80 FR 61439 - Submission for OMB Review; 30-Day Comment Request: National Institute of Mental Health (NIMH) Recruitment Milestone Reporting System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 197 (October 13, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 197 (October 13, 2015)
| Page Range | 61439-61440 | |
| FR Document | 2015-25941 |
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)] [Notices] [Pages 61439-61440] From the Federal Register Online [www.thefederalregister.org] [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, [email protected] 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: [email protected]. 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
![Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61439
Place: Sheraton Chapel Hill Hotel, One Name of Committee: National Institute of single study. Investigators who fail to
Europa Drive, Chapel Hill, NC 27517. Neurological Disorders and Stroke Special meet their milestones may be requested
Contact Person: Leroy Worth, Ph.D., Emphasis Panel; Review of Career to submit interim monthly reports.
Scientific Review Officer, Scientific Review Development Applications. NIMH has determined tri-annual
Branch, Division of Extramural Research and Date: October 28, 2015.
Training, Nat. Institute of Environmental Time: 11:00 a.m. to 12:30 p.m. reporting to be the minimum necessary
Health Sciences, P.O. Box 12233, MD EC–30/ Agenda: To review and evaluate grant to provide effective recruitment
Room 3171, Research Triangle Park, NC applications. monitoring. When studies fall
27709, 919/541–0670, worth@niehs.nih.gov. Place: National Institutes of Health, significantly behind their recruitment
Name of Committee: Neuroscience Center, 6001 Executive goals, monthly reporting is necessary in
National Institute of Environmental Health Boulevard, Rockville, MD 20852 (Telephone order to ensure the study can be
Sciences Special Emphasis Panel; Conference Call). completed within the proposed budget
Environmental Health Science Cores. Contact Person: Raul A. Saavedra, Ph.D., and timeframe. Based on current study
Date: November 6, 2015 Scientific Review Officer, Scientific Review
performance, NIMH expects less than
Time: 1:00 p.m. to 3:00 p.m. Branch, Division of Extramural Research,
Agenda: To review and evaluate grant NINDS/NIH/DHHS/Neuroscience Center, 5% of respondents will require monthly
applications. 6001 Executive Boulevard, Suite 3208, MSC reporting. The purpose of this notice is
Place: Sheraton Imperial Center, One 9529, Bethesda, MD 20892–9529, 301–496– to allow an additional 30 days for public
Europa Drive, Chapel Hill, NC 27517. 9223, saavedrr@ninds.nih.gov. comment. The National Institute of
Contact Person: Leroy Worth, Ph.D., (Catalogue of Federal Domestic Assistance Mental Health, National Institutes of
Scientific Review Officer, Scientific Review Program Nos. 93.853, Clinical Research Health, may not conduct or sponsor,
Branch, Division of Extramural Research and and the respondent is not required to
Related to Neurological Disorders; 93.854,
Training, Nat. Institute of Environmental respond to, an information collection
Biological Basis Research in the
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
Neurosciences, National Institutes of Health, that has been extended, revised, or
HHS) implemented on or after October 1,
27709, (919) 541–0670, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance Dated: October 6, 2015. 1995, unless it displays a currently valid
Program Nos. 93.115, Biometry and Risk Carolyn Baum, OMB control number.
Estimation—Health Risks from Direct Comments to OMB: Written
Program Analyst, Office of Federal Advisory
Environmental Exposures; 93.142, NIEHS Committee Policy. comments and/or suggestions regarding
Hazardous Waste Worker Health and Safety the item(s) contained in this notice,
[FR Doc. 2015–25906 Filed 10–9–15; 8:45 am]
Training; 93.143, NIEHS Superfund especially regarding the estimated
Hazardous Substances—Basic Research and BILLING CODE 4140–01–P
public burden and associated response
Education; 93.894, Resources and Manpower time, should be directed to the: Office
Development in the Environmental Health of Management and Budget, Office of
Sciences; 93.113, Biological Response to DEPARTMENT OF HEALTH AND
Environmental Health Hazards; 93.114,
Regulatory Affairs, OIRA_submission@
HUMAN SERVICES
Applied Toxicological Research and Testing, omb.eop.gov or by fax to 202–395–6974,
National Institutes of Health, HHS) National Institutes of Health Attention: NIH Desk Officer.
Comment Due Date: Comments
Dated: October 6, 2015.
Submission for OMB Review; 30-Day regarding this information collection are
Carolyn Baum, best assured of having their full effect if
Comment Request: National Institute
Program Analyst, Office of Federal Advisory received within 30-days of the date of
of Mental Health (NIMH) Recruitment
Committee Policy. this publication.
Milestone Reporting System
[FR Doc. 2015–25903 Filed 10–9–15; 8:45 am] FOR FURTHER INFORMATION CONTACT: To
BILLING CODE 4140–01–P SUMMARY: Under the provisions of obtain a copy of the data collection
section 3507(a)(1)(D) of the Paperwork plans and instruments or request more
Reduction Act of 1995, the National information on the proposed project
DEPARTMENT OF HEALTH AND Institute of Mental Health (NIMH), contact: NIMH Project Clearance
HUMAN SERVICES National Institutes of Health (NIH), has Liaison, Science Policy and Evaluation
submitted to the Office of Management Branch, OSPPC, NIMH, NIH,
National Institutes of Health and Budget (OMB) a request for review Neuroscience Center, 6001 Executive
and approval of the information Boulevard, MSC 9667, Rockville Pike,
National Institute of Neurological collection listed below. This proposed
Disorders and Stroke; Notice of Closed Bethesda, MD 20892, or call 301–443–
information collection was previously 4335, or Email your request, including
Meetings published in the Federal Register on your address to:
Pursuant to section 10(d) of the June 1, 2015, page 31053, and allowed nimhprapubliccomments@mail.nih.gov.
Federal Advisory Committee Act, as 60-days for public comment. Four (4) Formal requests for additional plans and
amended (5 U.S.C. App.), notice is public comments were received. instruments must be requested in
hereby given of the following meetings. Comments include concerns about the writing.
This meeting will be closed to the clarity of the announcement, the utility
public in accordance with the of the information collected, and the Proposed Collection
provisions set forth in sections frequency of tri-annual and monthly National Institute of Mental Health
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., reporting. NIMH carefully considered (NIMH) Recruitment Milestone
as amended. The grant applications and all comments received and has changed Reporting System (OMB control number
mstockstill on DSK4VPTVN1PROD with NOTICES
the discussions could disclose the language in the supporting 0925–0697)—REVISION—National
confidential trade secrets or commercial statement to confirm that reporting of Institute of Mental Health (NIMH),
property such as patentable material, recruitment milestones in the RMR National Institute of Health (NIH).
and personal information concerning applies to participants in all extramural
individuals associated with the grant NIMH-sponsored clinical trials, Need and Use of Information Collection
applications, the disclosure of which regardless of size, as well as other The Recruitment Milestone Reporting
would constitute a clearly unwarranted clinical research studies that plan to (RMR) System allows NIMH staff to
invasion of personal privacy. enroll 150 or more human subjects in a monitor more effectively the
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![61440 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
recruitment of participants in all NIMH- recruitment is scheduled to begin, studies, NIMH can reduce the need to
sponsored clinical trials, regardless of investigators report actual progress on extend timelines or supplement funds
size, and other clinical research studies recruitment milestones three times per in order to complete the research
that plan to enroll 150 or more human year, by April 1, August 1, and project, potentially increasing efficiency
subjects in a single study. Clinical December 1. Investigators who fail to in the funding process and expediting
studies can have difficulty recruiting, meet their milestones may be requested the availability of treatments for mental
and accurate and timely reporting is the to submit interim monthly reports. The illness.
best way to ensure recruitment goals are primary use of this information is to
met within the expected timeframe. ensure that realistic recruitment OMB approval is requested for 3
Investigators develop a recruitment plan milestones are established from the years. There are no costs to respondents
that includes tri-yearly milestones for onset of a project, and that these other than their time. The total
recruitment of the total study milestones are met throughout the estimated annualized burden hours are
population, and for recruitment of racial course of the research. By ensuring 2,295.
and ethnic minority participants. Once timely recruitment into clinical research
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Form name Type of respondent responses per
respondents response burden hours
respondent (in hours)
Tri-yearly NIMH Recruitment Milestone Reporting NIMH Principal Inves- 900 3 45/60 2,025
(RMR). tigators.
Monthly NIMH Recruitment Milestone Reporting NIMH Principal Inves- 40 9 45/60 270
(RMR). tigators.
Total ............................................................... ....................................... 940 3,060 45/60 2,295
Dated: October 6, 2015. on or after October 1, 1995, unless it on Drug Abuse (NIDA), National
Melba Rojas, displays a currently valid OMB control Institutes of Health (NIH).
NIMH Project Clearance Officer, NIMH, NIH. number. Need and Use of Information
[FR Doc. 2015–25941 Filed 10–9–15; 8:45 am] Direct Comments to OMB: Written Collection: Initially this collection was
BILLING CODE 4140–01–P comments and/or suggestions regarding part of a clearance request for the
the item(s) contained in this notice, application forms for two programs, and
especially regarding the estimated due to protracted delays in the readiness
DEPARTMENT OF HEALTH AND public burden and associated response of one of the programs it became
HUMAN SERVICES time, should be directed to the: Office necessary to create a stand-alone request
of Management and Budget, Office of for this program. This request is for the
National Institutes of Health Regulatory Affairs, Application Form for this international
OIRA_submission@omb.eop.gov or by training program. The program will
Submission for OMB Review; 30-Day recruit post-doctoral researchers into a
Comment Request: International HIV/ fax to 202–395–6974, Attention: Desk
Officer for NIH. new fellowship research training
AIDS Research Fellowship Award program for HIV and drug use. The
Program (NIDA) Comment Due Date: Comments
regarding this information collection are program will train new researchers in
SUMMARY: Under the provisions of best assured of having their full effect if research to advance the science of HIV
Section 3507(a)(1)(D) of the Paperwork received within 30-days of the date of and drug use and foster multinational
Reduction Act of 1995, the National this publication. research in this disease area. The
Institutes of Health (NIH) has submitted program is open to all foreign nationals.
to the Office of Management and Budget FOR FURTHER INFORMATION CONTACT: To The Application Form will collect
(OMB) a request to review and approve obtain a copy of the data collection necessary information for determining
the information collection listed below. plans and instruments or request more the most meritorious applicants. NIDA
This proposed information collection information on the proposed project is requesting approval from OMB for
was previously published in the Federal contact: Steve W. Gust, Ph.D., Director, this application form to be used by the
Register on October 8, 2014, page NIDA International Program, NIDA, Institute’s fellowship program to train
60895, and allowed 60 days for public NIH, 6001 Executive Blvd., Bethesda, new researchers and fund experienced
comment. No comments were received. Maryland 20892–0234; or call non-toll- scientists, of other nations, in research
The purpose of this notice is to allow an free number (301) 443–6480; or Email: to advance the science of HIV and drug
additional 30 days for public comment. your request, including your address to: use while fostering multinational
The National Institute on Drug Abuse sgust@nida.nih.gov. Formal requests for research in this disease area. The
(NIDA), National Institutes of Health, additional plans and instruments must application form will be web-based.
mstockstill on DSK4VPTVN1PROD with NOTICES
may not conduct or sponsor, and the be requested in writing. OMB approval is requested for 3
respondent is not required to respond Proposed Collection: International years. There are no costs to respondents
to, an information collection that has HIV/AIDS Research Fellowship Award other than their time. The total annual
been extended, revised, or implemented Program, 0925–New, National Institute estimated burden hours are 83.
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Document Created: 2018-02-27 08:48:09
Document Modified: 2018-02-27 08:48:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. | |
| 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, | |
| FR Citation | 80 FR 61439 |
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