[Federal Register: March 18, 2002 (Volume 67, Number 52)]
[Notices]
[Page 12021-12022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr02-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0002]
Draft Guidance for Industry on Developing Drugs To Treat
Inhalational Anthrax (Post-Exposure); 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availability of a draft guidance for industry entitled ``Inhalational
Anthrax (Post-Exposure)--Developing Antimicrobial Drugs.'' This
guidance focuses on the development of antimicrobial drugs for
administration to persons who have inhaled aerosolized Bacillus
anthracis, but who do not yet have the established disease. The
treatment goal would be to prevent development of the infection in such
persons.
DATES: Submit written or electronic comments on the draft guidance by
May 17, 2002. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.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:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Inhalational Anthrax (Post-Exposure)--Developing
Antimicrobial Drugs.'' This guidance focuses on the development of
antimicrobial drugs for administration to persons who have inhaled
aerosolized B. anthracis, but who do not yet have the established
disease. The treatment goal would be to prevent development of the
infection in such persons.
In the fall of 2001, B. anthracis, the bacterium that causes
anthrax, was used as a bioterrorism agent and sent through the U.S.
mail, resulting in cases of cutaneous and inhalational anthrax in New
York, New Jersey, the District of Columbia, Florida, and Connecticut.
Ciprofloxacin hydrochloride tablets, ciprofloxacin intravenous (IV)
solution, ciprofloxacin IV in 5 percent dextrose, ciprofloxacin IV in
0.9 percent saline, and ciprofloxacin oral suspension, which the agency
had approved in August 2000 for use in the management of patients who
have been exposed to aerosolized spores of B. anthracis, were used to
treat the potentially infected persons.
Because of the bioterrorism incident, the agency is encouraging the
development of additional antimicrobial agents to be used in the event
of inhalational exposure to B. anthracis. This guidance provides
recommendations on how to develop such agents. The guidance is intended
to assist applicants who wish to plan, design, conduct, and
appropriately monitor the studies, including clinical studies, for
drugs to treat persons exposed to B. anthracis. Applications submitted
to the agency based on studies conducted as recommended in this
guidance should yield the information necessary for the agency to
determine whether the antimicrobial under study is safe and effective
for use
[[Page 12022]]
in persons exposed to aerosolized B. anthracis who do not yet have
established disease.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance
represents the agency's current thinking on this topic. 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 statutes and
regulations.
II. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments on the draft guidance by
May 17, 2002. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
Dated: January 14, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6319 Filed 3-15-02; 8:45 am]
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