[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48669-48671]
[FR Doc No: 2022-17184]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1588]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exemptions From
Substantial Equivalence Requirements for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 9, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0684. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Exemptions From Substantial Equivalence Requirements for Tobacco
Products

OMB Control Number 0910-0684--Revision

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a chapter granting FDA important authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    The Consolidated Appropriations Act of 2022 (Pub. L. 117-103) (the
Appropriations Act), enacted on March 15, 2022, amended the definition
of the term ``tobacco product'' in section 201(rr) of the FD&C Act (21
U.S.C. 321(rr)) to include products that contain nicotine from any
source. As a result, non-tobacco nicotine (NTN) products that were not
previously subject to the FD&C Act (e.g., products containing synthetic
nicotine) are now subject to all of the tobacco product provisions in
the FD&C Act beginning on April 14, 2022, including the requirement of
premarket review for new tobacco products.
    The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, the new tobacco product must
undergo premarket review by FDA. FDA must issue an order authorizing
the commercial distribution of the new tobacco product or find the
product exempt from the requirements of substantial equivalence under
section 910(a)(2)(A) of the FD&C Act (21 U.S.C. 387j(a)(2)(A)), before
the product may be introduced into commercial distribution.
    FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec.  1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec.  1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or

increasing or decreasing the quantity of an existing tobacco additive,
from the requirement of demonstrating substantial equivalence if the
Agency determines that: (1) the modification would be a minor
modification of a tobacco product that can be sold under the FD&C Act;
(2) a report demonstrating substantial equivalence is not necessary to
ensure that permitting the tobacco product to be marketed would be
appropriate for the protection of public health; and (3) an exemption
is otherwise appropriate.
    Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)) may be made only by
the manufacturer of a legally marketed tobacco product for a minor
modification to that tobacco product and that the manufacturer must
submit the request and all information supporting it to FDA. The
request must be made in an electronic format that FDA can process,
review, and archive (or a written request must be made by the
manufacturer explaining in detail why the manufacturer cannot submit
the request in an electronic format and requesting an alternative means
of submission to the electronic format).
    An exemption request must contain: (1) the manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25; 42 U.S.C. 4332(2))
prepared in accordance with the requirements of Sec.  25.40 (21 CFR
25.40)).
    The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4347) states national environmental objectives and imposes upon
each Federal Agency the duty to consider the environmental effects of
its actions. Section 102(2)(C) of NEPA requires the preparation of an
environmental impact statement for every major Federal action that will
significantly affect the quality of the human environment.
    The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial equivalence require the submission of an
EA. An EA provides information that is used to determine whether an FDA
action could result in a significant environmental impact. Section
25.40(a) and (c) specifies the content requirements for EAs for non-
excluded actions.
    The information required by Sec.  1107.1(b) is submitted to FDA so
FDA can determine whether an exemption from substantial equivalence to
the product is appropriate for the protection of the public health.
Section 1107.1(c) states that FDA will review the information submitted
and determine whether to grant or deny an exemption based on whether
the criteria in section 905(j)(3) of the FD&C Act are met. FDA may
request additional information if necessary, to make a determination
and may consider the exemption request withdrawn if the information is
not provided within the requested timeframe.
    This collection of information also contains a requirement that a
manufacturer submit a report (referred to as an ``abbreviated report'')
at least 90 days prior to making an introduction or delivery for
introduction into interstate commerce for commercial distribution of a
tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that
if an exemption has been requested and granted, the manufacturer must
submit to FDA a report that demonstrates that the tobacco product is
modified within the meaning of section 905(j)(3), the modifications are
to a product that is commercially marketed and in compliance with the
requirements of the FD&C Act, and all the modifications are covered by
exemptions granted by the Secretary under section 905(j)(3).
    Description of Respondents: The respondents to this collection of
information are tobacco product manufacturers defined as any person,
including any repacker or relabeler, who: (1) manufactures, fabricates,
assembles, processes, or labels a tobacco product; or (2) imports a
finished tobacco product for sale or distribution in the United States.
    Section 1107.1(b) requires that the exemption request and
supporting information be submitted in an electronic format that FDA
can process, review, and archive. The exemption request and supporting
information must be legible and in English. These requirements ensure
that FDA can review the exemption request expeditiously and
appropriately. FDA provides information on its website on how
manufactures may provide electronic submissions and regulatory
correspondence, such as the exemption request and supporting
information, as well as the abbreviated report, to FDA (e.g.,
information on electronic media and methods of transmission). Steps on
how to prepare and the recommended structure of an exemption request
and abbreviated report can be found at: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence. Information on how to submit exemption requests and
abbreviated reports to the CTP Portal can be found here: https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal.
    FDA does not anticipate any need to submit an exemption request or
supporting information in a non-electronic format. However, a company
that is not able to submit the documentation in an electronic format
may submit a written request to the Center for Tobacco Products
document control center (https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp).
    In the Federal Register of February 25, 2022 (87 FR 10797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment responsive to the four
information collection topics solicited was received. The comment
stated that the Agency should consider making the exemption request
pathway (section 905(j)(3) of the FD&C Act) more flexible for new
products, devices, and technology innovations.
    FDA appreciates the comment and notes that although we may consider
the comment, these types of actions may necessitate guidance (as noted
in the comment). Currently, we believe that the exemption pathway is
providing applicants an efficient pathway to make additive changes to
their products and receive a marketing order. If the Agency decides to
consider revising the suggested actions, these types of actions would
need to be done pursuant to separate notice and comment procedures.

    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
 21 CFR section and/or activity      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.   1107.1(b); Optional                   812               1             812              24          19,488
 preparation of tobacco product
 exemption from substantial
 equivalence request; and Sec.
 25.40; Preparation of an
 environmental assessment.......
Sec.   1107.1(c); Preparation of             150               1             150               3             450
 additional information for
 tobacco product exemption from
 substantial equivalence request
Abbreviated report submitted to            1,217               1           1,217               2           2,434
 demonstrate: tobacco product is
 modified under section
 905(j)(3) of the FD&C Act,
 modifications are to a product
 that is commercially marketed
 and compliant, and
 modifications covered by
 exemptions granted by Secretary
 under section 905(j)(3)........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,372
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that we will receive 812 exemption requests under
Sec.  1107.1(b) for 24 hours per response including EA for a total of
19,488 hours. Since an EA is required for each Sec.  1107.1(b)
(Optional Preparation of Tobacco Product Exemption From Substantial
Equivalence Request), the burden per response for EAs (12 hours) has
been combined with the 12 hours for an exemption request for a total of
24 hours per response.
    FDA further estimates, that we will receive 150 submissions
requiring additional information in support of the initial exemption
request, and it is expected that it will take an average of 3 hours to
prepare the additional information for a total of 450 hours.
    FDA estimates that 1,217 respondents will prepare 1,217 responses
and each response will take approximately 2 hours to prepare an
abbreviated report, as required by section 905(j)(1)(A)(ii), for a
total of 2,434 hours. The estimates reflect a decrease of 1,217 hours
to account for a reduction in average response time for preparing an
abbreviated report. FDA provides a recommended format for applicants in
the exemption order letter that significantly reduces the burden hours
for preparing the abbreviated report. Therefore, FDA now estimates that
the hours for the collection of information associated with exemptions
from substantial equivalence requirements total 22,372 hours.
    Although there may be year-to-year variability in the absolute
number of exemption requests submitted, FDA considers any trends in our
analysis, and the overall number of extension requests from
manufacturers of tobacco products has remained consistent.
Additionally, although manufacturers of NTN products are now subject to
all of the tobacco product provisions in the FD&C Act, including the
need to submit premarket submissions to FDA and obtain authorization
from the Agency to market their product, FDA expects to receive
premarket tobacco product applications for most currently marketed NTN
products. FDA does not expect to receive many exemption requests for
currently marketed NTN products. Thus, no additional adjustments to the
number of respondents in our burden estimate are needed for NTN
products as the current estimate accounts for some year-to-year
variability in the absolute number of exemption requests submitted.

    Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17184 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Notices]
[Page 65191-65193]
[DOCID:fr09de09-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61102; File No. SR-ISE-2009-102]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the $1 Strike Program To Allow Low-Strike LEAPS

December 3, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 24, 2009, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which items have been prepared by
the Exchange. The Exchange has filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section

19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the $1 Strike Program. The text of
the proposed rule change is available on the Exchange's Web site http:/
/www.ise.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The self-regulatory organization has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to expand the $1 Strike
Program (``Program'') in a limited fashion to allow ISE to list new
series in $1 intervals up to $5 in long-term options series (``LEAPS'')
in up to 200 options classes on individual stocks.\5\ Currently, under
the Program, ISE may not list LEAPS at $1 strike price intervals for
any class selected for the Program. ISE is also restricted from listing
any series that would result in strike prices being $0.50 apart, unless
the series are part of the $0.50 Strike Program.\6\
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    \5\ Under ISE Rule 506, LEAPS expire from 12-39 months from the
time they are listed.
    \6\ See Securities Exchange Act Release No. 60696 (September 18,
2009), 74 FR 49053 (September 25, 2009) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Relating to Strike
Price Intervals of $0.50 for Options on Stocks Trading At or Below
$3.00).
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    ISE believes that this proposed rule change is appropriate and will
allow investors to establish options positions that are better tailored
to meet their investment objectives, vis-[agrave]-vis credit risk,
using deep out-of-the-money put options. Deep out-of-the-money put
options are viewed as a viable, liquid alternative to OTC-traded credit
default swaps (``CDS''). These options do not possess the negative
characteristics associated with CDS, namely, lack of transparency,
insufficient collateral requirements, and inefficient trade processing.
Moreover, deep out-of-the-money put options and CDS are functionally
similar, as there is a high correlation between low-strike put prices
and CDS spreads.
    ISE notes that this proposal is limited in scope, as $1 strikes in
LEAPS may only be listed up to $5 and in only up to 200 options
classes. As is currently the case, ISE would not list series with $1
intervals within $0.50 of an existing $2.50 strike price in the same
series. As a result, ISE does not believe that this proposed rule
change will cause a significant increase in quote traffic.
    Moreover, as the SEC is aware, ISE has adopted various quote
mitigation strategies on an effort to lessen the growth rate of options
quotations. When ISE expanded the Program several months ago, ISE
included a delisting policy that would be applicable with regard to
this proposed expansion.\7\ ISE and the other options exchanges amended
the Options Listing Procedures Plan (``OLPP'') in 2008 to impose a
minimum volume threshold of 1,000 contracts national average daily
volume per underlying class to qualify for an additional year of LEAP
series.\8\ Most recently, ISE, along with the other options exchanges,
amended the OLPP to adopt objective, exercise price range limitations
applicable to equity options classes, options on ETFs and options on
trust issued receipts.\9\ ISE believes that these price range
limitations will have a meaningful quote mitigation impact.
Additionally, pursuant to its policy to delist options with ADV of less
than 50 contracts, ISE has, since January 2009, delisted 95 options
classes.\10\
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    \7\ The delisting policy includes a provision that states ISE
may grant member requests to add strikes and/or maintain strikes in
series of options classes traded pursuant to the Program that are
eligible for delisting.
    \8\ See SEC Release No. 34-58630 (September 24, 2008), approving
Amendment No. 2 to the OLPP.
    \9\ See SEC Release No. 34-60531 (August 19, 2009), approving
Amendment No. 3 to the OLPP. This proposed rule change would not be
subject to the exercise price range limitations contained in the
OLPP.
    \10\ Members are advised of an Involuntary Delisting through an
Information Alert sent via Electronic Mail by the Exchange. An
Information Alert announcing the delisting of 21, 33, 28 and 13
options classes as part of the Exchange's delisting program was sent
to Members on January 16, 2009, April 13, 2009, July 17, 2009 and
October 30, 2009, respectively.
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    The margin requirements set forth in Chapter 12 of the Exchange's
rules and the position and exercise requirements set forth in Rules 412
and 414 will continue to apply to these new series, and no changes are
being proposed to those requirements by this proposed rule change.
    ISE has analyzed its capacity and represents that it and the
Options Price Reporting Authority have the necessary systems capacity
to handle the additional traffic associated with the listing and
trading of an expanded number of series as proposed by this filing.
    The Exchange also proposes to make a non-substantive change to Rule
504 by relocating the provision ``A stock shall remain in the $1 Strike
Program until otherwise designated by the Exchange'' to the end of
Supplementary Material .01 to Rule 504.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (``Exchange
Act'') for this proposed rule change is the requirement under Section
6(b)(5) of the Exchange Act \11\ that an exchange have rules that are
designed to promote just and equitable principles of trade, and to
remove impediments to and perfect the mechanism for a free and open
market and a national market system, and in general, to protect
investors and the public interest. In particular, the proposed rule
change will allow the Exchange to list $1 strike prices in LEAPS series
for the benefit of investors and as a competitive response to the
listing of $1 strike prices in LEAPS series by another exchange.
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    \11\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect

the protection of investors or the public interest; (ii) impose any
significant burden on competition; or (iii) become operative for 30
days after the date of the filing, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, it has become effective pursuant to
Section 19(b)(3)(A) of the Act \12\ and Rule 19b-4(f)(6)
thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Commission has waived this requirement in this case.
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    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission hereby grants that request.\14\ The
Commission believes that waiver of the operative delay is consistent
with the protection of investors and the public interest because it
recently approved a proposal from CBOE which is identical to the
current proposal in all material respects and on which no comments were
received.\15\ Therefore, the proposal is operative upon filing.
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    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \15\ See Exchange Act Release No. 60978 (November 10, 2009), 74
FR 59296 (November 17, 2009) (approving SR-CBOE-2009-68).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-ISE-2009-102 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-ISE-2009-102. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISE-2009-102 and should be
submitted on or before December 30, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-29388 Filed 12-8-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 219 (Tuesday, November 15, 2022)]
[Notices]
[Page 68480]
[FR Doc No: 2022-24835]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IN12-17-000]

Total Gas & Power North America, Aaron Hall and Therese Tran;
Updated Notice of Designation of Commission Staff as Non-Decisional

    With respect to an order issued by the Commission on April 28, 2016
in the above-captioned docket,\1\ with the exceptions noted below, the
staff of the Office of Enforcement are designated as non-decisional in
deliberations by the Commission in this docket. Accordingly, pursuant
to 18 CFR 385.2202 (2022), they will not serve as advisors to the
Commission or take part in the Commission's review of any offer of
settlement. Likewise, as non-decisional staff, pursuant to 18 CFR
385.2201 (2022), they are prohibited from communicating with advisory
staff concerning any deliberations in this docket.
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    \1\ Total Gas & Power North America, Aaron Hall and Therese
Tran, 155 FERC ] 61,105 (2016).
---------------------------------------------------------------------------

    Exceptions to this designation as non-decisional are:

Ruedi Aebersold
Jeffrey Fang
Martin Lawera
Eric Primosch
Felice Richter
Derek Shiau
Nicholas Stavlas
Ambrea Watts
Mehrdad Barikbin
Samantha Maurer
David Zlotnick
Sheryl Caro
Serrita Hill

Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-24835 Filed 11-14-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Rules and Regulations]
[Pages 24037-24041]
[FR Doc No: 2022-08563]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1078; Project Identifier MCAI-2020-01574-R;
Amendment 39-22014; AD 2022-08-11]
RIN 2120-AA64

Airworthiness Directives; Bell Textron Canada Limited 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
certain Bell Textron Canada Limited Model 429 helicopters. This AD was
prompted by in-service reports of the loss of display and subsequent
recovery of certain display units (DUs). This AD requires revising the
existing rotorcraft flight manual supplement (RFMS) for your helicopter
and disabling the traffic alert and collision avoidance system (TCAS)
POP-UP feature for certain DUs. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective May 27, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of May 27, 2022.

ADDRESSES: For service information identified in this final rule,
contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J 1R4, Canada; telephone 1-450-437-2862 or 1-800-363-8023; fax
1-450-433-0272; email [email protected]; or at https://www.bellflight.com/support/contact-support. 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. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
1078.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1078; 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 final rule, the
Transport Canada AD, any comments received, and other information. The
street 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: Darren Gassetto, Aerospace Engineer,
COS Program Management Section, FAA, Operational Safety Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-
7323; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Bell Textron Canada
Limited Model 429 helicopters, serial numbers 57001 through 57369
inclusive, 57371, and 57373. The NPRM published in the Federal Register
on December 28, 2021 (86 FR 73708; corrected January 10, 2022 (87 FR
1083)). In the NPRM, the FAA proposed to require revising the existing
RFMS for your helicopter and disabling the TCAS POP-UP feature for
certain DUs. The NPRM was prompted by Transport Canada AD CF-2020-18R1,
dated November 27, 2020 (Transport Canada AD CF-2020-18R1), issued by
Transport Canada, which is the aviation authority for Canada, to
correct an unsafe condition for Bell Textron Canada Limited Model 429
helicopters, serial numbers 57001 through 57369, 57371, and 57373.
Transport Canada advises that it has received in-service reports of the
loss of display and subsequent recovery of the DU manufactured by
Rogerson Kratos (RK). During an instrument flight rules approach, a
Bell Textron Canada Limited Model 429 helicopter lost its center DU
display, which then rebooted, and subsequently lost its right-hand side
(RHS) DU display, which then also rebooted. Investigation revealed that
the DUs' power cycle occurred while in Map-Mode, which was caused by
the RK DUs' limited processing capability for excessive null waypoints
generated by the Garmin GTN 750/650 GPS/NAV/COMM/MFD.
    Transport Canada also advises that the use of Map-Mode to the
center DU should be limited only for Bell Textron Canada Limited Model
429 helicopters equipped with RK DUs and Garmin GTN 750/650 main
software version 6.21 or later and that the use of Map-Mode should be
prohibited on both the RHS DU and left-hand side DU, if installed. In
addition, Transport Canada advises that a new emergency and malfunction
procedure in the event of center DU failure should be implemented. If
not addressed, a DU power cycle occurring during flight and consequent
momentary loss of display information on the primary flight display and
other DUs could result in the unexpected loss of display of important
flight parameters to the pilots, including attitude, approach,
airspeed, altitude, flight director information, navigation system
cues, as well as engine and rotor drive system indications.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from one commenter, Bell Textron Canada
Limited. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request To Revise Figures 1 and 2 to Paragraph (g) To Match the RFMS

    Bell Textron Canada Limited requested that the limitations
specified in figures 1 and 2 to paragraph (g) of the proposed AD be
revised to reflect the limitations identified in Bell Alert Service
Bulletin 429-20-51, Revision B, dated July 17, 2021; and Bell 429
Rotorcraft Flight Manual Supplement BHT-429-FMS-19, Revision 7, dated
December 14, 2021. The commenter noted that the unsafe condition
identified in the NPRM is only present when Garmin GTN 650/750 main
software version 6.21 or later is installed because these software
versions introduce an increased number of waypoints that can be
displayed, which is beyond the memory capability of the RK DU. In
addition, the commenter explained that the Garmin main software version
is obvious to the pilot because it is displayed on the GTN 650/750
``splash''screen when the DUs are powered-up and can be easily accessed
prior to flight through the GTN 650/750 configuration pages.
    The FAA partially agrees with the commenter's request. The FAA
agrees with revising the limitations specified in figures 1 and 2 to
paragraph (g) of this AD to reflect the Garmin GTN 650/750 main
software versions specified in Bell 429 Rotorcraft Flight Manual
Supplement BHT-429-FMS-19, Revision 7, dated December 14, 2021, because
the unsafe condition is limited to Garmin GTN 650/750 main software
version 6.21 or later, and the flight crew can determine the software
version from the DUs and not from memory or running a diagnostic
program. The FAA has revised figures 1 and 2 to paragraph (g) of this
AD accordingly. The FAA notes that Bell Alert Service Bulletin

429-20-51, Revision B, dated July 17, 2021, refers to an older revision
of the Bell 429 Rotorcraft Flight Manual Supplement BHT-429-FMS-19,
which does not include all of the clarifying information regarding the
affected manufacturer and software versions.

Request To Revise Figure 3 to Paragraph (g) To Specify the RK DU
Configuration

    Bell Textron Canada Limited requested that figure 3 to paragraph
(g) of the proposed AD be revised to specify that the revision to the
Emergency and Malfunction Procedures (section 3) of the existing RFMS
applies to a center DU with the RK DU configuration. The commenter
explained that Bell 429 Rotorcraft Flight Manual Supplement BHT-429-
FMS-19, Revision 7, dated December 14, 2021, included a revision to
Section 3-14-B., CENTER DU FAILURE, to clarify that the Emergency and
Malfunction Procedure applied only to the RK DU configuration.
    The FAA agrees with the commenter's request and has revised
paragraph (g) of this AD and figure 3 to paragraph (g) of this AD to
specify that the Emergency and Malfunction Procedures apply to a center
DU with the RK DU configuration. The FAA contacted Transport Canada,
the State of Design Authority for Bell Textron Canada Limited Model 429
helicopters, and confirmed that the Emergency and Malfunction
Procedures are applicable only to a center DU with the RK DU
configuration.

Request To Revise Note 1 to Paragraph (g) To Refer to a Later Revision
of the RFMS

    Bell Textron Canada Limited requested that Note 1 to paragraph (g)
be revised to refer to only Bell 429 Rotorcraft Flight Manual
Supplement BHT-429-FMS-19, Revision 7, dated December 14, 2021. The
commenter explained that this revision level provides additional
clarifying information regarding the manufacturer and software versions
affected by the unsafe condition identified in the NPRM.
    The FAA agrees with the commenter's request for the reason provided
by the commenter and because the FAA has additionally agreed to certain
changes in the information presented in figures 1, 2, and 3 to
paragraph (g) of this AD in response to the commenter's previous
comments regarding the RFMS revision. In the proposed AD Note 1 to
paragraph (g) was as follows: ``Note 1 to paragraph (g): The
information in the '`CENTER DU FAILURE' specified in figure 3 to
paragraph (g) of this AD can be found in Bell 429 Rotorcraft Flight
Manual Supplement BHT-429-FMS-19, Revisions 3, 4, 5, and 6.'' In this
AD the FAA revised Note 1 to paragraph (g) to refer to Bell 429
Rotorcraft Flight Manual Supplement BHT-429-FMS-19, Revision 7, dated
December 14, 2021, and to include the pertinent changes that resulted
from the other Bell Textron Canada Limited comments previously
discussed.

Changes Since the NPRM Was Issued

    After the NPRM was issued, Transport Canada issued Transport Canada
AD CF-2020-18R2, dated January 27, 2022 (Transport Canada AD CF-2020-
18R2), which superseded Transport Canada AD CF-2020-18R1. Transport
Canada AD CF-2020-18R2, mandates incorporation of Bell 429 Rotorcraft
Flight Manual Supplement BHT-429-FMS-19, Revision 7, dated December 14,
2021, which specifies disabling the TCAS POP-UP feature for certain
DUs. That action was included in the proposed AD requirements, and in
the NPRM preamble, was identified in the Differences Between this
Proposed AD and the Transport Canada AD section because it was not
included in Transport Canada AD CF-2020-18R1 but was included in the
proposed AD requirements. That difference has been removed from this
final rule.

Conclusion

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with Canada, Transport Canada, its
technical representative, has notified the FAA of the unsafe condition
described in its AD. The FAA reviewed the relevant data, considered the
comments received, and determined that, except for the changes
described previously, air safety requires adopting this AD as proposed.
Accordingly, the FAA is issuing this AD to address the unsafe condition
on these helicopters. Except for minor editorial changes, and any other
changes described previously, this AD is adopted as proposed in the
NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Bell Alert Service Bulletin 429-20-51, Revision B,
dated July 17, 2021, which specifies procedures for disabling the TCAS
POP-UP feature for certain DUs. This material 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.

Differences Between This AD and the Transport Canada AD

    Transport Canada AD CF-2020-18R2 requires operators to ``advise all
flight crews'' of the changes introduced by the RFMS revision. However,
this AD does not specifically require that action. 14 CFR 91.9 requires
that no person may operate a civil aircraft without complying with the
operating limitations specified in the RFMS. Therefore, including a
requirement in this AD to operate the helicopter according to the
revised RFMS would be redundant and unnecessary. Further, compliance
with such a requirement in an AD would be impracticable to demonstrate
or track on an ongoing basis; therefore, a requirement to operate the
helicopter in such a manner would be unenforceable. The flight manual
supplement changes in this AD also apply to the emergency and
malfunction procedures section of the existing RFMS for your
helicopter. FAA regulations mandate compliance only with the operating
limitations section of the flight manual. Nonetheless, the FAA
recommends that flight crews of the helicopters listed in the
applicability operate in accordance with the revised emergency and
malfunction procedures specified in this AD.

Costs of Compliance

    The FAA estimates that this AD affects 88 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Revising the existing RFMS for your helicopter takes about 1 work-
hour for an estimated cost of $85 per helicopter and $7,480 for the
U.S. fleet.
    Disabling the TCAS POP-UP feature for your helicopter takes about
0.5 work-hours for an estimated cost of $43 per helicopter and $3,784
for the U.S. fleet.

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 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.

List of Subjects in 14 CFR Part 39

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

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:

2022-08-11 Bell Textron Canada Limited: Amendment 39-22014; Docket
No. FAA-2021-1078; Project Identifier MCAI-2020-01574-R.

(a) Effective Date

    This airworthiness directive (AD) is effective May 27, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bell Textron Canada Limited Model 429
helicopters, certificated in any category, serial numbers 57001
through 57369 inclusive, 57371, and 57373.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 3100, Indicating/
Recording System.

(e) Unsafe Condition

    This AD was prompted by in-service reports of the loss of
display and subsequent recovery of certain display units (DUs). The
FAA is issuing this AD to address a DU power cycle occurring during
flight and consequent momentary loss of display information on the
primary flight display and other DUs, which if not addressed, could
result in the unexpected loss of display of important flight
parameters to the pilots, including attitude, approach, airspeed,
altitude, flight director information, navigation system cues, as
well as engine and rotor drive system indications.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revising the Rotorcraft Flight Manual Supplement (RFMS)

    Within 30 days after the effective date of this AD: Revise the
Types of Operation--Limitations (section 1-3-A.) of the existing
RFMS for your helicopter to include the information in the
``Limitations'' specified in figure 1 to paragraph (g) of this AD,
revise the Configuration (section 1-5.) of the existing RFMS for
your helicopter to include the information in the ``Configuration''
specified in figure 2 to paragraph (g) of this AD, and revise the
Emergency and Malfunction Procedures (section 3) of the existing
RFMS for your helicopter to include the information in the ``CENTER
DU FAILURE (RK CONFIGURATION)'' specified in figure 3 to paragraph
(g) of this AD.
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    Figure 1 to paragraph (g)--Limitations revision
    [GRAPHIC] [TIFF OMITTED] TR22AP22.000

    Figure 2 to paragraph (g)--Configuration revision
    [GRAPHIC] [TIFF OMITTED] TR22AP22.001

    Figure 3 to paragraph (g)--Emergency and Malfunction Procedures
revision
[GRAPHIC] [TIFF OMITTED] TR22AP22.002

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    Note 1 to paragraph (g): The information in the ``Limitations''
specified in figure 1 to paragraph (g), ``Configuration'' specified
in figure 2 to paragraph (g), and ``CENTER DU FAILURE (RK
CONFIGURATION)'' specified in figure 3 to paragraph (g) of this AD
can be found in Bell 429 Rotorcraft Flight Manual Supplement BHT-
429-FMS-19, Revision 7, dated December 14, 2021.

(h) Disabling the Traffic Alert and Collision Avoidance System (TCAS)
POP-UP Feature

    Within 30 days after the effective date of this AD: Disable the
TCAS POP-UP mode, including those helicopters equipped with the TCAS
kit, in the parameter setup page on all RK DUs, in accordance with
paragraph 3. of the Accomplishment Instructions of Bell Alert
Service Bulletin 429-20-51, Revision B, dated July 17, 2021.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, 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 manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (j)(1) of
this AD. Information may be emailed to: [email protected].
    (2) 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.

(j) Related Information

    (1) For more information about this AD, contact Darren Gassetto,
Aerospace Engineer, COS Program Management Section, FAA, Operational
Safety Branch, Compliance & Airworthiness Division, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>;
email [email protected].
    (2) The subject of this AD is addressed in Transport Canada AD
CF-2020-18R2, dated January 27, 2022. You may view the Transport
Canada AD at https://www.regulations.gov in Docket No. FAA-2021-
1078.
    (3) Bell 429 Rotorcraft Flight Manual Supplement BHT-429-FMS-19,
Revision 7, dated December 14, 2021, which is not incorporated by
reference, contains additional information about the subject of this
AD. This service information is available at the contact information
specified in paragraphs (k)(3) and (4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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) Bell Alert Service Bulletin 429-20-51, Revision B, dated
July 17, 2021.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact Bell
Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J
1R4, Canada; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-
433-0272; email [email protected]; or at https://www.bellflight.com/support/contact-support.
    (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 protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 5, 2022.
Derek Morgan,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-08563 Filed 4-21-22; 8:45 am]
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