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]


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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
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