Pediatric Advisory Committee; Notice of Meeting, 58712-58713 [05-20303]
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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 https://
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.
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
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
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Fmt 4703
Sfmt 4703
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 https://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).
E:\FR\FM\07OCN1.SGM
07OCN1
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:
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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,
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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
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]]>Agencies
[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58712-58713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20303]
-----------------------------------------------------------------------
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 https://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).
[[Page 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
