[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]
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