[Federal Register Volume 68, Number 178 (Monday, September 15, 2003)]
[Notices]
[Page 53984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0094]


Guidance for Industry on Investigational New Drug Application 
Exemptions for Studies of Lawfully Marketed Drug or Biological Products 
for the Treatment of Cancer; 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 ``IND Exemptions for 
Studies of Lawfully Marketed Drug or Biological Products for the 
Treatment of Cancer.'' This guidance clarifies FDA's policy on 
exemption from investigational new drug application (IND) requirements 
for studies of marketed cancer drug or biological products. This 
guidance is intended to decrease the submission of unnecessary IND 
exemptions.

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 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 one self-addressed adhesive label to 
assist that office in processing your requests. This guidance document 
may also be obtained by mail by calling the CBER Voice Information 
System at 1-800-835-4709 or 301-827-1800. Submit written comments on 
the guidance to the Division of Dockets Management (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 
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, 301-594-5758, 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 ``IND Exemptions for Studies of Lawfully Marketed Drug or 
Biological Products for the Treatment of Cancer.'' Exemption from IND 
regulation of certain studies of marketed drugs is allowed under 21 CFR 
312.2(b)(1). Along with other criteria outlined in the regulation, 
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 from the 
requirements for an IND. This guidance discusses the pertinent 
regulations relating to exemption of INDs, the risk/benefit 
determination in the practice of oncology, FDA's policy for determining 
exemption status based on risk, and specific examples of studies 
generally considered exempt.
    In the Federal Register of April 9, 2002 (67 FR 17078), FDA 
announced the availability of a draft version of this guidance and gave 
interested persons an opportunity to submit comments through June 10, 
2002. The agency received comments from investigators at two 
institutions and took the comments into consideration when finalizing 
the guidance. However, the final guidance includes no substantive 
changes, only editorial and clarifying changes.
    This 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 IND exemptions based on risk 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 Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two copies of 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 Division of Dockets Management 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, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 5, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23510 Filed 9-12-03; 8:45 am]
BILLING CODE 4160-01-S