National Cancer Institute; Notice of Closed Meetings, 14863-14864 [2016-06194]
Download as PDF
Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
to patients. Instead, between
approximately July 11, 2008 and
September 3, 2008, Mr. McQuerry
deposited over $2,300 of gift checks into
his personal bank account. He
additionally used the gift checks to
make direct purchases at various
retailers. Mr. McQuerry’s fraud resulted
in a loss of approximately $200,098 to
the pharmaceutical company.
As a result of this conviction, FDA
sent Mr. McQuerry by certified mail on
October 30, 2015, a notice proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(A) and (a)(2)(B) of the FD&C
Act, that Mr. McQuerry was convicted
of a felony under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of a drug
product, and conduct otherwise relating
to the regulation of a drug product
under the FD&C Act. The proposal also
offered Mr. McQuerry an opportunity to
request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
him that failure to request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Mr. McQuerry
did not request a hearing and has,
therefore, waived his opportunity for a
hearing and any contentions concerning
his debarment (21 CFR part 12).
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Wesley A.
McQuerry, in any capacity during his
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If Mr.
McQuerry provides services in any
capacity to a person with an approved
or pending drug product application
during his period of debarment, he will
be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review
any abbreviated new drug applications
from Wesley A. McQuerry during his
period of debarment (section
306(c)(1)(B) of the FD&C Act.
Any application by Mr. McQuerry for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2015–N–3225 and sent to the
Division of Dockets Management (see
ADDRESSES). All such submissions are to
be filed in four copies. The public
availability of information in these
submissions is governed by 21 CFR
10.20.
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
sections 306(a)(2)(A) and (a)(2)(B) of the
FD&C Act, under authority delegated to
him (Staff Manual Guide 1410.35), finds
that Wesley A. McQuerry has been
convicted of a felony under Federal law
for conduct relating to the development
or approval, including the process for
development or approval, of a drug
product and conduct otherwise relating
to the regulation of a drug product
under the FD&C Act.
As a result of the foregoing finding,
Wesley A. McQuerry is permanently
debarred from providing services in any
capacity to a person with an approved
or pending drug product application
under sections 505, 512, or 802 of the
FD&C Act (21 U.S.C. 355, 360b, or 382),
or under section 351 of the Public
Health Service Act (42 U.S.C. 262),
effective (see DATES) (see section
201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act, (21
U.S.C. 321(dd), 335a(c)(1)(B), and
335a(c)(2)(A)(ii)). Any person with an
[FR Doc. 2016–06104 Filed 3–17–16; 8:45 am]
VerDate Sep<11>2014
19:50 Mar 17, 2016
Jkt 238001
Dated: March 11, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Advisory Committee on Research on
Women’s Health.
The meeting will be open to the
public, 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.
Name of Committee: Advisory Committee
on Research on Women’s Health.
Date: April 19, 2016.
Time: 9:00 a.m. to 4:00 p.m.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
14863
Agenda: The Committee serves to advise
and make recommendations to the Director,
Office of Research on Women’s Health
(ORWH) on a broad range of topics.
Information is also available on the
Institute’s/Center’s home page: https://orwh.
od.nih.gov/about/acrwh/index.asp where an
agenda and any additional information for
the meeting will be posted when available.
Place: National Institutes of Health,
Building 31, Room 6C, 31 Center Drive,
Bethesda, MD 20892.
Contact Person: Terri L. Cornelison, MD,
Ph.D., Associate Director for Clinical
Research, Office of Research on Women’s
Health, Office of the Director, 6707
Democracy Blvd., Bethesda, MD 20817, 301–
402–1770, cornelit@od.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:
www4.ordh.od.nih.gov/, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: March 14, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–06075 Filed 3–17–16; 8:45 am]
BILLING CODE 4140–01–P
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.
E:\FR\FM\18MRN1.SGM
18MRN1
14864
Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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, birdr@mail.nih.gov.
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, birdr@mail.nih.gov.
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
pw2q@nih.gov.
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.
VerDate Sep<11>2014
19:50 Mar 17, 2016
Jkt 238001
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, ss537t@nih.gov.
(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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Alternative Approaches for Acute
Inhalation Toxicity To Address Global
Regulatory and Non-Regulatory Data
Requirements; Notice of Webinars;
Registration Information
The National Toxicology
Program (NTP) Interagency Center for
the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces the webinar series,
‘‘Alternative Approaches for Acute
Inhalation Toxicity to Address Global
Regulatory and Non-Regulatory Data
Requirements.’’ Webinar speakers will
discuss the state of the science of
alternative approaches for identifying
acute systemic toxicants due to
inhalation exposure, and identify
knowledge and data gaps that need to be
addressed prior to implementation of
those approaches.
DATES:
First Webinar: March 29, 2016, from
11 a.m. to 12 p.m. Eastern Daylight
Time (EDT).
Subsequent Webinars: Five
subsequent webinars will be presented
monthly through August 2016; dates of
the webinars will posted on the Web
page.
Registration for Webinars:
Registration for each webinar will be
open during the webinar.
ADDRESSES: Web page: The preliminary
agenda, registration, and other meeting
materials are at https://ntp.niehs.nih.gov/
go/inhalation-2016.
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Dr.
Warren Casey, Director, NICEATM;
email: warren.casey@nih.gov; telephone:
(919) 316–4729.
SUPPLEMENTARY INFORMATION:
Background: Acute systemic toxicity
tests are designed to identify chemicals
that could cause illness or death
immediately or shortly after a single
exposure. This webinar series will
explore and discuss alternative
approaches that could replace, reduce,
or refine the use of animals for
identifying chemicals that may cause
acute systemic toxicity when inhaled.
During the webinar series,
participants will (1) define when and
how acute systemic toxicity data are
used for assessing inhalation toxicity
hazard potential for both regulatory and
non-regulatory testing; (2) review
existing alternative approaches for
identifying chemicals likely to cause
acute systemic toxicity via inhalation,
which could include mechanism-based
models (i.e., in vitro and in silico
approaches); and (3) identify
mechanisms of acute toxicity that may
constitute key events in adverse
outcome pathways for acute inhalation
toxicity.
The webinar series steering committee
is comprised of members from
government and nongovernment
stakeholder organizations including
NICEATM, People for the Ethical
Treatment of Animals, International
Science Consortium Ltd., The Dow
Chemical Company, European Union
Reference Laboratory for Alternatives to
Animal Testing, Simulations Plus, Inc.,
Netherlands Organisation for Applied
Scientific Research, and U.S.
Environmental Protection Agency.
List of Webinar Topics and Other
Information: A link to registration and
additional information about the
webinar series are available at https://
ntp.niehs.nih.gov/go/inhalation-2016.
Dates and topics for each webinar will
be posted on this page as they are
finalized.
Meeting and Registration: The
webinars are open to the public, free of
charge, with attendance limited only by
available webcast capacity. Individuals
who plan to attend the first webinar
should register at https://
ntp.niehs.nih.gov/go/inhalation-2016 by
March 29, 2016. Subsequent webinars
will be convened monthly; registration
for any webinar will automatically
register the viewer for all subsequent
webinars. Interested individuals are
encouraged to visit https://
ntp.niehs.nih.gov/go/inhalation-2016
for future webinar dates and topics and
to stay abreast of the most current
information about the webinar series.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\18MRN1.SGM
18MRN1
Agencies
[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14863-14864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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,
birdr@mail.nih.gov.
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,
birdr@mail.nih.gov.
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 pw2q@nih.gov.
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,
ss537t@nih.gov.
(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