[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Notices]
[Page 51491-51492]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se08-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0470]
International Conference on Harmonisation; Draft Guidance on
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for 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availability of a draft guidance entitled ``M3(R2) Nonclinical Safety
Studies for the Conduct of Human Clinical Trials and Marketing
Authorization for 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 The draft guidance was prepared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 The draft guidance, which is a revision of an existing
guidance, discusses the types of nonclinical studies, their scope and
duration, and their relation to the conduct of human clinical trials
and marketing authorization for pharmaceuticals. The draft guidance is
intended to facilitate the timely conduct of clinical trials and reduce
the unnecessary use of animals and other drug development resources.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 20, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
two self-addressed adhesive labels 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 Submit written comments on the draft guidance to the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.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6484, Silver Spring, MD, 20993-0002, 301-796-0174, or
Martin D. Green, Center for Biologics Evaluation and Research (HFM-
475), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-3070.
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 June 2008, the ICH Steering Committee agreed that a draft
guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct
of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals'' should be made available for public comment. The
draft guidance is the product of the Multidisciplinary Safety and
Efficacy (M3) Expert Working Group of the ICH. Comments about this
draft will be considered by FDA and the M3 Expert Working Group.
The purpose of the draft guidance is to recommend international
standards for, and promote harmonization of, the nonclinical safety
studies recommended to support human clinical trials of a given scope
and duration. The revisions in this draft guidance further harmonize
the recommendations in a number of areas and include a new section on
exploratory clinical studies. The recommendations should promote safe
and ethical development and availability of new pharmaceuticals.
The document provides guidance on nonclinical safety studies and
their relation to the conduct of human clinical trials and marketing of
a pharmaceutical, primarily addressing timing. The discussion includes
safety pharmacology studies, repeated dose toxicity studies,
toxicokinetic and nonclinical pharmacokinetic studies, reproduction
toxicity studies, genotoxicity studies, and (for drugs that have
special cause for concern or are intended for a long duration of use)
an assessment of carcinogenic potential. The draft guidance discusses
other nonclinical studies that should be conducted on a case-by-case
basis as appropriate, including phototoxicity studies, immunotoxicity
studies, juvenile animal toxicity studies, and abuse potential studies.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The 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.
Submit a single copy of electronic comments or
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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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/cder/guidance/index.htm,
or http:www/fda.gov/cber/guidelines.htm.
Dated: August 26, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20294 Filed 9-2-08; 8:45 am]
BILLING CODE 4160-01-S