Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director), 83855-83856 [2016-28140]

Download as PDF Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director) sradovich on DSK3GMQ082PROD with NOTICES 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 section 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 Heart, Lung, and Blood Institute Special Emphasis Panel; Heart, Lung, Blood and Sleep Conference Support Applications. Date: December 12–13, 2016. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Stephanie J. Webb, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301–435–0291, stephanie.webb@nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; R25 Diversity: Short-Term Research Education to Increase Diversity. Date: December 12, 2016. Time: 10:00 a.m. to 11:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Room 7189, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Stephanie L. Constant, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7189, Bethesda, MD 20892, 301– 443–8784, constantsl@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: November 16, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–27997 Filed 11–21–16; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 16:52 Nov 21, 2016 Jkt 241001 AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the 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 August 22, 2016, page 56667 (81 FR 56667) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. 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. SUMMARY: Written comments and/or suggestions regarding the items(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. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Julia Slutsman, Health Science Policy Analyst, Office of Human Subjects Research Protections (OHSRP), IRP, OD, NIH, Building 10, Room 1C154, 10 Center Drive, Bethesda, MD 20892, or call non-toll-free number 301–402–3444 or email your request, including your address to: PHERRB@ mail.nih.gov. Formal requests for additional materials must be requested in writing. SUPPLEMENTARY INFORMATION: The Office of Human Subjects Research Protections (OHSRP), Office of the Director (OD), 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 ADDRESSES: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 83855 after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Materials to Support NIH Serving As an IRB of Record or a Single IRB for Outside Institutions, 0925-New, Office of Human Subjects Research Protections (OHSRP), Office of the Director, National Institutes of Health (NIH). Need and Use of Information Collection: The NIH Human Research Protections Program (HRPP) is preparing to implement the recent ‘‘NIH Policy on the Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research,’’ which requires the use of a single IRB of record for human subject protections review of certain multisite studies. Additionally, the NIH and HHS have recently established the Public Health Emergency Research Review Board (PHERRB) mechanism, for human subject protections review of certain— typically multisite—public health emergency research studies. Any of the 12 NIH intramural IRBs can be designated to serve as the PHERRB for review of a public health emergency research protocol. Finally, proposed changes to federal human subject protections regulations, if finalized, will require the use of single IRB review for the majority of HHS funded, multi-site studies. To meet all of these needs, and support efficient single IRB review, researchers at outside institutions will need to provide information to the NIH HRPP, which includes the NIH intramural IRBs, using materials developed by the NIH Office of Human Subject Protections. The required materials include: The Application for PHERRB Review (APR); the Initial Review Local Context Worksheet (IRLCW); and the Continuing Review Local Context Worksheet (CRLCW). This information collection is intended to provide the NIH HRPP and the NIH IRBs with information necessary for NIH to maintain regulatory compliance in its conduct of human subject protections review when an NIH IRB serves an IRB of record for multisite research and to provide high quality and timely human subject protections reviews. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annual burden hours are 790. E:\FR\FM\22NON1.SGM 22NON1 83856 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Estimated number of respondents Estimated number of responses per respondent Average time per response (in hours) Estimated total annual burden hours Data collection activity Type of respondents APR ............................... IRLCW ........................... Principal Investigator (MD or PhD) ..................... Principal Investigator (MD or PhD degree) or Research Coordinator (RN, BA, MA degree) or Regulatory Staff (BA degree). Principal Investigator (MD or PhD degree) or Research Coordinator (RN, BA, MA degree) or Regulatory Staff (BA degree). 20 250 1 1 2 2 40 500 250 1 1 250 .............................................................................. 520 520 ........................ 790 CRLCW .......................... Total ........................ Dated: November 16, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Need and Use of Information Collection: The Cancer Therapy Evaluation Program (CTEP) establishes and supports programs to facilitate the participation of qualified investigators on CTEP-supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Currently guided by the efforts of the Clinical Trials Working Group (CTWG) and the Institute of Medicine (IOM) recommendations to revitalize the Cooperative Group program, CTEP has funded the Cancer Trials Support Unit (CTSU). The CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. In addition, CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk, the CTSU Web site, and the Protocol and Information Office (PIO). An ongoing user satisfaction survey is in place for the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and are used to direct improvements to processes and technology. OMB approval for an extension to the existing approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,204. Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll-free number 240–276–6080 or Email your request, including your address to: montellom@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–28140 Filed 11–21–16; 8:45 am] BILLING CODE 4140–01–P Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute) National Institutes of Health. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. SUMMARY: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Michael Montello, Pharm. D., FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Cancer Trials Support Unit (CTSU) (NCI), 0925–0624, EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). sradovich on DSK3GMQ082PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hour Form name Type of respondent CTSU IRB/Regulatory Approval Transmittal Form. CTSU IRB Certification Form ......................... CTSU Acknowledgement Form ...................... Withdrawal from Protocol Participation Form Health Care Practitioner ..... 9,000 12 2/60 3,600 Health Care Practitioner ..... Health Care Practitioner ..... Health Care Practitioner ..... 8,500 500 50 12 12 12 10/60 5/60 5/60 17,000 500 50 VerDate Sep<11>2014 16:52 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83855-83856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Materials To 
Support NIH Serving as an IRB of Record or a Single IRB for Outside 
Institutions (Office of the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
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 August 
22, 2016, page 56667 (81 FR 56667) and allowed 60 days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

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.

ADDRESSES: Written comments and/or suggestions regarding the items(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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Julia Slutsman, Health Science Policy Analyst, 
Office of Human Subjects Research Protections (OHSRP), IRP, OD, NIH, 
Building 10, Room 1C154, 10 Center Drive, Bethesda, MD 20892, or call 
non-toll-free number 301-402-3444 or email your request, including your 
address to: PHERRB@mail.nih.gov. Formal requests for additional 
materials must be requested in writing.

SUPPLEMENTARY INFORMATION: The Office of Human Subjects Research 
Protections (OHSRP), Office of the Director (OD), 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.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health has submitted to the 
Office of Management and Budget (OMB) a request for review and approval 
of the information collection listed below.
    Proposed Collection: Materials to Support NIH Serving As an IRB of 
Record or a Single IRB for Outside Institutions, 0925-New, Office of 
Human Subjects Research Protections (OHSRP), Office of the Director, 
National Institutes of Health (NIH).
    Need and Use of Information Collection: The NIH Human Research 
Protections Program (HRPP) is preparing to implement the recent ``NIH 
Policy on the Use of a Single Institutional Review Board (sIRB) of 
Record for Multi-Site Research,'' which requires the use of a single 
IRB of record for human subject protections review of certain multisite 
studies. Additionally, the NIH and HHS have recently established the 
Public Health Emergency Research Review Board (PHERRB) mechanism, for 
human subject protections review of certain--typically multisite--
public health emergency research studies. Any of the 12 NIH intramural 
IRBs can be designated to serve as the PHERRB for review of a public 
health emergency research protocol. Finally, proposed changes to 
federal human subject protections regulations, if finalized, will 
require the use of single IRB review for the majority of HHS funded, 
multi-site studies.
    To meet all of these needs, and support efficient single IRB 
review, researchers at outside institutions will need to provide 
information to the NIH HRPP, which includes the NIH intramural IRBs, 
using materials developed by the NIH Office of Human Subject 
Protections. The required materials include: The Application for PHERRB 
Review (APR); the Initial Review Local Context Worksheet (IRLCW); and 
the Continuing Review Local Context Worksheet (CRLCW). This information 
collection is intended to provide the NIH HRPP and the NIH IRBs with 
information necessary for NIH to maintain regulatory compliance in its 
conduct of human subject protections review when an NIH IRB serves an 
IRB of record for multisite research and to provide high quality and 
timely human subject protections reviews.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annual burden 
hours are 790.

[[Page 83856]]



                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Estimated
                                                                                             Estimated       number of     Average time      Estimated
            Data collection activity                       Type of respondents               number of     responses per   per response    total annual
                                                                                            respondents     respondent      (in hours)     burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
APR............................................  Principal Investigator (MD or PhD).....              20               1               2              40
IRLCW..........................................  Principal Investigator (MD or PhD                   250               1               2             500
                                                  degree) or Research Coordinator (RN,
                                                  BA, MA degree) or Regulatory Staff (BA
                                                  degree).
CRLCW..........................................  Principal Investigator (MD or PhD                   250               1               1             250
                                                  degree) or Research Coordinator (RN,
                                                  BA, MA degree) or Regulatory Staff (BA
                                                  degree).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             520             520  ..............             790
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: November 16, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-28140 Filed 11-21-16; 8:45 am]
 BILLING CODE 4140-01-P