[Federal Register Volume 71, Number 71 (Thursday, April 13, 2006)]
[Notices]
[Pages 19193-19194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0022]


International Conference on Harmonisation; Guidance on S8 
Immunotoxicity Studies for Human Pharmaceuticals; 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 entitled ``S8 Immunotoxicity Studies for 
Human

[[Page 19194]]

Pharmaceuticals.'' The guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The guidance 
provides recommendations on nonclinical testing approaches to identify 
compounds that have the potential to be immunotoxic and guidance on a 
weight-of-evidence decisionmaking approach for immunotoxicity testing. 
The guidance is intended to provide recommendations on nonclinical 
testing for immunotoxicity induced by human pharmaceuticals. The 
guidance applies to unintended immunosuppression and immunoenhancement, 
excluding allergenicity or drug-specific autoimmunity.

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. 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, 
20857. The guidance may also be obtained by mail by calling CBER at 1-
800-835-4709 or 301-827-1800. Requests and comments should be 
identified with the docket number found in brackets in the heading of 
this document. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Kenneth L. Hastings, Center for Drug 
Evaluation and Research (HFD-024), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, rm. 6480, Silver Spring, MD 20993-0002, 
301-796-0169.
    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

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    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, the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, 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 (IFPMA).
    The ICH steering committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of February 8, 2005 (70 FR 6697), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``S8 Immunotoxicity Studies for Human 
Pharmaceuticals.'' The notice gave interested persons an opportunity to 
submit comments by April 11, 2005. After consideration of the comments 
received and revisions to the guidance, a final draft of the guidance 
was submitted to the ICH steering committee and endorsed by the three 
participating regulatory agencies in August 2005.
    The guidance provides the following information: (1) 
Recommendations on nonclinical testing approaches to identify compounds 
which have the potential to be immunotoxic, and (2) guidance on a 
weight-of-evidence decisionmaking approach for immunotoxicity testing. 
The guidance is intended to provide recommendations on nonclinical 
testing for immunotoxicity induced by human pharmaceuticals. The 
guidance applies to immunosuppression and immunoenhancement, excluding 
allergenicity or drug-specific autoimmunity.
    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 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 comments regarding this document. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. 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: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5495 Filed 4-12-06; 8:45 am]
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