[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68545-68547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27986]


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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Institutions and Institutional Review Boards; Draft Guidance; 
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.

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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Administration (FDA) are announcing the availability of a draft 
guidance entitled ``Minutes of Institutional Review Board (IRB) 
Meetings: Guidance for Institutions and IRBs.'' The draft guidance is 
intended for institutions and 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

[[Page 68546]]

draft guidance is to assist institutions and IRBs in preparing and 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 The draft guidance also provides general 
recommendations on the type and amount of information to be included in 
the minutes.

DATES: You can comment on any guidance at any time (21 CFR 
10.115(g)(5)). To ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either written or electronic comments by January 4, 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-2015-D-3638 for ``Minutes of Institutional Review Board Meetings: 
Guidance for Institutions and Institutional Review Boards; Draft 
Guidance; Availability'' 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.
     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.

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 ``Minutes of Institutional Review Board Meetings: 
Guidance for Institutions and Institutional Review Boards; Draft 
Guidance; Availability.'' Because IRBs have been cited in OHRP 
determination letters and FDA warning letters as having inadequate 
minutes, OHRP and FDA are providing recommendations on the type and 
amount of information to include in minutes in order to help IRBs meet 
the regulatory requirements for 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 
draft 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 draft guidance document which will clearly demonstrate 
the Agencies' harmonious approach to the topic of preparing and 
maintaining minutes of IRB meetings.
    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 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.

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 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.

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III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm, 
or http://www.hhs.gov/ohrp/newsroom/index.html, or http://www.regulations.gov.

    Dated: October 23, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health. U.S. Department of Health and 
Human Services.
    Dated: October 27, 2015.
Leslie Kux,
Assistant Commissioner for Policy, U.S. Food and Drug Administration.
[FR Doc. 2015-27986 Filed 11-4-15; 8:45 am]
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