[Federal Register Volume 63, Number 213 (Wednesday, November 4, 1998)]
[Notices]
[Page 59569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29515]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 98N-0517 and 98D-0548]
Development and Use of Guidances on Antimicrobial Drug Products;
Draft Guidances for Industry on the Development of Antimicrobial Drug
Products; 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
January 29, 1999, the comment period for two Federal Register notices
regarding guidance documents on developing antimicrobial drug products:
A notice requesting comment on the agency's process for developing and
using guidance documents on the development of antimicrobial drug
products (63 FR 39096, July 21, 1998) and a notice announcing the
availability of a general draft guidance for industry entitled
``Developing Antimicrobial Drugs--General Considerations for Clinical
Trials'' and 17 draft guidances on developing antimicrobial drug
products to treat individual indications (63 FR 40532, July 29, 1998).
FDA is reopening the comment period for both notices to provide
interested persons additional time for review and comment.
DATES: Written comments by January 29, 1999. General comments on agency
guidance documents are welcome at any time.
ADDRESSES: Copies of the 18 draft guidances 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 guidances 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
guidances 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: Renata Albrecht, Center for Drug
Evaluation and Research (HFD-590), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2336.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 21, 1998 (63
FR 39096), FDA's Center for Drug Evaluation and Research (CDER)
published a notice requesting comments on the development and use of
guidance documents for antimicrobial drug products. CDER requested
comment on the process the center is using to revise old and develop
new guidances for industry on the development of antimicrobial drug
products for the treatment of infections. In the Federal Register of
July 29, 1998 (63 FR 40532), CDER published a notice announcing the
availability of a general draft guidance for industry entitled
``Developing Antimicrobial Drugs--General Considerations for Clinical
Trials'' and 17 draft guidances on issues related to developing
antimicrobial drug products to treat individual indications. The July
21 and July 29, 1998, notices invited interested persons to submit
written comments within 90 days.
The agency has decided to reopen the comment period for both
notices until January 29, 1999, in response to requests for additional
time for public review and comment on the documents because of the
large number of draft guidances that were issued at one time.
Interested persons may, on or before January 29, 1999, submit
written comments to the Dockets Management Branch (address above). 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 guidances
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 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-29515 Filed 11-3-98; 8:45 am]
BILLING CODE 4160-01-F