[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Draft Guidance for Industry on Developing Antimicrobial Drugs to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availability of a draft guidance for industry entitled ``Catheter-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 This draft guidance is one in a series of guidances being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DATES: Written comments on the draft guidance may be submitted by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ADDRESSES: Copies of this draft guidance for industry are available on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written requests for single copies of the draft guidance entitled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comments on the draft guidance to the Dockets Management Branch (HFA-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draft guidance for industry entitled ``Catheter-Related Bloodstream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draft guidance discusses catheter-related bloodstream infections, i.e.,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]
BILLING CODE 4160-01-F
