[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]

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