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1. National Institute of Environmental Health Sciences; Amended Notice of Meeting

NOTICES: National Institute of Environmental Health Sciences,

Notice is hereby given of a change in the meeting of the National Institute of Environmental Health Sciences Special Emphasis Panel, December 10, 2002, 4 p.m. to December 10, 2002, 5 p.m., which was published in the Federal Register on November 6, 2002, FR 67: 67635.

The telephone conference call meeting will be held on January 14, 2003 at

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2. Clinical Center; Notice of Meeting

NOTICES: Xenotransplantation Advisory Committee,

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of a meeting of the Board of Governors of the Warren Grant Magnuson Clinical Center.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

3. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 and Inclusion

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

This final rule with comment period refines the resource-based practice expense relative value units (RVUs) and makes other changes to Medicare Part B payment policy. In addition, as required by statute, we are announcing the physician fee schedule update for CY 2003.

The update to the physician fee schedule occurs as a result of a calculation

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Veterans Affairs Department

4. Implantation or Injectable Dosage Form New Animal Drugs; Praziquantel Injectable Solution

RULES: Praziquantel injectable solution,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for the veterinary prescription
[[Page 79853]]
use of an injectable praziquantel solution in dogs and cats for the removal of various species of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Uniform Compliance Date for Food Labeling Regulations

RULES: Food labeling—; Uniform compliance date,

The Food and Drug Administration (FDA) is establishing January 1, 2006, as the uniform compliance date for food labeling regulations that are issued between January 1, 2003, and December 31, 2004. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 20,
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. International Conference on Harmonisation; Draft Guidance on Addendum to E2C Clinical Safety Data Management:

NOTICES: E2C clinical safety data management; periodic safety update reports for marketed drugs; addendum,

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. National Center for Research Resources; Notice of Meeting

NOTICES: National Center for Research Resources,

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Research Resources Council.

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

8. National Eye Institute; Notice of Meeting

NOTICES: National Eye 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 a meeting of the National Advisory Eye Council.

[[Page 79941]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

9. 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 : National Institutes of Health

10. National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting

NOTICES: National Institute of Allergy and Infectious Diseases,

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

11. National Institute of Child Health and Human Development; Notice of Closed Meeting

NOTICES: National Institute of Child Health and Human Development,

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

12. National Institute of Child Health and Human Development; Notice of Meeting

NOTICES: National Institute of Child Health and Human Development,

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of a meeting of the National Advisory Child Health and Human Development Council.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

13. Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Medical Device Shortage

NOTICES: Proposed collection; comment request,

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

14. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Participation

NOTICES: Submission for OMB review; comment request,

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

15. International Conference on Harmonisation; Draft Guidance on the M4 Common Technical Document--Quality: Questions and

NOTICES: M4 common technical document; quality; questions and answers/location issues,

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Common Technical Document Quality: Questions and Answers/Location Issues.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

16. Determination That Diazepam Autoinjector Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

NOTICES: New drug applications—; Diazepam Autoinjector,

The Food and Drug Administration (FDA) has determined that Diazepam Autoinjector (diazepam for injection) 5 milligrams per milliliter
[[Page 79641]]
(mg/mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diazepam for injection 5 mg/mL.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

17. Citizens Advisory Committee on Public Health Service (PHS) Activities and Research at Department of Energy (DOE)

NOTICES: Public Health Service Activities and Research at DOE Sites Citizens Advisory Committee,

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC) announce the following meeting.

Name: Citizens Advisory Committee on PHS Activities and Research at DOE Sites: Oak Ridge Reservation

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Toxic Substances and Disease Registry

18. Proposed Data Collections Submitted for Public Comment and Recommendations

NOTICES: Proposed collection; comment request,

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

19. Agency Forms Undergoing Paperwork Reduction Act Review

NOTICES: Submission for OMB review; comment request,

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

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

20. National Vaccine Advisory Committee, Subcommittee on Future Vaccines, Subcommittee on Immunization Coverage, and

NOTICES: National Vaccine Advisory Committee,

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 Federal advisory committee meetings.

Name: National Vaccine Advisory Committee (NVAC).

Times and Dates: 9 a.m.5 p.m., February 4, 2003; 8:30 a.m.3 p.m., February 5, 2003.

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

21. Medicare Program; Renewal and Amendment of the Charter of the Medicare Coverage Advisory Committee (MCAC)

NOTICES: Medicare Coverage Advisory Committee,

This notice announces the renewal and amendment of the Charter of the Medicare Coverage Advisory Committee (the Committee). The Committee advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on whether adequate evidence exists to determine whether
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

22. Service of Process: Amendment for Materials Related to Petitions Under the National Vaccine Injury Compensation

RULES: National Vaccine Injury Compensation Program; materials related to petitions; service of process,

Current regulations regarding service of legal process provide that all service of process relating to petitions for compensation under the National Vaccine Injury Compensation Program (VICP) are to be sent to the Director, Bureau of Health Professions (BHPr), Health Resources and Services Administration (HRSA). Because the Acting Administrator,
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration

23. Notice of Hearing: Reconsideration of Disapproval of New Jersey State Plan Amendment 02-10

NOTICES: State plan amendments, reconsideration; hearings—; New Jersey,

This notice announces an administrative hearing to be held on February 4, 2003, 10 a.m., Centers for Medicare & Medicaid Services' New York Regional Office, 26 Federal Plaza, Room 38110A; New York, New York 102780063, to reconsider our decision to disapprove New Jersey State Plan Amendment 0210.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

24. Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--July 2002 Through September 2002

NOTICES: Program issuances and coverage decisions; quarterly listing,

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2002, through September 2002, relating to the Medicare and Medicaid programs. This notice also provides information on national coverage determinations affecting specific medical and health care
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

25. Medicare Program: National Medicare+Choice Risk Adjustment Public Meeting--February 3, 2003

NOTICES: Medicare+Choice organizations—; Risk adjustment; training sessions,

This notice announces a national Medicare+Choice risk adjustment public meeting for Medicare+Choice organizations, Medicare capitated demonstration projects, PACE plans, Evercare plans, Social Health Maintenance Organizations, Wisconsin Partnership program, Minnesota Senior Health Options, providers, practitioners, and other interested parties.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services
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