[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13649-13650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7132]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97D-0099]
Draft Guidance for Industry: FDA Approval of New Cancer Treatment
Uses for Marketed Drug and Biological Products; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 13650]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled, ``Guidance for Industry: FDA
Approval of New Cancer Treatment Uses for Marketed Drug and Biological
Products.'' The draft guidance considers the quality and quantity of
data that may be adequate to add a new use to the prescribing
information for a product used in the treatment of cancer. The draft
guidance is part of the agency's ``New Use Initiative--Evidence for
Primary and Supplemental Approvals,'' which is exploring ways to
expedite the development of new and supplemental uses for drug and
biological products. Elsewhere in this issue of the Federal Register,
FDA is publishing a notice of availability of a draft guidance that
discusses what clinical evidence of efficacy should be provided in new
drug and biological product license applications as well as in
supplemental applications. The agency is seeking public comment on the
draft guidance.
DATES: Written comments on the draft guidance by May 20, 1997. General
comments on agency guidance documents may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: FDA Approval of New Cancer
Treatment Uses for Marketed Drug and Biological Products'' to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857;
or the Office of Communication, Training and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.
Send two self-addressed adhesive labels to assist the offices in
processing your requests. The draft guidance also may be obtained by
mail by calling the CBER Voice Information System at 1-800-835-4709 or
301-827-1800, or by facsimile by calling the FAX Information System at
1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance. Submit written
comments on the draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert J. Delap, Center for Drug
Evaluation and Research (HFD-150), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2473.
SUPPLEMENTARY INFORMATION:
I. Background
When drugs approved for one use prove safe and effective for
treating other conditions, information on the new use should be added
to the product labeling as soon as possible. FDA has launched the ``New
Use Initiative--Evidence for Primary and Supplemental Approvals'' to
explore ways the agency can improve the supplemental application
process. FDA believes it can expedite the development of new and
supplemental uses of drug and biological products by doing the
following: (1) Clarifying what evidence should be provided in primary
as well as supplemental applications and (2) working with industry to
reduce barriers to submitting applications for new uses for their
products.
Some of the information submitted in a supplemental application may
be available from the primary application. As a result, the agency
decided that its first step would be to clarify what information
sponsors should provide in applications in general. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of a
draft guidance entitled ``Guidance for Industry: Providing Clinical
Evidence of Effectiveness for Human Drug and Biological Products,'' The
draft guidance addresses the information that should be provided in new
drug and biological product license applications as well as
supplemental applications.
The draft guidance entitled ``Guidance for Industry: FDA Approval
of New Cancer Treatment Uses for Marketed Drug and Biological
Products'' focuses on the particular information to be provided when
submitting an application for the approval of a supplemental new use
for a drug product to treat cancer. Cancer treatments often yield
potential new uses for already marketed drugs.
Although this draft guidance does not create or confer any rights
on any person, and does not operate to bind FDA in any way, it does
represent the agency's current thinking on new cancer treatment uses
for marketed drug and biological products.
II. Request for Comments
Interested parties may submit written comments on the draft
guidance to the Dockets Management Branch (address above). 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 may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
III. Electronic Access
An electronic version of the draft guidance also is available via
Internet using the World Wide Web (WWW) (connect to the CDER home page
at attp://www.fda.gov/cder and go to the ``Regulatory Guidance''
section, or to the CBER home page at http://www.fda.gov/cber/
cberfp.html).
Dated: March 14, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7132 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F
