[Federal Register Volume 64, Number 123 (Monday, June 28, 1999)]
[Notices]
[Pages 34660-34661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0529]


Draft Guidance for Industry on Changes to an Approved NDA or 
ANDA; 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availability of a draft guidance for industry entitled ``Changes to an 
Approved NDA or ANDA.'' This draft guidance is intended to assist 
applicants in determining how they should report changes to an approved 
NDA or ANDA under the proposed revision to the drug regulations 
pertaining to supplements and other changes to an approved application 
published elsewhere in this issue of the Federal Register.

DATES: Written comments may be submitted on the draft guidance document 
by August 27, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm''. Submit written 
requests for single copies of the draft guidance for industry to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send one self-addressed adhesive label to assist the office 
in processing your requests. Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research (HFD-357), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5633.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Changes to an Approved New Drug 
(NDA) or Abbreviated New Drug (ANDA) Application.''
    On November 21, 1997, the President signed the Food and Drug 
Administration Modernization Act (the Modernization Act) (Pub. L. 105-
115). Section 116 of the Modernization Act amended the Federal Food, 
Drug, and Cosmetic Act (the act) by adding section 506A (21 U.S.C. 
356a), which provides requirements for making and reporting 
manufacturing changes to an approved application and for distributing a 
drug product made with such changes. FDA is proposing to amend its 
regulations entitled Supplements and other changes to an approved 
application at Sec. 314.70 (21 CFR 314.70) to conform to section 506A 
of the act. This proposed rule is published elsewhere in this issue of 
the Federal Register.
    The purpose of this draft guidance is to provide recommendations to 
holders of NDA's and ANDA's who intend to make postapproval changes in 
accordance with section 506A of the act and the proposed amended 
regulations at Sec. 314.70. This draft guidance covers recommended 
reporting categories for postapproval changes for drugs, other than 
specified biotechnology and specified synthetic biological products. 
Recommendations are provided for postapproval changes in: (1) 
Components and composition, (2) sites, (3) manufacturing process, (4) 
specification(s), (5) package, (6) labeling, and (7) miscellaneous 
changes. This guidance does not provide recommendations on the specific 
information that should be developed by the 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.
    The guidance document, which cites the proposed rule for amending 
Sec. 314.70, will be revised based on public comments and implemented 
for use as a companion document to Sec. 314.70 when the rule is 
finalized. FDA welcomes comments that provide additional examples of 
major, moderate, and minor changes.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). This guidance 
document represents the agency's current thinking on reporting 
categories for postapproval changes of drugs, other than specified 
biotechnology and specified synthetic biological products. 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.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). 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. The draft guidance 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.


[[Page 34661]]


    Dated: March 25, 1999.

William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-16190 Filed 6-25-99; 8:45 am]
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