Solicitation for Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections, 66007-66008 [2013-26291]
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Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices
particular, this meeting seeks to
evaluate the cost recovery system of
blood centers, their perceived capacity
for product and services innovations,
and to promote risk based decision
making from donor to recipient. The
Committee will also hear from the
World Health Organization’s NOTIFY
Library Project and their efforts to
improve vigilance and surveillance of
adverse transplant events relating to
human cells, tissues, and organs.
Additionally, the Committee will
receive updates on recommendations
from the ACBTSA Subcommittees
addressing Disaster Preparedness;
Tissue and Blood Safety; and Informed
Consent in Transfusion and
Transplantation.
The public will have the opportunity
to present their views to the Committee
during a public comment session
scheduled for December 4, 2013.
Comments will be limited to five
minutes per speaker and must be
pertinent to blood and tissue safety and
availability. Pre-registration is required
for participation in the public comment
session. Any member of the public who
would like to participate in this session
should to contact the designated Federal
official to register prior to close of
business on December 2, 2013. If it is
not possible to provide 30 copies of the
material to be distributed, then
individuals are requested to provide a
minimum of one (1) copy of the
document(s) to be distributed prior to
the close of business on December 2,
2013. It is also requested that any
member of the public who wishes to
provide comments to the Committee
utilizing electronic data projection to
submit the necessary material to the
Executive Secretary prior to the close of
business on December 2, 2013.
Dated: October 28, 2013.
James J. Berger,
Senior Advisor for Blood and Tissue Safety
Policy.
[FR Doc. 2013–26292 Filed 11–1–13; 8:45 am]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Nominations for
Membership on the Secretary’s
Advisory Committee on Human
Research Protections
Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
17:07 Nov 01, 2013
Jkt 232001
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.
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–
SUMMARY:
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66007
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.
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
SUPPLEMENTARY INFORMATION:
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66008
Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
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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Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–14BB]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project:
Evaluation of Rapid HIV HomeTesting among MSM Trial—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Innovative testing strategies are
needed to reduce levels of undiagnosed
Human immunodeficiency virus (HIV)
infection and increase early access to
treatment. Rapid home HIV tests may
play an important role in efforts to
reduce both HIV morbidity and
mortality. Given the unrelenting HIV
crisis among men who have sex with
men (MSM) and the release into the
market of a rapid HIV test for at-home
use, it is necessary to evaluate the
impact of providing rapid HIV hometest kits on repeat HIV testing, linkage
to care, partner testing, serosorting, and
HIV sexual risk behaviors among MSM.
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This information will assist the Division
of HIV/AIDS Prevention (DHAP) in
developing recommendations, future
research and program needs concerning
home-testing for MSM.
Specific Aims
This study is a randomized trial
which aims to evaluate the use and
effectiveness of home-test kits as a
public health strategy for increasing
testing among MSM. A secondary aim of
the randomized trial is to evaluate the
extent to which MSM (both HIVnegative and HIV-positive) distribute
HIV home-test kits to their social and
sexual networks.
The population for the randomized
trial will be men over the age of 18 years
who self-report that they have had anal
sex with at least one man in the past
year. We will recruit approximately
3,200 men who report their HIV status
to be negative or who are unaware of
their HIV status and 300 men who selfreport that they are HIV-positive. Men
will be recruited from the 12 cities:
Atlanta, Georgia; Baltimore, Maryland;
Chicago, Illinois; Dallas, Texas; District
of Columbia; Houston, Texas; Los
Angeles, California; Miami, Florida;
New York City, New York; Philadelphia,
Pennsylvania; San Francisco, California;
and San Juan, Puerto Rico. We will
ensure that at least 20% of participants
are black and at least 15% are Hispanic.
Recruitment will be conducted through
banner advertisements displayed on
social networking sites such as
Facebook and dating and sex-seeking
sites such as Manhunt and
Adam4Adam.
This study also has a qualitative
component that aims to examine the
experiences of participants in the
randomized control trial (RCT).
Participants for the qualitative data
collection will be drawn from the
randomized control trial. Two data
collection techniques will be used:
focus group discussions (FGD) (both
online and in-person) and individual indepth interviews (IDIs).
CDC is requesting approval for a 3year clearance for data collection. All
participant consenting and data
collection for the RCT will be completed
using an online reporting system. Data
will be collected using an eligibility
screener, an online study registration
process, a baseline survey, HIV test
results reporting system, and follow-up
surveys. Men will be asked to use the
study Web site or download and access
a secure cell phone application prior to
enter results of their rapid HIV hometests that they receive and conduct at
home and to take the follow-up surveys
which will collect information on HIV
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Agencies
[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]
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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.
-----------------------------------------------------------------------
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]
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