[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Notices]
[Pages 66647-66648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0177]


Guidance for Industry on Immunotoxicology Evaluation of 
Investigational New Drugs; 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 ``Immunotoxicology 
Evaluation of Investigational New Drugs.'' This guidance provides 
recommendations for sponsors of investigational new drugs (INDs) on 
what parameters to routinely assess in toxicology studies to determine 
effects on immune function, when to conduct additional immunotoxicity 
studies, and when additional mechanistic information could better 
characterize a given effect on the immune system.

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. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the 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 
guidance document.

FOR FURTHER INFORMATION CONTACT: Kenneth L. Hastings, Center for Drug 
Evaluation and Research (HFD-590), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2489.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Immunotoxicology Evaluation of Investigational New Drugs.'' 
The human immune system is a complex set of cells and organs that can 
be adversely affected by drugs. Impairment of the immune system can 
result in increased susceptibility to infections and tumors, allergic 
responses to drugs, autoimmune reactions, or other forms of immune 
system disease. Immunotoxicology studies can be conducted in animals to 
determine the potential of an investigational drug to adversely affect 
the immune system. This guidance provides advice on: (1) When to 
conduct immunotoxicology studies, (2) what types of effects can be 
observed in standard nonclinical toxicology studies that would indicate 
that a drug has immunotoxic potential, and (3) what types of studies 
could be useful in determining the nature of the immunotoxicity. It is 
expected that this guidance will provide sponsors with useful 
information for proper assessment of the immunotoxic potential of 
drugs.
    In the Federal Register of May 11, 2001 (66 FR 24145), FDA 
published a draft guidance entitled ``Immunotoxicology Evaluation of 
Investigational New Drugs.'' The notice gave interested persons an 
opportunity to submit comments. Based on the comments, FDA has revised 
the guidance.
    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 immunotoxicology evaluation of INDs. 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 comments on the 
guidance to the Dockets Management

[[Page 66648]]

Branch (see ADDRESSES). 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 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/ohrms/dockets/default.htm.

    Dated: October 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27883 Filed 10-31-02; 8:45 am]
BILLING CODE 4160-01-S