[Federal Register: February 20, 2002 (Volume 67, Number 34)]
[Notices]
[Page 7704]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe02-64]
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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Draft Guidance for Industry on Exercise-Induced Bronchospasm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availability of a draft guidance for industry entitled ``Exercise-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draft guidance is intended to assist sponsors in developing clinical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 The draft guidance addresses the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DATES: Submit written or electronic comments on the draft guidance by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draft guidance to the Dockets Management Branch (HFA-305), Food and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draft guidance document.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FDA is announcing the availability of a draft guidance for industry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 This draft guidance is intended to assist sponsors in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]
BILLING CODE 4160-01-S