[Federal Register Volume 72, Number 104 (Thursday, May 31, 2007)]
[Notices]
[Page 30386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10515]



[[Page 30386]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-1651] (formerly Docket No. 99D-1651)


Guidance for Industry: Chemistry, Manufacturing, and Control 
Changes to an Approved New Animal Drug Application or Abbreviated New 
Animal Drug Application

AGENCY: Food and Drug Administration.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry (83) entitled 
``Chemistry, Manufacturing, and Control Changes to an Approved NADA or 
ANADA.'' This guidance is intended to provide recommendations to 
holders of new animal drug applications (NADAs) and abbreviated new 
animal drug applications (ANADAs) on how they should report certain 
changes to such applications, in accordance with the final regulation, 
21 CFR 514.8, which was issued in the Federal Register of December 13, 
2006 (71 FR 74766).

DATES: Comments on agency guidances are welcome at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
document 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 request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document. Submit written comments 
on the guidance document to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:  Dennis Bensley, Jr., Center for 
Veterinary Medicine (HFV-140), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-6956, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 1, 1999 (64 FR 53281), FDA 
published a proposed rule to implement section 506A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356a) for NADAs and ANDAs. In 
that same issue of the Federal Register (64 FR 53393), FDA published a 
notice announcing the availability of a draft guidance for industry 
entitled ``Chemistry, Manufacturing, and Control Changes to an Approved 
NADA or ANADA,'' giving interested persons until December 15, 1999, to 
submit comments. FDA considered all comments received and, where 
appropriate, incorporated them into the guidance.
    This guidance covers recommended reporting categories for various 
postapproval manufacturing changes and provides recommendations to 
holders of NADAs and ANADAs on how they should report such changes in 
accordance with the final regulation, 21 CFR 514.8, issued in the 
Federal Register of December 13, 2006 (71 FR 74766). Recommendations 
are provided for postapproval changes in: (1) Components and 
composition, (2) manufacturing sites, (3) manufacturing process, (4) 
specifications, (5) container closure system, as well as (6) 
miscellaneous changes and (7) multiple related changes. This guidance 
does not provide recommendations on the specific information that 
should be developed by an applicant to assess the effect of the change 
on the identity, strength (e.g., assay, content uniformity), quality 
(e.g., physical, chemical, and biological properties), purity (e.g., 
impurities and degradation products), or potency (e.g., biological 
activity, bioavailability, bioequivalence) of a drug as these factors 
may relate to the safety or effectiveness of the drug. An applicant 
should consider all relevant FDA guidance documents for recommendations 
on the information that should be submitted to support a given change.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This 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 method may be used as long as it 
satisfies the requirements of 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 sections II through XI of the guidance 
have been approved under OMB Control No. 0910-0600.

IV. Comments

    As with all of FDA's guidance, the public is encouraged to submit 
written or electronic comments with new data or other new information 
pertinent to this guidance. FDA periodically will review the comments 
in the docket and, where appropriate, will amend the guidance. The 
agency will notify the public of any such amendments through a notice 
in the Federal Register.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments should be identified with the full title of the guidance 
document and the docket number found in brackets in the heading of this 
document. A copy of the document and 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 a copy of the 
guidance document entitled ``Chemistry, Manufacturing and Control 
Changes to an Approved NADA or ANADA'' from the CVM home page at http://www.fda.gov/cvm.

    Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10515 Filed 5-30-07; 8:45 am]
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