National Institute on Drug Abuse; Notice of Closed Meetings, 7085-7086 [2019-03565]

Download as PDF jbell on DSK30RV082PROD with NOTICES Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices information you claim to be confidential with a heading or cover note that states ‘‘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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Annette Marthaler, 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled VerDate Sep<11>2014 18:13 Feb 28, 2019 Jkt 247001 ‘‘Enforcement Policy for Certain Marketed Tobacco Products.’’ FDA is issuing this draft guidance to provide information regarding FDA’s enforcement policy for certain marketed tobacco products that become the subject of an NSE order. This policy primarily involves provisional tobacco products that become subject to NSE orders issued under section 910(a)(2)(B) of the FD&C Act (21 U.S.C. 387j(a)(2)(B)). This policy extends to new tobacco products created by modifying the quantity of a provisional tobacco product in a pending SE Report that become subject to NSE orders. The draft guidance also provides information on FDA’s enforcement policy for when FDA receives from an applicant a request for supervisory review under 21 CFR 10.75 within 30 calendar days of the issue date of the NSE order. The draft guidance provides that for these new tobacco products, FDA intends to offer copies of those final scientific reviews that supported the basis of the Agency’s decision to the applicant concurrent with the NSE order for provisional tobacco products. II. Significance of Draft Guidance FDA is issuing this draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Enforcement Policy for Certain Marketed Tobacco Products,’’ and will supersede ‘‘Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent; Guidance for Industry and Tobacco Retailers’’ (the availability of which was announced in the Federal Register (80 FR 55124, September 14, 2015)). It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons with access to the internet may obtain an electronic version of the draft guidance at either https:// www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. Dated: February 25, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–03657 Filed 2–28–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 7085 DEPARTMENT OF HEALTH AND HUMAN SERVICES Retail Pharmacy Interest in Utilization of Innovative Educational Technology To Increase Human Papillomavirus (HPV) Vaccination Rates in Rural Areas; Correction National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice; correction. AGENCY: SUMMARY: The Department of Health and Human Services published a document in the Federal Register of February 15, 2019, concerning a request for information (RFI) for informational and planning purposes only. We would like to extend the deadline in order to provide more time to the public to submit their response. FOR FURTHER INFORMATION CONTACT: Kara Elam, National Vaccine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services; telephone (202) 690– 5566; email: nvpo@hhs.gov. SUPPLEMENTARY INFORMATION: Correction In the Federal of February 15, 2019, in FR Doc. 2019–02548, on page 4483, in the first column, correct the DATES caption to read: DATES: Information from retail pharmacies with greater than 100 stores in geographic areas considered to be rural by the census definition (<50,000 population) should submit responses to this RFI as described in the addresses section below no later than midnight, 12:00 a.m. EDT on March 15, 2019. Dated: February 25, 2019. Tammy Beckham, Acting Director, National Vaccine Program Office. [FR Doc. 2019–03698 Filed 2–28–19; 8:45 am] BILLING CODE 4150–44–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; 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 E:\FR\FM\01MRN1.SGM 01MRN1 7086 Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices 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. jbell on DSK30RV082PROD with NOTICES Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Multisite Clinical Trials. Date: March 7, 2019. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Alumit Ishai, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301–827–5819, alumit.ishai@ nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (UM1—Clinical Trail Required). Date: March 21, 2019. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: National Institutes of Health, Neuroscience Center Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Tracy L. Waldeck, Ph.D., Director, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4243, MSC 9550, Bethesda, MD 20892, 301– 827–5844, waldeckt@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: February 25, 2019. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–03565 Filed 2–28–19; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 18:13 Feb 28, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Advance analysis of MR images [2019/05 ZAG1 ZIJ– P (C1) 1]. Date: March 25, 2019. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Nijaguna Prasad, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–496–9667, nijaguna.prasad@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: February 25, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–03579 Filed 2–28–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 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 Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIH Support for Conferences and Scientific Meetings (R13). Date: April 3–5, 2019. Time: 7:00 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Virtual Meeting). Contact Person: Tracy A. Shahan, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3F31, National Institutes of Health/ NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892–9834, (240) 669–5030, tshahan@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: February 25, 2019. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–03569 Filed 2–28–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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; Member Conflict: AIDS and Related Research. Date: April 5, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\01MRN1.SGM 01MRN1

Agencies

[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7085-7086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Drug Abuse; 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

[[Page 7086]]

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 Institute on Drug Abuse Special 
Emphasis Panel; Multi-site Clinical Trials.
    Date: March 7, 2019.
    Time: 1:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center 
Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852 
(Telephone Conference Call).
    Contact Person: Alumit Ishai, Ph.D., Scientific Review Officer, 
Office of Extramural Policy and Review, Division of Extramural 
Research, National Institute on Drug Abuse, NIH, DHHS, 6001 
Executive Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301-
827-5819, alumit.ishai@nih.gov.

    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: National Institute on Drug Abuse Special 
Emphasis Panel; HEALing Communities Study: Developing and Testing an 
Integrated Approach to Address the Opioid Crisis (Research Sites) 
(UM1--Clinical Trail Required).
    Date: March 21, 2019.
    Time: 9:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate cooperative agreement 
applications.
    Place: National Institutes of Health, Neuroscience Center 
Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852 
(Telephone Conference Call).
    Contact Person: Tracy L. Waldeck, Ph.D., Director, Office of 
Extramural Policy and Review, Division of Extramural Research, 
National Institute on Drug Abuse, NIH, DHHS, 6001 Executive 
Boulevard, Room 4243, MSC 9550, Bethesda, MD 20892, 301-827-5844, 
waldeckt@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug 
Abuse and Addiction Research Programs, National Institutes of 
Health, HHS)

    Dated: February 25, 2019.
Natasha M. Copeland,
 Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-03565 Filed 2-28-19; 8:45 am]
 BILLING CODE 4140-01-P
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