Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 58713 

Dated: October 3, 2005. 

Jason D. Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20303 Filed 10–5–05; 11:25 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0404] 

Solicitation of Public Review and 

Comment on Research Protocol: 

Gonadotropin-releasing Hormone 

Agonist Test in Disorders of Puberty 

AGENCY: Office of Public Health and 

Science and Food and Drug 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

Public Health and Science, Department 

of Health and Human Services (HHS), 

and the Food and Drug Administration 

(FDA), are soliciting public review and 

comment on a proposed research 

protocol entitled ‘‘Gonadotropinreleasing Hormone (GnRH) Agonist Test 

in Disorders of Puberty.’’ The proposed 

research would be conducted at the 

University of Chicago Hospitals General 

Clinical Research Facility and 

supported by the National Center for 

Research Resources of the National 

Institutes of Health (NIH). Public review 

and comment are solicited regarding the 

proposed research protocol under the 

requirements of HHS and FDA 

regulations. 

DATES: To be considered, written or 

electronic comments on the proposed 

research must be received on or before 

4:30 p.m. on Tuesday, November 1, 

2005. 

ADDRESSES: Electronic copies of the 

documents for public review can be 

viewed at the Pediatric Advisory 

Committee (PAC) 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 meetings.) Submit 

written comments to the Division of 

Dockets Management (HFA–305), 

Docket No. 2005N–0404, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 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. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Prohaska, Office for Human 

Research Protections, The Tower 

Building, 1101 Wootton Pkwy., suite 

200, Rockville, MD 20852, 240–453–

6900, FAX: 240–453–6909, e-mail: 

kprohaska@osophs.dhhs.gov; or Jan N. 

Johannessen, Office of the 

Commissioner (HF–33), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, rm. 14C–06), 

Rockville, MD 20857, 301–827–6687, or 

by e-mail: jjohannessen@fda.gov. 

SUPPLEMENTARY INFORMATION: All 

studies conducted or supported by HHS 

that are not otherwise exempt and that 

propose to involve children as subjects 

require Institutional Review Board (IRB) 

review in accordance with the 

provisions of HHS regulations for the 

protection of human subjects in 45 CFR 

part 46, subpart D. Under FDA’s interim 

final rule effective April 30, 2001, FDA 

adopted similar regulations in part 50, 

subpart D (21 CFR part 50, subpart D) 

to provide safeguards for children 

enrolled in clinical investigations of 

products regulated by FDA. Because the 

proposed research, ‘‘Gonadotropinreleasing Hormone (GnRH) Agonist Test 

in Disorders of Puberty,’’ would be 

supported by NIH, a component of HHS, 

and would be regulated by FDA, both 

HHS and FDA regulations apply to this 

proposed research. 

Under HHS regulations in 45 CFR 

46.407, and FDA regulations in § 50.54, 

if an IRB reviewing a protocol to be 

conducted or supported by HHS for a 

clinical investigation regulated by FDA 

does not believe that the proposed 

research involving children as subjects 

meets the requirements of HHS 

regulations in 45 CFR 46.404, 46.405, or 

46.406, and FDA regulations in §§ 50.51, 

50.52, or 50.53, respectively, the 

research may proceed only if the 

following conditions are met: (1) IRB 

finds that the research presents a 

reasonable opportunity to further the 

understanding, prevention, or 

alleviation of a serious problem 

affecting the health or welfare of 

children; and (2) the Secretary (HHS) 

and the Commissioner (FDA), after 

consultation with experts in pertinent 

disciplines (e.g., science, medicine, 

education, ethics, law) and following 

opportunity for public review and 

comment, determine either: (a) That the 

research in fact satisfies the conditions 

of 45 CFR 46.404, 46.405, or 46.406 

under HHS regulations, and §§ 50.51, 

50.52, or 50.53 under FDA regulations, 

or (b) that the following conditions are 

met: (i) The research or clinical 

investigation presents a reasonable 

opportunity to further the 

understanding, prevention, or 

alleviation of a serious problem 

affecting the health or welfare of 

children; (ii) the research or clinical 

investigation will be conducted in 

accordance with sound ethical 

principles; and (iii) adequate provisions 

are made for soliciting the assent of 

children and the permission of their 

parents or guardians, as set forth in 45 

CFR 46.408 and § 50.55. 

HHS has received a request on behalf 

of the University of Chicago Hospitals’

IRB to review under 45 CFR 46.407 the 

protocol entitled ‘‘Gonadotropinreleasing Hormone (GnRH) Agonist Test 

in Disorders of Puberty.’’ The principal 

investigator proposes to administer 

leuprolide 10 micrograms/kilogram to 

approximately 300 subjects with and 

without a disorder of puberty followed 

by serial blood determinations of 

endogenous sex-related hormones. 

Serial blood draws will be done through 

an indwelling venous catheter using an 

automated pump. Children will be 

closely supervised in the research 

facility for two overnight stays. The 

specific aim of the study is to test the 

hypothesis that the response to the 

injection of the GnRH agonist, 

leuprolide acetate, will distinguish 

among the causes of precocious puberty 

and delayed puberty. 

The University of Chicago Hospitals 

IRB determined that the full protocol 

was not approvable under 45 CFR 

46.404, 46.405, or 46.406 because the 

proposed administration of leuprolide 

acetate poses more than minimal risks 

to the control subjects, there is no 

prospect of direct benefit to the 

individual control subjects, the 

interventions or procedures do not 

present an experience to the control 

group that is reasonably commensurate 

with those inherent in their expected 

medical situation, and the control group 

does not have the condition or disorder 

under study. However, the IRB did find 

that this research presents a reasonable 

opportunity to understand, prevent, or 

alleviate a serious problem affecting the 

health or welfare of children. 

Accordingly, the University of Chicago 

Hospitals IRB forwarded the protocol to 

OHRP under 45 CFR 46.407 for 

consideration. Because this clinical 

investigation is regulated by FDA, 

FDA’s regulations at part 50, subpart D, 

specifically § 50.54, apply as well. 

In accordance with 45 CFR 46.407(b) 

and § 50.54(b), OHRP and FDA are 

soliciting public review and comment 

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)