[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66007-66008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation for Nominations for Membership on the Secretary's
Advisory Committee on Human Research Protections
AGENCY: Office for Human Research Protections, Office of the Assistant
Secretary for Health, Office of the Secretary, Department of Health and
Human Services.
ACTION: Notice.
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Authority: 42 U.S.C. 217a, Section 222 of the Public Health
Service Act, as amended. The Committee is governed by the provisions
of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of advisory committees.
SUMMARY: The Office for Human Research Protections (OHRP), a program
office in the Office of the Assistant Secretary for Health, Department
of Health and Human Services (HHS), is seeking nominations of qualified
candidates to be considered for appointment as members of the
Secretary's Advisory Committee on Human Research Protections (SACHRP).
SACHRP provides advice and recommendations to the Secretary, HHS,
through the Assistant Secretary for Health, on matters pertaining to
the continuance and improvement of functions within the authority of
HHS directed toward protections for human subjects in research. SACHRP
was established by the Secretary, HHS, on October 1, 2002. OHRP is
seeking nominations of qualified candidates to fill three positions on
the Committee membership that will be vacated during the 2014 calendar
year.
A notice was published in the Federal Register on September 27,
2013, to solicit names of qualified applicants to be considered for
appointment to the Committee. The due date for all applications was
October 28, 2013. Response to this solicitation notice has been low; a
sufficient number of applications has not been received to identify
qualified candidates to be considered for appointment. In view of the
Government shutdown, it has been determined that more time should be
given for individuals to submit applications to be considered for
appointment to the Committee. Therefore, this notice is being published
in the Federal Register again to allow more time for qualified
individuals to submit applications to fill the impending vacancies on
SACHRP.
DATES: Nominations for membership on the Committee must be received no
later than December 4, 2013.
ADDRESSES: Nominations should be mailed or delivered to Dr. Jerry
Menikoff, Director, Office for Human Research Protections, Department
of Health and Human Services, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852. Nominations will not be accepted by email or by
facsimile.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, Executive Director,
SACHRP, Office for Human Research Protections, 1101 Wootton Parkway,
Suite 200, Rockville, MD 20852, telephone: 240-453-8141. A copy of the
Committee charter and list of the current members can be obtained by
contacting Ms. Gorey, accessing the SACHRP Web site at www.hhs.gov/ohrp/sachrp, or requesting via email at [email protected].
SUPPLEMENTARY INFORMATION: The Committee provides advice on matters
pertaining to the continuance and improvement of functions within the
authority of HHS directed toward protections for human subjects in
research. Specifically, the Committee provides advice relating to the
responsible conduct of research involving human subjects with
particular emphasis on special populations such as neonates and
children, prisoners, and the decisionally impaired; pregnant women,
embryos and fetuses; individuals and populations in international
studies; investigator conflicts of interest; and populations in which
there are individually identifiable samples, data or information.
In addition, the Committee is responsible for reviewing selected
ongoing work and planned activities of the OHRP and other offices/
agencies within HHS responsible for human subjects protection. These
evaluations may include, but are not limited to, a review of assurance
systems, the application of minimal research risk standards, the
granting of waivers, education programs sponsored by OHRP, and the
ongoing monitoring and oversight of institutional review boards and the
institutions that sponsor research.
Nominations: The OHRP is requesting nominations to fill three
positions for voting members of SACHRP. One position will become vacant
in March, 2014; two others will become vacant in July. If you submitted
a nomination in response to the solicitation request posted in the
Federal Register on September 27, 2013, you do not need to resubmit
your nomination. Nominations of potential candidates for consideration
are being sought from a wide array of fields, including, but not
limited to: Public health and medicine, behavioral and social sciences,
health administration, and biomedical ethics. To qualify for
consideration of appointment to the Committee, an individual must
possess demonstrated experience and expertise in any of the several
disciplines and fields pertinent to human subjects protection and/or
clinical research.
The individuals selected for appointment to the Committee can be
invited to serve a term of up to four
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years. Committee members receive a stipend and reimbursement for per
diem and any travel expenses incurred for attending Committee meetings
and/or conducting other business in the interest of the Committee.
Interested applicants may self-nominate. Nominations may be retained
and considered for future vacancies.
Nominations should be typewritten. The following information should
be included in the package of material submitted for each individual
being nominated for consideration: (1) A letter of nomination that
clearly states the name and affiliation of the nominee, the basis for
the nomination (i.e., specific attributes which qualify the nominee for
service in this capacity), and a statement that the nominee is willing
to serve as a member of the Committee; (2) the nominator's name,
address, daytime telephone number, and the home and/or work address,
telephone number, and email address of the individual being nominated;
and (3) a current copy of the nominee's curriculum vitae. Federal
employees should not be nominated for consideration of appointment to
this Committee.
The Department makes every effort to ensure that the membership of
HHS Federal advisory committees is fairly balanced in terms of points
of view represented and the committee's function. Every effort is made
to ensure that individuals from a broad representation of geographic
areas, women and men, ethnic and minority groups, and the disabled are
given consideration for membership on HHS Federal advisory committees.
Appointment to this Committee shall be made without discrimination on
the basis of age, race, ethnicity, gender, sexual orientation,
disability, and cultural, religious, or socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is necessary in order to determine if the selected
candidate is involved in any activity that may pose a potential
conflict with the official duties to be performed as a member of
SACHRP.
Dated: October 25, 2013.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2013-26291 Filed 11-1-13; 8:45 am]
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