
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50711-50712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Food and Drug Administration

[Docket No. FDA-2016-D-1605]


Institutional Review Board Written Procedures: Guidance for 
Institutions and Institutional Review Boards; Draft Guidance; 
Availability

AGENCY: The Office for Human Research Protections, Office of the 
Assistant Secretary for Health, Office of the Secretary, HHS, and the 
Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health, and the Food and Drug 
Administration (FDA) are announcing the availability of a draft 
guidance entitled ``Institutional Review Board (IRB) Written 
Procedures: Guidance for Institutions and IRBs.'' The purpose of this 
draft guidance is to assist IRB administrators, IRB chairpersons, and 
other institutional officials responsible for preparing and maintaining 
written procedures for IRBs. The draft guidance is intended for IRBs 
and institutions responsible for review and oversight of human subject 
research under the HHS or FDA regulations, or both.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1605 for ``Institutional Review Board (IRB) Written 
Procedures: Guidance for Institutions and IRBs.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 50712]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Janet Donnelly, Office of Good 
Clinical Practice, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5167, Silver Spring, MD 20993-0002, 301-796-4187; 
or Irene Stith-Coleman, Office for Human Research Protections, 1101 
Wootton Pkwy., Suite 200, Rockville, MD 20852, 240-453-6900.

SUPPLEMENTARY INFORMATION:

I. Background

    OHRP and FDA are announcing the availability of a draft guidance 
document entitled ``Institutional Review Board (IRB) Written 
Procedures: Guidance for Institutions and IRBs.'' This guidance is 
intended to assist IRB administrators, IRB chairpersons, and other 
institutional officials responsible for preparing and maintaining 
written procedures for IRBs.
    OHRP and FDA frequently receive requests for clarification 
regarding the scope and content of IRB written procedures. We recognize 
that procedures may vary among institutions and IRBs due to differences 
in the type of research studies reviewed by the IRB, institutional 
policy or administrative practices, number of IRBs at the institution, 
affiliation with an institution, and local and State laws and 
regulations. In order to provide guidance on the appropriate content of 
written procedures, while taking into account these variations, we 
created an IRB Written Procedures Checklist to assist IRBs in preparing 
and maintaining detailed written procedures suitable for their 
institutions. The IRB Written Procedures Checklist incorporates the HHS 
and FDA regulatory requirements for IRB written procedures and 
additional topics that we recommend including in written procedures. 
The draft guidance, when finalized, will supersede OHRP's July 1, 2011, 
``Guidance on Written IRB Procedures'' and FDA's 1998 ``Appendix H: A 
Self-Evaluation Checklist for IRBs,'' (formerly part of FDA's 
Information Sheet Guidance for IRBs, Clinical Investigators, and 
Sponsors).
    To enhance human subject protection and reduce regulatory burden, 
OHRP and FDA have been actively working to harmonize the Agencies' 
regulatory requirements and guidance for human subject research. This 
guidance document was developed as a part of these efforts. OHRP and 
FDA believe that it will be most helpful to the regulated community to 
issue a joint guidance document that will clearly demonstrate the 
Agencies' harmonized approach to the topic of preparing and maintaining 
IRB written procedures.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent OHRP's and FDA's current thinking on IRB 
written procedures. It does not establish any rights for any person and 
is not binding on OHRP, FDA, or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information 
referenced in this guidance that are related to IRB recordkeeping 
requirements under 21 CFR 56.115, including the information collection 
activities in the provisions in 21 CFR 56.108(a)(1) and (b), have been 
approved under OMB control number 0910-0130. The collections of 
information referenced in this guidance that are related to IRB 
recordkeeping requirements under 45 CFR 46.115, including the 
information collection activities in the provisions in 45 CFR 
46.103(b)(4) and (5) have been approved under OMB control number 0990-
0260.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm, 
http://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html, or http://www.regulations.gov.

    Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy, U.S. Food and Drug Administration.
    Dated: July 15, 2016.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, U.S. Department of Health and 
Human Services.
[FR Doc. 2016-18191 Filed 8-1-16; 8:45 am]
 BILLING CODE 4164-01-P


