[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78238-78239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31593]


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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Institutions and Institutional Review Boards; Draft Guidance; Extension 
of the Comment Period

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; extension of comment period.

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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Administration (FDA) are extending the comment period for the draft 
guidance entitled ``Minutes of Institutional Review Board (IRB) 
Meetings: Guidance for Institutions and IRBs.'' A notice of 
availability requesting comments on the draft guidance document 
appeared in the Federal Register of November 5, 2015. The Agencies are 
taking the initiative to extend the comment period for an additional 30 
days because the timing of the due date for comments intersects with 
comment periods on other Federal Register documents requiring review by 
the same group of stakeholders. This extension will allow interested 
persons additional time to submit comments.

DATES: OHRP and FDA are extending the comment period on the draft 
guidance entitled ``Minutes of Institutional Review Board (IRB) 
Meetings: Guidance for Institutions and IRBs.'' Submit either 
electronic or written comments by February 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

[[Page 78239]]

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: In the Federal Register of November 5, 2015 
(80 FR 68545), OHRP and FDA published a notice of availability with a 
60-day comment period to request comments on a draft guidance document 
entitled ``Minutes of Institutional Review Board Meetings: Guidance for 
Institutions and Institutional Review Boards; Draft Guidance; 
Availability.'' The Agencies are taking the initiative to extend the 
comment period for an additional 30 days because the timing of the due 
date for comments intersects with comment periods on other Federal 
Register documents requiring review by the same group of stakeholders. 
We believe that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying finalizing 
the guidance on these important issues.

    Dated: December 9, 2015.
Leslie Kux,
Associate Commissioner for Policy, U.S. Food and Drug Administration.
    Dated: December 4, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, U.S. Department of Health and 
Human Services.
[FR Doc. 2015-31593 Filed 12-15-15; 8:45 am]
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