[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Proposed Rules]
[Pages 44660-44663]
[FR Doc No: 2021-17044]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0660; Project Identifier AD-2021-00398-T]
RIN 2120-AA64

Airworthiness Directives; Learjet Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Learjet Inc. Model 45 airplanes. This proposed AD was
prompted by a report of a fuel leak due to a cracked fuel line between
the engine fuel control and the engine fuel flow meter. This proposed
AD would require replacing the existing fuel flow meter bracket
assembly with a redesigned bracket assembly and reporting information
to the FAA. 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 September
27, 2021.

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 https://www.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.
    For service information identified in this NPRM, contact Learjet
Inc., One Learjet Way, Wichita, KS 67209; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>website: https://businessaircraft.bombardier.com/en/aircraft/Learjet.html. You may view
this service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by

searching for and locating Docket No. FAA-2021-0660; 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, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: James Galstad, Aviation Safety
Engineer, Wichita ACO Branch, FAA, 1801 S Airport Road, Wichita, KS
67209; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>or b5e2dcd6dddcc1d498f6fae6f5d3d4d49bd2dac3; or Thomas Teplik, Aviation Safety Engineer, Wichita ACO
Branch, FAA, 1801 S Airport Road, Wichita, KS 67209; phone: (316) 946-
4196; email<EMAIL_ADDRESS>or 5c0b353f3435283d711f130f1c3a3d3d723b332a.

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-2021-0660; Project Identifier
AD-2021-00398-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
https://www.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 James
Galstad, Aviation Safety Engineer, or Thomas Teplik, Aviation Safety
Engineer, Wichita ACO Branch, FAA, 1801 S Airport Road, Wichita, KS
67209. Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA received a report of a fuel leak due to a cracked fuel line
between the engine fuel control and the engine fuel flow meter on a
Learjet Model 45 (Learjet 45) airplane. There are four different Model
45 configurations: Model 45 (Learjet 40), Model 45 (Learjet 45), Model
45 (Learjet 70), and Model 45 (Learjet 75). They all are susceptible to
cracked fuel lines with possible fuel leakage because the fuel flow
meter bracket and fuel line is common to each model. Further analysis
of the fleet of all the 45 models revealed similar failures in this
area including the following: 16 fuel line failures, 2 instances of
multiple inlet attaching bolts breaking, 9 leaking fuel controls, a
broken gearbox strut, 4 cracked No. 6 bearing oil supply lines, and 7
cracked engine oil tanks. The FAA evaluated the flammable fluid leaks
and broken parts and determined that they may have resulted from
vibration.
    Following the above report and analysis, Learjet designed a new
engine fuel flow meter bracket and incorporated it during production.
The unsafe condition, if not addressed, could result in an engine
installation fire, which could progress to an uncontrolled fire and
consequent loss of control of the airplane.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Bombardier Learjet 40 Service Bulletin (SB) SB 40-
73-01, Revision 1, Bombardier Learjet 45 SB 45-73-2, Revision 1,
Bombardier Learjet 70 SB 70-73-01, Revision 1, and Bombardier Learjet
75 SB 75-73-01, Revision 2, all dated January 9, 2017. This service
information specifies procedures for replacing the existing fuel flow
meter bracket assembly with a redesigned bracket assembly with pad fuel
flow meter that has an increased material thickness. These documents
are distinct since they apply to different airplane models. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information already described, except as discussed under
``Differences Between this Proposed AD and the Service Information.''

Differences Between This Proposed AD and the Service Information

    This proposed AD would require reporting certain maintenance
information to the FAA, where the service information does not. The
information provided in the reports would be related to contributing
factors that the FAA found showed a correlation between the reported
engine fan vibration levels and the cracking fuel line between engine
fuel control and the engine fuel flow meter and a correlation between
the cracking fuel line and a certain batch of fan disks. In addition,
the FAA found that a contributing factor could be the susceptibility of
the fuel flow meter bracket assembly and the susceptibility of the
bracket assembly with pad fuel flow meter to the vibration induced. The
requested reporting information would allow the FAA to determine
whether further rulemaking action would be necessary to mitigate the
unsafe condition.
    Also, the effectivity of Bombardier Learjet 45 SB 45-73-2, Revision
1, dated January 9, 2017, begins with serial number 45-005. This
proposed AD would also apply to airplane serial numbers 45-002 through
45-004 because, although these three airplanes are not currently in
service, they are subject to the unsafe condition. Thus, it is
necessary to include them in the event they are returned to service.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 443 airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
             Action                    Labor cost              Parts cost             product        operators
----------------------------------------------------------------------------------------------------------------
Replacing the bracket assembly..  4.5 work-hours x     $3,895...................       $4,277.50   $1,894,932.50
                                   $85 per hour =
                                   $382.50.
Reporting and reviewing logbooks  9 work-hours x $85   Not Applicable...........             765         338,895
                                   per hour = $765.
----------------------------------------------------------------------------------------------------------------

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 9 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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
tween 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:

Learjet Inc.: Docket No. FAA-2021-0660; Project Identifier AD-2021-
00398-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 27, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Learjet Inc. Model 45 (Learjet 40), Model 45
(Learjet 45), Model 45 (Learjet 70), and Model 45 (Learjet 75)
airplanes, serial numbers 45-002 through 45-556 and 45-2001 through
45-2146, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7100, Powerplant
System.

(e) Unsafe Condition

    This AD was prompted by a report of a fuel leak due to a cracked
fuel line between the engine fuel control and the engine fuel flow
meter. The FAA is issuing this AD to prevent cracking and failures.
The unsafe condition, if not addressed, could result in an engine
installation fire, which could progress to an uncontrolled fire and
consequent loss of control of the airplane.

(f) Compliance

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

(g) Reporting Requirement

    Within 60 days after the effective date of this AD, report the
following information, where available, to the Wichita ACO Branch
via email at<EMAIL_ADDRESS>5d293532303c2e7329382d3134361d3b3c3c733a322b, and
<EMAIL_ADDRESS>or by mail to Wichita ACO Branch, Attn: James
Galstad/Thomas Teplik, 1801 S Airport Road, Room 100, Wichita, KS
67209.
    (1) Name of the owner; the address of the owner; name of the
organization doing the actions required by this AD; the date the
actions were completed; the name of the person submitting the
report; the address, telephone number, and email of the person
submitting the report.
    (2) The fan vibration levels that have been recorded in the
airplane and engine maintenance records since November 1, 2019.
Include the airplane and engine serial numbers.
    (3) The date of each vibration level recorded and the associated
hours time-in-service for the airplane and each engine.
    (4) For each fan vibration level reported, include:
    (i) Whether molybdenum coating for the fan was applied per
Temporary Revision 72-494, dated August 15, 2017 (or as subsequently
incorporated into the engine's Inspection/Repair Manual TFE731 (ATA
Number 72-IR-02).
    (ii) If molybdenum coating was applied using a different process
than Temporary Revision 72-494, dated August 15, 2017 (or as
subsequently incorporated into the engine's Inspection/Repair Manual
TFE731 (ATA Number 72-IR-02), report the process by which the
molybdenum coating was applied and the revision level of the
document defining the application process for the molybdenum
coating.

    Note 1 to paragraph (g)(4): Temporary Revision 72-494, dated
August 15, 2017, specifies applying a dry film lubricant on the
mating surfaces of the fan hub and the fan blades. The lubricating
solid for this dry film lubricant is molybdenum disulfide, which is
referred to in this AD as molybdenum coating.

    (5) For each fan vibration level reported, the fan hub serial
number and hours time-in-service for this fan hub.
    (6) Installation date and service bulletin (SB) revision level
for the installation of the bracket assembly with pad fuel flow
meter and hose if installed before the effective date of this AD.
    (7) Any failures of the bracket assembly with pad fuel flow
meter and hose installed in accordance with any SB listed in
paragraph (h) or any prior revision of these SBs.
    (8) Installation date and SB revision level used for
installation of the fuel control screws within the engine fuel
control in accordance with Honeywell SB TFE731-73-5146
    (9) Any failures of fuel control screws after compliance with
Honeywell SB TFE731-73-5146.

(h) Replacement

    Within 12 months after the effective date of this AD or 750
hours time-in-service after the effective date of this AD, whichever
occurs first, replace the engine fuel flow meter bracket in
accordance with the Accomplishment Instructions, paragraphs 3.A
through 3.C, of the following Bombardier SB applicable to your
airplane model.
    (1) Bombardier Learjet 40 SB 40-73-01, Revision 1, dated January
9, 2017.
    (2) Bombardier Learjet 45 SB 45-73-2 Revision 1, dated January
9, 2017.
    (3) Bombardier Learjet 70 SB 70-73-01 Revision 1, dated January
9, 2017.
    (4) Bombardier Learjet 75 SB 75-73-01, Revision 2, dated January
9, 2017.

 (i) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Bombardier Learjet 40 SB 40-73-01,
Basic Issue, Bombardier Learjet 45 Service Bulletin SB 45-73-2,
Basic Issue, Bombardier Learjet 70 SB 70-73-01, Basic Issue, or
Bombardier Learjet 75 SB 75-73-01, Basic Issue, all dated October 3,
2016, or Bombardier Learjet 75 SB 75-73-01, Revision 1, dated
October 10, 2016.
    (2) To take credit for any previous action, you must comply with
paragraph (g) of this AD within 60 days after the effective date of
this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita 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 local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in Related Information.
    (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.

(k) Related Information

    (1) For more information about this AD, contact James Galstad,
Aviation Safety Engineer, Wichita ACO Branch, FAA, 1801 S Airport
Road, Wichita, KS 67209; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>or 6b3c020803021f0a462824382b0d0a0a450c041d; or Thomas Teplik,
Aviation Safety Engineer, Wichita ACO Branch, FAA, 1801 S Airport
Road, Wichita, KS 67209; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Learjet Inc., One Learjet Way, Wichita, KS, 67209; phone: (316) 946-
2000; email<EMAIL_ADDRESS>website: https://businessaircraft.bombardier.com/en/aircraft/Learjet.html. You may
view this referenced service information at the FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, MO 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    Issued on August 5, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-17044 Filed 8-12-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Rules and Regulations]
[Pages 54492-54495]
[FR Doc No: 2019-22152]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0441; Product Identifier 2019-NM-036-AD; Amendment
39-19753; AD 2019-19-17]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2000-03-20
R1, which applied to all Airbus SAS Model A300 B4-601, B4-603, and B4-
620, Model A300 B4-600R series, and Model A300 F4-605R airplanes. AD
2000-03-20 R1 required repetitive inspections to detect cracks on the
forward fittings in the radius of a certain frame, adjacent to the
tension bolts in the center section of the wings, and various follow-on
actions. This AD retains the requirements of AD 2000-03-20 R1, adds new
airplanes to the applicability, and introduces new compliance times for
the required inspections, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. This AD
was prompted by reports of cracking due to fatigue-related stress in
the radius of frame 40, adjacent to the tension bolts at the center/
outer wing junction. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective November 14, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 14,
2019.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0441.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0441; 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 regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South

216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2000-03-20 R1, Amendment 39-12298 (66 FR
34530, June 29, 2001) (``AD 2000-03-20 R1''). AD 2000-03-20 R1 applied
to all Airbus SAS Model A300 B4-601, B4-603, and B4-620, Model A300 B4-
600R series, and Model A300 F4-605R airplanes. The NPRM published in
the Federal Register on June 17, 2019 (84 FR 27990). The NPRM was
prompted by reports of cracking due to fatigue-related stress in the
radius of frame 40, adjacent to the tension bolts at the center/outer
wing junction. The NPRM proposed to require initial and repetitive
ultrasonic (UT) and high frequency eddy current (HFEC) inspections and
applicable corrective actions. The FAA is issuing this AD to address
fatigue cracking on the forward fittings in the radius of frame 40,
adjacent to the tension bolts in the center section of the wings, which
could result in reduced structural integrity of the wings.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0044, dated March 7, 2019
(``EASA AD 2019-0044'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A300 B4-600 series, Model A300
B4-600R series, Model A300 F4-605R, and Model A300 C4-605R Variant F
airplanes. See the MCAI for additional background information.

Comment

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comment
received. Patrick Imperatrice indicated support for the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0044 describes procedures for initial and repetitive
UT and HFEC inspections and applicable corrective actions. Corrective
actions include reworking the fuselage lateral panel at frame 40,
blending out around cracks, and repair. 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 65 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.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2000-03-20 R1  2 work-hours x $85 per                $0            $170         $11,050
                                         hour = $170.
New actions...........................  161 work-hours x $85 per               0          13,685         889,525
                                         hour = $13,685.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for reporting.

    The FAA estimates that it would take about 1 work-hour per product
to comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, the FAA estimates the
cost of reporting the inspection results on U.S. operators to be
$5,525, or $85 per product.
    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition actions specified
in this AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    The FAA has determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2000-03-20 R1, Amendment 39-12298 (66 FR 34530, June 29, 2001), and
adding the following new AD:

2019-19-17 Airbus SAS: Amendment 39-19753; Docket No. FAA-2019-0441;
Product Identifier 2019-NM-036-AD.

(a) Effective Date

    This AD is effective November 14, 2019.

(b) Affected ADs

    This AD replaces AD 2000-03-20 R1, Amendment 39-12298 (66 FR
34530, June 29, 2001) (``AD 2000-03-20 R1'').

(c) Applicability

    This AD applies to Airbus SAS airplanes identified in paragraphs
(c)(1) through (4) of this AD, certificated in any category, as
identified in European Union Aviation Safety Agency (EASA) AD 2019-
0044, dated March 7, 2019 (``EASA AD 2019-0044'').
    (1) Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.
    (2) Model A300 B4-605R and B4-622R airplanes.
    (3) Model A300 F4-605R airplanes.
    (4) Model A300 C4-605R Variant F airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by reports of cracking due to fatigue-
related stress in the radius of frame 40, adjacent to the tension
bolts at the center/outer wing junction. The FAA is issuing this AD
to address fatigue cracking on the forward fittings in the radius of
frame 40, adjacent to the tension bolts in the center section of the
wings, which could result in reduced structural integrity of the
wings.

(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, EASA AD 2019-0044.

(h) Exceptions to EASA AD 2019-0044

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0044 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0044 does not apply
to this AD.
    (3) Paragraph (5) of EASA AD 2019-0044 specifies to report all
inspection results to Airbus. For this AD, report all inspection
results to Airbus Service Bulletin Reporting Online Application on
Airbus World (https://w3.airbus.com/) at the applicable time
specified in paragraph (h)(3)(i) or (ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.
    (4) For Model A300 B4-622 and A300 C4-605R Variant F airplanes:
The initial compliance time for the inspections required by EASA AD
2019-0044 is at the applicable time specified in EASA AD 2019-0044,
or within 12 months after the effective date of this AD, whichever
occurs later.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (j) of this AD. Information may
be emailed to<EMAIL_ADDRESS>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.
    (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
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0044 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.
    (4) Paperwork Reduction Act Burden Statement: A federal agency
may not conduct or sponsor, and a person is not required to respond
to, nor shall a person be subject to a penalty for failure to comply
with a collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 1
hour per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW, Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(j) Related Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(k) 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.
    (3) The following service information was approved for IBR on
November 14, 2019.
    (i) European Union Aviation Safety Agency (EASA) AD 2019-0044,
dated March 7, 2019.
    (ii) [Reserved]
    (4) For information about EASA AD 2019-0044, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email

<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (5) You may view this material at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. This
material may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0441.
    (6) 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_ADDRESS>or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on September 24, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-22152 Filed 10-9-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 28 (Tuesday, February 11, 2020)]
[Notices]
[Pages 7778-7779]
[FR Doc No: 2020-02634]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0007; OMB No. 1660-0143]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Federal Emergency Management Agency Individual
Assistance Customer Satisfaction Surveys

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take the opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the collection of Individual
Assistance customer satisfaction survey responses and information for
assessment and improvement of the delivery of disaster assistance to
individuals and households.

DATES: Comments must be submitted on or before April 13, 2020.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2020-0007. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW, Room 8NE, Washington, DC
20472-3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy and
Security Notice that is available via the link on the homepage of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jessica Guillory, Statistician,
Customer Survey & Analysis Section, Recovery Directorate, FEMA at
<EMAIL_ADDRESS>You may contact the Records Management
Division for copies of the proposed collection of information at email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This collection is in accordance with
Executive Orders 12862 and 13571 requiring all Federal agencies to
survey customers to determine the kind and quality of services they
want and their level of satisfaction with existing services. The
Government Performance and Results Act (GPRA) requires agencies to set
missions and goals and measure performance against them and the GPRA
Modernization Act of 2010 requires quarterly performance assessments of
government programs for the purposes of assessing agency performance
and improvement. FEMA will fulfill these requirements by collecting
customer satisfaction program information through surveys of the
Recovery Directorate's external customers.

Collection of Information

    Title: Federal Emergency Management Agency Individual Assistance
Customer Satisfaction Surveys.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0143.
    FEMA Forms: FEMA Form 519-0-36, Initial Survey--Phone, FEMA Form
519-0-37, Initial Survey--Electronic; FEMA Form 519-0-38, Contact
Survey--Phone, FEMA Form 519-0-39, Contact Survey--Electronic; FEMA
Form 519-0-40, Assessment Survey--Phone, FEMA Form 519-0-41, Assessment
Survey--Electronic.
    Abstract: Federal agencies are required to survey their customers
to determine the kind and quality of services customers want and their
level of satisfaction with those services. Analysis from the survey is
used to measure FEMA's Strategic Plan's objective 3.1 Streamline the
Disaster Survivor Experience.
    Affected Public: Individuals or households.
    Estimated Number of Respondents: 38,864.
    Estimated Number of Responses: 38,864.
    Estimated Total Annual Burden Hours: 8,982.
    Estimated Total Annual Respondent Cost: $327,573
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $1,785,889.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the

accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) enhance the quality, utility, and clarity of
the information to be collected; and (d) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Maile Arthur,
Acting Records Management Program Chief, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2020-02634 Filed 2-10-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47545-47546]
[FR Doc No: 2017-22035]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0001]

Notice of Adjustment of Disaster Grant Amounts

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: FEMA gives notice of an adjustment to the threshold for Small
Project subgrants made to state, tribal, and local governments and
private nonprofit facilities for disasters declared on or after October
1, 2017.

DATES: This adjustment applies to major disasters and emergencies
declared on or after October 1, 2017.

FOR FURTHER INFORMATION CONTACT: Christopher Logan, Recovery
Directorate, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207, as amended by the Sandy
Recovery Improvement Act, Public Law 113-2, provides that FEMA will
annually adjust the threshold for assistance provided under section
422, Simplified Procedures, relating to the Public Assistance program,
to reflect changes in the Consumer Price Index for All Urban Consumers
published by the Department of Labor.
    FEMA gives notice that $125,500 is the threshold for any Small
Project subgrant made to state, tribal, and local governments or to the
owner or operator of an eligible private nonprofit facility under
section 422 of the Stafford Act for all major disasters or emergencies
declared on or after October 1, 2017.

    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.9 percent for the 12-month period
that ended in August 2017. This is based on information released by the
Bureau of Labor Statistics at the U.S. Department of Labor on September
14, 2017.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-22035 Filed 10-11-17; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Rules and Regulations]
[Pages 63840-63841]
[FR Doc No: 2011-26524]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0893]

Drawbridge Operation Regulation; Corson Inlet, Strathmere, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander Fifth Coast Guard District has issued a
temporary deviation from the regulations governing the operation of the
Corson Inlet Bridge (County Route 619), at mile 0.9, across Corson
Inlet, in Strathmere, NJ. The deviation is necessary to facilitate the
replacement of the steel railing. This deviation restricts operation of
the draw span by not allowing openings during the project while the
railings on the moveable span portion of the bridge are replaced.

DATES: This deviation is effective from 5 a.m. on October 17, 2011
until 5 p.m. on November 17, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0893 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0893 in the
``Keyword'' box and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Terrance Knowles, Environmental Protection Specialist,
Fifth Coast Guard District; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the
docket,

call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: The Cape May County Bridge Commission, who
owns and operates this bascule drawbridge, has requested a temporary
deviation from the current operating regulations set out in 33 CFR
117.714 to facilitate the replacement of the bridge railings.
    The Corson Inlet Bridge (CR-619) at mile 0.9, across Corson Inlet
in Strathmere, NJ has a vertical clearance in the closed position to
vessels of 15 feet above mean high water. Though the span will be
closed for the project, the 15 feet of vertical navigation clearance
will remain available throughout the project. Furthermore, the 50 feet
of horizontal clearance will be reduced to 25 feet temporarily only if/
when barges are used beneath the span.
    Under this temporary deviation, the Corson Inlet Bridge will be
closed to vessels requiring an opening from 5 a.m. on October 17, 2011
until 5 p.m. on November 17, 2011. The drawbridge will not be able to
open in the event of an emergency. Vessels that can pass under the
bridge without a bridge opening may do so at all times. Vessels have an
alternate ocean route to the south through Townsends Inlet.
    There were no bridge openings provided in 2010. The Coast Guard has
coordinated the restrictions with the Cape May County Bridge
Commission/contractor and will inform the other users of the waterways
through our Local and Broadcast Notices to Mariners of the closure
periods for the bridge so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 30, 2011.
Waverly W. Gregory, Jr.,
Bridge Program Manager, By direction of the Commander, Fifth Coast
Guard District.
[FR Doc. 2011-26524 Filed 10-13-11; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Page 79754]
[FR Doc No: 2011-32858]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Recording of
Aircraft Conveyances and Security Documents

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. Approval is needed for security reasons such as mortgages
submitted by the public for recording against aircraft, engines,
propellers, and spare parts locations.

DATES: Written comments should be submitted by February 21, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: OMB Control Number: 2120-0043.
    Title: Recording of Aircraft Conveyances and Security Documents.
    Form Numbers: FAA Form 8050-41.
    Type of Review: Renewal of an information collection.
    Background: Title 49, U.S.C. Section 44108 provides for
establishing and maintaining a system for the recording of security
conveyances affecting title to, or interest in U.S. civil aircraft, as
well as certain specifically identified engines, propellers, or spare
parts locations, and for recording of releases relating to those
conveyances. The original security conveyance is examined by the Civil
Aviation Registry to insure that it meets recording requirements as set
forth in FAR Part 49. If it does, it is given a recording number and
made a permanent part of the aircraft record.
    Respondents: Approximately 45,469 lienholders.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 45,469 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on December 15, 2011.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2011-32858 Filed 12-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35869-35871]
[FR Doc No: 2019-15831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0994]

Modified Risk Tobacco Product Applications for VLNTM King and
VLNTM Menthol King, Combusted, Filtered Cigarettes,
Submitted by 22nd Century Group, Inc.

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of modified risk tobacco product
applications (MRTPAs) for VLNTM King and VLNTM
Menthol King, combusted, filtered cigarettes, submitted by 22nd Century
Group, Inc.

DATES: Electronic or written comments on the application may be
submitted beginning July 25, 2019. FDA will establish a closing date
for the comment period as described in section I.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-0994 for ``Modified Risk Tobacco Product Applications for
VLNTM King and VLNTM Menthol King, Combusted,
Filtered Cigarettes Submitted by 22nd Century Group Inc.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not

in the body of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read the electronic and
written/paper comments received, go to https://www.regulations.gov and
insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 387k) addresses the marketing and distribution of modified
risk tobacco products (MRTPs). MRTPs are tobacco products that are sold
or distributed for use to reduce harm or the risk of tobacco-related
disease associated with commercially marketed tobacco products. Section
911(a) of the FD&C Act prohibits the introduction or delivery for
introduction into interstate commerce of any MRTP unless an order
issued by FDA pursuant to section 911(g) of the FD&C Act is effective
with respect to such product.
    Section 911(d) of the FD&C Act describes the information that must
be included in a MRTPA, which must be filed and evaluated by FDA before
an applicant can receive an order from FDA. FDA is required by section
911(e) of the FD&C Act to make a MRTPA available to the public (except
for matters in the application that are trade secrets or otherwise
confidential commercial information) and to request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying the application.
The determination of whether an order is appropriate under section 911
of the FD&C Act is based on the scientific information submitted by the
applicant as well as the scientific evidence and other information that
is made available to the Agency, including through public comments.
    Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA under either section
911(g)(1) or (g)(2). The applicant, 22nd Century Group, Inc., is
seeking an order under section 911(g)(2) of the FD&C Act.
    FDA may issue an order under section 911(g)(2) of the FD&C Act with
respect to a tobacco product that does not satisfy the section
911(g)(1) standard. A person seeking an order under section 911(g)(2)
of the FD&C Act must show that:
     Such an order would be appropriate to promote the public
health;
     any aspect of the label, labeling, and advertising for the
product that would cause the product to be an MRTP is limited to an
explicit or implicit representation that the tobacco product or its
smoke does not contain or is free of a substance or contains a reduced
level of a substance, or presents a reduced exposure to a substance in
tobacco smoke;
     scientific evidence is not available and, using the best
available scientific methods, cannot be made available without
conducting long-term epidemiological studies for an application to meet
the standards for obtaining an order under section 911(g)(1);
     the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity or mortality among
individual tobacco users is reasonably likely in subsequent studies;
     the magnitude of overall reductions in exposure to the
substance or substances which are the subject of the application is
substantial, such substance or substances are harmful, and the product
as actually used exposes consumers to the specified reduced level of
the substance or substances;
     the product as actually used by consumers will not expose
them to higher levels of other harmful substances compared to the
similar types of tobacco products then on the market unless such
increases are minimal and the reasonably likely overall impact of use
of the product remains a substantial and measurable reduction in
overall morbidity and mortality among individual tobacco users;
     testing of actual consumer perception shows that, as the
applicant proposes to label and market the product, consumers will not
be misled into believing that the product is or has been demonstrated
to be less harmful or presents or has been demonstrated to present less
of a risk of disease than one or more other commercially marketed
tobacco products; and
     issuance of an order with respect to the application is
expected to benefit the health of the population as a whole taking into
account both users of tobacco products and persons who do not currently
use tobacco products.
    Section 911(g)(4) of the FD&C Act describes factors that FDA must
take into account in evaluating whether a tobacco product satisfies the
requirements in section 911(g)(2).
    FDA is issuing this notice to inform the public that the MRTPAs for
the following products submitted by 22nd Century Group, Inc. have been
filed and are being made available for public comment:

 MR0000140: VLNTM King
 MR0000141: VLNTM Menthol King

    FDA will post the application documents, including any amendments,
to its website for the MRTPAs (see section II) for public comment on a
rolling basis as they are redacted in accordance with applicable laws.
In this document, FDA is announcing the availability of the first batch
of application documents for public comment. FDA intends to establish a
closing date for the comment period that is both at least 180 days
after the date of this notice and at least 30 days after the final
documents from the applications are made available for public comment.
FDA will announce the closing date at least 30 days in advance. FDA
believes that this comment period is appropriate given the volume and
complexity of the applications being posted.
    FDA will notify the public about the availability of additional
application documents and the comment period closing date via the
Agency's web page for the MRTPAs (see section II) and by other means of
public communication, such as by email to individuals who have signed
up to receive email alerts. FDA does not intend to issue additional
notices in the Federal Register regarding the availability of
additional application documents, including amendments, or the comment
period for these MRTPAs. To receive email alerts, visit FDA's email
subscription service management website (https://updates.fda.gov/subscriptionmanagement), provide an email address, scroll down to the
``Tobacco'' heading, select ``Modified Risk Tobacco Product Application
Update,'' and click ``Submit.'' To encourage public participation

consistent with section 911(e) of the FD&C Act, FDA is making the
redacted MRTPAs that are the subject of this notice available
electronically (see section II).

II. Electronic Access

    Persons with access to the internet may obtain the documents at
https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications.

    Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15831 Filed 7-24-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Rules and Regulations]
[Pages 61118-61122]
[FR Doc No: 2015-25690]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0043; FRL-9934-74]

Trans-1,3,3,3-tetrafluoroprop-1-ene; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of trans-1,3,3,3-tetrafluoroprop-1-ene (CAS
Reg. No. 29118-24-9) when used as an inert ingredient (propellant) in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals, and when used as an inert
ingredient in antimicrobial pesticide formulations for food-contact
surface sanitizing solutions. The Acta Group, L.L.C. on behalf of
Honeywell International, Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of trans-1,3,3,3-tetrafluoroprop-1-ene.

DATES: This regulation is effective October 9, 2015. Objections and
requests for hearings must be received on or before December 8, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0043, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0043 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 8, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0043, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 1E7938) by The
Acta Group, L.L.C. (2200 Pennsylvania Avenue NW., Suite 100W,
Washington, DC 20037) on behalf of Honeywell International, Inc., 101
Columbia Road, Morristown, NJ 07962. The petition requested that 40 CFR
180.910, 180.930 and 180.940(a) be amended by establishing an exemption
from the requirement of a tolerance for residues of trans-1,3,3,3-
tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an inert
ingredient (propellant) in pesticide formulations applied to growing
crops, raw agricultural commodities after harvest, and animals, and
when used as an inert ingredient in antimicrobial pesticide
formulations for food-contact surface sanitizing solutions,
respectively. That document referenced a summary of the petition
prepared by The Acta Group, L.L.C. on behalf of Honeywell
International, Inc., the petitioner, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the

inert ingredient through food, drinking water, and through other
exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for trans-1,3,3,3-tetrafluoroprop-
1-ene including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
trans-1,3,3,3-tetrafluoroprop-1-ene follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by trans-1,3,3,3-tetrafluoroprop-1-ene as
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
    Acute inhalation toxicity is low for trans-1,3,3,3-tetrafluoroprop-
1-ene. Acute inhalation LD50s are >101,850 parts per million
(ppm); approximately 713 milligram/kilogram (mg/kg) in rats and mice.
Trans-1,3,3,3-tetrafluoroprop-1-ene is not a dermal irritant in rabbits
or a sensitizer in humans.
    Two subchronic toxicity studies via the inhalation route of
exposure are available for trans-1,3,3,3-tetrafluoroprop-1-ene in
rodents. Toxicity is not observed in rats or mice at doses as high as
5,000 ppm (approximately equivalent to 7,800 milligram/kilogram/day
(mg/kg/day) human equivalent dose) following 13 weeks and 90 days of
exposure, respectively. The 90-day inhalation toxicity study in mice
also evaluated the carcinogenic potential of trans-1,3,3,3-
tetrafluoroprop-1-ene by conducting a toxicogenomic assessment. Trans-
1,3,3,3-tetrafluoroprop-1-ene is classified as non-carcinogenic by the
toxicogenomic assessment at 10,000 ppm (approximately equivalent to
15,600 mg/kg/day human equivalent dose), the highest dose tested (HDT).
    Developmental toxicity studies via the inhalation route are
available in rats and rabbits. Neither maternal nor developmental
toxicity is observed in either study up to 15,000 ppm (approximately
equivalent to 23,400 mg/kg/day human equivalent dose), the HDT.
    Two Ames Tests via gas exposure are available for review with
trans-1,3,3,3-tetrafluoroprop-1-ene. The mouse micronucleus assay was
performed via inhalation exposure. These tests are negative.
    A chronic study with trans-1,3,3,3-tetrafluoroprop-1-ene is not
available for review. Although a chronic toxicity study is not
available, there is no concern for the lack of it because toxicity is
not seen following up to 13 weeks of exposure to trans-1,3,3,3-
tetrafluoroprop-1-ene at excessive doses (7,800 and 15,600 mg/kg/day).
Also, toxicity is not seen in the developmental study at an excessive
dose of 23,400 mg/kg/day. Therefore, the likelihood that chronic
exposure to doses below the limit dose will result in toxic effects is
highly unlikely.
    Neurotoxicity studies are not available for review. However,
evidence of neurotoxicity is not observed in the submitted inhalation
studies.
    Immunotoxicity studies are not available for review. However, very
slight mononuclear cell infiltrates in the heart are observed in only
females (3/5) at the LOAEL of =5,000 ppm (approximately
7,800 mg/kg/day human equivalent dose lowest dose tested) following 10
days of exposure via inhalation in Sprague Dawley rats. This effect is
not dose dependent with regard to either incidence or severity. Similar
effects along with increased monocyte count are observed in the heart
at 15,000 ppm (approximately 23,400 mg/kg/day human equivalent dose;
HDT) in a 13-week study via inhalation in Sprague Dawley rats. The
NOAEL is 5,000 ppm (equivalent to 7,800 mg/kg/day human equivalent
dose). This study included more rats, is conducted in the same species
of rats that underwent the same route of exposure and was of longer
duration (13 weeks vs 10 days). Mononuclear cell infiltrates in the
heart are not observed at 5,000 ppm (equivalent to 7,800 mg/kg/day
human equivalent dose) in either the male or female rat as was observed
in the 10-day study. Therefore, since the incidence and severity of
these effects are not dose-dependent in the 10-day study, the 13-week
study is considered more reflective of toxicity resulting from exposure
to trans-1,3,3,3-tetrafluoroprop-1-ene. However, the Agency is not
concerned about these effects since they occur well above the limit
dose and exposure above that is highly unlikely and unrealistic.
    Two studies are available for trans-1,3,3,3-tetrafluoroprop-1-ene
on male rats and mice metabolism and pharmacokinetics. In rats and
mice, trans-1,3,3,3-tetrafluoroprop-1-ene via the inhalation route of
exposure is rapidly absorbed, metabolized and excreted. The urine is
the major route of excretion. In rats, the major metabolite is S-
(3,3,3-trifluoro-trans-propenyl)-mercaptolactic acid. In mice, the
major metabolite is a presumed amino acid conjugate of 3, 3, 3-
trifluoropropionic acid. Other identified metabolites are S-(3, 3, 3-
trifluoro-transpropenyl)-L-cysteine, N-acetyl-S-(3,3,3-trifluoro-trans-
propenyl)-L-cysteine and 3,3,3-trifluoropropionic acid.
    Specific information on the studies received on trans-1,3,3,3-
tetrafluoroprop-1-ene as well as the no-observed-adverse-effect level
(NOAEL) and the lowest- observed- adverse-effect level (LOAEL) from the
toxicity studies can be found at http://www.regulations.gov in the
document, ``Trans-1,3,3,3-tetrafluoroprop-1-ene; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2012-0043.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that trans-1,3,3,3-
tetrafluoroprop-1-ene has very low overall toxicity. The lowest NOAEL
in the database was 5,000 ppm (approximately 7,800 mg/kg/day human
equivalent dose) observed in a 13 week toxicity study in rats via the
inhalation route of exposure. Since signs of toxicity were not observed
at well above the limit dose an endpoint of concern for risk assessment
purposes was not identified.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trans-1,3,3,3-tetrafluoroprop-1-ene, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from trans-1,3,3,3-
tetrafluoroprop-1-ene in food as follows:

    The general population may be exposed via the diet to trans-
1,3,3,3-tetrafluoroprop-1-ene as a result of eating foods containing
residues of trans-1,3,3,3-tetrafluoroprop-1-ene. However, since a
hazard endpoint of concern was not identified for the acute and chronic
dietary assessment (food and drinking water), a dietary exposure risk
assessment was not conducted.
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    The term ``residential exposure'' is used in this document to refer
to non-occupational, non-dietary exposure (e.g., textiles (clothing and
diapers), carpets, swimming pools, and hard surface disinfection on
walls, floors, tables). Trans-1,3,3,3-tetrafluoroprop-1-ene may be used
as an inert ingredient in pesticide products that could result in
short- and intermediate-term residential exposure. However, based on
the lack of toxicity, a quantitative exposure assessment from
residential exposures was not performed.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found trans-1,3,3,3-tetrafluoroprop-1-ene to share a
common mechanism of toxicity with any other substances, and trans-
1,3,3,3-tetrafluoroprop-1-ene does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that trans-1,3,3,3-
tetrafluoroprop-1-ene does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
Safety Factor (FQPA SF). In applying this provision, EPA either retains
the default value of 10X, or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor.
    As part of its qualitative assessment, the Agency did not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children. Based on the lack of
effects in subchronic and developmental toxicity studies, and an
assessment of trans-1,3,3,3-tetrafluoroprop-1-ene, EPA has concluded
that there are no toxicological endpoints of concern for the U.S.
population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA
concludes that aggregate exposure to residues of trans-1,3,3,3-
tetrafluoroprop-1-ene will not pose a risk to the U.S. population,
including infants and children, and that there is a reasonable
certainty that no harm will result to the general population, or to
infants and children from aggregate exposure to trans-1,3,3,3-
tetrafluoroprop-1-ene residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910, 180.930 and 180.940(a) for trans-
1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an
inert ingredient (propellant) in pesticide formulations applied to
formulations applied to growing crops, raw agricultural commodities
after harvest, and animals, and when used as an inert ingredient in
antimicrobial pesticide formulations for food-contact surface
sanitizing solutions, respectively.

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or

contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 1, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910, add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

----------------------------------------------------------------------------------------------------------------
               Inert ingredients                      Limits                            Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg.   ..................  Propellant.
 No. 29118-24-9).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. In Sec.  180.930 add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

----------------------------------------------------------------------------------------------------------------
               Inert ingredients                      Limits                            Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg.   ..................  Propellant.
 No. 29118-24-9).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
4. In Sec.  180.940(a), add alphabetically the inert ingredient to the
table to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solution).

    (a) * * *

----------------------------------------------------------------------------------------------------------------
              Pesticide chemical                   CAS Reg. No.                        Limits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene...........         29118-24-9   None.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-25690 Filed 10-8-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Notices]
[Page 29611]
[FR Doc No: 2016-11312]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Unified Carrier Registration Plan Board of Directors
Meeting.

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

TIME AND DATE: The meeting will be held on June 8, 2016, from 9:00 a.m.
to 1:00 p.m. Eastern Daylight Time.

PLACE: The meetings will be open to the public at the Courtyard
Providence Downtown by Marriott, 32 Exchange Terrace at Memorial Blvd.,
Providence, RI 02903, and via conference call. Those not attending the
meetings in person may call 1-877-422-1931, passcode<PHONE_NUMBER>, to
listen and participate in the meetings.

STATUS:  Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: May 6, 2016.
Larry W. Minor,
Associate Administrator, Office of Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2016-11312 Filed 5-10-16; 4:15 pm]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4478-4479]
[FR Doc No: 2018-01899]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2002-0011; FRL-9973-14-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Laboratory Quality Assurance Evaluation
Program for Analysis of Cryptosporidium Under the Safe Drinking Water
Act (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR)--Laboratory Quality Assurance
Evaluation Program for Analysis of Cryptosporidium Under the Safe
Drinking Water Act, EPA ICR No. 2067.06, OMB Control No. 2040-0246--to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through March 31,
2018. Public comments were previously requested via the Federal
Register on October 16, 2017, during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before March 2, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2002-0011, to (1) EPA online using www.regulations.gov (our preferred
method), by email to [email protected], or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Dan Hautman, Technical Support Center
(TSC), Office of Ground Water and Drinking Water, (MC-140),
Environmental Protection Agency, 26 West Martin Luther King Drive,
Cincinnati, Ohio 45268; telephone number:<PHONE_NUMBER>; fax number:
513-569-7191; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Under the Long Term 2 Enhanced Surface Water Treatment
Rule (LT2ESWTR), EPA requires public water systems (PWS) to use
approved laboratories when conducting Cryptosporidium monitoring. The
Code of Federal Regulations (CFR) at 40 CFR 141.705(a) provides for
approval of Cryptosporidium laboratories by ``an equivalent'' state
laboratory certification program (i.e., equivalent to EPA's Laboratory
Quality Assurance Evaluation Program). In the preamble to the LT2ESWTR
as well as several other notices, EPA has described the criteria for
approval of laboratories to analyze Cryptosporidium samples under the
LT2ESWTR.
    Form Numbers: None.
    Respondents/affected entities: Interested states and laboratories.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 43 labs and 20 states/territories.
    Frequency of response: Annual.
    Total estimated burden: 3,741 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $669,490, includes $332,891 annualized
capital or operation & maintenance (O&M) costs.

    Changes in Estimates: There is a decrease of 1,731 hours and
$134,284 in the total estimated respondent burden compared with the ICR
currently approved by OMB. This decrease is due to a reduced number of
laboratories (45 to 43), re-evaluation of hours for tasks, and an
improved demonstration of capability by the laboratories.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-01899 Filed 1-30-18; 8:45 am]
 BILLING CODE 6560-50-P