, the racial composition of the neighborhood, and any areas of racial or minority racial group concentration.
For this competition, when determining the racial and ethnic composition of the neighborhood surrounding the proposed site, use data from the 2000 Census of Population. Data from the 2000 Census may be found at
(vii) A Phase I Environmental Site Assessment (ESA), in accordance with the ASTM Standard E 1527-05, as amended, using the table-of-contents and report format specified at Appendix X4 thereto and completed or updated as specified at Section 4.6 thereto, must be undertaken and completed by you and submitted with the application. In order for the Phase I ESA to be acceptable, it must have been completed or updated no earlier than 180 days prior to the application deadline date. Therefore, it is important to start the site assessment process as soon after the publication of the NOFA as possible.
A Phase I ESA that is not properly updated that does not use the report format specified at Appendix X4 of ASTM Standard E 1527-05, or that is prepared in accordance with an older version of ASTM E 1527 will result in a technical rejection of your application.
If the Phase I ESA indicates possible presence of contamination and/or hazards, you must decide whether to continue with this site or choose another site. Should you choose another site, the same Phase I ESA process identified above must be followed for the new site. If you choose to continue with the original site on which the Phase I ESA indicated contamination and/or hazards, you must undertake a detailed Phase II ESA by an appropriate professional. If the Phase II Assessment reveals site contamination, you must submit, to HUD Headquarters, the extent of the contamination and a plan for clean-up of the site, including a contract for remediation of the problem(s) and an approval letter from the applicable federal, state, and/or local agency with jurisdiction over the site. The Phase II ESA and any necessary plans for clean-up do not have to be submitted with the application, but must be received by Aretha Williams, Director, Grant Policy and Management Division, U.S. Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410, by August 1, 2008. If it is not received by that date, the application will be rejected.
You must pay for the cost of any clean-up or remediation, which can be very expensive. See Section III.C.2.b.(3)(c)(iii).
(viii) You must submit one of the following:
(A) If there are no pre-1978 structures on the site or if there are pre-1978 structures that most recently consisted of solely four or fewer units of single-family housing, including appurtenant structures thereto, a statement to this effect, or
(B) If there are pre-1978 structures on the site, other than for a site that most recently consisted of solely four or fewer units of single-family housing, including appurtenant structures thereto, a comprehensive building asbestos survey that is based on a thorough inspection to identify the location and condition of asbestos throughout any structures.
In those cases where suspect asbestos is found, it would either be assumed to be asbestos or would require confirmatory testing. If the asbestos survey indicates the presence of asbestos or the presence of asbestos is assumed, and if the application is approved, HUD will condition the approval on an appropriate mix of asbestos abatement and an asbestos Operations and Maintenance Plan.
(ix) Letter to the State/Tribal Historic Preservation Officer (SHPO/THPO) and a statement that the SHPO/THPO failed to respond to you OR a copy of the response letter received from the SHPO/THPO.
(x) You must comply with the requirements of the Lead-Based Paint Poisoning Prevention Act (42 U.S.C. 4821-4846), the Residential Lead-Based Paint Hazard Reduction Act (42 U.S.C. 4851
(2) Exhibit 5—Supportive Services Plan.
It is crucial to the success of your project that you collaborate with other community organizations, agencies, businesses, and/or groups to provide on-site and, when necessary, off-site comprehensive supportive services tailored to meet the needs of intergenerational families, including elderly persons and children. Because of the lack of funds available under this NOFA for supportive services, it is critical that you find ways to obtain and maintain the supportive services needed to assist the target population. Consideration must be given to the availability of transportation for off-site services. Your application must include a comprehensive Supportive Services Plan and firm commitments for individualized case management and supportive services to be offered. A copy of the Supportive Services Plan must be submitted to the appropriate state and/or local agency as instructed in Section III.C.3.c. above.
(a) Services must be provided in accordance with the requirements of 12 U.S.C. 1701q(g).
(b) Supportive services provided through collaboration, whether provided on-site and/or off-site, must include a range of services that are tailored to meet the needs of intergenerational families, including elderly persons and children. Services will be designed with the age of the children in mind, and the fact that the children will be aging. Services for youth need to be different than services for younger children. You must ensure that services will include:
(i) Individualized case management. This case management must link residents to available services on-site and/or off-site, in addition to helping them access additional services available in the community. All projects funded under this NOFA must have sufficient case management and service coordination in place. Your plan for individualized case management must be described in the application.
(ii) Services that are determined essential for each of the populations served, which will likely include support groups, other mental health services, before- and after-school activities, tutoring, and safe and accessible transportation.
(iii) Additional services, which may include, but not be limited to, other recreational activities or opportunities
(c) Your application must provide:
(i) A detailed description of the supportive services proposed to be provided.
(ii) A description of public or private sources of assistance that reasonably could be expected to fund the proposed services.
(iii) The manner in which such services will be provided to such persons (
You may not require residents, as a condition of admission or occupancy, to accept any supportive services.
(1) Exhibit 6: Staffing Plan, Tenant Selection, Residency Requirements, and Written Rules and Procedures.
(a) A staffing plan, which includes:
(i) Number of staff and positions;
(ii) Measures to be taken to encourage staff retention. Continuity in the lives of the children and youth is particularly important for this population;
(iii) Whether the staff will reflect the population being served. For example, some intergenerational housing programs have found it effective to hire staff from the community, particularly case managers, who are relative caregivers with similar socioeconomic backgrounds.
(b) Written tenant selection procedures and residency requirements that the applicant must address the following questions (these procedures and requirements will vary based on the needs of the target population):
(i) What the caregivers will have to prove concerning their relationship to the children in order to qualify for housing?
(ii) Will the program be open to “other relatives,” such as aunts and uncles, raising children?
(iii) Will birth parents be allowed to live on the property? What are birth parent visitation rights?
(c) A description of the written rules and procedures to be developed for the following:
(i) Handling family crises, such as a caregiver's sickness, hospitalization, or death.
(ii) Assisting grandparents and other relatives with a secondary permanency plan for the child.
(iii) Handling security issues, including screening residents, how visitors' identities will be verified, determining whether guests have been barred from visiting by court order, and safeguarding against intrusions from outsiders (both those uninvited and those invited by other residents).
(iv) Monitoring and prohibiting illegal and inappropriate behavior, and evicting residents who are involved in such activities.
(v) Determining whether a curfew for youths will be in place.
(vi) Identify how these rules and procedures will be communicated to tenants and enforced.
(2) Exhibit 7: A statement that:
(a) Identifies all persons (families, individuals, businesses, and nonprofit organizations) by race/minority group, and their status as owners or tenants occupying the property on the date of submission of the application.
(b) Indicates the estimated cost of relocation payments and other services.
(c) Identifies the staff organization that will carry out the relocation activities.
(d) Identifies all persons that have moved from the site within the past 12 months and the reason for such moves.
(e) Indicates that all persons occupying the site have been issued the appropriate required General Information Notice and advisory services information, receipt required, either at the time the option to acquire the property is executed, or at the time the application is submitted.
If any of the relocation costs will be funded from sources other than the demonstration program funds, you must provide evidence of a firm commitment of these funds. When evaluating applications, HUD will consider the total cost of proposals (
(3) Exhibit 8: Standard Forms, Certifications, and Resolutions. You are required to submit completed copies of the following forms, which are available at
(a) Form SF-424, Application for Federal Assistance, including a DUNS number, an indication of whether you are delinquent on any federal debt, and compliance with Executive Order 12372 (a certification that you have submitted a copy of your application to the state agency Single Point of Contact (SPOC) for state review. If the SPOC requires a review of your application, you must include in your application a copy of the cover letter sent to the SPOC.
For intergenerational housing purposes, in Item 14, Areas Affected by Project, of SF-424, provide the names of the city, county, and state where the project will be located.
(b) SF-424 Supplement, Survey for Ensuring Equal Opportunity for Applicants (“Faith Based EEO Survey (SF-424 SUPP)” on Grants.gov). Although the information on this form will not be considered in making funding decisions, it will assist the federal government in ensuring that all qualified applicants have an equal opportunity to compete for federal funding.
(c) Form HUD-2880, Applicant/Recipient Disclosure/Update Report (“HUD Applicant Recipient Disclosure Report” on Grants.gov), including Social Security and Employee Identification Numbers. A disclosure of assistance from other government sources received in connection with the project.
(d) Form HUD-2991, Certification of Consistency with the Consolidated Plan (Plan) for the jurisdiction in which the proposed project will be located. The certification must be made by the unit of general local government, if it is required to have or has a complete Plan. Otherwise, the certification may be made by the state or by the unit of general local government, if the project will be located within the jurisdiction of the unit of general local government authorized to use an abbreviated strategy, and if it is willing to prepare such a Plan. All certifications must be made by the public official responsible for submitting the Plan to HUD. The certifications must be submitted by the application deadline date. The Plan regulations are published in 24 CFR part 91.
(e) Form HUD-2994-A, You Are Our Client! Grant Applicant Survey. This is an optional form, which may be used to provide suggestions and comments to the Department regarding your application submission experience.
(f) Standard Form—LLL, Disclosure of Lobbying Activities, if applicable. A disclosure of activities conducted that may influence any federal transactions.
(g) Form HUD-96010, Program Outcome Logic Model. In addition to the Project Development Timeline to be submitted, the information provided in the Logic Model will be used in rating your application for rating factor 5, Achieving Results and Program Evaluation. (See Section V.A.5. below.)
(h) Form HUD-27300, America's Affordable Communities Initiative/Removal of Regulatory Barriers (“HUD Communities Initiative Form” on Grants.gov) (and supporting documentation), if applicable.
(i) Form HUD-2990, Certification of Consistency with RC/EZ/EC-II Strategic Plan. A certification that the project is consistent with the RC/EZ/EC-II strategic plan, is located within the RC/
(j) Form HUD-92041, Sponsor's Conflict-of-Interest Resolution. This is a Certified Board Resolution that no officer or director of the Sponsor or Owner has or will have any financial interest in any contract with the Owner or in any firm or corporation that has or will have a contract with the Owner, including a current listing of all duly qualified and sitting officers and directors by title and the beginning and ending dates of each person's term. The Owner should complete and sign this form for this demonstration although the word Sponsor is used in the title.
(k) Form HUD-92042, Sponsor's Resolution for Commitment to Project. A Certified Board Resolution acknowledging responsibilities of sponsorship, long-term support of the project(s), your willingness to help the Owner to develop, own, manage, and provide appropriate services in connection with the proposed project; and reflecting the will of your membership. Also, it shall indicate your willingness to fund the estimated start-up expenses and the estimated cost of any amenities or features (and operating costs related thereto) that would not be covered by the approved funding.
(l) Form HUD-96011, Facsimile Transmittal Form, is required only if you are using the facsimile method to fax third-party and other documents for your electronic application, in accordance with the instructions in the General Section.
(m) Form HUD-92910, Demonstration Program for Elderly Housing for Intergenerational Families. The form identifies the applicant and its known development team members and collects basic information with regard to the proposed project's characteristics. HUD staff will use this exhibit to obtain basic information regarding the proposed project. The information collected from the applicant relative to item 2 of this form is needed for the Department's Minority Business Enterprise goals.
HUD will not accept entire applications by fax. If you submit the application entirely by fax, it will be disqualified.
If a waiver is granted, you must submit the required number of copies of your application to Aretha Williams, Director, Grant Policy and Management Division, U.S. Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410-8000, and the application must be received no later than 5 p.m. eastern time on the application deadline date. The waiver approval notification will identify the required number of copies that must be submitted. If you do not submit the required number of copies, your application will not be reviewed.
1. State Review. Applicants for funding under this NOFA are subject to Executive Order 12372, Intergovernmental Review of Federal Programs. You must contact your state's SPOC to find out about and comply with the state's process under EO 12372. The names and addresses of the SPOCs are listed on the Office of Management and Budget's (OMB) home page at
2. HUD/RHS Agreement. HUD and the Rural Housing Service (RHS) have an agreement to coordinate the administration of the agencies' respective rental assistance programs. As a result, HUD is required to notify RHS of applications received for housing assistance. This notification gives RHS the opportunity to comment if it has concerns about the demand for additional assisted housing and possible harm to existing projects in the same housing market area. HUD will consider RHS' comments in its review and application selection process.
1. Funding available under this NOFA does not cover the costs of supportive services, except as provided in Section III.C.1.c. The services not covered under this section must be paid for through other sources. If funding has been secured by any third parties, see Section IV.B.2.c.(2)(c) above.
2. Ineligible Activities. Demonstration Program funds may not be used for:
a. Nursing homes;
b. Infirmaries;
c. Medical facilities;
d. Mobile homes;
e. Community centers;
f. Headquarters for organizations for the elderly;
g. Nonhousekeeping accommodations (
h. Refinancing of sponsor-owned facilities without rehabilitation;
i. Housing that you currently own or lease that is occupied by elderly persons; and
j. Projects licensed or to be licensed as assisted-living facilities.
You may propose to rehabilitate an existing currently owned or leased structure that does not already serve intergenerational families, except that the refinancing of any federally funded or assisted project, or any project insured or guaranteed by a federal agency, is not permissible under this NOFA. HUD does not consider it appropriate to utilize scarce program resources to refinance projects that have already received some form of assistance under a federal program. (For example, Section 202 or Section 202/8 direct loan projects cannot be refinanced with capital advances, demonstration program funds and project rental assistance.)
3. Development Cost Limits.
a. The following development cost limits, adjusted by locality, must be used to determine the amount to be reserved for projects for intergenerational families.
The funding awarded for the project is to be considered the total amount of funds
(1) The amount for the project attributable to dwelling use (less the incremental development cost and the capitalized operating costs associated with any excess amenities and design features and other costs you must pay for) may not exceed:
$67,202 per family unit with two bedrooms;
$86,020 per family unit with three bedrooms; and
$95,830 per family unit with four bedrooms.
$70,893 per family unit with two bedrooms;
$91,712 per family unit with three bedrooms; and
$100,672 per family unit with four bedrooms.
(2) These cost limits reflect those costs reasonable and necessary to develop a project of modest design that complies with HUD minimum property standards, the accessibility requirements of § 891.120(b), and the project design and cost standards of § 891.120 and § 891.210.
b. Increased development cost limits.
(1) HUD may increase the development cost limits set forth above, by up to 140 percent in any geographic area where the cost levels require such an increase, and may increase the development cost limits by up to 160 percent on a project-by-project basis. This increase may include covering additional costs to make dwelling units accessible through rehabilitation.
In applying the applicable high-cost percentage, HUD Headquarters may use a percentage that is higher or lower than that which is assigned to the jurisdiction of the proposed project if it is needed to provide an amount that is comparable to what it typically costs to develop a project in that area.
(2) If HUD finds that high construction costs in Alaska, Guam, the Virgin Islands, or Hawaii make it infeasible to construct dwellings within the development cost limits provided in sections IV.E.3.a.(1) and IV.E.3.b.(1) above without the sacrifice of sound standards of construction, design, and livability, the amount of the funding may be increased to compensate for such costs. The increase may not exceed the limits established under this section (including any high-cost area adjustment) by more than 50 percent.
4. Commercial Facilities. A commercial facility for the benefit of the residents may be located and operated in the project. However, the commercial facility cannot be funded with the use of demonstration program or PRAC funds. The maximum amount of space permitted for a commercial facility cannot exceed 10 percent of the total project floor space. An exception to this 10 percent limitation is if the project involves acquisition or rehabilitation and the additional space was incorporated in the existing structure at the time the proposal was submitted to HUD. Commercial facilities are considered public accommodations under Title III of the Americans with Disabilities Act of 1990 (ADA), and thus must comply with all the accessibility requirements of the ADA.
5. Expiration of Demonstration Program Funds. The Department of Housing and Urban Development Appropriations Act, 2006, requires HUD to obligate all Demonstration Program funds appropriated in FY2006 by September 30, 2009. Under 31 U. S. C. 1551, no funds can be disbursed from this account after September 30, 2014. The obligation of funds occurs for the demonstration program funds and project rental assistance upon fund reservation and acceptance. If all funds are not disbursed by HUD and expended by the project Owner by September 30, 2014, the funds, even though obligated, will expire and no further disbursements can be made from this account. Furthermore, all unexpended balances, including any remaining balance on PRAC contracts, will be cancelled as of October 1, 2014.
1. Address for Submitting Applications. All applications must be submitted to
Policy Priorities. HUD encourages applicants to undertake specific activities that will assist the Department in implementing its policy priorities and that help the Department achieve its strategic goals for FY2007. Refer to the General Section for information regarding HUD's Strategic Goals and Policy Priorities. For the demonstration program, applicants who include work activities that specifically address the policy priorities of encouraging accessible design features by incorporating visitability standards and universal design, removing barriers to affordable housing, promoting energy efficiency in design and operations, and expanding training and employment opportunities for low- and very low-income persons and business concerns (Section 3 requirements) will receive additional points. A Notice pertaining to the removal of barriers to affordable housing was published in the
Rating Factors. HUD will rate applications under this NOFA that successfully complete the threshold review using the Rating Factors set forth below and in accordance with the application submission requirements identified in Sections IV.B.2. above. The maximum number of points an application may receive under this NOFA is 102.
This factor addresses your capacity to develop and operate a successful intergenerational housing program in a timely, cost-conscious, and effective manner. This also addresses your Plan to provide comprehensive on-site and off-site supportive services, including your community support, your experience providing similar services, and the experience of your collaborators. This factor also addresses your experience in providing housing and/or related services and your ties to the community at large, to minority and elderly communities, and to intergenerational housing communities in particular. Submit information responding to this factor in accordance with application submission
In rating this factor, HUD will consider:
a. (9 points). The scope, extent, and quality of your experience in providing housing or related services to those proposed to be served by the project and the scope of the proposed project (
b. (5 points). The scope, extent, and quality of your ties to the community at large, to minority and elderly communities, and to intergenerational communities in particular.
c. (4 points). The scope, extent, and quality of your Supportive Services Plan, including your experience in providing housing or related on-site and/or off-site services to intergenerational families.
d. (1 point). The scope, extent, and quality of the experience of your collaborating agencies, organizations, businesses, and other groups in serving intergenerational families.
e. (1 point). The scope, extent, and quality of your proposal to partner, fund, or subcontract with grassroots organizations. HUD will consider a “grassroots organization” if the organization is headquartered in the local community and has a social services budget of $300,000 or less or has six or fewer full-time equivalent employees.
This factor addresses the extent to which the intergenerational dwelling units are needed by the target population. The application must include evidence of current housing needs among intergenerational families, including economic and demographic information on such families. Submit information responding to this factor in accordance with the application submission requirements in Exhibits 4(a) and 4(b) above.
In rating this factor, HUD will consider:
a. (10 points). The extent that your application demonstrates the housing needs of intergenerational families in the community in which the proposed project will be located and whether the community currently offers intergenerational housing and, if so, data and other information evidencing that the proposed project is also needed by intergenerational families in the community.
b. (3 points). The scope, extent, and quality of your assessment of the target population and a description of how they were involved in developing the application, participating with the project's planning committee, developing the project's operating philosophy, reviewing the application prior to submission to HUD, and your intent to involve them in the operation of the project.
c. (2 points). The extent that a connection has been established between the project and the community's Consolidated Plan, Analysis of Impediments to Fair Housing Choice (AI), or another planning document that analyzes fair housing issues and is prepared by a local planning or similar organization.
This factor addresses the quality and effectiveness of your proposal in developing and operating intergenerational housing; the individualized case management planned; and the comprehensive, tailored supportive services to be offered on-site and/or off-site that are crucial to the success of the project. This factor further addresses whether the jurisdiction in which the proposed project will be located has undertaken successful efforts to remove regulatory barriers to affordable housing; your plans to incorporate energy efficiency in the design and operation of the proposed project; your plans to provide training, employment, and economic opportunities to low- and very low-income persons; and the extent to which you have evidenced general support for intergenerational housing by participating in your community's Consolidated Planning Process and involving the target population in the planning process. For your application to receive points for this factor, there must also be a relationship between the proposed activities, the project and community needs, and the purposes of the funding available under this NOFA. Submit information responding to this factor in accordance with application submission requirements in Exhibits 3(c), 3(f), 3(k), 4(c), 4(d), 5, and 6.
In rating this factor, HUD will consider:
a. (10 points). The extent to which the proposed design, including security, will accommodate all ages being served at reasonable cost. (Meets needs = 10 points; partially meets needs = 5 points; and does not meet needs = 0 points)
b. (5 points). The extent to which the staffing plan, written tenant selection procedures, residency requirements, and other rules and procedures will be developed, enforced, and communicated to tenants and identifies the tenant's role in development and enforcement of these procedures. (Meets needs = 5 points; partially meets needs = 3 points; does not meet needs = 0 points)
c. (5 points). The extent to which the proposed comprehensive on-site and/or off-site supportive services meet the identified needs of all ages being served in the intergenerational housing. (Meets needs = 5 points; partially meets needs = 3 points; does not meet needs = 0 points)
d. (4 points). The extent to which you demonstrate that individualized case management will be provided. (Meets needs = 4 points; partially meets needs = 2 points; does not meet needs = 0 points)
e. (5 points). The suitability of the site from the standpoint of promoting a greater choice of housing opportunities for minority, elderly persons/intergenerational families and affirmatively furthering fair housing. In reviewing this criterion, HUD will assess whether the site meets the site and neighborhood standards at 24 CFR 891.125(b) and (c), by examining relevant data in your application or in the local HUD office. Where appropriate, HUD may visit the site.
(1) The site will be deemed acceptable if it increases housing choice and opportunity by expanding housing opportunities in nonminority neighborhoods (if located in such a neighborhood). The term “nonminority area” is defined as one in which the minority population is lower than 10 percent. If the site will be in a minority neighborhood, the site will be deemed acceptable if it contributes to the revitalization of and reinvestment in the minority neighborhood, including improvement of the level, quality, and affordability of services furnished to minority elderly. When considering sites for your project, you should refer to the Site and Neighborhood Standards provisions of the regulations governing the Section 202 Supportive Housing for the Elderly program (24 CFR 891.125(b) and (c)).
(2) For the purpose of this competition, the term “minority neighborhood (area of minority concentration)” is defined as one where any of the following statistical conditions exists:
(a) The neighborhood's percentage of persons of a particular racial or ethnic minority is at least 20 percentage points higher than the percentage of that particular racial or ethnic minority in the housing market area. The percentage
(b) The neighborhood's total percentage of minority persons is at least 20 percentage points higher than the total percentage of minorities for the housing market area;
(c) In the case of a metropolitan area, the neighborhood's total percentage of minority persons exceeds 50 percent of its population.
f. (2 points). The extent to which the jurisdiction in which your project will be located has undertaken successful efforts to remove regulatory barriers to affordable housing and the steps you have taken to support these efforts.
This is an optional requirement, but to receive up to 2 points for removal of regulatory barriers, applicants must include in their response the completed questionnaire found in form HUD-27300 and provide some form of documentation where requested, including point of contact and Web site references, or submit the required documentary evidence. (Refer to Section IV.B.2.b.(2)(c) above and the General Section for more information.)
g. (1 point). The extent to which you describe how you plan to incorporate energy efficiency activities in the design and operation of the housing.
h. (2 points). The extent to which you describe how you propose to provide opportunities to train and employ low- and very low-income persons in the project area; and how you plan to award contracts to business concerns that provide economic opportunities to low- and very low-income persons and people with disabilities in your community.
This is an optional requirement, but to receive up to 2 points, the applicant must have adequately addressed the following in the application. Refer to the General Section for further information:
(1) (1 point)—Provide opportunities to train and employ low- and very low-income residents of the project area.
(2) (1 point)—Award substantial contracts to persons residing in the area.
i. (5 points). The scope, extent, and quality of your plan for carrying out the physical construction of the project, including the time frame.
j. (1 point). The extent to which the proposed design incorporates visitability standards and/or universal design in the construction or rehabilitation of the project. Refer to the General Section for further information.
k. (−1 point). The site(s) is not permissively zoned for the intended use.
This factor addresses your ability to secure other community resources that can be combined with HUD funds to achieve the purpose of expanding the supply of intergenerational dwelling units. For your intergenerational housing project to succeed, you must generate other funding. Submit information responding to this factor in accordance with application submission requirements in Exhibits 3(e) and 5 above.
In rating this factor, HUD will consider:
a. (10 points). The extent to which collaborating agencies, organizations, businesses, and other groups have made commitments to provide supportive services and/or fund them.
b. (5 points). The extent to which firm commitments of $100,000 or more in funding other than that available under this NOFA has already been secured for the project.
This factor reflects HUD's goal to embrace high standards of ethics, management, and accountability. This factor emphasizes HUD's commitment to ensure that promises you make in the application are kept; and to ensure that performance goals with outcomes are established and met. Outcomes may include the extent to which your project will implement practical solutions that will accommodate all ages being served, as well as the extent to which the project will be viable absent HUD funds and rely more on other funding sources. Submit information responding to this factor in accordance with application submission requirements in Exhibits 3(i), 3(j), 3(k), 3(l), 6, and 8(i) of Section IV.B. above. Applicants must complete form HUD-96010, Program Outcome Logic Model, in responding to this rating factor.
In rating this factor, HUD will consider:
a. (4 points). The extent to which your project's development time frame adequately reflects the length of time it will take to develop the project, your full understanding of the development process, and how residents of all ages will benefit from the project.
b. (2 points). The extent to which your project will implement practical solutions that will enable residents of the project to meet the terms and conditions of the lease. This element demonstrates assisting residents of all ages achieve an improved living environment, independent living, and educational opportunities.
c. (2 points). The extent to which the project will be viable as housing with the availability of supportive services for very low-income intergenerational families, absent HUD funds, while relying more on other funding sources for the term of the mortgage.
d. (1 point). The extent to which the project's operating philosophy will involve residents and consider the needs of residents of all ages.
e. (1 point). The extent to which your past performance evidences that the proposed project will result in the timely development of the project. Evidence of your past performance could include the development of previous construction projects, including, but not limited to, Section 202 and Section 811.
The project is located in an RC/EZ/EC-II area.
You should ensure that your application is complete before submitting it to HUD. Upon receipt of the applications by HUD staff, the applications will be screened to determine if there are any curable deficiencies. A curable deficiency is a missing exhibit or portion of an exhibit that will not affect the rating of the application. Refer to the General Section for additional information regarding procedures for corrections to deficient applications.
With respect to the correction of deficient applications, HUD may not, after the application deadline date and consistent with HUD regulations in 24 CFR part 4, subpart B, consider any unsolicited information you may want to provide. HUD may contact you to clarify an item in the application or to correct curable deficiencies. Please note, however, that HUD may not seek clarification of items or responses that improve the substantive quality of a response to any rating factors. In order not to unreasonably exclude applications from being rated and ranked, HUD may contact you to ensure proper completion of the application and will do so on a uniform basis for all applicants. In each such case, under this NOFA, HUD will notify you in writing by describing the clarification or curable deficiency. You must submit clarifications or responses to curable deficiencies in accordance with the information provided by HUD within 14 calendar days of the date of HUD notification. (If the due date falls on a Saturday, Sunday, or federal holiday,
HUD Headquarters will notify you, in writing, if your application is missing any of the above exhibits or portions of exhibits and will provide you with a specified deadline to submit the information required to cure the noted deficiencies. The exhibits identified by an asterisk (*) must be dated on or before the application deadline date. If an exhibit or portion of an exhibit listed above as curable is not discovered as missing until technical processing, HUD will provide you with a deadline to cure the deficiency.
2. Threshold Review. Only those applications that meet all threshold requirements will be eligible to receive further review for an award of funds. Applications that do not meet the threshold requirements will be rejected. (See Section III.C.2. above and the General Section for threshold requirements.)
3. Review Panels. HUD may establish panels to review and rate all applications that have met the threshold requirements. These panels may include intergenerational housing experts or consultants not currently employed by HUD. These individuals may be included to provide certain expertise. Persons brought into HUD to review applications are subject to conflict-of-interest provisions. See the General Section for additional information.
4. Rating. HUD will review and rate your application in accordance with the Review and Selection Process in the General Section, except as described in “5. Appeal Process” found below. Your application will be either rated or technically rejected at the end of technical review. If your application meets all program eligibility requirements after completion of technical review, it will be rated according to the rating factors in Section V.A. above.
5. Appeal Process. HUD will not reject your application based on technical review without notifying you of that rejection with all the reasons for that rejection, and providing you with an opportunity to appeal. You will have 14 calendar days from the date of HUD's written notice to appeal a technical rejection to HUD Headquarters. In HUD's review of any appeal, it should be noted that in conformance with its regulations at 24 CFR part 4, subpart B, HUD will not consider any unsolicited information that you, the applicant, may want to provide. HUD Headquarters will make a determination on an appeal before finalizing selection recommendations.
6. Ranking and Selection Procedures. Applications submitted in response to this NOFA that meet all of the applicable threshold requirements of the General Section and this NOFA and have a total base score of 75 points or more (without the addition of the RC/EZ/EC-II bonus points) are eligible for selection. Any bonus points the application receives for RC/EZ/EC-II will be added to the total base score of 75 points or more. Not less than two and not more than four of these applications will be selected based on rank order; however, HUD reserves the right to fund out of rank order based on national geographical diversity, the ability of the applicant to develop and operate intergenerational dwelling units, and ratio of funds requested to remaining fund amounts.
7. Tie. In the event of a tie, HUD Headquarters will make its selection based on the following:
a. National geographical diversity.
b. The ability of the applicant to develop and operate intergenerational dwelling units;
c. The application that demonstrates the most need in the project location, based on verifiable statistical data contained in the application.
d. Amount of funds requested.
e. The date and time when the application was received.
1. Agreement Letter. If you are selected to receive an intergenerational housing fund reservation, you will receive an Agreement Letter that stipulates the terms and conditions for the fund reservation award, as well as the submission requirements following the fund reservation award. The duration of the fund reservation award for the funds is 18 months from the date of issuance of the fund reservation. Immediately upon your acceptance of the Agreement Letter, you are expected to begin work towards the submission of a Firm Commitment Application, which is the next application submission stage. You are required to submit a Firm Commitment Application to HUD Headquarters within 180 days from the date of the Agreement Letter. Initial closing of the program funds and start of construction of the project are expected to be accomplished within the duration of the fund reservation award. Final closing of the program funding is expected to occur no later than 6 months after completion of project construction.
2. Non-selection Letters. If your application is approvable but unfunded due to insufficient funds or receives a rating that is below the minimum threshold score established for funding eligibility, you will get a letter to that effect.
3. Adjustments to Funding. HUD will not fund any portion of your application that is not eligible for funding under specific program statutory or regulatory requirements; that does not meet the requirements of this NOFA; or that may be duplicative of other funded programs or activities. Only the eligible portions
4. Applicant Debriefing. All requests for debriefing must be made in writing and submitted to HUD Headquarters. Refer to the General Section for further information regarding debriefings, except that the request for a debriefing must be made to: Aretha Williams, Director, Grant Policy and Management Division, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410-8000.
1. Ensuring the Participation of Small Businesses, Small Disadvantaged Businesses, and Women-Owned Businesses. Although the Section 202 program is not subject to the provisions of 24 CFR 85.36(e), as described in the corresponding paragraph in the General Section, you are required to comply with Executive Order 12432, Minority Business Enterprise Development, and Executive Order 11625, Prescribing Additional Arrangements for Developing and Coordinating a National Program for Minority Business Enterprise, as they relate to the encouragement of HUD grantees to utilize minority business enterprises.
2. Acquisition and Relocation. You must comply with the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, as amended (49 CFR part 24 and 24 CFR 891.155(e)) (URA), which covers the acquisition of sites, with or without existing structures; and with 24 CFR 8.4(b)(5) of the Section 504 regulations, which prohibits discrimination based on disability in determining the site or location of a federally assisted facility. However, you are exempt from complying with the site acquisition requirements of the URA if: (1) You do not have the power of eminent domain, and (2) prior to entering into a contract of sale, option to purchase, or any other method of obtaining site control, you inform the seller of the land in writing: (a) that you do not have the power of eminent domain and, therefore, you will not acquire the property if negotiations fail to result in an amicable agreement, and (b) of the estimate of the fair market value of the property. An appraisal is not required to meet this requirement; however, your files must include an explanation (with reasonable evidence) of the basis for the estimate. Evidence of compliance with this advance notice requirement must be included in Exhibit 4(d)(iv) of your application.
3. Flood Disaster Protection Act of 1973 and Coastal Barrier Resources Act. You must comply with the requirements under the Flood Disaster Protection Act of 1973 (42 U.S.C. 4001-4128) and the Coastal Barrier Resources Act (16 U.S.C. 3601).
4. Environmental Impact. A Finding of No Significant Impact with respect to the environment has been made for this notice, in accordance with HUD regulations at 24 CFR part 50 that implement Section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332 (2)(C)). The Finding of No Significant Impact is available for public inspection between 8 a.m. and 5 p.m., except federal holidays, in the Office of General Counsel, Regulations Division, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500.
1. The Program Outcome Logic Model (form HUD-96010) must be completed, indicating the results achieved against the proposed output goal(s) and proposed outcome(s) that you stated in your approved application and that were agreed upon by HUD. HUD is considering a new concept for the Logic Model—a Return on Investment (ROI) statement. HUD will be publishing a separate notice on the ROI concept.
These reporting requirements are to be submitted to HUD as follows:
2. Racial and Ethnic Data. HUD requires that funded recipients collect racial and ethnic beneficiary data. HUD has adopted OMB's Standards for the Collection of Racial and Ethnic Data. In view of these requirements, applicants should use form HUD-27061, Race and Ethnic Data Reporting Form, found on
The Regulatory Agreement requires the Owner of the Intergenerational Housing project to submit an annual financial statement for the project. This financial statement must be audited by an Independent Public Accountant who is a Certified Public Accountant or by another person acceptable to HUD and filed electronically with HUD's Real Estate Assessment Center (REAC) through the Financial Assessment Subsystem for Multifamily Housing (MF-FASS). The submission of annual financial statements is required throughout the term of the mortgage.
For Technical Assistance. For technical assistance in downloading an application package from