[Federal Register Volume 65, Number 218 (Thursday, November 9, 2000)]
[Notices]
[Pages 67389-67390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28776]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1562]


Draft Guidance for Industry on Cancer Drug and Biological 
Products--Clinical Data in Marketing Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 67390]]

availability of a draft guidance for industry entitled ``Cancer Drug 
and Biological Products--Clinical Data in Marketing Applications.'' The 
draft guidance document provides recommendations for sponsors designing 
clinical trials to demonstrate the safety and efficacy of cancer 
treatments on the collection of data that may be submitted to support 
marketing claims in new drug applications (NDA's), biologics license 
applications (BLA's), or applications for supplemental indications.

DATES: Submit written comments on the draft guidance by January 8, 
2001. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist the 
office in processing your requests. The document may also be obtained 
by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-
827-3844. See the Supplementary Information section for electronic 
access to the draft guidance.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Grant A. Williams, Center for Drug 
Evaluation and Research (HFD-150), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5740, or Patricia Keegan, 
Center for Biologics Evaluation and Research (HFM-573), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5093.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Guidance for Industry: Cancer Drug and Biological Products--
Clinical Data in Marketing Applications.'' This draft guidance provides 
general principles for data collection and submission for sponsors of 
investigational new drug applications, NDA's, BLA's, or applications 
for supplemental indications. It is intended to enable sponsors to more 
effectively create plans to record and report the data from controlled 
trials that form the clinical basis for approval of anticancer drug and 
biological products.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (65 FR 56468, September 19, 2000). The draft 
guidance represents the agency's current thinking on clinical data in 
marketing applications for cancer drug or biologic products. 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 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 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/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm.

    Dated: October 30, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-28776 Filed 11-8-00; 8:45 am]
BILLING CODE 4160-01-F