[Federal Register: May 31, 2007 (Volume 72, Number 104)]
[Notices]
[Page 30386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31my07-86]
[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
dennis.bensley@fda.hhs.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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