58714 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 

on this proposed clinical investigation. 

In particular, comments are solicited on 

the following questions: (1) What are the 

potential benefits, if any, to the subjects 

and to children in general; (2) what are 

the types and degrees of risk that this 

research presents to the subjects; (3) are 

the risks to the subjects reasonable in 

relation to the anticipated benefits, and 

is the research likely to result in 

knowledge that can be generalized about 

the subjects’ disorder or condition; and 

(4) does the research present a 

reasonable opportunity to further the 

understanding, prevention, or 

alleviation of a serious problem 

affecting the health or welfare of 

children. 

To facilitate the public review and 

comment process, FDA has established 

a public docket and placed in that 

docket information relating to the 

proposed clinical investigation, 

including the following items: 

Correspondence from the University of 

Chicago referring the proposed research 

protocol to HHS for consideration under 

45 CFR 46.407, correspondence from 

FDA and OHRP to the University of 

Chicago regarding the proposed 

protocol, the research protocol, NIH’s 

grant funding the protocol, IRB’s 

deliberations on the proposed research, 

and the parental permission documents. 

Electronic copies of these documents 

can be viewed at PAC’s Docket Web site 

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

ac/acmenu.htm. (Click on the year 2005 

and scroll down to Pediatric Ethics 

Subcommittee of PAC meetings.) These 

materials are also available on OHRP’s 

Web site at http://www.hhs.gov/ohrp/ 

children/. (FDA has verified the Web 

site address but is not responsible for 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

All written comments concerning this 

proposed research should be submitted 

to FDA’s Division of Dockets 

Management under 21 CFR 10.20, no 

later than 4:30 p.m. on Tuesday, 

November 1, 2005. The background 

materials and received comments may 

be viewed on FDA’s Web site at http:// 

www.fda.gov/ohrms/dockets/05n0404/ 

05n0404.htm or may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. The background 

materials may also be viewed on 

OHRP’s Web site at http://www.hhs.gov/ 

ohrp/children/. (FDA has verified the 

Web site address but is not responsible 

for subsequent changes to the Web site 

after this document publishes in the 

Federal Register.) 

Dated: October 3, 2005. 

Jason D. Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20301 Filed 10–5–05; 11:25 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2) 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 Cancer 

Institute Initial Review Group. Subcommittee 

F—Manpower & Training, NCI–F Initial 

Review of Manpower and Training Grants. 

Date: October 25–26, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Crystal Gateway, 1700 

Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Lynn M. Amende, PhD, 

Scientific Review Administrator, Resources 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8105, 

Bethesda, MD 20892, 301–451–4759, 

amendel@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 27, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–20234 Filed 10–6–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. appendix 2), notice 

is hereby given of a meeting of the 

Board of Scientific Counselors, National 

Cancer Institute. 

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 for the review, discussion, 

and evaluation of individual intramural 

programs and projects conducted by the 

National Cancer Institute, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, National Cancer Institute 

Clinical Sciences and Epidemiology. 

Date: November 7, 2005. 

Time: 9 a.m. to 3 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

National Cancer Institute, 9000 Rockville 

Pike, Building 31, Conference Room 10, 

Bethesda, MD 20892. 

Time: 7 p.m. to 11 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: Holiday Inn Select Bethesda, 

Versailles I, 8120 Wisconsin Avenue, 

Bethesda, MD 20814. 

Contact Person: Brian E. Wojcik, PhD, 

Senior Review Administrator, Institute 

Review Office, Office of the Director, 

National Cancer Institute, 6116 Executive 

Boulevard, Room 2114, Bethesda, MD 20892, 

(301) 496–7628, wojcikb@mail.nih.gov. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and signin at the security desk upon entering the 

building. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS)