[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12952-12954]
[FR Doc No: 2021-04606]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0180]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Quantitative
Data on Tobacco Products and Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the generic clearance for the collection of
quantitative data on tobacco products and communications.

DATES: Submit either electronic or written comments on the collection
of information by May 4, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 4, 2021. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-0180 for ``Generic Clearance for the Collection of
Quantitative Data on Tobacco Products and Communications.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Generic Clearance for the Collection of Quantitative Data on Tobacco
Products and Communications

OMB Control Number 0910-0810--Extension

    To conduct educational and public information programs relating to
tobacco use as authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's Center for
Tobacco Products will conduct research and use a variety of media to
inform and educate the public, tobacco retailers, and health
professionals about the health risks of tobacco use, how to quit using
tobacco products, and FDA's role in regulating tobacco.
    To ensure that these educational and public information programs
have the highest potential to be received, understood, and accepted by
those for whom they are intended, the Center for Tobacco Products will
conduct research and develop health messages relating to the control
and prevention of disease. In conducting such research, FDA will use
quantitative methods (i.e., surveys, experimental studies) for studies
about tobacco products. These studies may be used to collect
information related to the formative pretesting of tobacco
communication messages and other materials directed at consumers. This
type of research involves: (1) Assessing audience knowledge, attitudes,
behaviors, and other characteristics for the purpose of determining the
need for and developing health messages, communication strategies, and
public information programs; (2) pretesting these health messages,
strategies, and program components while they are in developmental form
to assess audience comprehension, reactions, and perceptions; and (3)
adding to the regulatory science knowledge base. Quantitative studies
play an important role in exploring areas of research and gathering
information because they can be used to summarize a population of
interest on key variables or reveal systematic relationships between
variables.
    Formative pretesting is a staple of best practices in
communications research. Obtaining voluntary feedback from intended
audiences during the development of messages and materials is crucial
for the success of every communication program. The purpose of
obtaining information from formative pretesting is that it allows FDA
to improve materials and strategies while revisions are still
affordable and possible. Formative pretesting can also avoid
potentially expensive and dangerous unintended outcomes caused by
audiences interpreting messages in a way that was not intended by the
drafters. By maximizing the effectiveness of messages and strategies
for reaching targeted audiences, the frequency with which tobacco
communication messages need to be modified should be greatly reduced.
    The voluntary information collected will serve the primary purpose
of providing FDA information about the perceived effectiveness of
messages, advertisements, and materials in reaching and successfully
communicating with their intended audiences. Quantitative testing
messages and other materials with a sample of the target audience will
allow FDA to refine messages, advertisements, and materials, including
questionnaires or images, directed at consumers while the materials are
still in the developmental stage.
    In addition, quantitative information is needed by FDA to track
changes in response to policy and regulatory actions and to expand the
tobacco regulatory science base by providing information on behavior,
knowledge, and attitudes about tobacco products, including
postmarketing surveillance of tobacco products.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                              Number  of
                 Activity                     Number  of     responses per   Total annual           Average burden  per response            Total hours
                                              respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener..................................         485,580               1         485,580  0.083 (5 minutes)...........................          40,465
Self-Administered Surveys.................         133,728               1         133,728  0.33 (20 minutes)...........................          44,576
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................          85,041
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Number of respondents to be included in each new survey will vary,
depending on the nature of the material or message being tested and the
target audience. Table 1 provides examples of the types of activities
that may be administered and estimated burden levels during the 3-year
period. Time to read, review, or complete the activity is built into
the ``Average Burden per Response'' figures. Our estimated burden for
the information collection reflects an overall increase of 60,000 hours
and a corresponding increase of 461,808 responses. We attribute the
adjustment to an increase in the number of new quantitative studies
that are anticipated underneath this information collection during the
next 3 years (proposed extension).

    Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04606 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2007-0450]; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Delaware;

Open Burning

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Delaware.  This SIP revision pertains
to the amendments of Delaware’s open burning regulation.  This action
is being taken under the Clean Air Act (CAA).

DATES:  Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-

2007-0450 by one of the following methods:

A.    www.regulations.gov.  Follow the on-line instructions for
submitting comments.

B.    E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    Mail:  EPA-R03-OAR-2007-0450, Christopher Cripps, Acting Chief,
Air Quality Planning

Branch, Mailcode 3AP21, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.    Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2007-0450.  EPA's policy is that all comments received will
be included in the public docket without change, and

may be made available online at www.regulations.gov, including any
personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.  Do not submit
information that you consider to be CBI or otherwise protected through
www.regulations.gov or e-mail.  The www.regulations.gov website is an
(anonymous access( system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment.  If you send an e-mail comment directly to EPA without going
through  www.regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet.  If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit.  If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.  Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or

in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.  Copies of the State submittal
are available at the Delaware Department of Natural Resources &
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19901.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On May 2, 2007, the Delaware Department of Natural Resources and
Environmental Control (DNREC) submitted a revision to its SIP for
Regulation No. 1113 – Open Burning.  The SIP revision includes (1)
expanding the open burning ban from New Castle and Kent Counties to
statewide; (2) expanding the open burning ban from June 1 through August
31 in the current regulation to May 1 through September 30; and (3) to
clarify the prohibitions in the existing regulation and their
interaction with other applicable laws and regulations.

II.  Summary of SIP Revision

Delaware’s Open Burning Regulation, Regulation No. 1113, applies to
all open burning activities in the State of Delaware which includes the
counties of New Castle, Kent and Sussex.  The following are the
prohibitions and provisions of open burning activities in the State of
Delaware during May 1 through September 30:

The regulation prohibits leaf and refuse burning statewide.

The regulation allows the following without permission from DNREC:
domestic burning of branches and limbs from trees and shrubs statewide;
and agricultural burning statewide to cultivate and/or prepare soil for
the production of crops or the support of livestock.

 The regulation requires permission from DNREC for the following types
of open burning:  prescribed burning for conservation practices,
wildlife habitat management, or plant, pest or disease control; and
burning of wooden buildings for fire fighting instruction conducted by
authorized fire companies.

Commercial operations are not permitted to burn for disposal, e.g.
burning of tree limbs, stumps as a result of land clearing, and
construction debris.

All allowable types of burning can be conducted between the hours of
8:00 am to 4:00 pm.  Approval can be obtained from DNREC to burn outside
of those hours for reasons of safety, smoke reduction or a more
efficient or complete burn.

The following types of burning are exempt from the regulation, and can
be conducted at any time:  cooking fires; recreational fires; ceremonial
fires; emergency signaling flares; backburning to suppress wildfires;
and fire fighting instruction conducted by the Delaware State Fire
School.

III.  Proposed Action

EPA is proposing to approve the Delaware SIP revision for Regulation No.
1113 – Open Burning submitted on May 2, 2007.  This regulation will
result in the control of volatile organic compound (VOC) and nitrogen
oxides (NOx) emissions by establishing rules for open burning activities
in the State of Delaware during the ozone season.  EPA is soliciting
public comments on the issues discussed in this document.  These
comments will be considered before taking final action.

IV.  Statutory and Executive Order Reviews

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a "significant regulatory action" and therefore
is not subject to review by the Office of

Management and Budget.  For this reason, this action is also not subject
to Executive Order 13211, "Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use"  (66 Fed. Reg.
28355 (May 22, 2001)).  This action merely proposes to approve state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this proposed rule will not have a significant economic
impact on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.).  Because this rule proposes to
approve pre-existing requirements under state law and does not impose
any additional enforceable duty beyond that required by state law, it
does not contain any unfunded mandate or significantly or uniquely

affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4).  This proposed rule also does not have a
substantial direct effect on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it have substantial direct effects
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, as specified in Executive Order 13132
(64 FR 43255, August 10, 1999), because it merely proposes to approve a
state rule implementing a Federal requirement, and does not alter the
relationship or the distribution of power and responsibilities
established in the Clean Air Act. This proposed rule also is not subject
to Executive Order 13045 (62 FR 19885, April 23, 1997), because it
approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for

the State to use voluntary consensus standards (VCS), EPA has no
authority to disapprove a SIP submission for failure to use VCS.  It
would thus be inconsistent with applicable law for EPA, when it reviews
a SIP submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.  As required by section 3 of
Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this
proposed rule, EPA has taken the necessary steps to eliminate drafting
errors and ambiguity, minimize potential litigation, and provide a clear
legal standard for affected conduct.  EPA has complied with Executive
Order 12630 (53 FR 8859, March 15, 1988) by examining the takings
implications of the rule in accordance with the (Attorney General(s
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings( issued under the executive order.

This proposed rule pertaining to Delaware’s Open Burning Regulation,
does not impose an information collection burden under the provisions of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

Authority: 42 U.S.C. 7401 et seq.

        /s/

___________________________           ____________________________

Dated:  June 12, 2007             	       Donald S. Welsh,

Regional Administrator,

                                                                 Region
III.

 PAGE  7


[Federal Register Volume 85, Number 28 (Tuesday, February 11, 2020)]
[Rules and Regulations]
[Pages 7653-7655]
[FR Doc No: 2020-02587]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 85, No. 28 / Tuesday, February 11, 2020 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0052; Product Identifier 2016-SW-081-AD; Amendment
39-21024; AD 2020-02-11]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Inc.
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2015-04-04
for Bell Helicopter Textron Inc. (Bell) Model 412 and 412EP
helicopters. AD 2015-04-04 required revising the Rotorcraft Flight
Manual (RFM) for your helicopter and installing a placard to limit
flights to visual flight rules (VFR) and prohibit night operations
because of failing inverters. This AD requires replacing the affected
inverter with a new inverter. This AD was prompted by numerous failures
of inverters. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective March 17, 2020.

ADDRESSES: For service information identified in this final rule,
contact Bell Helicopter Textron, Inc., P.O. Box 482, Fort Worth, TX
76101; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.bellcustomer.com. 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.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.govby searching for and locating Docket No. FAA-2017-
0052; 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 economic evaluation, any comments received, and other
information. The address for Docket Operations is Docket Operations,
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: Tim Beauregard, Aviation Safety
Engineer, DSCO Branch, AIR-7J0, 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 to supersede AD 2015-04-04, Amendment 39-18106 (80 FR 9594,
February 24, 2015) (``AD 2015-04-04''). AD 2015-04-04 applied to Bell
Model 412 and 412EP helicopters with a static inverter part number (P/
N) 412-375-079-101 or 412-375-079-103 with a serial number 29145 or
higher installed. The NPRM published in the Federal Register on August
2, 2018 (83 FR 37764). The NPRM was prompted by numerous failures of
inverters and a newly introduced improved inverter, which corrects the
unsafe condition. Bell determined the root causes of the failures were
an external connector that caused a short circuit inside inverter P/N
412-375-079-101 and components chafing because of variations in the
assembly process and packaging tolerances for inverter P/N 412-375-079-
103. Bell introduced an improved inverter, P/N 412-375-079-105, and
retrofit kits to replace inverter P/N 412-375-079-101 or 412-375-079-
103 on helicopters with serial numbers 33001 or higher. These
replacements and repairs correct the unsafe condition by providing 450
voltage amperes (VA) of total power instead of 500 VA, thereby reducing
the input power to the inverter. The NPRM proposed to require these
repairs and replacements. The FAA is issuing this AD to address the
unsafe condition on these products.

Comments

    After the NPRM was published, The FAA received comments from two
commenters, Bell and Leonardo Helicopters. The following presents the
comments received on the NPRM, and the FAA's response to each comment.
    Request: Bell and Leonardo Helicopters requested clarification as
to why the FAA did not indicate that the NPRM applied to helicopters
with static inverters that had a serial number 29145 or higher in the
NPRM's Applicability section. Leonardo Helicopters stated no evidence
exists that static inverters with a serial number lower than 29145 have
the unsafe condition described in the NPRM.
    FAA Response: The FAA agrees and has revised this AD to specify
that this AD only applies to static inverters with serial numbers 29145
or higher.
    Request: Bell requested the FAA allow inverter P/N 412-375-079-103
450 VA or P/N 412-375-079-101 450 VA to be replaced by inverter P/N
412-075-158-101 250 VA if the Electrical Load Analysis (ELA)
requirements are met per Bell Alert Service Bulletin 412-16-171, dated
March 22, 2016 (ASB 412-16-171).
    FAA Response: The FAA disagrees. ASB 412-16-171 does not have a
standard listed for how to conduct the ELA or the margins that may be
acceptable. Therefore, the FAA could not legally enforce such a
requirement.
    Request: Bell requested the FAA either increase the 25 hours time-
in-service (TIS) compliance time or add an alternate compliance date
because no additional failures have occurred since ASB 412-16-171 was
issued.
    FAA Response: The FAA disagrees. ASB 412-16-171 set a compliance
time no later than January 1, 2017. The FAA believes that 25 hours TIS
is appropriate given that three years have passed between the deadline
in ASB 412-16-171 and the publication of this final rule.
    Request: Bell requested that the FAA correct an error in the NPRM.
The NPRM stated that Bell introduced a new inverter and recommended
repairs that ``correct the unsafe condition by providing 250 VA of
total power instead of 500 VA, thereby reducing the input power to the
inverter.'' Bell stated that ``250 VA'' should be changed to ``450
VA.''
    FAA Response: The FAA agrees and has revised this AD to include the
requested change.
    Request: Bell stated that Bell Alert Service Bulletin 412-13-156,
dated

April 25, 2013 (ASB 412-13-156) related to P/N 412-375-079-101 only and
that inverter P/N 412-375-079-103 would eventually replace inverter P/N
412-375-079-101 but was not part of ASB 412-13-156's method of
compliance. Bell stated the NPRM did not match the ASB.
    FAA Response: The FAA disagrees because ASB 412-13-156's method of
compliance appears to include replacing inverter P/N 412-375-079-101
with inverter P/N 412-375-079-103. Paragraph 9 of ASB 412-13-156
states, ``Remove the affected inverter and replace with inverter P/N
412-375-079-103[.]''
    Request: Bell requested that the FAA add more information in the
Discussion paragraph regarding an alternative method of compliance
(AMOC) issued to AD 2015-04-04. Bell requested this information should
include Bell Alert Service Bulletin 412-15-164, dated March 13, 2015
(ASB 412-15-164), which was issued to notify individuals that an AMOC
to AD 2015-04-04, was available. Bell ASB 412-15-164 specifies the FAA-
approved AMOC, which allows instrument flight rules (IFR) and night
operations provided the helicopter is flown by two pilots.
    FAA Response: The FAA agrees and has revised the information in the
Related Service Information section.
    Request: Bell requested the FAA clarify a statement in the NPRM
that Bell notified the FAA that ASB 412-16-171 contained errors in the
serial numbers listed in Part B.
    FAA Response: The FAA agrees. The FAA noticed an error in the
serial numbers listed in ASB 412-16-171, Part B, and reached out to
Bell for clarification. The FAA received an email from Bell dated
August 29, 2017, confirming the existence of an error. The email from
Bell stated: ``There is an error in Part B. According to the
`Helicopters Affected' block, helicopters 36696 through 36999 and 37013
through subsequent have the intent of the bulletin accomplished prior
to delivery therefore, Part B should read: Part B is applicable to
helicopters 36248 through 36695 and 37002 through 37012.''

FAA's Determination

    The FAA has reviewed the relevant information and determined that
an 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 with
the changes described previously. These changes are consistent with the
intent of the proposals in the NPRM and will not increase the economic
burden on any operator nor increase the scope of the AD.

Related Service Information

    The FAA reviewed Bell ASB 412-15-164, which specifies an AMOC
approved by the FAA for AD 2015-04-04. Instead of the flight
limitations mandated by AD 2015-04-04, ASB 412-15-164 limits allow
operation under IFR and night operations with two pilots.
    The FAA reviewed Bell ASB 412-16-171, which specifies replacing
certain serial-numbered inverters P/N 412-375-079-101 and 412-375-079-
103 with inverter P/N 412-375-079-105 as a direct replacement or with a
retrofit kit. Bell specifies that completing the actions specified by
the ASB constitute terminating action for Bell ASB 412-15-164.
    The FAA also reviewed Bell Service Instruction for Inverter
Retrofit Kit BHT-412-SI-93, dated February 15, 2016, which provides
instructions for installing retrofit kit P/N 412-704-058-103.

Costs of Compliance

    The FAA estimates that this AD affects 73 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.
    Installing an inverter or retrofit kit requires about 3 work-hours
and parts cost about $15,749, for an estimated cost of $16,004 per
helicopter and $1,168,292 for the U.S. fleet.

Differences Between This AD and the Service Information

    Bell ASB 412-16-171 requires compliance no later than January 1,
2017, while this AD requires compliance within 25 hours TIS. Bell ASB
412-16-171 makes an ELA a determining factor for corrective actions.
This proposed AD makes no such requirement. Bell ASB 412-16-171
provides instructions for helicopters with serial numbers 36649, 36658,
36659, 36673, 36681 through 36684, 36686, 36688, 36690, 36692, 36694,
and 36696 through 36704, and this AD does not. Bell has notified the
FAA of errors in the S/Ns listed for Part B of ASB 412-16-171.
Accordingly, this AD is only applicable to those serial-numbered
helicopters subject to the unsafe condition.

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

    The FAA has determined that 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 that 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.
    The FAA prepared an economic evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

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 removing Airworthiness Directive (AD)
2015-04-04, Amendment 39-18106 (80 FR 9594, February 24, 2015), and
adding the following new AD:

2020-02-11 Bell Helicopter Textron Inc.: Amendment 39-21024; Docket
No. FAA-2017-0052; Product Identifier 2016-SW-081-AD.

(a) Effective Date

    This AD is effective March 17, 2020.

(b) Applicability

    This AD applies to Model 412 and 412EP helicopters with serial
number (S/N) 33001 through 33213, 34001 through 34036, 36001 through
36648, 36650 through 36657, 36660 through 36672, 36674 through
36680, 36685, 36687, 36689, 36691, 36693, 36695, and 37002 through
37012, certificated in any category, with a static inverter
(inverter) part number (P/N) 412-375-079-101 or 412-375-079-103 with
S/N 29145 or higher, installed.

(c) Unsafe Condition

    This AD defines the unsafe condition as the failure of an
inverter under instrument meteorological conditions or night flight.
This condition could result in smoke in the cockpit, increased pilot
workload due to the loss of primary flight and navigation displays,
alternating current powered engine and transmission indicators, and
autopilot, and subsequent loss of control of the helicopter.

(d) Affected ADs

    This AD replaces AD 2015-04-04, Amendment 39-18106 (80 FR 9594,
February 24, 2015).

(e) 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.

(f) Required Actions

    (1) Within 25 hours time-in-service:
    (i) For helicopters with S/N 33001 through 33213, 34001 through
34036, and 36001 through 36086, replace the inverter with inverter
P/N 412-375-079-105.
    (ii) For helicopters with a S/N 36087 through 36648, 36650
through 36657, 36660 through 36672, 36674 through 36680, 36685,
36687, 36689, 36691, 36693, 36695, and 37002 through 37012, install
retrofit kit P/N 412-704-058-103 and replace the inverter with
inverter P/N 412-375-079-105.
    (2) After accomplishing the actions required by paragraph (f)(1)
of this AD, you may remove the placard and Rotorcraft Flight Manual
limitations, required by AD 2015-04-04, prohibiting night operations
and restricting flights to visual flight rules.
    (3) After the effective date of this AD, do not install an
inverter P/N 412-375-079-101 or 412-375-079-103 on any helicopter.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, DSCO Branch, may approve AMOCs for this AD.
Send your proposal to: Tim Beauregard, Aviation Safety Engineer,
DSCO Branch, AIR-7J0, FAA, 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.

(h) Related Information

    For more information about this AD, contact Tim Beauregard,
Aviation Safety Engineer, DSCO Branch, AIR-7J0, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued in Fort Worth, Texas, on January 22, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-02587 Filed 2-10-20; 8:45 am]
 BILLING CODE 4910-13-P