[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Notices]
[Pages 5831-5832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0582]


Draft Guidance for Industry on Available Therapy; Availability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availability of a draft guidance for industry entitled ``Available 
Therapy.'' The document is intended to provide guidance to industry on 
the meaning of the term available therapy, as used by the Center for 
Drug Evaluation and Research (CDER) and the Center for Biologics 
Evaluation and Research (CBER).

DATES: Submit written or electronic comments on the draft guidance by 
April 8, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.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:   
    For information regarding human drug products: Janet Jones, Center 
for Drug Evaluation and Research (HFD-

[[Page 5832]]

040), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5445.
    For information regarding biological products: Karen Weiss, Center 
for Biologics Evaluation and Research (HFM-570), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1148, 301-827-
5093.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Available Therapy.'' Available therapy and related terms, 
such as existing treatments and existing therapy, appear in a number of 
regulations and policy statements issued by CDER and CBER, but these 
terms have never been formally defined by the agency. Some confusion 
has arisen regarding whether available therapy refers only to products 
approved by FDA for the use in question, or whether it could also refer 
to products used off-label or to treatments not regulated by FDA, such 
as surgery. The draft guidance document is intended to inform the 
public of the agency's interpretation of available therapy.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). It 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. 
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 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/guidelines.htm.

    Dated: January 25, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2948 Filed 2-6-02; 8:45 am]
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