81 FR 83855 - 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)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 225 (November 22, 2016)

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.

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83855-83856]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28140]


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

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, 
[email protected] 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: [email protected]. 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