[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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