81_FR_32357 81 FR 32258 - Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period

81 FR 32258 - Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 99 (May 23, 2016)

Page Range32258-32259
FR Document2016-12026

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.

Federal Register, Volume 81 Issue 99 (Monday, May 23, 2016) 
[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Proposed Rules]
[Pages 32258-32259]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P

32258 Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Proposed Rules (a) Comments Due Date 116, Transport Airplane Directorate, FAA; or October 7, 2015, for related information. This We must receive comments by July 7, 2016. the European Aviation Safety Agency MCAI may be found in the AD docket on the (EASA); or Airbus’s EASA Design Internet at http://www.regulations.gov by (b) Affected ADs Organization Approval (DOA). searching for and locating Docket No. FAA– None. 2016–6671. (j) Follow-On Actions for Crack Findings (2) For service information identified in (c) Applicability If any crack is confirmed during the this AD, contact Airbus SAS, Airworthiness This AD applies to Airbus Model A300B4– inspection required by paragraph (h) of this Office—EAW, 1 Rond Point Maurice 203 and A300B4–2C airplanes, certificated in AD, repair before further flight using a Bellonte, 31707 Blagnac Cedex, France; any category, manufacturer serial numbers method approved by the Manager, telephone +33 5 61 93 36 96; fax +33 5 61 210, 212, 218, 220, 227, 234, 235, 236, 239, International Branch, ANM–116, Transport 93 44 51; email account.airworth-eas@ 247, 255, 256, 259, 261, 274, 277, 292, 299, Airplane Directorate, FAA; or EASA; or airbus.com; Internet http://www.airbus.com. and 302. Airbus’s EASA DOA. You may view this service information at the (k) Credit for Previous Actions FAA, Transport Airplane Directorate, 1601 (d) Subject Lind Avenue SW., Renton, WA. For Air Transport Association (ATA) of This paragraph provides credit for actions information on the availability of this America Code 54, Nacelles/Pylons. required by paragraphs (g), (h), (i), and (j) of material at the FAA, call 425–227–1221. this AD, if those actions were performed (e) Reason before the effective date of this AD using the Issued in Renton, Washington, on May 11, This AD was prompted by cracks found on service information specified in paragraphs 2016. pylon side panels (upper section) at rib 8. We (k)(1) through (k)(4) of this AD. Suzanne Masterson, are proposing this AD to detect and correct (1) Airbus Service Bulletin A300–54–0075, Acting Manager, Transport Airplane cracking of the pylon side panels. Such dated August 11, 1993, which was Directorate, Aircraft Certification Service. cracking could result in pylon structural incorporated by referenced in AD 2010–06– 04, Amendment 39–16228 (75 FR 11428, [FR Doc. 2016–11681 Filed 5–20–16; 8:45 am] failure and in-flight loss of an engine. March 11, 2010); corrected May 4, 2010 (75 BILLING CODE 4910–13–P (f) Compliance FR 23572). Comply with this AD within the (2) Airbus Service Bulletin A300–54–0075, compliance times specified, unless already Revision 01, dated November 9, 2007, which done. is not incorporated by reference in this AD. DEPARTMENT OF HEALTH AND (3) Airbus Service Bulletin A300–54–0075, HUMAN SERVICES (g) Detailed Inspection of Pylons and Revision 02, dated June 26, 2008, which is Corrections not incorporated by reference in this AD. Food and Drug Administration At the applicable time specified in Airbus (4) Airbus Service Bulletin A300–54–0075, Service Bulletin A300–54–0075, Revision 04, Revision 03, dated March 27, 2013, which is 21 CFR Parts 882 and 895 dated May 26, 2015: Do a detailed inspection not incorporated by reference in this AD. for crack indications of the pylons 1 and 2 [Docket No. FDA–2016–N–1111] side panels (upper section) at rib 8, in (l) Other FAA AD Provisions accordance with the Accomplishment The following provisions also apply to this Banned Devices; Proposal To Ban Instructions of Airbus Service Bulletin A300– AD: Electrical Stimulation Devices Used To 54–0075, Revision 04, dated May 26, 2015. (1) Alternative Methods of Compliance Treat Self-Injurious or Aggressive (AMOCs): The Manager, International Behavior; Extension of Comment (h) Crack Confirmation Branch, ANM–116, FAA, has the authority to Period If any crack indication is found during the approve AMOCs for this AD, if requested inspection required by paragraph (g) of this using the procedures found in 14 CFR 39.19. AGENCY: Food and Drug Administration, AD: Before further flight, do a high frequency In accordance with 14 CFR 39.19, send your HHS. eddy current (HFEC) inspection to confirm request to your principal inspector or local the crack, in accordance with the Flight Standards District Office, as Proposed rule; extension of ACTION: Accomplishment Instructions of Airbus appropriate. If sending information directly comment period. Service Bulletin A300–54–0075, Revision 04, to the International Branch, send it to ATTN: dated May 26, 2015. Dan Rodina, Aerospace Engineer, SUMMARY: The Food and Drug International Branch, ANM–116, Transport Administration (FDA) is extending the (i) Follow-On Actions for No Crack/ Airplane Directorate, FAA, 1601 Lind comment period for the proposed rule Indication Avenue SW., Renton, WA 98057–3356; that appeared in the Federal Register of If the inspection required by paragraph (g) telephone 425–227–2125; fax 425–227–1149. April 25, 2016. In the proposed rule, of this AD reveals no crack indication, or if Information may be emailed to: 9-ANM-116- the HFEC inspection specified by paragraph FDA requested comments for a ban on AMOC-REQUESTS@faa.gov. Before using (h) of this AD confirms no crack: Do the any approved AMOC, notify your appropriate electrical stimulation devices (ESDs) actions specified in either paragraph (i)(1) or principal inspector, or lacking a principal used for self-injurious or aggressive (i)(2) of this AD. inspector, the manager of the local flight behavior (SIB or AB). The Agency is (1) Repeat the inspection required by standards district office/certificate holding taking this action in response to paragraph (g) of this AD at the applicable district office. The AMOC approval letter requests for an extension to allow time specified in Airbus Service Bulletin must specifically reference this AD. interested persons additional time to A300–54–0075, Revision 04, dated May 26, (2) Contacting the Manufacturer: For any submit comments. 2015. requirement in this AD to obtain corrective (2) At the applicable time specified in actions from a manufacturer, the action must DATES: FDA is extending the comment Airbus Service Bulletin A300–54–0081, be accomplished using a method approved period on the proposed rule published dated August 11, 1993: Modify the pylons, in by the Manager, International Branch, ANM– April 25, 2016 (81 FR 24386). Submit sradovich on DSK3TPTVN1PROD with PROPOSALS accordance with Airbus Service Bulletin 116, Transport Airplane Directorate, FAA; or either electronic or written comments 300–54–0081, dated August 11, 1993. the EASA; or Airbus’s EASA DOA. If by July 25, 2016. Thereafter, repeat the HFEC inspection approved by the DOA, the approval must ADDRESSES: You may submit comments specified in paragraph (h) of this AD at the include the DOA-authorized signature. applicable interval specified in Airbus as follows: Service Bulletin A300–54–0075, Revision 04, (m) Related Information Electronic Submissions dated May 26, 2015, and repair any crack (1) Refer to Mandatory Continuing before further flight using a method approved Airworthiness Information (MCAI) EASA Submit electronic comments in the by the Manager, International Branch, ANM– Airworthiness Directive 2015–0201, dated following way: VerDate Sep<11>2014 16:06 May 20, 2016 Jkt 238001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\23MYP1.SGM 23MYP1

Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Proposed Rules 32259 • Federal eRulemaking Portal: http:// Agency will review this copy, including Dated: May 17, 2016. www.regulations.gov. Follow the the claimed confidential information, in Leslie Kux, instructions for submitting comments. its consideration of comments. The Associate Commissioner for Policy. Comments submitted electronically, second copy, which will have the [FR Doc. 2016–12026 Filed 5–20–16; 8:45 am] including attachments, to http:// claimed confidential information BILLING CODE 4164–01–P www.regulations.gov will be posted to redacted/blacked out, will be available the docket unchanged. Because your for public viewing and posted on http:// comment will be made public, you are www.regulations.gov. Submit both solely responsible for ensuring that your DEPARTMENT OF THE INTERIOR copies to the Division of Dockets comment does not include any Management. If you do not wish your Bureau of Ocean Energy Management confidential information that you or a name and contact information to be third party may not wish to be posted, made publicly available, you can 30 CFR Part 550 such as medical information, your or provide this information on the cover anyone else’s Social Security number, or sheet and not in the body of your [Docket ID: BOEM–2013–0081] confidential business information, such comments and you must identify this as a manufacturing process. Please note RIN 1010–AD82 information as ‘‘confidential.’’ Any that if you include your name, contact information marked as ‘‘confidential’’ Air Quality Control, Reporting, and information, or other information that will not be disclosed except in Compliance identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be applicable disclosure law. For more AGENCY: Bureau of Ocean Energy posted on http://www.regulations.gov. information about FDA’s posting of Management (BOEM), Interior. • If you want to submit a comment ACTION: Proposed rule; notice of comments to public dockets, see 80 FR with confidential information that you extension of public comment period. 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ public, submit the comment as a SUMMARY: BOEM is extending the public regulatoryinformation/dockets/ written/paper submission and in the comment period to submit comments on default.htm. manner detailed (see ‘‘Written/Paper the proposed rule entitled ‘‘Air Quality Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to Control, Reporting, and Compliance,’’ read background documents or the which was published in the Federal Written/Paper Submissions electronic and written/paper comments Register on April 5, 2016. The original Submit written/paper submissions as received, go to http:// public comment period to submit follows: www.regulations.gov and insert the comments on this rulemaking would • Mail/Hand delivery/Courier (for docket number, found in brackets in the have ended on June 6, 2016. However, written/paper submissions): Division of heading of this document, into the BOEM has received public comments Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts requesting an extension of the comment and Drug Administration, 5630 Fishers and/or go to the Division of Dockets period. BOEM has reviewed the Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. extension requests and has determined • For written/paper comments 1061, Rockville, MD 20852. that a 14-day comment period extension submitted to the Division of Dockets to June 20, 2016, is appropriate. The Management, FDA will post your FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and proposed rule specified a separate, comment, as well as any attachments, shorter period to submit comments to except for information submitted, Radiological Health, Food and Drug Administration, 10903 New Hampshire the Office of Management and Budget marked and identified, as confidential, on the information collection (IC) if submitted as detailed in Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993–0002, 301–796–6527. burden in this rulemaking. That ‘‘Instructions.’’ comment period ended on May 5, 2016, Instructions: All submissions received SUPPLEMENTARY INFORMATION: In the and will not be extended. must include the Docket No. FDA– Federal Register of April 25, 2016, FDA 2016–N–1111 for ‘‘Proposal to Ban DATES: The comment period for published a proposed rule with a 30-day comments on the substance of the Electrical Stimulation Devices Used to comment period to request comments Treat Self-Injurious or Aggressive proposed rule published on April 5, on a proposal to ban ESDs used for SIB 2016 (81 FR 19717), has been extended. Behavior.’’ Received comments will be or AB. Comments on the proposed ban placed in the docket and, except for Written comments must be received by will inform FDA’s rulemaking. the extended due date of June 20, 2016. those submitted as ‘‘Confidential Submissions,’’ publicly viewable at The Agency has received requests for BOEM may not fully consider comments http://www.regulations.gov or at the a 60-day extension of the comment received after this date. Division of Dockets Management period for the proposed rule. Each ADDRESSES: You may submit comments between 9 a.m. and 4 p.m., Monday request conveyed concern that the identified by the number 1010–AD82, through Friday. current 30-day comment period does by any of the following methods: • Confidential Submissions—To not allow sufficient time to develop a • Federal rulemaking portal: http:// submit a comment with confidential meaningful or thoughtful response to www.regulations.gov. Follow the information that you do not wish to be the proposed rule. instructions for submitting comments. sradovich on DSK3TPTVN1PROD with PROPOSALS made publicly available, submit your FDA has considered the requests and • Mail: Department of the Interior, comments only as a written/paper is extending the comment period for the Bureau of Ocean Energy Management, submission. You should submit two proposed rule for 60 days, until July 25, Office of Policy, Regulation and copies total. One copy will include the 2016. The Agency believes that a 60-day Analysis, Attention: Peter Meffert, information you claim to be confidential extension allows adequate time for 45600 Woodland Road, Sterling, with a heading or cover note that states interested persons to submit comments Virginia 20166. ‘‘THIS DOCUMENT CONTAINS without significantly delaying • Hand delivery: Front Desk, CONFIDENTIAL INFORMATION.’’ The rulemaking on this important issue. Department of the Interior, Bureau of VerDate Sep<11>2014 16:06 May 20, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\23MYP1.SGM 23MYP1


Document Created: 2018-02-07 15:07:20
Document Modified: 2018-02-07 15:07:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule; extension of comment period.
DatesFDA 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.
ContactRebecca 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.
FR Citation81 FR 32258 
CFR Citation21 CFR 882
21 CFR 895
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