Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices 3471 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

45 CFR 309—Plan .......................................................................................... 33 1 480 15,840 

Form OCSE 34A .............................................................................................. 49 4 8 1,568 

Estimated total burdenhours .................................................................... ........................ ........................ ........................ 17,408 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: January 14, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–963 Filed 1–20–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0470] 

International Conference on 

Harmonisation; 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 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
3472 Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices 

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/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group; Microbiology and Infectious Diseases 

B Subcommittee. 

Date: February 11–12, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Chevy Chase, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Gary S. Madonna, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIAID, National Institutes of Health, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892, 301–496–3528, gm12w@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Clinical Trial 

Planning (R34) Grants and Implementation 

(U01) Cooperative Agreements. 

Date: February 12, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Hotel—Silver Spring, 

8777 Georgia Avenue, Silver Spring, MD 

20910. 

Contact Person: B. Duane Price, PhD, 

Scientific Review Officer, Scientific Review 

Program, HHS/NIH/NIAID/DEA, Room 3139, 

6700B Rockledge Drive, MSC 7616, Bethesda, 

MD 20892, (301) 451–2592, 

pricebd@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 14, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–1050 Filed 1–20–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, NIDDK KUHFellowship Review. 

Date: February 19, 2010. 

Time: 8 a.m. to 5 p.m. 


jlentini on DSKJ8SOYB1PROD with NOTICES