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Table of Contents
Guidance Documents
Under Development
Purpose
Legal Effect
How to Comment
Obtaining Copies
Additional Information
CFR Citations
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CVM Guidance Documents Under Development
(expected to publish as drafts or finals during the next
year)
Introduction
In November 1999, FDA announced the publication of a guidance
agenda and committed to publishing, on a semiannual basis, possible
guidance topics or documents for development or revision during
the next year, and asked for public comment on additional ideas
for new guidance documents or revisions to existing ones (64
FR 6881). In September 2000, the agency stated it would publish
such a list annually (64 FR 56477). Since the publication of
the agency's guidance agenda in November 1999, we have received
requests from stakeholders to update the list.
The following list of guidance topics includes possible new
topics for guidance documents or revisions to existing guidance
documents that the CVM is considering. We currently intend to
fully develop guidance on each topic; however, the Center is
neither bound by this list of topics, nor required to issue
every guidance document on this list. We are not precluded from
developing guidance documents on topics not on this list. We
expect to update the list every 6 months.
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Docket No. 2004N-0234, OC 2004131. Annual Guidance Agenda.
Pages 41510-41540 [FR Doc. 04-15660] July 9, 2004 [TXT]
[PDF]
Comments by July 9, 2006
To Comment on Guidance Documents Under
Development
Comments on this CVM list, such as the presence or absence
of a specific guidance topic/document, or ideas for topics not
on the list may be sent to Dockets Management Branch (HFA-305),
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Such comments
should refer to Docket Number 98D-0928.
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I. Center for Veterinary Medicine
(CVM) |
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Category - New Animal Drug Applications
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| 1. Administrative New Animal
Drug Application Process (#132) |
Gail Schmerfeld, Center for Veterinary
Medicine (HFV- 100), Food and Drug Administration, 7500
Standish Place, Rm. 384, MPN2, Rockville, MD 20855, 301-827-1796,
gschmer1@cvm.fda.gov. |
| 2. Waivers of In Vivo Demonstration of
Bioequivalence of Certain Animal Drugs in Soluble Powder
Oral Dosage Form Products and Type A Medicated Articles
(#171) |
Marilyn Martinez, Center for Veterinary Medicine (HFV-
130), Food and Drug Administration, 7500 Standish Place,
Rm. 332, MPN-2, Rockville, MD 20855, 301-827-7577, mmartin1@cvm.fda.gov. |
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| Category - Labeling |
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3. Manufacture and Labeling of Raw Meat Diets for Consumption
by Dogs, Cats, and Captive Non-companion Animal Carnivores
and Omnivores (#122) |
William Burkholder, Center for Veterinary Medicine
(HFV-228), Food and Drug Administration, 7500 Standish
Place, Rm. 413, MPN-2, Rockville, MD 20855, 301-827-0179,
bburkhol@cvm.fda.gov. |
4. Content and Format for Labeling of New Animal Drug
Products (#134)
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Douglass Oeller, Center for Veterinary Medicine (HFV-112),
Food and Drug Administration, 7500 Standish Place, Rm.
324, MPN-2, Rockville, MD 20855, 301-827-0131, doeller@cvm.fda.gov. |
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| Category –
Statutory Requirements |
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| 5. Dispute Resolution – FDA Modernization
Act (#79) |
Marcia Larkins, Center for Veterinary Medicine (HFV-1),
Food and Drug Administration, 7519 Standish Place, Rm.
165, MPN-4, Rockville, MD 20855, 301-827-4535, mlarkins@cvm.fda.gov. |
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| 6. Animal Drug Sponsor Fees
Under the Animal Drug User Fee Act (#173) |
David Newkirk, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500
Standish Place, Rm. 390, MPN-2, Rockville, MD 20855, 301-827-6967,
dnewkirk@cvm.fda.gov. |
| 7. Chemistry, Manufacturing,
and Control Changes to an Approved NADA or ANADA (#83) |
Dennis Bensley, Center for Veterinary
Medicine (HFV-143), Food and Drug Administration, 7500
Standish Place, Rm. 320, MPN-2, Rockville, MD 20855, 301-827-6956,
dbensley@cvm.fda.gov. |
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| Category –
International Harmonization |
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| 8. GL-27: Pre-Approval Information
for Registration of New Veterinary Medicinal Products
for Food-producing Animals with Respect to Antimicrobial
Resistance (#144) |
William T. Flynn, Center for Veterinary
Medicine (HFV-2), Food and Drug Administration, 7519 Standish
Place, Rm. 173, MPN-4, Rockville, MD 20855, 301-827-4514,
wflynn@cvm.fda.gov. |
| 9. GL-28: Studies to Evaluate the Safety
of Residues of Veterinary Drugs in Human Food: Carcinogenicity
Testing (#141) |
Thomas Mulligan, Center for Veterinary
Medicine (HFV-153), Food and Drug Administration, Rm.
E375, MPN2, 7500 Standish Place, Rockville, MD 20855,
301-827-6984, tmulliga@cvm.fda.gov. |
| 10. GL-33:Studies to Evaluate the Safety
of Residues of Veterinary Drugs in Human Food: General
Approach to Testing (#149) |
Thomas Mulligan, Center for Veterinary
Medicine (HFV-153), Food and Drug Administration, Rm.
E375, MPN2, 7500 Standish Place, Rockville, MD 20855,
301-827-6984, tmulliga@cvm.fda.gov. |
| 11. GL-36: Studies to evaluate the Safety
of Residues of Veterinary Drugs in Human Food: General
Approach to Establish a Microbiological ADI (#159) |
Thomas Mulligan, Center for Veterinary Medicine (HFV-153),
Food and Drug Administration, Rm. E375, MPN2, 7500 Standish
Place, Rockville, MD 20855, 301-827-6984, tmulliga@cvm.fda.gov. |
| 12. GL-37 Studies to Evaluate the Safety
of Residues of Veterinary Drugs in Human Food: Repeat-Dose
(Chronic) Toxicity Testing (#160) |
Thomas Mulligan, Center for Veterinary Medicine (HFV-153),
Food and Drug Administration, Rm. E375, MPN2, 7500 Standish
Place, Rockville, MD 20855, 301-827-6984, tmulliga@cvm.fda.gov. |
| 13. GL-38 Environmental Impact
Assessments for Veterinary Medicinal Products - Phase
II (#166) |
Charles Eirkson, Center for Veterinary
Medicine (HFV-103), Food and Drug Administration, Rm.
137, MPN4, 7500 Standish Place, Rockville, MD 20855, 301-827-8561,
ceirkson@cvm.fda.gov. |
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| Category –
Target Animal Safety and Effectiveness |
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| 14. Development of Target
Animal Safety and Effectiveness Data to Support Approval
of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for
use in Animals (#123) |
Linda Wilmot, Center for Veterinary Medicine
(HFV-114), Food and Drug Administration, 7500 Standish
Place, Rm. N316, MPN2, Rockville, MD 20855, 301-827-0135,
lwilmot@cvm.fda.gov. |
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| Category –
Human Food Safety |
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| 15. Dioxin in Minerals Used
in Animal Feed (#161)
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Gloria Dunnavan, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7500
Standish Place, Rm. E480, MPN2, Rockville, MD 20855, 301-827-1168,
gdunnava@cvm.fda.gov. |
| 16. Salmonella Contamination
of Feeds Compliance Policy Guide |
Henry Ekperigin, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7500
Standish Place, Rm. E417, MPN2, Rockville, MD 20855, 301-827-0174,
hekperig@cvm.fda.gov. |
| 17. BSE Compliance Program |
Neal Bataller, Center for Veterinary
Medicine, (HFV-230), Food and Drug Administration, 7500
Standish Place, Rm. E441, MPN2, Rockville, MD 20855, 301-827-0163,
nbatalle@cvm.fda.gov. |
| 18. Validation of Analytical
Procedures for Type C Medicated Feed (#135) |
Mary G. Leadbetter, Center for Veterinary
Medicine (HFV- 141), Food and Drug Administration, 7500
Standish Place, Rm. E307, MPN2, Rockville, MD 20855, 301-827-6964,
mleadbet@cvm.fda.gov. |
Updated
Tuesday, July13, 2004 at 11:06 AM ET - hd
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