[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44630-44631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. FDA-2015-D-3638]


Minutes of Institutional Review Board Meetings; 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 ``Minutes of Institutional Review Board Meetings; Guidance for 
Institutions and Institutional Review Boards.'' The guidance is 
intended for institutions and Institutional Review Boards (IRBs) that 
are responsible for the review and oversight of human subject research 
conducted or supported by the U.S. Department of Health and Human 
Services (HHS) or regulated by FDA. The purpose of the guidance is to 
assist institutions and IRBs in preparing and maintaining minutes of 
IRB meetings (also referred to in the guidance as minutes) that meet 
the regulatory requirements for minutes set forth in FDA and HHS 
regulations. The guidance also provides general recommendations on the 
type and amount of information to be included in the minutes. The 
guidance announced in this notice finalizes the draft guidance of the 
same title dated November 2015.

DATES: The announcement of the guidance is published in the Federal 
Register on September 25, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2015-D-3638 for ``Minutes of Institutional Review Board Meetings; 
Guidance for Institutions and Institutional Review Boards.'' 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 office of Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
    <bullet> 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

[[Page 44631]]

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 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.
    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 ``Minutes of Institutional Review Board Meetings; Guidance for 
Institutions and Institutional Review Boards.'' OHRP and FDA are 
providing recommendations on the type and amount of information to 
include in minutes.
    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 November 5, 2015 (80 FR 68545), OHRP and 
FDA announced the availability of the draft guidance of the same title 
dated November 2015. OHRP and FDA received several comments on the 
draft guidance, and those comments were considered as the guidance was 
finalized. Changes include modifying certain recommendations for 
inclusion of information in minutes when such information may be 
addressed in other IRB records. In addition, editorial changes were 
made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated November 2015.

II. Significance of Guidance

    The 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 minutes of IRB meetings. 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.

III. 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 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 have been approved under OMB control 
number 0990-0260.

IV. 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: August 30, 2017.
Don Wright,
Acting Assistant Secretary for Health.
    Dated: Sept. 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20405 Filed 9-22-17; 8:45 am]
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