[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Rules and Regulations]
[Pages 70955-70958]
[FR Doc No: 2020-24626]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-1019; Product Identifier 2018-SW-011-AD; Amendment
39-21264; AD 2020-20-08]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Airbus Helicopters Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and
EC225LP helicopters. This AD requires, depending on helicopter
configuration, installing skived polytetrafluoroethylene tape (PTFE
tape) or removing PTFE tape and replacing window seals. This AD also
prohibits the installation of a jettisonable cabin window unless the
applicable requirements are accomplished. This AD was prompted by a
report of excessive friction between the window seal and the helicopter
airframe. The actions of this AD are intended to address an unsafe
condition on these products.

DATES: This AD is effective December 11, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of December 11,
2020.

ADDRESSES: For service information identified in this final rule,
contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html. You
may view this referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
1019.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
1019; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Union Aviation Safety Agency (EASA) AD, any
service information that is incorporated by reference, any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, AD Program Manager,
Operational Safety Branch, Airworthiness Products Section, General
Aviation and Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Airbus Helicopters
Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and EC225LP
helicopters. The NPRM published in the Federal Register on January 6,
2020 (85 FR 469). For all of the specified helicopter models without
Modification (MOD) 332P087140.00 installed, the NPRM proposed to
require installing PTFE tape to each jettisonable cabin window frame.
For some of the specified helicopter models with MOD 332P087140.00
installed, the NPRM proposed to require removing the PTFE tape, if
installed, from each jettisonable cabin window and replacing each VIP
jettisonable cabin window polychloroprene seal with a silicone seal.
The NPRM also proposed to prohibit the installation of a jettisonable

cabin window unless the applicable required actions were accomplished.
    The NPRM was prompted by EASA AD No. 2018-0039, dated February 9,
2018, and corrected March 7, 2018 (EASA AD 2018-0039), issued by EASA,
which is the Technical Agent for the Member States of the European
Union, to correct an unsafe condition for Airbus Helicopters (formerly
Eurocopter, Eurocopter France, Aerospatiale) Model AS 332 C, AS 332 C1,
AS 332 L, AS 332 L1, AS 332 L2, and EC 225 LP helicopters. EASA advises
of an emergency exit window that required excessive pushing force to
jettison. According to EASA, an investigation revealed the window seal
was in good condition with no indication of paint contamination or of
hardening. EASA advises that the root cause of the incident was
excessive friction between the window seal and the airframe. EASA
further advises that helicopters with VIP jettisonable cabin windows,
which corresponds to MOD 332P087140.00, with PTFE skived film
installed, require greater force to jettison than standard jettisonable
cabin windows with PTFE skived film installed due to the thickness of
the VIP jettisonable cabin windows.
    EASA states if this condition is not corrected, it could prevent
the window from jettisoning, subsequently affecting the evacuation of
passengers during an emergency situation. To address this unsafe
condition, EASA AD 2018-0039 requires installing PTFE skived film on
the window frames of helicopters with standard jettisonable cabin
windows, and removing PTFE skived film and replacing polychloroprene
seals with silicone seals on the window frames of helicopters with VIP
jettisonable cabin windows.

Actions Since the NPRM Was Issued

    After the NPRM was issued, EASA issued AD No. 2020-0061, dated
March 17, 2020 (EASA AD 2020-0061), for Airbus Helicopters Model AS 332
L2 helicopters without MOD 07 28630, 332P087142.00, or 332P087140.00
installed and Model EC 225 LP helicopters without MOD 07 28370,
332P087140.00, 332P087142.00, 332P087142.03, 332P087142.06,
332A087149.00, or 332A087149.03 installed. EASA AD 2020-0061 requires
modifying the window jettisoning system by removing the PTFE skived
film between the window seal and the helicopter airframe and installing
silicone seals. The FAA plans to publish a separate rulemaking to
address the unsafe condition in EASA AD 2020-0061. Further, EASA AD
2020-0061 advises that it is expected that Airbus Helicopters will also
develop similar MODs for helicopters affected by EASA AD 2018-0039,
which is the subject of this AD action. Accordingly, certain
configurations of Model AS332L2 and EC225LP helicopters have been
removed from the applicability and this Final Rule is an interim
action.
    Also after the NPRM was issued, EASA issued EASA AD No. 2018-
0039R1, dated September 25, 2020 (EASA AD 2018-0039R1), to revise EASA
AD 2018-0039. EASA AD 2018-0039R1 advises that Airbus Helicopters
developed various modifications and corresponding Alert Service
Bulletins (ASBs) for the window jettison system, which restore the
window jettison system's performance to the approved design standard.
Accordingly, EASA AD 2018-0039R1 excludes certain model helicopters
with the modifications installed from the applicability.
    Additionally, after the NPRM was published, Airbus Helicopters
revised the service information listed in the NPRM.
    Accordingly, the applicability, required actions, and the related
service information have been updated in this Final Rule to reflect the
updated revisions. These changes are consistent with the intent of the
proposals in NPRM and do not increase the economic burden on any
operator nor increase the scope of this AD.

Comments

    The FAA gave the public the opportunity to participate in
developing this AD, but the FAA did not receive any comments on the
NPRM.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all information provided by EASA and determining the unsafe
condition exists and is likely to exist or develop on other helicopters
of these same type designs and that air safety and the public interest
require adopting the AD requirements as proposed except for reducing
the applicability, updating the service information, and updating the
Cost of Compliance section due to an increase in the number of
registered helicopters. These changes are consistent with the intent of
the proposals in the NPRM and will neither increase the economic burden
on any operator nor increase the scope of this AD.

Interim Action

    The FAA considers this AD interim action. The design approval
holder is currently developing a modification that will address the
unsafe condition identified in this AD. Once this modification is
developed, approved, and available, the FAA might consider additional
rulemaking.

Differences Between This AD and the EASA AD

    The EASA AD allows compliance within 250 hours time-in-service
(TIS) for helicopters that do not operate over water. This AD requires
compliance within 110 hours TIS for all helicopters, regardless of
where they operate.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters ASB No. AS332-05.01.05 for
Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters, and
ASB No. EC225-05A046 for Model EC225LP helicopters, both Revision 1 and
dated February 8, 2018. This service information applies to helicopters
without VIP jettisonable cabin window MOD 332P087140.00 installed. This
service information specifies applying PTFE film to the jettisonable
cabin window frames. The FAA also reviewed ASB No. AS332-05.01.05 for
Model AS332C, AS332C1, AS332L, AS332L1, and AS332L2 helicopters, and
ASB No. EC225-05A046 for Model EC225LP helicopters, Revision 2, dated
April 10, 2019, and Revision 3, dated February 10, 2020. Revisions 2
and 3 contain the same procedures as Revision 1, except Revisions 2 and
3 cancel compliance for helicopters with certain modifications. The FAA
reviewed Airbus Helicopters ASB No. AS332-05.01.05, Revision 4, dated
September 23, 2020, which contains exceptions for compliance for
certain helicopters with POST MOD 0728630, 332P087142.09, or
332P087142.12.
    The FAA reviewed Airbus Helicopters ASB No. AS332-56.90.13 for
Model AS332L2 helicopters, and ASB No. EC225-56C012 for Model EC225LP
helicopters, both Revision 0 and dated February 2, 2018. This service
information applies to helicopters with VIP jettisonable cabin window
MOD 332P087140.00 installed. This service information specifies
removing the PTFE film, if installed between the VIP cabin window frame
and seal, from the VIP jettisonable cabin windows, and replacing the
VIP jettisonable cabin window polychloroprene seals with silicone
seals.
    This service information is reasonably available because the
interested parties

have access to it through their normal course of business or by the
means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Airbus Helicopters Information Notice No. 3012-I-
05, Revision 0, dated March 8, 2016, for Model AS332C, AS332C1, AS332L,
AS332L1, AS332L2, and EC225LP helicopters. This service information
provides additional information pertaining to the jettisonable window
system and the application of PTFE film to the jettisonable window
frames. This service information also advises that VIP windows are
thicker and stiffer than serial design windows and are subsequently
more difficult to jettison than standard cabin windows.
    The FAA reviewed Airbus Helicopters ASB No. AS332-56.90.14,
Revision 0, dated April 10, 2019, Airbus Helicopters ASB No. AS332-
56.00.16, Revision 0, dated February 10, 2020. The FAA also reviewed
Airbus Helicopters ASB No. AS332-56.00.18, Revision 0, Airbus
Helicopters ASB No. AS332-56.00.20, Revision 0, and Airbus Helicopters
ASB No. AS332-56.00.21, Revision 0, all dated September 23, 2020. The
FAA reviewed Airbus Helicopters ASB No. EC225-56A013, Revision 1,
Airbus Helicopters ASB No. EC225-56A015, Revision 0, Airbus Helicopters
ASB No. EC225-56A016, Revision 0, and Airbus Helicopters ASB No. EC225-
56A017, Revision 0, all dated February 10, 2020. This service
information provides additional information pertaining to the
jettisonable window system and the application of PTFE film to the
jettisonable window frames.

Costs of Compliance

    The FAA estimates that this AD affects approximately 39 helicopters
of U.S. Registry. The FAA estimates that operators may incur the
following costs in order to comply with this AD. Labor costs are
estimated at $85 per work-hour.
    Depending on your model helicopter and configuration, installing
PTFE tape takes about 8 work-hours and parts cost about $92, for an
estimated cost of $772 per helicopter and approximately $30,108 for the
U.S. fleet.
    There are no costs of compliance with removing the PTFE tape and
replacing the seals because there are no helicopters with a serial
number identified by Airbus Helicopters with MOD 332P087140.00
installed on the U.S. Registry.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2020-20-08 Airbus Helicopters: Amendment 39-21264; Docket No. FAA-
2019-1019; Product Identifier 2018-SW-011-AD.

(a) Applicability

    This Airworthiness Directive (AD) applies to Airbus Helicopters
Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and EC225LP
helicopters, certificated in any category, except:
    (1) Airbus Helicopters Model AS332C, AS332C1, AS332L, and
AS332L1 helicopters with Modification (MOD) 07 28630, MOD
332P087142.09, or MOD 332P087142.12 installed,
    (2) Airbus Helicopters Model AS332L2 helicopters with MOD 07
28630 or 332P087142.00 installed, and
    (3) Airbus Helicopters Model EC225LP helicopters with MOD 07
28370, 332A087149.00, 332A087149.03, 332P087142.00, 332P087142.03,
or 332P087142.06 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as excessive friction
between the jettisonable cabin window and the airframe. This
condition could result in the window failing to jettison, preventing
occupants from exiting the helicopter during an emergency.

(c) Effective Date

    This AD becomes effective December 11, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 110 hours time-in-service:
    (1) For Model AS332C, AS332C1, AS332L, and AS332L1 helicopters;
and Model AS332L2 and EC225LP helicopters without MOD 332P087140.00
installed, install skived polytetrafluoroethylene tape (PTFE tape)
to each jettisonable cabin window frame by following the
Accomplishment Instructions, paragraph 3.B.2., of Airbus Helicopters
Alert Service Bulletin (ASB) No. AS332-05.01.05 or ASB No. EC225-
05A046, both Revision 1 and dated February 8, 2018; or both Revision
2, dated April 10, 2019; or both Revision 3, dated February 10,
2020, or ASB No. AS332-05.01.05, Revision 4, dated September 23,
2020, as applicable to your model helicopter.
    (2) For Model AS332L2 and EC225LP helicopters with MOD
332P087140.00 installed:
    (i) Remove the PTFE tape, if installed between the VIP cabin
window frame and seal, from each jettisonable cabin window by
following the Accomplishment Instructions, paragraph 3.B.2., of
Airbus Helicopters ASB No. AS332-56.90.13 (ASB AS332-56.90.13) or
ASB No. EC225-56C012 (ASB EC225-56C012), both Revision 0 and dated
February 8, 2018, as applicable to your model helicopter.
    (ii) Replace each VIP jettisonable cabin window polychloroprene
seal with a silicone seal by following the Accomplishment
Instructions, paragraph 3.B.3., of ASB AS332-56.90.13 or ASB EC225-
56C012, as applicable to your model helicopter.

    Note 1 to paragraph (e)(2): Airbus Helicopters has identified
the following

helicopters as having MOD 332P087140.00 installed: Model AS332L2
serial numbers (S/Ns) 2388, 2390, 2565, 2573, 2577, 2578, and 2587;
and Model EC225LP S/Ns 2600, 2623, 2645, 2650, 2651, 2653, 2659,
2684, 2693, 2711, 2712, 2719, 2753, 2756, 2767, 2796, 2926, 2961,
2973, 2974, 2979, 3002, 3003, and 3012.

    (3) After the effective date of this AD, do not install a
jettisonable cabin window unless you comply with the requirements of
paragraph (e)(1) or (e)(2) of this AD, as applicable to your model
helicopter and configuration.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Rotorcraft Standards Branch, FAA, may approve
AMOCs for this AD. Send your proposal to: Matt Fuller, AD Program
Manager, Operational Safety Branch, Airworthiness Products Section,
General Aviation and Rotorcraft Unit, 10101 Hillwood Pkwy., Fort
Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(g) Additional Information

    (1) Airbus Helicopters Information Notice No. 3012-I-05,
Revision 0, dated March 8, 2016, Airbus Helicopters ASB No. AS332-
56.90.14, Revision 0, dated April 10, 2019, Airbus Helicopters ASB
No. AS332-56.00.16, Revision 0, dated February 10, 2020, Airbus
Helicopters ASB No. AS332-56.00.18, Revision 0, Airbus Helicopters
ASB No. AS332-56.00.20, Revision 0, and Airbus Helicopters ASB No.
AS332-56.00.21, Revision 0, all dated September 23, 2020, Airbus
Helicopters ASB No. EC225-56A013, Revision 1, Airbus Helicopters ASB
No. EC225-56A015, Revision 0, Airbus Helicopters ASB No. EC225-
56A016, Revision 0, and Airbus Helicopters ASB No. EC225-56A017,
Revision 0, all dated February 10, 2020, which are not incorporated
by reference, contains additional information about the subject of
this AD. For service information identified in this AD, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html.
You may view the referenced service information at the FAA, Office
of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Union
Aviation Safety Agency (EASA) AD No. 2018-0039R1, dated September
25, 2020. You may view the EASA AD on the internet at https://www.regulations.gov in Docket No. FAA-2019-1019.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6320, Main Rotor
Gearbox.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Helicopters Alert Service Bulletin (ASB) No. AS332-
05.01.05, Revision 1, dated February 8, 2018.
    (ii) Airbus Helicopters ASB No. AS332-05.01.05, Revision 2,
dated April 10, 2019.
    (iii) Airbus Helicopters ASB No. AS332-05.01.05, Revision 3,
dated February 10, 2020.
    (iv) Airbus Helicopters ASB No. AS332-05.01.05, Revision 4,
dated September 23, 2020.
    (v) Airbus Helicopters ASB No. AS332-56.90.13, Revision 0, dated
February 8, 2018.
    (vi) Airbus Helicopters ASB No. EC225-05A046, Revision 1, dated
February 8, 2018.
    (vii) Airbus Helicopters ASB No. EC225-05A046, Revision 2, dated
April 10, 2019.
    (viii) Airbus Helicopters ASB No. EC225-05A046, Revision 3,
dated February 10, 2020.
    (ix) Airbus Helicopters ASB No. EC225-56C012, Revision 0, dated
February 8, 2018.
    (3) For service information identified in this AD, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 2, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-24626 Filed 11-5-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69532-69535]
[FR Doc No: 2016-24234]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2896]

Public Meeting on Pre-Market Evaluation of Abuse-Deterrent
Properties of Opioid Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss scientific and technical issues relating to
formulation development and pre-market evaluation of opioid drug
products with abuse-deterrent properties. The meeting is intended to
give FDA the opportunity to discuss, and seek public input from
stakeholders on, the approach to testing FDA recommended in its draft
guidance ``General Principles for Evaluating the Abuse Deterrence of
Generic Solid Oral Opioid Drug Products.'' The meeting will also
provide an opportunity to discuss FDA's efforts to develop standardized
in vitro testing methodologies for evaluating the abuse deterrence of
opioid drug products. FDA is seeking input from all stakeholders,
including patients, health care providers, health care payers, the
pharmaceutical industry, patient advocates, academics, researchers, and
other government entities.
    FDA may hold one or more additional meetings in the future to
discuss the risk-benefit paradigm for opioid drug products to ensure
that FDA is appropriately considering the full public health impact of
prescription opioid drug products and the post-market impact (``real
world effects'') of abuse-deterrent opioid drug products.

DATES: The public meeting will be held on October 31, 2016, from 8:30
a.m. to 4:30 p.m. and November 1, 2016, from 8:30 a.m. to 4 p.m. The
meeting may be extended or end early depending on the level of public
participation. Individuals seeking to attend or to present at the
meeting must register by October 17, 2016. Please register here for the
meeting: http://www.cvent.com/d/wvq0sm/4W. Electronic or written
comments regarding scientific and technical issues relating to
formulation development and pre-market evaluation of abuse-deterrent
properties of opioid drug products will be accepted until December 1,
2016.

ADDRESSES: The public meeting will be held at College Park Marriott
Hotel and Conference Center, 3501 University Blvd. East, Hyattsville,
MD 20783.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     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-2896 for ``Public Meeting on Pre-Market Evaluation of Abuse-
Deterrent Properties of Opioid Drug Products.'' 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.
    FDA will post the agenda approximately 3 days before the public
meeting at: http://www.fda.gov/Drugs/NewsEvents/ucm509853.htm. FDA will
also post a link to the live Webcast of this public meeting on the day
of the public meeting.

FOR FURTHER INFORMATION CONTACT: Michelle Eby, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6184, Silver Spring, MD 20993, 301-796-
4714<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Background

    Prescription opioid analgesics are an important component of modern
pain management. Prescription opioid analgesic products such as
oxycodone, hydrocodone, and morphine, are widely prescribed for the
treatment of pain, and certain opioid drug products are also used in
opioid dependence treatment programs. When used properly, opioid drug
products can provide significant benefits for patients. Unfortunately,
misuse and abuse of opioid drug products is a serious public health
problem.
    When misused or abused, opioid drug products can cause serious
harm, including addiction, overdose, and death. According to the
Centers for Disease Control and Prevention (CDC), prescription opioid
drug products were involved in over 14,000 deaths in 2014.\1\ FDA is
determined to help defeat this epidemic through an adaptive, science-
based approach.
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    \1\ Wide-Ranging Online Data for Epidemiologic Research
(WONDER), National Center for Health Statistics; available at http://wonder.cdc.gov.
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    In February 2016, FDA announced a comprehensive action plan to take
concrete steps toward reducing the impact of opioid abuse on families
and communities.\2\ As part of this plan, FDA strongly supports the
development of, and transition to use of, opioid drug products with
meaningful abuse-deterrent formulations. FDA has taken and is
continuing to take steps to incentivize and support the development of
opioid drug products with progressively better abuse-deterrent
properties. These steps include working with individual sponsors on
promising abuse-deterrent technologies, publishing guidance on the
evaluation and labeling of abuse-deterrent drug products, and
conducting and supporting research in developing appropriate pre-market
testing methodologies for evaluating the abuse deterrence of both
innovator and generic drugs.
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    \2\ http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm.
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    FDA believes abuse-deterrent technologies can and will improve
substantially and can make a real impact in the fight against
prescription opioid abuse. FDA hopes that as the market transitions to
abuse-deterrent formulations, abuse rates will decrease and the most
significant consequences of that abuse (addiction, overdose, and death)
will diminish. To that end, fostering the development, marketing, and
iterative improvement of abuse-deterrent formulations of opioid drug
products, including generic opioid drug products, is a top priority. It
is important that generic versions of opioids that reference approved
opioids whose labeling describes abuse-deterrent properties are
available to help ensure widespread access to safe and effective
analgesics for patients who need them and to accelerate the prescribing
of abuse-deterrent opioids. Such generic opioids should be no less
abuse-deterrent than the opioids they reference; otherwise opioid
abusers could preferentially seek out and abuse easier-to-abuse
generics.
    FDA's work to date to support the development, marketing, and
iterative improvement of abuse-deterrent formulations includes:
     Holding a public meeting in October 2014 to discuss the
``Development and Regulation of Abuse-Deterrent Formulations of Opioid
Medications;''
     Issuing a final guidance in April 2015 on the ``Abuse-
Deterrent Opioids--Evaluation and Labeling.'' This guidance explains
FDA's current thinking about the studies, both pre- and post-marketing,
that should be conducted to demonstrate that a given formulation for
which a new drug application (NDA) is submitted has abuse-deterrent
properties. It also makes recommendations about how those studies
should be performed and evaluated and what information about a
product's abuse-deterrent properties should be included in labeling;
     To date, approving seven opioid analgesic drug products
with labeling describing abuse-deterrent properties \3\ consistent with
the final guidance on evaluation and labeling of abuse-deterrent
opioids;
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    \3\ A list of opioid medications with FDA-approved labeling
describing abuse-deterrent properties can be found at http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm514939.htm.
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     Seeking guidance from outside experts in the fields of
pain management and drug abuse. For example, FDA has asked the National
Academies of Sciences, Engineering, and Medicine to help develop a
framework for opioid drug product review, approval, and monitoring that
balances individual needs for pain control with the risk of addiction,
as well as the broader public health consequences of opioid drug
product misuse and abuse;
     Conducting or supporting research on opioid drug product
formulations designed to deter abuse. This includes development of in
vitro testing methodologies to assess purportedly abuse-deterrent
formulations; and
     Issuing a draft guidance on the ``General Principles for
Evaluating Abuse Deterrence of Generic Solid Oral Opioid Drug
Products.''
    In the notice of availability for the draft guidance on evaluating
abuse deterrence of generic opioid drug products, FDA announced its
intent to hold a public meeting following the close of the comment
period to discuss further the pre-market evaluation of the abuse
deterrence of generic opioid drug products and related issues, as
appropriate. FDA is opening a docket and holding this public meeting to
further discuss pre-market evaluation of the abuse deterrence of
generic opioid drug products and the development of standardized in
vitro testing methodologies for evaluating the abuse deterrence of
opioid drug products.
    Day 1 of this meeting will focus on scientific and technical issues
related to the pre-market evaluation of the abuse deterrence of generic
opioid drug products. It is important to have a viable pathway for
approval of generic abuse-deterrent opioid drug products to further
FDA's goal to transition to abuse-deterrent formulations as FDA looks
forward to a future in which all or substantially all opioid
medications are less susceptible to abuse than the formulations on the
market today. The availability of generic versions of opioid drug
products that reference listed drugs whose labeling describes abuse-
deterrent properties can help to ensure access to safe and effective,
and affordable, opioid analgesics for patients who need them.
    Day 2 will focus on FDA's efforts to develop standardized in vitro
testing methodologies for evaluating the abuse deterrence of opioid
drug products. In vitro testing should, to the greatest extent
possible, provide information sufficient to fully characterize a drug
product's abuse-deterrent properties, including the degree of effort
required to bypass or defeat those properties. In vitro studies should
assess each potential route of abuse (including ingestion, injection,
insufflation, and smoking) starting with simple and gentle mechanical
and chemical manipulations progressing to complex and more destructive
manipulations until a drug product's abuse-deterrent properties are
defeated or compromised. To be sufficiently comprehensive, in vitro
testing should address both the mechanisms by which abusers can be
expected to attempt to deliberately overcome the abuse-deterrent
properties of the product as well as the ways that patients may alter
the formulation (intentionally or unintentionally) that

change the rate or amount of drug released.

A. Day 1: FDA's Evaluation of Generic Abuse-Deterrent Opioids

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) (FD&C Act) permits any person to submit to the FDA an
abbreviated new drug application (ANDA) to seek approval to market a
generic version of a previously approved drug product. To obtain
approval, an ANDA applicant is not required to provide independent
evidence of the safety and effectiveness of the proposed generic drug.
Instead, the applicant relies on FDA's finding that a previously
approved drug product, i.e, the reference listed drug (RLD), is safe
and effective, and must demonstrate, among other things, that the
proposed generic drug is the ``same'' as the RLD in certain ways and is
bioequivalent.
    For FDA to approve an ANDA, the Agency must find, among other
things, that the generic drug product has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and, with limited exceptions, labeling as the RLD,
is bioequivalent to its RLD, that the methods used in, or the
facilities and controls used for, the manufacture, processing, and
packing of the drug are adequate to assure and preserve its identity,
strength, quality, and purity, and that the inactive ingredients and
composition of the generic drug are not unsafe under the conditions of
use prescribed, recommended, or suggested in the labeling. See section
505(j)(2)(A) and (j)(4) of the FD&C Act.
    FDA classifies as ``therapeutically equivalent'' those products
that meet the following general criteria: (1) They are approved as safe
and effective; (2) they are pharmaceutical equivalents in that they
contain identical amounts of the same active ingredient(s) with the
same route of administration and dosage form and meet compendial or
other applicable standards of strength, quality, purity, and identity;
(3) they are bioequivalent; (4) they are adequately labeled; and (5)
they are manufactured in compliance with current good manufacturing
practices regulations. See FDA's ``Approved Drug Products with
Therapeutic Equivalence Evaluations'' (the Orange Book), Preface. FDA
believes that a product classified as therapeutically equivalent can be
substituted with the full expectation that the substituted product will
produce the same clinical effect and safety profile as the reference
product.
    If the RLD's labeling describes properties that are expected to
deter misuse or abuse then the potential ANDA applicant should evaluate
its proposed generic drug product in comparative in vitro studies and,
in some cases, in relevant pharmacokinetic or other studies to show
that it is no less abuse-deterrent than the RLD with respect to all
potential routes of abuse.\4\
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    \4\ FDA's current thinking regarding the labeling of opioids is
described in FDA's guidance for industry on ``Abuse-Deterrent
Opioids--Evaluation and Labeling'' (April 2015). Any data relating
to abuse-deterrent properties would be included in the DRUG ABUSE
AND DEPENDENCE section of product labeling, 9.2 Abuse.
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    It is important that generic versions of opioid drug products
referencing opioid drug products with FDA-approved labeling describing
abuse-deterrent properties are available to help ensure availability of
analgesics for patients who need them. FDA is interested in supporting
the submission of ANDAs for which the RLD is an opioid drug product
whose labeling describes abuse-deterrent properties and ensuring that
generic opioid drug products are no less abuse-deterrent than the RLD
in its efforts to combat the opioid epidemic.
    Topics for discussion during the open public comment period on Day
1 and by the panel:
     Based on any testing you have attempted to perform or
performed in accordance with the March 2016 draft guidance, are there
any aspects of the guidance that need clarification or improvement?
     Are there any characteristics of the currently approved
abuse-deterrent RLDs for which issuance of product specific guidance,
beyond what is described in FDA's March 2016 draft guidance, would
facilitate development of abuse-deterrent generic opioid drug products?
     Are there approaches or technologies for evaluating the
abuse deterrence of generic opioid drug products that were not included
in the March 2016 draft guidance that should be?
     What additional actions could FDA take to encourage the
submission of ANDAs that reference an opioid drug product whose
labeling describes abuse-deterrent properties?
     Are there potential consequences of the development and
introduction of abuse-deterrent opioid drug products that warrant
further consideration?

B. Day 2: Development of Standardized In Vitro Testing To Evaluate
Abuse Deterrence

    The Office of Pharmaceutical Quality (OPQ) will discuss its vision
for standardizing in vitro testing methodologies for evaluating
purportedly abuse-deterrent formulations of opioid drug products. OPQ
will also discuss the efforts being made to standardize in vitro
testing conditions to apply to future products and some of the
challenges being encountered. OPQ's Office of Testing and Research will
then provide an update on its testing of abuse-deterrent formulations,
including approaches being taken to simulate the ways individuals who
abuse opioids manipulate opioid drug products for purposes of abuse
(e.g., crushing, heating, dissolving). FDA recognizes that new
technologies for deterring abuse of oral opioid drug products are
rapidly evolving and is seeking public input on novel mechanisms and
approaches being considered so that it may further consider how testing
could be standardized.
    FDA intends to issue a general guidance describing FDA's
recommendations for standardized in vitro testing to evaluate purported
abuse-deterrent properties and considerations for a potential applicant
as it develops an abuse-deterrent formulation of an opioid drug
product. Building on the testing FDA has conducted and other available
information including public input, FDA may recommend common protocols
that incorporate standard test conditions, specified performance
standards, control formulations and provide a tiered approach for
determining when abuse-deterrent properties have been defeated and how
that information may be used during drug development and for other
relevant comparative situations. The guidance also may describe
lifecycle considerations (e.g., the need for testing abuse deterrence
throughout shelf life to determine if any product changes over time
affect abuse-deterrence performance) and provide additional guidance on
evaluating novel technological approaches used to deter abuse of oral
opioid drug products.
    Topics for discussion during the open public comment period on Day
2 and by the panel:
     What technical and quantitative issues should FDA consider
as it develops guidance to recommend standardization of in vitro
testing to evaluate the abuse deterrence of opioid drug product
formulations for various routes of abuse, including ingestion,
insufflation, injection, and smoking? For example, what should FDA
consider with respect to mechanical manipulations (e.g., equipment,
amount of effort, and time), chemical manipulations (e.g., solvent
choice and availability), particle size distribution,

and volume of solvent used for extraction?
     How can FDA standardize in vitro testing to help
substantiate appropriate and consistent product manufacture that
assures abuse deterrence at release and through a drug product's shelf
life?
     How can performance attributes measured by in vitro
testing be quantified and linked to their impact on abuse deterrence?
For example, discuss what amount of time delay in defeating an abuse-
deterrent property should be considered significant and the basis for
the recommendation.
     How can FDA build flexibility into standardized testing so
that it may be suitable for application to emerging technologies? Are
there any specific emerging technologies that might require new types
of testing?

II. Registration and Accommodations

    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public meeting
must register by close of business on October 17, 2016.
    If you need special accommodations because of a disability, please
contact La'Shaune Morant,<PHONE_NUMBER>, email<EMAIL_ADDRESS>no later than October 12, 2016.
    To register for the public meeting, please visit http://www.cvent.com/d/wvq0sm/4W (FDA has verified the Web address, but FDA is
not responsible for subsequent changes to the Web site after this
document publishes in the Federal Register) by October 17, 2016. Those
without Internet access may register by contacting La'Shaune Morant,
240-316-3206. Early registration is recommended because facilities are
limited and, therefore, FDA may limit the number of participants from
each organization. You will receive confirmation after you have
registered and been accepted or you will be notified if you are on a
waiting list. FDA may allow onsite registration if space is available.
If registration reaches maximum capacity, FDA will post a notice
closing registration at http://www.fda.gov/Drugs/NewsEvents/ucm509853.htm.
    Streaming Webcast of the Public Meeting: The meeting will also be
Webcast. Persons interested in viewing the Webcast must register online
by October 17, 2016. Early registration is recommended because Webcast
connections may be limited. Organizations are requested to register all
participants, but to view using one connection per location. A link to
the live Webcast will be available at http://www.fda.gov/Drugs/NewsEvents/ucm509853.htm on the day of the public meeting. A video
record of the public meeting will be available at http://www.fda.gov/Drugs/NewsEvents/ucm509853.htm following the meeting. FDA has verified
the Web site addresses, as of the date this document publishes in the
Federal Register, but Web sites are subject to change over time.
    Requests for Oral Presentations: If you wish to present at the
public meeting, you must register and indicate which topic(s) you wish
to address: approach to testing FDA recommended in its draft guidance
``General Principles for Evaluating the Abuse Deterrence of Generic
Solid Oral Opioid Drug Products,'' new technologies for deterring abuse
of oral opioid drug products, or standardization of in vitro testing
methodologies for evaluating purportedly abuse-deterrent formulations
of opioid drug products. This will help FDA organize the presentations.
FDA will do its best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation. Following the close of the registration, FDA will
determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin, and will select
and notify participants by October 24, 2016. All requests to make oral
presentations must be received by the close of registration, October
17, 2016. If you are selected, any presentation materials must be
emailed to Michelle Eby (see FOR FURTHER INFORMATION CONTACT) no later
than October 27, 2016. No commercial or promotional material will be
permitted to be presented or distributed at the public meeting.
    FDA is holding this public meeting to obtain information on
scientific and technical issues relating to formulation development and
pre-market evaluation of opioid drug products with abuse-deterrent
properties. In order to permit the widest possible opportunity for
public comment, FDA is soliciting either electronic or written comments
on all aspects of the public meeting topics. The deadline for
submitting comments related to this public meeting is December 1, 2016.
    Accommodations: Attendees are responsible for their own hotel
accommodations. Attendees making reservations at the College Park
Marriott Hotel and Conference Center, 3501 University Blvd. East,
Hyattsville, MD 20783, are eligible for a reduced rate of $231/night,
not including applicable taxes. To receive the reduced rate, please
reference ``FDA Opioid Drug Meeting'' if you make your reservation by
calling 1-800-676-6137, or book your reservation at http://www.marriott.com/meeting-event-hotels/group-corporate-travel/groupCorp.mi?resLinkData=FDA%20Opioid%20Drug%20Meeting%5Ewasum%60FDGFDGA%60231.00%60USD%60false%602%6010/30/16%6011/1/16%6010/12/16&app=resvlink&stop_mobi=yes.
    If you need special accommodations because of a disability, please
contact La'Shaune Morant,<PHONE_NUMBER><EMAIL_ADDRESS>no
later than October 12, 2016.

III. Transcript Request

    Transcripts of the meeting will be available for review at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20850, and on the Internet
at http://www.regulations.gov approximately 30 days after the meeting.
A transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov.

    Dated: September 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24234 Filed 10-5-16; 8:45 am]
BILLING CODE 4164-01-P