National Cancer Institute; Notice of Closed Meetings, 10494-10495 [2018-04802]

Download as PDF 10494 Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. Goodwin Procter LLP submitted a citizen petition dated September 26, 2017 (Docket No. FDA–2017–P–5946), under 21 CFR 10.30, requesting that the Agency determine whether DORYX MPC (doxycycline hyclate), delayedrelease tablets, 60 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of DORYX MPC (doxycycline hyclate), delayedrelease tablets, 60 mg, from sale. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to this drug product may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: March 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–04726 Filed 3–8–18; 8:45 am] amozie on DSK30RV082PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 16:47 Mar 08, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Advisory Committee on Interdisciplinary, Community-Based Linkages Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of meetings. AGENCY: In accordance with the Federal Advisory Committee Act, notice is hereby given that two orientation meetings are scheduled for the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). These meetings will be open to the public. Information about the ACICBL and the agenda for these meetings can be obtained by accessing the ACICBL website at: https://www.hrsa.gov/ advisory-committees/interdisciplinarycommunity-linkages/meetings/ index.html. SUMMARY: In order to accommodate the schedules of the ACICBL members, two orientation meetings will be held. The first meeting will be on March 15, 2018 from 11:00 a.m.–4:00 p.m., ET and the second meeting will be on March 27, 2018 from 12:00 p.m.–5:00 p.m., ET. ADDRESSES: These meetings will be held via conference call/webinar. • The teleconference call-in number is 1–800–619–2521, passcode: 9271697. • The webinar link is https:// hrsa.connectsolutions.com/acicbl. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding the ACICBL should contact Joan Weiss, Ph.D., RN, CRNP, FAAN, HRSA, in one of three ways: (1) Send a request to the following address: Joan Weiss, Ph.D., RN, CRNP, FAAN, Senior Advisor and Designated Federal Officer, Division of Medicine and Dentistry, HRSA, 5600 Fishers Lane, Room 15N39, Rockville, Maryland 20857; (2) call (301) 443–0430; or (3) send an email to jweiss@hrsa.gov. SUPPLEMENTARY INFORMATION: The ACICBL provides advice and recommendations on a broad range of issues relating to grant programs authorized by sections 750–760, Title VII, Part D of the Public Health Service Act. During the March 15, 2018 and March 27, 2018 meetings. ACICBL members will be oriented to the work of the Committee and identify potential topics to work on for 2018. The ACICBL’s reports are submitted to the Secretary of HHS; the Committee DATES: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 on Health, Education, Labor, and Pensions of the U.S. Senate; and the Committee on Energy and Commerce of the U.S. House of Representatives. Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the ACICBL should be sent by March 13, 2018 for the March 15, 2018 meeting and by March 25, 2018 for the March 27, 2018 meeting. Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2018–04815 Filed 3–8–18; 8:45 am] BILLING CODE 4165–15–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, 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: National Cancer Institute Special Emphasis Panel; NCI Pediatric Early Phase Clinical Trials Network (PEP–CTN). Date: March 27, 2018. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W538, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Shamala K. Srinivas, Ph.D., Scientific Review Officer, Office of Referral, Review, and Program Coordination, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W530, Bethesda, MD 20892– 9750, 240–276–6430, ss537t@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; U01 SEP: Liquid Biopsy & Early Cancer Assessment. Date: May 1, 2018. Time: 10:00 a.m. to 5:00 p.m. E:\FR\FM\09MRN1.SGM 09MRN1 Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W102, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W102, Bethesda, MD 20892– 9750, 240–276–6349, ahmads@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE I Review. Date: May 10–11, 2018. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: David G. Ransom, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W124, Bethesda, MD 20892–9750, 240–276–6351, david.ransom@nih.gov. amozie on DSK30RV082PROD with NOTICES Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE IV Review. Date: May 17–18, 2018. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Sanita Bharti, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W122, Bethesda, MD 20892–9750, 240–276–5909, sanitab@mail.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 6, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–04802 Filed 3–8–18; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 16:47 Mar 08, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft National Institute of Environmental Health Sciences 2018– 2023 Strategic Plan National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services (HHS). ACTION: Request for comments. AGENCY: The NIEHS is updating its 2012–2017 NIEHS Strategic Plan, which can be viewed at www.niehs.nih.gov/ 2012plan. The goal of the current strategic planning process is to define Strategic Objectives to anticipate, set, and meet priorities in environmental health sciences research, training, and translation in support of the NIEHS mission and vision, as well as to identify key focus areas for implementation of such Strategic Objectives. NIEHS requests comment from researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public on these new Strategic Objectives and focus areas, which are detailed in ‘‘NIEHS Strategic Plan 2018–2023: Advancing Environmental Health Science, Improving Health 2.0.’’ The draft plan may be viewed online at www.niehs.nih.gov/strategicplan. DATES: Submit your comments online or by email on or before March 30, 2018, 5:00 p.m. EDT. ADDRESSES: Comments are strongly encouraged to be submitted online at https://www.research.net/r/niehs_ strategic_plan. They may also be submitted by email to ehs-strategicplan@niehs.nih.gov, or by mail to: Office of the Deputy Director, NIEHS/ NIH/HHS, P.O. Box 12233, Maildrop B2–06, Research Triangle Park, NC 27709. SUMMARY: Dr. Sheila Newton, Office of Policy, Planning and Evaluation; email: newton1@niehs.nih.gov, or call non-tollfree number 919–541–4343. SUPPLEMENTARY INFORMATION: Background: The mission of the NIEHS is to discover how the environment affects people, in order to promote FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 10495 healthier lives. The vision of the NIEHS is to provide global leadership for innovative research that improves public health by preventing disease and disability. The NIEHS achieves its mission and vision through multidisciplinary biomedical research programs, as well as prevention and intervention efforts. NIEHS research is disseminated to inform evidence-based environmental health policies to prevent disease and protect health. The NIEHS also focuses on communication and research translation strategies that encompass training, education, technology transfer, and community engagement. Request for Comment on Draft NIEHS Strategic Plan 2018–2023 During June–August 2017, the NIEHS solicited input to its strategic planning process through a public, online ‘‘Trends & Insights Survey.’’ This survey invited respondents to comment on any aspect of the 2012–2017 NIEHS Strategic Plan, as well as to offer potential new directions and priorities. Following this, NIEHS synthesized the input (∼2,000 unique comments) and reported it to the National Advisory Environmental Health Sciences Council (NAEHSC) at its September 2017 meeting. Two members of Council led a discussion to provide further feedback. From September 2017–February 2018, NIEHS Leadership discussed the compiled input and analysis, consulted the NIH Strategic Plan, and determined the current set of Strategic Objectives and supporting focus areas of effort that are detailed in the draft plan. This plan was presented and discussed at the NAEHSC’s February 2018 meeting. The NIEHS seeks Comments from all interested parties on its draft ‘‘NIEHS Strategic Plan 2018–2023: Advancing Environmental Health Science, Improving Health 2.0.’’ Input received in response to this request will be collected from February 21 to March 30, 2018. All comments should be submitted on or before COB (5:00 p.m. EDT) March 30, 2018. Dated: February 14, 2018. Linda S. Birnbaum, Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. 2018–04714 Filed 3–8–18; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10494-10495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04802]


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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, 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: National Cancer Institute Special Emphasis 
Panel; NCI Pediatric Early Phase Clinical Trials Network (PEP-CTN).
    Date: March 27, 2018.
    Time: 11:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Cancer Institute, Shady Grove, 9609 Medical 
Center Drive, Room 7W538, Rockville, MD 20850, (Telephone Conference 
Call).
    Contact Person: Shamala K. Srinivas, Ph.D., Scientific Review 
Officer, Office of Referral, Review, and Program Coordination, 
Division of Extramural Activities, National Cancer Institute, NIH, 
9609 Medical Center Drive, Room 7W530, Bethesda, MD 20892-9750, 240-
276-6430, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis 
Panel; U01 SEP: Liquid Biopsy & Early Cancer Assessment.
    Date: May 1, 2018.
    Time: 10:00 a.m. to 5:00 p.m.

[[Page 10495]]

    Agenda: To review and evaluate grant applications.
    Place: National Cancer Institute, Shady Grove, 9609 Medical 
Center Drive, Room 7W102, Rockville, MD 20850, (Telephone Conference 
Call).
    Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer, 
Research Technology and Contract Review Branch, Division of 
Extramural Activities, National Cancer Institute, NIH, 9609 Medical 
Center Drive, Room 7W102, Bethesda, MD 20892-9750, 240-276-6349, 
[email protected].

    Name of Committee: National Cancer Institute Special Emphasis 
Panel; NCI SPORE I Review.
    Date: May 10-11, 2018.
    Time: 4:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda North Marriott Hotel & Conference Center, 5701 
Marinelli Road, North Bethesda, MD 20852.
    Contact Person: David G. Ransom, Ph.D., Scientific Review 
Officer, Research Programs Review Branch, Division of Extramural 
Activities, National Cancer Institute, NIH, 9609 Medical Center 
Drive, Room 7W124, Bethesda, MD 20892-9750, 240-276-6351, 
[email protected].

    Name of Committee: National Cancer Institute Special Emphasis 
Panel; NCI SPORE IV Review.
    Date: May 17-18, 2018.
    Time: 8:00 a.m. to 12:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda North Marriott Hotel & Conference Center, 5701 
Marinelli Road, North Bethesda, MD 20852.
    Contact Person: Sanita Bharti, Ph.D., Scientific Review Officer, 
Research Program Review Branch, Division of Extramural Activities, 
National Cancer Institute, NIH, 9609 Medical Center Drive, Room 
7W122, Bethesda, MD 20892-9750, 240-276-5909, [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 6, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-04802 Filed 3-8-18; 8:45 am]
 BILLING CODE 4140-01-P
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