Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Extension of Comment Period, 32258-32259 [2016-12026]

Download as PDF 32258 Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Proposed Rules (a) Comments Due Date We must receive comments by July 7, 2016. (b) Affected ADs None. (c) Applicability This AD applies to Airbus Model A300B4– 203 and A300B4–2C airplanes, certificated in any category, manufacturer serial numbers 210, 212, 218, 220, 227, 234, 235, 236, 239, 247, 255, 256, 259, 261, 274, 277, 292, 299, and 302. (d) Subject Air Transport Association (ATA) of America Code 54, Nacelles/Pylons. (e) Reason This AD was prompted by cracks found on pylon side panels (upper section) at rib 8. We are proposing this AD to detect and correct cracking of the pylon side panels. Such cracking could result in pylon structural failure and in-flight loss of an engine. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Detailed Inspection of Pylons and Corrections At the applicable time specified in Airbus Service Bulletin A300–54–0075, Revision 04, dated May 26, 2015: Do a detailed inspection for crack indications of the pylons 1 and 2 side panels (upper section) at rib 8, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300– 54–0075, Revision 04, dated May 26, 2015. sradovich on DSK3TPTVN1PROD with PROPOSALS (h) Crack Confirmation If any crack indication is found during the inspection required by paragraph (g) of this AD: Before further flight, do a high frequency eddy current (HFEC) inspection to confirm the crack, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300–54–0075, Revision 04, dated May 26, 2015. (i) Follow-On Actions for No Crack/ Indication If the inspection required by paragraph (g) of this AD reveals no crack indication, or if the HFEC inspection specified by paragraph (h) of this AD confirms no crack: Do the actions specified in either paragraph (i)(1) or (i)(2) of this AD. (1) Repeat the inspection required by paragraph (g) of this AD at the applicable time specified in Airbus Service Bulletin A300–54–0075, Revision 04, dated May 26, 2015. (2) At the applicable time specified in Airbus Service Bulletin A300–54–0081, dated August 11, 1993: Modify the pylons, in accordance with Airbus Service Bulletin 300–54–0081, dated August 11, 1993. Thereafter, repeat the HFEC inspection specified in paragraph (h) of this AD at the applicable interval specified in Airbus Service Bulletin A300–54–0075, Revision 04, dated May 26, 2015, and repair any crack before further flight using a method approved by the Manager, International Branch, ANM– VerDate Sep<11>2014 16:06 May 20, 2016 Jkt 238001 116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus’s EASA Design Organization Approval (DOA). (j) Follow-On Actions for Crack Findings If any crack is confirmed during the inspection required by paragraph (h) of this AD, repair before further flight using a method approved by the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or EASA; or Airbus’s EASA DOA. (k) Credit for Previous Actions This paragraph provides credit for actions required by paragraphs (g), (h), (i), and (j) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraphs (k)(1) through (k)(4) of this AD. (1) Airbus Service Bulletin A300–54–0075, dated August 11, 1993, which was incorporated by referenced in AD 2010–06– 04, Amendment 39–16228 (75 FR 11428, March 11, 2010); corrected May 4, 2010 (75 FR 23572). (2) Airbus Service Bulletin A300–54–0075, Revision 01, dated November 9, 2007, which is not incorporated by reference in this AD. (3) Airbus Service Bulletin A300–54–0075, Revision 02, dated June 26, 2008, which is not incorporated by reference in this AD. (4) Airbus Service Bulletin A300–54–0075, Revision 03, dated March 27, 2013, which is not incorporated by reference in this AD. (l) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–2125; fax 425–227–1149. Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the EASA; or Airbus’s EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature. (m) Related Information (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015–0201, dated PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 October 7, 2015, for related information. This MCAI may be found in the AD docket on the Internet at https://www.regulations.gov by searching for and locating Docket No. FAA– 2016–6671. (2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email account.airworth-eas@ airbus.com; Internet https://www.airbus.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. Issued in Renton, Washington, on May 11, 2016. Suzanne Masterson, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2016–11681 Filed 5–20–16; 8:45 am] BILLING CODE 4910–13–P 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. Proposed rule; extension of comment period. ACTION: 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\23MYP1.SGM 23MYP1 Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Proposed Rules sradovich on DSK3TPTVN1PROD with PROPOSALS • 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): 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 https://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 VerDate Sep<11>2014 16:06 May 20, 2016 Jkt 238001 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 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: https://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 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 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. 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. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 32259 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 DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management 30 CFR Part 550 [Docket ID: BOEM–2013–0081] RIN 1010–AD82 Air Quality Control, Reporting, and Compliance Bureau of Ocean Energy Management (BOEM), Interior. ACTION: Proposed rule; notice of extension of public comment period. AGENCY: BOEM is extending the public comment period to submit comments on the proposed rule entitled ‘‘Air Quality Control, Reporting, and Compliance,’’ which was published in the Federal Register on April 5, 2016. The original public comment period to submit comments on this rulemaking would have ended on June 6, 2016. However, BOEM has received public comments requesting an extension of the comment period. BOEM has reviewed the extension requests and has determined that a 14-day comment period extension to June 20, 2016, is appropriate. The proposed rule specified a separate, shorter period to submit comments to the Office of Management and Budget on the information collection (IC) burden in this rulemaking. That comment period ended on May 5, 2016, and will not be extended. DATES: The comment period for comments on the substance of the proposed rule published on April 5, 2016 (81 FR 19717), has been extended. Written comments must be received by the extended due date of June 20, 2016. BOEM may not fully consider comments received after this date. ADDRESSES: You may submit comments identified by the number 1010–AD82, by any of the following methods: • Federal rulemaking portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Department of the Interior, Bureau of Ocean Energy Management, Office of Policy, Regulation and Analysis, Attention: Peter Meffert, 45600 Woodland Road, Sterling, Virginia 20166. • Hand delivery: Front Desk, Department of the Interior, Bureau of SUMMARY: E:\FR\FM\23MYP1.SGM 23MYP1

Agencies

[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.

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

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: 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): 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 https://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 https://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: https://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 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 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
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