58712 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 

hormonal actions of leuprolide, an 

overview of the protocol and the 

referring IRB’s deliberations on the 

protocol, and a summary of public 

comments received concerning whether 

the protocol should proceed, the 

subcommittee will discuss the proposed 

protocol and develop a recommendation 

regarding whether the protocol should 

proceed. The subcommittee’s 

recommendation will then be presented 

to the FDA Pediatric Advisory 

Committee on November 16, 2005; the 

announcement of the November 16 and 

17, 2005, Pediatric Advisory Committee 

meeting can be found elsewhere in this 

issue of the Federal Register. 

Elsewhere in this issue of the Federal 

Register is also a notice announcing a 

public comment period concerning 

whether the proposed clinical 

investigation should proceed. 

Information regarding submitting 

comments during that period is 

contained in that notice. 

The background materials for the 

subcommittee meeting will be made 

publicly available no later than the day 

before the meeting and will be posted 

under the PAC Docket site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm. (Click on the year 2005 

and scroll down to Pediatric Advisory 

Committee, Pediatric Ethics 

Subcommittee meetings.) 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by November 4, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11 

a.m. and 12 noon. 

Time allotted for each presentation 

may be limited. Those desiring to make 

formal oral presentations should notify 

the contact person by November 4, 

2005, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please notify Jan 

Johannessen at least 7 days prior to the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 3, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20302 Filed 10–5–05; 11:25 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. The committee 

also advises and makes 

recommendations to the Secretary of 

Health and Human Services under 45 

CFR 46.407 on research involving 

children as subjects that is conducted or 

supported by the Department of Health 

and Human Services (HHS), when that 

research is also regulated by FDA. 

Date and Time: The meeting will be 

held on Wednesday, November 16, 

2005, from 8 a.m. to 6 p.m., and 

Thursday, November 17, 2005, from 8 

a.m. to 5 p.m. 

Location: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD. 

Contact Person: Jan N. Johannessen, 

Office of Science and Health 

Coordination of the 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 or FDA Advisory 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 8732310001. Please call the 

Information Line for up to date 

information on this meeting. 

Agenda: On Wednesday, November 

16, 2005, the committee will hear and 

discuss the recommendation of the 

Pediatric Ethics Subcommittee from its 

meeting on November 15, 2005, 

regarding a referral by an Institution 

Review Board of a proposed clinical 

investigation involving children as 

subjects that is regulated by FDA and is 

conducted or supported by the 

Department of Health and Human 

Services. The committee will also 

discuss pediatric obesity and clinical 

trial designs for the evaluation of 

devices intended to treat pediatric 

obesity. 

On Thursday, November 17, 2005, the 

committee will continue its discussion 

of clinical trial designs for, and ethical 

issues related to, the evaluation of 

devices intended to treat pediatric 

obesity. 

The background material will become 

available no later than the day before 

the meeting and will be posted under 

the Pediatric Advisory Committee (PAC) 

Docket site at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm. (Click 

on the year 2005 and scroll down to 

Pediatric Advisory Committee 

meetings.) 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by November 4, 2005. Oral 

presentations from the public will be 

scheduled on Wednesday, November 

16, 2005 between approximately 1:30 

p.m. and 2:30 p.m. and Thursday, 

November 17, 2005, between 

approximately 9:15 a.m. and 10:15 a.m. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person by November 4, 

2005, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please notify Jan 

Johannessen at least 7 days in advance 

of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

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