National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings, 35975-35976 [2017-16192]
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sradovich on DSKBCFCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
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
(Secretary), 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 on October 1, 2002. OHRP
is seeking nominations of qualified
candidates to fill four positions on the
Committee membership that will be
vacated during the 2018 calendar year.
DATES: Nominations for membership on
the Committee must be received no later
than September 18, 2017.
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, 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
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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 four positions for
voting members of SACHRP. One
position will become vacant in January
2018, with three others becoming vacant
in October 2018. 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
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 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
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35975
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.
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.
Dated: July 26, 2017.
Julia Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections,
Office for Human Research Protections
[FR Doc. 2017–16156 Filed 8–1–17; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings will be open to the
public as indicated below, with
attendance 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 Contact Person listed below
in advance of the meeting.
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
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35976
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
sradovich on DSKBCFCHB2PROD with NOTICES
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: September 6, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To present the Director’s Report
and other scientific presentations.
Place: National Institutes of Health,
Natcher Building Forty-five, Conference
Rooms E1/E2, 45 Center Drive, Bethesda, MD
20892.
Closed: 3:45 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building Forty-five, Conference
Rooms E1/E2, 45 Center Drive, Bethesda, MD
20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.
Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Diabetes, Endocrinology and
Metabolic Diseases.
Date: September 6, 2017.
Closed: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building Forty-five, Natcher
Conference Center, Room E1, 45 Center
Drive, Bethesda, MD 20892.
Open: 2:00 p.m. to 3:30 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Natcher Building Forty-five, Natcher
Conference Center, Room E1, 45 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.
Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Kidney, Urologic and Hematologic
Diseases.
Date: September 6, 2017.
Open: 1:00 p.m. to 3:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Natcher Building Forty-five, Natcher
Conference Center, Room F2, 45 Center
Drive, Bethesda, MD 20892.
Closed: 3:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building Forty-five, Natcher
Conference Center, Room F2, 45 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.
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Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Digestive Diseases and Nutrition.
Date: September 6, 2017.
Open: 1:00 p.m. to 2:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Natcher Building Forty-five, Natcher
Conference Center, Room F1, 45 Center
Drive, Bethesda, MD 20892.
Closed: 2:15 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building Forty-five, Natcher
Conference Center, Room F1, 45 Center
Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.
Room 7323, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/fund/divisions/DEA/
Council/coundesc.htm., where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 27, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–16192 Filed 8–1–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Letters of Interest for NCI–
MATCH Laboratories
The National Cancer Institute
(NCI) in collaboration with the NCI
SUMMARY:
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Molecular Analysis for Therapy Choice
(MATCH) trial leadership (NCT
02465060) invites applications for
Clinical Laboratory Improvements
Program (CLIA) certified/accredited
laboratories that test tumor specimens
from patients utilizing Next Generation
Sequencing (NGS) assays to participate
in the NCI MATCH trial. The NCI
MATCH trial has implemented a new
process for identifying patients for arms
with rare variant eligibility criteria.
Laboratories will contact any of the
approximately 1100 sites that have
activated NCI MATCH if a specimen
sent from one of these sites has a rare
variant that would potentially make the
patient eligible for one of the treatment
arms open in this initiative.
DATES: LOIs should be submitted to the
National Cancer Institute (NCI),
National Institutes of Health (NIH) on or
before 5:00 p.m. EST on January 31,
2018.
ADDRESSES: Submit LOIs by email to
NCIMATCHLabApps@nih.gov. 9609
Medical Center Drive, 3 West, Room
526, MSC 9728, Rockville, MD 20892.
FOR FURTHER INFORMATION CONTACT:
Questions about this request for LOIs
should be directed to
NCIMATCHLabApps@nih.gov. James V.
Tricoli tricolij@mail.nih.gov can also
provide further information.
SUPPLEMENTARY INFORMATION: NCI–
MATCH aims to establish whether
patients with tumor mutations,
amplifications or translocations in one
of the genetic pathways of interest are
likely to derive clinical benefit (primary
objective: Objective response; secondary
objective: Progression-free survival of at
least 6 months) if treated with agents
targeting that specific pathway in a
single-arm design (see current arms
below).
Patients with histologically
documented solid tumors, lymphomas
and multiple myeloma whose disease
has progressed following at least one
line of standard systemic therapy or for
whom no standard therapy exists are
eligible if they meet the eligibility
criteria for the trial. Further information
about the NCI–MATCH trial may be
found at https://ecog-acrin.org/trials/ncimatch-eay131.
The selected collaborating
laboratories may only act (i.e., refer
patients) on any of the rare variant arms
for which their assay reports actionable
mutations of interest (aMOIs). The assay
must also report all exclusionary
variants for the arm unless these occur
at a frequency of >1% in cancer
patients.
CLIA accredited/certified laboratories
located in the United States may be
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]]>Agencies
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35975-35976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16192]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of meetings of the
National Diabetes and Digestive and Kidney Diseases Advisory Council.
The meetings will be open to the public as indicated below, with
attendance 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 Contact Person
listed below in advance of the meeting.
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
[[Page 35976]]
applications, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council.
Date: September 6, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To present the Director's Report and other scientific
presentations.
Place: National Institutes of Health, Natcher Building Forty-
five, Conference Rooms E1/E2, 45 Center Drive, Bethesda, MD 20892.
Closed: 3:45 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building Forty-
five, Conference Rooms E1/E2, 45 Center Drive, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council; Diabetes, Endocrinology and Metabolic
Diseases.
Date: September 6, 2017.
Closed: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building Forty-
five, Natcher Conference Center, Room E1, 45 Center Drive, Bethesda,
MD 20892.
Open: 2:00 p.m. to 3:30 p.m.
Agenda: To review the Division's scientific and planning
activities.
Place: National Institutes of Health, Natcher Building Forty-
five, Natcher Conference Center, Room E1, 45 Center Drive, Bethesda,
MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council; Kidney, Urologic and Hematologic
Diseases.
Date: September 6, 2017.
Open: 1:00 p.m. to 3:00 p.m.
Agenda: To review the Division's scientific and planning
activities.
Place: National Institutes of Health, Natcher Building Forty-
five, Natcher Conference Center, Room F2, 45 Center Drive, Bethesda,
MD 20892.
Closed: 3:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building Forty-
five, Natcher Conference Center, Room F2, 45 Center Drive, Bethesda,
MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and Digestive and Kidney
Diseases Advisory Council; Digestive Diseases and Nutrition.
Date: September 6, 2017.
Open: 1:00 p.m. to 2:00 p.m.
Agenda: To review the Division's scientific and planning
activities.
Place: National Institutes of Health, Natcher Building Forty-
five, Natcher Conference Center, Room F1, 45 Center Drive, Bethesda,
MD 20892.
Closed: 2:15 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Natcher Building Forty-
five, Natcher Conference Center, Room F1, 45 Center Drive, Bethesda,
MD 20892.
Contact Person: Brent B. Stanfield, Ph.D., Director, Division of
Extramural Activities, National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd. Room 7323, MSC 5452,
Bethesda, MD 20892, (301) 594-8843, stanfibr@niddk.nih.gov.
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
Information is also available on the Institute's/Center's home
page: www.niddk.nih.gov/fund/divisions/DEA/Council/coundesc.htm.,
where an agenda and any additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: July 27, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-16192 Filed 8-1-17; 8:45 am]
BILLING CODE 4140-01-P
