81_FR_36661 81 FR 36552 - National Institute of Mental Health; Notice of Closed Meetings

81 FR 36552 - National Institute of Mental Health; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 109 (June 7, 2016)

Page Range36552-36553
FR Document2016-13310

Federal Register, Volume 81 Issue 109 (Tuesday, June 7, 2016) 
[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36552-36553]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13310]


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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 (5 U.S.C. App.), 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 of Mental Health Special 
Emphasis Panel Pilot

[[Page 36553]]

Effectiveness Trials for Treatment, Preventive and Services 
Interventions (R34)
    Date: June 24, 2016.
    Time: 11:30 a.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: Karen Gavin-Evans, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, National Institute of 
Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, 
Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356, 
[email protected].

    Name of Committee: National Institute of Mental Health Special 
Emphasis Panel, Fellowship and Dissertation Grants Review Meeting.
    Date: June 30, 2016.
    Time: 12:00 p.m. to 5:00 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: Marcy Ellen Burstein, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, National Institute of 
Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 
6143, MSC 9606, Bethesda, MD 20892-9606, 301-443-9699, 
[email protected].

    Name of Committee: National Institute of Mental Health Special 
Emphasis Panel, Mental Health Services Conflicts (Teleconference).
    Date: June 30, 2016.
    Time: 12:30 p.m. to 1:30 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: Karen Gavin-Evans, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, National Institute of 
Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard, 
Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356, 
[email protected].

(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental 
Health Research Grants, National Institutes of Health, HHS)

    Dated: June 1, 2016.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-13310 Filed 6-6-16; 8:45 am]
 BILLING CODE 4140-01-P

36552 Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices holds the biological product license, for manufacturers of biological products pattern; (2) method of consignee other than human blood and blood other than human blood and blood notification; (3) consignee(s) of products components, and who had control over components, (2) licensed manufacturers for further manufacture; (4) additional a distributed product when the of blood and blood components product information; (5) updated deviation occurred, to report to the including Source Plasma, (3) unlicensed product disposition; and (6) industry Center for Biologics Evaluation and registered blood establishments, (4) recall contacts. This information is Research (CBER) or to the Center for transfusion services, and (5) requested by CBER through email Drugs Evaluation and Research (CDER) establishments that manufacture non- notification to the submitter of the BPD as soon as possible but at a date not to reproductive HCT/Ps regulated solely report. This information is used by exceed 45 calendar days after acquiring under section 361 of the PHS Act as CBER for recall classification purposes. information reasonably suggesting that a described in § 1271.10. The number of At this time, Form FDA 3486A is being reportable event has occurred. Section respondents and total annual responses used only for those BPD reports 606.171, in brief, requires licensed are based on the BPD reports and HCT/ submitted under § 606.171. CBER manufacturers of human blood and P deviation reports FDA received in estimates that 5 percent of the total BPD blood components, including Source fiscal year 2015. The number of licensed Plasma, unlicensed registered blood manufacturers and total annual reports submitted to CBER under establishments, and transfusion responses under § 600.14 include the § 606.171 would need additional services, who had control over a estimates for BPD reports submitted to information submitted in Form FDA distributed product when the deviation both CBER and CDER. Based on the 3486A. CBER further estimates that it occurred, to report to CBER as soon as information from industry, the would take between 10 to 20 minutes to possible but at a date not to exceed 45 estimated average time to complete a complete Form FDA 3486A. For calendar days after acquiring deviation report is 2 hours, which calculation purposes, CBER is using 15 information reasonably suggesting that a includes a minimal one-time burden to minutes. reportable event has occurred. create a user account for those reports Activities such as investigating, Similarly, § 1271.350(b), in brief, submitted electronically. The changing standard operating procedures requires HCT/P establishments that availability of the standardized report or processes, and followup are currently manufacture non-reproductive HCT/Ps form, Form FDA 3486, and the ability to required under parts 211 (approved described in § 1271.10 to investigate and submit this report electronically to under OMB control number 0910–0139), report to CBER all HCT/P deviations CBER (CDER does not currently accept part 606 (approved under OMB control relating to a distributed HCT/P that electronic filings) further streamlines number 0910–0116), part 820 (approved relates to the core CGTP requirements, the report submission process. under OMB control number 0910–0073), if the deviation occurred in the CBER has developed a Web-based and part 1271 (approved under OMB establishment’s facility or in a facility addendum to Form FDA 3486 (Form control number 0910–0543) and, that performed a manufacturing step for FDA 3486A) to provide additional information when a BPD report has been therefore, are not included in the the establishment under contract, reviewed by FDA and evaluated as a burden calculation for the separate agreement, or other arrangement. Form possible recall. The additional requirement of submitting a deviation FDA 3486 is used to submit BPD reports and HCT/P deviation reports. information requested includes report to FDA. Respondents to this collection of information not contained in the Form FDA estimates the burden of this information are: (1) Licensed FDA 3486 such as: (1) Distribution collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Total Average FDA Number of Total 21 CFR section responses per annual burden form No. respondents hours respondent responses per response 600.14 .......................................... 3486 102 5.99 611 2 ................................ 1,222 606.171 ........................................ 3486 1,738 26.34 45,774 2 ................................ 91,548 1271.350(b) .................................. 3486 97 2.64 256 2 ................................ 512 Web-based Addendum ................ 2 3486A 87 26.31 2,289 .25 (15 minutes) ........ 572 Total ...................................... ........................ ........................ ........................ ........................ .................................... 93,854 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Five percent of the number of respondents (1,738 × 0.05 = 87) and total annual responses to CBER (45,774 × 0.05 = 2,289). Dated: May 26, 2016. DEPARTMENT OF HEALTH AND provisions set forth in sections Leslie Kux, HUMAN SERVICES 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Associate Commissioner for Policy. as amended. The grant applications and National Institutes of Health the discussions could disclose [FR Doc. 2016–13366 Filed 6–6–16; 8:45 am] confidential trade secrets or commercial asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4164–01–P National Institute of Mental Health; property such as patentable material, Notice of Closed Meetings and personal information concerning Pursuant to section 10(d) of the individuals associated with the grant Federal Advisory Committee Act, as applications, the disclosure of which amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted hereby given of the following meetings. invasion of personal privacy. The meetings will be closed to the Name of Committee: National Institute of public in accordance with the Mental Health Special Emphasis Panel Pilot VerDate Sep<11>2014 19:13 Jun 06, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1

Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices 36553 Effectiveness Trials for Treatment, Preventive Dated: June 1, 2016. FOR FURTHER INFORMATION CONTACT: To and Services Interventions (R34) Carolyn A. Baum, obtain a copy of the data collection Date: June 24, 2016. Program Analyst, Office of Federal Advisory plans and instruments, or request more Time: 11:30 a.m. to 3:00 p.m. Committee Policy. information on the proposed project, Agenda: To review and evaluate grant contact*: Michele M. Doody, Radiation [FR Doc. 2016–13310 Filed 6–6–16; 8:45 am] applications. Epidemiology Branch, National Cancer BILLING CODE 4140–01–P Place: National Institutes of Health, Institute, 9609 Medical Center Drive, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Room 7E566, Rockville, MD 20850, or Conference Call). DEPARTMENT OF HEALTH AND call non-toll-free number 301–414– Contact Person: Karen Gavin-Evans, Ph.D., HUMAN SERVICES 0308. Or Email your request, including Scientific Review Officer, Division of your address to: doodym@mail.nih.gov. Extramural Activities, National Institute of National Institutes of Health Formal requests for additional plans and Mental Health, NIH, Neuroscience Center, instruments must be requested in 6001 Executive Boulevard, Room 6153, MSC Submission for OMB Review; 30-day writing. 9606, Bethesda, MD 20892, 301–451–2356, Comment Request, U.S. Nuclear Proposed Collection: U.S. Nuclear gavinevanskm@mail.nih.gov. Medicine Technologists Study (NCI) Medicine Technologists Study, 0925– Name of Committee: National Institute of 0656, Expiration Date 04/30/2015— SUMMARY: Under the provisions of Mental Health Special Emphasis Panel, REINSTATEMENT WITH CHANGE, Section 3507(a)(1)(D) of the Paperwork Fellowship and Dissertation Grants Review National Cancer Institute (NCI), Meeting. Reduction Act of 1995, the National National Institutes of Health (NIH). Date: June 30, 2016. Cancer Institute, the National Institutes Need and Use of Information Time: 12:00 p.m. to 5:00 p.m. of Health, has submitted to the Office of Collection: We propose to collect from Agenda: To review and evaluate grant Management and Budget (OMB) a U.S. nuclear medicine technologists applications. request for review and approval of the (USNMT) certified after 1980 historical Place: National Institutes of Health, information collection listed below. information about nuclear medicine Neuroscience Center, 6001 Executive This proposed information collection procedures performed, radioisotopes Boulevard, Rockville, MD 20852, (Telephone was previously published in the Federal used, related work and safety practices, Conference Call). Register on March 28, 2016 and allowed Contact Person: Marcy Ellen Burstein, and places of employment. The primary 60-days for public comment. No public Ph.D., Scientific Review Officer, Division of objectives of the current feasibility effort comments were received. The purpose Extramural Activities, National Institute of are: (a) To identify a cohort of nuclear of this notice is to allow an additional Mental Health, NIH Neuroscience Center, medicine technologists certified after 30 days for public comment. The 6001 Executive Blvd., Room 6143, MSC 9606, 1980 by the American Registry of National Cancer Institute, National Bethesda, MD 20892–9606, 301–443–9699, Radiologic Technologists (ARRT) and/or Institutes of Health, may not conduct or bursteinme@mail.nih.gov. the Nuclear Medicine Technologist sponsor, and the respondent is not Name of Committee: National Institute of Certification Board (NMTCB); and (b) to required to respond to, an information Mental Health Special Emphasis Panel, characterize individual organ-specific collection that has been extended, Mental Health Services Conflicts occupational radiation doses from revised, or implemented on or after (Teleconference). radioisotope procedures. More recently Date: June 30, 2016. October 1, 1995, unless it displays a certified technologists, who specialized Time: 12:30 p.m. to 1:30 p.m. currently valid OMB control number. in nuclear medicine, are expected to Agenda: To review and evaluate grant Direct Comments to OMB: Written have greater exposures to radioisotopes applications. comments and/or suggestions regarding than the general radiologic technologists Place: National Institutes of Health, the item(s) contained in this notice, in the U.S. Radiologic Technologist Neuroscience Center, 6001 Executive especially regarding the estimated (USRT) cohort owing to performing Boulevard, Rockville, MD 20852, (Telephone public burden and associated response such procedures with greater frequency. Conference Call). time, should be directed to the: Office Contact Person: Karen Gavin-Evans, Ph.D., The proposed USNMT study would be of Management and Budget, Office of a direct follow-on to the USRT Study to Scientific Review Officer, Division of Regulatory Affairs, OIRA_submission@ Extramural Activities, National Institute of assess health risks associated with omb.eop.gov or by fax to 202–395–6974, occupational exposure to these much Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC Attention: NIH Desk Officer. higher-energy radiopharmaceuticals. 9606, Bethesda, MD 20892, 301–451–2356, Comment Due Date: Comments OMB approval is requested for 3 gavinevanskm@mail.nih.gov. regarding this information collection are years. There are no costs to respondents (Catalogue of Federal Domestic Assistance best assured of having their full effect if other than their time. The total Program No. 93.242, Mental Health Research received within 30 days of the date of estimated annualized burden hours are Grants, National Institutes of Health, HHS) this publication. 125. ESTIMATED ANNUALIZED BURDEN HOURS Average time Number of Frequency of Annual hour Type of respondent Instrument per response respondents response burden asabaliauskas on DSK3SPTVN1PROD with NOTICES (hours) Nuclear Medicine Technologists ....... Nuclear Medicine Questionnaire ...... 250 1 30/60 125 Total ........................................... ........................................................... 250 250 ........................ 125 VerDate Sep<11>2014 19:13 Jun 06, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1


Document Created: 2018-02-08 07:31:29
Document Modified: 2018-02-08 07:31:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesJune 24, 2016.
FR Citation81 FR 36552 
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