International Conference on Harmonisation; Draft Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability, 51491-51492 [E8-20294]

Download as PDF Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 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AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0470] International Conference on Harmonisation; Draft Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and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. sroberts on PROD1PC70 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human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 The draft guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 20, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: VerDate Aug<31>2005 22:59 Sep 02, 2008 Jkt 214001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 51491 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 E:\FR\FM\03SEN1.SGM 03SEN1 51492 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 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 https://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 25, 2008, from 8:30 a.m. to approximately 4 p.m. Location: Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910 Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), VerDate Aug<31>2005 22:59 Sep 02, 2008 Jkt 214001 Food and Drug Administration, 1401 Rockville Pike, Rockville, MD, 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: In open session the Committee will be briefed on the Office of Vaccine’s Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) response to OVRR Office Site Visit Review Report that was presented and approved by this committee on January 25, 2007. The Committee will also hear presentations and hold discussion on the use of Madin-Darby canine kidney (MDCK) Cells for manufacture of live attenuated Influenza Virus Vaccines. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 18, 2008. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 8, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 11, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 27, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–20372 Filed 9–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meeting: Name: Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). Dates and Times: October 1, 2008, 1 p.m. to 5 p.m.; October 2, 2008, 8 a.m. to 3 p.m. Place: Capital Hilton, 1001 16th Street, NW., Washington, DC 20036. Status: The meeting will be open to the public with attendance limited to space availability. Participants are asked to register for the meeting by going to the registration Web site at https:// events.SignUp4.com/ACHDNC1008. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should indicate their E:\FR\FM\03SEN1.SGM 03SEN1

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[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Notices]
[Pages 51491-51492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20294]



[[Page 51491]]

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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.

-----------------------------------------------------------------------

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 https://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

[[Page 51492]]

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 https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.regulations.gov, https://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

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