Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

Pursuant to section 10(d) of the Federal Advisory Committee Act, as [[Page 56852]]
amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Application 60/891,856 filed February 27, 2007 (E0842007/0US01) and International Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

The Food and Drug Administration (FDA) is announcing the Web location where the agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development in fiscal year (FY) 2009. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Antiviral Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration

The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D so that, in addition to the claim for calcium and osteoporosis, an additional claim can be made for calcium and vitamin D and osteoporosis; eliminate the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our regulations to require that the holder of a new drug application (NDA) submit certain information in an annual report regarding authorized generic

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces our decision to approve Det Norske Veritas Healthcare, Inc. (DNVHC) for recognition as a national accreditation program for hospitals seeking to participate in the Medicare or Medicaid programs.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

Proposed Projects

Title: Child Care and Development Fund Plan for States/Territories for FFY 20102011 (ACF118).

OMB No.: 09700114.

Description: The Child Care and Development Fund (CCDF) Plan (the Plan) for States and Territories is required from each CCDF Lead agency in accordance with Section 658E of the Child Care and Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Proposed Projects

Title: Methodology for Determining Whether an Increase in a State's Child Poverty Rate Is the Result of the TANF ProgramNPRM.

OMB No.: 09700186.

Description: In accordance with Section 413(i) of the Social Security Act and 45 CFR part 284, the Department of Health and Human Services (HHS) intends to reinstate the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Proposed Projects

Title: Protection and Advacacy (P&A) Voting Access Application and Annual Report.

OMB No.: 09700326.

Description: This is a revision to include the application for the previously cleared Help America Vote Act (HAVA) Annual report.

An application is required by Federal statute (the Help America Vote Act (HAVA) of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). To request a copy of the clearance requests submitted to OMB for review, email

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2008 through June 2008, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Veterans Employment and Training Service

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2009. The

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 19, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

Part F of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), (Federal Register, Vol. 73, No. 127, pp. 3746337464, dated Tuesday, July 1, 2008) is amended to reflect an update to the functions for the Center for Medicare

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal title IVD child support enforcement databases and
significantly enhanced access to information for title IVD child support purposes. States are moving toward integrated service delivery and developing enterprise architecture

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Veterans Employment and Training Service

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``EndofPhase 2A Meetings.'' This draft guidance provides information on endofphase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs) who seek guidance on employing clinical trial simulation and quantitative

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration