Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 34025 

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 alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control no. 0910–0635. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.fda.gov/FoodGuidances or http:// 

www.regulations.gov. 

Dated: July 8, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16702 Filed 7–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0312] 

Guidance for Institutional Review 

Boards, Frequently Asked Questions— 

Institutional Review Board 

Registration; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for Institutional Review 

Boards (IRBs), Frequently Asked 

Questions — IRB Registration.’’ This 

guidance is intended to assist IRBs in 

complying with the new requirement for 

IRB registration. This new rule requires 

each IRB in the United States that 

reviews FDA-regulated research to 

register using an Internet-based 

registration system that is maintained by 

the Department of Health and Human 

Services (HHS). This registration system 

is a modification of the one currently 

used by the Office for Human Research 

Protections (OHRP) for registration of 

IRBs that are designated by institutions 

under Federalwide Assurances (FWAs). 

OHRP has issued a similar rule 

requiring IRBs designated by 

institutions under FWAs to register or 

update their registration information 

using this modified system. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written comments 

on this 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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Jean 

Toth-Allen, Office of Science and 

Health Coordination/Good Clinical 

Practice Program (HF–34), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

1585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance document for IRBs entitled, 

‘‘Guidance for Institutional Review 

Boards (IRBs), Frequently Asked 

Questions — IRB Registration.’’ This 

guidance is intended to assist IRBs in 

complying with the new requirement for 

IRB registration under amended 21 CFR 

56.106, which is effective July 14, 2009. 

Registration will be accomplished 

through a modified version of the 

Internet-based registration system used 

by OHRP for registration of IRBs that are 

designated by institutions under FWAs. 

This guidance document addresses 

basic information, such as why FDA 

issued the new rule, which IRBs are 

subject to the new regulation, the type 

of information to be provided when 

registering, and implications of noncompliance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance is being issued as a level 

1 guidance for immediate 

implementation in accordance with 21 

CFR 10.115(g). Prior public 

participation is not feasible and FDA 

believes the guidance is necessary to 

help IRBs better understand their 

responsibilities under the new 

registration rule, which will go into 

effect on July 14, 2009. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to a previously 

approved collection of information 

required by the FDA new final rule on 

registration requirements. This 

collection of information is subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

21 CFR 56.106(b) has been approved 

under 0990–0279. 

III. Comments 

Interested persons may submit written 

or electronic comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES). 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/oc/gcp/draft.html or 

http://www.fda.gov/ohrms/dockets/ 

default.htm 

Dated: July 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16703 Filed 7–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; 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., 

mstockstill on DSKH9S0YB1PROD with NOTICES

34026 Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices 

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 

General Medical Sciences Special Emphasis 

Panel Minority Biomedical Research 

Support. 

Date: July 23, 2009. 

Time: 1 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Margaret J. Weidman, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18B, Bethesda, MD 

20892. 301–594–3663. 

weidmanma@nigms.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel ZGM1–BRT–0–CO. 

Date: August 3, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN18, 45 Center 

Drive, Bethesda, MD 20892. (Virtual 

Meeting). 

Contact Person: Margaret J. Weidman, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18B, Bethesda, MD 

20892. 301–594–3663. 

weidmanmanigms.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel ARRA Funds—ZGM1–GDB–7–CR. 

Date: August 7, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AN12, 45 Center 

Drive, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Lisa A. Dunbar, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN12, Bethesda, MD 

20892. 301–594–2849. 

dunbarl©mail.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel Trauma/Burn Program Projects. 

Date: August 11, 2009. 

Time: 12 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Room 3AS13, 45 Center 

Drive, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Meredith D. TempleO’Connor, PhD, Scientific Review Officer, 

Office of Scientific Review, National Institute 

of General Medical Sciences, National 

Institutes of Health, 45 Center Drive, Room 

3AN12C, Bethesda, MD 20892. 301–594– 

2772. templeocm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.701, ARRA 

Related Biomedical Research and Research 

Support Awards, National Institutes of 

Health, HHS) 

Dated: July 7, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–16569 Filed 7–13–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): RFA–DP09– 

101SUPP09: Health Promotion and 

Disease Prevention Research Centers: 

Special Interest Project Competitive 

Supplements (SIPS) (U48 Panels A–M) 

This meeting is for the initial review 

of applications. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Dates and Times: 

July 29, 2009, 9 a.m.–5 p.m. Closed. 

July 30, 2009, 9 a.m.–5 p.m. Closed. 

July 31, 2009, 10 a.m.–4 p.m. Closed. 

August 3, 2009, 9 a.m.–5 p.m. Closed. 

August 4, 2009, 9 a.m.–5 p.m. Closed. 

Place: W Hotel, 3377 Peachtree Road, NE., 

Atlanta, GA 30326, 770–488–3024 and 

teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of the application received in 

response to ‘‘RFA–DP09–101SUPP09: Health 

Promotion ans Disease Prevention 

ResearchCenters: Special Interest Project 

Competitive Supplements (SIPS) (U48Panels 

A–M).’’ 

For More Information Contact: Brenda 

Colley Gilbert, PhD, Director, Extramural 

Research Program Office, CCHP, 4770 Buford 

Highway, M/S K–92, Atlanta, GA 30341; 

770–488–6295. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: July 8, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–16647 Filed 7–13–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

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 meeting. 

The meeting 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; Digestive Diseases 

and Nutrition Mentored Applications 

Review. 

Date: July 31, 2009. 

Time: 3 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Lakshmanan Sankaran, 

PhD, Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 755, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7799, ls38z@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

mstockstill on DSKH9S0YB1PROD with NOTICES