[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Draft Guidance for Industry on ANDA's: Impurities in Drug 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November 23, 1998, the comment period for the draft guidance for 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published a notice of availability of the draft guidance in the Federal 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DATES:  Written comments on the draft guidance may be submitted by 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ADDRESSES:  Copies of the draft guidance are available on the Internet 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requests for single copies of the draft guidance to the Drug 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draft guidance for industry entitled ``ANDA's: Impurities in Drug 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 The draft guidance provides recommendations for including 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]
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