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

NOTICES: Cellular, Tissue, and Gene Therapies Advisory Committee,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

102. Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

NOTICES: Psychopharmacologic Drugs Advisory Committee,

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

103. Agency Information Collection Activities: Proposed Collection; Comment Request

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services Administration

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

NOTICES: FDA Modernization Act of 1997—; Recognized Standards List modifications (Recognition List Number 019),

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

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:

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services Administration

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

NOTICES: Disease, Disability, and Injury Prevention and Control Special Emphasis Panels,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

NOTICES: Disease, Disability, and Injury Prevention and Control Special Emphasis Panels,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

NOTICES: National Center for Health Statistics—; Scientific Counselors Board,

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:

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

NOTICES: Radiation and Worker Health Advisory Board,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

NOTICES: Medicaid—; State Children's Health Insurance Program; additional allotments to eliminate funding shortfalls,

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

111. Solicitation of New Safe Harbors and Special Fraud Alerts

PROPOSED RULES: New safe harbors and special fraud alerts; solicitations,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Inspector General Office, Health and Human Services Department

112. Government-Owned Inventions; Availability for Licensing

NOTICES: Inventions, Government-owned; availability for licensing,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

113. Government-Owned Inventions; Availability for Licensing

NOTICES: Inventions, Government-owned; availability for licensing,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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

RULES: Vaginal contraceptive and spermicide products (OTC) containing nonoxynol 9; label requirements,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

115. Revisit User Fee Program for Medicare Survey and Certification Activities

RULES: Revisit User Fee Program; Medicare Survey and certification activities,

This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Further Continuing Appropriations, 2008 Resolution (``Continuing Resolution'') budget legislation passed by the Congress and signed by the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

116. Agency Forms Undergoing Paperwork Reduction Act Review

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6394766 or send an email

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

117. Agency Forms Undergoing Paperwork Reduction Act Review

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6394766 or send an email

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

118. Proposed Data Collections Submitted for Public Comment and Recommendations

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

119. Expert Meeting on Disease Management Outcomes Measurement

NOTICES: Disease Management Outcomes Measurement,

This notice announces the date and location of the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (HHS/ASPE) Expert Meeting on Disease Management Outcomes Measurement. The objective of the meeting is to convene a panel of experts from government, academia, and private industry to discuss
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

120. National Heart, Lung, and Blood Institute; Notice of Closed Meeting

NOTICES: National Heart, Lung, and Blood Institute,

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 : Health and Human Services Department

121. Additional Consolidated Health Information (CHI) Health Information Technology Standards

NOTICES: Health information technology: interoperability standards,

This notice identifies three (3) additional Consolidated Health Informatics (CHI) messaging and vocabulary standards (Multimedia, Allergy, and Disability and Assessments) adopted for use in Federal government health information technology systems. This work supplements the work to further the adoption of the first set of 5 standards adopted on
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

122. National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of

NOTICES: Special Exposure Cohort; employee class designations—; Pantex Plant, TX,

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Pantex Plant, Amarillo, Texas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

123. Agency Information Collection Activities: Proposed Collection: Comment Request

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

In compliance with the requirement for the 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

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

124. Part C HIV Early Intervention Services Grant

NOTICES: Chase Brexton Health Services,

HRSA will be providing temporary critical HIV medical care and treatment services through Chase Brexton Health Services to avoid a disruption of HIV clinical care to homeless populations in the Baltimore, Maryland, area.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration

125. International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial

NOTICES: International Conference on Harmonisation—; Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions,

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The draft guidance was prepared under the auspices of the International
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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