Center For Scientific Review; Notice of Closed Meetings, 42366-42367 [2016-15320]
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Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–4361 for ‘‘Gifts to FDA:
Evaluation and Acceptance: Draft
Guidance for the Public and FDA Staff;
Availability’’. Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
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information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Submit written requests for single
copies of the draft guidance to the Office
of Policy, Office of the Commissioner,
Food and Drug Administration, Bldg.
32, Rm. 4235, 10903 New Hampshire
Ave., Silver Spring, MD, 20993. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Aaron Zimmerman, Office of Policy,
Office of the Commissioner, Food and
Drug Administration, Bldg. 32, Rm.
4235, 10903 New Hampshire Ave.,
Silver Spring, MD, 20993. 301–796–
0339, aaron.zimmerman@fda.hhs.gov.
Alternate contact: Office of Policy, 301–
796–4830.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for the public and FDA
staff entitled ‘‘Gifts to FDA: Evaluation
and Acceptance.’’ The Secretary of HHS
has the authority to accept conditional
or unconditional gifts on behalf of the
United States. The Secretary has
delegated this gift authority to the
Commissioner of Food and Drugs. This
guidance provides the process and
principles we will use in implementing
this authority.
FDA will consider gifts from all
sources on a case-by-case basis using a
balancing test, described in the draft
guidance. While any person may offer a
gift, there are five reasons we should
reject a gift without additional
evaluation. We should not accept a gift
if: (1) The donor imposes conditions
that are illegal, are contrary to public
policy, are unreasonable to administer,
are contrary to FDA’s current policies
and procedures, or are contrary to
generally accepted public standards; (2)
the donor requires us to provide the
donor with some privilege, concession,
or other present or future benefit in
return for the gift; (3) a debarred entity
offers the gift; (4) a different authority or
financial mechanism applies; or (5) the
total costs associated with acceptance
are expected to exceed the cost of
purchasing a similar item and the cost
of normal care and maintenance.
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This draft guidance is being issued
consistent with our good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent our current thinking on this
matter. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: June 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–15385 Filed 6–28–16; 8:45 am]
BILLING CODE 4164–01–P
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; Member
Conflict: Transport Synapses and
Cytoskeletal Dynamics.
Date: July 13, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Joanne T Fujii, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4184,
MSC 7850, Bethesda, MD 20892, (301) 435–
1178, fujiij@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
E:\FR\FM\29JNN1.SGM
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; US-China
Program for Collaborative Biomedical
Research.
Date: July 21, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Suzan Nadi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Microbial Pathogenesis and Therapeutic
Research.
Date: July 21, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Gagan Pandya, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, RM 3200, MSC 7808,
Bethesda, MD 20892, 301–435–1167,
pandyaga@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA:
Oncological Sciences Grant Applications.
Date: July 22, 2016.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Svetlana Kotliarova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
Bethesda, MD 20892, 301–594–7945,
kotliars@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RM15–013:
MoTrPAC Preclinical Animal Study Sites
(U01).
Date: July 22, 2016.
Time: 11:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Richard Ingraham, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116,
MSC 7814, Bethesda, MD 20892, 301–496–
8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–13–
327: Innovative Molecular Analysis
Technology Development for Cancer
Research and Clinical Care.
Date: July 26, 2016.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Zhang-Zhi Hu, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6186,
MSC 7804, Bethesda, MD 20892, (301) 594–
2414, huzhuang@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: June 23, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–15320 Filed 6–28–16; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institutes of Health, Precision
Medicine Initiative® (PMI) Cohort
Program; Notice of Meeting
Notice of Meeting.
Pursuant to the NIH Reform
Act of 2006 (42 U.S.C. 281(d)(4)), notice
is hereby given that the National
Institutes of Health (NIH), Precision
Medicine Initiative® (PMI) Cohort
Program will host two (2)
teleconferences to enable public
discussion of its proposal to align the
authority and responsibility for the
execution of PMI Cohort Program by
establishing this program within the
NIH Office of the Director, and reporting
to the NIH Director.
DATES: Two (2) teleconferences will be
held on the following days:
(1) Tuesday, July 5, 2016, 3:00–3:45
p.m. ET
(2) Wednesday, July 13, 2016, 2:00–
2:45 p.m. ET
Any interested person may submit
their written comments via the form
provided at https://grants.nih.gov/grants/
rfi/rfi.cfm?ID=59 by Wednesday, July
13, 2016. The message should include
the individual’s name and organization/
professional affiliation, when
applicable.
SUMMARY:
Members of the public
wishing to attend the July 5
teleconference are asked to Web RSVP
by 12:00 p.m., Tuesday, July 5, 2016 at
https://www.mymeetings.com/emeet/
rsvp/index.jsp?customHeader=
mymeetings&Conference_ID=8723518&
passcode=2802855; Conference number:
8723518; Passcode: 2802855,
ADDRESSES:
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Teleconference number: 877–922–4780,
Participant passcode: 2802855.
Members of the public wishing to
attend the July 13 teleconference are
asked to Web RSVP by 11:00 a.m. ET,
Wednesday, July 13, 2016, at https://
www.mymeetings.com/emeet/rsvp/
index.jsp?customHeader=mymeetings&
Conference_ID=8723531&passcode=
4607754; Conference number: 8723531;
Passcode: 4607754, Teleconference
number 888–810–5910, Participant
passcode: 4607754.
FOR FURTHER INFORMATION CONTACT: The
PMI Cohort Program at Precision
Medicine@nih.gov with subject line
‘‘PMI Cohort Program Office
Organization.’’
The PMI
Working Group of the Advisory
Committee to the NIH Director (ACD)
recommended that the authority and
responsibility for the implementation
and execution of the PMI Cohort
Program be established in the NIH
Office of the Director and that the PMI
Cohort Program Director report to the
NIH Director. On September 17, 2015,
the NIH ACD supported the PMI
Working Group Report with this
recommendation and this report was
subsequently accepted by the NIH
Director. For additional information
about the PMI Cohort Program, please
visit the Web site at https://www.nih.
gov/precision-medicine-initiativecohort-program.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
42367
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Dated: June 23, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–15395 Filed 6–28–16; 8:45 am]
BILLING CODE 4140–01–P
ADVISORY COUNCIL ON HISTORIC
PRESERVATION
Notice of Advisory Council on Historic
Preservation Quarterly Business
Meeting
Advisory Council on Historic
Preservation.
ACTION: Notice of Advisory Council on
Historic Preservation Quarterly Business
Meeting.
AGENCY:
Notice is hereby given that
the Advisory Council on Historic
Preservation (ACHP) will hold its next
quarterly meeting on Thursday, July 14,
2016. The meeting will be held in Room
SR325 at the Russell Senate Office
Building at Constitution and Delaware
Avenues NE., Washington, DC, starting
at 10:30 a.m. DST.
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42366-42367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15320]
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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; Member Conflict: Transport Synapses and Cytoskeletal
Dynamics.
Date: July 13, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Joanne T Fujii, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4184, MSC 7850, Bethesda, MD
20892, (301) 435-1178, fujiij@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing
[[Page 42367]]
limitations imposed by the review and funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; US-China Program for Collaborative Biomedical Research.
Date: July 21, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Suzan Nadi, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-
1259, nadis@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Topics in Microbial Pathogenesis and Therapeutic Research.
Date: July 21, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Gagan Pandya, Ph.D., Scientific Review Officer,
National Institutes of Health, Center for Scientific Review, 6701
Rockledge Drive, RM 3200, MSC 7808, Bethesda, MD 20892, 301-435-
1167, pandyaga@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AREA: Oncological Sciences Grant Applications.
Date: July 22, 2016.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Svetlana Kotliarova, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214, Bethesda, MD 20892, 301-
594-7945, kotliars@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; RM15-013: MoTrPAC Preclinical Animal Study Sites (U01).
Date: July 22, 2016.
Time: 11:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Richard Ingraham, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD
20892, 301-496-8551, ingrahamrh@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-13-327: Innovative Molecular Analysis Technology
Development for Cancer Research and Clinical Care.
Date: July 26, 2016.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Zhang-Zhi Hu, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, (301) 594-
2414, huzhuang@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: June 23, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-15320 Filed 6-28-16; 8:45 am]
BILLING CODE 4140-01-P
