Notice: International Conference on Harmonisation; Guidance on M3(R2) 
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and 
Marketing Authorization for Pharmaceuticals; Availability

Federal Register: January 21, 2010 (Volume 75, Number 13)              
                  Page 3471-3472

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies 
for the Conduct of Human Clinical Trials and Marketing Authorization 
for 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, 
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 guidance is intended to facilitate the timely 
conduct of clinical trials and reduce the unnecessary use of animals 
and other drug development resources.

DATES:  Submit written or electronic comments on agency guidance at any 
time.

ADDRESSES:  Submit written requests for single copies of the 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, or the Office of 
Communication, Outreach and Development (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 CBER at 1-800-835-4709 or 301-827-1800. 
Send two self-addressed adhesive labels to assist the office in 
processing your requests.
    Submit electronic comments to http://www.regulations.gov. 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 20852. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the 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

[[Page 3472]]

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 September 3, 2008 (73 FR 51491), FDA 
published a notice 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 
notice gave interested persons an opportunity to submit comments by 
October 20, 2008.
    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 June 2009.
    Guidance is provided on the various nonclinical studies recommended 
to support conduct of clinical trials and marketing. The guidance 
further harmonizes the recommendations in a number of areas and 
includes a new section on exploratory clinical trials. The 
recommendations should promote safe and ethical development and 
availability of new pharmaceuticals.
    The guidance reflects revisions made in response to comments 
received on the draft guidance. The revisions include more detailed 
discussions of some types of nonclinical studies and editorial changes 
to provide further clarification in a number of areas.
    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) electronic or written comments on the guidance. 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.regulations.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: January 15, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1027 Filed 1-20-10; 8:45 am]
BILLING CODE 4160-01-S