DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore forming microorganisms. FDA is amending the regulations due to advances in facility, system, and equipment design and in sterilization technologies that

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with sporeforming microorganisms. FDA is proposing this amendment due to advances in facility, system, and equipment design and in sterilization

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notices announces the availability of a Request for Applications (RFA) on Implementation grants to evaluate the effects of health information technology (HIT) on improving patient safety and quality of health care.

The objective of this RFA is to support organization and community wide implementation and diffusion of HIT and to assess the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Healthcare Research and Quality

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This draft guidance provides recommendations for sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for generic

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

In accordance with section 10(d) of the Federal Advisory Committee Act as amended (5 U.S.C., Appendix 2), the Agency for Healthcare Research and Quality (AHRQ) announces meetings of scientific peer review groups. The subcommittees listed below are part of the Agency's Health Services Research Initial Review Group Committee.

The subcommittee

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Healthcare Research and Quality

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements to conduct methodologically sound research on how media violence affects youth violent behavior was published in the Federal Register on November 28, 2003, Volume 68, Number 229, pages 6682966834. The notice is amended as follows:

On page 66833,

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

Announcement Type: New.

Funding Opportunity Number: 04072.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates: Application Deadline: February 13, 2004. I. Funding Opportunity Description

Authority: This program is authorized under section 301(a) of the Public Health Service Act, (42 U.S.C. 241(a)).

Purpose: The

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

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreement to conduct a systematic examination of the impact of home visitor training and factors related to the implementation of an existing efficacious or effective home visiting program on family outcomes of child maltreatment and risk behaviors for youth

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

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements for Capacity Building Assistance to Improve the Delivery and Effectiveness of HIV Prevention Services for Racial/ Ethnic Minority Populations was published in the Federal Register, Tuesday, December 2, 2003, Volume 68, Number 231, pages 6755867566.

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

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 (301) 4437978.

Protection

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

Announcement Type: New.

Funding Opportunity Number: 04069.

Catalog of Federal Domestic Assistance Number: 93.943.

Key Dates:

Application Deadline: February 2, 2004.

I. Funding Opportunity Description

Authority: This program is authorized under sections 301(a) and 317(k)(2) of the Public Health Service Act, 42 U.S.C., 241 and

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

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 (301) 4437978.

Evaluation

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services 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 contract proposals 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 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 contract proposals and the discussions

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

The U.S. Department of Health and Human Services and the U.S. Department of Agriculture (a) provide notice of the second meeting of the Committee, (b) invite requests for oral testimony, and (c) solicit written comments.

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

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements for Capacity Building Assistance to Improve the Delivery and Effectiveness of HIV Prevention Services for Racial/ Ethnic Minority Populations was published in the Federal Register, Tuesday, December 2, 2003, Volume 68, Number 231, pages 6755867566. The

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

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 following meeting:

Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Competitive Funds for National Programs to Improve the Health, Education, and

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

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) announces the following committee meeting.

Name: Board of Scientific Counselors, NCHS.

Times and Dates: 2 p.m.5:40 p.m., January 22, 2004.

8:30

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

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

This final rule amends Medicare certification and payment requirements for rural health clinics (RHCs) as required by the Balanced Budget Act of 1997 (BBA). It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes criteria for identifying RHCs essential to delivery of primary care services

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Veterans Affairs Department

This final rule further delays for 6 months, until July 7, 2004, the effective date of the last sentence of 42 CFR 411.354(d)(1). This section was promulgated in the final rule entitled ``Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships,'' published in the Federal Register

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

This proposed notice would establish the procedures for maintaining the lists of codes that were included in the national coverage determinations (NCDs) that were announced in the final rule published in the Federal Register on November 23, 2001 (66 FR 58788). It also sets forth the circumstances in which a laboratory is permitted to use the date

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

In notice document FR Doc. 03-22427, Vol. 68, No. 171, Thursday, September 4, 2003, make the correction:

On page 52658, in the third column under ``Limited Competition:'' Correct the areas of limited competition to add: LABaton Rouge.

Dated: December 17, 2003.
Elizabeth M. Duke,
Administrator.
[FR Doc. 0331771 Filed 122303; 8:45 am]
BILLING

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

This notice describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries, carriers, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) regional carriers in the administration of the Medicare program beginning on the first day of the first month following publication of this

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