[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Notices]
[Page 56799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4328]


Draft Guidance for Industry on Developing Antimicrobial Drugs to 
Treat Catheter-Related Bloodstream Infections; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Catheter-
Related Bloodstream Infections--Developing Antimicrobial Drugs for 
Treatment.'' This draft guidance is one in a series of guidances being 
developed to assist pharmaceutical manufacturers in developing 
antimicrobial drug products.

DATES: Written comments on the draft guidance may be submitted by 
December 20, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 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written requests for single copies of the draft guidance entitled 
``Catheter-Related Bloodstream Infections--Developing Antimicrobial 
Drugs for Treatment'' 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comments on the draft guidance to the Dockets Management Branch (HFA-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.

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: FDA is announcing the availability of a 
draft guidance for industry entitled ``Catheter-Related Bloodstream 
Infections--Developing Antimicrobial Drugs for Treatment.'' This is one 
of a series of guidances under development to assist manufacturers in 
planning the necessary clinical studies and designing and implementing 
the clinical protocols for drug products to treat infections. This 
draft guidance discusses catheter-related bloodstream infections, i.e., 
bloodstream infections resulting from an infected vascular access 
device or contaminated infusate. The issues raised in this draft 
guidance will be discussed at a meeting of the Anti-Infective Drugs 
Advisory Committee, scheduled for October 20, 1999 (64 FR 54335, 
October 6, 1999).
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on catheter-related 
bloodstream infections. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Interested persons may submit written comments on the draft 
guidance 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 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 15, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy.
[FR Doc. 99-27580 Filed 10-19-99; 11:59 am]
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