National Institute on Drug Abuse; Notice of Closed Meetings, 55902 [2018-24470]

Download as PDF 55902 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2 Number of respondents 21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours 310.305(c)(5) ........................................................................ 314.80(c)(1)(iii) ..................................................................... 314.80(c)(2) .......................................................................... Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c)) ............................................................ 3 5 810 1 1 17.19 3 5 13,923.90 1 1 60 3 5 835,434 283 687.099 194,449 6 1,166,694 Total .............................................................................. ........................ ........................ ........................ ........................ 2,002,136 1 The 2 The reporting burden for § 310.305(c)(1), (2), and (3), and § 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0645. capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2 Number of recordkeepers 21 CFR section Average burden per recordkeeping Total annual records Total hours 310.305(g) ............................................................................ 314.80(j) ............................................................................... Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 25 352 300 1 1,870 885.6667 25 658,240 265,700 16 16 8 400 10,531,840 2,125,600 Total .............................................................................. ........................ ........................ ........................ ........................ 12,657,840 1 There 2 There are no capital costs or operating costs associated with this collection of information. are maintenance costs of approximately $22,000 annually. Based on submissions received we have increased our burden estimate for reporting under part 314.80(c)(2) and recordkeeping under part 314.80(j). Additionally, and as previously stated, we are consolidating burden associated with reporting and recordkeeping under section 760 of the FD&C Act. Based on our records, we received 194,449 total annual reports from approximately 283 respondents for nonprescription drugs marketed without an approved application. We estimate each submission takes approximately 6 hours to prepare and submit. We estimate that there are 265,700 records per year maintained by approximately 300 respondents, and that it takes 8 hours to maintain each record. Dated: November 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–24442 Filed 11–7–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health daltland on DSKBBV9HB2PROD with NOTICES Number of records per recordkeeper 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 VerDate Sep<11>2014 16:51 Nov 07, 2018 Jkt 247001 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 Institute on Drug Abuse Special Emphasis Panel; R13 Conference Grant Review. Date: November 14, 2018. Time: 12:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Ipolia R. Ramadan, 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 4228, MSC 9550, Bethesda, MD 20892, 301–827–5842, ramadanir@ mail.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; Multisite Clinical Trials. Date: November 16, 2018. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Ipolia R. Ramadan, 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 4228, MSC 9550, Bethesda, MD 20892, 301–827–5842, ramadanir@ mail.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. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: November 2, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–24470 Filed 11–7–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 E:\FR\FM\08NON1.SGM 08NON1

Agencies

[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Page 55902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24470]


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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 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; R13 Conference Grant Review.
    Date: November 14, 2018.
    Time: 12:00 p.m. to 3:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852, (Telephone Conference 
Call).
    Contact Person: Ipolia R. Ramadan, 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 4228, MSC 9550, Bethesda, MD 20892, 
301-827-5842, [email protected].
    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; Multi-site Clinical Trials.
    Date: November 16, 2018.
    Time: 12:00 p.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).

    Contact Person: Ipolia R. Ramadan, 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 4228, MSC 9550, Bethesda, MD 20892, 
301-827-5842, [email protected].
    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.

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

    Dated: November 2, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-24470 Filed 11-7-18; 8:45 am]
 BILLING CODE 4140-01-P