National Preparedness and Response Science Board; Call for Nominees, 18657-18658 [2017-08005]
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Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
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[FR Doc. 2017–07989 Filed 4–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,,
notice is hereby given that the
Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
will hold a meeting that will be open to
the public. Information about SACHRP
and the full meeting agenda will be
posted on the SACHRP Web site at:
https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/.
DATES: The meeting will be held on
Thursday, May 25, from 8:30 a.m. until
5:00 p.m., and Friday, May 26 from 8:30
a.m. until 4:30 p.m. Please note: this
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SUMMARY:
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meeting was originally scheduled to be
held March 15–16, but was postponed
due to a predicted snow storm.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will be open to
the public at 8:30 a.m., on Thursday,
May 25, 2017, followed by opening
remarks from Dr. Jerry Menikoff,
Director of OHRP and Executive
Secretary of SACHRP, and Dr. Stephen
Rosenfeld, SACHRP Chair. Dr. Menikoff
will then lead a discussion focusing on
selected sections of the new Common
Rule, which was published January 19,
2017, with an effective date of January
19, 2018 (see https://www.gpo.gov/
fdsys/pkg/FR-2017-01-19/html/201701058.htm).
The SOH will present their
recommendations for consideration of
the new Common Rule’s compliance
dates and transition provisions, as well
as for the interpretation and
implementation of the new broad
consent provision.
The SAS will discuss their report on
the interpretation of the new exemption
involving benign behavioral
interventions.
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18657
The Thursday meeting will adjourn at
approximately 5:00 p.m.
The Friday, May 26, meeting will
begin at 8:30 a.m. with
recommendations from the SOH on the
FDA Draft Guidance ‘‘Use of Real-World
Evidence to Support Regulatory
Decision-Making for Medical Devices,’’
issued July 27, 2016. SOH will also
present recommendations on the return
of incidental findings to research
subjects. The SAS will present
recommendations surrounding the new
Common Rule’s expedited review
requirements.
The meeting will adjourn at 4:30 p.m.
May 26, 2017. Time for public comment
sessions will be allotted both days. Note
that public comment must be relevant to
issues being addressed by the SACHRP.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated SACHRP point of contact at
the address/phone number listed above
at least one week prior to the meeting.
On-site registration is required for
participation in the live public comment
session. Individuals who would like to
submit written statements as public
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Dated: April 17, 2017.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2017–08017 Filed 4–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Preparedness and Response
Science Board; Call for Nominees
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Office of the Secretary
seeks application submissions from
qualified individuals for consideration
for membership on the National
Preparedness and Response Science
Board (NPRSB). Terms of eight members
expire December 31, 2017; therefore, the
Secretary must appoint eight new voting
members. Nominees shall represent the
following categories: Industry,
academia, health care consumer
organizations, and organizations
representing other appropriate
SUMMARY:
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18658
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
stakeholders. Please visit the NPRSB
Web site at https://www.phe.gov/nprsb
for all application submission
information and instructions. If
interested, please submit your
application by the deadline of June 7,
2017, at 11:59 p.m.
FOR FURTHER INFORMATION CONTACT: CDR
Evelyn Seel, MPH, Designated Federal
Official, National Preparedness and
Response Science Board, Office of the
Assistant Secretary for Preparedness
and Response, U.S. Department of
Health and Human Services, Thomas P.
O’Neill Federal Building, Room Number
22H11, 200 C St. SW., Washington, DC
20024; Office: 202–205–7960, Email
address: evelyn.seel@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to section 319M of the Public Health
Service (PHS) Act (42 U.S.C. 247d–7f)
and section 222 of the PHS Act (42
U.S.C. 217a), the Department of Health
and Human Services (HHS) established
the NPRSB. The Board shall provide
expert advice and guidance to the
Secretary on scientific, technical, and
other matters of special interest to HHS
regarding current and future chemical,
biological, nuclear, and radiological
agents, whether naturally occurring,
accidental, or deliberate. The Board may
also provide advice and guidance to the
Secretary and/or the Assistant Secretary
for Preparedness and Response (ASPR)
on other matters related to public health
emergency preparedness and response.
Description of Duties: The Board shall
advise the Secretary and/or ASPR on
current and future trends, challenges,
and opportunities presented by
advances in biological and life sciences,
biotechnology, and genetic engineering
with respect to threats posed by
naturally occurring infectious diseases
and chemical, biological, radiological,
and nuclear agents. At the request of the
Secretary and/or ASPR, the Board shall
review and consider any information
and findings received from the working
groups established under 42 U.S.C.
247d–7f(b). At the request of the
Secretary and/or ASPR, the Board shall
provide recommendations and findings
for expanded, intensified, and
coordinated biodefense research and
development activities. The Secretary
and/or ASPR may assign additional
advisory duties concerning public
health emergency preparedness and
response at his/her discretion.
Structure: The Board shall consist of
13 voting members, including the
chairperson; additionally, there may be
non-voting ex officio members. Pursuant
to 42 U.S.C. 247d–7f(a), the Secretary
shall appoint members and the
Chairperson from among the nation’s
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preeminent scientific, public health,
and medical experts, as follows: (a)
Such federal officials as the Secretary
determines are necessary to support the
functions of the Board; (b) four
individuals from the pharmaceutical,
biotechnology, and device industries; (c)
four academicians; and, (d) five other
members as determined appropriate by
the Secretary and/or ASPR, one of
whom must be a practicing health care
professional, one of whom must be from
an organization representing health care
consumers, one of whom must have
pediatric subject matter expertise, and
one of whom shall be a state, tribal,
territorial, or local public health official.
The Secretary will appoint additional
members for category (d), above, from
among emergency medical responders
and organizations representing other
appropriate stakeholders. A member of
the Board described in (b), (c), or (d) in
the above paragraph shall serve for a
term of three years, except that the
Secretary may adjust the terms of the
initial Board appointees in order to
provide for a staggered term of
appointment of all members. The
Secretary shall appoint members who
are not full-time or permanent part-time
federal employees as special
government employees.
Dated: April 14, 2017.
George W. Korch Jr.,
Acting Assistant Secretary for Preparedness
and Response.
[FR Doc. 2017–08005 Filed 4–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel RFA–OD–
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15–004—Tobacco Regulatory Sciences Small
Grant Program for New Investigators (R03).
Date: May 15, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Hotel Reston, 11810
Sunrise Valley Dr., Herndon, VA 20191.
Contact Person: Malaya Chatterjee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, (301) 806–
2515, chatterm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Risk
Prevention and Health Behavior AREA
Review.
Date: May 15, 2017.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: John H. Newman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3222,
MSC 7808, Bethesda, MD 20892, (301) 435–
0628, newmanjh@csr.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group, Nuclear and
Cytoplasmic Structure/Function and
Dynamics Study Section.
Date: May 18, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, 301–435–
1022, balasundaramd@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 14, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–07931 Filed 4–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
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Agencies
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18657-18658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08005]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Preparedness and Response Science Board; Call for
Nominees
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office of the Secretary seeks application submissions from
qualified individuals for consideration for membership on the National
Preparedness and Response Science Board (NPRSB). Terms of eight members
expire December 31, 2017; therefore, the Secretary must appoint eight
new voting members. Nominees shall represent the following categories:
Industry, academia, health care consumer organizations, and
organizations representing other appropriate
[[Page 18658]]
stakeholders. Please visit the NPRSB Web site at https://www.phe.gov/nprsb for all application submission information and instructions. If
interested, please submit your application by the deadline of June 7,
2017, at 11:59 p.m.
FOR FURTHER INFORMATION CONTACT: CDR Evelyn Seel, MPH, Designated
Federal Official, National Preparedness and Response Science Board,
Office of the Assistant Secretary for Preparedness and Response, U.S.
Department of Health and Human Services, Thomas P. O'Neill Federal
Building, Room Number 22H11, 200 C St. SW., Washington, DC 20024;
Office: 202-205-7960, Email address: evelyn.seel@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to section 319M of the Public
Health Service (PHS) Act (42 U.S.C. 247d-7f) and section 222 of the PHS
Act (42 U.S.C. 217a), the Department of Health and Human Services (HHS)
established the NPRSB. The Board shall provide expert advice and
guidance to the Secretary on scientific, technical, and other matters
of special interest to HHS regarding current and future chemical,
biological, nuclear, and radiological agents, whether naturally
occurring, accidental, or deliberate. The Board may also provide advice
and guidance to the Secretary and/or the Assistant Secretary for
Preparedness and Response (ASPR) on other matters related to public
health emergency preparedness and response.
Description of Duties: The Board shall advise the Secretary and/or
ASPR on current and future trends, challenges, and opportunities
presented by advances in biological and life sciences, biotechnology,
and genetic engineering with respect to threats posed by naturally
occurring infectious diseases and chemical, biological, radiological,
and nuclear agents. At the request of the Secretary and/or ASPR, the
Board shall review and consider any information and findings received
from the working groups established under 42 U.S.C. 247d-7f(b). At the
request of the Secretary and/or ASPR, the Board shall provide
recommendations and findings for expanded, intensified, and coordinated
biodefense research and development activities. The Secretary and/or
ASPR may assign additional advisory duties concerning public health
emergency preparedness and response at his/her discretion.
Structure: The Board shall consist of 13 voting members, including
the chairperson; additionally, there may be non-voting ex officio
members. Pursuant to 42 U.S.C. 247d-7f(a), the Secretary shall appoint
members and the Chairperson from among the nation's preeminent
scientific, public health, and medical experts, as follows: (a) Such
federal officials as the Secretary determines are necessary to support
the functions of the Board; (b) four individuals from the
pharmaceutical, biotechnology, and device industries; (c) four
academicians; and, (d) five other members as determined appropriate by
the Secretary and/or ASPR, one of whom must be a practicing health care
professional, one of whom must be from an organization representing
health care consumers, one of whom must have pediatric subject matter
expertise, and one of whom shall be a state, tribal, territorial, or
local public health official. The Secretary will appoint additional
members for category (d), above, from among emergency medical
responders and organizations representing other appropriate
stakeholders. A member of the Board described in (b), (c), or (d) in
the above paragraph shall serve for a term of three years, except that
the Secretary may adjust the terms of the initial Board appointees in
order to provide for a staggered term of appointment of all members.
The Secretary shall appoint members who are not full-time or permanent
part-time federal employees as special government employees.
Dated: April 14, 2017.
George W. Korch Jr.,
Acting Assistant Secretary for Preparedness and Response.
[FR Doc. 2017-08005 Filed 4-19-17; 8:45 am]
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