Document ID: FDA-2016-N-1111-0382
Agency: fda
Document Type: Proposed Rule
Title: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To
Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period
Posted Date: 2016-05-23T04:00Z

[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Proposed Rules]
[Pages 32258-32259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12026]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 895

[Docket No. FDA-2016-N-1111]

Banned Devices; Proposal To Ban Electrical Stimulation Devices 
Used To Treat Self-Injurious or Aggressive Behavior; 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) is extending the 
comment period for the proposed rule that appeared in the Federal 
Register of April 25, 2016. In the proposed rule, FDA requested 
comments for a ban on electrical stimulation devices (ESDs) used for 
self-injurious or aggressive behavior (SIB or AB). The Agency is taking 
this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published April 25, 2016 (81 FR 24386). Submit either electronic or 
written comments by July 25, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 32259]]

     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-2016-N-1111 for ``Proposal to Ban Electrical Stimulation Devices 
Used to Treat Self-Injurious or Aggressive Behavior.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' 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: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 25, 2016, 
FDA published a proposed rule with a 30-day comment period to request 
comments on a proposal to ban ESDs used for SIB or AB. Comments on the 
proposed ban will inform FDA's rulemaking.
    The Agency has received requests for a 60-day extension of the 
comment period for the proposed rule. Each request conveyed concern 
that the current 30-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 60 days, until July 25, 2016. The Agency 
believes that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
this important issue.

    Dated: May 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12026 Filed 5-20-16; 8:45 am]
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