[Federal Register Volume 63, Number 163 (Monday, August 24, 1998)]
[Notices]
[Page 45075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22565]



[[Page 45075]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
 [Docket No. 98D-0362]


Draft Guidance for Industry on Stability Testing of Drug 
Substances and Drug Products; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
December 8, 1998, the comment period for the draft guidance for 
industry entitled ``Stability Testing of Drug Substances and Drug 
Products.'' The draft guidance provides recommendations regarding the 
stability studies that should be performed to support new drug 
applications (NDA's), abbreviated new drug applications (ANDA's), 
investigational new drug applications (IND's), biologics license 
applications (BLA's), product license applications (PLA's), and 
supplements to these applications. FDA published a notice of 
availability of the draft guidance in the Federal Register of June 8, 
1998 (63 FR 31224). FDA is taking this action in response to several 
requests for an extension.
DATES: Written comments on the draft guidance may be submitted by 
December 8, 1998. General comments on the draft guidance are welcome at 
any time.

ADDRESSES: Copies of the draft guidance for industry are available on 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written requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 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: Kenneth J. Furnkranz, 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 June 8, 1998 (63 
FR 31224), FDA published a notice announcing the availability of a 
draft guidance for industry entitled ``Stability Testing of Drug 
Substances and Drug Products.'' The draft guidance provides 
recommendations regarding the stability studies that should be 
performed to support NDA's, ANDA's, IND's, BLA's, PLA's, and 
supplements to these applications. Interested persons were given until 
September 9, 1998, to submit written comments on the draft guidance.
    On June 18, 1998, FDA received a letter from Perrigo requesting 
that the agency extend the comment period on the draft guidance 120 
days. On June 29, 1998, FDA received a letter from Pharmaceutical 
Research and Manufacturers of America requesting that the agency extend 
the comment period on the draft guidance 90 days.
    This draft guidance is long and complex and introduces a number of 
new issues. Therefore the agency has decided to extend the comment 
period on the draft guidance to December 8, 1998, to allow the public 
more time to review and comment on its contents.
    Interested persons may, on or before December 8, 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: August 12, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-22565 Filed 8-21-98; 8:45 am]
BILLING CODE 4160-01-F