
[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Proposed Rules]
[Pages 65322-65323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 312, and 812

[Docket No. FDA-2018-N-2727]
RIN 0910-AH52


Institutional Review Board Waiver or Alteration of Informed 
Consent for Minimal Risk Clinical Investigations; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the proposed rule that appeared in the 
Federal Register of November 15, 2018. The Agency is taking this action 
in response to a request for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published November 15, 2018 (83 FR 57378). Submit either electronic or 
written comments by February 13, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 13, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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

[[Page 65323]]

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-2018-N-2727 for ``Institutional Review Board Waiver or Alteration 
of Informed Consent for Minimal Risk Clinical Investigations.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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 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.

FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-1127.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 15, 
2018, FDA published a proposed rule with a 60-day comment period to 
implement the statutory changes made to the Federal Food, Drug, and 
Cosmetic Act by section 3024 of the 21st Century Cures Act (Pub. L. 
114-255) to allow for a waiver or alteration of informed consent when a 
clinical investigation poses no more than minimal risk to the human 
subject and includes appropriate safeguards to protect the rights, 
safety, and welfare of human subjects. The proposed rule, if finalized, 
would permit an institutional review board (IRB) to waive or alter 
certain informed consent elements or to waive the requirement to obtain 
informed consent, under limited conditions, for certain minimal risk 
clinical investigations. Comments on the proposed rule will inform 
FDA's rulemaking to establish regulations for IRB waiver or alteration 
of informed consent for certain minimal risk clinical investigations.
    The Agency has received a request for a 60-day extension of the 
comment period for the proposed rule. This request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the request and is extending the comment period 
for the proposed rule for 30 days, until February 13, 2019. The Agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

    Dated: December 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27519 Filed 12-19-18; 8:45 am]
 BILLING CODE 4164-01-P


