[Federal Register: February 7, 2002 (Volume 67, Number 26)]
[Notices]
[Page 5831-5832]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07fe02-71]
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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Draft Guidance for Industry on Available Therapy; Availability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availability of a draft guidance for industry entitled ``Available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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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access to the draft guidance document.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FDA is announcing the availability of a draft guidance for industry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]
BILLING CODE 4160-01-S