[Federal Register Volume 67, Number 52 (Monday, March 18, 2002)]
[Notices]
[Pages 12021-12022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6319]


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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Draft Guidance for Industry on Developing Drugs To Treat 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availability of a draft guidance for industry entitled ``Inhalational 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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://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access to the draft guidance document.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    FDA is announcing the availability of a draft guidance for industry 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://www.fda.gov/cder/guidance/index.htm or 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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