Submission for OMB Review; 30-Day Comment Request: National Institute of Mental Health (NIMH) Recruitment Milestone Reporting System, 61439-61440 [2015-25941]

Download as PDF Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices Place: Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27517. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30/ Room 3171, Research Triangle Park, NC 27709, 919/541–0670, worth@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Environmental Health Science Cores. Date: November 6, 2015 Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Imperial Center, One Europa Drive, Chapel Hill, NC 27517. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30/ Room 3171, Research Triangle Park, NC 27709, (919) 541–0670, worth@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: October 6, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–25903 Filed 10–9–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSK4VPTVN1PROD with NOTICES National Institute of Neurological Disorders and Stroke; 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. This 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. 21:23 Oct 09, 2015 (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: October 6, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–25906 Filed 10–9–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: National Institute of Mental Health (NIMH) Recruitment Milestone Reporting System Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 1, 2015, page 31053, and allowed 60-days for public comment. Four (4) public comments were received. Comments include concerns about the clarity of the announcement, the utility of the information collected, and the frequency of tri-annual and monthly reporting. NIMH carefully considered all comments received and has changed the language in the supporting statement to confirm that reporting of recruitment milestones in the RMR applies to participants in all extramural NIMH-sponsored clinical trials, regardless of size, as well as other clinical research studies that plan to enroll 150 or more human subjects in a SUMMARY: BILLING CODE 4140–01–P VerDate Sep<11>2014 Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Review of Career Development Applications. Date: October 28, 2015. Time: 11:00 a.m. to 12:30 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: Raul A. Saavedra, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496– 9223, saavedrr@ninds.nih.gov. Jkt 238001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 61439 single study. Investigators who fail to meet their milestones may be requested to submit interim monthly reports. NIMH has determined tri-annual reporting to be the minimum necessary to provide effective recruitment monitoring. When studies fall significantly behind their recruitment goals, monthly reporting is necessary in order to ensure the study can be completed within the proposed budget and timeframe. Based on current study performance, NIMH expects less than 5% of respondents will require monthly reporting. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301–443– 4335, or Email your request, including your address to: nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection National Institute of Mental Health (NIMH) Recruitment Milestone Reporting System (OMB control number 0925–0697)—REVISION—National Institute of Mental Health (NIMH), National Institute of Health (NIH). Need and Use of Information Collection The Recruitment Milestone Reporting (RMR) System allows NIMH staff to monitor more effectively the E:\FR\FM\13OCN1.SGM 13OCN1 61440 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices recruitment of participants in all NIMHsponsored clinical trials, regardless of size, and other clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best way to ensure recruitment goals are met within the expected timeframe. Investigators develop a recruitment plan that includes tri-yearly milestones for recruitment of the total study population, and for recruitment of racial and ethnic minority participants. Once recruitment is scheduled to begin, investigators report actual progress on recruitment milestones three times per year, by April 1, August 1, and December 1. Investigators who fail to meet their milestones may be requested to submit interim monthly reports. The primary use of this information is to ensure that realistic recruitment milestones are established from the onset of a project, and that these milestones are met throughout the course of the research. By ensuring timely recruitment into clinical research studies, NIMH can reduce the need to extend timelines or supplement funds in order to complete the research project, potentially increasing efficiency in the funding process and expediting the availability of treatments for mental illness. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,295. ESTIMATED ANNUALIZED BURDEN HOURS Form name Tri-yearly NIMH Recruitment Milestone Reporting (RMR). Monthly NIMH Recruitment Milestone Reporting (RMR). Total ............................................................... Dated: October 6, 2015. Melba Rojas, NIMH Project Clearance Officer, NIMH, NIH. [FR Doc. 2015–25941 Filed 10–9–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: International HIV/ AIDS Research Fellowship Award Program (NIDA) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 8, 2014, page 60895, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:23 Oct 09, 2015 Number of respondents Type of respondent Jkt 238001 Average burden per response (in hours) Total annual burden hours NIMH Principal Investigators. NIMH Principal Investigators. 900 3 45/60 2,025 40 9 45/60 270 ....................................... 940 3,060 45/60 2,295 on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Steve W. Gust, Ph.D., Director, NIDA International Program, NIDA, NIH, 6001 Executive Blvd., Bethesda, Maryland 20892–0234; or call non-tollfree number (301) 443–6480; or Email: your request, including your address to: sgust@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: International HIV/AIDS Research Fellowship Award Program, 0925–New, National Institute FOR FURTHER INFORMATION CONTACT: PO 00000 Number of responses per respondent Frm 00107 Fmt 4703 Sfmt 4703 on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: Initially this collection was part of a clearance request for the application forms for two programs, and due to protracted delays in the readiness of one of the programs it became necessary to create a stand-alone request for this program. This request is for the Application Form for this international training program. The program will recruit post-doctoral researchers into a new fellowship research training program for HIV and drug use. The program will train new researchers in research to advance the science of HIV and drug use and foster multinational research in this disease area. The program is open to all foreign nationals. The Application Form will collect necessary information for determining the most meritorious applicants. NIDA is requesting approval from OMB for this application form to be used by the Institute’s fellowship program to train new researchers and fund experienced scientists, of other nations, in research to advance the science of HIV and drug use while fostering multinational research in this disease area. The application form will be web-based. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annual estimated burden hours are 83. E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61439-61440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25941]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: National 
Institute of Mental Health (NIMH) Recruitment Milestone Reporting 
System

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Mental Health (NIMH), 
National Institutes of Health (NIH), has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on June 1, 
2015, page 31053, and allowed 60-days for public comment. Four (4) 
public comments were received. Comments include concerns about the 
clarity of the announcement, the utility of the information collected, 
and the frequency of tri-annual and monthly reporting. NIMH carefully 
considered all comments received and has changed the language in the 
supporting statement to confirm that reporting of recruitment 
milestones in the RMR applies to participants in all extramural NIMH-
sponsored clinical trials, regardless of size, as well as other 
clinical research studies that plan to enroll 150 or more human 
subjects in a single study. Investigators who fail to meet their 
milestones may be requested to submit interim monthly reports. NIMH has 
determined tri-annual reporting to be the minimum necessary to provide 
effective recruitment monitoring. When studies fall significantly 
behind their recruitment goals, monthly reporting is necessary in order 
to ensure the study can be completed within the proposed budget and 
timeframe. Based on current study performance, NIMH expects less than 
5% of respondents will require monthly reporting. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Institute of Mental Health, National Institutes of Health, may 
not conduct or sponsor, and the respondent is not required to respond 
to, an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project contact: NIMH Project Clearance Liaison, Science 
Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 
6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, 
or call 301-443-4335, or Email your request, including your address to: 
nimhprapubliccomments@mail.nih.gov. Formal requests for additional 
plans and instruments must be requested in writing.

Proposed Collection

    National Institute of Mental Health (NIMH) Recruitment Milestone 
Reporting System (OMB control number 0925-0697)--REVISION--National 
Institute of Mental Health (NIMH), National Institute of Health (NIH).

Need and Use of Information Collection

    The Recruitment Milestone Reporting (RMR) System allows NIMH staff 
to monitor more effectively the

[[Page 61440]]

recruitment of participants in all NIMH-sponsored clinical trials, 
regardless of size, and other clinical research studies that plan to 
enroll 150 or more human subjects in a single study. Clinical studies 
can have difficulty recruiting, and accurate and timely reporting is 
the best way to ensure recruitment goals are met within the expected 
timeframe. Investigators develop a recruitment plan that includes tri-
yearly milestones for recruitment of the total study population, and 
for recruitment of racial and ethnic minority participants. Once 
recruitment is scheduled to begin, investigators report actual progress 
on recruitment milestones three times per year, by April 1, August 1, 
and December 1. Investigators who fail to meet their milestones may be 
requested to submit interim monthly reports. The primary use of this 
information is to ensure that realistic recruitment milestones are 
established from the onset of a project, and that these milestones are 
met throughout the course of the research. By ensuring timely 
recruitment into clinical research studies, NIMH can reduce the need to 
extend timelines or supplement funds in order to complete the research 
project, potentially increasing efficiency in the funding process and 
expediting the availability of treatments for mental illness.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,295.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Tri-yearly NIMH Recruitment     NIMH Principal               900               3           45/60           2,025
 Milestone Reporting (RMR).      Investigators.
Monthly NIMH Recruitment        NIMH Principal                40               9           45/60             270
 Milestone Reporting (RMR).      Investigators.
                                                 ---------------------------------------------------------------
    Total.....................  ................             940           3,060           45/60           2,295
----------------------------------------------------------------------------------------------------------------


    Dated: October 6, 2015.
Melba Rojas,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2015-25941 Filed 10-9-15; 8:45 am]
 BILLING CODE 4140-01-P
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