The Federal Register

Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety

Wed, Dec 19 2007 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the CDC announces the following meeting of the aforementioned committee and subcommittee:
Subcommittee Meeting Time and Date
10 a.m.12:30 p.m., January 8, 2008
Advisory Board Meeting Times and Dates
1 p.m.4:30 p.m., January 8, 2008
9:30 a.m.5 p.m., January 9, 2008
8:30 a.m.2:30 p.m., January 10, 2008
Public Comment Times and Dates
5 p.m.6 p.m., January 8, 2008

7:30 p.m.8:30 p.m., January 9, 2008

Place: Suncoast Hotel and Casino, 9090 Alta Drive, Las Vegas, NV 89145. Phone 702.636.7111, Fax 702.636.7050.

Status: Open to the public, limited only by the space available. The meeting space accommodates approximately 75 to 100 people.

Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program (EEOICP) Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensati

State Children's Health Insurance Program (SCHIP); Additional Allotments To Eliminate FY 2007 Funding Shortfalls

Wed, Dec 19 2007 11:00:00 GMT

This notice describes the methodology and process we are using for determining the amounts of certain States' remaining SCHIP funding shortfalls in Federal fiscal year (FY) 2007, in accordance with the provisions of the U.S. Troop Readiness, Veteran's Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007. This notice also contains the amounts of the additional allotments to be provided to such States to eliminate such FY 2007 funding shortfalls, determined in accordance with this methodology.

Solicitation of New Safe Harbors and Special Fraud Alerts

Wed, Dec 19 2007 11:00:00 GMT

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal antikickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

Government-Owned Inventions; Availability for Licensing

Wed, Dec 19 2007 11:00:00 GMT

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Government-Owned Inventions; Availability for Licensing

Wed, Dec 19 2007 11:00:00 GMT

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federallyfunded research and development. Foreign patent [[Page 71932]]
applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling

Wed, Dec 19 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all overthecounter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after con

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Wed, Dec 19 2007 11:00:00 GMT

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.

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Wed, Dec 19 2007 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee.

[[Page 71923]]

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

Date and Time: The meeting will be held on April 10, 2008, from 9 a.m. to approximately 6 p.m. and on April 11, 2008, from 8 a.m. to approximately 12 noon.

Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select ``2007N0471Scientific
Considerations for Safety Testing for Cellular Therapy Products Derived From Human Embryonic Stem Cell'' and follow prompts to submit your statement. Written comments should be submitted to the Division of Dockets M

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

Wed, Dec 19 2007 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Psychopharmacologic Drugs Advisory Committee.

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

Date and Time: The meeting will be held on February 6, 2008, from 8 a.m. to 5 p.m.

Location: Crowne Plaza Silver Spring, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD. The hotel phone number is 301587 4791.

Contact Person: DiemKieu Ngo, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email:
diemkieu.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code
3014512544. Please ca

Agency Information Collection Activities: Proposed Collection; Comment Request

Wed, Dec 19 2007 11:00:00 GMT

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 2761243.

Comments are invited on: (a) Whether the proposed collections of information are 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 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
[[Page 71933]]
respondents, including through the use of automated coll

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards,

Wed, Dec 19 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 019'' (Recognition List Number: 019), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Wed, Dec 19 2007 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: SAMHSA/CMHS Initiative to Evaluate Mental Health

Transformation: 9 State Incentive GrantsNEW

The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS), has funded an Initiative to help grantees transform their mental health and related service systems. Mental Health Transformation State Incentive Grants (MHT SIG) awards were made to 9 States: Connecticut, Hawaii, Maryland, Missouri, New Mexico, Ohio, Oklahoma, Texas and Washington. Associated with this project is an OMBrequired independent evaluation of the program.

With input from CMHS staff, MHT SIG State representatives and consumer and family

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Centers for Disease Control and

Wed, Dec 19 2007 11:00:00 GMT

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting.

Time and Date: 1 p.m.3 p.m., January 29, 2008 (Closed).

Place: Teleconference.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ``CDC Grants for Public Health Research Dissertation,'' PAR07231, Panel D.

Contact Person for More Information: Maurine Goodman, M.A., M.P.H., Scientific Review Administrator, Office of the Chief Science Officer, CDC, 1600 Clifton Road NE., Mailstop D 72, Atlanta, GA 30333, Telephone 4046394737.

The Director, Management Analysis and Services Office, has been delegated the auth

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Field Trails To Evaluate

Wed, Dec 19 2007 11:00:00 GMT

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 8 a.m.5 p.m., February 8, 2008 (Closed).

Place: Sheraton Gateway Atlanta Airport Hotel, 1900 Sullivan Road, [[Page 71914]]

Atlanta, Georgia 30337, Telephone (770) 9971100.

Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ``Field Trails to Evaluate Efficacy of Natural Products for the Control of the Tick Vectors of Lyme Disease Spirochetes, FOA Number CK08001; Evaluation of ReservoirTargeted Vaccine Formulations to Prevent Enzootic Transmission of Borrelia Burgdorferi (Lyme Borreliosis), FOA Numbe

Board of Scientific Counselors, National Center for Health Statistics (NCHS)

Wed, Dec 19 2007 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the CDC announces the following meeting of the aforementioned committee:

Times and Dates: 11 a.m.5:30 p.m., January 23, 2008. 8:30 a.m.2 p.m., January 24, 2008.

Place: NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782.

Status: This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or nonUS citizens, preapproval is required (please contact Althelia Harris, 3014584261, adw1@cdc.gov or Virginia Cain, vcain@cdc.gov at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulations, subpart 10120.301, all p