[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availability of a general draft guidance for industry entitled 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