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201. National Institute of Mental Health; Notice of Meeting

NOTICES: National Institute of Mental Health,

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

202. Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for

NOTICES: Reclassification Petitions for Medical Devices,

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

203. Medicaid Program; State Flexibility for Medicaid Benefit Packages

Part II: Health and Human Services Department, Centers for Medicare & Medicaid Services,

This final rule will implement provisions of section 6044 of the Deficit Reduction Act of 2005, which amends the Social Security Act by adding a new section 1937 related to the coverage of medical assistance under approved State plans. It also provides States increased flexibility under an approved State plan to define the scope of covered medical
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Veterans Affairs Department

204. Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability

NOTICES: Submission of Patent Information for Certain Old Antibiotics; Draft Guidance for Industry,

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Patent Information for Certain Old Antibiotics.'' The draft guidance describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

205. National Institute of General Medical Sciences; Notice of Closed Meeting

NOTICES: National Institute of General Medical Sciences,

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

206. Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates: Fiscal Year 2009 Wage

NOTICES: Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Fiscal Year 2009 Wage Index Changes etc.,

This notice contains fiscal year (FY) 2009 revised final wage indices and hospital reclassifications for 27 hospitals. These revised final wage indices and hospital reclassifications were made according to special procedural rules set forth in the FY 2009 hospital inpatient prospective payment systems final rule (73 FR 485889).
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

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

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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, Public Law 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

208. Proposed Information Collection Activity; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

Proposed Projects

Title: TANF Quarterly Financial Report, ACF196.

OMB No.: 09700247.

Description: The Tribal TANF Quarterly Financial Report provides specific data regarding expenditures and provides a mechanism for Tribes to request grant awards and certify the availability of State matching funds. Failure to collect this data would

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

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

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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. Chapter 35). 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

210. Government-Owned Inventions; Availability for Licensing

NOTICES: Government-Owned Inventions; 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

211. Government-Owned Inventions; Availability for Licensing

NOTICES: Government-Owned Inventions; 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

212. National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

NOTICES: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Transmission and Pathogenesis of HIV in Women,

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(c)(4) 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

213. Proposed Substances To Be Evaluated for Set 23 Toxicological Profiles

NOTICES: Proposed Substances to be Evaluated for Set 23 Toxicological Profiles,

This notice announces the list of proposed substances that will be evaluated for CERCLA Set 23 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Toxic Substances and Disease Registry

214. Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

NOTICES: Current List of Laboratories Which Meet Minimum Standards to Engage in Urine Drug Testing for Federal Agencies,

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970),
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services Administration

215. 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

216. 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

217. Proposed Information Collection Activity; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

Proposed Projects

Title: HHS/ACF/OPRE Head Start Classroombased Approaches and Resources for Emotion and Social skill promotion (CARES) project: Impact and Implementation Studies.

OMB No.: New Collection.

Description: The Head Start Classroombased Approaches and Resources for Emotion and Social skill promotion (CARES) project will

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

218. New Animal Drugs; Ractopamine

RULES: Ractopamine,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

219. Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated

NOTICES: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Data Retention When Subjects Withdraw from FDARegulated Clinical Trials.'' This guidance clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

220. 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. Proposed

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

221. Center for Substance Abuse Prevention; Notice of Meeting

NOTICES: Center for Substance Abuse Prevention,

Pursuant to Public Law 92463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention (CSAP) National Advisory Council will meet on December 15, 2008, from 2 p.m. to 3 p.m. via

teleconference.

The meeting will include discussion and evaluation of grant

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

222. Center for Substance Abuse Treatment; Notice of Meeting

NOTICES: Center for Substance Abuse Treatment,

Pursuant to Public Law 92463, notice is hereby given of the meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council on December 11, 2008.

The meeting is open to the public and will include discussion of the Center's policy issues, and current administrative, legislative, and program developments.

Attendance

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

223. Agency Information Collection Request. 60-Day Public Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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

224. Draft Guidance on Important Considerations for When Participation of Human Subjects in Research Is Discontinued

NOTICES: Draft Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,'' and is seeking comment on the draft guidance. The draft guidance document, when
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Colorado Regional Health Information Exchange (CORHIO) Point of Care Exchange System Evaluation: Point of Care Questionnaires and Focus
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Healthcare Research and Quality

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