Document ID: FDA-2003-D-0243-0020
Agency: fda
Document Type: Notice
Title: Guidance For Industry; Availability: Drug Substance Chemistry, Manufacturing, and Controls Information
Posted Date: 2010-08-06T04:00Z

[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]               
[Page 47604-47605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au10-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-D-0243] (formerly 2003D-0571)

 
Guidance for Industry on Drug Substance Chemistry, Manufacturing, 
and Controls Information; 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 169 entitled ``Drug 
Substance Chemistry, Manufacturing, and Controls Information.'' This 
guidance provides recommendations on the chemistry, manufacturing, and 
controls (CMC) information for drug substances that should be submitted 
to support original new animal drug applications (NADAs) and 
abbreviated new animal drug applications (ANADAs). The guidance is 
structured to facilitate the preparation of applications submitted in 
Common Technical Document (CTD) format.

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 to http://www.regulations.gov. Submit 
written comments on the guidance to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Alem Ghiorghis, Center for Veterinary 
Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8266, email: alem.ghiorghis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 1, 2006 (71 FR 31194), FDA 
published the notice of withdrawal and revision of seven guidances. CVM 
made Level II revisions to draft guidance entitled ``Drug Substance 
Chemistry, Manufacturing, and Controls

[[Page 47605]]

Information'' to support their continued use in CVM for the approval of 
new animal drugs (e.g., removed references to human drug and biological 
products). The guidance announced in this notice finalizes the draft 
guidance dated June 1, 2006.

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 represents 
the agency's current thinking on the 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 section 512 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360b) have been approved under OMB Control 
No. 0910-0032.

IV. Comments

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

    Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19360 Filed 8-5-10; 8:45 am]
BILLING CODE 4160-01-S