Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices 31795 

new Information Sheet Guidances as 

needed. 

In the Federal Register of July 29, 

2008 (73 FR 43940), FDA announced the 

availability of a draft version of the 

guidance entitled, ‘‘Draft Information 

Sheet Guidance for Sponsors, Clinical 

Investigators, and IRBs; Frequently 

Asked Questions—Statement of 

Investigator (Form FDA 1572).’’ The July 

2008 guidance gave interested persons 

an opportunity to submit comments 

through September 29, 2008. All 

comments received during the comment 

period have been carefully reviewed 

and, where appropriate, incorporated in 

the guidance. As a result of the public 

comments and editorial changes, the 

guidance is clearer than the draft 

version. 

This information sheet guidance is 

being issued consistent with FDA’s 

GGPs regulation (21 CFR 10.115). The 

information sheet guidance represents 

the agency’s current thinking on 

completing the Form FDA 1572. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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 collections of information for 

Form FDA 1572 have been approved 

under OMB Control No. 0910–0014. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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/Drugs/Guidance7

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: May 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13420 Filed 6–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review, 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: Center for Scientific 

Review Special Emphasis Panel; Cell Death 

in Neurodegeneration. 

Date: June 11, 2010. 

Time: 9 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites, 1250 22nd Street, 

NW., Washington, DC 20037. 

Contact Person: Seetha Bhagavan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 237– 

9838, bhagavas@csr.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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: May 27, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13412 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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 

Child Health and Human Development 

Special Emphasis Panel, Pediatric Trials 

Network. 

Date: June 23, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 

Institute of Child Health and Human 

Development, 6100 Executive Boulevard, 

Room 5B01, Bethesda, MD 20892–9304. (301) 

435–6680. skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: May 26, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–13482 Filed 6–3–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Biotechnology Activities; 

Recombinant DNA Research: 

Amended Notice of Meeting 

ACTION: Notice of cancellation of 

consideration of a proposed action 


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