[Federal Register Volume 64, Number 190 (Friday, October 1, 1999)]
[Notices]
[Pages 53393-53394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25492]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1651]
Guidance for Industry: Chemistry, Manufacturing and Control
Changes to an Approved NADA or ANADA; 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availability of a draft guidance entitled ``Guidance for Industry:
Chemistry, Manufacturing and Control Changes to an Approved NADA or
ANADA.'' This draft guidance is intended to provide recommendations to
holders of new animal drug applications (NADA's) and abbreviated new
animal drug applications (ANADA's) on how they should report changes to
such applications in accordance with proposed amended regulations that
are found elsewhere in this issue of the Federal Register.
DATES: Written comments should be submitted by December 15, 1999.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine (CVM), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
the office in processing your requests. Submit written comments to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be
identified with the full title of the draft guidance and the docket
number found in brackets in the heading of this document. See the
SUPPLEMENTARY INFORMATION section of this document for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Dennis M. Bensley, Office of New
Animal Drug Evaluation (HFV-140), Center for Veterinary Medicine, Food
[[Page 53394]]
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
827-6956.
SUPPLEMENTARY INFORMATION:
I. Background
Section 116 of the Food and Drug Administration Modernization Act
(the Modernization Act) amended the Federal Food, Drug, and Cosmetic
Act (the act) by adding section 506A (21 U.S.C. 356a). This section
provides requirements for making and reporting manufacturing changes to
an approved application and for distributing a drug product made with
such change. Elsewhere in this issue of the Federal Register, FDA is
proposing to amend its regulations on supplements and other changes to
an approved application Sec. 514.8 (21 CFR 514.8) to conform to section
506A of the act.
The purpose of this draft guidance is to provide recommendations to
holders of NADA's and ANADA's who intend to make postapproval changes
in accordance with section 506A of the act and the proposed amended
regulations at Sec. 514.8. The draft guidance covers recommended
reporting categories for postapproval changes for new animal drugs.
Recommendations are provided for postapproval changes in: (1)
Components and composition, (2) sites, (3) manufacturing process, (4)
specification(s), (5) package, and (6) miscellaneous changes. This
draft guidance does not provide recommendations on the specific
information that should be developed by an applicant to validate 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 product as they may relate to the safety or effectiveness of the
product. FDA has published guidances, including the Scale-up and
Postapproval Changes (SUPAC) guidances, that provide recommendations on
reporting categories and/or the type of information that should be
developed by the applicant to validate the effect of the change on the
identity, strength, quality, purity, or potency of a product as they
may relate to the safety or effectiveness of the product. The draft
guidance, which cites proposed Sec. 514.8, will be revised based on
public comments and implemented for use as a companion document when
Sec. 514.8 is finalized.
This draft guidance represents the agency's current thinking on
this subject. 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 requirement of the
applicable statute, regulations, or both.
II. Comment
Interested persons may, on or before December 15, 1999, submit to
the Dockets Management Branch (address above) written comments
regarding the draft guidance. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. A copy of the draft guidance and received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
using the World Wide Web (WWW). For WWW access, connect to CVM at
``http://www.fda.gov/cvm''.
Dated: June 23, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-25492 Filed 9-30-99; 8:45 am]
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