[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66007-66008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26291]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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 sachrp@osophs.dhhs.gov.

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

[[Page 66008]]

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]
BILLING CODE 4150-36-P