[Federal Register Volume 63, Number 201 (Monday, October 19, 1998)]
[Notices]
[Pages 55876-55877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27888]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0514]
Draft Guidance for Industry on ANDA's: Impurities in Drug
Substances; Availability; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until
November 23, 1998, the comment period for the draft guidance for
industry entitled ``ANDA's: Impurities in Drug Substances.'' FDA
published a notice of availability of the draft guidance in the Federal
Register of July 24, 1998 (63 FR 39880). FDA is taking this action in
response to several requests for an extension.
DATES: Written comments on the draft guidance may be submitted by
November 23, 1998. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of the draft guidance are available on the Internet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requests for single copies of the draft guidance to the Drug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 that office in
processing your requests. Submit written comments on the draft
[[Page 55877]]
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments are to be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Robert W. Trimmer, Office of Generic
Drugs, Center for Drug Evaluation and Research (HFD-625), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855-2737, 301-827-
5848.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 24, 1998
(63 FR 39880), FDA published a notice announcing the availability of a
draft guidance for industry entitled ``ANDA's: Impurities in Drug
Substances.'' The draft guidance provides recommendations for including
information in abbreviated new drug applications and supporting drug
master files on the content and qualification of impurities in drug
substances produced by chemical syntheses for both monograph and
nonmonograph drug substances. Interested persons were given until
September 22, 1998, to submit written comments on the draft guidance.
On August 4, 1998, FDA received a letter from Perrigo requesting
that the agency extend the comment period on the draft guidance 120
days. On August 10, 1998, FDA received a letter from the National
Association of Pharmaceutical Manufacturers requesting that the agency
extend the comment period on the draft guidance 60 days. On September
4, 1998, FDA received a letter from the Generic Pharmaceutical Industry
Association requesting that the agency extend the comment period on the
draft guidance 60 days.
This draft guidance is complex and introduces a number of new
issues. Therefore, the agency has decided to reopen the comment period
on the draft guidance until November 23, 1998, to allow the public more
time to review and comment on its contents.
Interested persons may, on or before November 23, 1998, submit to
the Dockets Management Branch (address above) written comments on the
draft guidance. 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 are available for
public examination in the Dockets Management Branch between 9 a.m. and
4 p.m., Monday through Friday.
Dated: October 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-27888 Filed 10-16-98; 8:45 am]
BILLING CODE 4160-01-F
