Under the regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-51, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.

Section 319.56-4 of the regulations contains a performance-based process for approving the importation of commodities that, based on the findings of a pest risk analysis, can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. One of the designated phytosanitary measures is that the fruits or vegetables are imported from a pest-free area in the country of origin that meets the requirements of § 319.56-5 for freedom from that pest and are accompanied by a phytosanitary certificate stating that the fruits or vegetables originated in a pest-free area in the country of origin. 1

Under the regulations in § 319.56-5, APHIS requires that determinations of pest-free areas be made in accordance with the criteria for establishing freedom from pests found in International Standards for Phytosanitary Measures (ISPM) No. 4, “Requirements For the Establishment of Pest Free Areas.” The international standard was established by the International Plant Protection Convention of the United Nations' Food and Agriculture Organization and is incorporated by reference in our regulations in 7 CFR 300.5. In addition, APHIS must also approve the survey protocol used to determine and maintain pest-free status, as well as protocols for actions to be performed upon detection of a pest. Pest-free areas are subject to audit by APHIS to verify their status.

APHIS received a request from the Government of Argentina to recognize an additional area of that country as being free of Ceratitis capitata, Mediterranean fruit fly (Medfly). Specifically, the Government of Argentina asked that we recognize the Southern and Central Oases in the southern half of Mendoza Province as an area that is free of Medfly.

In accordance with our process, we published a notice  2 in the Federal Register on June 25, 2010 (75 FR 36347-36348, Docket No. APHIS-2010-0032), in which we announced the availability, for review and comment, of a commodity import evaluation document (CIED) that evaluates the information presented by Argentina in support of its request to recognize additional areas as pest-free areas for Mediterranean fruit fly ( Ceratitis capitata ) in Argentina. We solicited comments on the notice for 60 days ending on August 24, 2010. We received two comments by that date, one from a State agricultural official and the other from an official of Argentina's national plant protection organization (NPPO). The first commenter acknowledged Argentina's history of successful Medfly control efforts, but stated that APHIS should not relax its fruit fly-related restrictions until it can confirm that no other pest fruit flies-notably Anastrepha species fruit flies-are present in the area. The second commenter provided information to support a finding that the Mendoza Province is free of the South American fruit fly ( Anastrepha fraterculus ). As a result of these comments, APHIS contacted the Argentine NPPO, which requested that, in addition to the pest-free status for Ceratitis capitata, the Mendoza province of Argentina also be recognized as free of A. fraterculus.

In accordance with our regulations and the criteria set out in ISPM No. 4, we have reviewed and approved the survey protocols and other information provided by Argentina relative to its system to establish A. fraterculus freedom, phytosanitary measures to maintain freedom, and system for the verification of the maintenance of freedom. Because this action concerns the expansion of a currently recognized pest-free area in Argentina from which fruits and vegetables are authorized for importation into the United States, our review of the information presented by Argentina in support of its subsequent request to recognize the Mendoza province of Argentina as free of A. fraterculus is examined in a CIED titled “Recognition of additional Provinces as Anastrepha fraterculus Pest-Free Areas (PFA) for Argentina.”

The CIED may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for instructions for accessing Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the CIED by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT .

Therefore, in accordance with § 319.56-5(c), we are announcing the Administrator's determination that the Southern and Central Oases in the southern half of Mendoza Province meet the criteria of § 319.56-5(a) and (b) with respect to freedom from the South American fruit fly and all other economically important species of Anastrepha. After reviewing the comments we receive on this notice and taking into consideration the comments we received on our June 2010 notice regarding the areas' Medfly status, we will announce our decision regarding the status of these areas with respect to their freedom from Medfly and South American fruit fly. If the Administrator's determination remains unchanged, we will amend the list of pest-free areas to list Southern and Central Oases of the Mendoza Province of Argentina as free of Medfly and South American fruit fly.

1. Background

Schools that participate in the SMPs must meet Federal meal pattern requirements and compliance assessments. Selecting and ordering foods commercially and through the USDA Foods program involves a number of factors that include an understanding of both the nutritional content of and ingredients contained in food offered to schools and ultimately served to students. In addition, as schools look to increase the nutritional quality of the meals served, meet revised meal pattern requirements, apply for HealthierUS School Challenge certification, and/or detect allergens that may affect their students, access to relevant, timely and comprehensive nutrition information and ingredient lists is essential.

FNS would like to better understand what, where, and how nutrition information and ingredient lists are provided to schools—and what information schools are seeking—when ordering and receiving products to prepare as part of a school meal.

This document requests the public to inform FNS on the following statements as they relate to foods served in school meal programs:

a. How schools obtain nutrition information and ingredient lists about foods used in school food service, including commercially selected foods and USDA Foods, when ordering food for a school ( e.g., computerized ordering system, contacting the manufacturer directly, searching the manufacturer's Web site, etc. ).

b. How schools obtain nutrition information and ingredient lists about commercially selected foods and USDA Foods when food gets delivered to a school ( e.g., fact sheet, label on institutional pack, vendor Web site, etc. ).

c. Whether nutrition information and ingredient lists are easily accessible prior to ordering food.

d. Whether nutrition information and ingredient lists are easily accessible when food gets delivered to a school.

e. Whether nutrition information and ingredient lists available to schools prior to ordering food are adequate.

f. Whether nutrition information and ingredient lists provided upon delivery to schools are adequate.

g. Challenges food manufacturers, processors, distributors, brokers and others in food service may face when providing nutrition information and ingredient lists to schools.

h. Most desirable method to obtain nutrition information and ingredient lists when ordering food for a school.

i. Most desirable method to obtain nutrition information and ingredient lists when food gets delivered to a school.

j. Whether a school food authority's solicitation for food items contains clear statements regarding the need for nutrition information and/or ingredient lists.

k. Schools' whole-grain ordering needs, including:

(1) Whether schools receive adequate ingredient information to determine whether foods are whole-grain.

(2) What specific documentation, if any, a school is looking for when purchasing whole-grain products.

l. Whether schools tend to use previously developed specifications or develop new specifications to reflect nutritional and ingredient needs of the program/students.

m. The frequency with which schools write specifications using ingredient lists or nutrition information from previously ordered products.

Extensive research has demonstrated that current ponderosa pine forests of the Southwest are greatly altered in terms of forest structure, density, and ecological function. Most pine forests in the Southwest are at much higher risk of high intensity and severe fire than they were prior to European settlement (Covington 1993, Moore et al. 1999). A century ago the pine forests had widely-spaced large trees with a more open, herbaceous forest floor (Cooper 1960). These conditions were maintained by fairly frequent low-severity surface fires that did not kill the large trees (Fiedler et al. 1996). These fires occurred every 2 to 21 years and maintained an open canopy structure (Moir et al. 1997). Fire suppression, cattle grazing, timber production, and general human habitation in and near the forests over the last 100 years interrupted fire's natural role in these fire-adapted ponderosa pine forests. As a result, the forests have shifted from naturally open conditions to high densities of small diameter trees (Covington and Moore 1994) dramatically increasing the size and severity of wildland fires (Swetnam and Betancourt 1998). The forests have become less resilient to natural disturbances and are vulnerable to large-scale disturbances such as changing climatic conditions (drought), fire, insect, and disease.

In contrast to having a ponderosa pine ecosystem consisting of groups of trees with an open tree canopy density mixed with interspaces, approximately 75 percent of the ponderosa pine forest type within the project area has a moderately closed to closed tree canopy density. An open tree canopy mixed with interspaces which mimic historical spatial patterns and provide for tree regeneration and the development of grass and forbs are lacking. There is a need to use management strategies that promote tree regeneration and understory vegetation. There is a need to move towards the historic range of variability for tree canopy density and patterns of tree groups and interspaces. Forest resiliency and diversity is dependent on the distribution of age and size classes.

Currently, over 50 percent of the project area lacks age and size class diversity and is in an even-aged structure. The desired condition is to have a forest structure that represents all age classes necessary for a sustainable balance of regeneration, growth, mortality and decomposition. There is a need to implement un-even aged management strategies where appropriate. In goshawk habitat, habitat components such as an intermix of vegetation structural stages are lacking or limited in most stands. There is a need to manage for a balanced interspersion of age classes in goshawk foraging and PFA/nest stand habitat. Forest structure in Mexican spotted owl (MSO) habitat has an excess of the smaller size classes (12″ to 18″) and is deficit in trees 18″ to 24″ dbh in restricted habitat and in target/threshold, a component of restricted habitat. There is a need to implement uneven-aged management strategies and manage for high-density, relatively uneven-aged stands in MSO restricted habitat, including target/threshold habitats.

In both goshawk and MSO habitat, stand conditions are on a trajectory towards density-related mortality. The desired condition is to improve forest health by reducing the potential for density-related mortality and move towards forest plan desired conditions for snags and course woody debris. There is a need to reduce stand densities in all habitats except MSO restricted and target threshold.

Approximately 25 percent to 35 percent of the project area has some level of infection ranging from light to extreme. The desired condition is to have a varied level of mistletoe across the landscape that is comparable with historic reference conditions. There is a need to use management strategies that would reduce stand densities in order to reduce (but not eliminate) the level of dwarf mistletoe infection.

Vegetation diversity throughout the project area has declined (USDA 2009). A lack of fire, which ultimately allowed for increased stand densities, has allowed Gambel oak to become overtopped by fast growing ponderosa pine. The desired condition is to develop and maintain a variety of oak size classes and forms, where they occur, that range from shrubby thickets and pole-sized clumps to large trees across the landscape. There is a need to use management strategies that stimulate new growth and maintain growth in large diameter trees.

There are approximately 7,700 acres of aspen in the project area. Aspen is dying or rapidly declining on both forests due to the combined effects of conifer encroachment, browsing, insect, disease, severe weather events, and lack of fire disturbance (USDA 2008 2009). The desired condition is to maintain and/or regenerate aspen. Where possible, there is a need to stimulate growth and increase individual recruitment of aspen. On the Coconino NF, grasslands have decreased from approximately 8 percent to 3 percent since historic conditions (generally pre-1900). On the Kaibab NF, grasslands have decreased from approximately 15 to 7 percent (USDA 2008) (USDA 2009). The desired condition is to move towards the historic range of variability of tree canopy cover that ranges from 0 to 9 percent. Fire should function as a natural disturbance across the landscape without causing loss to ecosystem function or to human safety, lives, and values. There is a need to reduce (and in some cases remove) tree encroachment which has reduced the size and function of landscapes that were historically grasslands.

Big sage and ponderosa pine co-occur on approximately 6,094 acres of the Tusayan district portion of the project area. The desired condition for the pine/sage understory community is a shifting mosaic of sagebrush with a mix of age classes averaging from 3 to 5 percent cover. With other shrub canopies combined, the percent cover would average around 9 to 14 percent under a 25 to 30 percent canopy of ponderosa pine. The mosaic pattern would be largely regulated by low intensity fires. On approximately 40 percent of the pine-sage cover type, there is a need to retain vegetation age class diversity in big sage and promote a shifting mosaic of shrub cover.

Approximately 41 percent of the project area has the potential to sustain crown fire and about 58 percent has the potential for surface fire. Dense forest conditions (numerous trees with interlocking crowns) are common within the project area and would support active crown fire. Even without crown fire, a high intensity surface fire burning though this area could scorch the canopy sufficiently to cause widespread mortality. The current fire return interval is approximately 43 years, about four times longer than the desired fire return interval which is between 2 and 21 years. The desired condition is to have fire, as a disturbance process, maintain a mosaic of diverse native plant communities. No more than 10 percent of the analysis area should be prone to crown fire. When crown fire does occur, it would be mostly passive crown fire, occurring in single trees, groups, or clumps, or areas where there had been mortality (wind throw, insects, etc.). There is a need to reduce the potential for crown and high intensity surface fire.

Across the entire analysis area, 75 percent is currently rated as condition class 3 which indicates the fire regime is significantly departed from historical ranges. In a condition class 3, the risk of losing key ecosystem components is high. Fire frequencies have departed from historical frequencies by multiple return intervals resulting in dramatic alterations to fire size, intensity, severity, landscape patterns, and/or vegetation attributes. The desired condition is to have 99 percent of the analysis area in FRCC 1. There is a need to reduce the percent of area in FRCC 3 and move the fire regimes towards FRCC 1.

Springs and seeps play an important role on the landscape for hydrological function of watersheds and they are very important for wildlife and plant diversity. Fifty-one developed springs on the Coconino NF are not functioning at or near potential and 27 springs on the Kaibab NF have reduced function. The desired condition is to have the necessary soil, water, and vegetation attributes to be healthy and functioning at or near potential. Ephemeral streams are important for hydrological function of watersheds and provide important seasonal habitat for a variety of wildlife, in particular, migratory birds and dispersing amphibians. On the Coconino NF, approximately 36 miles of channels are heavily eroded with excessive bare ground, denuded vegetation, and head cuts. Of the total miles, approximately 6 miles are riparian streams and 30 miles are non-riparian streams. The Kaibab NF has approximately 7 miles of channels in this condition and all are non-riparian reaches. The desired condition is to restore the functionality of both springs and ephemeral streams. On all springs and streams and channels, there is a need to return fire, a natural disturbance processes, to the system.

Both forests have identified the needed road system for public and administrative motorized use through the Travel Management Rule (TMR) process. As a precursor to the TMR process, the Coconino NF identified roads that should be closed to public travel, decommissioned, or considered for other uses because they were no longer needed to meet resource management objectives (USDA 2010). A review of 2010 data indicates there is a need to decommission approximately 941 miles of existing system and unauthorized roads on the Coconino NF. Similar to the Coconino process, the Kaibab NF identified resource risks and access benefits associated with all roads. A review of Kaibab NF data indicates approximately 170 miles of unauthorized roads are recommended for decommissioning. The desired condition is to have soils in satisfactory condition so that the soil can resist erosion, recycle nutrients and absorb water. There is a need to decommission the roads that have been identified.

In addition to the need for decommissioning roads, there is a need to have adequate access to the project area for implementation. There is a need to upgrade road segments which have resource or health and human safety concerns, construct temporary roads that could be used for access, and temporarily open existing closed roads. Once the project is completed, there is a need to decommission the temporary roads and closed roads.

In response to the purpose and need, the Coconino and Kaibab National Forests propose to conduct approximately 595,370 acres of restoration activities (within the 988,764 acre project area) over approximately 10 years or until objectives are met. Approximately 20,000 to 30,000 acres of vegetation would be treated annually and up to 60,000 acres prescribed burned annually across the two forests. Restoration activities would: (1) Mechanically cut trees and prescribe burn on approximately 389,993 acres, (2) cut trees by hand and prescribe burn on slopes greater than 40 percent on approximately 99 acres, (3) prescribe burn only on approximately 205,278 acres, (4) decommission 941 miles of roads designated “closed”, (5) decommission 170 miles of unauthorized roads, (6) construct 46 miles of temporary roads for haul access and obliterate when treatments are finished, (7) reconstruct 27 miles of existing open roads for natural resource, health and human safety concerns, (8) open 183 miles of existing closed roads in order to conduct treatments and close and rehabilitate as needed when treatments are finished, (9) restore 78 springs, (10) restore 43 miles of ephemeral channels, and, (11) construct 82 miles of protective (aspen and springs) fencing. An old tree implementation strategy, that is integral to the proposed action, is included in appendix B in the proposed action document. A large tree implementation strategy, that is not part of the proposed action, is included in appendix C. Appendix C has been included for comment purposes only.

Forest plan amendments are integral to the proposed action. Three non-significant forest plan amendments would be required on the Coconino NF to implement the proposed action. One non-significant forest plan amendment would be required on the Kaibab NF. The proposed amendments are located at appendix F in the proposed action document.

A full range of alternatives to the proposed action, including a no-action alternative, will be considered. The no-action alternative represents no change and serves as the baseline for the comparison among the action alternatives.

The Responsible Officials are the Coconino Forest Supervisor and Kaibab Forest Supervisor.

Given the purpose and need of the project, the forest supervisors will review the proposed action, other alternatives and the environmental consequences in order to make the following decisions including determining: (1) Whether to select the proposed action or another alternative; (2) the location, design, and scheduling of proposed restoration activities; (3) the estimated products, if any, to be made available from the project; (4) mitigation measures, monitoring requirements and adaptive management actions; and, (5) whether forest plan amendments are needed.

This corrected notice of intent initiates the scoping process, which guides the development of the environmental impact statement. Two open houses are planned during the comment period. The first open house will be held on August 25, 2011 at the Williams Ranger District, 742 South Clover Road, Williams, Arizona, from 4 p.m. to 7:30 p.m. The second open house will be held on August 27, 2011 at the Coconino National Forest Supervisor's Office, 1824 S. Thompson Street, Flagstaff, AZ 86101, from 10 a.m. to 2 p.m. Please contact Paula Cote at (928) 226-4686 for additional information.

It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.

Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, however.

The following business will be conducted: General business, previous project status updates, project funding, review and selection of proposed projects. Full agenda may be previewed at Homochitto District office during regular business hours or on the Web at https://fsplaces.fs.fed.us/fsfiles/unit/wo/secure_rural_schools.nsf/RAC/ Southwest+Mississippi. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 14, 2011 to be scheduled on the agenda. Written comments and requests for time for oral comments must be sent to 1200 Hwy 184 East, Meadville, MS 39653, or by email to dochabreck@fs.fed.us, or via facsimile to 601-384-2172. A summary of the meeting will be posted at https://fsplaces.fs.fed.us/fsfiles/unit/wo/secure_rural_schools.nsf/RAC/Southwest+Mississippi within 21 days of the meeting.

Background

On April 9, 2010, the Department initiated an administrative review of 92 producers/exporters of subject merchandise from the PRC. 3 Subsequently, pursuant to 19 CFR 351.213(d)(1), the Department rescinded the administrative review with respect to Allied Pacific Aquatic Products Zhanjiang Co., Ltd. and Allied Pacific Food (Dalian) Co., Ltd. based on upon Petitioner's timely withdrawal of its review request. 4 As noted above, on February 14, 2011, the Department published the Preliminary Results of this administrative review. 5 In those Preliminary Results, the Department preliminarily rescinded the review with respect to several companies that submitted no shipment certifications and for which we have not found any information to contradict these claims. These companies are Yangjiang City Yelin Hoitat Quick Frozen Seafood Co., Ltd., Fuqing Yihua Aquatic Food Co., Ltd., Fuqing Minhua Trade Co., Ltd., and Shantou Yelin Frozen Seafood Co., Ltd. (d.b.a. Shantou Yelin Quick-Freeze Marine Products Co., Ltd.).

On March 3, 2011, we extended the deadline for parties to submit the case briefs and rebuttal briefs to March 21, 2011, and March 28, 2011, respectively. 6 On March 7, 2011, the Petitioner, 7 Domestic Processors, 8 and Hilltop submitted additional surrogate value information. On March 17, 2011, Domestic Processors submitted rebuttal surrogate value information.

On March 21, 2010, Domestic Processors and Hilltop filed case briefs. On March 21, 2010, we received new factual information contained within Petitioner's case brief. On March 24, 2011, we rejected Petitioner's new factual information as being untimely filed, removed the new factual information from the record of this review and provided Petitioner until March 28, 2011 to re-file its case brief. Additionally, we extended the deadline for rebuttal briefs until March 30, 2011. 9 On March 28, 2011, Petitioner resubmitted its case brief. On March 30, 2010, Petitioner, Domestic Processors, and Hilltop filed rebuttal briefs. On May 24, 2011, the Department extended the deadline for the completion of the final results of this review until August 13, 2011. 10 On June 21 and July 11, 2011, the Department place on the record, information pertaining to the Department's recently revised labor rate methodology. 11 Between July 7 and July 14, 2011, interested parties submitted comments regarding the Department's recently revised surrogate labor methodology.

All issues raised in the case and rebuttal briefs by parties to this review are addressed in the “Fifth Administrative Review of Frozen Warmwater Shrimp from the People's Republic of China: Issues and Decision Memorandum for the Final Results,” which is dated concurrently with this notice (“ I&D Memo” ). A list of the issues that parties raised and to which we respond in the I&D Memo is attached to this notice as an Appendix. The I&D Memo is a public document and is on file in the Central Records Unit (“CRU”), Main Commerce Building, Room 7046, and is accessible on the Department's website at http://www.trade.gov/ia . The paper copy and electronic version of the memorandum are identical in content.

Based on a review of the record as well as comments received from parties regarding our Preliminary Results, we made two revisions to Hilltop's margin calculation for the final results. First, we have revised the surrogate value source for shrimp larvae. For the Preliminary Results, we used Sharat Industries Limited (“Sharat”) 2008-2009 financial statements to value shrimp larvae. 12 For the final results, the Department has determined to use Sharat's 2009-2010 financial statements as a surrogate value source for shrimp larvae. For further information see I&D Memo at Comment 3.

National Oceanic and Atmospheric Administration (NOAA) collects information to implement the International Dolphin Conservation Program Act (Act). The Act allows entry of yellowfin tuna into the United States (U.S.), under specific conditions, from nations in the International Dolphin Conservation Program that would otherwise be under embargo. The Act also allows U.S. fishing vessels to participate in the yellowfin tuna fishery in the eastern tropical Pacific Ocean (ETP) on terms equivalent with the vessels of other nations. NOAA collects information to allow tracking and verification of “dolphin safe” and “non-dolphin safe” tuna products from catch through the U.S. market.

The regulations implementing the Act are at 50 CFR parts 216 and 300. The recordkeeping and reporting requirements at 50 CFR parts 216 and 300 form the basis for this collection of information. This collection includes permit applications, notifications, tuna tracking forms, reports, and certifications that provide information on vessel characteristics and operations in the ETP, the origin of tuna and tuna products, and certain other information necessary to implement the Act.

Paper applications, other paper records, electronic and facsimile reports, and telephone calls are required from participants. Methods of submittal include transmission of paper forms via regular mail and facsimile as well as electronic submission via e-mail or an ETP site (password protected).

OMB Control Number: 0648-0387.

Form Number: None.

Type of Review: Regular submission (extension of a current information collection).

Affected Public: Business or other for-profit organizations; individuals or households.

Estimated Number of Respondents: 101.

Estimated Time per Response: 35 minutes for a vessel permit application; 10 minutes for an operator permit application, a notification of vessel arrival or departure, a change in permit operator; a notification of a net modification or a monthly tuna storage removal report; 30 minutes for a request for a waiver to transit the ETP without a permit (and subsequent radio reporting) or for a special report documenting the origin of tuna (if requested by the NOAA Administrator); 10 hours for an experimental fishing operation waiver; 15 minutes for a request for a Dolphin Mortality Limit; 35 minutes for written notification to request active status for a small tuna purse seine vessel; 5 minutes for written notification to request inactive status for a small tuna purse seine vessel or for written notification of the intent to transfer a tuna purse seine vessel to foreign registry and flag; 60 minutes for a tuna tracking form; 60 minutes for a monthly tuna receiving report.

Estimated Total Annual Burden Hours: 328.

Estimated Total Annual Cost to Public: $950.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

I. Abstract

National Marine Fisheries Service (NMFS) Southeast Region manages the United States (U.S.) fisheries of the exclusive economic zone (EEZ) off the South Atlantic, Caribbean, and Gulf of Mexico under the Fishery Management Plans (FMP) for each Region. The Regional Fishery Management Councils prepared the FMPs pursuant to the Magnuson-Stevens Fishery Conservation and Management Act. The regulations implementing the FMPs that have reporting requirements are at 50 CFR part 622.

The recordkeeping and reporting requirements at 50 CFR part 622 form the basis for this collection of information. NMFS Southeast Region requests information from the shrimp fishery participants to certify individual Bycatch Reduction Devices (BRDs). This information, upon receipt, results in an increasingly more efficient and accurate database for management and permitting of the fisheries of the EEZ off the South Atlantic, Caribbean, and Gulf of Mexico.

This request is for an extension of a currently approved information collection.

Paper applications, electronic reports, and telephone calls are required from participants, and methods of submittal include Internet, electronic forms, and facsimile transmission of paper forms.

OMB Control Number: 0648-0345.

Form Number: None.

Type of Review: Regular submission (extension of a currently approved collection).

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 32.

Estimated Time per Response: Station Sheet BRD Form, Species Characterization Form, Length Frequency Form, Condition and Fate Form, and Trip Report/Cover Sheet, one minute; Independent BRD Test Form, 5 minutes; Vessel Information Application and the Gear Specification Form, 20 minutes.

Estimated Total Annual Burden Hours: 71.

Estimated Total Annual Cost to Public: $640 in recordkeeping/reporting costs.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

The Springfield Science Museum is requesting a permit to continue enhancement activities previously authorized under Permit No. 1555. Activities would include the acquisition of up to five captive-bred, non-releasable shortnose sturgeon. The display would be used to increase public awareness of the shortnose sturgeon and its status by educating the public on shortnose sturgeon life history and the reasons for the species decline. The proposed project to display endangered cultured shortnose sturgeon responds directly to a recommendation from the NMFS recovery plan outline for this species. The permit would not authorize any takes from the wild, nor would it authorize any release of captive sturgeon into the wild. The permit is requested for a duration of five years.

NMFS is the Federal agency responsible for management and recovery of Hawaiian monk seals under the Endangered Species Act (ESA; 16 U.S.C. 1531 et seq. ) and the Marine Mammal Protection Act (MMPA; 16 U.S.C. 1361 et seq. ). In 1976, NMFS listed Hawaiian monk seals as “endangered” under the ESA and “depleted” under the MMPA. As required under section 4 of the ESA, NMFS published a Recovery Plan for the species in 1983, which was revised in 2007.

NMFS administers funds that have been appropriated by Congress and allocated within NMFS' annual budget for the purpose of carrying out recovery actions for Hawaiian monk seals. This PEIS would satisfy the NEPA compliance requirements for funding and undertaking recovery actions for Hawaiian monk seals, including the requirements for obtaining MMPA and ESA permits.

The Hawaiian monk seal ( Monachus schauinslandi ) is a critically endangered species found only in the U.S., within the Hawaiian Archipelago and at Johnston Atoll. The population is estimated to have 1,125 individuals remaining and is declining by roughly 4.5% each year.

Since the 1980's, NMFS has conducted research to understand, and enhancement activities to mitigate, threats to the survival of monk seals. Most of this work has been in the Northwestern Hawaiian Islands (NWHI) where the majority of seals live and breed. More recently, a natural increase in the number of seals in the Main Hawaiian Islands (MHI) has prompted researchers and managers to begin studying and aiding seals in the MHI.

Despite measures taken to save the monk seal, the species is not showing signs of recovery. In the NWHI, young seals are continuing to starve to death, nursing and newly weaned pups are being killed by sharks, seals are getting entangled in marine debris, and sea level rise threatens terrestrial habitats. Low juvenile survival over the past two decades is the primary cause of the population's decline. There is insufficient recruitment into the breeding population, and the population decline will likely continue without intervention.

On October 1, 2010, NMFS provided public notice (75 FR 60721) that it would prepare a PEIS to assess the impacts of implementing specific management actions and administering a research and enhancement program to improve survival of Hawaiian monk seals. The 45 day public scoping period was extended 15 days (75 FR 69398), and the comment period ended November 30, 2010.

Scoping was the first step in this NEPA process (as required under 40 CFR 1501.7). Scoping provided an opportunity for the public and agencies to express their views and identify issues to be addressed in the Draft PEIS regarding activities that may be performed on Hawaiian monk seals in an effort to recover the species.

As part of scoping, NMFS hosted public meetings to introduce the project proposal, describe the PEIS process, and solicit input on the issues and alternatives to be evaluated. Public scoping meetings were held in October 2010 on the islands of O`ahu, Hawai'i, Maui, Moloka'i, and Kaua`i. During the scoping comment period, 139 public comments were received. A report summarizing these comments is available on the project Web site: http://www.nmfs.noaa.gov/pr/permits/eis/hawaiianmonkseal.htm.

Issues identified by the public during the scoping process include, but are not limited to, concerns regarding bringing young seals to the MHI and returning them to the NWHI, Native Hawaiian beliefs and culture, fisheries interactions, and human-seal encounters. Substantive comments received during the scoping period have been addressed in the Draft PEIS.

NMFS has evaluated a preferred alternative and three other alternatives in the Draft PEIS. These are summarized as follows:

Alternative 1: Status Quo Alternative: Under the Status Quo Alternative, research and enhancement activities would be carried out as currently permitted under the MMPA and ESA. New permits could be issued in the future to maintain the current levels of research and enhancement activities. Some elements of this alternative include:

• Population assessment (e.g., counting, marking for identification);

• Health and disease studies (e.g., tissue sampling, taking measurements);

• Foraging studies (e.g., telemetry, scat collection);

• De-worming research (e.g., fecal samples, testing anti-parasite treatments);

• Translocation of weaned pups within the NWHI to improve juvenile survival;

• Mitigation of fishery interactions (e.g., disentanglement, removal of hooks); and

• Mitigation of adult male aggression (e.g., removal of aggressive males).

Alternative 2: No Action: Under this alternative, the above-mentioned permitted research and enhancement activities on Hawaiian monk seals would stop in 2014 when the current MMPA-ESA permit expires. No new permits would be issued.

Alternative 3: Limited Translocation: Alternative 3 would include all currently permitted activities and further address the recommendations of the Hawaiian Monk Seal Recovery Plan by including new research and enhancement activities. New activities would include, but would not be limited to:

• Expanding the scope and number of seal translocations, including (1) moving seals with unmanageable human interactions from the MHI to NWHI, (2) taking seals age three years and older from the MHI to NWHI to examine their subsequent survival, and (3) using a two-stage translocation program whereby weaned pups are taken from areas of lower survival to areas of higher survival. This would include the option of returning the seals to their birth island or nearby site at age three years and older, but would exclude moving seals from the NWHI to the MHI.

• Research and development of tools for modifying undesirable seal behavior related to interactions with humans and fishing gear in the MHI.

• Potential implementation of de-worming as a tool to improve juvenile survival.

• Supplementing monk seal diet using feeding stations in NWHI locations where seals are released after being cared for in captivity.

• Vaccination studies and potential use of vaccines to mitigate infectious diseases (West Nile Virus and Morbilliviruses).

• Chemical alteration of aggressive male monk seal behavior using a testosterone suppressant.

• Expanded surveys and use of new tools (such as remote cameras and unmanned remotely operated aircraft).

A distinctive feature of Alternative 3 is that translocations of young animals from the NWHI to the MHI would not be permitted.

Alternative 4: Enhanced Implementation (Preferred Alternative): Alternative 4, the enhanced implementation alternative, is the Preferred Alternative. This alternative would encompass all the activities under Alternative 3, with the additional option to temporarily translocate weaned pups from the NWHI to the MHI to improve survival. At age three years, surviving translocated seals would be returned to the NWHI.

Alternative 4 encompasses the range of actions considered most promising to prevent the extinction of the species. Before any translocation between the NWHI and MHI would be attempted, extensive outreach and engagement with local stakeholders would be conducted, and programs to reduce seal-human interactions, including interactions between seals and fishing gear, would be developed and implemented.

Comments will be accepted at public hearings (see below) and during the public comment period, and must be submitted to NMFS by October 17, 2011 (see FOR FURTHER INFORMATION CONTACT ). We request that you include in your comments: (1) Your name, address, and affiliation (if any); and (2) background documents to support your comments as appropriate.

Public hearings will take place on the following dates, times, and locations:

1. Monday, September 12, 2011, 5:30 p.m.-8:30 p.m., Central Union Church, 1660 South Beretania Street, Honolulu, O`ahu.

2. Tuesday, September 13, 2011, 6 p.m.-8:30 p.m., Hale Mahaolu Home Pumehana, 290 Kolapa Place, Kaunakakai, Moloka'i.

3. Wednesday, September 14, 2011, 6 p.m.-9 p.m., Mokupāpapa Discovery Center, 308 Kamehameha Avenue, Suite 109, Hilo, Hawai'i.

4. Thursday, September 15, 2011, 6 p.m.-9 p.m., Kīhei Community Center, 303 East Lipoa Street, Kīhei, Maui.

5. Saturday, September 17, 2011, 9 a.m.-12 p.m. and 4 p.m.-7 p.m., Wilcox Elementary School, 4319 Hardy Street, Līhu`e, Kaua`i.

These meetings are accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Rachel Sprague, (808) 944-2200 (phone) or (808) 973-2941 (fax), at least 5 days before the scheduled meeting date.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specific geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “* * * an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) further established a 45-day time limit for NMFS' review of an application, followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as:

On February 22, 2011, NMFS received an application from the Port of Vancouver, USA (Port), requesting an IHA for the take, by Level B harassment, of small numbers of Pacific harbor seals ( Phoca vitulina richardii ), California sea lions ( Zalophus californianus ), and Steller sea lions ( Eumatopius jubatus ) incidental to pile driving activities conducted during the construction of the Terminal 5 Bulk Potash Handling Facility. Upon receipt of additional information and a revised application (submitted May 6, 2011), NMFS determined the application complete and adequate on June 7, 2011.

The applicant proposes to lease part of Terminal 5, located at the Port of Vancouver, for the purposes of constructing and operating a bulk potash handling facility on the Columbia River. The facility would allow shipping of potash (salts containing potassium in water-soluble form) to global markets. The proposed project would require pile installation of up to 203 steel piles and removal of 177 wood piles. Because elevated sound levels from pile driving have the potential to result in marine mammal harassment, NMFS is proposing to issue an IHA for take incidental to the specified activity.

The proposed project would involve construction of a potash handling facility along the Columbia River in Vancouver, Washington. The facility would accept potash shipped by rail from potash mines in Saskatchewan, Canada. On-site infrastructure is proposed to enable the unloading of rail cars into on-site storage, and the conveyance of potash to vessels at a new berth to be constructed on the Columbia River adjacent to the facility. The on-site infrastructure would include dedicated rail facilities and the construction and installation of materials handling equipment, storage structures, utilities, and internal access roads on the site, a marine berth with ship loaders, and other related ancillary infrastructure.

To support the new facility, a maximum of 203 steel piles would be installed at the proposed project site (specifically, Terminal 5) using vibratory and impact pile driving. These piles would be necessary for construction of a ship loading system, marine berthing facilities, and a new stormwater outfall system. A breakdown of pile size and associated activity are shown in Table 1.

Of the 100, 36- to 40-in (914- to 1,016-mm) steel pipe piles, 36 would be used for quadrant beams and pivot supports, 42 would be used for the mooring and berthing dolphins and platform, 10 would be used for access trestles, and the remaining 12 would be intended as a contingency should additional piles be required. Approximately two piles would be installed per day over a four-month period. Although the exact duration of pile driving would vary depending on the installation procedures and geotechnical conditions, the applicant estimates that each permanent pile would require between two and three hours of vibratory installation and between one and two hours of impact driving to install. To the extent possible, all piles would be installed with an APE Model 200 (or similar) vibratory hammer; however, it may be necessary to seat a pile using an impact hammer. The temporary piles (18- to 24-in diameter) would be driven solely with a vibratory hammer. Should an impact hammer be necessary for finishing the installation of permanent piles, the Port would use a DELMAG D46-32 with 60-80 maximum blows per foot, a DELMAG D80 with 20-30 maximum blows per foot, or a similar model. Sound attenuation devices, such as a bubble curtain, would be used during any impact hammering.

In addition to pile installation, a total of 272 piles would also be removed using vibratory extraction or a crane. These consist of the 95 temporary piles and 177 old wood piles upstream of Terminal 5 (Table 1). The 177 wood piles are located at Terminal 2, about two miles upstream from Terminal 5, and do not have much structural capacity. A pneumatic underwater chainsaw may be used if a pile breaks in the process, but associated noise is expected to be negligible. Above-water work would also be necessary to complete construction of each project component. There could be barges in the water to support construction activities; however, these would be concentrated in the direct vicinity of Terminal 5. Because pile repair, pile removal, and use of barges do not release loud sounds into the environment, marine mammal harassment from these activities is not anticipated.

The proposed activity would occur within the Lower Columbia River sub-basin. The Columbia River and its tributaries are the dominant aquatic system in the Pacific Northwest, originating in Canada's Rocky Mountains and flowing approximately 1,200 mi (1,931 km) to the Pacific Ocean. Saltwater intrusion from the Pacific Ocean extends approximately 23 mi (37 km) upstream from the river mouth at Astoria, Oregon and coastal tides influence the flow rate and river level up to the Bonneville Dam at river mile 146. The proposed construction would take place at 5701 NW Lower River Road in Vancouver, Washington, about 3 mi (4.8 km) northwest of downtown Vancouver, Washington. The area is composed of submerged, tidal, nearshore, and upland lands along a 2,300-ft (701-m) long section on the north bank of the Columbia River. The proposed project site is centered around river mile 103.3, a reach of the Columbia River that is about 3,000 ft (914 m) wide on average, but would also include additional pile removal at river mile 105. A heavy industrial site, this area has been used since the 1940s for aluminum smelting as well as for the fabrication and outdoor storage of aluminum ingots, but is currently used for storage of windmill components.

The Washington Department of Fish and Wildlife's recommended in-water work window for this area is November 1 through February 28. Timing restrictions such as this are used to avoid in-water work when listed species are most likely to be present. Proposed pile installation and removal activities are scheduled to occur between November 1, 2012 and February 28, 2013, in agreement with the state's recommendation.

For background, sound is a mechanical disturbance consisting of minute vibrations that travel through a medium, such as air or water, and is generally characterized by several variables. Frequency describes the sound's pitch and is measured in hertz (Hz) or kilohertz (kHz), while sound level describes the sound's loudness and is measured in decibels (dB). Sound level increases or decreases exponentially with each dB of change. For example, 10 dB yields a sound level 10 times more intense than 1 dB, while a 20 dB level equates to 100 times more intense, and a 30 dB level is 1,000 times more intense. Sound levels are compared to a reference sound pressure (micro-Pascal) to identify the medium. For air and water, these reference pressures are “re: 20 μPa” and “re: 1 μPa,” respectively. Root mean square (RMS) is the quadratic mean sound pressure over the duration of an impulse. RMS is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1975). RMS accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units rather than by peak pressures.

Data from a Washington Department of Transportation monitoring project at Port Townsend was used for the vibratory pile driving noise analysis (WSDOT, 2010b). There is a lack of information related to the size of the impact hammer and the resulting sound levels for 36- to 40-in (914- to 1,016-mm) pile installations; therefore, noise levels recorded for projects in Alameda, California and Port Townsend, Washington, using similar equipment were used to estimate sound levels (CalTrans, 2009; WSDOT, 2010b). Maximum sound levels for impact and vibratory pile driving are shown in Table 2. No reference underwater sound levels are available for this area, so 120 dB RMS (the lowest potential impact threshold for marine mammals) was used as a surrogate (WSDOT, 2010a). The Port applied a practical spreading loss model to calculate sound propagation, which assumes that noise attenuates at a rate of 4.5 dB per doubling distance, and this attenuation rate increases to 10 dB per doubling distance beyond 0.6 mile (1 km) (WSDOT, 2010a). Using this model, the largest noise impact zone is expected to result from vibratory pile driving of 36- to 40-in (914- to 1,016-mm) steel pipe piles. It may take up to 7 miles (11 km) for underwater sound to attenuate to below 120 dB. Because of the project area's location on a river bend and across from Hayden Island, sound transmission will be stopped by land masses much earlier in certain directions. In-air sound from pile driving also has the potential to affect marine mammals. However, in-air sound is not a concern here because there are no pinniped haul-out sites near the project area.

Table 2. Maximum sound levels for impact and vibratory installation of unattenuated steel piles.

Three marine mammal species have known distribution ranges that include the proposed project area: Pacific harbor seal, California sea lion, and Steller sea lion. These species may use the proposed project area as a seasonal transit corridor to and from the Bonneville Dam.

Pacific harbor seals reside in coastal and estuarine waters off Baja, California, north to British Columbia, west through the Gulf of Alaska, and in the Bering Sea. Harbor seals in the Columbia River are part of the Oregon/Washington coastal stock. The most recent NMFS stock assessment report estimated this stock to be at least 22,380 individuals and the population is likely at carrying capacity and no longer increasing (NMFS, 2007). The Oregon/Washington stock is not listed under the Endangered Species Act (ESA) nor considered depleted under the MMPA.

Harbor seals are infrequently observed as far upstream in the Columbia River as Vancouver. The nearest known haul-out is approximately 60 miles (97 km) downstream of the proposed project area. Since 2002, the Army Corps of Engineers has documented less than four harbor seals at Bonneville Dam (approximately 40 miles [64 km] from the proposed project area) and harbor seals potentially within the proposed project area will likely be transiting to or from Bonneville Dam.

California sea lions reside throughout the Eastern North Pacific Ocean in shallow coastal and estuarine waters, ranging from Central Mexico to British Columbia, Canada. Their primary breeding range extends from Central Mexico to the Channel Islands in Southern California. The U.S. stock abundance is estimated at 238,000 sea lions (NMFS, 2007). This stock is approaching carrying capacity and is reaching “optimum sustainable population” limits, as defined by the MMPA. California sea lions are not listed under the ESA nor considered depleted under the MMPA.

Historically, California sea lions are the most frequently observed pinnipeds at Bonneville Dam, with the largest number (104) of individuals recorded in 2003. There are no California sea lion haul-outs within the action area, so individuals present during construction would likely be passing through the area.

Steller sea lions reside along the North Pacific Rim from northern Japan to California, with centers of abundance and distribution in the Gulf of Alaska and Aleutian Islands, respectively. Steller sea lions in the Columbia River are part of the eastern distinct population segment, which is listed as threatened under the ESA and designated as depleted under the MMPA. Since the 1970s, the average annual population growth rate has been three percent (NMFS, 2008a).

Since 2002, observers have rarely seen Steller sea lions at Bonneville Dam, with less than ten sea lions recorded in most years. However, since 2008, the numbers of Steller sea lions documented at the dam have increased steadily to 75 individuals in 2010. The most recent stock assessment (NOAA, 2010) cited 516 individuals as the population count for the entire state of Washington. No Steller sea lion haul-outs or haul-out habitat are known within the proposed project area and there are no Steller sea lion rookeries in Washington. Any Steller sea lions present during construction would likely be passing through the area.

All species of pinnipeds produce a wide range of social signals, most occurring at relatively low frequencies (Southall et al., 2007), suggesting that hearing is keenest at these frequencies. Pinnipeds communicate acoustically both on land and underwater, but have different hearing capabilities dependent upon the medium (air or water). Based on numerous studies, as summarized in Southall et al. (2007), pinnipeds are more sensitive to a broader range of sound frequencies underwater than in air. Underwater, pinnipeds can hear frequencies from 75 Hz to 75 kHz. In air, pinnipeds can hear frequencies from 75 Hz to 30 kHz (Southall et al., 2007).

The proposed action consists of both upland and marine components, but the only project component with the potential to take marine mammals is impact and vibratory pile driving. Elevated in-water sound levels from pile driving in the proposed project area may temporarily impact marine mammal behavior. Elevated in-air sound levels are not a concern because the nearest pinniped haul-out is approximately 60 miles (97 km) away. Marine mammals are continually exposed to many sources of sound. For example, lightning, rain, sub-sea earthquakes, and animals are natural sound sources throughout the marine environment. Marine mammals produce sounds in various contexts and use sound for various biological functions including, but not limited to, (1) social interactions; (2) foraging; (3) orientation; and (4) predator detection. Interference with producing or receiving these sounds may result in adverse impacts. Audible distance or received levels will depend on the sound source, ambient noise, and the sensitivity of the receptor (Richardson et al., 1995). Marine mammal reactions to sound may depend on sound frequency, ambient sound, what the animal is doing, and the animal's distance from the sound source (Southall et al., 2007).

Marine mammals may experience temporary or permanent hearing impairment when exposed to loud sounds. Hearing impairment is classified by temporary threshold shift (TTS) and permanent threshold shift (PTS). There are no empirical data for when PTS first occurs in marine mammals; therefore, it must be estimated from when TTS first occurs and from the rate of TTS growth with increasing exposure levels. PTS is likely if the animal's hearing threshold is reduced by ≥ 40 dB of TTS. PTS is considered auditory injury (Southall et al., 2007) and occurs in a specific frequency range and amount. Irreparable damage to the inner or outer cochlear hair cells may cause PTS; however, other mechanisms are also involved, such as exceeding the elastic limits of certain tissues and membranes in the middle and inner ears and resultant changes in the chemical composition of the inner ear fluids (Southall et al., 2007). Due to proposed mitigation measures and source levels in the proposed project area, NMFS does not expect marine mammals to be exposed to PTS levels.

TTS is the mildest form of hearing impairment that can occur during exposure to a loud sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises and a sound must be louder in order to be heard. TTS can last from minutes or hours to days, occurs in specific frequency ranges (i.e., an animal might only have a temporary loss of hearing sensitivity between the frequencies of 1 and 10 kHz), and can occur to varying degrees (e.g., an animal's hearing sensitivity might be reduced by 6 dB or by 30 dB). For sound exposures at or somewhat above the TTS-onset threshold, hearing sensitivity recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals. Southall et al. (2007) considers a 6 dB TTS (i.e., baseline thresholds are elevated by 6 dB) sufficient to be recognized as an unequivocal deviation and thus a sufficient definition of TTS-onset. Because it is non-injurious, NMFS considers TTS as Level B harassment that is mediated by physiological effects on the auditory system; however, NMFS does not consider onset TTS to be the lowest level at which Level B harassment may occur. Southall et al. (2007) summarizes underwater pinniped data from Kastak et al. (2005), indicating that a tested harbor seal showed a TTS of around 6 dB when exposed to a non-pulse noise at SPL 152 dB re: 1 µPa for 25 minutes. In contrast, a tested sea lion exhibited TTS-onset at 174 dB re: 1 µPa under the same conditions as the harbor seal. Data from a single study on underwater pulses found no signs of TTS-onset in sea lions at exposures up to 183 dB re: 1 µPa (peak-to-peak) (Finneran et al., 2003).

There are limited data available on the effects of non-pulse noise (for example, vibratory pile driving) on pinnipeds while underwater; however, field and captive studies to date collectively suggest that pinnipeds do not react strongly to exposures between 90 and 140 dB re: 1 microPa; no data exist from exposures at higher levels. Jacobs and Terhune (2002) observed wild harbor seal reactions to high-frequency acoustic harassment devices around nine sites. Seals came within 44 m of the active acoustic harassment devices and failed to demonstrate any behavioral response when received SPLs were estimated at 120-130 dB. In a captive study (Kastelein, 2006), scientists subjected a group of seals to non-pulse sounds between 8 and 16 kHz. Exposures between 80 and 107 dB did not induce strong behavioral responses; however, a single observation from 100 to 110 dB indicated an avoidance response. The seals returned to baseline conditions shortly following exposure. Southall et al. (2007) notes contextual differences between these two studies; the captive animals were not reinforced with food for remaining in the noise fields, whereas free-ranging animals may have been more tolerant of exposures because of motivation to return to a safe location or approach enclosures holding prey items. While most of the pile driving at the proposed project site would be vibratory, an impact hammer (pulse noise) may be used to complete installation and to verify the piles' strength. Vibratory and impact pile driving may result in anticipated hydroacoustic levels between 174 and 195 dB root mean square. Southall et al. (2007) reviewed relevant data from studies involving pinnipeds exposed to pulse noise and concluded that exposures to 150 to 180 dB generally have limited potential to induce avoidance behavior.

Vibratory pile driving emits low-frequency broadband noise, which may be detectable by marine mammals within the proposed project area. The average value of 174 dB RMS from a Washington State Department of Transportation monitoring project of vibratory installation of a 36-inch (917-mm) steel pipe pile at Port Townsend was used in the noise analysis for vibratory pile installation (WSDOT, 2010b). There is a lack of information related to the size of the impact hammer and the resulting sound levels for 36- to 40-inch (914 to 1,016-mm) pile installations. Therefore, noise levels recorded for a project in Alameda, California that installed 40-inch (1,016-mm) steel pipe piles using a DELMAG D80 impact hammer were used in the noise attenuation analysis (Caltrans, 2009).

No impacts to pinniped reproduction are anticipated because there are no known haul-outs or rookeries within the proposed project area. NMFS expects any impacts to marine mammal behavior to be temporary, Level B harassment, for two reasons: first, animals may avoid the area around the hammer, thereby reducing their exposure to elevated sound levels; and second, pile driving does not occur continuously throughout the day; the vibratory hammer would operate for about 2-3 hours per pile and the impact hammer would operate for about 1-2 hours per pile. The applicant anticipates an average of two pilings to be driven per day, resulting in a total of 6-10 hours of pile driving within a 24-hour period. Disturbance to marine mammal behavior may be in the form of temporary avoidance or alteration of transiting near the pile driving location. In addition, because a vibratory hammer would be used as much as possible, and the 190 dB isopleth for the impact hammer is 70 ft (21 m), marine mammal injury or mortality is not likely. Impact pile driving would cease if a marine mammal is observed nearing or within the 190 dB isopleth. For these reasons, NMFS expects any changes to marine mammal behavior to be temporary and result in a negligible impact to affected species and stocks.

A small area of shallow water habitat with silt/sand substrate would be shaded by the proposed structure, but this was minimized by placing the structure at a height which would allow for some light penetration and by lessening the width of the structure. A deep water area and shallow water area with riprap substrate would also be shaded, but these habitats provide few functions and are plentiful in the surrounding ecosystem. Pile installation and removal would result in some disturbance of the river substrate; however, this disturbance is expected to be local and temporary. Pile driving activities ( i.e., temporary ensonification) may impact prey species and marine mammals by resulting in avoidance or abandonment of the area; however these impacts are also expected to be local and temporary. Overall, the proposed activity is not expected to cause significant or long-term impacts on marine mammal habitat.

Essential Fish Habitat consultation is ongoing between the Port and NMFS for the proposed IHA, but will be concluded before NMFS makes a final determination on the issuance of an IHA.

In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.

The applicant has proposed the following mitigation measures to minimize adverse impacts to marine mammals:

The Washington Department of Fish and Wildlife recommends an in-water work window of November 1 through February 28, annually. This work window was designed to protect fish species, particularly salmonid eggs and fry. However, by limiting pile driving activities to this period of time, the peak sea lion run to and from the Bonneville Dam is also avoided.

To the extent possible, a vibratory hammer would be used to drive all piles. In the event that an impact hammer is necessary, a bubble curtain or similar noise attenuation method would be used as an attenuation device to reduce hydroacoustic sound levels to avoid the potential for injury.

During all in-water impact pile driving, the Port would establish a preliminary marine mammal exclusion zone of 70 ft (21 m) around each pile to avoid exposure to sounds at or above 190 dB. The exclusion zone would be monitored during all impact pile driving to ensure that no marine mammals enter the 70 ft (21 m) radius. The purpose of this area is to prevent Level A harassment (injury) of any marine mammal species. A safety zone for vibratory pile driving is unnecessary to prevent Level A harassment as source levels would not exceed the Level A harassment threshold.

If a protected species observer sees a marine mammal within or approaching the exclusion zone prior to start of impact pile driving, the observer would notify the on-site construction manager (or other authorized individual), who would then be required to delay pile driving until the marine mammal has moved outside of the exclusion zone or if the animal has not been resighted within 15 minutes. If a marine mammal is sighted within or on a path toward the exclusion zone during pile driving, pile driving would cease until that animal has cleared and is on a path away from the exclusion zone or 15 minutes has lapsed since the last sighting.

A “soft-start” technique would be used at the beginning of each pile installation to allow any marine mammal that may be in the immediate area to leave before the pile hammer reaches full energy. For vibratory pile driving, the soft-start procedure requires contractors to initiate noise from the vibratory hammer for 15 seconds at 40-60 percent reduced energy followed by a 1-minute waiting period. The procedure would be repeated two additional times before full energy may be achieved. For impact hammering, contractors would be required to provide an initial set of three strikes from the impact hammer at 40 percent energy, followed by a 1-minute waiting period, then two subsequent three-strike sets. The soft-start procedure would be conducted prior to driving each pile if vibratory hammering ceases for more than 30 minutes.

NMFS has carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals; (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation, including consideration of personnel safety, and practicality of implementation.

Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable adverse impacts on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for IHAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present.

The Port must designate at least one biologically-trained, on-site individual, approved in advance by NMFS, to monitor the area for marine mammals 20 minutes before, during, and 20 minutes after all impact pile driving activities and call for shut down if any marine mammal is observed within or approaching the designated exclusion zone (preliminarily set at 70 ft [21 m]). In addition, at least two NMFS-approved protected species observers would conduct behavioral monitoring at least two days per week to estimate take and evaluate the behavioral impacts pile driving has on marine mammals out to the Level B harassment isopleths. Note that for impact hammering, this distance is about 1.3 mi (2 km). For vibratory hammering, this estimated distance is about 7 mi (11 km); however, sound will dissipate before then (in about 6 mi [9.7 km]) due to the shape and configuration of the river. Protected species observers would be provided with the equipment necessary to effectively monitor for marine mammals (for example, high-quality binoculars, spotting scopes, compass, and range-finder) in order to determine if animals have entered into the exclusion zone or Level B harassment isopleth and to record species, behaviors, and responses to pile driving.

Protected species observers would be required to submit a report to NMFS within 120 days of expiration of the IHA or completion of pile driving, whichever comes first. The report would include data from marine mammal sightings (such as species, group size, and behavior), any observed reactions to construction, distance to operating pile hammer, and construction activities occurring at time of sighting.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as:

Based on the application and subsequent analysis, the impact of the described pile driving operations may result in, at most, short-term modification of behavior by small numbers of marine mammals within the action area. Marine mammals may avoid the area or temporarily alter their behavior at time of exposure.

Current NMFS practice regarding exposure of marine mammals to anthropogenic noise is that in order to avoid the potential for injury (PTS), cetaceans and pinnipeds should not be exposed to impulsive sounds of 180 and 190 dB or above, respectively. This level is considered precautionary as it is likely that more intense sounds would be required before injury would actually occur (Southall et al., 2007). Potential for behavioral harassment (Level B) is considered to have occurred when marine mammals are exposed to sounds at or above 160 dB for impulse sounds (such as impact pile driving) and 120 dB for non-pulse noise (such as vibratory pile driving), but below the aforementioned thresholds. These levels are also considered precautionary.

Based on empirical measurements taken by WSDOT and Caltrans (which are presented in the Description of Specified Activities section above), estimated distances to NMFS' current threshold sound levels from pile driving during the proposed construction activities are presented in Table 3. Effects from the removal of the 177 wood piles upstream from the main construction site are included in the 6-mi (9.7 km) Level B isopleth (based at Terminal 5) due to the river bend. The 70-ft distance to the Level A harassment threshold provides protected species observers plenty of time and adequate visibility to prevent marine mammals from entering the area during impact pile driving. This would prevent marine mammals from being exposed to sound levels that reach the Level A harassment threshold.

The estimated number of marine mammals that could be harassed was based on the Army Corps of Engineers' evaluation of pinniped predation on fish near the Bonneville Dam in 2010. Based on the 2010 Steller sea lion counts at Bonneville Dam, the Port requested a total take of 50 Steller sea lions. This number was reached based on the estimated 75 individuals that passed through the action area in 2010 during their migration to and from Bonneville Dam, for a total of 150 individual trips through the action area. Since all pile installation would occur between November 1 and February 28, the peak of the run in April and May would be avoided. Steller sea lion presence at the dam in January and February 2010 represented (conservatively) less than a third of the total run for the year. Therefore, the Port estimated that no more than one-third of the total run of Steller sea lions (approximately 25 individuals) could be exposed to Level B harassment. Since each individual could potentially be exposed on both the upstream and downstream trip, a total of 50 takes of Steller sea lions could occur. Upon further consultation with NMFS Northwest Regional Office, and in consideration of steadily increasing numbers of Steller sea lions since 2008, NMFS is proposing to increase the number of Steller sea lions that could be exposed to Level B harassment. This is based on the fact that abundance estimates increased three-fold between 2009 and 2010, and may continue. Therefore, it is reasonable to assume that 2,025 individuals may make the trip to and from the dam during the proposed activity (based on a conservative three-fold increase in 2011, 2012, and again in 2013). Considering the avoidance of the peak run and potential exposure during the upstream and downstream migration, NMFS proposes to authorize the incidental take, by Level B harassment only, of 1,350 Steller sea lion exposures (accounting for one-third of the total run—about 675 animals—traveling to and from the dam). In addition, the Port requested take of 60 California sea lions (based on the same analysis that was applied for Steller sea lions) and six harbor seals (the maximum number of harbor seals documented at Bonneville Dam since 2002). These numbers take the proposed mitigation measures into consideration, but are conservative and represent the maximum number of animals expected to occur within the Level B harassment isopleth. The actual number of animals that may be harassed is likely to be significantly less.

NMFS has defined “negligible impact” in 50 CFR 216.103 as “* * *an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” In making a negligible impact determination, NMFS considers a number of factors which include, but are not limited to, number of anticipated injuries or mortalities (none of which would be authorized here), number, nature, intensity, and duration of Level B harassment, and the context in which takes occur.

As described above, marine mammals would not be exposed to activities or sound levels which would result in injury (PTS), serious injury, or mortality. Pile driving would occur in shallow coastal waters of the Columbia River. The action area (waters around Terminal 5) is not considered significant habitat for pinnipeds. The closest haul-out is 50 mi (80 km) away, which is outside the project area's largest harassment zone. Marine mammals approaching the action area would likely be traveling or opportunistically foraging. The amount of take the Port requested for each species, and NMFS proposes to authorize, is considered small (less than five percent) relative to the estimated populations of 22,380 Pacific harbor seals, 238,000 California sea lions, and 30,403 Steller sea lions. Marine mammals may be temporarily impacted by pile driving noise. However, marine mammals are expected to avoid the area, thereby reducing exposure and impacts. Pile driving activities are expected to occur for approximately 101 days. Furthermore, this section of the Columbia River is a highly industrialized area, so animals are likely tolerant or habituated to anthropogenic disturbance, including low level vibratory pile driving operations, and noise from other anthropogenic sources (such as vessels) may mask construction related sounds. There is no anticipated effect on annual rates of recruitment or survival of affected marine mammals.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS preliminarily determines that the proposed pile driving would result in the incidental take of small numbers of marine mammals, by Level B harassment only, and that the total taking would have a negligible impact on the affected species or stocks.

There are no relevant subsistence uses of marine mammals implicated by this action.

The Steller sea lion is listed as endangered under the ESA with confirmed occurrence within the action area. NMFS is in the process of consulting with the Port and will consult internally on the issuance of an IHA under section 101(a)(5)(A) of the MMPA for the take of Steller sea lions incidental to the proposed activity. ESA consultation will be concluded prior to a determination on the issuance of a final IHA.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), as implemented by the regulations published by the Council on Environmental Quality (40 CFR parts 1500-1508), and NOAA Administrative Order 216-6, NMFS is preparing an Environmental Assessment (EA) to consider the direct, indirect, and cumulative effects to marine mammals and other applicable environmental resources resulting from issuance of a one-year IHA and the potential issuance of additional authorizations for incidental harassment for the ongoing project. Upon completion, this EA will be available on the NMFS website listed in the beginning of this document.

The Council was established in March 2001 to assure continued public participation in the management of the Sanctuary. The Council's 23 members represent a variety of local user groups, as well as the general public, plus seven local, state and federal government agencies. Since its establishment, the Council has played a vital role in advising NOAA on critical issues and is currently focused on the sanctuary's final five-year Management Plan.

The Stellwagen Bank National Marine Sanctuary encompasses 842 square miles of ocean, stretching between Cape Ann and Cape Cod. Renowned for its scenic beauty and remarkable productivity, the sanctuary supports a rich diversity of marine life including 22 species of marine mammals, more than 30 species of seabirds, over 60 species of fishes, and hundreds of marine invertebrates and plants.

Additions

On 6/17/2011 (76 FR 35415-35417), 6/24/2011 (76 FR 37069-37070), and 7/1/2011 (76 FR 38641-38642), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to furnish the products and services and impact of the additions on the current or most recent contractors, the Committee has determined that the products and services 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 and services to the Government.

2. The action will result in authorizing small entities to furnish the products 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 products and services proposed for addition to the Procurement List.

Accordingly, the following products and services are added to the Procurement List:

On 5/27/2011 (76 FR 30923-30924) and 6/24/2011 (76 FR 37069-37070), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the products and a service 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 will 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 products and 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 products and service deleted from the Procurement List.

Accordingly, the following products and service are deleted from the Procurement List:

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 addition, the entities of the Federal Government identified in this notice will be required to procure the service listed below from the nonprofit agency 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 provide the service to the Government.

2. If approved, the action will result in authorizing small entities to provide 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 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 service is proposed for addition to Procurement List for production by the nonprofit agency listed:

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 additional reporting, recordkeeping or other compliance requirements for small entities.

2. If approved, the action may result in authorizing small entities to provide the 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 services proposed for deletion from the Procurement List.

The following services are proposed for deletion from the Procurement List:

This Draft EIS/EIR has been filed with the Environmental Protection Agency to be published in the Federal Register . The review period for the Draft EIS/EIR will begin from the date of publishing the Notice of Availability in the Federal Register , which is expected to be on August 17, 2011. Comments on the Draft EIS/EIR will be accepted 60 days later, until October 17, 2011.

NSA Bethesda is a 243-acre health care, medical education and research installation located in Bethesda in Montgomery County, Maryland and is the home of the world renowned NNMC. The installation provides logistical and service support to all of its tenant commands, including JTF CapMed, NNMC, and USUHS. In September 2011, with the completion of 2005 BRAC mandated relocation of WRAMC tertiary medical services to NNMC and its transformation to WRNMMCB, the facility will become the premier DoD medical center offering intensive and complex specialty and subspecialty medical services for the most seriously injured personnel from all military services. WRNMMCB and USUHS will also provide training and post-graduate level education to the military medical community and serve as a critical medical research center.

The purpose of the Medical Facilities Development is to implement the Congressional mandate from the FY2010 National Defense Authorization Act to achieve the new statutory world-class standards for military medicine at the WRNMMCB by providing enduring facilities commensurate in quality, capability and condition as those provided by the BRAC investment. The Medical Facilities Development is needed because current space is insufficient to meet world class standards such as decompression to single occupancy patient rooms, a state-of-the-art simulation center, and a health innovation center. The purpose of, and need for, the Medical Facilities Development was identified subsequent to the programming for BRAC 2005, which was specifically designed to accommodate the transfer of WRAMC to WRNMMCB and was never intended to address the mission capability or functionality of the existing infrastructure.

The primary purpose of the University Expansion is to address the significant space and operational limitations that exist for education and research activities due to the fragmented, aging, and inefficient infrastructure and enable USUHS to serve as the core academic health research center at WRNMMCB. The University Expansion is needed because the USUHS operations are currently fragmented between off-site leased space in Montgomery County, Maryland and other dispersed buildings on NSA Bethesda. Additionally, the University Expansion will address the most recent Liaison Committee on Medical Education accreditation requirements, and provide adequate education and research space to meet Military Health System commitments to deliver training and post-graduate level education to the military medical community.

The Medical Facilities Development resulted from an iterative planning process which resulted in the Comprehensive Master Plan (CMP) developed by JTF CapMed in response to the FY10 NDAA Congressional mandate, which identified and evaluated alternatives based on the departmental needs anticipated at the WRNMMCB after the completion of the BRAC-mandated relocations in September 2011. The CMP development process identified the proposed action as the best approach to meet the Congressional mandate for world class facilities commensurate in quality, capability and condition with the BRAC investment. The Medical Facilities Development, as described in the CMP, entails demolition of Buildings 2, 4, 6, 7, and 8 (approximately 326,000 square feet (SF)) of and construction of a single, 5-story facility totaling approximately 563,000 SF in the same basic footprint. The Medical Facilities Development also proposes utilities and power capacity upgrades, internal renovations in Buildings 1, 3, 5, 9 and 10, and the use of the northwest parking lot for temporary medical facilities to maintain uninterrupted patient care during the construction period.

The Medical Facilities Development also proposes, in the lawn in front of Building 1, the construction of an approximately 203,000 SF, 500-space underground parking garage, which in addition to the medical center, will serve the overall parking needs at NSA Bethesda. The EIS will analyze three alternative sites at NSA Bethesda for the underground parking garage: The warehouse area in the northeast corner, the Taylor Road site in the northeast area, and H-Lot in the south area, respectively.

The EIS will consider two alternative sites for the University Expansion: Alternative 1 and Alternative 2 are south and west, respectively, of the existing USUHS campus. Under either of the alternative sites, the University Expansion would entail an approximately 341,000 SF education and research facility and an approximately 144,000 SF, 400-space parking structure that will serve USUHS and the overall parking needs across NSA Bethesda.

The EIS will also consider the No Action Alternative, which will evaluate the impact at NSA Bethesda in the event that the proposed actions do not occur.

The EIS will address the potential impacts of the proposed actions on the number of staff, patients, and visitors at NSA Bethesda. In addition, the EIS will evaluate the potential direct, indirect, short-term, long-term, and cumulative impacts to the human and natural environment, to include potential impacts to topography, geology, and soils; water resources, biological resources, air quality, noise, infrastructure and utilities, traffic and transportation, cultural resources, land use, socioeconomics, environmental justice, and public health and safety. Known areas of concern associated with proposed actions include providing the required space and facilities at NSA Bethesda in consideration of historic characteristics of the installation, and the impact to local traffic and on-base parking associated with personnel and patient visits. Other recent changes at, and in the vicinity of, NSA Bethesda will be evaluated to ensure consideration of the cumulative impacts of the proposed actions in the context of the ongoing and programmed projects as well as reasonably foreseeable projects identified in the 2012 Master Plan.

The EIS will also consider the 2012 NSA Bethesda Master Plan relative to the implementation of the Medical Facilities Development and University Expansion. The EIS will evaluate the cumulative impacts of the proposed actions in the context of the programmed projects already in progress and the programmatic effects of the potential future development opportunities identified in the 2012 NSA Bethesda Master Plan.

The DoN encourages agencies and the public to provide written comments in addition to, or in lieu of, oral comments at the public scoping meetings. To be most helpful, comments should clearly describe specific issues or topics that the EIS should address. Written comments must be postmarked within 45 days of the date of publication of this notice in the Federal Register and should be mailed to the address below. Comments may also be submitted via e-mail and/or the Web site listed below, within 45 days of the date of publication of this notice in the Federal Register . Requests for inclusion on the EIS mailing list may also be submitted to: Sandy Dean, NSA Bethesda Public Affairs Office, 8901 Wisconsin Avenue, Bethesda, Maryland 20889; via e-mail at NNMC.NSABETHESDAEIS@med.navy.mil; via telephone at 301-295-5727; or visit the project Web site at http://www.bethesda.med.navy.mil/nsa/eis.aspx.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The OMB is particularly interested in comments which: (1) 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; (2) 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; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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.

Type of Review: Extension.

Title of Collection: Protection and Advocacy of Individual Rights (PAIR) Program Assurances.

OMB Control Number: 1820-0652.

Agency Form Number(s): N/A.

Frequency of Responses: Submitted once prior to FY 2007, and thereafter only upon the redesignation of the Protection &Advocacy.

Affected Public: Not-for-profit Institutions.

Total Estimated Number of Annual Responses: 57.

Total Estimated Annual Burden Hours: 9.

Abstract: Section 509 of the Rehabilitation Act of 1973, as amended (Act), and its implementing Federal Regulations at 34 CFR part 381, require the Protection and Advocacy of Individual Rights (PAIR) grantees to submit an application to the Rehabilitation Services Administration Commissioner in order to receive assistance under Section 509 of the Act. The Act requires that the application contain Assurances to which the grantee must comply. Section 509(f) of the Act specifies the Assurances. There are 57 PAIR grantees. All 57 grantees are required to be part of the protection and advocacy system in each State established under the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 6041 et seq. ).

Copies of the information collection submission for OMB review may be accessed from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAMain or from the Department's Web site at http://edicsweb.ed.gov , by selecting the “Browse Pending Collections” link and by clicking on link number 4638. When you access the information collection, click on “Download Attachments ” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Washington, DC 20202-4537. Requests may also be electronically mailed to the Internet address ICDocketMgr@ed.gov or faxed to 202-401-0920. Please specify the complete title of the information collection and OMB Control Number when making your request.

Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that Federal agencies provide interested parties an early opportunity to comment on information collection requests. The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: Extension.

Title of Collection: Consolidated State Performance Report.

OMB Control Number: 1810-0576.

Agency Form Number(s): N/A.

Frequency of Responses: Annually.

Affected Public: State, Local or Tribal Government.

Total Estimated Number of Annual Responses: 52.

Total Estimated Number of Annual Burden Hours: 38,532

Abstract: Title IX, Part C, Sections 9301-9306, of the Elementary and Secondary Education Act (ESEA), as amended (No Child Left Behind [NCLB] Pub. L. 107-110), authorizes the Secretary of Education to provide States the option of submitting consolidated applications to obtain funds for covered programs in which the State participates. The purpose of consolidated applications as defined in NCLB is to improve teaching and learning by encouraging greater cross-program coordination, planning, and service delivery; to enhance program integration; and to provide greater flexibility and less burden for State educational agencies.

The Department will use the information from the consolidated State application as the basis for approving funding under the covered ESEA, as amended programs (in which the State participates). The Department also will use the performance targets, baseline data, and other related information in the consolidated application to continue to assess the degree of progress States make over time in achieving ESEA goals. As with previous collections, the information in this collection will allow the Department to continue to monitor effectiveness of the use of program funds, and provide grantees with technical assistance

Copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov , by selecting the “Browse Pending Collections” link and by clicking on link number 4691. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Washington, DC 20202-4537. Requests may also be electronically mailed to ICDocketMgr@ed.gov or faxed to 202-401-0920. Please specify the complete title of the information collection and OMB Control Number when making your request.

Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

The information collected under the requirements of FERC-512, “Application for Preliminary Permit” (OMB No. 1902-0073), is used by the Commission to implement the statutory provisions of Sections 4(f), 5 and 7 of the Federal Power Act (FPA), 16 U.S.C. sections 797, 798 & 800. The purpose of obtaining a preliminary permit is to maintain priority of the application for a license for a hydropower facility while the applicant conducts surveys to prepare maps, plans, specifications and estimates; conducts engineering, economic and environmental feasibility studies; and making financial arrangements. The conditions under which the priority will be maintained are set forth in each permit. During the term of the permit, no other application for a preliminary permit or application for a license submitted by another party can be accepted. The term of the permit is three years. The information collected under the designation FERC-512 is in the form of a written application for a preliminary permit which is used by Commission staff to determine an applicant's qualifications to hold a preliminary permit, review the proposed hydro development for feasibility and to issue a notice of the application in order to solicit public and agency comments. The Commission implements these mandatory filing requirements in the Code of Federal Regulations (CFR) under 18 CFR 4.31-4.33, 4.81-4.83.

Action: The Commission is requesting a three-year extension of the current expiration date, with no changes to the existing collection of data.

Burden Statement: Public reporting burden for this collection is estimated as:

Estimated cost burden to respondents is $508,000; [ i.e., (7 hours @$200 an hour (legal) × 200 respondents) + (30 hours @$38 an hour (technical) × 200 respondents)] per year equals $508,000)]. The average annual cost burden per respondent is $2,540 ($508,000/200 = $2,540).

The reporting burden includes the total time, effort, or financial resources expended to generate, maintain, retain, or disclose or provide the information including: (1) Reviewing instructions; (2) developing, acquiring, installing, and utilizing technology and systems for the purposes of collecting, validating, verifying, processing, maintaining, disclosing and providing information; (3) adjusting the existing ways to comply with any previously applicable instructions and requirements; (4) training personnel to respond to a collection of information; (5) searching data sources; (6) completing and reviewing the collection of information; and (7) transmitting, or otherwise disclosing the information.

The estimate of cost for respondents is based upon salaries for professional and clerical support, as well as direct and indirect overhead costs. Direct costs include all costs directly attributable to providing this information, such as administrative costs and the cost for information technology. Indirect or overhead costs are costs incurred by an organization in support of its mission. These costs apply to activities which benefit the whole organization rather than anyone particular function or activity.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) 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; (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 those who are to respond, including 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.

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2003-0017, which is available for online viewing at http://www.regulations.gov, or in person viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC 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 Reading Room is 202-566-1744, and the telephone number for the Water Docket is 202-566-2426.

Use http://www.regulations.gov to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified in this document.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:

(i) 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;

(ii) 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;

(iii) enhance the quality, utility, and clarity of the information to be collected; and

(iv) 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. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Offer alternative ways to improve the collection activity.

6. Make sure to submit your comments by the deadline identified under DATES .

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

Affected entities: Entities potentially affected by this action are owners and operators of underground injection wells, State Underground Injection Control (UIC) primacy agencies, and U.S. EPA Regional Offices with Direct Implementation (DI) UIC programs.

Title: Underground Injection Control (UIC) Program.

ICR numbers: EPA ICR No. 0370.24, OMB Control No. 2040-0042.

ICR status: This ICR is currently scheduled to expire on December 31, 2011. An Agency 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. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: The Underground Injection Control (UIC) Program under the Safe Drinking Water Act established a Federal and State regulatory system to protect underground sources of drinking water (USDWs) from contamination by injected fluids. Injected fluids include trillions of gallons of various types of fluids each year such as hazardous waste, oil field brines or produced water, mineral processing fluids, various types of industrial fluids, automotive, sanitary and other wastes, and carbon dioxide injected for geologic sequestration. Owners/operators of underground injection wells must obtain permits, conduct environmental monitoring, maintain records, and report results to EPA or the State UIC primacy agency. States must report to EPA on permittee compliance, owners/operators of rule-authorized well compliance and related information. The mandatory information is reported using standardized forms and annual reports, and the regulations are codified at 40 CFR Parts 144 through 148. The data are used by UIC authorities to ensure the protection of underground sources of drinking water.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2.32 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:

Estimated total number of potential respondents: 53,772.

Frequency of response: annual, semi-annual, and quarterly.

Estimated total average number of responses for each respondent: 10.39.

Estimated total annual burden hours: 1,296,167 hours.

Estimated total annual costs: $194,842,061. This includes an estimated burden cost of $54,384,103 and an estimated cost of $140,457,959 for capital investment or maintenance and operational costs.

There is an increase of 233,836 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This increase reflects a variety of adjustments and program changes. Most of the burden increase is due to increases in the inventory of injection wells and the number of permit applications and mechanical integrity tests submitted by operators and reviewed by permitting authorities. Other changes and adjustments relate to reduced activities associated with the Florida Class I Rule and the 1999 Class V Rule, addition of burden associated with the 2010 Class VI Rule, granting of primacy to two Tribes, and burden reduction associated with electronic reporting via the National UIC database.

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT .

In accordance with ARRA Section 1605(c), the EPA hereby provides notice that it is granting a project waiver of the requirements of Section 1605(a) of Public Law 111-5, Buy American requirements, to Mason County, Washington, for the utilization and installation of six specific turbo aeration blower units as part of the County's Belfair Wastewater and Water Reclamation Facilities project. Based on the information provided by the County and its consultant project manager, EPA has determined that it is inconsistent with the public interest for the County to further delay the project and incur significant additional costs to pursue the purchase and installation of domestic manufactured turbo aeration blower units.

Section 1605 of the ARRA requires that none of the appropriated funds may be used for the construction, alteration, maintenance, or repair of a public building or a public works project unless all of the iron, steel, and manufactured goods used in the project are produced in the United States, or unless a waiver is provided to the recipient by the head of the appropriate agency, in this case, the EPA. A waiver may be provided under Section 1605(b) if EPA determines that (1) applying these requirements would be inconsistent with the public interest; (2) iron, steel, and the relevant manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality; or (3) inclusion of iron, steel, and the relevant manufactured goods produced in the United States will increase the cost of the overall project by more than 25 percent.

Consistent with the direction of OMB's regulation at 2 CFR 176.120, the EPA will generally consider a waiver request with respect to components that were specified in the bid solicitation or in a general/primary construction contract or those made after obligating ARRA funds for a project to be a “late” request. However, in this case EPA has determined that the County's request, though made after the date the contract was signed, can be evaluated as timely because of the extenuating circumstances surrounding this on-going project.

The Membrane Bioreactor (MBR) system works using a combination of filtration and biological processes and is a critical component of the treatment process to remove nutrients (nitrogen) and other pollutants from the wastewater. The MBR system is comprised of MBR filtration cassettes, aeration and membrane scouring blowers, and several other auxiliary components integral to the efficient operation of the system. The County decided the MBR process was the most environmentally sound and cost effective solution to treat the wastewater to the “Class A” reuse standards in order to meet the County's water reuse goal and the anticipated regulatory and permit requirements. The MBR system was procured by the County for use at the new wastewater treatment plant prior to enactment of ARRA with non ARRA funding. The KUBOTA Submerged Membrane Unit® system and accompanying MBR components were selected and contracted with Enviroquip (now Ovivo USA) in March 2008 during the early phases of design. The design for the treatment plant was based on this pre-selected MBR equipment and continued until project construction went to bid in late 2009. As a result of a value engineering study during the design process, a change order was signed in October 2009 to incorporate specific components including energy-efficient blowers and feed pumps as part of the MBR system.

Though the MBR equipment was procured by a pre-ARRA contract before ARRA was enacted, the actual installation is being completed through Mason County's ARRA Clean Water State Revolving Fund (CWSRF) loan (#L100026). Due to EPA's ARRA Buy American implementation guidance dated April 28, 2009, that defines a project as all work “closely related in purpose, time and place,” this previously contracted MBR equipment needs to meet Buy American requirements as an integral component of the Belfair Wastewater and Water Reclamation Facilities project. There is not a mechanism authorizing previously contracted, purchased, or owned equipment as exempt from Buy American requirements. As context, the entire project cost is estimated at $28.8 million—$9.6 million is ARRA funded, $3.8 million is paid by an EPA Special Appropriations Act Project grant (for the MBR equipment), and $15.4 million is non-federally funded. The KTurbo blowers, which are the subject of this waiver, are estimated to cost approximately $345,900.

The initial procurement of the MBR system occurred well in advance of ARRA, and the fact that the MBR equipment was not being reimbursed by ARRA funds created a complex situation that State, EPA regional and EPA headquarters staff had to thoroughly review and research to determine the applicability of ARRA. Therefore, it is understandable that the County was unaware of the need to purchase and install a Buy American compliant MBR system and could not reasonably foresee the need for a waiver until recently. Also of note, KTurbo is currently suspended from participating in procurement and nonprocurement transactions pending the termination of the suspension or implementation of a debarment proceeding. However, this suspension does not invalidate transactions entered into prior the suspension date of April 19, 2011. The KTurbo blowers being utilized in the County project were clearly procured well in advance of April 19, 2011, thus the procurement transaction is not covered by the temporary suspension. Additionally, these blowers were identified as Korean/Canadian made and not claimed to be manufactured in the U.S., thus there is no evidence of false claim pertaining to the Mason County project.

The MBR system contract with Enviroquip/Ovivo USA requires 95% payment to the supplier (of the $2.1 million contract) for equipment delivered. Therefore the County would be obligated to pay for at least most of the KTurbo blowers cost, plus an estimated $540,000 extra for replacement domestic blowers, an estimated $80,000 for redesign and reconstruction costs, and up to $30,000 per month for construction delay costs per the prime contractor's agreement. Additionally, the three year warranty for the MBR system identified in the project specifications would be voided, as the manufacturer stipulated the warranty for the MBR system is valid only if system components identified in the manufacturer's proposal are utilized.

Furthermore, not allowing the installation of the six specified turbo aeration blower units that have been delivered to the site could cause a significant time delay to the project. The County would need to completely redesign, procure, and have domestic manufactured turbo aeration blower units delivered to the site. According to the County, the construction completion date could be delayed by four months or more. Of significant note, the County is scheduled to complete the project in September 2011. Increased delays in to the project schedule could push completion into the rainy season, during which the typical wet weather associated with October through January could cause runoff over areas of failing septic systems and pose a risk to environmental and water quality protection.

Finally, the purpose of the ARRA is to stimulate economic recovery by funding current infrastructure construction, not to delay or require the substantial redesign of projects that are “shovel ready”, such as this project in Mason County, Washington. The implementation of the ARRA Buy American requirements in this case would result in an unreasonable delay in its completion. Such delay would also directly conflict with a fundamental economic purpose of ARRA, which is to create or retain jobs. More importantly, the imposition of the Buy American requirement would result in additional risk to water quality protection.

The Grants and Strategic Planning Unit of EPA has reviewed this waiver request and has determined that the supporting documentation provided by the County established a proper basis to specify that using the domestic manufactured good would be inconsistent with the public interest of Mason County, Washington. The March 31, 2009, Delegation of Authority Memorandum provided Regional Administrators with the authority to issue exceptions to Section 1605 of ARRA within the geographic boundaries of their respective regions and with respect to requests by individual grant recipients.

Having established both a proper basis to specify the particular good required for this project and that using a domestically available alternative manufactured good would be inconsistent with the public interest, Mason County, Washington, is hereby granted a waiver from the Buy American requirements of Section 1605(a) of Public Law 111-5. This waiver permits use of ARRA funds for the installation and utilization of the six specified turbo aeration blower units that have already been delivered to the construction site as noted in the County's May 27, 2011 request and additional follow up documentation. This supplementary information constitutes the detailed written justification required by Section 1605(c) for waivers based on a finding under subsection (b).

As required by the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4) and (e)(11), this document sets forth notice of this proposed new system of records maintained by the FCC. The FCC previously gave complete notice of the two systems of records, FCC/OMD-14, “Pay and Leave” and FCC/OMD-21, “Garnishment and Levy of Wages,” which the Commission intends to cancel upon both the approval and deployment of FCC/OMD-28, “Time and Attendance Records,” as referenced under this Notice by publication in the Federal Register on April 5, 2006 (71 FR 17234, 17257 and 17266 respectively). This notice is a summary of the more detailed information about the proposed new system of records, which may be viewed at the location given above in the ADDRESSES section. The purposes for adding this new system of records, FCC/OMD-28, “Time and Attendance Records,” are for the Agency to use the records in this system of records primarily to prepare time and attendance records and to certify hours worked/leave earned and leave taken and to administer the FCC's time and attendance/payroll program. These records may also be used to validate and verify hours worked/leave taken/credit hours claimed and to ensure appropriate recordkeeping as well as appropriate expenditure of Federal funds. The new system of records will consolidate FCC/OMD-14 and FCC/OMD-21 that the Agency currently uses so that all the PII data in the two information systems are now housed in a single Agency system of records.

This notice meets the requirement documenting the change to the systems of records that the FCC maintains, and provides the public, OMB, and Congress with an opportunity to comment.

This is a summary of the Commission's Order, ET Docket No. 04-186 and 02-380, DA 11-1291, adopted July 28, 2011 and released July 29, 2011. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: http://www.fcc.gov.

1. In this Order, the Office of Engineering and Technology designates Microsoft Corporation as a TV bands database administrator pursuant to § 15.715 of its rules, subject to conditions described. The TV bands databases will be used by fixed and personal portable unlicensed devices to identify unused channels in the spectrum used principally by the broadcast television service that are available at their geographic locations. Microsoft is the tenth entity designated to develop a database that will enable the introduction of this new class of unlicensed broadband wireless devices in the TV spectrum.

2. On September 23, 2010, the Commission adopted a Second Memorandum Opinion and Order ( Second MO&O ) in ET Docket No. 04-186, 75 FR 75814, December 6, 2010, that updated the rules for unlicensed wireless devices that can operate in broadcast television spectrum at locations where that spectrum is unused by licensed services. This unused TV spectrum is commonly referred to as television “white spaces.” The rules allow for the use of unlicensed TV bands devices in the unused spectrum to provide broadband data and other services for consumers and businesses.

3. To prevent interference to authorized users of the TV bands, TV bands devices must include a geo-location capability and the capability to access a database that identifies incumbent users entitled to interference protection, including, for example, full power and low power TV stations, broadcast auxiliary point-to-point facilities, PLMRS/CMRS operations on channels 14-20, and the Offshore Radiotelephone Service. The database will calculate and communicate to a TV bands device which TV channels are vacant and can be used at the device's location. The database will also register the locations of fixed TV bands devices and protected locations and channels of certain incumbent services that are not recorded in Commission databases. The rules state that the Commission will designate one or more entities to administer a TV bands database.

4. The Office of Engineering and Technology (OET) released a public notice on November 25, 2009, inviting entities interested in being designated as a TV bands database administrator to file proposals with the Commission and inviting comments on the proposals. The notice requested that entities address how the basic components of a TV band database as required by the Commission's rules would be satisfied— i.e., a data repository, a data registration process, and a query process—and whether the entity sought to provide all or only some of these functions. Entities were also required to affirm that the database service would comply with all of the applicable rules. Nine parties filed proposals in response to this public notice.

5. On January 26, 2011, OET issued an Order designating all nine parties that filed proposals as TV bands database administrators, subject to certain conditions. Specifically, the administrators were required to: (1) Supplement their initial filings to show how they will comply with the rule changes adopted in the Second MO&O; (2) attend workshops conducted by OET to address the operation of the databases to ensure consistency and compliance with the rules; (3) cooperate with any steps OET deems necessary to ensure compliance with the rules; and (4) agree that they will not use their capacity as a database manager to engage in any discriminatory or anti-competitive practices or any practices that may compromise the privacy of users. In addition, each administrator's database will be subject to a trial period of not less than 45 days before it is allowed to be made available for actual use by TV bands devices to allow interested parties an opportunity to check that the database is providing accurate results. OET conducted three workshops after the release of the January 26, 2011 order.

6. On April 18, 2011, Microsoft Corporation filed a proposal with OET seeking designation as a TV bands database administrator. Microsoft's proposal addressed the questions in the November 25, 2009, public notice that invited proposals from parties seeking to be designated as database administrators. In addition, Microsoft provided information to show that it will comply with the rule changes adopted in the Second MO&O and stated that it will comply with the other three conditions in the January 26, 2011, order that conditionally designated the nine database administrators. Microsoft representatives attended all three of OET's database administrator workshops. On April 29, 2011, OET issued a public notice seeking comment on Microsoft's proposal. Two parties filed comments, and Microsoft filed reply comments.

7. Based upon our review of its proposal and the record before us, OET is designating Microsoft Corporation as a TV bands database administrator, subject to the conditions described. OET finds that Microsoft has shown that it has the technical expertise to develop and operate a TV bands database. Moreover, none of the concerns raised by any of the commenters in the record before us causes us to conclude that Microsoft is not capable of meeting all the requirements placed on database administrators by the Commission's rules in the Second Report and Order and as modified in the Second MO&O or that it should otherwise not be designated as a database administrator.

8. OET is not persuaded that the factors cited by the Engineers for the Integrity of Broadcast Auxiliary Services Spectrum (EIBASS) demonstrate that Microsoft is not qualified to administer a TV bands database. With regard to the issue of the timeliness of Microsoft's proposal, the rules do not prohibit additional parties from requesting designation as a TV bands database administrator after other parties have already been designated. In fact, the rules were designed with the expectation that there could be changes in database administrators over time, e.g., administrators are designated for a five-year term, subject to renewal at the Commission's discretion, and an administrator that ceases operation must transfer its database to another designated entity that takes its place. The original filing deadline was established by OET to allow orderly processing of the initial prospective database administrators as a group. However, this deadline was not intended to preclude other parties from requesting designation as a database administrator at a later date.

9. With regard to the issue of the protection of authorized services, the Commission's November 25, 2009 public notice did not request that prospective database administrators submit a complete list of every licensed service that is eligible for protection from TV bands devices. The Commission's rules and procedures for database testing and approval will ensure that all TV bands databases protect all eligible facilities. We note that Microsoft's proposal and response states that it will obtain information about protected services from several different sources, including the Commission's databases, which contains information on the services that EIBASS referenced in its comments.

10. The Commission authorized the channel range for the Microsoft STA that EIBASS contends is overly large and contains operating TV stations. The Commission specified the large channel range requested by Microsoft to simplify processing of the STA. Rather than determining in advance which channels within that range were vacant at the STA's location, the Commission made operation subject to the condition that Microsoft coordinate with the Society of Broadcast Engineers (SBE) to ensure that operation would occur only on vacant TV channels. The Commission has taken this same approach with other experimental authorizations for operations in the TV bands. While EIBASS is correct that the Microsoft STA does not name the precise location of operation within Las Vegas, one can easily determine that the geographic coordinates specified in the STA correspond to the Las Vegas Convention Center. As for EIBASS's contention that Microsoft initially failed to contact SBE, the parties do not dispute the fact that coordination did occur before Microsoft began operations. Microsoft states that it did coordinate with SBE and EIBASS prior to operating, and EIBASS states that the Las Vegas area frequency coordinator was made aware of the STA prior to operation. Furthermore, the Commission received no complaints of interference resulting from Microsoft's operation under this STA. We find no basis here to reject Microsoft as a TV bands database administrator.

11. Cohen, Dippell and Everist, P.C. (“CDE”) filed brief comments on the Microsoft proposal. CDE recommends that the database be updated at 12-hour intervals, seven days a week to provide the most accurate and timely information to white spaces users. However, making this change mandatory for database administrators would require modifications to our rules, which currently require synchronization of TV bands databases with the Commission databases once a week and synchronization between TV bands databases once every 24 hours. Such rule changes are outside the scope of this Order.

12. OET is designating Microsoft as a TV bands database administrator subject to the same conditions it required of the nine previously designated administrators. Microsoft has already satisfied several of these conditions. Specifically, it included in its request to be designated as a database administrator information to show that it complies with the rule changes adopted in the Second MO&O and stated that it would not use its capacity as a database manager to engage in any discriminatory or anti-competitive practices or practices that may compromise the privacy of users. Microsoft also participated in all three database administrator workshops held by OET thus far. Microsoft will also be required to take part in any future workshops that may be held by OET that address database implementation details and provide guidance on the requirements to the database administrators. In addition, Microsoft must cooperate with any steps OET deems necessary to ensure that the TV bands databases provide accurate and consistent lists of protected services and available channels. Further, it must support capabilities that OET deems necessary to ensure that any changes in registration of protected facilities in one database are rapidly reflected in all others.

13. Consistent with our previous action designating database administrators, Microsoft's database will be subject to a trial period of not less than 45 days before it is allowed to be made available for actual use by TV bands devices to allow interested parties an opportunity to check that the database is providing accurate results. A longer trial period may be required if we determine that its database is not in compliance with the Commission's rules. OET will determine the details of the trial, balancing the need to ensure that the database is working properly with the need to avoid an unnecessarily cumbersome and burdensome process.

14. If Microsoft successfully satisfies all of the conditions herein, it will be allowed to make its database available for actual use for the five year term specified in our rules. In such case, OET will announce the public availability of the database, at which time the five year term for that database will commence.

15. In summary, OET has considered Microsoft's proposal and all the comments and replies filed in response to the April 29, 2011 Public Notice. We conclude that Microsoft is capable of meeting the Commission's regulatory requirements for serving as a database administrator, as set forth in the Commission's rules, including the rule revisions adopted in the Second MO&O. Accordingly, we are designating Microsoft Corporation as a TV bands database administrator subject to the conditions described.

16. Pursuant to the authority contained in sections 4(i), 302, 303(e), 303(f), and 307 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(c), 303(f), and 307, and §§ 0.31 and 0.241 of the Commission's rules, 47 CFR 0.31, 0.241, Microsoft Corporation is designated as a TV bands database administrator as set forth in Section 15.715 of the Commission's rules, 47 CFR 15.715, subject to the conditions specified.

PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services, through the Administration on Developmental Disabilities, on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. The PCPID Executive Order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of workplace integration; (D) improvement of transportation options; (E) expansion of full access to community living; and (F) increasing access to assistive and universally designed technologies.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the introduction or delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary ingredient (NDI), a manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, is to submit to FDA (as delegate for the Secretary of Health and Human Services) the information which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing an NDI will reasonably be expected to be safe. Section 190.6 (21 CFR 190.6) implements this statutory provision. Section 190.6(a) requires each manufacturer or distributor of a dietary supplement containing an NDI, or of an NDI, to submit to the Office of Nutrition, Labeling, and Dietary Supplements notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. Section 190.6(b) requires that the notification include the following: (1) The complete name and address of the manufacturer or distributor, (2) the name of the NDI, (3) a description of the dietary supplements that contain the NDI, and (4) the history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe.

The notification requirements described previously are designed to enable FDA to monitor the introduction into the food supply of NDIs and dietary supplements that contain NDIs, in order to protect consumers from the introduction of unsafe dietary supplements into interstate commerce. FDA uses the information collected under these regulations to help ensure that a manufacturer or distributor of a dietary supplement containing an NDI is in full compliance with the FD&C Act.

Description of Respondents: The respondents to this collection of information are firms in the dietary supplement industry, including dietary supplement and dietary ingredient manufacturers, packagers and re-packagers, holders, labelers and re-labelers, distributors, warehouses, exporters, and importers.

In the Federal Register of June 3, 2011 (76 FR 32214), FDA published a 60-day notice (the June 3, 2011, notice) requesting public comment on the proposed extension of this collection of information. FDA received five letters in response to the notice, each containing multiple comments. Several comments were generally supportive of FDA's information collection provisions in § 190.6. Additional comments were outside the scope of the four collection of information topics on which the notice solicits comments, and will not be discussed in this document.

(Comment 1) FDA received several comments on the utility of the premarket notification procedures. Some comments stated that the information collection is necessary for the performance of FDA's functions and that the information will be of great practical utility to FDA in carrying out its role of protecting consumers from the introduction of unsafe dietary supplements into interstate commerce.

(Response) FDA agrees. As noted, section 413(a) of the FD&C Act requires a manufacturer or distributor of an NDI, or of the dietary supplement that contains the NDI, to submit the information which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing an NDI will reasonably be expected to be safe. Section 190.6 implements this statutory provision, and is essential to protecting consumers from unsafe dietary supplements.

(Comment 2) Several comments argued that FDA underestimated the burden hours associated with complying with the provisions of § 190.6. One comment argued that FDA's estimate of 20 hours per notification is too low and stated that firms filing notifications require 100 to 350 hours to generate data to meet the requirements of an NDI notification. The comment argued that FDA did not fully consider the time needed to acquire the required information.

(Response) FDA disagrees. FDA appreciates the data provided in the comment. However, the Agency stands by its estimate of the paperwork burden resulting from § 190.6. As noted in the June 3, 2011, notice, § 190.6(a) requires each manufacturer or distributor of a dietary supplement containing an NDI, or of an NDI, to submit notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. The Agency believes that there is minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the Agency is requesting only that information that the manufacturer or distributor should already have developed as the basis for its conclusion that a dietary supplement containing an NDI will reasonably be expected to be safe. Therefore, the Agency estimates that extracting and summarizing the relevant information from the company's files, and presenting it in a format that will meet the requirements of section 413(a) of the FD&C Act and § 190.6 will require a burden of approximately 20 hours of work per submission.

(Comment 3) One comment argued that FDA's estimate of 20 hours per notification is too low and stated that FDA should use burden hour data from “successful” notifications only, indicating that the number of hours spent on notifications to which FDA does not object more accurately reflect the burden on industry.

(Response) FDA disagrees that the estimate of 20 hours per notification is too low for the reasons stated in response to Comment 2. In addition, the Agency does not regularly collect from those submitting notifications under § 190.6 information about the number of hours they spent preparing the notifications, whether “successful” or “unsuccessful.” FDA appreciates the suggestion provided in the comment, however, and will consider doing so when it prepares its next regular information collection request for this collection.

(Comment 4) One comment argued that FDA's estimate that it will receive 55 premarket notifications annually is inaccurate and “deeply flawed.”

(Response) FDA disagrees that the estimate of 55 notifications annually is inaccurate. As stated in the June 3, 2011, notice, the estimated number of premarket notifications is an average based on the Agency's experience with notifications received during the last 3 years. FDA received 77 notifications in 2008, 39 notifications in 2009, and 48 notifications in 2010, for an average of 55 notifications. The sum of 77 + 39 + 48 equals 164. Dividing that sum by 3 yields an average of 54.66, which has been rounded up to 55.

(Comment 5) Several comments argued that FDA incorrectly estimated that there are no capital costs associated with submitting premarket notifications under § 190.6. Comments argued that FDA did not fully consider that notifiers invest significant capital resources in hiring consultants to extract and summarize information for NDI notifications, paying for full-text scientific journal articles and obtaining legal review of NDI notifications.

(Response) FDA disagrees. The comment mischaracterizes the significant costs associated with hiring consultants, obtaining reference materials, and securing legal review of a notification as capital costs. For purposes of information collection requests under the PRA, capital costs are costs for equipment, machinery, and construction that, if not for FDA's request or requirement, the respondent would not incur. This includes buying new software and new computer equipment; monitoring, sampling, drilling and testing equipment; record storage facilities; the cost of purchasing or contracting out information collection services; and, postage costs to mail in a report. Capital costs do not include costs to achieve regulatory compliance with requirements not associated with the information collection. Hiring consultants to extract and summarize information for NDI notifications, paying for full-text scientific journal articles and obtaining legal review of NDI notifications are costs associated with developing information that the manufacturer or distributor uses to satisfy itself that a dietary supplement containing an NDI is in full compliance with section 413(a) of the FD&C Act; thus, these costs are not a capital cost because they are costs associated with achieving regulatory compliance with requirements of the FD&C Act, not costs associated specifically with filing a notification under § 190.6. FDA notes that it has added a reference to these costs as “Costs to Respondent” in section 12(b) of the supporting statement component of the information collection request that it has submitted to OMB.

(Comment 6) Several comment letters noted that on July 5, 2011, FDA issued a draft guidance entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm ). Some comments argued that FDA underestimated the burden of the notification procedures under § 190.6 because it failed to take into account the provisions of the new draft guidance.

(Response) FDA disagrees that we underestimated the burden of the notification procedures under § 190.6. The collection of information analysis in the June 3, 2011, notice was limited to the sole collection of information contained in § 190.6; that is, the regulation itself and not the provisions of the new draft guidance. The notification requirements set forth in § 190.6 remain unchanged. The notice of availability for the new draft guidance (76 FR 39111, July 5, 2011) states that FDA will estimate the paperwork burden of the draft guidance document and submit it for OMB review under the PRA in a future issue of the Federal Register . Comments on the new draft guidance and any information collection provisions therein are outside the scope of the comment request in the June 3, 2011, notice, and will not be discussed in this document.

FDA estimates the burden of this collection of information as follows:

As previously discussed, the Agency believes that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the Agency is requesting only that information that the manufacturer or distributor should already have developed as the basis for its conclusion that a dietary supplement containing an NDI will reasonably be expected to be safe. Therefore, the Agency estimates that extracting and summarizing the relevant information from the company's files, and presenting it in a format that will meet the requirements of section 413(a) of the FD&C Act and § 190.6 will require a burden of approximately 20 hours of work per submission.

The estimated number of premarket notifications and hours per response is an average based on the Agency's experience with notifications received during the last 3 years and information from firms that have submitted recent premarket notifications. FDA received 77 notifications in 2008, 39 notifications in 2009, and 48 notifications in 2010, for an average of 55 notifications. Accordingly, we estimate that 55 respondents will submit 1 premarket notification each and that it will take a respondent 20 hours to prepare the notification, for a total of 1,100 hours.

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 Food, Drug, and Cosmetic Act (FD&C 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. Under section 403(r)(6)(A) of the FD&C Act, such a statement is one that “claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption for a nutrient or dietary ingredient.”

The guidance document entitled “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” provides FDA's recommendations to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6) of the FD&C Act. The guidance does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim. The guidance document is intended to assist manufacturers in their efforts to comply with Section 403(r)(6). Persons with access to the Internet may obtain the guidance at http://www.cfsan.fda.gov/~dms/guidance.html.

Dietary supplement manufacturers collect the necessary substantiating information for their product as required by section 403(r)(6) of the FD&C Act. The guidance provides information to manufacturers to assist them in doing so. The recommendations contained in the guidance are voluntary. 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 choose to place a claim on their product's label.

The standard discussed in the 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.

In the Federal Register of June 3, 2011 (76 FR 32215), FDA published a 60-day notice requesting public comment on the proposed extension of this collection of information. FDA received five letters in response to the notice, each containing multiple comments. Several comments were generally supportive of the necessity of the information collection provisions of the guidance. Additional comments were outside the scope of the four collection of information topics on which the notice solicits comments, and will not be discussed in this document.

(Comment 1) Several comment letters noted the accuracy of FDA's estimate of the burden hours, which ranges from 44 to 120 hours per claim depending upon the nature of the claim.

(Response) FDA agrees. As discussed in this notice, 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.

(Comment 2) One comment stated that FDA incorrectly estimated that there are no capital costs associated with developing information that meets the guidance's recommendations to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6) of the FD&C Act. The comment argued that FDA did not fully consider that manufacturers invest significant capital resources in subscriptions to scientific journals and libraries to gain access to full-text scientific literature, consultants to develop appropriate wording for claims, and legal review of claims.

(Response) FDA disagrees. The comment mischaracterizes the significant costs associated with hiring consultants, obtaining reference materials, and securing legal review of a notification as capital costs. For purposes of information collection requests under the Paperwork Reduction Act, capital costs are costs for equipment, machinery, and construction that, if not for FDA's request or requirement, the respondent would not incur. This includes: Buying new software and new computer equipment; monitoring, sampling, drilling and testing equipment; record storage facilities; the cost of purchasing or contracting out information collection services; and postage costs to mail in a report. Capital costs do not include costs to achieve regulatory compliance with requirements not associated with the information collection. Subscriptions to scientific journals and libraries to gain access to full-text scientific literature, hiring consultants to develop appropriate wording for claims, and legal review of claims are costs associated with developing information that the manufacturer uses to satisfy itself that it has met the guidance's recommendations to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6) of the FD&C Act; thus, these costs are not capital costs because they are costs associated with achieving regulatory compliance with requirements of the FD&C Act, not costs associated specifically with equipment, machinery, and construction needed to retain appropriate substantiating evidence. FDA notes that it has added a reference to these costs as “Costs to Respondent” in section 12(b) of the supporting statement component of the Information Collection Request that it has submitted to OMB.

(Comment 3) One comment suggested that, to enhance the quality, utility and clarity of the information as well as minimize the burden of collection on manufacturers, FDA explore options for electronic submission and a digital, interactive database so the information can be easily reviewed, collated, analyzed and reported.

(Response) FDA notes that dietary supplement manufacturers making a nutritional deficiency, structure/function, or general well-being claim are required by section 403(r)(6) of the FD&C Act to have substantiation that the claim is truthful and not misleading. There is no requirement in the FD&C Act or recommendation in the guidance document that manufacturers submit the substantiation information to FDA. The information is retained by the manufacturers in their records. The guidance does not specifically prescribe the use of automated, electronic, mechanical, or other technological techniques or other forms of information technology as necessary for use by dietary supplement manufacturers. Companies are free to use whatever forms of information technology that may best assist them in developing substantiation information.

(Comment 4) One comment stated that FDA should provide clarity on what type of evidence is needed to substantiate a traditional use claim. The comment argued that Canada, the European Union, and Australia recognize traditional use evidence to support appropriate claim statements. The comment stated that several authoritative labeling standards monographs for herbal products specify traditional use claim statements, such as Health Canada Natural Health Products Directorate (NHPD) monographs, European Medicines Agency (EMA) European Community Herbal Monographs, and World Health Organization (WHO) Monographs on Selected Medicinal Plants. The comment recommended that FDA allow such monographs as acceptable pieces of evidence to substantiate a traditional use claim. The comment concluded that FDA's acceptance of label claim statements listed in appropriate monographs and clear guidance on other types of evidence that could be used to substantiate traditional use claims would significantly reduce the burden of collecting such information.

(Response) FDA disagrees that traditional use evidence is sufficient to meet the substantiation standard of competent and reliable scientific evidence applied by FDA in “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.” A claim based on historical or traditional use is not a claim that is substantiated by scientific evidence. Claims permitted by foreign and international monographs do not always have to be substantiated by scientific studies but may be acceptable if, in some cases, they are accompanied by disclosures that the claim is not scientifically established or are deemed appropriate merely by their history of use for a particular intended use. Therefore, FDA does not believe that these monographs are adequate to meet the substantiation standard applied by FDA.

(Comment 5) One comment suggested that FDA should identify monographs that are already recognized in other countries as substantiation for claims made for products that are manufactured in strict conformity to these monographs. The comment identified two specific compendia of monographs and recommended that FDA recognize these monographs as “constituting in and of themselves substantiation for a pre-existing widely established claim that may be made for a dietary supplement under section 403(r)(6) of the FD&C Act, so long as the claim is not a drug claim and is significantly similar to the use or purpose described in a monograph, and the conditions and level of use of the ingredient(s) that is the basis of the claim is within the dosage range described in the monograph.”

(Response) FDA disagrees that foreign or other third-party monographs assure that a claim is substantiated by competent and reliable scientific evidence, which is the standard applied by FDA. Claims that may be permitted by foreign and international monographs do not always have to be substantiated by scientific studies but may be acceptable if substantiated, in whole or in part, by evidence not deemed adequate for a claim made for a dietary supplement in the United States, such as animal data or traditional medicinal use. Therefore, FDA does not believe that these monographs are adequate to meet the substantiation standard applied by FDA

(Comment 6) One comment argued that FDA overestimated the burden of the information collection by overestimating the number of respondents. The comment noted that FDA's website contains a list of notifications submitted in compliance with the requirements of 21 CFR 101.93 (a)(1) and stated that their review of the notices submitted between December 2007 and August 2010 indicates that the Agency has received an average of approximately 1,600 to 1,650 annually during this time, not the 2,001 per year estimated by FDA.

(Response) FDA disagrees that it has overestimated the number of respondents and stands by the estimate of 2,001 annual respondents for the next 3 years. The number of such notifications received by FDA in any given year can vary quite widely (by up to 300). In addition, the number of firms keeping records in anticipation of submitting a notification may be greater than the number of notification submitted. Thus, FDA believes retaining the estimate of 2,001 from the prior submission is appropriate.

FDA estimates the burden of this collection of information as follows:

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. 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 Federal Register of January 6, 2000, FDA published a final rule on statements made for dietary supplements concerning the effect of the product on the structure or function of the body (65 FR 1000). FDA estimated that there were 29,000 dietary supplement products marketed in the United States (65 FR 1000 at 1045). Assuming that the flow of new products is 10 percent per year, then 2,900 new dietary supplement products will come on the market each year. The structure/function final rule estimated that about 69 percent of dietary supplements have a claim on their labels, most probably a structure/function claim (65 FR 1000 at 1046). Therefore, we assume that supplement manufacturers will need time to assemble the evidence to substantiate each of the 2,001 claims (2,900 × 69 percent) made each year. If we assume that the 2,001 claims are equally likely to be pre-existing widely established claims, novel claims, or pre-existing claims that are not widely established, then we can expect 667 of each of these types of claims to be substantiated per year. Table 1 of this document shows that the annual burden hours associated with assembling evidence for claims is 189,428 (the sum of 667 × 44 hours, 667 × 120 hours, and 667 × 120 hours).

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) is the subject of NDA 21-749, held by Hameln Pharmaceuticals GmbH, and initially approved on August 11, 2004. PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.

In a letter dated June 24, 2010, Hameln Pharmaceuticals GmbH notified FDA that PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.

Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG submitted a citizen petition dated November 26, 2010 (Docket No. FDA-2010-P-0628), under 21 CFR 10.30, requesting that the Agency determine whether PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records, FDA has determined under § 314.161 that PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) is the subject of NDA 21-751, held by Hameln Pharmaceuticals GmbH, and initially approved on August 11, 2004. PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.

In a letter dated June 24, 2010, Hameln Pharmaceuticals GmbH notified the FDA that PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.

Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG submitted a citizen petition dated December 6, 2010 (Docket No. FDA-2010-P-0630), under 21 CFR 10.30, requesting that the Agency determine whether PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records, FDA has determined under § 314.161 that PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)), in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If the FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Standards for Clinical Trial Imaging Endpoints.” This draft guidance is intended to assist sponsors in the standardization of imaging procedures when an important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product, especially for an efficacy endpoint. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA 4), FDA committed to certain performance goals (see letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record). 1 This draft guidance addresses one of these goals with the creation of a guidance document that addresses the “imaging standards for use as an endpoint in clinical trials.” This draft guidance also follows the April 13, 2010, public workshop “Standards for Imaging Endpoints in Clinical Trials” cosponsored by FDA, the Society of Nuclear Medicine, and the Radiological Society of North America. 2

This draft guidance outlines the major considerations for standardization of image acquisition, image interpretation methods, and other procedures to help ensure imaging data quality. The draft guidance describes two categories of image acquisition and interpretation standardization, a medical practice standard and a clinical trial standard, and provides guidance on the role of each standard in a clinical trial. With a medical practice standard, the image acquisition and interpretation methods in the trial do not exceed those used in medical practice. In contrast, a clinical trial standard involves imaging methods that exceed those used in medical practice. The draft guidance focuses on the methods important for image acquisition and interpretation and provides a detailed outline of other procedures important for optimizing clinical trial imaging data quality.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on standards for clinical trial imaging endpoints. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.egulations.gov.