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RULES: Decoquinate and Monensin,
Published: 2000-12-29
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
NOTICES: Identity standards deviation; market testing permits—; Kraft foods, Inc.; grated parmesan cheese,
Published: 2000-12-29
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
NOTICES: Veterinary antimicrobial decision support system,
Published: 2000-12-29
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
NOTICES: Test procedures and acceptance criteria for new drug substances and new drug products; chemical substances; Q6A specifications,
Published: 2000-12-29
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
NOTICES: Human pharmaceutical facilities, good manufacturing practice inspections; information exchange; U.S. FDA and Australian Therapeutic Goods Administration,
Published: 2000-12-29
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
NOTICES: Food-producing animals; resistance and monitoring thresholds establishment,
Published: 2000-12-29
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
NOTICES: Investigational new drug applications; electronic submission using XML to create cumulative table of contents,
Published: 2000-12-29
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
NOTICES: Antimicrobial drugs use in food-producing animals; thresholds establishment; discussion paper,
Published: 2000-12-29
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
RULES: Miscellaneous CFR corrections,
Published: 2000-12-27
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.
RULES: Definitions; CFR correction,
Published: 2000-12-27
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
NOTICES: Interstate Shellfish Sanitation Conference,
Published: 2000-12-27
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
NOTICES: Anti-Infective Drugs Advisory Committee,
Published: 2000-12-27
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.
NOTICES: Antiviral Drugs Advisory Committee,
Published: 2000-12-27
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
NOTICES: Antiviral Drugs Advisory Committee,
Published: 2000-12-27
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
NOTICES: Arthritis Advisory Committee,
Published: 2000-12-27
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
NOTICES: Ranch Hand Advisory Committee,
Published: 2000-12-27
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).
NOTICES: Transmissible Spongiform Encephalopathies Advisory Committee,
Published: 2000-12-27
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
NOTICES: Vaccines and Related Biological Products Advisory Committee,
Published: 2000-12-27
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
NOTICES: Submission for OMB review; comment request,
Published: 2000-12-26
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.
NOTICES: Submission for OMB review; comment request,
Published: 2000-12-26
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.
NOTICES: Proposed collection; comment request,
Published: 2000-12-21
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
NOTICES: Reporting and recordkeeping requirements,
Published: 2000-12-21
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.
NOTICES: Reporting and recordkeeping requirements,
Published: 2000-12-21
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.
NOTICES: Submission for OMB review; comment request,
Published: 2000-12-21
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.
RULES: Polydextrose,
Published: 2000-12-20
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.