81 FR 14863 - National Cancer Institute; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range		14863-14864
FR Document		2016-06194

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14863-14864]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06194]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; 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.

[[Page 14864]]

    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: National Cancer Institute Special Emphasis 
Panel; Population Science (U01).
    Date: April 5, 2016.
    Time: 8:00 a.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Cancer Institute Shady Grove, 9609 Medical 
Center Drive, Rockville, MD 20850 (Telephone Conference Call).
    Contact Person: Robert Bird, Ph.D., Scientific Review Officer, 
Resources and Training Review Branch, Division of Extramural 
Activities, National Cancer Institute, 9609 Medical Center Drive, 
Room 7W110, Bethesda, MD 20892-9750, 240-276-6344, 
[email protected].

    Name of Committee: National Cancer Institute Special Emphasis 
Panel; Fundamental Mechanisms of Affective and Decisional Processes 
in Cancer Control (U01).
    Date: April 6, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Cancer Institute Shady Grove, 9609 Medical 
Center Drive, Rockville, MD 20850 (Telephone Conference Call).
    Contact Person: Robert Bird, Ph.D., Scientific Review Officer, 
Resources and Training Review Branch, Division of Extramural 
Activities, National Cancer Institute, 9609 Medical Center Drive, 
Room 7W110, Bethesda, MD 20892-9750, 240-276-6344, 
[email protected].

    Name of Committee: National Cancer Institute Special Emphasis 
Panel; Oncology Co-Clinical Imaging Methods and Precision Medicine.
    Date: April 8, 2016.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications and/or 
proposals.
    Place: National Cancer Institute Shady Grove, 9609 Medical 
Center Drive, Room 7W514, Rockville, MD 20850 (Telephone Conference 
Call).
    Contact Person: Peter J. Wirth, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, National Cancer 
Institute, NIH, 9609 Medical Center Drive, 7W514, Rockville, MD 
20850, 240-276-6434 [email protected].

    Name of Committee: National Cancer Institute Special Emphasis 
Panel; Subcommittee A--Cancer Centers.
    Date: May 5, 2016.
    Time: 8:00 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, 
Chevy Chase, MD 20815.
    Contact Person: Shamala K. Srinivas, Ph.D., Associate Director, 
Office of Referral, Review, and Program Coordination, Division of 
Extramural Activities, National Cancer Institute, NIH, 9609 Medical 
Center Drive, Room 7W530, Rockville, MD 20850, 240-276-6442, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.392, 
Cancer Construction; 93.393, Cancer Cause and Prevention Research; 
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer 
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer 
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer 
Control, National Institutes of Health, HHS)

    Dated: March 15, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-06194 Filed 3-17-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices 14863

to patients. Instead, between approved or pending drug product Agenda: The Committee serves to advise
approximately July 11, 2008 and application who knowingly employs or and make recommendations to the Director,
September 3, 2008, Mr. McQuerry retains as a consultant or contractor, or Office of Research on Women’s Health
deposited over $2,300 of gift checks into otherwise uses the services of Wesley A. (ORWH) on a broad range of topics.
Information is also available on the
his personal bank account. He McQuerry, in any capacity during his Institute’s/Center’s home page: http://orwh.
additionally used the gift checks to debarment, will be subject to civil od.nih.gov/about/acrwh/index.asp where an
make direct purchases at various money penalties (section 307(a)(6) of the agenda and any additional information for
retailers. Mr. McQuerry’s fraud resulted FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. the meeting will be posted when available.
in a loss of approximately $200,098 to McQuerry provides services in any Place: National Institutes of Health,
the pharmaceutical company. capacity to a person with an approved Building 31, Room 6C, 31 Center Drive,
As a result of this conviction, FDA or pending drug product application Bethesda, MD 20892.
sent Mr. McQuerry by certified mail on during his period of debarment, he will Contact Person: Terri L. Cornelison, MD,
October 30, 2015, a notice proposing to be subject to civil money penalties Ph.D., Associate Director for Clinical
permanently debar him from providing (section 307(a)(7) of the FD&C Act). In Research, Office of Research on Women’s
services in any capacity to a person that Health, Office of the Director, 6707
addition, FDA will not accept or review Democracy Blvd., Bethesda, MD 20817, 301–
has an approved or pending drug any abbreviated new drug applications 402–1770, cornelit@od.nih.gov.
product application. The proposal was from Wesley A. McQuerry during his
based on a finding, under section Any interested person may file written
period of debarment (section comments with the committee by forwarding
306(a)(2)(A) and (a)(2)(B) of the FD&C 306(c)(1)(B) of the FD&C Act. the statement to the Contact Person listed on
Act, that Mr. McQuerry was convicted Any application by Mr. McQuerry for this notice. The statement should include the
of a felony under Federal law for special termination of debarment under name, address, telephone number and when
conduct relating to the development or section 306(d)(4) of the FD&C Act applicable, the business or professional
approval, including the process for should be identified with Docket No. affiliation of the interested person.
development or approval, of a drug FDA–2015–N–3225 and sent to the In the interest of security, NIH has
product, and conduct otherwise relating Division of Dockets Management (see instituted stringent procedures for entrance
to the regulation of a drug product ADDRESSES). All such submissions are to
onto the NIH campus. All visitor vehicles,
under the FD&C Act. The proposal also including taxicabs, hotel, and airport shuttles
be filed in four copies. The public will be inspected before being allowed on
offered Mr. McQuerry an opportunity to availability of information in these campus. Visitors will be asked to show one
request a hearing, providing him 30 submissions is governed by 21 CFR form of identification (for example, a
days from the date of receipt of the letter 10.20. government-issued photo ID, driver’s license,
in which to file the request, and advised Publicly available submissions may or passport) and to state the purpose of their
him that failure to request a hearing be seen in the Division of Dockets visit.
constituted a waiver of the opportunity Management between 9 a.m. and 4 p.m., Information is also available on the
for a hearing and of any contentions Monday through Friday. Institute’s/Center’s home page:
concerning this action. Mr. McQuerry www4.ordh.od.nih.gov/, where an agenda
Dated: March 11, 2016. and any additional information for the
did not request a hearing and has,
therefore, waived his opportunity for a Armando Zamora, meeting will be posted when available.
hearing and any contentions concerning Deputy Director, Office of Enforcement and (Catalogue of Federal Domestic Assistance
his debarment (21 CFR part 12). Import Operations, Office of Regulatory Program Nos. 93.14, Intramural Research
Affairs. Training Award; 93.22, Clinical Research
II. Findings and Order [FR Doc. 2016–06104 Filed 3–17–16; 8:45 am] Loan Repayment Program for Individuals
Therefore, the Director, Office of BILLING CODE 4164–01–P from Disadvantaged Backgrounds; 93.232,
Enforcement and Import Operations, Loan Repayment Program for Research
Generally; 93.39, Academic Research
Office of Regulatory Affairs, under Enhancement Award; 93.936, NIH Acquired
sections 306(a)(2)(A) and (a)(2)(B) of the DEPARTMENT OF HEALTH AND
Immunodeficiency Syndrome Research Loan
FD&C Act, under authority delegated to HUMAN SERVICES Repayment Program; 93.187, Undergraduate
him (Staff Manual Guide 1410.35), finds Scholarship Program for Individuals from
that Wesley A. McQuerry has been National Institutes of Health Disadvantaged Backgrounds, National
convicted of a felony under Federal law Institutes of Health, HHS)
Office of the Director, National
for conduct relating to the development Dated: March 14, 2016.
Institutes of Health; Notice of Meeting
or approval, including the process for Carolyn Baum,
development or approval, of a drug Pursuant to section 10(a) of the
Program Analyst, Office of Federal Advisory
product and conduct otherwise relating Federal Advisory Committee Act, as Committee Policy.
to the regulation of a drug product amended (5 U.S.C. App.), notice is
[FR Doc. 2016–06075 Filed 3–17–16; 8:45 am]
under the FD&C Act. hereby given of a meeting of the
BILLING CODE 4140–01–P
As a result of the foregoing finding, Advisory Committee on Research on
Wesley A. McQuerry is permanently Women’s Health.
debarred from providing services in any The meeting will be open to the
DEPARTMENT OF HEALTH AND
capacity to a person with an approved public, with attendance limited to space
HUMAN SERVICES
or pending drug product application available. Individuals who plan to
under sections 505, 512, or 802 of the attend and need special assistance, such
asabaliauskas on DSK3SPTVN1PROD with NOTICES

National Institutes of Health
FD&C Act (21 U.S.C. 355, 360b, or 382), as sign language interpretation or other
or under section 351 of the Public reasonable accommodations, should National Cancer Institute; Notice of
Health Service Act (42 U.S.C. 262), notify the Contact Person listed below Closed Meetings
effective (see DATES) (see section in advance of the meeting.
201(dd), 306(c)(1)(B), and Name of Committee: Advisory Committee Pursuant to section 10(d) of the
306(c)(2)(A)(ii) of the FD&C Act, (21 on Research on Women’s Health. Federal Advisory Committee Act, as
U.S.C. 321(dd), 335a(c)(1)(B), and Date: April 19, 2016. amended (5 U.S.C. App.), notice is
335a(c)(2)(A)(ii)). Any person with an Time: 9:00 a.m. to 4:00 p.m. hereby given of the following meetings.

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14864 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices

The meetings will be closed to the Place: Courtyard by Marriott Chevy Chase, FOR FURTHER INFORMATION CONTACT: Dr.
public in accordance with the 5520 Wisconsin Avenue, Chevy Chase, MD Warren Casey, Director, NICEATM;
provisions set forth in sections 20815. email: warren.casey@nih.gov; telephone:
Contact Person: Shamala K. Srinivas,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Ph.D., Associate Director, Office of Referral,
(919) 316–4729.
as amended. The grant applications and Review, and Program Coordination, Division SUPPLEMENTARY INFORMATION:
the discussions could disclose of Extramural Activities, National Cancer Background: Acute systemic toxicity
confidential trade secrets or commercial Institute, NIH, 9609 Medical Center Drive, tests are designed to identify chemicals
property such as patentable material, Room 7W530, Rockville, MD 20850, 240– that could cause illness or death
and personal information concerning 276–6442, ss537t@nih.gov. immediately or shortly after a single
individuals associated with the grant (Catalogue of Federal Domestic Assistance exposure. This webinar series will
applications, the disclosure of which Program Nos. 93.392, Cancer Construction; explore and discuss alternative
would constitute a clearly unwarranted 93.393, Cancer Cause and Prevention approaches that could replace, reduce,
Research; 93.394, Cancer Detection and
invasion of personal privacy. or refine the use of animals for
Diagnosis Research; 93.395, Cancer
Name of Committee: National Cancer Treatment Research; 93.396, Cancer Biology identifying chemicals that may cause
Institute Special Emphasis Panel; Population Research; 93.397, Cancer Centers Support; acute systemic toxicity when inhaled.
Science (U01). 93.398, Cancer Research Manpower; 93.399, During the webinar series,
Date: April 5, 2016. Cancer Control, National Institutes of Health, participants will (1) define when and
Time: 8:00 a.m. to 4:30 p.m. HHS) how acute systemic toxicity data are
Agenda: To review and evaluate grant Dated: March 15, 2016. used for assessing inhalation toxicity
applications.
Melanie J. Gray, hazard potential for both regulatory and
Place: National Cancer Institute Shady non-regulatory testing; (2) review
Grove, 9609 Medical Center Drive, Rockville, Program Analyst, Office of Federal Advisory
Committee Policy. existing alternative approaches for
MD 20850 (Telephone Conference Call). identifying chemicals likely to cause
Contact Person: Robert Bird, Ph.D., [FR Doc. 2016–06194 Filed 3–17–16; 8:45 am]
acute systemic toxicity via inhalation,
Scientific Review Officer, Resources and BILLING CODE 4140–01–P
which could include mechanism-based
Training Review Branch, Division of
Extramural Activities, National Cancer models (i.e., in vitro and in silico
Institute, 9609 Medical Center Drive, Room DEPARTMENT OF HEALTH AND approaches); and (3) identify
7W110, Bethesda, MD 20892–9750, 240–276– HUMAN SERVICES mechanisms of acute toxicity that may
6344, birdr@mail.nih.gov. constitute key events in adverse
Name of Committee: National Cancer National Institutes of Health outcome pathways for acute inhalation
Institute Special Emphasis Panel; toxicity.
Fundamental Mechanisms of Affective and Alternative Approaches for Acute The webinar series steering committee
Decisional Processes in Cancer Control (U01). Inhalation Toxicity To Address Global is comprised of members from
Date: April 6, 2016. Regulatory and Non-Regulatory Data government and nongovernment
Time: 8:00 a.m. to 5:00 p.m. Requirements; Notice of Webinars; stakeholder organizations including
Agenda: To review and evaluate grant Registration Information NICEATM, People for the Ethical
applications. Treatment of Animals, International
Place: National Cancer Institute Shady SUMMARY: The National Toxicology Science Consortium Ltd., The Dow
Grove, 9609 Medical Center Drive, Rockville, Program (NTP) Interagency Center for Chemical Company, European Union
MD 20850 (Telephone Conference Call). the Evaluation of Alternative
Contact Person: Robert Bird, Ph.D., Reference Laboratory for Alternatives to
Toxicological Methods (NICEATM) Animal Testing, Simulations Plus, Inc.,
Scientific Review Officer, Resources and
announces the webinar series, Netherlands Organisation for Applied
Training Review Branch, Division of
Extramural Activities, National Cancer ‘‘Alternative Approaches for Acute Scientific Research, and U.S.
Institute, 9609 Medical Center Drive, Room Inhalation Toxicity to Address Global Environmental Protection Agency.
7W110, Bethesda, MD 20892–9750, 240–276– Regulatory and Non-Regulatory Data List of Webinar Topics and Other
6344, birdr@mail.nih.gov. Requirements.’’ Webinar speakers will Information: A link to registration and
Name of Committee: National Cancer discuss the state of the science of additional information about the
Institute Special Emphasis Panel; Oncology alternative approaches for identifying webinar series are available at http://
Co-Clinical Imaging Methods and Precision acute systemic toxicants due to ntp.niehs.nih.gov/go/inhalation-2016.
Medicine. inhalation exposure, and identify Dates and topics for each webinar will
Date: April 8, 2016. knowledge and data gaps that need to be be posted on this page as they are
Time: 1:00 p.m. to 5:00 p.m. addressed prior to implementation of finalized.
Agenda: To review and evaluate grant
those approaches. Meeting and Registration: The
applications and/or proposals.
Place: National Cancer Institute Shady DATES: webinars are open to the public, free of
Grove, 9609 Medical Center Drive, Room First Webinar: March 29, 2016, from charge, with attendance limited only by
7W514, Rockville, MD 20850 (Telephone 11 a.m. to 12 p.m. Eastern Daylight available webcast capacity. Individuals
Conference Call). Time (EDT). who plan to attend the first webinar
Contact Person: Peter J. Wirth, Ph.D., Subsequent Webinars: Five should register at http://
Scientific Review Officer, Division of subsequent webinars will be presented ntp.niehs.nih.gov/go/inhalation-2016 by
Extramural Activities, National Cancer monthly through August 2016; dates of March 29, 2016. Subsequent webinars
Institute, NIH, 9609 Medical Center Drive, the webinars will posted on the Web will be convened monthly; registration
asabaliauskas on DSK3SPTVN1PROD with NOTICES

7W514, Rockville, MD 20850, 240–276–6434 page. for any webinar will automatically
pw2q@nih.gov. Registration for Webinars: register the viewer for all subsequent
Name of Committee: National Cancer Registration for each webinar will be webinars. Interested individuals are
Institute Special Emphasis Panel; open during the webinar.
Subcommittee A—Cancer Centers. encouraged to visit http://
Date: May 5, 2016. ADDRESSES: Web page: The preliminary ntp.niehs.nih.gov/go/inhalation-2016
Time: 8:00 a.m. to 4:00 p.m. agenda, registration, and other meeting for future webinar dates and topics and
Agenda: To review and evaluate grant materials are at http://ntp.niehs.nih.gov/ to stay abreast of the most current
applications. go/inhalation-2016. information about the webinar series.

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Document Created: 2018-02-02 15:13:26
Document Modified: 2018-02-02 15:13:26

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		April 5, 2016.
FR Citation		81 FR 14863

81 FR 14863 - National Cancer Institute; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 53 (March 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health