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Agency: Food and Drug Administration

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The Federal Register
200020012002200320042005200620072008

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1. New Animal Drugs for Use in Animal Feeds; Decoquinate and Monensin

RULES: Decoquinate and Monensin,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for use of approved, singleingredient decoquinate and monensin Type A medicated articles to make twoway combination drug Type B and Type C medicated
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Grated Parmesan Cheese Deviating From Identity Standard; Temporary Permit for Market Testing; Extension of Temporary

NOTICES: Identity standards deviation; market testing permits—; Kraft foods, Inc.; grated parmesan cheese,

The Food and Drug Administration (FDA) is announcing the extension of a temporary permit issued to Kraft Foods, Inc., to market test products designated as ``100% Grated Parmesan Cheese'' that deviate from the U.S. standards of identity for parmesan cheese and grated cheese. The extension will allow the permit holder to continue to collect data on
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Veterinary Antimicrobial Decision Support System

NOTICES: Veterinary antimicrobial decision support system,

The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announces that funds may be available to support an unsolicited grant application submitted by Iowa State University. The applicant has requested funds to develop a webbased, peerreviewed antimicrobial decision support system centered on therapeutic applications that will
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria

NOTICES: Test procedures and acceptance criteria for new drug substances and new drug products; chemical substances; Q6A specifications,

The Food and Drug Administration (FDA) is publishing a guidance entitled ``Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.'' The 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

5. Cooperative Arrangement Between the United States Food and Drug Administration and Therapeutic Goods Administration,

NOTICES: Human pharmaceutical facilities, good manufacturing practice inspections; information exchange; U.S. FDA and Australian Therapeutic Goods Administration,

The Food and Drug Administration (FDA) is providing notice of cooperative arrangement between the Food and Drug Administration, Department of Health and Human Services, United States of America and the Therapeutic Goods Administration, Department of Health and Aged Care, Commonwealth of Australia. The purpose of the arrangement is to enable each
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. Use of Antimicrobial Drugs in Food Animals and Establishment of Regulatory Thresholds on Antimicrobial Resistance;

NOTICES: Food-producing animals; resistance and monitoring thresholds establishment,

The Food and Drug Administration (FDA) is amending an announcement of the following meeting: Use of Antimicrobial Drugs in Food Animals and Establishment of Regulatory Thresholds on Antimicrobial Resistance. The topic to be discussed is the Center for Veterinary Medicine's (CVM's) current thinking on concepts for the establishment of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. Electronic Investigational New Drug Application: Cumulative Table of Contents; Public Meeting

NOTICES: Investigational new drug applications; electronic submission using XML to create cumulative table of contents,

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the possibility of using extensible markup language (XML) to create a cumulative table of contents for investigational new drug applications (IND's) intended to be submitted electronically to the Center for Biologics Evaluation and Research (CBER) or the Center for
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Discussion Paper: An Approach for Establishing Thresholds in Association With the Use of Antimicrobial Drugs in

NOTICES: Antimicrobial drugs use in food-producing animals; thresholds establishment; discussion paper,

The Food and Drug Administration (FDA) is announcing the availability of a discussion paper entitled ``An Approach for Establishing Thresholds in Association With the Use of Antimicrobial Drugs in FoodProducing Animals (discussion paper).'' This discussion paper reflects the Center for Veterinary Medicine's (CVM's) current thinking on one concept
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

9. Drugs for Human Use

RULES: Miscellaneous CFR corrections,

CFR Correction

In Title 21 of the Code of Federal Regulations, parts 300 to 499, revised as of April 1, 2000, make the following corrections:

1. On page 56, Sec. 310.545 is corrected by adding paragraph (d)(2) to read as follows:
Sec. 310.545 Drug products containing certain active ingredients offered overthecounter (OTC) for certain uses.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

10. Protection of Human Subjects

RULES: Definitions; CFR correction,

CFR Correction

In Title 21 of the Code of Federal Regulations, parts 1 to 99, revised as of April 1, 2000, on page 278, Sec. 50.3 is corrected by removing and reserving paragraph (b)(11).
[FR Doc. 0055520 Filed 122600; 8:45 am] BILLING CODE 150501D

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

11. Cooperative Agreement to Support the Shellfish and Seafood Safety Assistance Project; Notice to Accept and Consider a

NOTICES: Interstate Shellfish Sanitation Conference,

The Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Seafood (OS) is announcing its intent to award, noncompetitively, a cooperative agreement to the Interstate Shellfish Sanitation Conference (ISSC) in the amount of $275,000 for the first year. Subject to the availability of Federal funds and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

12. Anti-Infective Drugs Advisory Committee; Notice of Meeting

NOTICES: Anti-Infective 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: AntiInfective 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

13. Antiviral Drugs Advisory Committee; Notice of Meeting

NOTICES: Antiviral 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: Antiviral Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

14. Antiviral Drugs Advisory Committee; Notice of Meeting

NOTICES: Antiviral 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: Antiviral Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

15. Arthritis Advisory Committee; Notice of Meeting

NOTICES: Arthritis 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: Arthritis Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

16. Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and

NOTICES: Ranch Hand 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: Advisory Committee on Special Studies Relating to the Possible LongTerm Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee).

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

17. Transmissible Spongiform Encephalopathies (TSE) Advisory Committee; Notice of Meeting

NOTICES: Transmissible Spongiform Encephalopathies Advisory Committee,

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Transmissible Spongiform Encephalopathies (TSE) Advisory Committee.

General Function of the Committee: To provide advice and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

18. Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

NOTICES: Vaccines and Related Biological Products 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: Vaccines and Related Biological Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

19. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Adverse Experience Reporting

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

20. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Threshold of Regulation for

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

21. Agency Information Collection Activities; Proposed Collection; Comment Request; Transmittal of Advertising and

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

22. Agency Information Collection Activities; Announcement of OMB Approval; Medicated Feed Mill License

NOTICES: Reporting and recordkeeping requirements,

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medicated Feed Mill License'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

23. Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry on How to Use E-Mail to

NOTICES: Reporting and recordkeeping requirements,

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on How to Use EMail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

24. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry: Changes

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

25. Food Additives Permitted for Direct Addition to Food for Human Consumption; Polydextrose

RULES: Polydextrose,

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polydextrose as a bulking agent, texturizer, or both in fruit and water ices. This action is in response to a petition filed by Pfizer, Inc.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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