[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Notices]
[Page 58713-58714]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc05-65]
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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.
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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
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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, ``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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
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