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[FR Doc 03-32242] 1. Biological Response Modifiers Advisory Committee; Notice of Meeting
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: Biological Response Modifiers Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32166] 2. Proposed Data Collections Submitted for Public Comment and Recommendations
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
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention
[FR Doc 03-32006] 3. Memorandum of Understanding Between the Food and Drug Administration,
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Department of Health and Human Services of the United States of America and Swissmedic of the Swiss Confederation. The purpose of this MOU is to further enhance and strengthen communication and existing public
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32016] 4. Medicare Program; Medicare Program; Changes to the Hospital Outpatient
This document corrects errors in the final rule with comment
period that appeared in the Federal Register on November 7, 2003,
entitled ``Medicare Program; Changes to the Hospital Outpatient Prospective Payment System
[[Page 75443]]
and Calendar Year 2004 Payment Rates; Final Rule.'' This notice is a
supplement to the November 7, 2003 final rule
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services
[FR Doc 03-32104] 5. Memorandum of Understanding Between the Food and Drug Administration and the
The Food and Drug Administration is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration (FDA), Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada. The purpose of this MOU is to enhance and strengthen the exchange of
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32151] 6. Request for Public Comments on the Proposed Merger of Two Head Start Grantees
This notice is to solicit public comments and statements of interest from interested parties on the merger of two Rhode Island Head Start Programs.
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration
[FR Doc 03-32102] 7. Over-the-Counter Drug Products; Safety and Efficacy Review
The Food and Drug Administration (FDA) is announcing a call for data for certain categories of ingredients in overthecounter (OTC) drug products that are eligible for the original OTC drug review but have not been reviewed by FDA to date. FDA will review the submitted data and information as part of its ongoing review of OTC drug products to
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-31374] 8. Statement of Organization, Functions, and Delegations of Authority
This notice amends Part K of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (DHHS), Administration for Children and Families (ACF) as follows: Chapter KB, the Children's Bureau, Administration on Children, Youth and Families (ACYF) (66 FR 3021518), as last amended June 5,
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration
[FR Doc 03-32005] 9. Exchange of Letters Between the Food and Drug Administration and the European
The Food and Drug Administration (FDA) is providing notice of an exchange of letters between FDA and the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA). The participants concluded this exchange of letters on September 12, 2003. These letters express the intentions of FDA, the European Commission, and
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32122] 10. Secretary's Council on Public Health Preparedness; Notice of Meeting
Pursuant to Section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is given of a meeting of the Secretary's Council on Public Health Preparedness.
The purpose of this public meeting is to convene the Council to discuss issues related to preparing the nation to respond to public health emergencies in
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department
[FR Doc 03-32121] 11. National Institute of Allergy and Infectious Diseases; Notice of Closed
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
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc 03-32162] 12. Agency Information Collection Activities: Proposed Collection: Comment
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
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration
[FR Doc 03-32161] 13. National Advisory Committee on Rural Health and Human Services; Notice of
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92463), notice is hereby given that the following committee will convene its fortysixth meeting.
Name: National Advisory Committee on Rural Health and Human Services
Date and Time: February 22, 2004; 2 p.m.5 p.m.; February 23, 2004; 8:30 a.m.5 p.m.;
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration
[FR Doc 03-32119] 14. National Institute of Mental Health; Notice of Closed Meetings
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 contract proposals and the
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health
[FR Doc 03-32101] 15. Food Additives Permitted for Direct Addition to Food for Human Consumption;
The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of acesulfame
potassium (ACK) as a generalpurpose sweetener and flavor enhancer in food, not including meat and poultry. This action
[[Page 75412]]
is in response to a food additive petition filed by Nutrinova, Inc. It
will simplify the
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32100] 16. Pediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for overthecounter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32160] 17. Agency Information Collection Activities; Submission for Office of Management
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32164] 18. Proposed Data Collections Submitted for Public Comment and Recommendations
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
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention
[FR Doc 03-32103] 19. Advisory Committees; Tentative Schedule of Meetings for 2004
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2004. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-32165] 20. Proposed Data Collections Submitted for Public Comment and Recommendations
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) 4981210. Send written
Published: 2003-12-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention
[FR Doc 03-32053] 21. President's Committee for People With Intellectual Disabilities (PCPID):
Published: 2003-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration
[FR Doc 03-31919] 22. Revision of the Requirements for Spore-Forming Microorganisms
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
Published: 2003-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-31918] 23. Revision of the Requirements For Spore-Forming Microorganisms; Companion to
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
Published: 2003-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 03-31958] 24. Notice of Availability on Transforming Healthcare Quality Through Information
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
Published: 2003-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Healthcare Research and Quality
[FR Doc 03-31917] 25. Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In
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
Published: 2003-12-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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