UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

July 18, 2011

MEMORANDUM

SUBJECT:	Meeting with Nissan on December 7, 2010

FROM:	Don Kopinski

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on December 7, 2010 between Nissan, DoT,  and EPA staff.  The following people attended:

      Nissan:  Jeff Marsee, Takuya Ikeda, Asae Miyake, Brian Bolton              EPA:  Tony Fernandez, Byron Bunker, Jeff Cherry, Cle Jackson, Don Kopinski              DoT:  Maurice Hicks, Ryan Harrington, Kevin Green, Angel Jackson

The discussion focused on requirements for Class 2b and 3 vehicles in the HD GHG/fuel consumption rule, including credits for FFVs, full useful life and warranty requirements, and air conditioning leakage.


[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Rules and Regulations]
[Pages 77482-77485]
[FR Doc No: 2022-27391]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1236; Project Identifier MCAI-2021-01376-T;
Amendment 39-22275; AD 2022-25-19]
RIN 2120-AA64

Airworthiness Directives; Airbus Canada Limited Partnership (Type
Certificate Previously Held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-
1A11 airplanes. This AD was prompted by a report of a thrust reverser
actuation system (TRAS) deploy hose failure upon the commanded
deployment of a thrust reverser. This AD requires removing each non-
conforming TRAS deploy hose, and replacing it with a conforming TRAS
deploy hose, as specified in a Transport Canada AD, which is
incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective January 23, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 23,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1236; 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 mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
Transport Canada, Transport Canada National Aircraft Certification, 159
Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-
3639; email [email protected]; website tc.canada.ca/en/aviation.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2022-1236.

FOR FURTHER INFORMATION CONTACT: Joseph Catanzaro, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; 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 certain Airbus Canada
Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The
NPRM published in the Federal Register on October 5, 2022 (87 FR
60349). The NPRM was prompted by AD CF-2021-46, dated December 8, 2021,
issued by Transport Canada, which is the aviation authority for Canada
(Transport Canada AD CF-2021-46) (also referred to as the MCAI). The
MCAI states a report of a TRAS deploy hose failure upon the commanded
deployment of a thrust reverser. It was found that certain TRAS deploy
hoses were made with incomplete installation of the wire overbraid,
which created a weak point and subsequently led to failure of the
deploy hose. The failure of a deploy hose could lead to loss of thrust
reverser function and hydraulic systems. The loss of one or both thrust
reversers during landing on a contaminated runway could lead to a
runway excursion.
    In the NPRM, the FAA proposed to require removing each non-
conforming TRAS deploy hose, and replacing it with a conforming TRAS
deploy hose, as specified in Transport Canada AD CF-2021-46. The FAA is
issuing this AD to address the unsafe condition on these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1236.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from Air Line Pilots Association,
International (ALPA) who supported the NPRM without change.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comment received, and determined that air safety requires adopting this
AD as proposed. Accordingly, the FAA is issuing this AD to address the
unsafe condition on this product. Except for minor editorial changes,
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

    Transport Canada AD CF-2021-46 specifies procedures for removing
each non-conforming TRAS deploy hose, and replacing it with a
conforming TRAS deploy hose. 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.

Costs of Compliance

    The FAA estimates that this AD affects 8 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255...........................          \*\ $0             $255           $2,040
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the cost estimates for the parts specified in this
  AD.

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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:

2022-25-19 Airbus Canada Limited Partnership (Type Certificate
Previously Held by C Series Aircraft Limited Partnership (CSALP);
Bombardier, Inc.): Amendment 39-22275; Docket No. FAA-2022-1236;
Project Identifier MCAI-2021-01376-T

(a) Effective Date

    This airworthiness directive (AD) is effective January 23, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Canada Limited Partnership (Type
Certificate previously held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Model BD-500-1A10 and BD-500-1A11
airplanes, certificated in any category, as identified in Transport
Canada AD CF-2021-46, dated December 8, 2021 (Transport Canada AD
CF-2021-46).

(d) Subject

    Air Transport Association (ATA) of America Code 14, Hardware;
78, Engine Exhaust.

(e) Unsafe Condition

    This AD was prompted by a report of a thrust reverser actuation
system (TRAS) deploy hose failure upon the commanded deployment of a
thrust reverser. The FAA is issuing this AD to address failure of a
deploy hose, which could lead to loss of thrust reverser function
and hydraulic systems. Losing one or both thrust reversers during
landing on a contaminated runway could lead to a runway excursion.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, Transport Canada AD CF-2021-46.

(h) Exception to Transport Canada AD CF-2021-46

    (1) Where Transport Canada AD CF-2021-46 refers to hours air
time, this AD requires using flight hours.
    (2) Where Transport Canada AD CF-2021-46 refers to its effective
date, this AD requires using the effective date of this AD.
    (3) Where any service information referenced in Transport Canada
AD CF-2021-46 lists affected thrust reversers, this AD requires
using the serial and part numbers listed in table 1 to paragraph
(h)(3) of this AD.

Table 1 to Paragraph (h)(3) of This AD--Affected Thrust Reversers

BILLING CODE 4910-13-P
[GRAPHIC] [TIFF OMITTED] TR19DE22.000

BILLING CODE 4910-13-C

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO 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 responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada; or Airbus Canada Limited
Partnership's Transport Canada Design Approval Organization (DAO).
If approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Additional Information

    For more information about this AD, contact Joseph Catanzaro,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

(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 this AD specifies otherwise.
    (i) Transport Canada AD CF-2021-46, dated December 8, 2021.
    (ii) [Reserved]
    (3) For Transport Canada AD CF-2021-46, contact Transport
Canada, Transport Canada National Aircraft Certification, 159
Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-
3639; email [email protected]; website tc.canada.ca/en/aviation.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material 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: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 2, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-27391 Filed 12-16-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Notices]
[Pages 11892-11895]
[FR Doc No: 2013-03836]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0961]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Environmental Impact
Considerations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 (the PRA).

DATES: Fax written comments on the collection of information by March
22, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0322.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Environmental Impact Considerations--(OMB Control Number 0910-0322)--
Revision

    FDA is requesting OMB approval for the reporting requirements
contained in the FDA collection of information ``Environmental Impact
Considerations.''
    The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4327)
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 (EIS) for every major Federal action that will
significantly affect the quality of the human environment.
    FDA's NEPA regulations are in part 25 (21 CFR part 25). All
applications or petitions requesting Agency action require the
submission of a claim for categorical exclusion or an environmental
assessment (EA). A categorical exclusion applies to certain classes of
FDA-regulated actions that usually have little or no potential to cause
significant environmental effects and are excluded from the
requirements to prepare an EA or EIS. Section 25.15(a) and (d)
specifies the procedures for submitting to FDA a claim for a
categorical exclusion. Extraordinary circumstances (Sec.  25.21), which
may result in significant environmental impacts, may exist for some
actions that are usually categorically excluded. An EA provides
information that is used to determine whether an FDA action could
result in significant environmental impact. Sections 25.40(a) and (c)
specifies the content requirements for EAs for nonexcluded actions.
    This collection of information is used by FDA to assess the
environmental impact of Agency actions and to ensure that the public is
informed of environmental analyses. Firms wishing to manufacture and
market substances regulated under statues for which FDA is responsible
must, in most instances, submit applications requesting approval.
Environmental information must be included in such applications for the
purpose of determining whether the proposed action may have a
significant impact on the environment. Where significant adverse events
cannot be avoided, the Agency uses the submitted information as the
basis for preparing and circulating to the public an EIS, made
available through a Federal Register document also filed for comment at
the Environmental Protection Agency. The final EIS, including the
comments received, is reviewed by the Agency to weigh environmental
costs and benefits in determining whether to pursue the proposed action
or some alternative that would reduce expected environmental impact.
    Any final EIS would contain additional information gathered by the
Agency after the publication of the draft EIS, a copy or a summary of
the comments received on the draft EIS, and the Agency's responses to
the comments, including any revisions resulting from the comments or
other information. When the Agency finds that no significant
environmental effects are expected, the Agency prepares a finding of no
significant impact.
    In the Federal Register of September 28, 2012 (77 FR 59619), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments that were PRA related were
received from one commenter.
    (Comment 1) The commenter indicated that FDA underestimates the
hours required to complete an environmental assessment for tobacco
products, and that FDA's 12 hours burden estimate per response is
substantially underestimated. The commenter said, based on the
commenter's experience, an environmental assessment for tobacco
products should take approximately 80 hours to complete.
    (Response 1) FDA agrees with this comment. Upon further review of
the number of hours required to complete an environmental assessment
for tobacco products, FDA has determined that 12 hours is too low an
estimate and has revised the burden estimate per response for
completing an environmental assessment for tobacco products from 12 to
80 hours. This revision was based upon revisiting this estimate with
the Center for Tobacco Products staff and this comment. Rethinking the
time to prepare an environmental assessment for tobacco products
resulted in revising the burden per response to 80 hours.
    (Comment 2) The commenter also encouraged the Agency to establish
categorical exclusions for environmental assessments for tobacco
product submittals under section 905(j) of the

Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
387e(j)).
    (Response 2) FDA has decided to not establish categorical
exclusions for tobacco products at this time.
    FDA estimates the burden of this collection of information as
follows:

Estimated Annual Reporting Burden for Human Drugs (Including Biologics
in the Center for Drug Evaluation and Research)

    Under 21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i), each investigational new drug application (IND), new
drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for categorical exclusion under Sec.  25.30 or
Sec.  25.31 or an EA under Sec.  25.40. In 2011, FDA received 2,818
INDs from 2,064 sponsors, 99 NDAs from 79 applicants, 3,247 supplements
to NDAs from 376 applicants, 5 biologic license applications (BLAs)
from 5 applicants, 287 supplements to BLAs from 50 applicants, 895
ANDAs from 195 applicants, and 5,348 supplements to ANDAs from 299
applicants. FDA estimates that it will receive approximately 15,699
claims for categorical exclusions as required under Sec.  25.15(a) and
(d), and 10 EAs as required under Sec.  25.40(a) and (c). Therefore,
over the next 3 years, FDA estimates that approximately 3,175
respondents will submit an average of 4 applications for categorical
exclusion and 10 respondents will submit an average of 1 EA. Based on
information provided by the pharmaceutical industry, FDA estimates that
it takes sponsors or applicants approximately 8 hours to prepare a
claim for a categorical exclusion and approximately 3,400 hours to
prepare an EA.

                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................           3,175               4          12,700               8         101,600
25.40(a) and (c)................              10               1              10           3,400          34,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         135,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Human Foods

    Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive
petitions, color additive petitions, requests from exemption from
regulation as a food additive, and submission of a food contact
notification for a food contact substance must contain either a claim
of categorical exclusion under Sec.  25.30 or Sec.  25.32 or an EA
under Sec.  25.40. In 2011, FDA received 97 industry submissions. FDA
received an annual average of 42 claims of categorical exclusions as
required under Sec.  25.15(a) and (d), and 33 EAs as required under
Sec.  25.40(a) and (c). Therefore, over the next 3 years, FDA estimates
that approximately 42 respondents will submit an average of 1
application for categorical exclusion and 33 respondents will submit an
average of 1 EA. FDA estimates that, on average, it takes petitioners,
notifiers, or requestors approximately 3 hours to prepare a claim of
categorical exclusion and approximately 210 hours to prepare an EA.

                         Table 2--Estimated Annual Reporting Burden for Human Foods \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................              42               1              42               8             336
25.40(a) and (c)................              33               1              33             210           6,930
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,266
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Medical Devices

    Under 21 CFR 814.20(b)(11), premarket approvals (PMA) (original
PMAs and supplements) must contain a claim for categorical exclusion
under Sec.  25.30 or Sec.  25.34 or an EA under Sec.  25.40. In 2011,
FDA received approximately 52 claims (original PMAs and supplements)
for categorical exclusions as required under Sec.  25.15(a) and (d),
and 0 EAs as required under Sec.  25.40(a) and (c). Therefore, over the
next 3 years, FDA estimates that approximately 52 respondents will
submit an average of 1 application for categorical exclusion. Based on
information provided by less than 10 sponsors, FDA estimates that it
takes approximately 6 hours to prepare a claim for a categorical
exclusion.

                                           Table 3--Estimated Annual Reporting Burden for Medical Devices \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d)...................................................              52                1               52                6              312
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Estimated Annual Reporting Burden for Biological Products, Drugs, and
Medical Devices in the Center for Biologics Evaluation and Research

    BLAs under 21 CFR 601.2(a), as well as INDs (Sec.  312.23), NDAs
(Sec.  314.50), ANDAs (Sec.  314.94), and PMAs (Sec.  814.20), must
contain either a claim of categorical exclusion under Sec.  25.30 or
Sec.  25.32 or an EA under Sec.  25.40. In 2011, FDA received 14 BLAs
from 14 applicants, and 831 BLA supplements to license applications
from 153 applicants, 288 INDs from 210 sponsors, 1 NDA from 1
applicant, 37 supplements to NDAs from 9 applicants, 1 ANDA from 1
applicant, 12 supplements to ANDAs from 2 applicants, and 45 PMA
supplements from 11 applicants. FDA estimates that approximately 10
percent of these supplements would be submitted with a claim for
categorical exclusion or an EA.
    FDA estimates that it received approximately 481 claims for
categorical exclusion as required under Sec.  25.15(a) and (d), and 2
EAs as required under Sec.  25.40(a) and (c). Therefore, over the next
3 years, FDA estimates that approximately 247 respondents will submit
an average of 2 applications for categorical exclusion and 2
respondents will submit an average of 1 EA. Based on information
provided by industry, FDA estimates that it takes sponsors and
applicants approximately 8 hours to prepare a claim of categorical
exclusion and approximately 3,400 hours to prepare an EA for a
biological product.

                     Table 4--Estimated Annual Reporting Burden for Biological Products \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................             247               2             494               8           3,952
25.40(a) and (c)................               2               1               2           3,400           6,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,752
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Animal Drugs

    Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs), 21 CFR 514.8(a)(1)
supplemental NADAs and ANADAs, 21 CFR 511.1(b)(10) investigational new
animal drug applications (INADs), and 21 CFR 571.1(c), food additive
petitions must contain a claim for categorical exclusion under Sec.
25.30 or Sec.  25.33 or an EA under 25.40. In 2011, FDA's Center for
Veterinary Medicine has received approximately 698 claims for
categorical exclusion as required under Sec.  25.15(a) and (d), and 10
EAs as required under Sec.  25.40(a) and (c). Therefore, over the next
3 years, FDA estimates that approximately 70 respondents will submit an
average of 10 applications for categorical exclusion and 10 respondents
will submit an average of 1 EA. FDA estimates that it takes sponsors/
applicants approximately 3 hours to prepare a claim of categorical
exclusion and an average of 2,160 hours to prepare an EA.

                         Table 5--Estimated Annual Reporting Burden for Animal Drugs \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................              70              10             700               3           2,100
25.40(a) and (c)................              10               1              10           2,160          21,600
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          23,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Reporting Burden for Tobacco Products

    Under sections 905, 910, and 911 of the FD&C Act (21 U.S.C. 387j
and 387k), premarket tobacco applications (PMTAs), applications for
substantial equivalence (SEs), Exemption from SEs, and modified risk
tobacco products must contain a claim for categorical exclusion under
Sec.  25.30 or Sec.  25.34 or an EA under Sec.  25.40. When estimating
the burden for tobacco products, FDA considered the environmental
impacts associated with different applications. Specifically, in 2011,
FDA estimated it will receive approximately 20 PMTAs and supplements
from 20 respondents, 150 reports intended to demonstrate the SE of a
new tobacco product from 150 respondents, 500 exemptions from SE
requirements applications from 500 respondents, and 3 modified risk
tobacco product applications from 3 respondents. FDA is also not
accepting claims for categorical exclusions at this time, and estimates
that there will be 135 EAs from 135 respondents as required under Sec.
25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that
approximately 135 respondents will submit an average of 1 application
for environmental assessment. Part of the information in the EA will be
developed while writing other parts of a PMTA, SE., exemption from SE,
or modified risk tobacco product application. Based on FDA's
experience, previous information provided by potential sponsors,
information provided by a commenter to this collection of information,
and knowledge that part of the EA information has already been produced
in one of the tobacco product applications, FDA estimates that it takes
approximately 80 hours to prepare an EA.

                       Table 6--Estimated Annual Reporting Burden for Tobacco Products \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................             135               1             135              80          10,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                      Table 7--Estimated Annual Total Reporting Burden for All Centers \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................           3,586  ..............          13,998  ..............         108,300
25.40(a) and (c)................             190  ..............             190  ..............          80,130
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         188,430
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03836 Filed 2-19-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 9 (Friday, January 13, 2023)]
[Proposed Rules]
[Pages 2295-2298]
[FR Doc No: 2023-00263]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0012; Project Identifier MCAI-2022-01317-T]
RIN 2120-AA64

Airworthiness Directives; ATR--GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain ATR--GIE Avions de Transport R[eacute]gional Model ATR42-
500 and 72-212A airplanes. This proposed AD was prompted by in-service
experience that has shown that the lateral flight guidance of the
flight director/auto pilot

may not limit HI BANK turns in severe icing conditions. This proposed
AD would require the replacement of the affected new avionics suite
(NAS), as specified in a European Union Aviation Safety Agency (EASA)
AD, which is proposed for incorporation by reference (IBR). This
proposed AD would also prohibit the installation of the affected NAS on
any airplane. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by February
27, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0012; 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 NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For EASA material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu. It is
also available at regulations.gov under Docket No. FAA-2023-0012.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation Branch,
2200 South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0012; Project Identifier
MCAI-2022-01317-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Shahram Daneshmandi, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines, WA
98198; telephone<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2022-0206, dated October 7, 2022
(EASA AD 2022-0206) (also referred to as the MCAI), to correct an
unsafe condition for certain ATR--GIE Avions de Transport
R[eacute]gional Model ATR42-500 and ATR72-212A airplanes. The MCAI
states that in-service experience has shown that the lateral flight
guidance of the flight director/auto pilot may not limit HI BANK turns
in severe icing conditions. The airplane is only protected during LO
BANK turns. This condition, if not addressed, could result in loss of
control of the airplane.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0012.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0206 specifies procedures for replacement of the
affected NAS with NAS standard 2.2 or 3.1, or later approved NAS
standard. EASA AD 2022-0206 also prohibits the installation of the
affected NAS on any airplane. 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 ADDRESSES.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
described above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2022-0206 described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2022-0206 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2022-0206 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in

EASA AD 2022-0206 does not mean that operators need comply only with
that section. For example, where the AD requirement refers to ``all
required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in EASA AD 2022-0206. Service information
required by EASA AD 2022-0206 for compliance will be available at
regulations.gov under Docket No. FAA-2023-0012 after the FAA final rule
is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 20 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................            * $0              $85           $1,700
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the cost estimates for the parts specified in this
  proposed AD.

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this proposed AD may be covered under warranty, thereby reducing the
cost impact on affected operators.

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 determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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 Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

ATR--GIE Avions de Transport R[eacute]gional: Docket No. FAA-2023-
0012; Project Identifier MCAI-2022-01317-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by February 27, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to ATR--GIE Avions de Transport R[eacute]gional
Model ATR42-500 and ATR72-212A airplanes, certificated in any
category, as identified in European Union Aviation Safety Agency
(EASA) AD 2022-0206, dated October 7, 2022 (EASA AD 2022-0206).

(d) Subject

    Air Transport Association (ATA) of America Code 31, Instruments.

(e) Unsafe Condition

    This AD was prompted by in-service experience that has shown
that the lateral flight guidance of the flight director/auto pilot
may not limit HI BANK turns in severe icing conditions. The FAA is
issuing this AD to address the lateral flight guidance not limiting
HI BANK turns in severe icing conditions. The unsafe condition, if
not addressed, could result in loss of control of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, EASA AD 2022-0206.

(h) Exceptions to EASA AD 2022-0206

    (1) Where EASA AD 2022-0206 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not adopt the ``Remarks'' section of EASA AD
2022-0206.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-0206
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): 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 responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (k) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or ATR--GIE Avions de Transport
R[eacute]gional's EASA Design

Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Additional Information

    For more information about this AD, contact Shahram Daneshmandi,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0206,
dated October 7, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0206, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. 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: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 5, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-00263 Filed 1-12-23; 8:45 am]
BILLING CODE 4910-13-P