[Federal Register Volume 67, Number 68 (Tuesday, April 9, 2002)]
[Notices]
[Page 17078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8462]



[[Page 17078]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0094]


Draft Guidance for Industry on IND Exemptions for Studies of 
Lawfully Marketed Cancer Drug or Biological Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``IND Exemptions 
for Studies of Lawfully Marketed Cancer Drug or Biological Products.'' 
This guidance clarifies FDA's policy on exemption from investigational 
new drug (IND) application requirements for studies of marketed cancer 
drug or biological products. This guidance is intended to decrease the 
burden to investigators and regulators of submitting unnecessary IND 
applications.

DATES: Submit written or electronic comments on the draft guidance by 
June 10, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, http://www.fda.gov/cder/guidance/index.htm, 
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, http://www.fda.gov/cber/guidelines.htm. Send one self-addressed adhesive label 
to assist the office in processing your requests. The document may also 
be obtained by mail by calling the CBER Voice Information System at 1-
800-835-4709 or 301-827-1800, or by calling the Fax Information System 
at 1-888-CBER-FAX or 301-827-3844. Submit written or electronic 
comments on the draft guidance to the Dockets Management Branch (HFA-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electronic access to the draft guidance document.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: 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 ``IND Exemptions for Studies of Lawfully Marketed Cancer Drug 
or Biological Drug Products.'' Exemption of certain studies of marketed 
drugs from IND regulation is allowed under 21 CFR 312.2(b)(1). 
Investigations that involve a route of administration or dosage level 
or use in a patient population or other factor that significantly 
increases the risks (or decreases the acceptability of the risks) 
associated with the use of the drug product are not exempt. This 
guidance discusses the risk/benefit determination in the practice of 
oncology, the pertinent regulations relating to exemption of INDs, 
FDA's policy for determining exemption status, and specific examples of 
studies generally considered exempt.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking on IND 
exemptions for studies of lawfully marketed cancer drug or biological 
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 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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8462 Filed 4-8-02; 8:45 am]
BILLING CODE 4160-01-S