[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availability of a draft guidance entitled ``Guidance for Industry: 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 This draft guidance is intended to provide recommendations to 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ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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identified with the full title of the draft guidance and the docket 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access to the draft guidance.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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