[Federal Register Volume 66, Number 92 (Friday, May 11, 2001)]
[Notices]
[Pages 24145-24146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11879]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0177]


Draft Guidance for Industry on Immunotoxicology Evaluation of 
Investigational New Drugs; 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availability of a draft guidance for industry entitled 
``Immunotoxicology Evaluation of Investigational New Drugs.'' This 
draft guidance provides recommendations for sponsors of investigational 
new drugs (INDs) on the parameters that should be routinely assessed in 
toxicology studies to determine effects on immune function, when 
additional specific immunotoxicity studies should be conducted, and 
when additional mechanistic information could better evaluate a given 
effect on the immune system.

DATES: Submit written comments on the draft guidance by August 9, 2001. 
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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph J. DeGeorge, Center for Drug 
Evaluation and Research (HFD-24), Food and Drug Administration, 5600 
Fishers Lane,Rockville, MD 20857, 301-594-5476.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Immunotoxicology Evaluation of Investigational New Drugs.'' 
The immune system consists of a diffuse and complex set of cells and 
organs that have complicated interactions with each other and with 
other physiological systems. These complexities make the detection and 
evaluation of drug-induced immunotoxicity in animal models difficult. 
Immunotoxicologic findings could suggest the need for additional 
followup studies, particularly if the observed adverse effects are 
serious. The objective of these followup studies would be to 
investigate the nature and mechanism of the immunotoxic effects. 
Immunotoxicity findings could lead to modifications in proposed 
clinical trials or could be included in the investigator's brochure or 
product label. Rarely, immunotoxicity findings could indicate that a 
drug is unsafe for some types of clinical investigations or certain 
indications.
    For the safety assessment of INDs, specific immunotoxicity testing 
should be conducted when drugs are to be administered by inhalation or 
topically. Specific immunotoxicity studies should also be considered 
for safety assessment purposes when: (1) The drug has the potential to 
elicit an anti-drug immune response; (2) use of the drug during 
pregnancy is likely; (3) there is an absence of immunotoxicity findings 
in the toxicology studies, but there is significant accumulation or 
retention of the drug in immune system tissues; or (4) the drug will be 
used to treat an immune-deficiency disease such as the human 
immunodeficiency virus (HIV). In most other instances, specific 
immunotoxicity studies are generally not needed to support initial 
clinical trials or continued development.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The

[[Page 24146]]

draft 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 submit to the Dockets Management Branch 
(address above) written 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/ohrms/dockets/default.htm.

    Dated: May 4, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-11879 Filed 5-10-01; 8:45 am]
BILLING CODE 4160-01-S