Complete details regarding the committee meetings, the nature of the projects, how to attend (including information about remote access and obtaining special accommodations for persons with disabilities), and how to submit comments to each committee can be found on the Conference's Web site, at http://www.acus.gov. Click on “Research,” then on “Committee Meetings.”

Comments may be submitted by email to Comments@acus.gov , with the name of the appropriate committee in the subject line, or by postal mail to the appropriate committee at the address given below.

The April 18, 2012 meeting of the Committee on Regulation, which was previously announced in the February 6, 2012 Federal Register (77 FR 5755), has been cancelled, and two additional meetings have been scheduled for April 4 and May 3, 2012. The Science in the Administrative Process project, which was scheduled to be discussed at the April 18 meeting, will be postponed, with additional meetings likely to take place in the fall of 2012. At the upcoming meetings, the Committee on Regulation will consider a report and set of draft recommendations dealing with regulatory analysis requirements. The report, authored by Curtis W. Copeland, analyzes the various regulatory analysis requirements with which agencies must comply and offers a set of recommendations for streamlining those processes. Reeve T. Bull is the Designated Federal Officer for this committee. More information can be found in the “Research” section of the Conference's Web site, at http://www.acus.gov. Click on “Research,” then on “Conference Projects,” and then on “Review of Regulatory Analysis Requirements.”

An additional meeting of the Committee on Adjudication has been scheduled for April 5, 2012. This meeting is in addition to the Committee's April 23, 2012 meeting, which will occur as scheduled. At the meeting, the Committee on Adjudication will discuss further a draft report on the Immigration Adjudication Project and a draft recommendation based on the consultants' report. The report, prepared by Professor Lenni B. Benson (New York Law School) and Russell Wheeler (Brookings Institution), presents the findings of a study of potential improvements to the procedures for immigration adjudication. Funmi E. Olorunnipa is the Designated Federal Officer for this committee. More information can be found in the “About” section of the Conference's Web site, at http://www.acus.gov. Click on “About,” then on “The Committees,” and then on “Committee on Adjudication.”

The objectives of this series of teleconferences are as follows:

• Enhance the effectiveness of the Section 538 Guaranteed Rural Rental Housing Program.

• Establish a two-way communications forum to update industry participants and Rural Housing Service (RHS) staff.

• Enhance RHS' awareness of the market and other forces that impact the Section 538 Guaranteed Rural Rental Housing Program.

Topics to be discussed could include, but will not be limited to, the following:

• Updates on USDA's Section 538 Guaranteed Rural Rental Housing Program activities.

• Perspectives on the current state of debt financing and its impact on the Section 538 program.

• Enhancing the use of Section 538 financing with the transfer and/or preservation of Section 515 developments.

• The impact of Low Income Housing Tax Credits program changes on Section 538 financing.

USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, age, disability, and where applicable, sex, marital status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because all or part of an individual's income is derived from any public assistance program. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD). To file a complaint of discrimination, write to USDA, Assistant Secretary for Civil Rights, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., STOP 9410, Washington, DC 20250-9410, or call (800) 795-3272 (voice), or (202) 720-6382 (TDD). “USDA is an equal opportunity provider, employer, and lender.”

Under the authority of the Strategic and Critical Materials Stock Piling Revision Act of 1979, as amended (the Stock Piling Act) (50 U.S.C. 98, et seq. ), the Department of Defense, as National Defense Stockpile Manager, maintains a stockpile of strategic and critical materials to supply the military, industrial, and essential civilian needs of the United States for national defense. Section 9(b)(2)(G)(ii) of the Stock Piling Act (50 U.S.C. 98(h)(b)(2)(G)(ii)) authorizes the National Defense Stockpile Manager to fund material research and development projects to develop new materials for the stockpile.

Section 3314 of the Fiscal Year (FY) 1993 National Defense Authorization Act (NDAA) (50 U.S.C. 98h-I) formally established a Market Impact Committee (the “Committee”) to “advise the National Defense Stockpile Manager on the projected domestic and foreign economic effects of all acquisitions and disposals of materials from the stockpile * * *.” The Committee must also balance market impact concerns with the statutory requirement to protect the U.S. Government against avoidable loss.

The Committee is comprised of representatives from the Departments of Commerce, State, Agriculture, Defense, Energy, Interior, the Treasury, and Homeland Security, and is co-chaired by the Departments of Commerce and State. The FY 1993 NDAA directs the Committee to consult with industry representatives that produce, process, or consume the materials stored in or of interest to the National Defense Stockpile Manager.

In Attachment 1, the Defense Logistics Agency (DLA) lists the quantities of materials associated with three proposed material research and development projects to supplement its FY 2012 Annual Materials Plan. Two of the material research and development projects relate to DLA establishing vendor-owned buffer inventories in the United States for cadmium zinc tellurium (CZT) substrates and trichlorobenzene (TCB) up to the levels enumerated in Attachment 1. In these material research and development projects, DLA would enter into arrangements with vendors to maintain inventories of the two materials with options that DLA could purchase material if needed. In the third material research and development project, DLA would establish a DLA administered material reclamation process project to recycle rhenium alloy which would be re-introduced into the market by the vendor up to the level enumerated in Attachment 1.

The Committee is seeking public comments on the potential market impact of the material research and development projects. Public comments are an important element of the Committee's market impact review process.

DLA is required to supplement its FY 2012 Annual Materials Plan to account for the three material research and development projects because DLA will be using the Defense National Stockpile Transaction Fund to pay for the three material research and development projects. The quantities listed in Attachment 1 are not acquisition target quantities, but rather a statement of the proposed maximum quantity of each listed material that may be associated with the three material research and development projects in FY 2012. DLA is not proposing to acquire these materials and add them to the National Defense Stockpile. The quantity of each material that will actually be associated with the three material research and development projects will depend on the market for the materials during the fiscal year as well as on the quantity of each material approved for these material research and development projects by Congress.

The Committee requests that interested parties provide written comments, supporting data and documentation, and any other relevant information on the potential market impact of the quantities associated with the three material research and development projects. All comments must be submitted to the address indicated in this notice. All comments submitted through email must include the phrase “Market Impact Committee Notice of Inquiry” in the subject line.

The Committee encourages interested persons who wish to comment to do so at the earliest possible time. The period for submission of comments will close on April 19, 2012. The Committee will consider all comments received before the close of the comment period. Comments received after the end of the comment period will be considered, if possible, but their consideration cannot be assured.

All comments submitted in response to this notice will be made a matter of public record and will be available for public inspection and copying. Anyone submitting business confidential information should clearly identify the business confidential portion of the submission and also provide a non-confidential submission that can be placed in the public record. The Committee will seek to protect such information to the extent permitted by law.

The Office of Administration, Bureau of Industry and Security, U.S. Department of Commerce, displays public comments on the BIS Freedom of Information Act (FOIA) Web site at http://www.bis.doc.gov/foia. This office does not maintain a separate public inspection facility. If you have technical difficulties accessing this Web site, please call BIS's Office of Administration at (202) 482-1900 for assistance.

Background

Section 723(a)(1) of the Defense Production Act of 1950, as amended (DPA) requires the President to submit an annual report to Congress on the impact of offsets on the U.S. defense industrial base. Section 723(a)(2) directs the Secretary of Commerce (Secretary) to prepare the President's report and to develop and administer the regulations necessary to collect offsets data from U.S. defense exporters.

The authorities of the Secretary regarding offsets have been delegated to the Under Secretary of Commerce for Industry and Security. The regulations associated with offsets reporting are set forth in part 701 of title 15 of the Code of Federal Regulations. Offsets are compensation practices required as a condition of purchase in either government-to-government or commercial sales of defense articles and/or defense services, as defined by the Arms Export Control Act and the International Traffic in Arms Regulations. For example, a company that is selling a fleet of military aircraft to a foreign government may agree to offset the cost of the aircraft by providing training assistance to plant managers in the purchasing country. Although this distorts the true price of the aircraft, the foreign government may require this sort of extra compensation as a condition of awarding the contract to purchase the aircraft. As described in the regulations, U.S. firms are required to report information on contracts for the sale of defense articles or defense services to foreign countries or foreign firms that are subject to offsets agreements exceeding $5,000,000 in value. U.S. firms are also required to report annually information on offsets transactions completed in performance of existing offsets commitments for which offsets credit of $250,000 or more has been claimed from the foreign representative.

Commerce's annual report to Congress includes an aggregated summary of the data reported by industry in accordance with the offsets regulation and the DPA. As provided by section 723(c) of the DPA, BIS will not publicly disclose individual firm information it receives through offsets reporting unless the firm furnishing the information specifically authorizes public disclosure. The information collected is sorted and organized into an aggregate report of national offsets data, and therefore does not identify company-specific information.

In order to enable BIS to prepare the next annual offset report reflecting calendar year 2011 data, U.S. firms must submit required information on offsets agreements and offsets transactions from calendar year 2011 to BIS no later than June 15, 2012.

Background

On December 1, 2011, the Department published the notice of initiation of the sunset reviews of the antidumping duty orders on stainless steel bar from Brazil, India, Japan, and Spain 1 pursuant to section 751(c) of the Act. See Initiation of Five-Year (“Sunset”) Review, 76 FR 74775 (December 1, 2011) ( Notice of Initiation ).

The Department received a notice of intent to participate in these sunset reviews from the domestic interested parties, Carpenter Technology Corporation, Crucible Industries LLC, Electralloy a G.O. Carlson Inc. Co., Universal Stainless & Alloy Products, Inc., and Valbruna Slater Stainless, Inc. (collectively, the domestic interested parties), within the 15-day period specified in 19 CFR 351.218(d)(1)(i). The domestic interested parties claimed interested-party status under section 771(9)(C) of the Act as manufacturers and/or producers of a domestic like product in the United States.

The Department received a complete substantive response to the Notice of Initiation from the domestic interested parties within the 30-day period specified in 19 CFR 351.218(d)(3)(i). The Department received no substantive response from any respondent interested parties. In accordance with section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), the Department is conducting expedited (120-day) sunset reviews of the antidumping duty orders on stainless steel bar from Brazil, India, Japan, and Spain.

Imports covered by the orders are shipments of stainless steel bar. Stainless steel bar means articles of stainless steel in straight lengths that have been either hot-rolled, forged, turned, cold-drawn, cold-rolled or otherwise cold-finished, or ground, having a uniform solid cross section along their whole length in the shape of circles, segments of circles, ovals, rectangles (including squares), triangles, hexagons, octagons, or other convex polygons. Stainless steel bar includes cold-finished stainless steel bars that are turned or ground in straight lengths, whether produced from hot-rolled bar or from straightened and cut rod or wire, and reinforcing bars that have indentations, ribs, grooves, or other deformations produced during the rolling process.

Except as specified above, the term does not include stainless steel semi-finished products, cut length flat-rolled products ( i.e., cut length rolled products which if less than 4.75 mm in thickness have a width measuring at least 10 times the thickness, or if 4.75 mm or more in thickness having a width which exceeds 150 mm and measures at least twice the thickness), wire ( i.e., cold-formed products in coils, of any uniform solid cross section along their whole length, which do not conform to the definition of flat-rolled products), and angles, shapes and sections.

The stainless steel bars subject to the orders is currently classifiable under subheadings 7222.10.00, 7222.11.00, 7222.19.00, 7222.20.00, and 7222.30.00 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the orders is dispositive.

All issues raised in these reviews are addressed in the “Issues and Decision Memorandum for the Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders on Stainless Steel Bar from Brazil, India, Japan, and Spain” from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Import Administration, dated concurrently with this notice (Issues and Decision Memo), which is hereby adopted by this notice. The Issues and Decision Memo addresses the likelihood of continuation or recurrence of dumping and the magnitude of the margins of dumping likely to prevail if the orders were revoked. Parties can find a complete discussion of all issues raised in these reviews and the corresponding recommendations in this public memorandum, which is on file in the Import Administration's Antidumping and Countervailing Duty Centralized Electronic Service System and is accessible on the Import Administration Web site at http://ia.ita.doc.gov/frn/index.html.

The Department determines that revocation of the antidumping duty orders on stainless steel bar from Brazil, India, Japan and Spain would be likely to lead to continuation or recurrence of dumping at the following weighted-average percentage margins:

This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a). Timely written notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

The Department is issuing and publishing the final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act.

This request is for extension of a current information collection.

National Marine Fisheries Service (NMFS) Northeast Region manages the tilefish fishery of the Exclusive Economic Zone (EEZ) of the Northeastern United States, through the Tilefish Fishery Management Plan (FMP). The Mid-Atlantic Fishery Management Council prepared the FMP pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The regulations implementing the FMP are specified at 50 CFR part 648 subpart N.

The recordkeeping and reporting requirements at § 648.294 form the basis for this collection of information. NMFS requests information from tilefish individual fishing quota (IFQ) permit holders in order to process applications to ensure that IFQ allocation owners are provided a statement of their annual catch quota, and for enforcement purposes, to ensure vessels are not exceeding an individual quota allocation. In conjunction with the application, NMFS also collects IFQ share accumulation information to ensure that an IFQ limited access privilege holder does not acquire an excessive share of the total limited access privileges, as required by section 303A(c)(5)(D) of the Magnuson-Stevens Act.

NMFS requests transfer application information to process and track requests from allocation holders to transfer quota allocation (permanent and temporary) to another entity. NMFS also collects information for cost recovery purposes as required under the Magnuson-Stevens Act to collect fees to recover the costs directly related to management, data collection and analysis, and enforcement of IFQ programs. Lastly, NMFS collects landings information to ensure that the amounts of tilefish landed and ex-vessel prices are properly recorded for quota monitoring purposes and the calculation of IFQ fees, respectively. Having this information results in an increasingly more efficient and accurate database for management and monitoring of fisheries of the Northeastern U.S. EEZ.

The IFQ Allocation permit application, IFQ ownership cap form, and the IFQ transfer form are all paper applications. These applications can be filled out online, but must be printed and signed to complete. The IFQ cost recovery process is entirely online at www.pay.gov and the IFQ reporting requirements are completed through a phone call to NMFS interactive voice response phone line.

OMB Control Number: 0648-0590.

Form Number: None.

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

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 79.

Estimated Time per Response: IFQ Allocation Permit Application, 30 minutes; IFQ Ownership Cap Form, 5 minutes; IFQ Transfer Form, 5 minutes; IFQ Cost Recovery, 2 hours; IFQ Reporting Requirements, 2 minutes.

Estimated Total Annual Burden Hours: 53.

Estimated Total Annual Cost to Public: $23.48.

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

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

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

Federal regulations at Title 50, Part 665, of the Code of Federal Regulations require that owners of vessels fishing for, or landing, pelagic squid in the western Pacific region obtain a permit from NOAA National Marine Fisheries Service (NMFS). In addition, the regulations require vessel operators to report fishing activity and harvest on daily logbooks and mark their vessels for identification.

The information collected is used to identify participants in the fishery, document fishing activities and landings, determine the conditions of the stocks, assess the effectiveness of management measures, evaluate the benefits and costs of changes in management measures, and monitor and respond to accidental takes of protected species, including seabirds, turtles, and marine mammals.

Vessel owners must identify their vessels to assist in aerial and at-sea enforcement of fishing regulations.

Respondents have a choice of either electronic or paper forms. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.

OMB Control Number: 0648-0589.

Form Number: None.

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

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

Estimated Number of Respondents: 30.

Estimated Time per Response: Permit applications, 3o minutes; permit appeal, 2 hours; logbooks, 15 minutes; vessel identification, 45 minutes.

Estimated Total Annual Burden Hours: 265 hours.

Estimated Total Annual Cost to Public: $765 in mailing/reporting/identification costs.

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

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

This request is for extension of a current information collection.

National Marine Fisheries Service (NMFS) Northeast Region manages the tilefish fishery of the Exclusive Economic Zone (EEZ) of the Northeastern United States, through the Tilefish Fishery Management Plan (FMP). The Mid-Atlantic Fishery Management Council prepared the FMP pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The regulations implementing the FMP are specified at 50 CFR part 648 subpart N.

The recordkeeping and reporting requirements at § 648.294 form the basis for this collection of information. NMFS requests information from tilefish individual fishing quota (IFQ) permit holders in order to process applications to ensure that IFQ allocation owners are provided a statement of their annual catch quota, and for enforcement purposes, to ensure vessels are not exceeding an individual quota allocation. In conjunction with the application, NMFS also collects IFQ share accumulation information to ensure that an IFQ limited access privilege holder does not acquire an excessive share of the total limited access privileges, as required by section 303A(c)(5)(D) of the Magnuson-Stevens Act.

NMFS requests transfer application information to process and track requests from allocation holders to transfer quota allocation (permanent and temporary) to another entity. NMFS also collects information for cost recovery purposes as required under the Magnuson-Stevens Act to collect fees to recover the costs directly related to management, data collection and analysis, and enforcement of IFQ programs. Lastly, NMFS collects landings information to ensure that the amounts of tilefish landed and ex-vessel prices are properly recorded for quota monitoring purposes and the calculation of IFQ fees, respectively. Having this information results in an increasingly more efficient and accurate database for management and monitoring of fisheries of the Northeastern U.S. EEZ.

The IFQ Allocation permit application, IFQ ownership cap form, and the IFQ transfer form are all paper applications. These applications can be filled out online, but must be printed and signed to complete. The IFQ cost recovery process is entirely online at www.pay.gov and the IFQ reporting requirements are completed through a phone call to NMFS interactive voice response phone line.

OMB Control Number: 0648-0590.

Form Number: None.

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

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 79.

Estimated Time per Response: IFQ Allocation Permit Application, 30 minutes; IFQ Ownership Cap Form, 5 minutes; IFQ Transfer Form, 5 minutes; IFQ Cost Recovery, 2 hours; IFQ Reporting Requirements, 2 minutes.

Estimated Total Annual Burden Hours: 53.

Estimated Total Annual Cost to Public: $23.48.

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

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

The Committee will begin developing specific measures for Framework 24. This action is primarily setting specifications for fishing years 2013 and 2014. At this meeting the Committee will primarily work on other measures that will be considered in this action in addition to specifications. Specifically, (1) possible modification of Georges Bank access area opening dates; (2) consider measures to address sub-ACL of yellowtail flounder for the LAGC trawl fishery; (3) consider modifying the effective date of YT sub-ACL AMs from Year 2 to Year 3; (4) leasing LAGC IFQ mid-year; and 5) expanding the observer set-aside program to include LAGC open area trips. The Committee will make recommendations for research priorities for the 2013 and 2014 Research Set-Aside program. If time permits, the Committee may review and provide input on a draft outline for a Performance Evaluation of the LAGC IFQ program to date. In addition, there will be a presentation from the Northeast Fisheries Science Center (NEFSC) on future plans for the federal scallop survey and how results will be integrated with existing survey methods. The Committee may discuss other business.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final 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 Paul J. Howard, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

The NWHI Coral Reef Ecosystem Reserve is a marine protected area designed to conserve and protect the coral reef ecosystem and related natural and cultural resources of the area. The NWHI Reserve was established by Executive Order 13178 (12/00) and Executive Order 13196 (1/01) pursuant to the National Marine Sanctuaries Amendments Act of 2000 (Pub. L.106-513). The Reserve was incorporated into Papahanaumokuakea Marine National Monument when the Monument was established in 2006 and is now also part of the Papahanaumokuakea Marine National Monument World Heritage site established by UNESCO in July, 2010.

The Reserve encompasses an area of the marine waters and submerged lands of the Northwestern Hawaiian Islands, extending approximately 1200 nautical miles long and 100 nautical miles wide. The Reserve is managed by the Secretary of Commerce pursuant to the National Marine Sanctuaries Act and the Executive Orders. The management principles and implementation strategy and requirements for the Reserve are found in the enabling Executive Orders, which are part of the application kit, and can be found on the Monument's Web site www.papahanaumokuakea.gov .

In designating the Reserve, the Secretary of Commerce was directed to establish a Coral Reef Ecosystem Reserve Advisory Council, pursuant to section 315 of the National Marine Sanctuaries Act, to provide advice and recommendations on the management of the natural and cultural resources within the Reserve.

The Office of National Marine Sanctuaries has established the Reserve Advisory Council and is now accepting applications from interested individuals for Representatives and/or Alternates for each of the following citizen/constituent positions on the Council:

1. One (1) Native Hawaiian Representatives (Native Hawaiian).

2. One (1) Ocean-Related Tourism Representative (Ocean-Related Tourism).

3. One (1) Native Hawaiian (Elder) Alternate (Native Hawaiian)

3. Two (2) Native Hawaiian Alternates (Native Hawaiian).

4. One (1) Conservation Alternate (Conservation).

Current Reserve Council Representatives and Alternates may reapply for these vacant seats.

The Council consists of 25 members, 15 of which are non-government voting members (the State of Hawai'i representative is a voting member) and 10 of which are government non-voting members. The voting members are representatives of the following constituencies: Conservation (2), Citizen-At-Large, Ocean-Related Tourism, Recreational Fishing, Research (3), Commercial Fishing, Education, State of Hawai'i and Native Hawaiian (3). The government non-voting seats are represented by the following agencies: Department of Defense, Department of the Interior, Department of State, Marine Mammal Commission, NOAA's Hawaiian Islands Humpback Whale National Marine Sanctuary, NOAA's National Marine Fisheries Service, National Science Foundation, U.S. Coast Guard, Western Pacific Regional Fishery Management Council, and NOAA's Papahanaumokuakea Marine National Monument.

The CINMS Advisory Council was originally established in December 1998 and has a broad representation consisting of 21 members, including ten government agency representatives and eleven members from the general public. The Council functions in an advisory capacity to the Sanctuary Superintendent. The Council works in concert with the Sanctuary Superintendent by keeping him or her informed about issues of concern throughout the Sanctuary, offering recommendations on specific issues, and aiding the Superintendent in achieving the goals of the Office National Marine Sanctuaries. Specifically, the Council's objectives are to provide advice on: (1) Protecting natural and cultural resources and identifying and evaluating emergent or critical issues involving Sanctuary use or resources; (2) Identifying and realizing the Sanctuary's research objectives; (3) Identifying and realizing educational opportunities to increase the public knowledge and stewardship of the Sanctuary environment; and (4) Assisting to develop an informed constituency to increase awareness and understanding of the purpose and value of the Sanctuary and the Office of National Marine Sanctuaries.

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).

The Senior Corps Grant Application is completed by applicant organizations interested in sponsoring a Senior Corps program. The application is also used by existing grantees to apply for continuation year grants (annual submissions in years two and three of a three year grant). The application is completed electronically using the Corporation's web-based grants management system, eGrants.

The Corporation seeks to renew the current application with modifications. The modifications are: to modify Grant Application Instructions to align with upcoming standard performance measure requirements; separate the currently combined Grant Application Instructions by program, with a set of instructions specifically for the RSVP program and a set of instructions for the Foster Grandparent and Senior Companion programs; and incorporate technical corrections and enhancements, including simplifying language, establishing page limits, requiring extended zip code (zip plus four), and others.

The information collection will otherwise be used in the same manner as the existing application.

Type of Review: Renewal.

Agency: Corporation for National and Community Service.

Title: National Senior Service Corps Grant Application.

OMB Number: 3045-0035.

Agency Number: SF 424-NSSC.

Affected Public: Current and prospective sponsors of National Senior Service Corps Grants.

Total Respondents: 1,250.

Frequency: Annually, with exceptions.

Average Time Per Response: Estimated at 16.5 hours each for 180 first-time respondents; 15 hours each for 900 continuation sponsors; 5 hours each for 270 revisions.

Estimated Total Burden Hours: 17,820 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): $6,497.

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.

Title: FERC-598, Self Certification for Entities Seeking Exempt Wholesale Generator or Foreign Utility Company Status.

OMB Control No.: 1902-0166.

Type of Request: Three-year extension of the FERC-598 information collection requirements with no changes to the reporting requirements.

Abstract: The Commission uses the information collected under the requirements of FERC-598, “Self Certification for Entities Seeking Exempt Wholesale Generator or Foreign Utility Company Status” (OMB Control No. 1902-0166), to implement the statutory provisions of Title XII, subchapter F of the Energy Policy Act of 2005 (EPAct 2005). 1

EPAct 2005 repealed the Public Utility Holding Company Act (PUHCA) of 1935 in its entirety, including section 32. This repeal enabled the Commission to exempt wholesale generators from PUHCA 1935 on a case-by-case basis. The Commission amended its regulations (in Order No. 667  2 ) to add procedures for self-certification by entities seeking exempt wholesale generator (EWG) and foreign utility company (FUCO) status. Moreover, Order No. 667 implemented the repeal of PUHCA 1935 and the supplementary enactment of PUHCA 2005. This self-certification is similar to the process available to entities that seek qualifying facility status.

An EWG is a “person engaged directly, or indirectly through one or more affiliates * * * and exclusively in the business of owning or operating, or both owning and operating, all or part of one or more eligible facilities and selling electric energy at wholesale.”  3 A FUCO is a company that “owns or operates facilities that are not located in any state and that are used for the generation, transmission, or distribution of electric energy for sale or the distribution at retail of natural or manufactured gas for heat, light, or power, if such company: (1) Derives no part of its income, directly or indirectly, from the generation, transmission, or distribution of electric energy for sale or the distribution at retail of natural or manufactured gas for heat, light, or power, within the United States; and (2) neither the company nor any of its subsidiary companies is a public-utility company operating in the United States.”  4

An exempt EWG or FUCO or its representative may file with the Commission a notice of self certification demonstrating that it satisfies the definition of exempt wholesale generator or foreign utility company. In the case of EWGs, the person filing a notice of self certification must also file a copy of the notice of self certification with the state regulatory authority of the state in which the facility is located and that person must also represent to the Commission in its submission that it has filed a copy of the notice with the appropriate state regulatory authority. 5

A submission of the information is necessary for the Commission to carry out its responsibilities under EPAct 2005. 6 The Commission implements its responsibilities through the Code of Federal Regulations (CFR) Title 18 Part 366. These filing requirements are mandatory.

Type of Respondents: EWGs and FUCOs.

Estimate of Annual Burden:   7 The Commission estimates the total Public Reporting Burden for this information collection as:

The total estimated annual cost burden to respondents is $41,890 [612 hours ÷ 2080  8 hours/year = 0.29423 years * $142,372  9 = $41,890].

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Title: FERC-716, Good Faith Request for Transmission Service and Response by Transmitting Utility Under Sections 211(a) and 213(a) of the Federal Power Act.

OMB Control No.: 1902-0170.

Type of Request: Three-year extension of the FERC-716 information collection requirements with no changes to the reporting requirements.

Abstract: The Commission uses the information collected under the requirements of FERC-716 to implement the statutory provisions of sections 211 and 213 of the Federal Power Act (FPA) as amended and added by the Energy Policy Act of 1992. FERC-716 also includes the requirement to file a section 211 request if the negotiations between the transmission requestor and the transmitting utility are unsuccessful. For the initial process, the information is not filed with the Commission. However, the request and response may be analyzed as a part of a section 211 action. The Commission may order transmission services under the authority of FPA 211.

The Commission's regulations in the Code of Federal Regulations (CFR), 18 CFR 2.20, provide standards by which the Commission determines if and when a valid good faith request for transmission has been made under section 211 of the FPA. By developing the standards, the Commission sought to encourage an open exchange of data with a reasonable degree of specificity and completeness between the party requesting transmission services and the transmitting utility. As a result, 18 CFR 2.20 identifies 12 components of a good faith estimate and 5 components of a reply to a good faith request.

Type of Respondents: Transmission Requestors and Transmitting Utilities.

Estimate of Annual Burden:   1 The Commission estimates the total Public Reporting Burden for this information collection as:

The total estimated annual cost burden to respondents is $21,082 [308 hours ÷ 2080  3 hours/year = 0.14807 years * $142,372  4 = $21,082].

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-RCRA-2012-0163, which is available for online viewing at www.regulations.gov, or in person viewing at the RCRA Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for RCRA Docket is (202) 566-0270.

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

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

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

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

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

2. Describe any assumptions that you used.

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

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

5. Offer alternative ways to improve the collection activity.

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

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

Affected entities: Entities potentially affected by this action are private as well as State, Local, or Tribal Governments.

Title: Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities.

ICR numbers: EPA ICR No. 2317.02, OMB Control No. 2050-0204.

ICR status: This ICR is currently scheduled to expire on July 31, 2012. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: The U.S. Environmental Protection Agency (EPA) has finalized an alternative set of generator requirements applicable to laboratories owned by eligible academic entities, as defined in the final rule. The rule, which establishes a new Subpart K within 40 CFR part 262, provides a flexible and protective set of regulations that address the specific nature of hazardous waste generation and accumulation in laboratories owned by colleges and universities, and teaching hospitals and non-profit research institutes that are either owned by or formally affiliated with a college or university. In addition, the final rule allows colleges and universities and these other eligible academic entities formally affiliated with a college or university the discretion to determine the most appropriate and effective method of compliance with these requirements by allowing them the choice of managing their hazardous wastes in accordance with the new alternative regulations as set forth in Subpart K or remaining subject to the existing generator regulations.

Burden Statement: The hourly reporting burden associated with the final rule is estimated to be 10 minutes per respondent. This includes time for preparing and submitting a Site Identification Form to opt into Subpart K. The hourly recordkeeping burden associated with the final rule is estimated to be approximately 130 hours per respondent. This includes time for reading the regulations, labeling containers, and preparing and maintaining specified documents (e.g., Laboratory Management Plan).

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

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

Estimated total number of potential respondents: 112.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: 6,429.

Estimated total annual burden hours: 14,459 hours.

Estimated total annual costs: $$562,079, which includes $516,116 annualized labor costs and $45,963 annualized capital or O&M costs.

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

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 March 14, 2012), 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 April 16, 2012. Write “Billion Auto, File No. 112 3209” 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/billionautoconsent 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 “Billion Auto, File No. 112 3209” 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 April 16, 2012. 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”) has accepted, subject to final approval, an agreement containing a consent order from Billion Auto, Inc. The proposed consent 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 FTC 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.

The respondent is a motor vehicle dealer. The matter involves its advertising of the purchase, financing, and leasing of its motor vehicles. According to the FTC complaint, respondent has represented that when a consumer trades in a used vehicle in order to purchase another vehicle, respondent will pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. The complaint alleges that in fact, when a consumer trades in a used vehicle with negative equity ( i.e. the loan balance on the vehicle exceeds the vehicle's value) in order to purchase another vehicle, respondent does not pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. Instead, the respondent includes the amount of the negative equity in the loan for the newly purchased vehicle. The complaint alleges therefore that the representation is false or misleading in violation of Section 5 of the FTC Act. In addition, the complaint alleges violations of the Truth in Lending Act (“TILA”) and Regulation Z for failing to disclose certain costs and terms when advertising credit. The complaint also alleges a violation of the Consumer Leasing Act (“CLA”) and Regulation M for failing to disclose the costs and terms of certain leases offered.

The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I of the proposed order prohibits the respondent from misrepresenting that it will pay the remaining loan balance on a consumer's trade-in vehicle such that the consumer will have no obligation for any amount of that loan. It also prohibits misrepresenting any other material fact relating to the financing or leasing of a motor vehicle.

Part II of the proposed order addresses the TILA allegations. It requires clear and conspicuous TILA/Regulation Z disclosures when advertising any of the relevant triggering terms with regard to issuing consumer credit. It also requires that if any finance charge is advertised, the rate be stated as an “annual percentage rate” using that term or the abbreviation “APR.” In addition, Part II prohibits any other violation of TILA or Regulation Z.

Part III of the proposed order addresses the CLA allegation. It requires that the respondent clearly and conspicuously make all of the disclosures required by CLA and Regulation M if it states relevant triggering terms, including the monthly lease payment. In addition, Part III prohibits any other violation of CLA and Regulation M.

Part IV of the proposed order requires respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements. Part V requires that respondent provide copies of the order to certain of its personnel. Part VI requires notification of the Commission regarding changes in corporate structure that might affect compliance obligations under the order. Part VII requires the respondent to file compliance reports with the Commission. Finally, Part VIII is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.

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 March 14, 2012), 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 April 16, 2012. Write “Ramey Motors, File No. 112 3207” on your comment. Your comment B—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/rameymotorsconsent 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 “Ramey Motors, File No. 112 3207” 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 April 16, 2012. 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 (“AFTC”) has accepted, subject to final approval, an agreement containing a consent order from Ramey Motors, Inc. The proposed consent 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 FTC 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.

The respondent is a motor vehicle dealer. The matter involves its advertising of the purchase and financing of its motor vehicles. According to the FTC complaint, respondent has represented that when a consumer trades in a used vehicle in order to purchase another vehicle, respondent will pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. The complaint alleges that in fact, when a consumer trades in a used vehicle with negative equity (i.e. the loan balance on the vehicle exceeds the vehicle's value) in order to purchase another vehicle, respondent does not pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. Instead, the respondent includes the amount of the negative equity in the loan for the newly purchased vehicle. The complaint alleges therefore that the representation is false or misleading in violation of Section 5 of the FTC Act. In addition, the complaint alleges violations of the Truth in Lending Act (“TILA”) and Regulation Z for failing to disclose certain costs and terms when advertising credit.

The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I of the proposed order prohibits the respondent from misrepresenting that it will pay the remaining loan balance on a consumer's trade-in vehicle such that the consumer will have no obligation for any amount of that loan. It also prohibits misrepresenting any other material fact relating to the financing or leasing of a motor vehicle.

Part II of the proposed order addresses the TILA allegations. It requires clear and conspicuous TILA/Regulation Z disclosures when advertising any of the relevant triggering terms with regard to issuing consumer credit. It also requires that if any finance charge is advertised, the rate be stated as an “annual percentage rate” using that term or the abbreviation “APR.” In addition, Part II prohibits any other violation of TILA or Regulation Z.

Part III of the proposed order requires respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements. Part IV requires that respondent provide copies of the order to certain of its personnel. Part V requires notification of the Commission regarding changes in corporate structure that might affect compliance obligations under the order. Part VI requires the respondent to file compliance reports with the Commission. Finally, Part VII is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.

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 March 14, 2012), 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 April 16, 2012. Write “Frank Myers AutoMaxx, File No. 112 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/fmautomaxxconsent by following the instructions on the Web-based form. If this Notice appears at http://www.regulations.gov/#!hom e, you also may file a comment through that Web site.

If you file your comment on paper, write “Frank Myers Automaxx, File No. 112 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 April 16, 2012. 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”) has accepted, subject to final approval, an agreement containing a consent order from Frank Myers AutoMaxx, LLC. The proposed consent 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 FTC 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.

The respondent is a motor vehicle dealer. The matter involves its advertising of the purchase, financing, and leasing of its motor vehicles. According to the FTC complaint, respondent has represented that when a consumer trades in a used vehicle in order to purchase another vehicle, respondent will pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. The complaint alleges that in fact, when a consumer trades in a used vehicle with negative equity (i.e. the loan balance on the vehicle exceeds the vehicle's value) in order to purchase another vehicle, respondent does not pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. Instead, the respondent may require the consumer to pay for the negative equity in cash at the time of sale. The complaint alleges therefore that the representation is false or misleading in violation of Section 5 of the FTC Act.

The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I of the proposed order prohibits the respondent from misrepresenting that it will pay the remaining loan balance on a consumer's trade-in vehicle such that the consumer will have no obligation for any amount of that loan. It also prohibits misrepresenting any other material fact relating to the financing or leasing of a motor vehicle.

Part II of the proposed order requires respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements. Part III requires that respondent provide copies of the order to certain of its personnel. Part IV requires notification of the Commission regarding changes in corporate structure that might affect compliance obligations under the order. Part V requires the respondent to file compliance reports with the Commission. Finally, Part VI is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.

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 March 14, 2012), 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 April 16, 2012. Write “Key Hyundai, File No. 112 3204” 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/keyhyundaiconsent 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 “Key Hyundai, File No. 112 3204” 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 April 16, 2012. 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”) has accepted, subject to final approval, an agreement containing a consent order from Key Hyundai of Manchester, LLC, and Hyundai of Milford, LLC. The proposed consent 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 FTC 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.

The respondents are motor vehicle dealers. The matter involves their advertising of the purchase, financing, and leasing of their motor vehicles. According to the FTC complaint, respondents have represented that when a consumer trades in a used vehicle in order to purchase another vehicle, respondents will pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. The complaint alleges that in fact, when a consumer trades in a used vehicle with negative equity (i.e. the loan balance on the vehicle exceeds the vehicle's value) in order to purchase another vehicle, respondents do not pay off the balance of the loan on the trade-in vehicle such that the consumer will have no remaining obligation for any amount of that loan. Instead, the respondents include the amount of the negative equity in the loan for the newly purchased vehicle. The complaint alleges therefore that the representation is false or misleading in violation of Section 5 of the FTC Act. In addition, the complaint alleges violations of the Truth in Lending Act (“TILA”) and Regulation Z for failing to disclose certain costs and terms when advertising credit. The complaint also alleges a violation of the Consumer Leasing Act (“CLA”) and Regulation M for failing to disclose the costs and terms of certain leases offered.

The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I of the proposed order prohibits the respondents from misrepresenting that they will pay the remaining loan balance on a consumer's trade-in vehicle such that the consumer will have no obligation for any amount of that loan. It also prohibits misrepresenting any other material fact relating to the financing or leasing of a motor vehicle.

Part II of the proposed order addresses the TILA allegations. It requires clear and conspicuous TILA/Regulation Z disclosures when advertising any of the relevant triggering terms with regard to issuing consumer credit. It also requires that if any finance charge is advertised, the rate be stated as an “annual percentage rate” using that term or the abbreviation “APR.” In addition, Part II prohibits any other violation of TILA or Regulation Z.

Part III of the proposed order addresses the CLA allegation. It requires that the respondents clearly and conspicuously make all of the disclosures required by CLA and Regulation M if it states relevant triggering terms, including the monthly lease payment. In addition, Part III prohibits any other violation of CLA and Regulation M.

Part IV of the proposed order requires respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements. Part V requires that respondent provide copies of the order to certain of its personnel. Part VI requires notification of the Commission regarding changes in corporate structure that might affect compliance obligations under the order. Part VII requires the respondent to file compliance reports with the Commission. Finally, Part VIII is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.

Subject of Challenge Competition

Entrants are asked to develop a Web-based application that can ingest open source Twitter data for a specified geographic area, count the frequency of common illness related terms based on a provided common disease term taxonomy, and produce a top five list of trending illnesses for the previous twenty-four hour period. The daily top five list would be automatically delivered daily to public health practitioners at health departments via a Web-based widget. The resulting information will then be available to health departments to use in a variety of ways including building a baseline of trend data, engaging the public on trending health topics, serving as an indicator of potential health issues emerging in the population, or cross-referencing other data sources.

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 ASPR;

(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;

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

(5) Shall not be an HHS employee working on their applications or submissions during assigned work hours;

(6) Shall not be an employee of the Office of the Assistant Secretary for Preparedness and Response;

(7) Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award;

(8) Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission.

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.

This Challenge is open to any Contestant, defined as (1) an individual or team of U.S. citizens or permanent residents of the United States who are 18 years of age and over, or (2) an entity incorporated in and maintaining a primary place of business in the United States. Foreign citizens can participate as employees of an entity that is properly incorporated in the U.S. and maintains a primary place of business in the U.S. Contestants may submit more than one entry, e.g., if they have developed more than one tool.

Any individual or team that supplies false information, enters the challenge by fraudulent means, or is otherwise determined to be in violation of the eligibility criteria or terms of the challenge shall be ineligible for any prize and shall be required to forfeit and prize obtained based on such information or means.

Eligibility for a prize award is contingent upon fulfilling all requirements set forth herein. ASPR will not select as a Winner an individual or entity that is currently on the Excluded Parties List ( https://www.epls.gov/ ).

By participating in this competition, participants 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 participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

By participating in this competition, participants agree to indemnify the Federal Government against third party claims for damage arising from or related to competition activities.

Based on the subject matter of the contest, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, or property damage, or loss potentially resulting from contest participation, Contestants are not required to obtain liability insurance or demonstrate financial responsibility in order to participate in this contest.

Upon submission, each Contestant warrants that he or she is the sole author and owner of the submission; that the submission is wholly original with the Contestant (or is an improved version of an existing tool that the Contestant has sufficient rights to use); and that it does not infringe any copyright or any other rights of any third party of which Contestant is aware. Each Contestant also warrants that their submission is free of malware. Each Contestant also warrants that he or she has complied with the Twitter API Guidelines and Terms listed on the following Web site: https://dev.twitter.com/docs.

By participating in this contest, each Contestant grants to ASPR an irrevocable, paid-up, royalty-free nonexclusive worldwide license to post, link to, share, and display publicly the submission on the Web, for the purpose of the Challenge, during the duration of the Challenge, and for a period of two years following announcement of the winners. Contestants with winning submissions also grant to ASPR an irrevocable, paid-up, royalty-free nonexclusive worldwide license to use winning submissions and distribute them to the public to enhance situational awareness and response to health threats for a period of two years following announcement of the winners. All Contestants will retain all other intellectual property rights in their submissions. For example, during the two-year period referenced above, contestants retain the right to utilize and modify their submissions as desired and to provide licenses (paid or un-paid) to other entities. Thereafter, the nonexclusive license will expire, and contestants could grant an exclusive license if they so desired.

Interested persons that meet the eligibility criteria above should register at www.nowtrendingchallenge.com. Registration is free and can be completed anytime during the Submission Period, 03-16-2012 to 06-01-2012.

At the culmination of the submission period, all submitted entries will be reviewed for eligibility criteria. Those entries that are found to be eligible will be reviewed by a judging panel for determination of one grand prize submission. The grand prize submission will be awarded $21,000.00. If a team wins the prize, the prize money will be divided evenly among all team members. The winning entry will also receive $1,000 to apply towards travel to Washington, DC for the announcement of the winner.

Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to Federal income taxes. Any Federal, state, and, local taxes, and all similar fees and assessments, are the sole responsibility of the prize recipients. HHS will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.

All submissions that satisfy eligibility criteria will be judged by an expert panel composed of ASPR staff. The expert panel may also include and/or consult with Federal employees from other HHS components and Federal agencies, State and Local public health representatives, and/or external members of the health information technology community in compliance with the requirements of the America COMPETES Act. Judges may be named after commencement of the challenge. The judging panel will make selections based upon the following criteria:

1. Accessibility: Each entry will be rated on its ease of accessibility. Preference will be given to applications that are easily accessible to a wide range of users, including those with disabilities, on a variety of platforms.

2. Innovation: Each tool must meet the basic requirements for entry in the competition. Beyond the basics, each entry will be rated to the degree of new thinking it brings to applications targeting health surveillance. Innovations that help refine the tool's output or add additional knowledge beyond the top five trends are encouraged. These innovations may include but are not limited to: Adaptability to categories beyond diseases, reduction of noise to improve data quality, refinement of geolocation ability, etc.

3. Usability: Each entry will be rated on its ease of usability and interactive capabilities. Entries will be judged based on the user interface for selecting the location of interest for reporting and on the user ability to interact with output data.

4. Potential for impact on ability to gain/maintain health situational awareness: Each entry will be rated on the strength of its potential to help health authorities increase their knowledge of emerging health topics in their population of interest.

Submissions should include a title; a description of the submission in the form of a document (5 page maximum) or a slide presentation (10 slide maximum); a Web address for the technology; instructions on how to operate the tool; and system requirements required to run the tool. Pictures and video are optional but helpful.

1. General —Contestants must provide continuous access to their submission, a detailed description of the tool, instructions on how to install and operate the tool, and system requirements required to run the tool.

2. Acceptable platforms —The submission must be designed for the Web, a personal computer, a mobile handheld device, console, or any platform broadly accessible on the open Internet.

3. Acceptable Twitter Sources —All participants must use openly available Twitter information via one of the following Twitter API's: REST API or Streaming API

3. Accessibility —The tool must, to the extent practicable, be accessible to a wide range of users, including users with disabilities. It should also aim to meet objectives for Federal compliance guidelines for information technology as addressed by Section 508 of the Rehabilitation Act of 1973: http://www.section508/gov.

4. Deadlines and Modifications —All submissions must be available for evaluation and judging by 11:59 p.m., EDT, on 06-01-2012.

5. Intellectual Property —The Submission must not infringe any copyright or any other rights of any third party.

6. No logo or endorsement —The tool must not use any HHS or ASPR logo or official seal in the submission and must not claim HHS or ASPR endorsement. The award of a prize in this Challenge does not constitute an endorsement of a specific product by HHS, ASPR, or the Federal Government.

7. Functionality/Accuracy —A Submission may be disqualified if the tool fails to function as expressed in the description provided by the user or if the tool provides inaccurate or incomplete information.

8. Security —Submissions must be free of malware. The Contestant agrees that HHS may conduct testing on the tool to determine whether malware or other security threats may be present. HHS may disqualify the tool if, in HHS's judgment, the tool may damage the Government's or others' equipment or operating environment.

9. Debarment and Suspension Screening. By submitting an entry, Contestants consent to debarment and compliance screening.

Finalists and the Challenge Winners must comply with all terms and conditions of these Official Rules and winning is contingent upon fulfilling all requirements contained herein. Awards may be subject to Federal income taxes, and the Department of Health and Human Services will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Winners will be notified by email, telephone, or mail after the date of the judging.

If contestants choose to provide ASPR with personal information by registering or filling out the submission form through the challenge Web site, that information is used to respond to contestants in matters regarding their submission; announcements of entrants, finalists, and winners of the Challenge; and in relation to promotion of the Challenge. Information is not collected for commercial marketing.

Winners are permitted to cite that they won this contest.

ASPR reserves the right to cancel, suspend, and/or modify the Competition, or any part of it, for any reason, at ASPR's sole discretion.

Participation in this Challenge constitutes a contestant's full and unconditional agreement to abide by the Challenge's Official Rules found at www.Challenge.gov.

Under the PRA (44 U.S.C. 3501-3520) Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Registe r concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at §§ 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take the action necessary to protect the public health from adverse drug experiences.

All applicants who have received marketing approval of drug products are required to report to FDA serious, unexpected adverse drug experiences, as well as followup reports when needed (§ 314.80(c)(1)). This includes reports of all foreign or domestic adverse experiences as well as those based on information from applicable scientific literature and certain reports from postmarketing studies. Section 314.80(c)(1)(iii) pertains to such reports submitted by nonapplicants. Under § 314.80(c)(2) applicants must provide periodic reports of adverse drug experiences. A periodic report includes, for the reporting interval, reports of serious, expected adverse drug experiences and all nonserious adverse drug experiences and an index of these reports, a narrative summary and analysis of adverse drug experiences, and a history of actions taken because of adverse drug experiences. Under § 314.80(i), applicants must keep for 10 years records of all adverse drug experience reports known to the applicant.

For marketed prescription drug products without approved new drug applications or abbreviated new drug applications, manufacturers, packers, and distributors are required to report to FDA serious, unexpected adverse drug experiences as well as followup reports when needed (§ 310.305(c)). Section 310.305(c)(5) pertains to the submission of followup reports to reports forwarded by FDA. Under § 310.305(f), each manufacturer, packer, and distributor shall maintain for 10 years records of all adverse drug experiences required to be reported.

The primary purpose of FDA's adverse drug experience reporting system is to provide a signal for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provide the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product's labeling (such as adding a new warning), decisions about risk evaluation and mitigation strategies or the need for postmarket studies or clinical trials, and when necessary, to initiate removal of a drug from the market.

Respondents to this collection of information are manufacturers, packers, distributors, and applicants. FDA estimates the burden of this collection of information as follows:

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

FDA's final rule entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” (the final rule), which published on January 24, 2006 (71 FR 3922), and was effective on June 30, 2006, amended FDA's regulations governing the format and content of labeling for human prescription drug and biological products to require that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements. These revisions were intended to make it easier for health care practitioners to access, read, and use information in prescription drug labeling; to enhance the safe and effective use of prescription drug products; and to reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information.

Section 201.56 (21 CFR 201.56) requires that prescription drug labeling contain certain information in the format specified in either § 201.57 (21 CFR 201.57) or § 201.80 (21 CFR 201.80), depending on when the drug was approved for marketing. Section 201.56(a) sets forth general labeling requirements applicable to all prescription drugs. Section 201.56(b) specifies the categories of new and more recently approved prescription drugs subject to the revised content and format requirements in §§ 201.56(d) and 201.57. Section 201.56(c) sets forth the schedule for implementing these revised content and format requirements. Section 201.56(e) specifies the sections and subsections, required and optional, for the labeling of older prescription drugs not subject to the revised format and content requirements.

Section 201.57(a) requires that prescription drug labeling for new and more recently approved prescription drug products include “Highlights of Prescribing Information.” Highlights provides a concise extract of the most important information required under § 201.57(c) (the Full Prescribing Information (FPI)), as well as certain additional information important to prescribers. Section 201.57(b) requires a table of contents to prescribing information, entitled “Full Prescribing Information: Contents,” consisting of a list of each heading and subheading along with its identifying number to facilitate health care practitioners' use of labeling information. Section 201.57(c) specifies the contents of the FPI. Section 201.57(d) mandates the minimum specifications for the format of prescription drug labeling and establishes minimum requirements for key graphic elements such as bold type, bullet points, type size, and spacing.

Older drugs not subject to the revised labeling content and format requirements in § 201.57 remain subject to labeling requirements at § 201.80 (in the final rule, former § 201.57 was redesignated as § 201.80). Section 201.80(f)(2) requires that within 1 year, any FDA-approved patient labeling be referenced in the “Precautions” section of the labeling of older products and either accompany or be reprinted immediately following the labeling.

The PRA information collection analysis in the final rule (71 FR 3964-3967) (currently approved under OMB control number 0910-0572) estimated the reporting burden for a multiyear period. We are requesting that OMB extend approval for the information in this collection, as described below that will continue to be submitted to FDA during this multiyear period.

New drug product applicants must: (1) Design and create prescription drug labeling containing Highlights, Contents, and FPI, (2) test the designed labeling (e.g., to ensure that the designed labeling fits into carton-enclosed products), and (3) submit it to FDA for approval. Based on the projected data estimated in the final rule, FDA estimates that it takes applicants approximately 3,349 hours to design, test, and submit prescription drug labeling to FDA as part of an NDA or a BLA under the revised regulations. Approximately 84 applicants submit approximately 105 new applications (NDAs and BLAs) to FDA per year, totaling 351,645 hours.

In the Federal Register of December 19, 2011 (76 FR 78668), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments.

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

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection approval request is for FDA guidance on the procedures for formal meetings between FDA and sponsors or applicants regarding the development and review of PDUFA products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how the Agency will interpret and apply section 119(a) of the Food and Drug Administration Modernization Act of 1997 (FDAMA), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82 (21 CFR 312.47 and 312.82)).

The guidance describes two collections of information: The submission of a meeting request containing certain information and the submission of an information package in advance of the formal meeting. Agency regulations at §§ 312.47(b)(1)(ii), (b)(1)(iv), and (b)(2) describe information that should be submitted in support of a request for an End-of-Phase 2 meeting and a Pre-NDA meeting. The information collection provisions of § 312.47 have been approved by OMB (OMB control number 0910-0014). However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting additional estimates for OMB approval.

Under the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) should submit a meeting request to the appropriate FDA component as an amendment to the underlying application. FDA regulations (§§ 312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information provided to the Agency as part of an Investigational New Drug Application (IND), New Drug Application (NDA), or Biological License Application (BLA) must be submitted with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571—OMB control number 0910-0014 and FDA Form 356h—OMB control number 0910-0338.

In the guidance document, CDER and CBER ask that a request for a formal meeting be submitted as an amendment to the application for the underlying product under the requirements of §§ 312.23, 314.50, and 601.2; therefore, requests should be submitted to the Agency with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted in this manner for two reasons: (1) To ensure that each request is kept in the administrative file with the entire underlying application and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the Agency to monitor progress on the activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner.

Under the guidance, the Agency requests that sponsors and applicants include in meeting requests certain information about the proposed meeting. Such information includes:

• Information identifying and describing the product;

• The type of meeting being requested;

• A brief statement of the purpose of the meeting;

• A list of objectives and expected outcomes from the meeting;

• A preliminary proposed agenda;

• A draft list of questions to be raised at the meeting;

• A list of individuals who will represent the sponsor or applicant at the meeting;

• A list of Agency staff requested to be in attendance;

• The approximate date that the information package will be sent to the Agency; and

• Suggested dates and times for the meeting.

This information will be used by the Agency to determine the utility of the meeting, to identify Agency staff necessary to discuss proposed agenda items, and to schedule the meeting.

A sponsor or applicant submitting an information package to the Agency in advance of a formal meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or Agency. The Agency recommends that information packages generally include:

• Identifying information about the underlying product;

• A brief statement of the purpose of the meeting;

• A list of objectives and expected outcomes of the meeting;

• A proposed agenda for the meeting;

• A list of specific questions to be addressed at the meeting;

• A summary of clinical data that will be discussed (as appropriate);

• A summary of preclinical data that will be discussed (as appropriate); and

• Chemistry, manufacturing, and controls information that may be discussed (as appropriate).

The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. Although FDA reviews similar information in the meeting request, the information package should provide updated data that reflect the most current and accurate information available to the sponsor or applicant. The Agency finds that reviewing such information is critical to achieving a productive meeting.

The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests as amendments to INDs, NDAs, and BLAs and to submit background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an End-of-Phase 2 meeting (§§ 312.47(b)(1)(ii) and (b)(1)(iv)) and a Pre-NDA meeting (§ 312.47(b)(2)).

1. Description of Respondents: A sponsor or applicant for a drug or biological product who requests a formal meeting with the Agency regarding the development and review of a PDUFA product.

2. Burden Estimate: Provided below is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance.

Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 975 sponsors and applicants (respondents) request approximately 2,014 formal meetings with CDER annually and approximately 127 respondents request approximately 253 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 10 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting.

Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 756 respondents submitted approximately 1,394 information packages to CDER annually and approximately 112 respondents submitted approximately 203 information packages to CBER annually prior to a formal meeting regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the Agency.

As stated earlier, the guidance provides information on how the Agency will interpret and apply section 119(a) of FDAMA, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82). The information collection provisions in § 312.47 concerning End-of-Phase 2 meetings and Pre-NDA meetings have been approved by OMB (OMB control number 0910-0014). However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting for OMB approval these additional estimates.

Under the PRA, 44 U.S.C. 3501-3520, Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection approval request is for FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented. The guidance provides information on how the Agency will interpret and apply provisions of the existing regulations regarding internal Agency review of decisions (§ 10.75 (21 CFR 10.75), dispute resolution during the investigational new drug (IND) process (§ 312.48 (21 CFR 312.48)), and the new drug application/abbreviated new drug application (NDA/ANDA) process (§ 314.103(21 CFR 314.103)). In addition, the guidance provides information on how the Agency will interpret and apply the specific Prescription Drug User Fee Act (PDUFA) goals for major dispute resolution associated with the development and review of PDUFA products.

Existing regulations, which appear primarily in 21 CFR parts 10, 312, and 314, establish procedures for the resolution of scientific and procedural disputes between interested persons and the Agency, CDER, and CBER. All Agency decisions on such matters are based on information in the administrative file (§ 10.75(d)). In general, the information in an administrative file is collected under existing regulations in part 312 (OMB control number 0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21 CFR part 601) (OMB control number 0910-0338), which specify the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of drugs and biological products. This information is usually submitted as part of an IND, NDA, or biologics license application (BLA), or as a supplement to an approved application. While FDA already possesses in the administrative file the information that would form the basis of a decision on a matter in dispute resolution, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the dispute. The guidance describes the following collection of information not expressly specified under existing regulations: The submission of the request for dispute resolution as an amendment to the application for the underlying product, including the submission of supporting information with the request for dispute resolution.

Agency regulations (§§ 312.23(11)(d), 314.50, 314.94, and 601.2) state that information provided to the Agency as part of an IND, NDA, ANDA, or BLA is to be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571—OMB control number. 0910-0014 and FDA Form 356h—OMB control number 0910-0338.

In the guidance document, CDER and CBER ask that a request for formal dispute resolution be submitted as an amendment to the application for the underlying product and that it be submitted to the Agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted as an amendment in this manner for two reasons: To ensure that each request is kept in the administrative file with the entire underlying application and to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the appropriate Agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner.

CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue ( i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last Agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the Agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3) the documents previously submitted to FDA under an OMB approved collection of information.

Based on FDA's experience with dispute resolution, the Agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the Agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal.

Description of respondents: A sponsor, applicant, or manufacturer of a drug or biological product regulated by the Agency under the Federal Food, Drug and Cosmetic Act or section 351 of the Public Health Service Act (42 U.S.C. 262) (Pub. L. 99-660) who requests formal resolution of a scientific or procedural dispute.

Burden Estimate: Provided below is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately nine sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately one respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 18 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with this guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the Agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 152 hours will be spent per year by respondents requesting formal dispute resolution under the guidance.

FDA is announcing its intention to hold a public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA), which authorizes FDA to collect user fees and use them for the process for the review of device applications until October 1, 2012. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the medical device review process.

As required by section 738A(b)(2), (3), and (6) of the FD&C Act (21 U.S.C. 379j-1(b)(2), (3), and (6)), FDA obtained prior public input and negotiated an agreement with regulated industry while periodically consulting with patient and consumer advocacy groups and making minutes of negotiation and stakeholder meetings publicly available (Ref. 1). Section 738A(b)(4) of the FD&C Act , requires that, after holding negotiations with regulated industry and before transmitting the Agency's final recommendations to Congress for the reauthorized program (MDUFA III), we do the following: (1) Present the draft recommendations to the Committee on Energy and Commerce of the U.S. House of Representatives and the Committee on Health, Education, Labor, and Pensions of the U.S. Senate; (2) publish the draft recommendations in the Federal Register ; (3) provide a period of 30 days for the public to provide written comments on the draft recommendations; (4) hold a meeting at which the public may present its views on the draft recommendations; and (5) after consideration of public views and comments, revise the draft recommendations as necessary. This notice, the 30 day comment period, and the public meeting will satisfy certain of these requirements. After the public meeting, we will revise the draft recommendations as necessary. In addition, the Agency will present the draft recommendations to the Congressional committees.

The purpose of the meeting is for the public to present its views on the draft recommendations for the reauthorized program (MDUFA III). In general, the meeting format will include a brief presentation by FDA, but will focus on hearing from different stakeholder interest groups (such as patient advocates, consumer advocates, industry, health professionals, and academic researchers). The Agency will also provide an opportunity for individuals to make presentations at the meeting and for organizations and individuals to submit written comments to the docket before and after the meeting. The following information is provided to help potential meeting participants better understand the history and evolution of the medical device user fee program and the current status of the MDUFA III draft recommendations.

In the years preceding enactment of Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical device program suffered a long-term, significant loss of resources that undermined the program's capacity and performance. MDUFMA was enacted “in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices are as safe and effective as original devices” (H.R. Rep. No. 107-728, at 21 (2002)). MDUFMA had a 5-year time frame and contained two particularly important features which relate to reauthorization:

• User fees for the review of medical device premarket applications, reports, supplements, and premarket notification submissions provided additional resources to make FDA reviews more timely, predictable, and transparent to applicants. MDUFMA fees and increased appropriations for the medical device program helped FDA expand available expertise, modernized its information management systems, provided new review options, and provided more guidance to prospective applicants. The ultimate goal was for FDA to approve and clear safe and effective medical devices more rapidly, benefiting applicants, the health care community and, most importantly, patients.

• Negotiated performance goals for many types of premarket reviews provided FDA with benchmarks for measuring review improvements. These quantifiable goals became more demanding each year and included FDA decision goals and cycle goals (cycle goals refer to FDA actions prior to a final action on a submission). Under MDUFMA, FDA also agreed to several commitments that did not have specific time frames or direct measures of performance, such as expanding the use of meetings with industry, maintenance of current performance in review areas where specific performance goals had not been identified, and publication of additional guidance documents.

Medical device user fees and increased appropriations were essential to support high-quality, timely medical device reviews, and other activities critical to the device review program.

MDUFMA provided for fee discounts and waivers for small businesses. Small businesses make up a large proportion of the device industry, and these discounts and waivers helped reduce the financial impact of the user fees on this sector of the device industry, which plays an important role in fostering innovation.

FDA provided periodic reports on its progress towards meeting these performance goals and commitments to stakeholders and Congress. FDA also provided an annual financial report to Congress, which provided transparency and accountability regarding the Agency's use of the additional resources provided by MDUFMA. Although FDA made progress towards achieving MDUFMA's central objectives, progress was limited by financial shortfalls and unpredictable fee revenues caused by variability in pre-market submission quantities.

In August 2005, Congress enacted the Medical Device User Fee Stabilization Act (Pub. L. 109-45) (MDUFSA), which modified several provisions of MDUFMA. MDUFSA: (1) Repealed the appropriations trigger for FY 2003 and FY 2004 and allowed for tolerances of up to 1 percent of the appropriations trigger for FY 2005-2007; (2) provided for predictable application fees by establishing fixed annual fees for FY 2006 and FY 2007, although at a lower rate of increase than under the original legislation; and (3) expanded the definition of “small business” for FY 2006 and FY 2007. However, MDUFSA did not address the issue of ensuring predictable revenues for FDA.

In 2007, Congress reauthorized medical device user fees through FY 2012 under the Medical Device User Fee Amendments of 2007 (MDUFA II) (title II of the Food and Drug Administration Amendments Act of 2007(FDAAA) (Pub. L. 110-85).

Under MDUFA II, the user fee program remained intact, with a few significant modifications to the program. The user fee framework was changed to provide a more reliable and stable funding stream. Specifically, MDUFA II included establishment registration as a new fee type that provided a more predictable amount of funds to be collected by the Agency in any given year. MDUFA II also included changes to the performance goals. Compared to MDUFMA, there were fewer performance goals under MDUFA II, yet the goals were more demanding. FDA published the commitment letter outlining the goals in the last reauthorization, as well as a number of reports that provide the public with useful background on MDUFMA, FDAAA, and MDUFA II (Ref. 2). FDA also posted video presentations on the medical device user fee program to give the public more background information on the program (Ref. 3).

In preparing the proposed recommendations to transmit to Congress for MDUFA reauthorization, we have conducted discussions with the device industry, and we have consulted with stakeholders as required by law. We began the MDUFA reauthorization process with a public meeting held on September 14, 2010 (75 FR 49502, August 13, 2010). The meeting included presentations by FDA and a series of panels representing different stakeholder groups, including patient advocates, consumer groups, the device industry, health care professionals, and scientific and academic experts.

From January 2011 through February 2012, FDA conducted negotiations with representatives of the device industry: The Advanced Medical Technology Association (AdvaMed); the Medical Device Manufacturers Association (MDMA); the Medical Imaging and Technology Alliance (MITA); and, the American Clinical Laboratory Association (ACLA). FDA also held monthly consultations with public stakeholders during that time period. As directed by Congress, FDA posted minutes of these discussions on its Web site (Ref. 4).

The proposed recommendations for MDUFA III address many of the priorities and concerns identified by public stakeholders and the device industry, and many of the important challenges identified by FDA. Each recommendation is briefly described with reference to the applicable section of the draft commitment letter (Ref. 5).

In conjunction with the proposed enhancements and performance goals outlined in the draft commitment letter, FDA is proposing new user fees and several statutory changes. The specific proposals are briefly described with reference to the applicable section of the draft legislative language (Ref. 6).

FDA is proposing several process improvements designed to increase the consistency, predictability, transparency, and efficiency of the device review program.

A Pre-Submission provides the opportunity for an applicant to obtain FDA feedback prior to submission of an investigational device exemption or marketing application. Although no specific resources are being allocated through the proposed MDUFA III user fees for the Pre-Submission program, FDA is proposing that we will institute a structured process for managing Pre-Submissions, as resources permit, and not to the detriment of meeting the quantitative review timelines in this proposal and statutory obligations. FDA is proposing to issue a draft guidance document and final guidance document on Pre-Submissions. The draft commitment letter includes additional details on the manner in which FDA intends to manage Pre-Submissions. These details can be found in section I.A of the draft commitment letter.

FDA is proposing to implement revised submission acceptance criteria through the publication of guidance. These revised criteria are intended to ensure that FDA is only reviewing complete submissions. The guidance will outline electronic copy of submissions (e-Copy) and objective criteria for revised “refuse to accept/refuse to file” checklists. This recommendation can be found in section I.B of the draft commitment letter. FDA is also proposing corresponding statutory language mandating e-Copy of submissions; this statutory requirement would be implemented through the guidance described in this paragraph. (See section III.L of this document for further information about this proposed statutory change).

FDA is proposing to continue to incorporate an interactive review process to provide for, and encourage, informal communication between FDA and applicants to facilitate timely completion of the review process based on accurate and complete information. This recommendation can be found in section I.C of the draft commitment letter.

FDA is proposing to apply user fee revenues to supplement the improvement of the process of developing, reviewing, tracking, issuing, and updating guidance documents. This recommendation can be found in section I.D of the draft commitment letter.

Although no specific resources are being allocated through the proposed MDUFA III user fees for the Third Party Review program, FDA is recommending reauthorization of the program and will work with interested parties to strengthen and improve the current program as resources permit. This recommendation can be found in section I.E of the draft commitment letter.

FDA proposes to fully implement final guidance on factors to consider when making benefit-risk determinations in medical device premarket review. FDA also proposes to meet with patient groups during MDUFA III to better understand the patient perspective on disease severity or unmet medical need. FDA also proposes to increase its utilization of FDA's Patient Representatives to provide patients' views early in the medical product development process. This recommendation can be found in section I.F of the draft commitment letter.

FDA proposes to identify additional low risk medical devices to exempt from premarket notification. This recommendation can be found in section I.G of the draft commitment letter.

FDA proposes to work with industry to develop a transitional In Vitro Diagnostics (IVD) approach for the regulation of emerging diagnostics. This recommendation can be found in section I.H of the draft commitment letter.

FDA is proposing to meet more rigorous goals for MDUFA III while streamlining management of the program. In making these proposals, we have taken into account efficiencies planned for in MDUFA III including: Additional scientific, regulatory, and leadership training; additional staff, including those with expertise demanded by increasingly complex device reviews; improved submission acceptance criteria; and information technology improvements that allow us to better track and manage the device review process.

FDA is proposing to eliminate the “two-tier” goal structure that we believe is an impediment to improving average total time to decision and to reaching the ultimate goal of the medical device user fee program—for safe and effective devices to reach patients and health care professionals more quickly. FDA is proposing a more simplified goal structure, which will be easier to implement and will improve predictability of the program, leaving the program less prone to unintended consequences. The simplified goal structure includes a single, high percentage goal for each performance metric. This provides more clarity to industry so applicants will know when to expect feedback from the Agency on their marketing submissions, and allows the Agency's review staff to better manage their time. This structure also allows more flexibility in the Agency's management strategy, allowing for adjustments as needed to ensure achievement of the desired outcomes—specifically, reducing review cycles and reducing average total time to decision.

FDA is proposing decision goals of 180 FDA days for premarket approval applications (PMAs) that do not require Advisory Committee input and for 180-Day PMA Supplements, 320 FDA days for PMAs that do require Advisory Committee input, 90 FDA days for Real-Time PMA Supplements, and 90 FDA days for premarket notification (510(k)) submissions. FDA is proposing performance goals for Clinical Laboratory Improvement Amendments (CLIA) waiver applications: 210 FDA days for dual submission of a 510(k) and CLIA waiver application; 180 FDA days for a CLIA waiver application not requiring Advisory Committee input; and 330 FDA days for CLIA waiver applications that do require Advisory Committee input. For each of these decision goals, FDA is proposing to “ramp-up” the percentage of applications that will be completed within the goal time line during the 5-year time period to correspond with the timetable for additional staff to be hired during MDUFA III. The goal percentages will increase to 90 or 95 percent in the final years of the program, depending on the submission type. Additionally, FDA is proposing to institute an acceptance/filing communication and Substantive Interaction goal for several submission types, which will track the Agency's communication with the applicant at specified points during the review process. FDA is proposing to retain the existing goals for Biological Licensing Applications (BLAs) and their supplements. Additional details regarding all of the quantitative review performance goals can be found in section II of the draft commitment letter.

FDA and representatives of the device industry believe that the process improvements outlined in the draft commitment letter, when implemented by all parties as intended, should reduce the average Total Time to Decision for PMA applications and 510(k) submissions, provided that the total funding of the device review program adheres to the assumptions underlying the agreement. Reducing average total time to decision is an important aspect of the ultimate goal of the user fee program, so that safe and effective devices reach patients and health care professionals more quickly. FDA proposes to report, on an annual basis, the average Total Time to Decision, as defined in the draft commitment letter, for PMA and 510(k) submissions, with shared goals for FDA and industry of 395 calendar days for PMAs and 135 calendar days for 510(k)s beginning with the FY 2013 receipt cohort, declining to 385 calendar days for PMAs and 124 calendar days for 510(k)s for the FY 2017 receipt cohort. Additional details regarding the shared outcome goals can be found in section III of the draft commitment letter.

FDA is proposing to apply user fee revenues to improve scientific and regulatory review capacity by reducing the ratio of review staff to front line supervisors and enhancing and supplementing scientific review capacity. FDA is seeking to obtain streamlined hiring authority in order to accomplish this (see section III.M of this document). FDA is proposing to apply user fee revenues to supplement training programs. FDA is proposing to continue efforts to improve its IT systems. Additional details regarding the infrastructure proposals can be found in section IV of the draft commitment letter.

In order to implement continued program improvements and efficiencies, FDA is proposing to conduct a comprehensive assessment of the process for the review of device applications. FDA is proposing to incorporate findings and recommendations of the independent assessment into its management of the premarket review program. Additional details regarding the independent assessment proposal can be found in section V of the draft commitment letter.

FDA is proposing to report its progress toward meeting the goals in the draft commitment letter through quarterly and annual reporting. The proposed reporting structure includes more detailed reporting than the Agency agreed to provide during MDUFA II. Additional details regarding the performance reporting structure can be found in section VI of the draft commitment letter.

In calculating user fees for each new FY in MDUFA III, FDA proposes to adjust the base revenue amount by inflation. This methodology is specified in the draft legislative language. The inflation adjuster accounts for changes in FDA's costs related to payroll compensation and benefits as well as changes in non-payroll costs through use of the Consumer Price Index. This weighted composite inflation adjuster will provide a degree of assurance that fees during MDUFA III keep pace with FDA's costs. Additionally, FDA proposes to adjust establishment registration fees annually, as needed, to account for any unanticipated variations in submission and registration quantities that are likely to result in FDA collecting more or less than the authorized amount of fees each year (as adjusted for inflation). Additional details regarding the annual fee setting and adjustments can be found in section 738(c) of the draft legislative language.

Implementing the proposed enhancements discussed in the previous sections of this document will require approximately $595 million, before adjustments for inflation, in device user fee revenue over the course of the 5-year MDUFA III period, FY 2013 through FY 2017. Proposed user fee collections, before adjustments for inflation, are: $97,722,301 in FY 2013; $112,580,497 in FY 2014; $125,767,107 in FY 2015; $129,339,949 in FY 2016; and $130,184,348 in FY 2017. This user fee revenue will support approximately 208 additional full-time equivalent (FTE) staff by the end of the MDUFA III period. In addition, these fee levels will support the continued funding of approximately 32 FTEs over current staffing levels that FDA plans to hire by the end of FY 2012 under MDUFA II using currently authorized and appropriated user fees. Therefore, the net increase over current staffing levels will be approximately 240 FTEs as a result of this proposal. Collections slightly above proposed user fee spending in the early years of MDUFA III will ensure that funds are available to hire additional staff in order to meet the proposed commitments, and will be balanced by collections slightly below proposed user fee spending in the later years of MDUFA III. As in MDUFA II, the premarket application fee and the establishment registration fee are set during the annual fee setting, and other submission fees are determined as a percentage of the premarket application fee. In MDUFA III, the percentage associated with a premarket notification (510(k)) is being raised from 1.84 percent of a premarket application fee to 2.0 percent of a premarket application fee. All other percentages remain the same as during MDUFA II. Base fee amounts for premarket applications, prior to adjustments for inflation, are proposed as: $248,000 in FY 2013; $252,960 in FY 2014; $258,019 in FY 2015; $263,180 in FY 2016; and $268,443 in FY 2017. Base fee amounts for establishment registration, prior to annual adjustments, are proposed as: $2,575 in FY 2013; $3,200 in FY 2014; $3,750 in FY 2015; $3,872 in FY 2016; and $3,872 in FY 2017. Additional details regarding the MDUFA III fees can be found in section 738(a) and (b) of the draft legislative language.

The proposed legislative language eliminates exemptions under MDUFA II that allowed certain types of establishments to meet their requirement to register without incurring a fee. This amendment will increase the base of establishments paying registration fees. Additional details regarding this modification can be found in section 737(13) of the draft legislative language.

FDA is proposing a provision for the Secretary of Health and Human Services (Secretary), in the Secretary's sole discretion, to grant a waiver or reduction of fees if the Secretary finds that such waiver or reduction is in the interest of public health. Additional details regarding this provision can be found in section 738(f) of the draft legislative language.

FDA is proposing to update the appropriations trigger and the spending trigger to FY 2009 levels. This will provide assurance to industry that user fees will be additive to Budget Authority appropriations, as was the original intent of the user fee program and of the appropriations and spending triggers. Additional details regarding these updates can be found in section 738(h)(1)(A) and (i)(2)(A)(ii) of the draft legislative language.

In order to implement revised submission acceptance criteria, FDA is proposing statutory language requiring an electronic copy (e-Copy) to be provided with any pre-submission or submission for devices. The proposed language provides that implementation of this requirement would occur following issuance of final guidance providing standards for such electronic copy. Additional details regarding this provision can be found under the heading “Subchapter D—Information and Education” in the draft legislative language.

In order to facilitate the steep ramp-up in hiring necessary to accomplish the goals agreed to in the draft commitment letter, FDA is proposing statutory language that would grant streamlined hiring authority to FDA for the first 3 years of MDUFA III. Additional details regarding this provision can be found under the heading “STREAMLINED HIRING AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE APPLICATIONS” in the draft legislative language.

The following references have been placed on display in the Division of Dockets Management (see Comments) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .)

1. The minutes from FDA's negotiation and stakeholder meetings are available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm236902.htm.

2. The MDUFA II commitment letter, key Federal Register documents, MDUFA II-related guidance documents, legislation, performance reports, and financial reports and plans are available at www.fda.gov/MDUFA.

3. The pre-recorded video presentations are available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109316.htm. FDAAA-specific information is available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm.

4. The minutes from FDA's negotiation and stakeholder meetings are available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm236902.htm.

5. Further information can be found on FDA's Web site at http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/ucm292860.htm.

6. Further information can be found on FDA's Web site at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm292860.htm.

Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov and at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm292860.htm. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the public meeting.

The Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (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; (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This Notice also lists the following information:

Title of Proposal: ONAP Training and Technical Assistance Information Collection.

OMB Control Number: Pending.

Description of the need for the information and proposed use:

The Department of Housing and Urban Development Appropriations Act, as approved on November 18, 2011 (Pub. L. 112-55, 125 Stat. 552) authorizes HUD to award training and technical assistance contracts on a competitive basis. HUD intends to competitively award training and technical assistance contracts to national and regional nonprofit and for-profit entities with demonstrated experience and expertise in the Native American Housing Assistance and Self-Determination Act of 1996 (NAHASDA).

The purpose of the ONAP Training and Technical Assistance program is to improve the quality and quantity of low-income housing in Native American, Alaska Native, and native Hawaiian communities, as funded by Indian Housing Block Grants (IHBG) and Native Hawaiian Housing Block Grants (NHHBG) and authorized by NAHASDA. The regulations for the IHBG program are at 24 CFR part 1000, and for the NHHBG program at 24 CFR part 1006.

Successful applicants will have demonstrated training and technical assistance experience and expertise in NAHASDA; low-income housing development, inspection, maintenance, modernization, and operation; admissions and occupancy; procurement; financial and fiscal management; program income; governance and organizational development; leveraged financing, including Low Income Housing Tax Credits; healthy home environments, including mold and air quality issues; homebuyer education; crime prevention; youth activities, including Boys and Girls Clubs; and other topics responsive to low-income housing issues in native communities. Training and technical assistance services will be provided onsite and remotely, on a one-on-one and classroom basis.

Respondents to the NOFA will be required to submit a single proposal regardless of the number of programs or areas of expertise for which they offer to provide training and technical assistance. Factors for award include Factor 1: Capacity and Experience, Factor 2: Soundness of Approach, Factor 3: Leveraging, and Factor 4: Achieving Results and Program Evaluation. Narratives addressing Factors 1-4 must be formatted so that the total number of pages submitted is equal to or no more than 25 single-sided pages. The one-page application summary, organizational chart, budget discussion, and required forms are not included in the 25 page limit. Required forms include HUD-2880 (Applicant/Recipient Disclosure Update), HUD-2993 (Acknowledgement of Application Receipt), HUD-96011 (HUD Facsimile Transmittal), SF-424 (Application for Federal Assistance), and SF-LLL (Disclosure of Lobbying Activities). Applicants must submit their applications electronically to Grants.Gov or request a waiver from HUD. HUD expects to receive 25 applications and select ten awardees to enter in 24-month cooperative agreements, with a 12-month option period.

Agency form numbers: HUD-2880, HUD-2993, HUD-96011.

Members of affected public: Nonprofit and for-profit entities.

Estimation of the total number of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: The estimated number of applicants is 25, responding once a year, for a total reporting burden of 1,500 hours. The estimated number of awardees is 10, the frequency of response is four times per year; and the total reporting burden is estimated at 1,830 hours.

Status of the proposed information collection: New collection.

The HOPE VI Revitalization Program provides grants to public housing authorities (PHAs) to: (1) Improve the living environment for public housing residents of severely distressed public housing projects through the demolition, rehabilitation, reconfiguration, or replacement of obsolete public housing projects; (2) revitalize sites on which such public housing projects are located and contribute to the improvement of the surrounding neighborhood; (3) provide housing that will avoid or decrease the concentration of very low-income families; and (4) build sustainable communities.

The FY2010 awards totaled $152,729,750, which included funds from both the FY2010 and FY2011 HOPE VI/Choice Neighborhood appropriation. The FY 2010 HOPE VI/Choice Neighborhood appropriation only allowed for the funding of six applications submitted in response to the FY2010 NOFA. In addition to the FY2010 HOPE VI/Choice Neighborhoods appropriation, HUD used the FY2011 HOPE VI/Choice Neighborhoods appropriation to fund two additional FY2010 HOPE VI applicants. HUD used the FY2011 HOPE VI/Choice Neighborhood assistance due to the need to award the FY2011 appropriation to communities as soon as possible and the fact that there were many more high-quality HOPE VI applicants in FY2010 than HUD was able to fund, for which use of the FY2011 appropriation provided a remedy. The results of HUD's HOPE VI selections were announced on May 23, 2011. At that time, and in addition to the applicant and Congressional notification processes, eight grantees and the amount of each award was posted to the HUD Web site at: http://portal.hud.gov/hudportal/HUD?src=/press/press_releases_media_advisories/2011/HUDNo.11-097. Applications were scored and selected for funding based on the selection criteria in the FY2010 HOPE VI Revitalization NOFA.

As a result of HUD's decision, HUD was able to fund eight public housing authorities (PHAs) from among 36 PHAs that applied for FY2010 HOPE VI Revitalization funding. Using the FY2011 HOPE VI/Choice Neighborhoods appropriation in this way allowed HUD to fund two additional FY2010 HOPE VI Revitalization applicants and two additional FY2010 Choice Neighborhoods applicants that would not have otherwise been funded (FY2010 Choice Neighborhoods awards are addressed in a separate Federal Register notice). In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545), the Department is publishing the names, addresses, and amounts of the eight awards made under the competition in Appendix A to this document.