On July 13, 2009, the Department published its Final Results. In the Final Results, the Department valued lindenwood pencil slats used by the respondent Rongxin with publicly available, published U.S. prices for American basswood lumber. See Final Results and accompanying I&D Memorandum at Comment 4a. In China First Pencil Co., Ltd. v. United States, 721 F. Supp. 2d 1369 (Ct. Int'l Trade 2010) (“ China First” ), the CIT determined that the Department's surrogate value for pencils slats used in the Final Results was unsupported by substantial evidence and was not in accordance with law. The CIT remanded the Department to recalculate a surrogate value for pencil slats using data from “Paper and Stationery,” an Indian trade publication. See China First, 721 F. Supp. 2d at 1375-77. On first remand, the Department used “Paper and Stationery” data to recalculate the surrogate value for pencil slats. See Final Results of Redetermination Pursuant to Remand, Consol. Court No. 09-00325, dated December 20, 2010, at 3-4, available at http://ia.ita.doc.gov/remands (“First Remand Results”). This redetermination on slats was sustained with respect to Rongxin in Shangdong Rongxin I.

Also in the Final Results, the Department valued black and color cores for Rongxin using World Trade Atlas data. See Final Results and accompanying I&D Memorandum at Comment 4b. In China First, the CIT determined that the Department's surrogate value for cores used in the Final Results was unsupported by substantial evidence and was not in accordance with law. The CIT remanded to the Department to identify separate surrogate values, supported by substantial evidence on the record, for black cores, color cores, thick black cores, and thick color cores. See China First, 721 F. Supp. 2d at 1379-1380. On first remand, the Department used “Paper and Stationery” data to recalculate the surrogate value for black and color cores. See First Remand Results at 4-6. The Department's redetermination on cores was sustained in Shangdong Rongxin I.

Additionally, in the Final Results, the Department calculated a surrogate wage value for Rongxin in accordance with the regression-based methodology set forth in 19 CFR 351.408(c)(3). See Final Results and accompanying I&D Memorandum at Comment 3. In Dorbest Ltd. v. United States, 604 F.3d 1363 (Fed. Cir. 2010) (“ Dorbest” ), the CAFC held that the Department's “{regression-based} method for calculating wage rates {as stipulated by 19 CFR 351.408(c)(3)} uses data not permitted by {the statutory requirements laid out in section 773 of the Tariff Act of 1930, as amended (“the Act”) ( i.e. 19 U.S.C. 1677b(c))}.” Dorbest, 604 F.3d at 1372. Specifically, the CAFC interpreted section 773(c) of the Act to require the use of data from market economy countries that are both economically comparable to the non-market economy country at issue and significant producers of the subject merchandise, unless such data are unavailable. Because the Department's regulation requires the Department to use data from economically dissimilar countries and from countries that do not produce comparable merchandise, the CAFC invalidated the Department's labor regulation at 19 CFR 351.408(c)(3). Following Dorbest, the Department requested a voluntary remand for its wage rate calculations for Rongxin in the Final Results. The CIT granted that request and in China First remanded the Final Results with instructions that the labor wage value be recalculated in accordance with the decision in Dorbest. See China First, 721 F. Supp. 2d at 1373.

On first remand, the Department adopted a wage calculation methodology with respect to Rongxin that averaged wages across countries that are both economically comparable and significant producers of merchandise comparable to the subject merchandise. See First Remand Results at 7-31. In Shandong Rongxin I, the CIT again remanded to the Department to address two issues concerning the surrogate value for labor applied with respect to Rongxin in the First Remand Results: (1) The Department's decision to omit certain labor data from its calculations because the data were reported under a previous revision of ISIC;  1 and (2) the Department's methodology for determining whether a country is a significant producer of comparable merchandise within the meaning of section 773(c)(4) of the Act.

On second remand, the Department revised its wage rate methodology to rely upon labor cost data from a single surrogate country. See Second Remand Results at 4-6 (citing Antidumping Methodologies in Proceedings Involving Non-Market Economies: Valuing the Factor of Production: Labor, 76 FR 36092 (June 21, 2011)). Through this revised approach, the Department's redetermination resulted in a change to Rongxin's margin from 11.48 percent in the Final Results to 0.72 percent. The CIT sustained the Department's Second Remand Results in Shangdong Rongxin II.

In its decision in Timken, 893 F.2d at 341, as clarified by Diamond Sawblades, the CAFC has held that, pursuant to section 516A(e) of the Act, the Department must publish a notice of a court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's August 30, 2011 judgment sustaining the Department's remand redetermination with respect to Rongxin constitutes a final decision of that court that is not in harmony with the Department's Final Results. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the subject merchandise pending the expiration of the period of appeal or, if appealed, pending a final and conclusive court decision. The cash deposit rate will remain the company-specific rate established for the subsequent and most recent period during which the respondent was reviewed. See Certain Cased Pencils From the People's Republic of China: Final Results of the Antidumping Duty Administrative Review, 76 FR 27988 (May 13, 2011).

Because there is now a final court decision with respect to Rongxin, the revised dumping margin is as follows:

In the event the CIT's ruling is not appealed or, if appealed, upheld by the CAFC, the Department will instruct U.S. Customs and Border Protection to assess antidumping duties on entries of the subject merchandise during the POR from Rongxin on the revised assessment rate calculated by the Department.

This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.

Background

On May 15, 1989, the Department published in the Federal Register the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy. See Antidumping Duty Orders: Ball Bearings, Cylindrical Roller Bearings, Spherical Plain Bearings, and Parts Thereof From France, 54 FR 20902 (May 15, 1989), Antidumping Duty Orders: Ball Bearings, Cylindrical Roller Bearings, and Spherical Plain Bearings and Parts Thereof From the Federal Republic of Germany, 54 FR 20900 (May 15, 1989), and Antidumping Duty Orders: Ball Bearings and Cylindrical Roller Bearings, and Parts Thereof From Italy, 54 FR 20903 (May 15, 1989).

On August 1, 2011, the Department initiated the sunset reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). See Initiation Notice. 1 We received no notice of intent to participate in response to the notice of initiation from domestic interested parties by the applicable deadline. See 19 CFR 351.218(d)(1)(i). As a result, the Department has concluded that no domestic party intends to participate in the sunset reviews. See 19 CFR 351.218(d)(1)(iii)(A). On August 24, 2011, we notified the International Trade Commission, in writing, that we intend to revoke the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy. See 19 CFR 351.218(d)(1)(iii)(B)(2).

The products covered by the orders are ball bearings and parts thereof. These products include all antifriction bearings that employ balls as the rolling element. Imports of these products are classified under the following categories: antifriction balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and parts thereof, and housed or mounted ball bearing units and parts thereof.

Imports of these products are classified under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 3926.90.45, 4016.93.10, 4016.93.50, 6909.19.50.10, 8414.90.41.75, 8431.20.00, 8431.39.00.10, 8482.10.10, 8482.10.50, 8482.80.00, 8482.91.00, 8482.99.05, 8482.99.35, 8482.99.25.80, 8482.99.65.95, 8483.20.40, 8483.20.80, 8483.30.40, 8483.30.80, 8483.50.90, 8483.90.20, 8483.90.30, 8483.90.70, 8708.50.50, 8708.60.50, 8708.60.80, 8708.93.30, 8708.93.60.00, 8708.99.06, 8708.99.31.00, 8708.99.40.00, 8708.99.49.60, 8708.99.58, 8708.99.80.15, 8708.99.80.80, 8803.10.00, 8803.20.00, 8803.30.00, 8803.90.30, 8803.90.90, 8708.30.50.90, 8708.40.75.70, 8708.40.75.80, 8708.50.79.00, 8708.50.89.00, 8708.50.91.50, 8708.50.99.00, 8708.70.60.60, 8708.80.65.90, 8708.93.75.00, 8708.94.75, 8708.95.20.00, 8708.99.55.00, 8708.99.68, and 8708.99.81.80.

Although the HTSUS item numbers above are provided for convenience and customs purposes, the written descriptions of the scope of the orders remain dispositive.

The size or precision grade of a bearing does not influence whether the bearing is covered by one of the orders. The orders cover all the subject bearings and parts thereof (inner race, outer race, cage, rollers, balls, seals, shields, etc. ) outlined above with certain limitations. With regard to finished parts, all such parts are included in the scope of the orders. For unfinished parts, such parts are included if they have been heat-treated or if heat treatment is not required to be performed on the part. Thus, the only unfinished parts that are not covered by the orders are those that will be subject to heat treatment after importation. The ultimate application of a bearing also does not influence whether the bearing is covered by the orders. Bearings designed for highly specialized applications are not excluded. Any of the subject bearings, regardless of whether they may ultimately be utilized in aircraft, automobiles, or other equipment, are within the scope of the orders.

For a list of scope determinations which pertain to the orders, see the “Memorandum to Laurie Parkhill” regarding scope determinations for the 2009/2010 administrative reviews dated April 14, 2011, which is on file in the Central Records Unit (CRU) of the main Commerce building, room 7046, in the General Issues record (A-100-001).

Pursuant to section 751(c)(3)(A) of the Act and 19 CFR 351.218(d)(1)(iii)(B)(3), if no domestic interested party files a notice of intent to participate, the Department shall issue a final determination revoking the order within 90 days of the initiation of the review. Because no domestic interested party filed a timely notice of intent to participate in the sunset reviews, the Department finds that no domestic interested party is participating in the sunset reviews. Therefore, we are revoking the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy. The effective date of revocation is September 15, 2011, the fifth anniversary of the continuation of the antidumping duty orders. See Tapered Roller Bearings and Parts Thereof from the People's Republic of China and Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Continuation of Antidumping Duty Orders, 71 FR 54469 (September 15, 2006).

Pursuant to section 751(c)(3)(A) of the Act and 19 CFR 351.222(i)(2)(i), the Department intends to issue instructions to U.S. Customs and Border Protection to terminate the suspension of liquidation of entries of the merchandise subject to the orders which were entered, or withdrawn from warehouse, for consumption on or after September 15, 2011. Entries of subject merchandise prior to September, 15, 2011, will continue to be subject to the suspension of liquidation and requirements for deposits of estimated antidumping duties. The Department will conduct administrative reviews of the orders with respect to subject merchandise entered prior to the effective date of revocation in response to appropriately filed requests for review.

These final results of the five-year (sunset) reviews and notice are published in accordance with sections 751(c) and 777(i)(1) of the Act.

Background

On April 1, 2011, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on magnesium metal from the PRC for the period April 1, 2010 through March 31, 2011. 3 On May 2, 2011, U.S. Magnesium LLC (“U.S. Magnesium”), a domestic producer and Petitioner in the underlying investigation of this case, made a timely request that the Department conduct an administrative review of TMI. 4 On May 27, 2011, in accordance with section 751(a) of the Tariff Act of 1930, as amended (“the Act”), the Department published in the Federal Register a notice of initiation of this antidumping duty administrative review. 5 On June 14, 2011, TMI submitted a letter to the Department certifying that it did not export magnesium metal for sale in the United States during the POR and that it did not make entries of such merchandise into the United States during the POR. 6

On June 20, 2011, the Department placed on the record information obtained in response to the Department's query to CBP concerning imports into the United States of subject merchandise during the POR. 7 This data indicates that there were no entries of subject merchandise during the POR that had been exported by TMI. In addition, on June 30, 2011, we notified CBP that we were in receipt of a no-shipment certification from TMI and requested CBP to report any contrary information within 10 days. 8 CBP did not report any contrary information.

On July 14, 2011, the Department notified interested parties of its intent to rescind this administrative review and gave parties until July 21, 2010, to provide comments. We did not receive any comments.

The product covered by this antidumping duty order is magnesium metal from the PRC, which includes primary and secondary alloy magnesium metal, regardless of chemistry, raw material source, form, shape, or size. Magnesium is a metal or alloy containing by weight primarily the element magnesium. Primary magnesium is produced by decomposing raw materials into magnesium metal. Secondary magnesium is produced by recycling magnesium-based scrap into magnesium metal. The magnesium covered by this order includes blends of primary and secondary magnesium.

The subject merchandise includes the following alloy magnesium metal products made from primary and/or secondary magnesium including, without limitation, magnesium cast into ingots, slabs, rounds, billets, and other shapes; magnesium ground, chipped, crushed, or machined into rasping, granules, turnings, chips, powder, briquettes, and other shapes; and products that contain 50 percent or greater, but less than 99.8 percent, magnesium, by weight, and that have been entered into the United States as conforming to an “ASTM Specification for Magnesium Alloy”  9 and are thus outside the scope of the existing antidumping orders on magnesium from the PRC (generally referred to as “alloy” magnesium).

The scope of this order excludes: (1) All forms of pure magnesium, including chemical combinations of magnesium and other material(s) in which the pure magnesium content is 50 percent or greater, but less than 99.8 percent, by weight, that do not conform to an “ASTM Specification for Magnesium Alloy”  10 ; (2) magnesium that is in liquid or molten form; and (3) mixtures containing 90 percent or less magnesium in granular or powder form by weight and one or more of certain non-magnesium granular materials to make magnesium-based reagent mixtures, including lime, calcium metal, calcium silicon, calcium carbide, calcium carbonate, carbon, slag coagulants, fluorspar, nephaline syenite, feldspar, alumina (Al203), calcium aluminate, soda ash, hydrocarbons, graphite, coke, silicon, rare earth metals/mischmetal, cryolite, silica/fly ash, magnesium oxide, periclase, ferroalloys, dolomite lime, and colemanite. 11

The merchandise subject to this order is classifiable under items 8104.19.00, and 8104.30.00 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS items are provided for convenience and customs purposes, the written description of the merchandise is dispositive.

Based upon the certifications and the evidence on the record, the Department finds TMI's claim of no shipments of subject merchandise to the United States during the POR to be substantiated. Pursuant to 19 CFR 351.213(d)(3), the Department may rescind an administrative review, in whole or with respect to a particular exporter or producer, if the Secretary concludes that, during the period covered by the review, there were no entries, exports, or sales of the subject merchandise. Therefore, the Department is rescinding this review in accordance with 19 CFR 351.213(d)(3). The Department intends to instruct CBP fifteen days after the publication of this notice to liquidate such entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(2).

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213(d)(4).

Illinois has submitted a coastal management program to NOAA for approval under the Coastal Zone Management Act (CZMA), 16 U.S.C. 1451, et. seq. The ICMP is the result of substantial efforts on the part of Federal, State, and local agencies, regional organizations, and public and private entities. Federal approval of the ICMP would make Illinois eligible for program administration grant funds and require Federal actions to be consistent with the federally-approved program.

Upon finding that a state program has satisfied the requirements of the CZMA, NOAA is required to prepare a DEIS. The Council on Environmental Quality regulations to implement the National Environmental Policy Act (NEPA), 40 CFR parts 1500-1508, apply to the preparation of the DEIS. Specifically, section 1506.6 requires agencies to provide public notice of NEPA-related hearings and the availability of environmental documents. This notice is part of NOAA's effort to comply with those regulations.

Copies of the DEIS are available by any one of the following methods:

• Contact Diana Olinger, NOAA Coastal Program Specialist, at the address indicated above;

• OCRM's Web site: http://coastalmanagement.noaa.gov/mystate/il.html ; or

• Illinois Department of Natural Resource's Web site: http://www.dnr.illinois.gov/cmp/Pages/documentation/aspx.

The purpose of the meeting is to discuss management issues and potential pilot programs for the charter for-hire sector in the Gulf of Mexico. Issues to be discussed include the design, implementation, monitoring, review, and, evaluation of charter for-hire pilot programs.

Copies of the agenda and other related materials can be obtained by calling (813) 348-1630 or can be downloaded from the Council's ftp site, ftp.gulfcouncil.org.

Although other non-emergency issues not on the agenda may come before the Ad Hoc Reef Fish Limited Access Privilege Program Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Ad Hoc Reef Fish Limited Access Privilege Program Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Council (see ADDRESSES ) at least 5 working days prior to the meeting.

The Board, which consists of a balanced representation from academia, industry, state government and citizens groups, was established in 1976 by Section 209 of the Sea Grant Improvement Act (Pub. L. 94-461, 33 U.S.C. 1128). The Board advises the Secretary of Commerce and the Director of the National Sea Grant College Program with respect to operations under the Act, and such other matters as the Secretary refers to them for review and advice.

The agenda for this meeting can be found at http://www.seagrant.noaa.gov/leadership/advisory_board.html.

The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.

Matters To Be Considered: The meeting will include the following topics: (1) Final Report from the Climate and Environmental Information Services Working Groups' Climate Partnership Task Force (2) Review of new members and renewal of member terms for the Environmental Information Services Working Group (3) Terms of Reference and Proposed Members for a Satellite Task Force (4) NOAA Request for SAB Review of the NOAA Research Enterprise and (5) NOAA Request for the Ecosystem Sciences and Management Working Group to vet reviewers for the National Marine Fisheries Science Centers. For the latest agenda, please visit the SAB Web site at http://www.sab.noaa.gov.

Section 108 of the CPSIA permanently prohibits the sale of any “children's toy or child care article” containing more than 0.1 percent of each of three specified phthalates: Di- (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP). Section 108 of the CPSIA also prohibits, on an interim basis, the sale of any “children's toy that can be placed in a child's mouth” or “child care article” containing more than 0.1 percent of each of three additional phthalates: diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di- n -octyl phthalate (DnOP).

Moreover, section 108 of the CPSIA requires the Commission to convene a CHAP “to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.” The CPSIA requires the CHAP to complete an examination of the full range of phthalates that are used in products for children and:

• Examine all of the potential health effects (including endocrine disrupting effects) of the full range of phthalates;

• Consider the potential health effects of each of these phthalates, both in isolation and in combination with other phthalates;

• Examine the likely levels of children's, pregnant women's, and others' exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products;

• Consider the cumulative effect of total exposure to phthalates, both from children's products and from other sources, such as personal care products;

• Review all relevant data, including the most recent, best available, peer-reviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods;

• Consider the health effects of phthalates, not only from ingestion, but also as a result of dermal, hand-to-mouth, or other exposure;

• Consider the level at which there is a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals and their offspring, reviewing the best available science, and using sufficient safety factors to account for uncertainties regarding exposure and susceptibility of children, pregnant women, and other potentially susceptible individuals; and

• Consider possible similar health effects of phthalate alternatives used in children's toys and child care articles.

The CPSIA contemplates completion of the CHAP's examination within 18 months of the panel's appointment. The CHAP must review prior work on phthalates by the Commission, but it is not to be considered determinative because the CHAP's examination must be conducted de novo.

The CHAP must make recommendations to the Commission about which phthalates, or combinations of phthalates (in addition to those identified in section 108 of the CPSIA), or phthalate alternatives should be prohibited from use in children's toys or child care articles or otherwise restricted. The Commission selected the CHAP members from scientists nominated by the National Academy of Sciences. See 15 U.S.C. 2077, 2030(b).

The CHAP met previously in April, July, and December 2010, and in March and July 2011, at the CPSC's offices in Bethesda, MD, and by teleconference in November 2010. The CHAP heard testimony from interested parties at the July 2010 meeting. The September 2011 conference call will include discussion of the CHAP's progress in its analysis of potential risks from phthalates and phthalate substitutes. There will not be any opportunity for public comment during the conference call.

The Corporation is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are expected 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 submissions of responses).

These application instructions will be used by applicants for funding through AmeriCorps State and National grant competitions.

The Corporation seeks to renew and revise the current AmeriCorps State and National Application Instructions. The Application Instructions are being revised for increased clarity and to align with provisions of the Serve America Act. The Application Instructions will be used in the same manner as the existing Application Instructions. The Corporation also seeks to continue using the current Application Instructions until the revised Application Instructions are approved by OMB. The current ICRs are due to expire on May 31, 2012.

Type of Review: Renewal.

Agency: Corporation for National and Community Service.

Title: AmeriCorps Application Instructions: State Commissions; State and National Competitive; Professional Corps; Indian Tribes; States and Territories without Commissions; and State and National Planning.

OMB Number: 3045-0047.

Agency Number: None.

Affected Public: Nonprofit organizations, State, Local and Tribal.

Total Respondents: 654.

Frequency: Annually.

Average Time per Response: 24 hours.

Estimated Total Burden Hours: 15,696 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

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

In accordance with section 2330a of title 10 United States Code, as amended by section 807 of the National Defense Authorization Act for Fiscal Year 2008, the Office of the Deputy Director, Defense Procurement and Acquisition Policy, Contract Policy and International Contracting (DPAP/CPIC) will make available to the public the annual inventory of contracts for services. The inventory will be posted to the Defense Procurement and Acquisition Policy Web site at http://www.acq.osd.mil/dpap/cpic/cp/acquisition_of_services_policy.html.

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: Generic Application Package for Discretionary Grant Programs.

OMB Control Number: 1894-0006.

Agency Form Number(s): N/A.

Frequency of Responses: New Awards.

Affected Public: Business or other for-profits; Individuals or households; not-for-profit institutions; private sector; State, Local or Tribal Governments.

Total Estimated Number of Annual Responses: 9,836.

Total Estimated Annual Burden Hours: 446,089.

Abstract: The Department of Education (ED) is requesting an extension of the approval for the Generic Application Package that numerous ED discretionary grant programs use to provide applicants the generic forms and information needed to apply for new grants under those grant program competitions.

ED will use this Generic Application package for discretionary grant programs that: (1) Use the standard ED or Federal-wide grant application forms that have been cleared separately through OMB and (2) use selection criteria from the Education Department General Administrative Regulations (EDGAR); statutory selection criteria or a combination of EDGAR and statutory selection criteria authorized under EDGAR, 34 CFR 75.200. The use of the standard ED grant application forms and the use of EDGAR and/or statutory selection criteria promote the standardization and streamlining of ED discretionary grant application packages.

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 4652. 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 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: DC School Choice Incentive Program.

OMB Control Number: 1855-0015.

Agency Form Number(s): N/A.

Frequency of Responses: Annually.

Affected Public: Individuals or households; not-for-profit institutions.

Total Estimated Number of Annual Responses: 3,000.

Total Estimated Annual Burden Hours: 1,000.

Abstract: The DC School Choice Incentive Program, authorized by the Consolidated Appropriations Act of 2004, awarded a grant to the DC Children and Youth Investment Trust Corporation that will administer scholarships to students who reside in the District of Columbia and come from households whose incomes do not exceed 185% of the poverty line. Priority is given to students who are currently attending schools in need of improvement, as defined by Title I. To assist in the student selection and assignment process, the information to be collected will be used to determine the eligibility of those students who are interested in the available scholarships. Also, since the authorizing statute requires an evaluation we are proposing to collect certain family demographic information because they are important predictors of school success. Finally, we are asking to collect information about parental participation and satisfaction because these are key topics that the statute requires the evaluation to address.

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 4710. 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.

This information collection request contains: (1) OMB No.: New; (2) Information Collection Request Title: Detailed Budget Justification; (3) Type of Request: New collection; (4) Purpose: This collection of information is necessary in order for DOE to identify allowable, allocable, and reasonable recipient project costs submitted by applicants to Grants and Cooperative Agreements under EERE programs; (5) Annual Estimated Number of Respondents: 406; (6) Annual Estimated Number of Total Responses: 406; (7) Annual Estimated Number of Burden Hours: 3 hours, one response; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: This collection of information does not necessitate any additional reporting or recordkeeping. The estimated cost for the one time response is $109.47.

Purpose of the Meeting: The Committee provides advice to the Director, Office of Science, on the many complex scientific and technical issues that arise in the development and implementation of the Biological and Environmental Research Program.

Tentative Agenda:

• Report from the Office of Biological and Environmental Research

• News from the Biological Systems Science and Climate and Environmental Sciences Divisions

• Discussions on the Biological Systems Science Division Committee of Visitors

• Workshop Reports

• New Business

• Public Comment

Public Participation: The BERAC meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact David Thomassen at the address or telephone number listed above. You must make your request for an oral statement at least five business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

Minutes: The minutes of this meeting will be available for public review and copying within 45 days at the BERAC Web site: http://science.energy.gov/ber/berac/meetings/berac-minutes/.

This action is directed to the public in general. Although this action may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under TSCA, FFDCA, or FIFRA, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at the estimate.

vi. Provide specific examples to illustrate your concerns and suggested alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA is announcing the availability of the draft test guidelines for Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents:

1. Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy Data Recommendations (OCSPP Guideline 810.2400).

2. Air Sanitizers—Efficacy Data Recommendations (OCSPP Guideline 810.2500).

3. Disinfectants for Use in Water—Efficacy Data Recommendations (OCSPP Guideline 810.2600).

These draft test guidelines address efficacy testing for antimicrobial agents intended to be used on hard, inanimate, environmental surfaces; in the air; and in water, and which bear label claims as disinfectants and/or sanitizers. Data from these studies are used to support the labeling claims for public health related antimicrobial agents.

As a guidance document, the test guidelines are not binding on either EPA or any outside parties. At places in this guidance, the Agency uses the word “should.” In this guidance, use of “should” with regard to an action means that the action is recommended rather than mandatory. The procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guideline, but EPA recognizes that departures may be appropriate in specific situations. EPA will consider alternatives to the recommendations described in the test guidelines on a case-by-case basis, after assessing whether the alternative will provide the data necessary to inform the regulatory decision that must be made.

The product performance guidelines for antimicrobial agents were last updated in 1982 under the “Pesticide Assessment Guidelines—Subdivision G, Product Performance.” Since then, the Agency has presented several issues at two separate meetings of the FIFRA SAP related to the conduct of studies for antimicrobial agents (the first meeting September 9-10, 1997, announced in the Federal Register issue of July 14, 1997 (62 FR 37584) (FRL-5731-4) and the second meeting July 17-19, 2007, announced in the Federal Register issue of March 14, 2007 (72 FR 11867) (FRL-8118-7)). Information and recommendations regarding these two SAPs can be found at the Office of Science and Coordination's Web site: http://www.epa.gov/scipoly/sap/index.htm. In addition to formatting changes to incorporate the guidelines into the OCSPP test guideline 810 series, EPA has added sections that incorporate new guidelines and clarifications from other guidance documents, and comments from the regulated industry. In particular, the waiver for the submission of efficacy data for air sanitizers that contain at least 5% glycol has been rescinded. Altogether, these draft test guidelines, once final, will represent the Agency's current recommendations for conducting studies to support antimicrobial pesticide label claims.

On October 8, 2008, EPA published in the Federal Register a proposed rule entitled “Data Requirements for Antimicrobial Pesticides” (73 FR 59382). Proposed 40 CFR 158.2220 contains a table entitled “Antimicrobial Product Performance Data Requirements,” which referenced under the “Guideline Number” column the 91 series of test guidelines. EPA's intention is to replace the 91 series test guideline designations with the appropriate 810 series test guideline designations. Therefore, at the time of the publication of the final rule, appropriate references to the 810 series test guideline numbers and names will be incorporated into the final rule.

This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA requires EPA to provide an explanation to Congress, through OMB, when the Agency decides not to use available and applicable voluntary consensus standards when NTTAA directs the Agency to do so.

These test guidelines represent an Agency effort to harmonize the test guidelines within OCSPP, as well as to harmonize the OCSPP test guidelines with those of OECD. The process for developing and amending these test guidelines, which began in 1991, includes public participation and the extensive involvement of the scientific community, including peer review by SAP and the SAB and other expert scientific organizations.

In the future, these test guidelines could be incorporated into regulatory actions taken by EPA under TSCA, i.e., with regard to the TSCA section 4 testing program. Although, NTTAA requirements do not specifically apply to the issuance of these particular test guidelines, EPA invites your comment on whether or not there are any voluntary consensus standards that should be considered during the development of the final test guidelines or any future regulatory action that may be taken under TSCA. Future regulatory actions under TSCA section 4 may involve notice and comment rulemaking or negotiated voluntary testing enforcement consent agreements/orders/decrees. Nevertheless, However, the Agency is interested in whether or not there are any voluntary consensus standards that EPA should consider either as part of the development of the final test guidelines themselves or in lieu of these final test guidelines when the Agency develops any future regulatory action that incorporates these test guidelines. Any comments provided will assist the Agency in complying with NTTAA by facilitating the Agency's identification of voluntary consensus standards that should be addressed in the test guideline or considered during the development of a proposed regulatory action that incorporates any standards included in the final test guidelines. Please submit your comments as directed under ADDRESSES .

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). If you are commenting on a docket that addresses multiple products, please indicate to which registration number(s) your comment applies.

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA received applications as follows to register pesticide products containing currently registered active ingredients pursuant to the provisions of section 3(c) of FIFRA, and is publishing this Notice of such applications pursuant to section 3(c)(4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications.

1. Registration Numbers: 100-815 and 100-816. Docket Number: EPA-HQ-OPP-2011-0657. Company Name and Address: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active Ingredient: S-metolachlor. Proposed Uses: Cilantro and beet, garden, leaves. Contact: Michael Walsh, Registration Division, (703) 308-2972, walsh.michael@epa.gov.

2 . Registration Numbers: 66330-45 and 66330-46. Docket Number: EPA-HQ-OPP-2011-0641. Company Name and Address: Arysta LifeScience North America LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. Active Ingredient: Amicarbazone. Proposed Use: Turf. Contact: Michael Walsh, Registration Division, (703) 308-2972, walsh.michael@epa.gov.

3. Registration Numbers: 62719-73, 62719-80, 62719-81, and 62719-84. Docket Number: EPA-HQ-OPP-2011-0569. Company Name and Address: Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. Active Ingredient: Clopyralid. Proposed Uses: Apple, Leafy Brassica Subgroup 5B, and Rapeseed Subgroup 20A. Contact: Michael Walsh, Registration Division, (703) 308-2972, walsh.michael@epa.gov.

4 . Registration Numbers: 100-1098 and 100-1120. Docket Number: EPA-HQ-OPP-2011-0398. Company Name and Address: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active Ingredient: Azoxystrobin. Proposed Uses: Post-harvest uses on potatoes, and crop group expansions for bulb vegetables 3-07A and 3-07B; caneberries 13-07A; bushberries 13-07B; small fruit vine climbing 13-07F, except fuzzy kiwifruit; low growing berry 13-07G, except cranberry; low growing berry 13-07H, except strawberry; citrus crop group 10-10; and fruiting vegetable crop group 8-10; dragon fruit as part of tropical fruits; wasabi as part of crop group 19; and oilseed crop group 20. Contact: Heather Garvie, Registration Division, (703) 308-0034, garvie.heather@epa.gov.

5 . Registration Number: 100-1178. Docket Number: EPA-HQ-OPP-2011-0398. Company Name and Address: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active Ingredients: Azoxystrobin and propiconazole. Proposed Uses: Beans, dry and succulent; and crop group expansions for caneberry, subgroup 13-07A; bushberry subgroup 13-07B; and bulb vegetable, crop group 3-07. Contact: Heather Garvie, Registration Division, (703) 308-0034, garvie.heather@epa.gov.

6 . Registration Number: 100-1308. Docket Number: EPA-HQ-OPP-2011-0398. Company Name and Address: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active Ingredients: Azoxystrobin and fludioxonil. Proposed Use: Crop group expansion on citrus crop group 10-10. Contact: Heather Garvie, Registration Division, (703) 308-0034, garvie.heather@epa.gov.

7 . Registration Number: 100-1313. Docket Number: EPA-HQ-OPP-2011-0398. Company Name and Address: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active Ingredients: Azoxystrobin and difenoconazole. Proposed Uses: Crop group expansions for citrus fruits, crop group 10-10; small fruit vine climbing 13-07F, except fuzzy kiwifruit; low growing berry subgroup 13-07G, except cranberry; bulb vegetable, crop group 3-07 and fruiting vegetable, crop group 8-10. Contact: Heather Garvie, Registration Division, (703) 308-0034, garvie.heather@epa.gov.

8. Registration Number: 100-1324. Docket Number: EPA-HQ-OPP-2011-0398. Company Name and Address: Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, NC 27419. Active Ingredients: Azoxystrobin and propiconazole. Proposed Uses: Beans, dry and succulent; and crop group expansions for caneberry, subgroup 13-07A; bushberry subgroup 13-07B; low growing berry subgroup 13-07G, except cranberry; and bulb onion subgroup 3-07A and green onion subgroup 3-07B. Contact: Heather Garvie, Registration Division, (703) 308-0034, garvie.heather@epa.gov.

9. File Symbol: 499-LLT. Docket Number: EPA-HQ-OPP-2011-0575. Company Name and Address: Whitmire Micro-Gen Research Laboratories, Inc., 3568 Tree Court Industrial Blvd., Saint Louis, MO 63122. Active Ingredient: Novaluron. Proposed Use: For control of termites. Contact: Jennifer Gaines, Registration Division, (703) 305-5967, gaines.jennifer@epa.gov.

10 . File Symbols: 66222-EGE and 66222-EGR. Docket Number: EPA-HQ-OPP-2011-0576. Company Name and Address: Makhteshim Agan of North America, Inc., 4515 Falls of Neuse Road, Suite 300, Raleigh, NC 27609. Active Ingredient: Novaluron. Proposed Use: For control of mosquito larvae. Contact: Jennifer Gaines, Registration Division, (703) 305-5967, gaines.jennifer@epa.gov.

11. Registration Numbers: 66330-64 and 66330-65. Docket Number: EPA-HQ-OPP-2009-0677. Company Name and Address: Arysta LifeScience, North America LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. Active Ingredient: Fluoxastrobin. Proposed Use: Rice grain. Contact: Heather Garvie, Registration Division, (703) 308-0034, garvie.heather@epa.gov.

12. File Symbol: 85685-E. Docket Number: EPA-HQ-OPP-2011-0664. Company Name and Address: FourStar Microbial Products LLC, 3330 Noyac Road, Bldg. E, Sag Harbor, NY 11963. Active Ingredients: Bacillus thuringiensis subspecies israelensis strain BMP 144 solids, spores and insecticidal toxins and Bacillus sphaericus. Proposed Use: Standing waters to control mosquitos. Contact: Kathleen Martin, Biopesticide and Pollution Prevention Division, (703) 308-2857, martin.kathleen@epa.gov.

13. File Symbol: 87766-R. Docket Number: EPA-HQ-OPP-2011-0630. Company Name and Address: Trifecta LLC, P.O. Box 9825, Fayetteville, AR 72703. Active Ingredient: Carbon dioxide (CO 2 ). Proposed Use: For control of fire ants. Contact: Gene Benbow, Registration Division, (703) 347-0235, benbow.gene@epa.gov.

14. File Symbol: 87942-R. Docket Number: EPA-HQ-OPP-2011-0629. Company Name and Address: Rentokil Initial plc, 33 Chicago Avenue, Oak Park, IL 60302. Active Ingredient: Carbon dioxide (CO 2 ). Proposed Uses: For control of Norway rats, roof rats, and house mice. Contact: Gene Benbow, Registration Division, (703) 347-0235, benbow.gene@epa.gov.

Background

On June 15, 1984, the OMB delegated to the Board its approval authority under the PRA, pursuant to 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR Part 1320 Appendix A.1. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Board may not conduct or sponsor, and a respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The following information collections, which are being handled under OMB delegated authority, have received initial Board approval and are hereby published for comment. After the comment deadline, the proposed information collections, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under this delegated authority. The Board requests comment on all aspects of the proposed surveys, as discussed further below, including the following:

a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;

b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected; and

d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

1. Report title: Government-administered, General-use Prepaid Card Surveys. 1

Agency form number: FR 3063a and FR 3063b.

OMB control number: 7100- to be assigned.

Frequency: Annual.

Reporters: Issuers of government-administered, general-use prepaid cards (FR 3063a) and state governments that administer general-use prepaid cards (FR 3063b).

Estimated annual reporting hours: FR 3063a: 1,000 hours; FR 3063b: 900 hours.

Estimated average hours per response: FR 3063a: 50 hours; FR 3063b: 15 hours.

Number of respondents: FR 3063a: 20; FR 3063b: 60.

General description of report: These information collections are authorized by section 920(a) of the EFTA, which was added by section 1075(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). 15 U.S.C. 1693o-2. EFTA Section 920(a) requires the Board to submit an annual report to the Congress on the prevalence of the use of general-use prepaid cards in federal, state, or local government-administered payment programs and the interchange transaction fees and card-holder fees charged with respect to the use of such general-use prepaid cards. 15 U.S.C. 1693o-2(a)(7)(D). EFTA Section 920(a) also provides the Board with authority to require issuers to provide information to enable the Board to carry out the provisions of EFTA Section 920(a). 15 U.S.C. 1693o-2(a)(3)(B).

The obligation of issuers to respond to the issuer survey (FR 3063a) is mandatory. Some of the data collected by FR 3063a may be kept confidential under exemption (b)(4) of the Freedom of Information Act (FOIA), which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” 5 U.S.C. 552(b)(4). Information collected under FR 3063a can be kept confidential under exemption (b)(4) if the release of data would cause substantial harm to the competitive position of the issuer.

The obligation of state governments to respond to the government survey (FR 3063b) is voluntary. The Board anticipates that all of the information collected by FR 3063b would be publicly available information and would not be given confidential treatment.

The Board specifically requests comment on the following:

a. What information collected by the issuer survey (FR 3063a) would consist of trade secrets or commercial or financial information;

b. Whether information collected by the government survey (FR 3063b) is publicly available information; and

c. Whether there are issuers of government-administered, general-use prepaid cards that are not depository institutions, and, if so, should the depository institution holding the insured deposits underlying the cards be required to report on behalf of those issuers.

Abstract: Section 920 of the EFTA provides that the Board shall provide annually a report to the Congress regarding the prevalence of the use of general-use prepaid cards in federal, state, and local government-administered payment programs, and the interchange and cardholder fees charged with respect to this use. Section 920(a) also provides the Board with authority to require card issuers to respond to information requests as may be necessary to carry out the provisions of the section.

On March 24, 2011, the Board distributed two surveys to industry participants (a depository institution survey and a state government survey) designed to assist the Board in meeting the reporting requirements in section 920(a) related to the prevalence of the use of general-use prepaid cards in federal, state, or local government-administered payment programs and associated fees. 2 In response to comments and survey submissions from issuers and governments, the Board developed the FR 3063a and 3063b surveys, as described below, which would replace the surveys distributed in March 2011.

Current Actions: The Board proposes to implement the issuer survey (FR 3063a) and the government survey (FR 3063b). Responding to the issuer survey (FR 3063a) would be required for approximately 20 depository institutions that issue general-use prepaid cards for federal, state, or local government-administered payment programs. The survey would request information on cards associated with accounts domiciled in the United States, District of Columbia, and U.S. territories. 3

In general, the issuer survey (FR 3063a) would collect information separately for each government-administered program for which the depository institution is the issuer of general-use prepaid cards as well as in the aggregate for all programs. The issuer survey would collect information on card programs using two types of authentication mechanisms: dual-message transactions (those generally requiring a signature) and single-message transactions (those generally requiring the input of a personal identification number (PIN)). 4 The first reporting period would cover the calendar year 2011, collected as of December 31, 2011.

The Board specifically requests comment on the following:

a. The best terms to use in identifying types of authentication mechanisms (single-message and dual-message versus PIN and signature) given that not all dual-message transactions require a signature and not all single-message transactions require a PIN.

The issuer survey would comprise 10 sections:

I. Respondent Information: Respondents would provide the name of the card issuer covered in the response; and the contact person(s) name, survey section for which they are responsible, e-mail, and phone number.

II. Card program information: Respondents would report summary information on card programs covered in the response, whether the response covers federal, state, or local programs, jurisdiction, 5 sponsoring government agency(ies), a description of payment type, recipients receiving payments on prepaid cards, and recipients receiving payments by all payment methods.

The Board specifically requests comment on the following:

a. The ability of issuers to provide the total number of recipients receiving payments, regardless of payment method.

III. Government-Administered Prepaid Cards: Respondents would report summary information on the number of cards outstanding, and the allocation of cards outstanding between cards that can be used on both dual-message (signature) and single-message (PIN) networks.

IV. Funding: Respondents would report the value of funds loaded into prepaid card accounts, funds outstanding on prepaid card accounts, and all funds disbursed by all payment methods.

The Board specifically requests comment on the following:

a. The ability of issuers to provide the total value of all funds disbursed, regardless of payment method.

b. Whether any funding patterns during the month may change significantly an issuer's response depending on the as-of date requested. Note —The draft survey requests outstanding funds at the end of the month.

V. ATM Transactions: Respondents would report summary information on the number of cards outstanding at year-end that can be used to make ATM cash withdrawals, the volume and value of ATM cash withdrawals, and the ATM fees charged for withdrawals by ATM operators at nonproprietary ATMs.

VI. Purchase Transactions: Respondents would report summary information on the volume and value of settled purchase transactions and the volume and value of settled purchase transactions for dual-message (signature) transactions and single-message (PIN) transactions.

VII. Interchange Fees: Respondents would report interchange fee revenues received on settled purchase transactions and the allocation of the interchange fee revenues received on settled purchase transactions  6 for dual-message (signature) transactions and single-message (PIN) transactions.

VIII. Fees Paid by Issuers: Respondents would report the fees paid on nonproprietary ATM cash withdrawals and the fees paid on over-the-counter cash withdrawals at other banks' teller stations.

The Board specifically requests comment on the following:

a. Whether fees paid for over-the-counter at-bank (teller) cash withdrawals should be included in the survey.

IX. Revenues From Cardholder Fees: Respondents would provide total revenues received on all fees charged to cardholders and the allocation of all fees charged to cardholders between routine purchase transaction fees, monthly fees, balance inquiry fees, ATM fees, over-the-counter at-bank (teller) fees, account servicing fees, penalty fees, and all other fees.

X. Fees Assessed to Cardholders: Respondents would provide summary information on fees assessed to cardholders by the issuer, including routine purchase transaction fees, monthly fees, balance inquiry fees, ATM fees charged to cardholders, over-the-counter at-bank (teller) fees, account servicing fees, penalty fees, and all other fees.

Responding to the government survey (FR 3063b) would be voluntary for approximately 60 government entities, including the states, the District of Columbia, and U.S. territories (collectively “state governments”). The survey would collect information about the prevalence of use of general-use prepaid cards in federal, state, and local government-administered payment programs. 7 The first reporting period would cover the calendar year 2011, collected as of December 31, 2011.

The government survey would comprise four sections:

I. Respondent Information: Respondents would identify the government agency (including federal, state or other jurisdiction) for which they are responding; and provide the contact person(s) name, survey section for which they are responsible, e-mail, and phone number.

II. Program information: Respondents would report summary information on card programs covered in the response, whether the response covers a federal, state, or local program, sponsoring government agency(ies), card-issuer(s), a description of payment type, the number of recipients receiving payments on prepaid cards, and the number of recipients receiving payments by all payment methods.

III. Cards: Respondents would report the number of cards outstanding.

IV. Funding: Respondents would report the value of funds loaded into prepaid card accounts and the value of all funds paid by all payment methods.

The issuer survey (FR 3063a) and the government survey (FR 3063b) would be made available online by mid-February 2012 and would request that the surveys be completed and returned to the Board within 30 calendar days.

The Board specifically requests comment on the following:

a. Whether 30 calendar days allows sufficient time for respondents to complete the proposed surveys.

2. Report title: Interchange Transaction Fees Surveys. 8

Agency form number: FR 3064a and FR 3064b.

OMB control number: 7100—to be assigned.

Frequency: FR 3064a—Biennial; FR 3064b—Annual.

Reporters: Issuers of debit cards (FR 3064a) and payment card networks (FR 3064b).

Estimated annual reporting hours: FR 3064a: 46,400 hours; FR 3064b: 425 hours.

Estimated average hours per response: FR 3064a: 80 hours; FR 3064b: 25 hours.

Number of respondents: FR 3064a: 580; FR 3064b: 17.

General description of report: These information collections are authorized by section 920(a) of the EFTA, which was added by section 1075(a) of the Dodd-Frank Act. 15 U.S.C. 1693o-2. This section requires the Board to (on a biennial basis) disclose aggregate or summary information concerning the costs incurred and interchange transactions fees charged or received, by issuers or payment card networks in connection with the authorization, clearance, or settlement of electronic debit transaction as the Board considers appropriate and in the public interest. 15 U.S.C. 1693o-2(a)(3)(B). It also provides the Board with authority to require issuers (or agents of issuers) and payment card networks to provide information to enable the Board to carry out the provisions of the section.

The obligation to respond to these surveys is mandatory. In accordance with the statutory requirement, the Board will release aggregate or summary information from the survey responses. Some of the data collected by the surveys may be kept confidential under exemption (b)(4) of FOIA, which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” 5 U.S.C. 552(b)(4). Information collected under the surveys can be kept confidential under exemption (b)(4) if the release of data would cause substantial harm to the competitive position of the respondent.

Abstract: Section 920(a)(3) of the EFTA provides that the Board shall at least on a biennial basis disclose aggregate or summary information concerning the costs incurred, and interchange transaction fees charged or received, by issuers or payment card networks in connection with debit card transactions. 15 U.S.C. 1693o-2(a)(3)(B). When the Board adopted Regulation II setting debit card interchange fee standards, the Board's rulemaking stated that information would be gathered from payment card networks annually regarding interchange fees that are received by covered and exempt issuers. 9

On September 13, 2010, the Board distributed three surveys to industry participants (a card issuer survey, a payment card network survey, and a merchant acquirer/processor survey) designed to gather information to assist the Board in developing Regulation II. Industry participants, including payment card networks, trade groups, and individual firms from both the banking industry and merchant community, commented on preliminary versions of the 2010 issuer and network surveys, through both written submissions and a series of drop-in calls. In response to the comments, the two surveys were modified, as appropriate. 10 The implementation of the FR 3064a and 3064b, as described below, would replace the 2010 surveys.

Current Actions: The Board proposes to implement the debit card issuer survey (FR 3064a) and the payment card network survey (FR 3064b). The debit card issuer survey would be required for each debit card issuer that, together with its affiliates, has assets of $10 billion or more. The survey would request information on accounts and cards associated with accounts domiciled in the United States, the District of Columbia, and U.S. territories. 11

The Board specifically requests comment on the following:

a. The feasibility of requiring each chartered entity that issues debit cards to complete a separate survey rather than requiring a holding company to complete one survey for all its chartered entities, as was done in the 2010 card issuer survey (12 CFR 235.8(b)).

In general, the debit card issuer survey (FR 3064a) would collect information on card programs that use two types of authentication mechanisms: Dual-message transactions (those generally requiring a signature) and single-message transactions (those generally requiring the input of a personal identification number (PIN)). Both programs include general-use prepaid card transactions. 12 The first reporting period would cover the calendar year 2011, collected as of December 31, 2011. If certain costs for a card program are shared with other card programs, respondents would be asked to allocate costs to a particular card program based on transaction volume.

The Board specifically requests comment on the following:

a. The best terms to use in identifying types of processing (single-message and dual-message versus PIN and signature) given that not all dual-message transactions require a signature and not all single-message transactions require a PIN.

b. Whether issuers should report general-use prepaid card data combined with other transaction data related to single- or dual-message systems (and if so, whether they would be able to do so) or should report general-use prepaid card activity separately.

The debit card issuer survey would comprise four sections:

I. Respondent Information: Respondents would provide the name of the debit card issuer covered in the response and the contact person(s) name, section of the survey for which they are responsible, e-mail, and phone number. Respondents also would report whether general-use prepaid cards are issued.

II. All Debit Card Transactions (including general-use prepaid card transactions): Respondents would report summary information for debit card (including general-use prepaid card) transaction volume and value; chargebacks to acquirers; costs of authorization, clearance, and settlement; payments and incentives paid by networks to issuers; costs for fraud prevention and data security; interchange fee revenue; fraudulent transactions; and fraud losses.

The Board specifically requests comment on the following:

a. Whether the guidance provided in the proposed survey is sufficient for issuers to report authorization, clearing, and settlement costs;

b. The usefulness of including a checklist of fraud prevention activities and, if so, which fraud prevention activities should be included in the checklist for the 2012 survey. If a checklist is provided in the survey, are the activities proposed in the draft survey (transaction monitoring, merchant blocking, data security, and PIN customization) the right categories or are other categories more meaningful? If a checklist is provided in the survey, the listed activities could be updated over time based on “other” activities reported.

c. The issuers' ability to allocate payments and incentives as specified and whether other major categories of payments and incentives should be included.

d. The issuers' ability to report the subset of customer service costs associated with customer inquiries regarding particular debit card transactions (as opposed to customer inquiries regarding the account, the debit card more generally, or credit cards/ATM cards).

III. All Single-Message (PIN) Debit Card Transactions (including general-use prepaid card transactions): Respondents would submit data for the same set of questions asked in Section II above, but specifically about single-message debit card programs, including general-use prepaid cards.

IV. All Dual-Message (Signature) Debit Card Transactions (including general-use prepaid card transactions): Respondents would submit data for the same set of questions asked in Section II above, but specifically about dual-message debit card programs, including general-use prepaid cards.

The payment card network survey (FR 3064b) would require payment card networks to submit information about debit card (including general-use prepaid card) transaction volume and value; interchange fees; other network fees; and incentives and discounts paid to acquirers, merchants, and issuers. 13 The first reporting period would cover the calendar year 2011, collected as of December 31, 2011.

The network survey would comprise two sections:  14

I. Respondent Information: Respondents would identify the network covered in the response and provide the contact person(s) name, section of the survey for which they are responsible, e-mail, and phone number. Respondents also would report whether the payment card network is a single-message (PIN) or dual-message (signature) network, whether the payment card network offers a tiered interchange fee rate schedule that differentiates between exempt issuers and non-exempt issuers, and the number of merchant locations that accept debit cards whose transactions can be processed by the payment card network.

II. Debit Card Transactions (including general-use prepaid card transactions): Respondents would report the volume and value of settled purchase transactions; as well as information related to card-present versus card-not-present transactions; general-use prepaid card versus non-general-use prepaid card transactions; general-use prepaid card transactions exempt from the interchange fee standards in Regulation II versus general-use prepaid card transactions that are not exempt; transactions processed for small issuers that are exempt from the interchange fee standards versus those processed for non-exempt issuers; pre- and post-effective date transactions processed for exempt and non-exempt debit card issuers; chargebacks and returns to merchants; the value of interchange fees; the value of network fees; and payments and incentives paid by networks to acquirers, merchants, and issuers.

The Board specifically requests comment on the following:

a. The payment card networks' ability to identify separately general-use prepaid card transactions from other debit card transactions.

b. Whether the networks can provide data for exempt and non-exempt issuers that compares information for three time periods: January 1 to June 30, 2011 (during which all transactions would be considered exempt); July 1 to September 30, 2011 (during which all transactions could be considered exempt, but some networks may begin to distinguish between exempt and non-exempt issuers, if such networks are offering a tiered interchange fee schedule); and October 1, 2011 to December 31, 2011 (during which all networks that provide a tiered interchange fee schedule would distinguish between exempt and non-exempt issuers).

The Board would make the payment card network survey available online by mid-January 2012 and would request that the survey be completed and submitted to the Board within 30 calendar days. The debit card issuer survey would be made available by mid-February 2012 and would request that the survey be completed and submitted to the Board within 60 calendar days. 15

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and §2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 8, 2011), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-2222.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 10, 2011. Write “DERMAPPS, File No. 102 3205” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). 1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/acneappconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that website.

If you file your comment on paper, write “DERMAPPS, File No. 102 3205” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before October 10, 2011. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Kobe Brown and Gregory W. Pearson, dba DERMAPPS (“respondents”).

The proposed consent order (“proposed order”) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

This matter involves the advertising of a mobile software application (“app”) called AcneApp which respondents developed and sold in Apple's iTunes Store. Respondents claimed that AcneApp effectively treats acne. The instructions for this app directed consumers to hold the light-emitting display screen next to the area of skin to be treated for several minutes each day.

The Commission's complaint alleges that respondents violated Sections 5 and 12 of the FTC Act by claiming, without substantiation, that the app provided an effective treatment for acne. The complaint also alleges that the respondents falsely represented that a study published in the British Journal of Dermatology proves that blue and red light therapy, such as that provided by AcneApp, is an effective treatment for acne.

The proposed consent order contains provisions designed to prevent respondents from engaging in similar practices in the future. Part I of the order prohibits respondents from making any representation that AcneApp, or any other device, as defined by Section 15 of the FTC Act, provides effective treatment for acne, unless respondents have competent and reliable scientific evidence to substantiate that claim.

Part II of the order requires respondents to have competent and reliable scientific evidence before making any safety, performance, benefits, or efficacy claim about any device.

Part III of the order is a standard order provision relating to establishment claims, prohibiting the misrepresentation of any research, tests, or studies.

Part IV of the order requires respondents, within 15 days of the order, to pay the Commission $14,294.

The remaining parts of the proposed order are standard provisions regarding record-keeping, dissemination of the order to officers and employees, prior notification to the Commission of corporate changes, notification of new employment, filing compliance of reports, and sunsetting of the order.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 USC 46(f), and § 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 8, 2011), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling (202) 326-2222.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 10, 2011. Write “Andrew N. Finkel, File No. 102 3206” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). 1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/acnepwnerconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

If you file your comment on paper, write “Andrew N. Finkel, File No. 102 3206” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before October 10, 2011. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Andrew N. Finkel (“respondent”).

The proposed consent order (“proposed order”) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

This matter involves the advertising of a mobile software application (“app”) called Acne Pwner which respondent developed and sold in Google's Android Marketplace. Respondent claimed that Acne Pwner effectively treats acne. The instructions for this app directed consumers to hold the light-emitting display screen next to the area of skin to be treated for a few minutes each day.

The Commission's complaint alleges that respondent violated Sections 5 and 12 of the FTC Act by claiming, without substantiation, that the app provided an effective treatment for acne.

The proposed consent order contains provisions designed to prevent respondent from engaging in similar practices in the future. Part I of the order prohibits respondent from making any representation that Acne Pwner, or any other device as defined by Section 15 of the FTC Act, provides effective treatment for acne, unless respondent has competent and reliable scientific evidence to substantiate that claim.

Part II of the order requires respondent to have competent and reliable scientific evidence before making any safety, performance, benefits, or efficacy claim about any device.

Part III of the order requires respondent, within 15 days of the date the order becomes final, to pay the Commission $1,700.

The remaining parts of the proposed order are standard provisions regarding recordkeeping, dissemination of the order to officers and employees, prior notification to the Commission of corporate changes, notification of new employment, filing of compliance reports, and sunsetting of the order.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

Subject of Challenge Competition: ONC, in collaboration with the Partnership for Patients, seeks to stimulate innovative approaches to care transitions and improving patient safety. Nearly one in five patients discharged from a hospital will be readmitted within 30 days. A large proportion of readmissions can be prevented by improving communications and coordinating care before and after discharge. The Centers for Medicare and Medicaid Services (CMS) provides a discharge checklist to help patients and their caregivers prepare to leave a hospital, nursing home, or other care setting. Research has shown that empowering patients and caregivers with information and tools to manage the next steps in their care more confidently is a very effective way to reduce errors, decrease complications, and prevent a return visit to the hospital. ONC is challenging software developers to improve care transitions and build upon these tools by generating an intuitive and easy-to-use application to empower patients and caregivers that leverages NwHIN standards and services.

Eligibility Rules for Participating in the Competition:

To be eligible to win a prize under this challenge, an individual or entity:

(1) Shall have registered to participate in the competition under the rules promulgated by Office of the National Coordinator for Health Information Technology;

(2) Shall have complied with all the requirements under this section;

(3) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and

(4) May not be a Federal entity or Federal employee acting within the scope of their employment.

An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

Registered participants shall be required to agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a competition, whether the injury, death, damage, or loss arises through negligence or otherwise.

Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the head of the Office of the National Coordinator for Health Information Technology, for claims by—

(1) A third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered participant's insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and

(2) the Federal Government for damage or loss to Government property resulting from such an activity.

Participants must be teams of at least two people.

All participants are required to provide written consent to the rules upon or before submitting an entry.

Dates:

• Submission Period Begins: 12:01 a.m., E.D.T., September 12, 2011.

• Submission Period Ends: 11:59 p.m., E.D.T., November 16, 2011.

Registration Process for Participants:

To register for this challenge participants should:

• Access the http://www.challenge.gov Web site and search for the “Ensuring Safe Transitions from Hospital to Home”.

• Access the ONC Investing in Innovation (i2) Challenge Web site at:

○ http://www.health2challenge.org/category/onc/

○ A registration link for the challenge can be found on the landing page under the challenge description.

Amount of the Prize:

• First Prize: $25,000.

• Second Prize: $10,000.

• Third Prize: $5,000.

Awards may be subject to Federal income taxes and HHS will comply with IRS withholding and reporting requirements, where applicable.

Basis Upon Which Winner Will Be Selected:

The judging panel will make selections based upon the following criteria:

1. Innovation.

2. Usability/Design.

3. Potential for impact.

4. Data integration.

5. Use of NwHIN standards and services.

Additional Information:

Ownership of intellectual property is determined by the following:

• Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement.

• By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty free, worldwide, license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

Subject of Challenge Competition: The “Reporting Device Adverse Events Challenge” asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. The application would make it easy for patients to report adverse events to their provider, support the download of information from EMR or PHR systems to populate the adverse event report and provide high quality data, capture useful information including patient demographics and device data that is easily accessible to all stakeholders (patients, providers, manufacturers, and researchers) using current technologies including PC-based browsers, mobile phones, and tablets, and leverage NwHIN standards and services including transport, content, and vocabularies.

Eligibility Rules for Participating in the Competition :

To be eligible to win a prize under this challenge, an individual or entity:

(1) Shall have registered to participate in the competition under the rules promulgated by Office of the National Coordinator for Health Information Technology;

(2) Shall have complied with all the requirements under this section;

(3) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and

(4) May not be a Federal entity or Federal employee acting within the scope of their employment.

An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

Registered participants shall be required to agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a competition, whether the injury, death, damage, or loss arises through negligence or otherwise.

Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the head of the Office of the National Coordinator for Health Information Technology, for claims by—

(1) A third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered participant's insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and

(2) the Federal Government for damage or loss to Government property resulting from such an activity.

Participants must be teams of at least two people.

All participants are required to provide written consent to the rules upon or before submitting an entry.

Dates:

• Submission Period Begins: 12:01 a.m., E.D.T., September 12, 2011.

• Submission Period Ends: 11:59 p.m., E.D.T., December 2, 2011.

Registration Process for Participants:

To register for this challenge participants should:

• Access the http://www.challenge.gov Web site and search for the “Reporting Device Adverse Events Challenge”.

• Access the ONC Investing in Innovation (i2) Challenge Web site at:

○ http://www.health2challenge.org/category/onc/.

○ A registration link for the challenge can be found on the landing page under the challenge description.

Amount of the Prize:

• First Prize: $25,000.

• Second Prize: $10,000.

• Third Prize: $5,000.

Awards may be subject to Federal income taxes and HHS will comply with IRS withholding and reporting requirements, where applicable.

Basis Upon Which Winner Will Be Selected:

The judging panel will make selections based upon the following criteria:

1. Effectiveness in facilitating adverse event reporting.

2. Usability and design.

3. Ability to integrate with electronic health records and other data sources.

4. Creativity and Innovation.

5. Use of NwHIN standards and services.

Additional Information:

Ownership of intellectual property is determined by the following:

• Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement.

• By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty free, worldwide, license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program is a multi-year initiative. AHRQ first launched the program in October 1995 in response to concerns about the lack of good information about the quality of health plans from the enrollees' perspective. Numerous public and private organizations collected information on enrollee and patient satisfaction, but the surveys varied from sponsor to sponsor and often changed from year to year. The CAHPS® program was designed to:

• Make it possible to compare survey results across sponsors and over time; and

• Generate tools and resources that sponsors can use to produce understandable and usable comparative information for consumers, health providers and for quality improvement purposes.

Over time, the program has expanded beyond its original focus on health plans to address a range of health care services and to meet the various needs of health care consumers, purchasers, health plans, providers, and policymakers. Based on a literature review and an assessment of currently available questionnaires, AHRQ identified the need to develop a health literacy module for the CAHPS® Health Plan Survey. The intent of the health literacy module is to examine health plan enrollees' perspectives on how well health information is communicated to them by health plans and by healthcare professionals in the health plan setting. The objective of the new module is to provide information to health plans, clinicians, group practices, and other interested parties regarding the quality of health information delivered to patients. The health literacy module will be pre-tested as a supplement to the CAHPS® Health Plan Survey.

This pre-test has the following goals:

(1) Analysis of item wording—Assess candidate wordings for items.

(2) Analysis of participation rate—Evaluate the overall response rate and the proportion of that obtained from mail versus telephone modes of data collection.

(3) Case mix adjustment analysis—Evaluate variables that need to be considered for case mix adjustment of scores.

(4) Psychometric Analysis—Provide information for the revision of the health literacy item set based on the assessment of the reliability and validity.

(5) Dissemination of the CAHPS Health Plan Health Literacy supplemental item set.

This study is being conducted by AHRQ through its contractor, the RAND Corporation, pursuant to AHRQ's statutory authority to conduct research and evaluations on health care and systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services. See 42 U.S.C. 299a(a)(1).

To achieve the goals of this pre-test the CAHPS Health Plan Health Literacy Survey will be implemented with a sample of persons from the surveys' target population, consumers of health care services offered by health plans. The data from this pre-test will be used to refine the health literacy module questions and will ensure that the future data collection yield high quality data and ensure a minimization of respondent burden, increase agency efficiency, and improve responsiveness to the public. The survey items will be added to currently available CAHPS surveys and will enhance the ability of health plans and health professionals working in a health plan primary care setting to assess the quality of their services.

Exhibit 1 shows the estimated annualized burden for the respondents' time to participate in this data collection. About 1000 persons will complete the CAHPS Health Plan Survey Health Literacy Module. The estimated response time of 25 minutes is based on the written length of the survey and AHRQ's experience with previous CAHPS® surveys of comparable length that were fielded with similar samples. The total burden hours are estimated to be 417 hours.

Exhibit 2 shows the respondents' cost burden associated with their time to participate in this data collection. The total cost burden is estimated to be $8,715.

Exhibit 3 shows the total and annualized cost to conduct this research. The total cost for this project is approximately $299,000. Since the data collection period is less than one year, the total and annualized costs are identical.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Employer-sponsored health insurance is the source of coverage for 85 million current and former workers, plus many of their family members, and is a cornerstone of the U.S. health care system. The Medical Expenditure Panel Survey—Insurance Component (MEPS-IC) measures the extent, cost, and coverage of employer-sponsored health insurance on an annual basis. These statistics are produced at the National, State, and sub-State (metropolitan area) level for private industry. Statistics are also produced for State and Local governments.

This research has the following goals:

(1) To provide data for Federal policymakers evaluating the effects of National and State health care reforms;

(2) to provide descriptive data on the current employer-sponsored health insurance system and data for modeling the differential impacts of proposed health policy initiatives; and

(3) to supply critical State and National estimates of health insurance spending for the National Health Accounts and Gross Domestic Product.

This study is being conducted by AHRQ through an interagency agreement with the U.S. Census Bureau and pursuant to AHRQ's statutory authority to conduct surveys to collect data on the cost, use and quality of health care, including the types and costs of private health insurance. 42 U.S.C. 299b-2(a).

To achieve the goals of this project the following data collections for both private sector and state and local government employers will be implemented:

(1) Prescreener Questionnaire—The purpose of the Prescreener Questionnaire, which is collected via telephone, varies depending on the insurance status of the establishment contacted. (Establishment is defined as a single, physical location in the private sector and a governmental unit in state and local governments.) For establishments that do not offer health insurance to their employees, the prescreener is used to collect basic information such as number of employees. Collection is completed for these establishments through this telephone call. For establishments that do offer health insurance, contact name and address information is collected that is used for the mailout of the establishment and plan questionnaires. Obtaining this contact information helps ensure that the questionnaires are directed to the person in the establishment best equipped to complete them.

(2) Establishment Questionnaire—The purpose of the mailed Establishment Questionnaire is to obtain general information from employers that provide health insurance to their employees. Information such as total active enrollment in health insurance, other employee benefits, waiting periods, and retiree health insurance is collected through the establishment questionnaire.

(3) Plan Questionnaire—The purpose of the mailed Plan Questionnaire is to collect plan-specific information on each plan (up to four plans) offered by establishments that provide health insurance to their employees. This questionnaire obtains information on total premiums, employer and employee contributions to the premium, and plan enrollment for each type of coverage offered—single, employee-plus-one, and family—within a plan. It also asks for information on deductibles, copays, and other plan characteristics. This information is needed in order to provide the tools for Federal, State, and academic researchers to evaluate current and proposed health policies and to support the production of important statistical measures for other Federal agencies.

Exhibit 1 shows the estimated annualized burden hours for the respondent's time to provide the requested data. The Prescreener questionnaire will be completed by 31,552 respondents and takes about 5 1/2 minutes to complete. The Establishment questionnaire will be completed by 25,839 respondents and takes about 23 minutes to complete. The Plan questionnaire will be completed by 23,230 respondents and will require an average of 2.1 responses per respondent. Each Plan questionnaire takes about 11 minutes to complete. The total annualized burden hours are estimated to be 21,440 hours.

Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to participate in this data collection. The annualized cost burden is estimated to be $614,256.

Exhibit 3 shows the estimated annualized cost of this data collection. The total cost over the 2 years of this clearance is $22,954,000.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Research shows that excess sodium consumption is a contributory factor in the development of hypertension, which is a leading cause of heart disease and stroke (Ref. 1), the first and fourth leading causes of death in the United States, respectively (Ref. 2). Research also shows that the increase in blood pressure seen with aging, common to most Western countries, is not observed in populations that consume low sodium diets (Refs. 3 and 4) and that the U.S. population consumes far more sodium than recommended (Ref. 5 and 7). Moreover, dietary reduction of sodium can lower blood pressure as has been demonstrated in the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial (Ref. 6). Because over three-quarters of sodium in the diet of the U.S. population is added during manufacturing of foods and preparation of restaurant foods, reduction in sodium consumption in the United States involves reduction in the sodium content of food in the U.S. marketplace (Refs. 5 and 7).

In this document, we refer primarily to “sodium,” a component of sodium chloride, commonly known as “salt.” Most but not all sodium is added to food in the form of salt and we are interested in all sources of sodium added to foods. The comments, data, and evidence regarding sodium reduction obtained by the establishment of these dockets will provide important information about current and emerging practices and approaches designed to reduce excess sodium intake, primarily coming from salt.

According to national food survey data from the “What We Eat in America, National Health and Nutrition Examination Survey (NHANES) 2007-2008,” estimated average sodium intake from foods among persons in the United States aged 2 years or older is approximately 3,300 milligrams per day (mg/d) (excluding salt added at the table) (Ref. 8). Most of this sodium comes from salt used in the manufacture or preparation of foods (Ref. 9). In 2005, the IOM set a Tolerable Upper Intake Level (UL) for sodium at 2,300 mg/d and an Adequate Intake (AI) at 1,500 mg/d for those 9 to 50 years of age, including pregnant and lactating women (AIs are lower for those 0-8 years of age and for those over 50 years of age) (Ref. 1). The 2010 Dietary Guidelines for Americans recommendations are to “reduce daily sodium intake to less than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among persons who are 51 and older and those of any age who are African American or have hypertension, diabetes, or chronic kidney disease.” The 1,500 mg recommendation applies to about half of the U.S. population (Ref. 7). Current sodium intake is substantially higher than what has been recommended by scientific and public health agencies and organizations in recent years. The Centers for Disease Control and Prevention (CDC) reported in 2010 that over 80 percent of adults (≥20 years) recommended to consume less than 2,300 mg/d of sodium in fact consumed more than 2,300 mg/d (Ref. 10).

The 2010 Dietary Guidelines for Americans also stated that “Given the current U.S. marketplace and the resulting excessive high sodium intake, it is challenging to meet even the less than 2,300 mg recommendation” and that a concerted effort is needed to reduce sodium in foods to help consumers meet the levels recommended (Ref. 7).

An analysis of the potential savings from reduced sodium consumption in the U.S. adult population found that reducing average dietary sodium intake to 2,300 mg/d among adults 18 years or older could have substantial health and financial benefits. Estimates showed potential reduction of 11 million hypertension cases and an annual savings of $18 billion health care costs (Ref. 11). Another assessment on the cost-effectiveness of reducing sodium intake found that an intervention achieving a reduction of 1,200 mg/d would save $10 to $24 billion in health care costs annually, comparable to benefits of population-wide reductions in tobacco use, obesity, and cholesterol levels (Ref. 12). Furthermore, this analysis found that a modest reduction over 10 years of about 400 mg sodium/d would be more cost-effective than using medications to lower blood pressure in all persons with hypertension (Ref. 12).

Since 1980, the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) have made recommendations in the Dietary Guidelines for Americans, including “avoid too much sodium,” “use salt and sodium only in moderation,” and “choose and prepare foods with less salt” (Refs. 7 and 13 through 17).

FDA has supported these recommendations with a variety of initiatives designed to promote informed choices on the part of consumers. In 1984, FDA required that information on sodium be included on the label whenever nutrition information appeared on food labels (49 FR 15510, April 18, 1984). In 1990, Congress enacted the Nutrition Labeling and Education Act (NLEA), which mandated nutrition labeling of food. In response to the NLEA, in 1993 FDA issued regulations requiring the declaration of sodium in absolute amounts and as a percentage of the Daily Value (58 FR 2206, January 6, 1993). FDA has also established standards for sodium-related nutrient content and health claims ( e.g., 21 CFR 101.13; 21 CFR 101.14; 21 CFR 101.61; 21 CFR 101.74). Furthermore, under section 403(q)(5)(H)(ii)(III) of the Federal Food, Drug, and Cosmetic Act, as amended by the Patient Protection and Affordable Care Act of 2010, certain restaurants and similar retail food establishments must provide, upon request, written nutrition information, which includes sodium content, for standard menu items. Additional efforts by FDA have included consumer education initiatives such as a joint sodium education initiative in 1981 with the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) as part of the National High Blood Pressure Education Program (Ref. 18), and a November 29, 2007, public hearing concerning policies regarding salt and sodium in food (72 FR 59973, October 23, 2007). At the hearing, there was general agreement that the levels of sodium in food are too high, but there was no consensus regarding approaches for reducing the levels of sodium in food (Ref. 19).

FSIS, the agency responsible for nutrition labeling requirements for meat and poultry products, also coordinates and collaborates with FDA on nutrition labeling issues. In 1993, FSIS issued regulations establishing nutrition labeling requirements for meat and poultry products (9 CFR 317, part 381, subpart Y). These regulations, similar to FDA's nutrition labeling regulations, required the declaration of sodium in absolute amounts and as a percentage of the Daily Value on the labeling of nonexempted meat and poultry products. In December 2010, FSIS issued regulations to ensure nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products on labels or at point-of-purchase, unless an exemption applies (75 FR 82148, December 29, 2010). These regulations also require nutrition labels on all ground or chopped meat and poultry products, with or without added seasonings, unless an exemption applies. Thus, these regulations increase the type of meat and poultry products that must declare sodium in absolute amounts and as a percentage of the Daily Value in their labeling.

Other U.S. public health agencies and organizations have also sought to inform consumers and encourage reduced sodium intake. In addition to conveying the benefits of reducing sodium related to hypertension through professional and consumer education activities, the NHLBI published guidelines recommending a sodium intake of no more than 2,400 mg/d dating back to 1993 (Refs. 20 through 26). More recently, the CDC has provided funding to various states and communities across the country in support of sodium reduction efforts to help create healthier food environments and reduce sodium intake by the population (Ref. 27). In addition, USDA, through the nutrition programs of the Center for Nutrition Policy and Promotion, promotes consumer messages related to sodium reductions via the interactive, web-based dietary assessment and weight management resources at ChooseMyPlate.gov, as well as through its MyPlate 2010 Dietary Guidelines for Americans consumer communications initiative and Consumer Brochure.

In 2008, the New York City Department of Health and Mental Hygiene initiated the National Sodium Reduction Initiative (NSRI), a partnership of 70 local and state health departments and health organizations, which has set targets to reduce sodium in restaurant and processed foods (Ref. 28). The goal of NSRI is to decrease average sodium intake by 20 percent over 5 years (2009 through 2014) by developing stepwise reductions from 2009 base levels to those desired by 2014. To-date, 28 companies have responded to NSRI, committing to reductions in the sodium content of some of their products.

These initiatives have been accompanied by efforts by industry, where a number of companies have played, and continue to play, a leadership role. Many food companies recognize that reduction of sodium in the American diet is an important public health issue. Some major food manufacturers have publicly committed to reducing the sodium content of their products over time. Certain companies have voluntarily identified specific product goals for sodium reduction. Many have demonstrated that substantial reductions in sodium can be achieved in certain food products and have established research programs to address key issues such as taste preference, technological advances, safety, and consumer acceptance in working through challenges and gaps in knowledge.

Other countries are also engaged in sodium reduction activities (Refs. 29 and 30).

In April 2010, the IOM released a report entitled “Strategies to Reduce Sodium Intake in the United States.” The report concluded that sodium intake, with the greatest contribution from salt, remains well above recommended levels despite several decades of education, labeling, and outreach efforts to reduce sodium consumption in the United States (Ref. 5). In the report, the committee considered past and current sodium reduction initiatives, consumer preference, the functional roles of sodium in food, research needs, regulatory options, and nutrition labeling in developing its recommendations. The IOM report acknowledged a number of complicating factors in reducing sodium in food. Although sodium primarily plays a role in altering taste, the IOM report noted that sodium chloride and other sodium-containing ingredients play a critical role in food safety by reducing the growth of pathogens thereby improving safety and shelf-life. In addition, these compounds provide functional and physical properties such as improving texture, controlling stickiness, and improving meltability. Among other things, the IOM report noted that more research is needed to develop and implement new technologies for sodium reduction and discussed the role of voluntary action by industry.

According to data presented to the IOM committee during the March 2009 public information gathering workshop (see Appendix L of the IOM Sodium Report), approximately 75 percent of the total sodium intake for most individuals is attributed to salt added as an ingredient or processing aid to processed and restaurant foods (Ref. 5). Sodium in the form of salt is added to food for many reasons. For example, salt functions as a seasoning agent and flavor-enhancer, a preservative and curing agent, a formulating and processing aid, and a dough conditioner (Ref. 5). Salt added at the table and in cooking provides only a small proportion of the total sodium that Americans consume (Ref. 9). A number of other sodium-containing ingredients contribute to sodium intake in lesser amounts (<1 percent) (Ref. 31). Some examples include sodium alginate, which alters viscosity; sodium phosphates, which bind liquid to reduce purge, in particular for solution-enhanced meat and poultry products; sodium sulfite, sodium nitrite, and sodium benzoate, which preserve food and inhibit microbial growth; and sodium lactate, diacetate, and acetate, which are dual purpose for flavoring and antimicrobial (pathogen reduction) purposes (Ref. 32). Non-sodium forms of these ingredients, which replace sodium with compounds such as potassium, calcium, and magnesium, are also available for some of these applications (Ref. 31).

According to the National Cancer Institute (NCI), individual and mixed foods contributing the highest proportion of sodium to the U.S. diet include yeast breads (250 mg/d), chicken and chicken mixed dishes (233 mg/d), pizza (217 mg/d), pasta and pasta dishes (174 mg/d), and cold cuts (155 mg/d) (Ref. 33). The CDC reported that close to 40 percent of daily sodium intake comes from grain-based products, such as breads, cakes, cookies, and crackers, and that almost 30 percent comes from processed meat products, such as bacon, sausage, lunch meat, poultry, and fish mixtures (Ref. 10). Sodium occurs naturally in nearly all foods; however this intrinsic sodium is not a significant dietary contributor for most Americans. Essentially, any single-ingredient food is low in sodium.

FDA and FSIS are considering potential ways to promote gradual, achievable and sustainable reduction of sodium intake over time. Research on a variety of issues, including the development of possible targets for the reduction of the sodium content of foods, is needed to assist FDA and FSIS in this effort. Sodium-containing food ingredients are used for multiple purposes at variable levels in diverse foods. The sodium intake of the U.S. population reflects both the sodium levels of individual foods and the amounts of foods consumed. As such, there are a variety of factors that may inform judgments about appropriate opportunities for sodium reduction. These factors include:

1. The important role that sodium has in food safety with respect to limiting microbial growth and maintaining the shelf-life of some foods;

2. The effect of sodium reduction on the physical attributes ( e.g., consistency, texture, shape, form) of some foods in ways that may impact consumer acceptance or food processing and manufacturing practices;

3. The feasibility, practicality, and cost of reducing sodium in various food categories;

4. The magnitude (time and percent sodium reduction) of any gradual or stepwise reduction effort;

5. The need to act gradually in a manner that is acceptable to consumers, while also achieving significant sodium reduction, because taste preference for sodium is acquired and can be modified (Refs. 34 and 35).

FDA and FSIS are establishing dockets to provide an opportunity for interested persons to submit comments, research, data, and other information that will better inform them about current and emerging practices by the private sector in sodium reduction; current consumer understanding of the role of sodium in hypertension and other chronic illnesses; sodium consumption practices; motivation and barriers in reducing sodium in their food intakes; and issues associated with the development of targets for sodium reduction in foods to promote reduction in excess sodium intake. In particular, both agencies welcome input on the following matters:

1. Comments and research related to recent sodium reduction initiatives by industry and the effects of those initiatives;

2. Comments and research related to consumer understanding of the role of sodium in hypertension and other chronic illnesses, sodium consumption practices, and motivation and barriers in reducing sodium in their food intakes;

3. Comments and research related to effective strategies for sustainable and meaningful reduction of sodium in foods sold in packaged or prepared form across the food supply, including and in particular foods with a high sales volume;

4. Comments and research related to existing or potential positive incentives for innovation in reformulating packaged and restaurant foods to reduce added sodium;

5. Comments and research related to the recommendations from the April 2010 IOM Sodium report on “Strategies to Reduce Sodium Intake in the United States,” including research related to information gaps identified in the IOM report (taste preferences for sodium, technological role of sodium/salt, role of food matrix, food safety, etc. );

6. Comments and research related to the following: (a) Methods for establishing sodium reduction targets, including information on general target design ( e.g., setting sodium reduction targets based on food categories, serving size, or formulations), (b) step-wise approaches to achieve sustainable sodium reductions and timeframes for achieving such reductions, and (c) methods for evaluating the impact of a sodium reduction strategy;

7. Comments and research related to avoiding potential unintended consequences for food safety, nutrition (including effects on added sugars or solid fats), or food manufacturing technologies that could result from interventions to reduce sodium;

8. Comments and research related to existing voluntary sodium reduction efforts, including the voluntary sodium reduction targets set by the New York City-initiated NSRI partnership, and their applicability to a potentential federal sodium reduction initiative;

9. Comments and research related to food formulation, processing, production, and other technology that could lead to meaningful and sustainable reductions in the amount of sodium in food, including specific food categories, targets, and methods to monitor;

10. Comments and research on the role that food standards of identity play in promoting or limiting the feasibility of sodium reduction of foods (among other things, standards of identity for certain foods define the nature of those foods, generally in terms of how those foods are prepared, the types of ingredients that they must contain ( i.e., mandatory ingredients) and that they may contain ( i.e., optional ingredients), and how those foods must be labeled (Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341); the Federal Meat Inspection Act (21 U.S.C. 607(c)); and the Poultry Products Inspection Act (21 U.S.C. 457(b)));

11. Comments and research on any advantages of sodium to consumers, including but not limited to, food safety, nutrition, and palatability;

12. Comments and research on the economic impacts of reducing sodium, including but not limited to, the cost of food, agricultural production, small businesses, jobs, and the health care system;

13. Comments and research on the impact of sodium reduction initiatives on consumer food choices and compliance with 2010 Dietary Guidelines for Americans recommendations;

14. Comments and research related to how consumers respond to sodium reductions ( i.e., adding back salt to foods, consumption of reformulated products); and

15. Comments and research related to effective methods for communicating to the public the health benefits associated with the sodium intake levels recommended by the 2010 Dietary Guidelines for Americans.

We anticipate that some interested persons may wish to provide FDA and FSIS with certain comments, research, data, and information that they consider to be trade secret or confidential commercial information (CCI) that would be exempt under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552). You may claim information that you submit to FDA and FSIS as CCI or trade secret by clearly marking both the document and the specific information as “confidential.” Information so marked will not be disclosed except in accordance with the Freedom of Information Act (5 U.S.C. 552) and the specific agency's disclosure regulations (FDA's regulations under 21 CFR part 20; FSIS's regulations under 9 CFR part 390). For electronic submissions to http://www.regulations.gov , indicate in the “comments” box of the appropriate docket that your submission contains confidential information. You must also submit a copy of the comment that does not contain the information claimed as confidential for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice.

A Federal Register notice will be published in the near future announcing a public meeting to discuss the topics set forth in this notice.

FDA: Interested persons may submit to FDA's 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.

FSIS: Interested persons may submit to FSIS's Docket Clerk (see ADDRESSES ) either electronic or written comments regarding this document. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the FSIS Docket Room between 8:30 a.m. and 4:30 p.m., Monday through Friday.

Because two docket numbers are associated with this document, please include with your comments the docket number that corresponds with the appropriate agency. Comments submitted for inclusion in both dockets should be separately submitted to each identified docket number to ensure consideration.

FDA has placed the following references on display in FDA's Division of Dockets Management (see ADDRESSES ). You may see them between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to Web sites after this document publishes in the Federal Register .)

FDA is announcing the availability of a guidance for industry (#207) entitled “Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods,” (VICH GL48). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries.

FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.

The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries.

Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings.

In the Federal Register of April 12, 2010 (75 FR 18504), FDA published a notice of availability for a draft guidance entitled “Draft Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods,” (VICH GL48), which gave interested persons until May 12, 2010, to comment on the draft guidance. FDA received a few comments on the draft guidance and those comments, as well as those received by other VICH member regulatory agencies, were considered as the guidance was finalized. At a meeting held in February 2011, the VICH Steering Committee endorsed the final guidance for industry (VICH GL48). The guidance announced in this notice finalizes the draft guidance dated April 12, 2010.

This VICH guidance document is one of a series developed to facilitate the mutual acceptance by national/regional regulators of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the European Union, Japan, the United States, Australia, New Zealand, and Canada.

As part of the approval process for veterinary medicinal products in food-producing animals, national/regional regulatory authorities require data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible tissues, including meat, milk, and eggs. The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.

This guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.

This guidance represents the Agency's current thinking on this topic. 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 applicable statutes and regulations.

This 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 this guidance have been approved under OMB control number 0910-0032.

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 guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.