[Federal Register Volume 69, Number 224 (Monday, November 22, 2004)]
[Notices]
[Pages 67930-67931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0494]


Guidance for Industry on Changes to an Approved New Drug 
Application or Abbreviated New Drug Application; Specifications--Use of 
Enforcement Discretion for Compendial Changes

AGENCY: Food and Drug Administration.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Changes to an 
Approved NDA or ANDA; Specifications--Use of Enforcement Discretion for 
Compendial Changes.'' This guidance informs new drug application (NDA) 
and abbreviated new drug application (ANDA) holders of FDA's plan to 
use enforcement discretion with regard to the regulation on changes to 
an approved application. This regulation describes the filing 
requirement that a relaxation of acceptance criteria or deletion of a 
test to comply with an official compendium must be reported in a 
changes-being-effected-in-30-days supplement (CBE-30). FDA does not 
intend to take enforcement action if manufacturers continue to submit 
such changes in their annual reports. The use of enforcement discretion 
will give the agency time to clarify that some of these types of 
postapproval changes can be submitted in an annual report, rather than 
in a CBE-30. The agency intends to clarify this issue in an upcoming 
revision to a guidance for industry.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that 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. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: David J. Cummings, Center for Drug 
Evaluation and Research (HFD-357), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5187.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 8, 2004 (69 FR 18728), FDA 
published a final rule entitled ``Supplements and Other Changes to an 
Approved Application.'' In the same issue of the Federal Register (69 
FR 18768), FDA announced the availability of the guidance for industry 
entitled ``Changes to an Approved NDA or ANDA'' (the changes guidance). 
Under Sec.  314.70(c)(2)(iii) (21 CFR 314.70(c)(2)(iii)) of the final 
rule, the relaxation of an acceptance criterion or deletion of a test 
to comply with an official compendium that is consistent with FDA 
statutory and regulatory requirements must be submitted as a CBE-30 
(see section VIII.C.1.e of the changes guidance).
    FDA is issuing this guidance to explain that it is using 
enforcement discretion with regard to Sec.  314.70(c)(2)(iii) to 
address concerns raised by stakeholders. FDA plans to clarify that some 
of these types of changes can be submitted in an annual report, instead 
of a CBE-30 supplement, in a revision of the guidance for industry 
entitled ``Changes to an Approved NDA or ANDA; Questions and Answers.''
    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in

[[Page 67931]]

this guidance was approved under OMB Control No. 0910-0001 and 0910-
0032.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on these topics. 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 requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may at any time submit to the Division of 
Dockets Management written or electronic comments on the guidance (see 
ADDRESSES). Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The guidance and received 
comments may be seen 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://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: November 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25748 Filed 11-19-04; 8:45 am]
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