[Federal Register: February 8, 2005 (Volume 70, Number 25)]
[Notices]
[Page 6697-6698]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe05-76]
-----------------------------------------------------------------------
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International Conference on Harmonisation; Draft Guidance on S8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availability of a draft guidance entitled ``S8 Immunotoxicity Studies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 The draft guidance was prepared under the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The draft guidance describes a weight-of-evidence approach to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 The draft guidance is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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://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.
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