[Federal Register: April 8, 2004 (Volume 69, Number 68)]
[Notices]
[Page 18768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap04-133]
[[Page 18768]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1999D-0529]
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 revised guidance for industry entitled ``Changes to
an Approved NDA or ANDA.'' The guidance has been revised to conform to
the final rule amending the agency's regulations on changes to an
approved NDA or ANDA published elsewhere in this issue of the Federal
Register. The guidance is intended to assist applicants in determining
how they should report changes to an approved new drug application
(NDA) or an abbreviated new drug application (ANDA).
DATES: Written comments may be submitted at any time.
ADDRESSES: Copies of this guidance are available on the Internet at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm. Submit written requests for
single copies of this guidance 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 guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY
INFORMATION section of this document for electronic access to the
guidance document.
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. The e-mail address for
questions about content of the guidance is pac314_70@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On November 21, 1997, the President signed the Food and Drug
Administration Modernization Act of 1997 (the Modernization Act)
(Public Law 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. The agency's final rule amending
its regulations at Sec. 314.70 (21 CFR 314.70) to implement section
506A of the act is published elsewhere in this issue of the Federal
Register.
FDA is announcing the availability of a revised guidance for
industry entitled ``Changes to an Approved NDA or ANDA.'' In the
Federal Register of November 23, 1999 (64 FR 65716), FDA announced the
availability of a guidance of the same title (November 1999 guidance).
The November 1999 guidance has been revised to conform to the final
rule amending Sec. 314.70 and to include nonsubstantive corrections
and clarifications. This revised guidance supersedes the November 1999
guidance.
The purpose of the 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 Sec. 314.70. The 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 the following areas: (1) Components and composition, (2)
manufacturing sites, (3) manufacturing process, (4) specifications, (5)
container closure system, (6) labeling, (7) miscellaneous changes, and
(8) multiple related changes. The guidance does not provide
recommendations on the specific information that should be developed by
the 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 product as these factors may
relate to the safety or effectiveness of the product.
This level 1 guidance document is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). The guidance
represents the agency's current thinking on this topic. Insofar as this
guidance adjusts reporting categories under section 506A of the act and
Sec. 314.70, it does have binding effect.
FDA has established an e-mail address where applicants can send
questions about the content of the guidance (see FOR FURTHER
INFORMATION CONTACT), such as requests for clarification of information
in the guidance or requests for guidance on the reporting category for
a particular change the applicant wants to implement.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written comments on the guidance at any time. 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 guidance and
received comments are available for public examination in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: March 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7533 Filed 4-7-04; 8:45 am]
BILLING CODE 4160-01-S