[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Draft Guidance for Industry: FDA Approval of New Cancer Treatment 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availability of a draft guidance entitled, ``Guidance for Industry: FDA 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 The draft guidance considers the quality and quantity of 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 The draft 
guidance is part of the agency's ``New Use Initiative--Evidence for 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FDA is publishing a notice of availability of a draft guidance that 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draft guidance.

DATES: Written comments on the draft guidance by May 20, 1997.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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: FDA Approval of New Cancer 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 The draft guidance also may be obtained by 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