Center for Scientific Review; Notice of Closed Meetings, 14121-14122 [2019-06994]

Download as PDF Federal Register / Vol. 84, No. 68 / Tuesday, April 9, 2019 / Notices Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). amozie on DSK9F9SC42PROD with NOTICES Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–0661 for ‘‘Modifications to Compliance Policy for Certain Deemed Tobacco Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states VerDate Sep<11>2014 18:15 Apr 08, 2019 Jkt 247001 ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877–287–1373, email: CTPRegulations@fda.hhs.gov. In the Federal Register of March 14, 2019, FDA published a draft guidance for industry with a 30-day comment period to request comments on changes to the compliance policies for premarket review requirements and how FDA plans to prioritize its enforcement resources with regard to certain deemed tobacco products in the United States that do not have the required FDA premarket authorization for marketing. Comments on the draft guidance for industry will inform how FDA intends to finalize the guidance. The Agency has received requests for an extension of the comment period for the draft guidance for industry. The requests conveyed concern that the current 30-day comment period does not allow sufficient time to develop a SUPPLEMENTARY INFORMATION: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 14121 response to the draft guidance for industry. FDA has considered the requests and is extending the comment period for the draft guidance for industry for 15 days, until April 30, 2019. The Agency believes that a 15-day extension allows adequate time for interested persons to submit comments without significantly delaying the process to finalize this guidance. Dated: April 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–06952 Filed 4–8–19; 8:45 am] BILLING CODE 4164–01–P 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, 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; RFA–MH– 19–425: Revision Application for Implementation Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis. Date: April 29, 2019. Time: 12:00 p.m. to 6:00 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: Jose H. Guerrier, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1137, guerriej@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–MH– 19–425: Revision Application for Implementation Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis. Date: April 29, 2019. Time: 12:00 p.m. to 4:00 p.m. E:\FR\FM\09APN1.SGM 09APN1 14122 Federal Register / Vol. 84, No. 68 / Tuesday, April 9, 2019 / Notices Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Mark P. Rubert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–16– 274 and PAR–16–275: Adverse Drug Reaction Research. Date: May 1, 2019. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alexander D. Politis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, (301) 435– 1150, politisa@csr.nih.gov. (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: April 4, 2019. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–06994 Filed 4–8–19; 8:45 am] BILLING CODE 4140–01–P Place: National Institutes of Health, Building 10, Room 6N106, 10 Center Drive, Bethesda, MD 20892 (Telephone Conference Call). Dial: 1–650–479–3207, Access Code: 732 082 860. Contact Person: Robert Yarchoan, M.D., Director, Office of HIV and AIDS Malignancy, Office of the Director, Chief, HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, Building 10, Room 6N106, 10 Center Drive, Bethesda, MD 20892, 240–496–0328, Robert.Yarchoan@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. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/bsa/bsa.htm, where an agenda and any additional information for the meeting will be posted when available. (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: April 4, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–06996 Filed 4–8–19; 8:45 am] National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Cancer Institute; Notice of Meeting National Institutes of Health amozie on DSK9F9SC42PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meeting will be held as a teleconference only and is open to the public to dial-in for participation. Individuals who plan to dial-in to the meeting and need special assistance or other reasonable accommodations in order to do so, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Cancer Institute Board of Scientific Advisors; Ad Hoc Subcommittee on HIV and AIDS Malignancy. Date: May 24, 2019. Time: 4:00 p.m. to 5:00 p.m. Agenda: To discuss recommendations of the BSA Ad Hoc Working Group on Immunology of Therapies & Vaccines and Research Structure. 18:15 Apr 08, 2019 Jkt 247001 Name of Committee: Board of Scientific Counselors, National Institute of Dental and Craniofacial Research DEBSC. Date: June 11, 2019. Time: 8:00 a.m. to 4:30 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health Building 31, 8600 Rockville Pike, Bethesda, MD 20892. Contact Person: Alicia J. Dombroski, Ph.D., Director, Division of Extramural Activities, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892. Information is also available on the Institute’s/Center’s home page: https:// www.nidcr.nih.gov/about/Council Committees.asp, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: April 4, 2019. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–07005 Filed 4–8–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 constitute a clearly unwarranted invasion of personal privacy. National Institute of Dental & Craniofacial Research; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual grant applications conducted by the NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 National Center for Advancing Translational Sciences; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the National Center for Advancing Translational Sciences. The meetings will be open to the public as indicated below, 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. 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 E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 84, Number 68 (Tuesday, April 9, 2019)]
[Notices]
[Pages 14121-14122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06994]


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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, 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; RFA-MH-19-425: Revision Application for Implementation 
Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis.
    Date: April 29, 2019.
    Time: 12:00 p.m. to 6:00 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: Jose H. Guerrier, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 
20892, 301-435-1137, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; RFA-MH-19-425: Revision Application for Implementation 
Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis.
    Date: April 29, 2019.
    Time: 12:00 p.m. to 4:00 p.m.

[[Page 14122]]

    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Mark P. Rubert, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 
20892, 301-435-1775, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR-16-274 and PAR-16-275: Adverse Drug Reaction Research.
    Date: May 1, 2019.
    Time: 1:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Alexander D. Politis, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 
20892, (301) 435-1150, [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: April 4, 2019.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-06994 Filed 4-8-19; 8:45 am]
BILLING CODE 4140-01-P
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