[Federal Register: April 13, 2006 (Volume 71, Number 71)]
[Notices]
[Page 19193-19194]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap06-89]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.
v/cber/publications.htm.
Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5495 Filed 4-12-06; 8:45 am]
BILLING CODE 4160-01-S