[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Notices]
[Page 51053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1562]


Guidance for Industry on Cancer Drug and Biological Products--
Clinical Data in Marketing Applications; 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 guidance for industry entitled ``Cancer Drug and 
Biological Products--Clinical Data in Marketing Applications.'' This 
guidance provides recommendations for sponsors designing clinical 
trials to demonstrate the safety and efficacy of cancer treatments on 
the collection of data that can be submitted to support marketing 
claims in new drug applications (NDAs), biologics license applications 
(BLAs), or applications for supplemental indications.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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, or the Office of Communications, 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. A faxed copy of this 
guidance can also be obtained 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 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. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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 guidance for industry 
entitled ``Cancer Drug and Biological Products--Clinical Data in 
Marketing Applications.'' This guidance provides general principles for 
data collection and submission for sponsors of investigational new drug 
applications, NDAs, BLAs, or supplemental applications for new 
indications. The guidance 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
    In the Federal Register of November 9, 2000 (65 FR 67389), FDA 
announced the availability of a draft version of this guidance. After 
FDA considered public comments on the draft guidance, the agency 
determined that revision of the draft guidance was necessary. The final 
guidance notes that tumor images usually are not submitted as part of 
the marketing application, but this should be clarified at 
presubmission meetings with FDA. The final guidance also states that 
information on drug dosing should be collected from all patients rather 
than from a sample of patients, as suggested in the draft guidance. 
Collecting dosing information in all patients allows a full assessment 
of the adequacy of dosing in both the investigational arm and the 
control arm of the submitted studies.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The 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, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (address 
above). Two copies of written mailed 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 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, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24946 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-01-S