81 FR 42366 - Center For Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 125 (June 29, 2016)

Page Range		42366-42367
FR Document		2016-15320

Federal Register, Volume 81 Issue 125 (Wednesday, June 29, 2016)

[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42366-42367]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

    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, [email protected].

    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, [email protected].

    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, [email protected].

    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, [email protected].

    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, [email protected].

(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

42366 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices

that if you include your name, contact information marked as ‘‘confidential’’ This draft guidance is being issued
information, or other information that will not be disclosed except in consistent with our good guidance
identifies you in the body of your accordance with 21 CFR 10.20 and other practices regulation (21 CFR 10.115).
comments, that information will be applicable disclosure law. For more The draft guidance, when finalized, will
posted on http://www.regulations.gov. information about FDA’s posting of represent our current thinking on this
• If you want to submit a comment comments to public dockets, see 80 FR matter. It does not establish any rights
with confidential information that you 56469, September 18, 2015, or access for any person and is not binding on
do not wish to be made available to the the information at: http://www.fda.gov/ FDA or the public. You can use an
public, submit the comment as a regulatoryinformation/dockets/ alternative approach if it satisfies the
written/paper submission and in the default.htm. requirements of the applicable statutes
manner detailed (see ‘‘Written/Paper Submit written requests for single and regulations.
Submissions’’ and ‘‘Instructions’’). copies of the draft guidance to the Office
II. Electronic Access
Written/Paper Submissions of Policy, Office of the Commissioner,
Food and Drug Administration, Bldg. Persons with access to the Internet
Submit written/paper submissions as 32, Rm. 4235, 10903 New Hampshire may obtain the document at either
follows: Ave., Silver Spring, MD, 20993. Send http://www.fda.gov/
• Mail/Hand delivery/Courier (for one self-addressed adhesive label to RegulatoryInformation/Guidances/
written/paper submissions): Division of default.htm or http://
assist that office in processing your
Dockets Management (HFA–305), Food www.regulations.gov.
requests. See the SUPPLEMENTARY
and Drug Administration, 5630 Fishers
INFORMATION section for electronic Dated: June 23, 2016.
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments access to the draft guidance document. Leslie Kux,
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy.
Management, FDA will post your Aaron Zimmerman, Office of Policy, [FR Doc. 2016–15385 Filed 6–28–16; 8:45 am]
comment, as well as any attachments, Office of the Commissioner, Food and BILLING CODE 4164–01–P
except for information submitted, Drug Administration, Bldg. 32, Rm.
marked and identified, as confidential, 4235, 10903 New Hampshire Ave.,
if submitted as detailed in Silver Spring, MD, 20993. 301–796– DEPARTMENT OF HEALTH AND
‘‘Instructions.’’ 0339, aaron.zimmerman@fda.hhs.gov. HUMAN SERVICES
Instructions: All submissions received Alternate contact: Office of Policy, 301–
must include the Docket No. FDA– 796–4830. National Institutes of Health
2015–D–4361 for ‘‘Gifts to FDA: SUPPLEMENTARY INFORMATION:
Evaluation and Acceptance: Draft Center For Scientific Review; Notice of
Guidance for the Public and FDA Staff; I. Background Closed Meetings
Availability’’. Received comments will FDA is announcing the availability of Pursuant to section 10(d) of the
be placed in the docket and, except for a draft guidance for the public and FDA Federal Advisory Committee Act, as
those submitted as ‘‘Confidential staff entitled ‘‘Gifts to FDA: Evaluation amended (5 U.S.C. App.), notice is
Submissions,’’ publicly viewable at and Acceptance.’’ The Secretary of HHS hereby given of the following meetings.
http://www.regulations.gov or at the has the authority to accept conditional The meetings will be closed to the
Division of Dockets Management or unconditional gifts on behalf of the public in accordance with the
between 9 a.m. and 4 p.m., Monday United States. The Secretary has provisions set forth in sections
through Friday. delegated this gift authority to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
• Confidential Submissions—To Commissioner of Food and Drugs. This as amended. The grant applications and
submit a comment with confidential guidance provides the process and the discussions could disclose
information that you do not wish to be principles we will use in implementing confidential trade secrets or commercial
made publicly available, submit your this authority. property such as patentable material,
comments only as a written/paper FDA will consider gifts from all and personal information concerning
submission. You should submit two sources on a case-by-case basis using a individuals associated with the grant
copies total. One copy will include the balancing test, described in the draft applications, the disclosure of which
information you claim to be confidential guidance. While any person may offer a would constitute a clearly unwarranted
with a heading or cover note that states gift, there are five reasons we should invasion of personal privacy.
‘‘THIS DOCUMENT CONTAINS reject a gift without additional
CONFIDENTIAL INFORMATION.’’ The evaluation. We should not accept a gift Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Agency will review this copy, including if: (1) The donor imposes conditions Conflict: Transport Synapses and
the claimed confidential information, in that are illegal, are contrary to public Cytoskeletal Dynamics.
its consideration of comments. The policy, are unreasonable to administer, Date: July 13, 2016.
second copy, which will have the are contrary to FDA’s current policies Time: 1:00 p.m. to 4:00 p.m.
claimed confidential information and procedures, or are contrary to Agenda: To review and evaluate grant
redacted/blacked out, will be available generally accepted public standards; (2) applications.
for public viewing and posted on http:// the donor requires us to provide the Place: National Institutes of Health, 6701
www.regulations.gov. Submit both donor with some privilege, concession, Rockledge Drive, Bethesda, MD 20892,
copies to the Division of Dockets or other present or future benefit in (Telephone Conference Call).
mstockstill on DSK3G9T082PROD with NOTICES

Contact Person: Joanne T Fujii, Ph.D.,
Management. If you do not wish your return for the gift; (3) a debarred entity Scientific Review Officer, Center for
name and contact information to be offers the gift; (4) a different authority or Scientific Review, National Institutes of
made publicly available, you can financial mechanism applies; or (5) the Health, 6701 Rockledge Drive, Room 4184,
provide this information on the cover total costs associated with acceptance MSC 7850, Bethesda, MD 20892, (301) 435–
sheet and not in the body of your are expected to exceed the cost of 1178, fujiij@csr.nih.gov.
comments and you must identify this purchasing a similar item and the cost This notice is being published less than 15
information as ‘‘confidential.’’ Any of normal care and maintenance. days prior to the meeting due to the timing

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Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 42367

limitations imposed by the review and Place: National Institutes of Health, 6701 Teleconference number: 877–922–4780,
funding cycle. Rockledge Drive, Bethesda, MD 20892. Participant passcode: 2802855.
Name of Committee: Center for Scientific Contact Person: Zhang-Zhi Hu, MD,
Members of the public wishing to
Review Special Emphasis Panel; US-China Scientific Review Officer, Center for
Scientific Review, National Institutes of attend the July 13 teleconference are
Program for Collaborative Biomedical
Research. Health, 6701 Rockledge Drive, Room 6186, asked to Web RSVP by 11:00 a.m. ET,
Date: July 21, 2016. MSC 7804, Bethesda, MD 20892, (301) 594– Wednesday, July 13, 2016, at https://
Time: 8:00 a.m. to 6:00 p.m. 2414, huzhuang@csr.nih.gov. www.mymeetings.com/emeet/rsvp/
Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance index.jsp?customHeader=mymeetings&
applications. Program Nos. 93.306, Comparative Medicine; Conference_ID=8723531&passcode=
Place: Hyatt Regency Bethesda, One 93.333, Clinical Research, 93.306, 93.333, 4607754; Conference number: 8723531;
Bethesda Metro Center, 7400 Wisconsin 93.337, 93.393–93.396, 93.837–93.844, Passcode: 4607754, Teleconference
Avenue, Bethesda, MD 20814. 93.846–93.878, 93.892, 93.893, National
Contact Person: Suzan Nadi, Ph.D.,
number 888–810–5910, Participant
Institutes of Health, HHS) passcode: 4607754.
Scientific Review Officer, Center for
Scientific Review, National Institutes of Dated: June 23, 2016. FOR FURTHER INFORMATION CONTACT: The
Health, 6701 Rockledge Drive, Room 5217B, Carolyn Baum, PMI Cohort Program at Precision
MSC 7846, Bethesda, MD 20892, 301–435– Program Analyst, Office of Federal Advisory Medicine@nih.gov with subject line
1259, nadis@csr.nih.gov. Committee Policy. ‘‘PMI Cohort Program Office
Name of Committee: Center for Scientific [FR Doc. 2016–15320 Filed 6–28–16; 8:45 am] Organization.’’
Review Special Emphasis Panel; Topics in
BILLING CODE 4140–01–P
Microbial Pathogenesis and Therapeutic SUPPLEMENTARY INFORMATION: The PMI
Research. Working Group of the Advisory
Date: July 21, 2016.
DEPARTMENT OF HEALTH AND Committee to the NIH Director (ACD)
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant HUMAN SERVICES recommended that the authority and
applications. responsibility for the implementation
Place: National Institutes of Health, 6701 National Institutes of Health and execution of the PMI Cohort
Rockledge Drive, Bethesda, MD 20892. Program be established in the NIH
Contact Person: Gagan Pandya, Ph.D., National Institutes of Health, Precision Office of the Director and that the PMI
Scientific Review Officer, National Institutes Medicine Initiative® (PMI) Cohort Cohort Program Director report to the
of Health, Center for Scientific Review, 6701 Program; Notice of Meeting NIH Director. On September 17, 2015,
Rockledge Drive, RM 3200, MSC 7808,
Bethesda, MD 20892, 301–435–1167, the NIH ACD supported the PMI
ACTION: Notice of Meeting. Working Group Report with this
pandyaga@mail.nih.gov.
Name of Committee: Center for Scientific recommendation and this report was
SUMMARY: Pursuant to the NIH Reform
Review Special Emphasis Panel; AREA: subsequently accepted by the NIH
Act of 2006 (42 U.S.C. 281(d)(4)), notice
Oncological Sciences Grant Applications. Director. For additional information
is hereby given that the National
Date: July 22, 2016. about the PMI Cohort Program, please
Time: 10:00 a.m. to 4:00 p.m. Institutes of Health (NIH), Precision
visit the Web site at https://www.nih.
Agenda: To review and evaluate grant Medicine Initiative® (PMI) Cohort
gov/precision-medicine-initiative-
applications. Program will host two (2)
cohort-program.
Place: National Institutes of Health, 6701 teleconferences to enable public
Rockledge Drive, Bethesda, MD 20892. discussion of its proposal to align the Dated: June 23, 2016.
Contact Person: Svetlana Kotliarova, Ph.D., authority and responsibility for the Lawrence A. Tabak,
Scientific Review Officer, Center for execution of PMI Cohort Program by Deputy Director, National Institutes of Health.
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
establishing this program within the [FR Doc. 2016–15395 Filed 6–28–16; 8:45 am]
Bethesda, MD 20892, 301–594–7945, NIH Office of the Director, and reporting BILLING CODE 4140–01–P
kotliars@mail.nih.gov. to the NIH Director.
Name of Committee: Center for Scientific DATES: Two (2) teleconferences will be
Review Special Emphasis Panel; RM15–013: held on the following days:
MoTrPAC Preclinical Animal Study Sites (1) Tuesday, July 5, 2016, 3:00–3:45 ADVISORY COUNCIL ON HISTORIC
(U01). p.m. ET PRESERVATION
Date: July 22, 2016.
(2) Wednesday, July 13, 2016, 2:00–
Time: 11:30 a.m. to 4:30 p.m. Notice of Advisory Council on Historic
Agenda: To review and evaluate grant 2:45 p.m. ET
Any interested person may submit Preservation Quarterly Business
applications. Meeting
Place: National Institutes of Health, 6701 their written comments via the form
Rockledge Drive, Bethesda, MD 20892, provided at http://grants.nih.gov/grants/ AGENCY: Advisory Council on Historic
(Virtual Meeting). rfi/rfi.cfm?ID=59 by Wednesday, July Preservation.
Contact Person: Richard Ingraham, Ph.D., 13, 2016. The message should include
Scientific Review Officer, Center for ACTION: Notice of Advisory Council on
the individual’s name and organization/
Scientific Review, National Institutes of
professional affiliation, when Historic Preservation Quarterly Business
Health, 6701 Rockledge Drive, Room 4116, Meeting.
MSC 7814, Bethesda, MD 20892, 301–496– applicable.
8551, ingrahamrh@mail.nih.gov. ADDRESSES: Members of the public SUMMARY: Notice is hereby given that
Name of Committee: Center for Scientific wishing to attend the July 5 the Advisory Council on Historic
mstockstill on DSK3G9T082PROD with NOTICES

Review Special Emphasis Panel; PAR–13– teleconference are asked to Web RSVP Preservation (ACHP) will hold its next
327: Innovative Molecular Analysis by 12:00 p.m., Tuesday, July 5, 2016 at quarterly meeting on Thursday, July 14,
Technology Development for Cancer
Research and Clinical Care.
https://www.mymeetings.com/emeet/ 2016. The meeting will be held in Room
Date: July 26, 2016. rsvp/index.jsp?customHeader= SR325 at the Russell Senate Office
Time: 11:00 a.m. to 5:00 p.m. mymeetings&Conference_ID=8723518& Building at Constitution and Delaware
Agenda: To review and evaluate grant passcode=2802855; Conference number: Avenues NE., Washington, DC, starting
applications. 8723518; Passcode: 2802855, at 10:30 a.m. DST.

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Document Created: 2018-02-08 07:42:31
Document Modified: 2018-02-08 07:42:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		July 13, 2016.
FR Citation		81 FR 42366

81 FR 42366 - Center For Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 125 (June 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health