The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products.'' As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures, FDA agreed

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a concept paper entitled ``PDUFA Pilot Project Proprietary Name Review.'' The concept paper provides information to pharmaceutical firms about how to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review under an anticipated

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity Act of 2003 (PREA). FDA has determined that approval of the suitability petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 23, 2008, 8 a.m. to October 24, 2008, 5 p.m., Holiday Inn Express Hotel and Suites, San Francisco Fisherman's Wharf, 550 North Point Street, San Francisco, CA, 91433 which was published in the Federal Register on September 19,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

Pursuant to section 10(d) of the Federal Advisory Committee Act, as [[Page 58607]]
amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552bcX4) 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

Proposed Projects

Title: State High Performance Bonus System (HPBS) Transmission File Layouts for HPBS Work Measures.

OMB No.: 09700230.

Description: This is a proposed reinstatement of a previously approved information collection. The purpose of this collection is to obtain data upon which to base the computation for measuring State

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Notice is hereby given of a change in the meeting of the National Institute of Mental Health Special Emphasis Panel, November 15, 2008, 10 am to November 15, 2008, 12 pm, National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD, 20852 which was published in the Federal Register on September 26, 2008,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d6d) to provide targeted liability protections for anthrax countermeasures based on a credible risk that the threat of exposure to Bacillus anthracis and the resulting disease constitutes a public health emergency.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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

Proposed Projects

Title: Refugee StateofOrigin Report (Form ORR11).

OMB No.: 09700043.

Description: The information collection of the ORR11 (Refugee StateofOrigin Report) is designed to satisfy the statutory requirements of the Immigration and Nationality Act. Section 412(a)(3) of the Act requires the Office of Refugee Resettlement to

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

The Secretary of the Department of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb3(b)(4), to justify the emergency use of doxycycline hyclate tablets accompanied by emergency use information, contained in emergency kits for eligible United

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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 closed to the public in accordance with the provisions set forth in sections 552b(cX4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

This notice announces that the Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), will award a program expansion supplement award to the Family Violence Prevention Fund (FVPF) in San Francisco, CA to continue the provision of technical support through the Family Violence Prevention and Services (FVPSA)

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.

[[Page 58244]]

Name: National Committee on Vital and Health Statistics (NCVHS) Executive Subcommittee.

Time and Date:
October 14, 2008, 1 p.m.5 p.m.
October 15, 2008, 8:30 a.m.4:30 p.m.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special emphasis Panel, October 27, 2008, 8 a.m. to October 28, 2008, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on September 25, 2008, 73 FR 5551755519.

The meeting will be

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), herein announces the awarding of a Mentoring Children of Prisoners (MCP) replacement grant to Mother Seton House, Inc., in Virginia Beach, VA. A prior grantee recently relinquished their MCP grant. With the funds provided, Mother Seton House, Inc.,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.

Name: National Committee on Vital and Health Statistics (NCVHS) Standards Subcommittee.

Time and Date: October 14, 2008 8:30 a.m.12 p.m.

Place: Radisson Hotel Reagan National Airport,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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

The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB),
[[Page 58247]]
herein announces the awarding of 27 program expansion supplemental awards in the amount of $2,462,128 in Fiscal Year (FY) 2008 funds to grantees under the Mentoring of Children of Prisoners (MCP) program. The additional funding will

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Secretary's Advisory Committee on Redesignation of Head Start Grantees, Department of Health and Human Services (HHS). The meeting will be held on Tuesday, October 21, 2008, from 9 a.m. to 5:30

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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.

[[Page 58251]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

This notice announces that the Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), will award a program expansion supplement to the National Latino Alliance for the Elimination of Domestic Violence (NLAEDV), in New York, NY. The additional funds will enable the grantee to continue the provision of technical

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

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 meeting of the President's Cancer Panel.

The meeting 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

The purpose of the ORR award is to assist California in providing medical screenings in accordance with ORR guidance in State Letter 9537, 11/21/95, and followup activities to newly arriving refugees for conditions of public health concern. California Senate Bill 162 established a new California Department of Public Health to take the place of the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

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