National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting, 91183-91184 [2016-30218]

Download as PDF 91183 Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices each year, 5 of which FDA expects to be HDEs. This estimate is based on the average of FDA’s receipt of new PMA applications. The Agency estimates that 10 of the estimated 40 original PMA submissions will fail to provide the required pediatric use information and their sponsors will therefore be required to submit PMA amendments. The Agency also expects to receive approximately 700 supplements that will include the pediatric use Furthermore, because supplements may include readily available information on pediatric populations by referencing a previous submission, FDA estimates the average time to obtain and submit the required information in a supplement to be 2 hours. FDA estimates that the total estimated burden is 1,760 hours. FDA estimates the burden of this collection of information as follows: information required by section 515A(a) of the FD&C Act and part 814 (21 CFR part 814). All that is required is to gather, organize, and submit information that is readily available, using any approach that meets the requirements of section 515A(a) of the FD&C Act and part 814. We believe that because the applicant is required to organize and submit only readily available information, no more than 8 hours will be required to comply. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Number of respondents Activity/21 CFR section Pediatric Pediatric Pediatric Pediatric in in in in Total annual responses Average burden per response Total hours an original PMA or PDP—814.20(b)(13) a PMA amendment—814.37(b)(2) .......... a PMA supplement—814.39(c)(2) ........... an HDE—814.104(b)(6) ........................... 30 10 700 5 1 1 1 1 30 10 700 5 8 8 2 8 240 80 1,400 40 Total ........................................................................................ ...................... ........................ ...................... ...................... 1,760 1 There information information information information Number of responses per respondent are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 12, 2016. Leslie Kux, Associate Commissioner for Policy. Dated: December 12, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016–30243 Filed 12–15–16; 8:45 am] [FR Doc. 2016–30398 Filed 12–15–16; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting mstockstill on DSK3G9T082PROD with NOTICES Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research The National Institutes of Health (NIH) is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research from May 25, 2017, to September 25, 2017. A copy of the NIH Policy was published in the Federal Register on June 21, 2016 (81 FR 40325). See https://www.gpo.gov/fdsys/pkg/FR2016-06-21/pdf/2016-14513.pdf. Guidance and Frequently Asked Questions to assist in the implementation of the policy will soon be available at https://osp.od.nih.gov/ office-clinical-research-and-bioethicspolicy/clinical-research-policy/modelsirb-review. For further information contact the NIH Office of Science Policy, Telephone: 301–496–9838, Email: SingleIRBPolicy@mail.nih.gov. VerDate Sep<11>2014 18:42 Dec 15, 2016 Jkt 241001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. The meeting 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 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 and/or contract proposals, the disclosure of which would PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Alcohol Abuse and Alcoholism. Date: February 9, 2017. Closed: 9:00 a.m. to 9:30 a.m. Agenda: BSC Report: Evaluation of the NIAAA Intramural Program. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference Rooms, Bethesda, MD 20892. Closed: 9:40 a.m. to 10:50 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference Rooms, Bethesda, MD 20892. Open: 11:00 a.m. to 3:15 p.m. Agenda: Presentations and other business of the Council. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference Rooms, Bethesda, MD 20892. Contact Person: Abraham P. Bautista, Ph.D., Executive Secretary, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, 301–443–9737 bautista@mail.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:// www.niaaa.nih.gov/AboutNIAAA/ AdvisoryCouncil/Pages/default.aspx, where an agenda and any additional information for the meeting will be posted when available. E:\FR\FM\16DEN1.SGM 16DEN1 91184 Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Dated: December 12, 2016. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–30218 Filed 12–15–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel, March 28, 2017, 08:30 a.m. to March 28, 2017, 05:00 p.m., National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference Room 508, Rockville, MD, 20892 which was published in the Federal Register on November 29, 2016, 81FR85983. This notice is amended to change the meeting date from March 28, 2017 to March 29, 2017. The meeting is closed to the public. Dated: December 12, 2016. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–30219 Filed 12–15–16; 8:45 am] 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 Drug Abuse Special Emphasis Panel; Synthesis and Distribution of Opioid and Related Peptides (7795). Date: January 5, 2017. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892– 9550, (301) 827–5702, lf33c.nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Affordable Care Act (ACA) Web Platform to Integrate Behavioral Health and Prevention with Primary Care (5679). Date: January 10, 2017. Time: 10:00 a.m. to 11:00 a.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Lyle Furr, Scientific Review Officer, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892– 9550, (301) 827–5702, lf33c.nih.gov. (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: December 12, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–30220 Filed 12–15–16; 8:45 am] BILLING CODE 4140–01–P Notice of accreditation and approval of Intertek USA, Inc. as a commercial gauger and laboratory. ACTION: Notice is hereby given, pursuant to CBP regulations, that Intertek USA, Inc. has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of May 25, 2016. SUMMARY: Effective Dates: The accreditation and approval of Intertek USA, Inc. as commercial gauger and laboratory became effective on May 25, 2016. The next triennial inspection date will be scheduled for May 2019. DATES: FOR FURTHER INFORMATION CONTACT: Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202– 344–1060. Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Intertek USA, Inc., 1211 Belgrove Drive, St. Louis, MO 63137 has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Intertek USA, Inc. is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API): SUPPLEMENTARY INFORMATION: API chapters 3 ................... 7 ................... 8 ................... 12 ................. 17 ................. Title Tank Gauging. Temperature Determination. Sampling. Calculations. Marine Measurement. National Institutes of Health mstockstill on DSK3G9T082PROD with NOTICES National Institute on Drug Abuse; Notice of Closed Meeting DEPARTMENT OF HOMELAND SECURITY 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 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 VerDate Sep<11>2014 18:42 Dec 15, 2016 Jkt 241001 U.S. Customs and Border Protection Accreditation and Approval of Intertek USA, Inc., as a Commercial Gauger and Laboratory Intertek USA, Inc. is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM): U.S. Customs and Border Protection, Department of Homeland Security. AGENCY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91183-91184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Alcohol Abuse and Alcoholism; Notice of 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
National Advisory Council on Alcohol Abuse and Alcoholism.
    The meeting 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 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 and/or contract proposals, the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy.

    Name of Committee: National Advisory Council on Alcohol Abuse 
and Alcoholism.
    Date: February 9, 2017.
    Closed: 9:00 a.m. to 9:30 a.m.
    Agenda: BSC Report: Evaluation of the NIAAA Intramural Program.
    Place: National Institutes of Health, National Institute on 
Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference 
Rooms, Bethesda, MD 20892.
    Closed: 9:40 a.m. to 10:50 a.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, National Institute on 
Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference 
Rooms, Bethesda, MD 20892.
    Open: 11:00 a.m. to 3:15 p.m.
    Agenda: Presentations and other business of the Council.
    Place: National Institutes of Health, National Institute on 
Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Terrace Conference 
Rooms, Bethesda, MD 20892.
    Contact Person: Abraham P. Bautista, Ph.D., Executive Secretary, 
National Institute on Alcohol Abuse and Alcoholism, National 
Institutes of Health, 5635 Fishers Lane, Room 2085, Rockville, MD 
20852, 301-443-9737 bautista@mail.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://www.niaaa.nih.gov/AboutNIAAA/AdvisoryCouncil/Pages/default.aspx, where an agenda and any additional information for the 
meeting will be posted when available.


[[Page 91184]]


(Catalogue of Federal Domestic Assistance Program Nos. 93.271, 
Alcohol Research Career Development Awards for Scientists and 
Clinicians; 93.272, Alcohol National Research Service Awards for 
Research Training; 93.273, Alcohol Research Programs; 93.891, 
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical 
Research and Research Support Awards., National Institutes of 
Health, HHS)

    Dated: December 12, 2016.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-30218 Filed 12-15-16; 8:45 am]
 BILLING CODE 4140-01-P
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