Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 51491 

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Harmonisation; Draft Guidance on 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availability of a draft guidance entitled 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 The draft guidance 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The draft guidance, which is a revision 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 The draft guidance is 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draft guidance by October 20, 2008.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single copies of the draft guidance to the 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the draft guidance to the Division of 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 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electronic access to the draft guidance 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 


sroberts on PROD1PC70 with NOTICES
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 

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 

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. 

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), 

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 http://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 

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 

http://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 http:// 

events.SignUp4.com/ACHDNC1008. 

Individuals who need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should indicate their 


sroberts on PROD1PC70 with NOTICES