Document ID: FDA-2011-D-0112-0004
Agency: fda
Document Type: Notice
Title: 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: 2012-03-08T05:00Z

[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Page 14022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5629]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, 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 guidance document.
    Submit electronic comments on the 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, email: 
michael.popek@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 14, 2011 (76 FR 13629), FDA 
published the notice of availability for a draft guidance entitled 
``Chemistry, Manufacturing, and Controls (CMC) Information--
Fermentation-Derived Intermediates, Drug Substances, and Related Drug 
Products for Veterinary Medicinal Use'' giving interested persons until 
May 30, 2011, to comment on the draft guidance. FDA received one 
comment on the draft guidance. No substantive changes were made in 
finalizing this guidance document.
    The guidance announced in this notice finalizes the draft guidance 
dated March 14, 2012.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance 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 guidance have been approved under 
OMB control number 0910-0032.

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. 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 guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5629 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P