[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22986-22987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


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

AGENCY: The Office for Human Research Protections, Office of the 
Assistant Secretary for Health, Office of the Secretary, 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 guidance 
entitled ``Institutional Review Board (IRB) Written Procedures: 
Guidance for Institutions and IRBs.'' The guidance is intended for 
institutions and IRBs responsible for review and oversight of human 
subject research under the Department of Health and Human Services 
(HHS) and FDA regulations. The purpose of this guidance is to assist 
staff at institutions and IRBs who are responsible for preparing and 
maintaining written procedures. The guidance announced in this notice 
finalizes the draft guidance of the same title dated August 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on May 17, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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

[[Page 22987]]

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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Good Clinical Practice (OGCP), Office of Special Medical 
Programs, Office of Medical Products and Tobacco, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993; or Division of Policy and Assurances, Office for 
Human Research Protections, 1101 Wootton Pkwy., Suite 200, Rockville, 
MD 20852. Send one self-addressed adhesive label to assist the office 
in processing your requests. The guidance may also be obtained by mail 
by calling OGCP at 301-796-8340 or OHRP at 240-453-6900 or 866-447-
4777. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the 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, 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 guidance document 
entitled ``Institutional Review Board (IRB) Written Procedures: 
Guidance for Institutions and IRBs.'' OHRP and FDA frequently receive 
questions about the scope and content of written procedures. We created 
a Written Procedures Checklist (also referred to as the Checklist) to 
assist institutions and IRBs in preparing and maintaining written 
procedures. The Checklist is designed to prompt a thorough evaluation 
of written procedures that help to ensure the protection of human 
research subjects. The Checklist incorporates the HHS and FDA 
regulatory requirements in 45 CFR 46.103(b)(4) and (5) and 21 CFR 
56.108(a) and (b) for written procedures for the IRB and 
recommendations about operational details to include to support each of 
these requirements. In addition, the Checklist identifies some 
additional topics the institution/IRB may consider when developing 
comprehensive procedures. This guidance supersedes 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).
    This document is a final guidance document, based on the Agencies' 
review of submitted comments. The Agencies are always open to 
additional comments on this and other Agency guidance.
    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. In 
addition, on December 13, 2016, the 21st Century Cures Act (Cures Act) 
(Pub. L. 114-255) was signed into law. Title III, section 3023 of the 
Cures Act requires the Secretary of HHS to harmonize differences 
between the HHS human subject regulations and FDA's human subject 
regulations. This guidance document is consistent with the goals of 
section 3023 of the Cures Act.
    In the Federal Register of August 2, 2016 (81 FR 50711), OHRP and 
FDA announced the availability of a draft guidance of the same title 
dated August 2016. OHRP and FDA received several comments on the draft 
guidance, and considered all comments in finalizing this guidance. OHRP 
and FDA revised the guidance to clarify which written procedures are 
specifically required, and which are recommended. In addition, 
editorial changes were made to improve clarity. The guidance announced 
in this notice finalizes the draft guidance dated August 2016.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of OHRP and FDA on written procedures for institutions 
and IRBs. 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This 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) and (b), have been 
approved under OMB control numbers 0910-0755 and 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 document at 
https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html, or https://www.regulations.gov.

    Dated: April 27, 2018.
Brett P. Giroir,
ADM, USPHS, Assistant Secretary for Health.
    Dated: May 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10441 Filed 5-16-18; 8:45 am]
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