[Federal Register Volume 67, Number 34 (Wednesday, February 20, 2002)]
[Notices]
[Page 7704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0003]


Draft Guidance for Industry on Exercise-Induced Bronchospasm 
(EIB)--Development of Drugs to Prevent EIB; 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availability of a draft guidance for industry entitled ``Exercise-
Induced Bronchospasm (EIB)--Development of Drugs to Prevent EIB.'' The 
draft guidance is intended to assist sponsors in developing clinical 
trials for drugs that prevent EIB. The draft guidance addresses the 
types of trials that should be performed. It also discusses such issues 
as exercise testing, efficacy end points, and statistical analyses.

DATES: Submit written or electronic comments on the draft guidance by 
April 22, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the 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draft guidance to the Dockets Management Branch (HFA-305), Food and 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draft guidance document.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: Sandra L. Barnes, Center for Drug 
Evaluation and Research (HFD-570), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1050.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Exercise-Induced Bronchospasm (EIB)--Development of Drugs to 
Prevent EIB.'' This draft guidance is intended to assist sponsors in 
designing clinical development programs to achieve an indication for 
the ``prevention'' of EIB. Drugs that are given chronically to control 
asthma may also lessen the propensity to develop EIB, as a general 
consequence of decreasing bronchial hyperreactivity. An important 
distinction is made, however, between such chronically administered 
drugs and shorter acting drugs that are given acutely to prevent or 
treat EIB. This guidance document is intended to provide trial design 
suggestions to help guide sponsors who are interested in developing 
drugs that are given acutely to prevent EIB.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on EIB and the 
development of drugs to prevent EIB. 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. 
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 30, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-4090 Filed 2-19-02; 8:45 am]
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