Document ID: FDA-2011-D-0112-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Availability: Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use
Posted Date: 2011-03-14T04:00Z

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Page 13629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0112]

Draft Guidance for Industry on Chemistry, Manufacturing, and 
Controls Information--Fermentation-Derived Intermediates, Drug 
Substances, and Related Drug Products for Veterinary Medicinal Use; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry 216 entitled 
``Chemistry, Manufacturing, and Controls (CMC) Information--
Fermentation-Derived Intermediates, Drug Substances, and Related Drug 
Products for Veterinary Medicinal Use''. The purpose of this document 
is to provide recommendations on what documentation to submit to 
support the CMC information for fermentation-derived intermediates, 
drug substances, and related drug products for veterinary medicinal 
use.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 30, 2011.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine 
(CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855. Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael J. Popek, Center for 
Veterinary Medicine (HFV-144), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8269, e-mail: 
michael.popek@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
216 entitled ``Chemistry, Manufacturing, and Controls (CMC) 
Information--Fermentation-Derived Intermediates, Drug Substances, and 
Related Drug Products for Veterinary Medicinal Use.'' This draft 
guidance provides recommendations on what documentation to submit to 
support the CMC information for fermentation-derived intermediates, 
drug substances, and related drug products for veterinary medicinal 
use. This information is filed to CVM in a new animal drug application 
(NADA), conditional NADA, investigational new animal drug file, 
abbreviated NADA, generic investigational new animal drug file, drug 
master file, or veterinary master file.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this draft guidance have been approved 
under OMB control number 0910-0032 (expiration date April 30, 2011).

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5816 Filed 3-11-11; 8:45 am]
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