[Federal Register: November 22, 2004 (Volume 69, Number 224)]
[Notices]
[Page 67930-67931]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no04-66]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://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: November 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-25748 Filed 11-19-04; 8:45 am]
BILLING CODE 4160-01-S