Solicitation of Public Review and Comment on Research Protocol: Gonadotropin-releasing Hormone Agonist Test in Disorders of Puberty, 58713-58714 [05-20301]
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Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
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
Office of Public Health and
Science and Food and Drug
Administration, HHS.
ACTION: Notice.
AGENCY:
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.
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.
DATES:
Electronic copies of the
documents for public review can be
viewed at the Pediatric Advisory
Committee (PAC) Docket Web site at
https://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 https://
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
ADDRESSES:
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
Web site at https://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,
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
58713
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
E:\FR\FM\07OCN1.SGM
07OCN1
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 https://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 https://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 https://
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 https://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.)
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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)
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58713-58714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20301]
-----------------------------------------------------------------------
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
``Gonadotropin-releasing 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
https://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 https://
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 https://
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, ``Gonadotropin-releasing 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
Sec. 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 Sec. Sec. 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 Sec. Sec. 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 Sec. 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
``Gonadotropin-releasing 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 Sec. 50.54, apply as well.
In accordance with 45 CFR 46.407(b) and Sec. 50.54(b), OHRP and
FDA are soliciting public review and comment
[[Page 58714]]
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 https://
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 https://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
https://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 https://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
