[Federal Register Volume 70, Number 25 (Tuesday, February 8, 2005)]
[Notices]
[Pages 6697-6698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2418]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0022]


International Conference on Harmonisation; Draft Guidance on S8 
Immunotoxicity Studies for Human Pharmaceuticals; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

[[Page 6698]]

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``S8 Immunotoxicity Studies 
for Human Pharmaceuticals.'' The draft guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The draft guidance describes a weight-of-evidence approach to 
determining whether additional immunotoxicity testing for nonbiological 
pharmaceuticals is appropriate when the findings from standard toxicity 
studies indicate signs of immunotoxicity. The draft guidance is 
intended to provide recommendations on nonclinical testing to identify 
compounds that have the potential to be immunosuppressive and guidance 
on a weight-of-evidence decision making approach for immunotoxicity 
testing.

DATES:  Submit written or electronic comments on the draft guidance by 
April 11, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), 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. The guidance may also be 
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800. Send one self-addressed adhesive label to 
assist the office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Kenneth L. Hastings, Center for Drug 
Evaluation and Research (HFD-024), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5922.
    Regarding the ICH:
    Michelle Limoli, Office of International Programs (HFG-1), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
4480.

SUPPLEMENTARY INFORMATION:

I. Background

    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission, the European Federation of Pharmaceutical Industries 
Associations, the Japanese Ministry of Health, Labour, and Welfare, the 
Japanese Pharmaceutical Manufacturers Association, CDER and CBER (FDA), 
and the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations.
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization (WHO), Health Canada, and the European Free Trade 
Area.
    In November 2004, the ICH Steering Committee agreed that a draft 
guidance entitled ``S8 Immunotoxicity Studies for Human 
Pharmaceuticals'' should be made available for public comment. The 
draft guidance is the product of the Safety Expert Working Group of the 
ICH. Comments about this draft guidance will be considered by FDA and 
the Safety Expert Working Group.
    The draft guidance describes a weight-of-evidence approach to 
determining whether additional immunotoxicity testing for nonbiological 
pharmaceuticals is appropriate when the findings from standard toxicity 
studies indicate signs of immunotoxicity. The draft guidance provides 
the following: (1) Recommendations on nonclinical testing approaches to 
identify compounds which have the potential to be immunosuppressive and 
(2) guidance on a weight-of-evidence decision making approach for 
immunotoxicity testing. The primary data are from routine nonclinical 
toxicology studies conducted during drug development. Additional causes 
for concern that can affect the decision for additional immunotoxicity 
testing include the pharmacology of the drug, intended patient 
population, known drug class effects, and retention of the drug in 
cells of the immune system.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the agency's current thinking on this 
topic. 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 draft guidance. 
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 
draft guidance and received comments may be seen 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 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: February 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2418 Filed 2-7-05; 8:45 am]
BILLING CODE 4160-01-S