                             Response to Comments
                  2014 Revised Shelby County Maintenance Plan

The Pollution Control Section of the Shelby County Health Department (Department) prepared a draft revision of the federally approved 2010 Maintenance Plan (Federal Register/Vol.75, No. 1/Monday, January 4, 2010) for public review and comment prior to submission for approval by the Tennessee Air Pollution Control Board and subsequent submission to the United States Environmental Protection Agency (EPA) for their consideration and approval. The required 30-day public comment period was formally opened on January 31, 2014 with the publication of a notice in the Memphis Daily News. In accordance with the Department's public notice protocol, electronic notice was sent to a list of interested individuals and local elected bodies on January 29, 2014. In addition, electronic notice was sent to local members of the Metropolitan Planning Organization (MPO) and the MPO distributed an electronic message on February 3, 2014. A press release was made by Shelby County Government on January 31, 2014, announcing the availability of the plan for review and comment.

Two public hearings were scheduled and held. One was held at the Benjamin L. Hooks Central Library in Memphis, Tennessee on Tuesday, March 4, 2014 at 6:00PM. The second public hearing was held at the Baker Community Center in Millington, Tennessee on Thursday, March 6, 2014 at 6:00PM. The comment period ended at the close of business on Friday March 14, 2014, although comments were accepted that were dated and post-marked for the following Monday, March 17, 2014.

The Department received comments from the Environmental Protection Agency, Region 4 (EPA), the Tennessee Department of Environment and Conservation (TDEC) and from the Memphis Metropolitan Planning Organization (MPO). A listing of those comments and the Department's response (in italics) follows.

Commenter 1 - EPA
The EPA submitted a letter dated March 6, 2014 by the United States Postal Service and electronically on March 10, 2014. The letter contained six (6) numbered comments.

EPA 1. Phase 3 of the Contingency Plan: For clarity, please specify that the regulatory programs that will be implemented to correct a monitored violation will be adopted and implemented within eighteen to twenty-four months of the trigger.

Shelby County Response to EPA 1. - Because of the nature of rulemaking in Tennessee, it is not possible to `pre-adopt' this contingency plan. However, the language for Phase 3 of the plan has been changed to more clearly indicate the steps and timing the Department will take in response to the trigger.

EPA 2. On page 9-11 the Motor Vehicle Emissions Budget (MVEB) Section: In Table III Shelby County has provided a great deal of detail on how the base year inventories with the safety margins have been prepared for Volatile Organic Compounds (VOC) and Nitrogen Oxides (NOx). However, this may be confusing to the general public. The EPA suggests that a Table IV be created to reflect MVEBs for years 2006 and 2021.

Shelby County Response to EPA 2. - EPA offered an example Table IV for use by Shelby County. That table has been utilized, in part, in the revised maintenance plan.

EPA 3. Please include a discussion on the methodology (MOVES2010b) used to calculate the mobile source emissions. The discussion can be included in attachments III through VI. A discussion on Temperatures, Reid Vapor Pressure, and Humidity used as inputs will be helpful. Also a statement on how these planning assumptions were agreed on by interagency consultation should be included.

Shelby County Response to EPA 3.  -  Information can be found in the document, "Methodology Used for MOVES Runspec", which describes the various parameters required to set up the MOVES Run Specification file for the MOVES2010b model. Information concerning methodology used to calculate mobile source emissions, temperatures, Reid Vapor Pressure, and humidity can be found in the document titled "Methodology Used to Develop MOVES Inputs". Both documents are located in Attachment VIII - Supplemental Support Documents of the maintenance plan revision. These assumptions were agreed upon and are as iterated in the May 17, 2013 IAC memorandum found in Attachment II  -  Intergovernmental Consultation.

EPA 4. On page 6 it clearly describes the attainment status for particulate matter. Doing the same for Lead, Nitrogen Dioxide and Sulfur Dioxide would enhance the non-interference showing.

Shelby County Response to EPA 4. - Changes have been made to clearly define the area's current status with regard to these pollutants.

EPA 5. When submitting the final plan, please ensure the MOVES input/output files are included in the submission. An electronic copy on CD may be substituted for a hard copy (input/output files only). Please ensure the files are unzipped and in excel format.

Shelby County Response to EPA 5. - An electronic copy (CD) of the MOVES input/output files are included in the submission. The files are unzipped and are in excel format.

EPA 6. On page 3 the second paragraph under section 5 Emissions Reduction Requirements, please clarify the current ozone nonattainment status for the 2008 8-hour ozone standard.

Shelby County Response to EPA 6. - Language has been added to improve clarity.

Commenter 2  -  TDEC
The TDEC submitted a letter dated March 17, 2014 by the United States Postal Service and electronically on March 17, 2014. The letter contained twelve (12) numbered comments.

TDEC 1. The emissions in Table 1 reflect tons/day. The discussions references tons/year. How were the tons/year derived? Was a model run conducted to generate the emissions in tons/year?

Shelby County Response to TDEC 1.  -  A model run was conducted to obtain VOC and NOx in tons/day. These numbers were then multiplied by 365 days/year to achieve tons/year. The document has been corrected to explain and show consistency between the numbers.

TDEC 2. Does the point source inventory for 2021 reflect all changes to the point source sector (other than Cleo Inc.) that have occurred since the second half of the maintenance plan was originally submitted? Have other industries expanded or shutdown since this maintenance plan was last submitted? If so, are those changes to the emission inventory reflected here? If not, why not?

Shelby County Response to TDEC 2.  -  The point source sector of the 2021 emissions inventory only reflects the reductions that have occurred due to the shutdown of Cleo Inc. Other industries relevant to the point source sector have shutdown. None have expanded and no new sources have been constructed. The reductions from these closures are a weight of evidence as to the continued progress of the overall plan to maintain air quality that attains the 1997 national ambient air quality standard for ozone, but are not necessary to demonstrate an offset of the emissions that occur with the shutdown of the vehicle inspection and maintenance (I/M) program by the City of Memphis. Further, until history proves otherwise, it is not known what emission reductions may or may not occur in the years ahead and until 2021 occurs. Consequently, the main issue of the entire revision is to assure the offset of emissions that occur with the shutdown of the I/M program.

TDEC 3. Page 11, 1[st] paragraph, the third sentence seems to indicate that there are reductions of NOx and VOCs from point sources, which is not borne out by the tables. In the second paragraph, the safety margins allocated to the MVEB do not appear to match the information in Table III.

Shelby County Response to TDEC 3.  -  The third sentence in the first paragraph has been corrected to reflect the figures in Table III. The safety margins discussed in the second paragraph have been corrected to match the information in Table III.

TDEC 4. The emissions inventory does not show interim emissions estimates between 2006 and 2021.

Shelby County Response to TDEC 4.  -  In early proposals by the Department to revise the 2010 Shelby County Maintenance Plan, several interim years were discussed with the IAC. In an October 31, 2013 IAC teleconference, " . . . it was agreed by those on the call that the SIP would consist of a base analysis year of 2006 and a final year of 2021. MVEB's will be established for 2006 and 2021." Reasons for this determination were summarized in the original minutes for the October 31 teleconference in a memorandum dated November 1, 2013. After review of the memorandum by the agencies attending the call, the memorandum was finalized and redistributed on November 18, 2013, by email, to the call attendees. This memorandum can be found in Attachment II  -  Intergovernmental Consultation of the proposed 2014 Revised Maintenance Plan and is entitled "SIP Revision Budget Years and Memphis MPO Conformity" in the Subject line.

TDEC 5. The documentation lacked information on how the inputs for the MOVES model were developed.

Shelby County Response to TDEC 5.  -  Documentation titled "Methodology Used to Develop MOVES Inputs" is included in the maintenance plan revision in Attachment VIII - Supplemental Support Documents.

TDEC 6. What was the source of the vehicle miles traveled VMT used? What are the VMT for each of the analysis years?

Shelby County Response to TDEC 6.  -  Vehicle miles traveled (VMT) were provided by the MPO and were generated by the Memphis Urban Area Travel Demand Model (TDM). The VMT for 2006 and 2021 are displayed in the tables below.

              Shelby County Annual VMT by Source Type and by Year
                                  Source Type
                                Source Type ID
                                Source Type VMT

                                     2006
                                     2021
Motorcycle
                                      11
                                                                     25,604,577
                                                                     30,597,047
Passenger Car
                                      21
                                                                  6,116,293,396
                                                                  7,308,869,710
Passenger Truck
                                      31
                                                                  1,393,265,928
                                                                  1,664,929,980
Light Commercial Truck
                                      32
                                                                    465,466,353
                                                                    556,224,433
Intercity Bus
                                      41
                                                                      3,712,127
                                                                      4,873,218
Transit Bus
                                      42
                                                                      1,942,992
                                                                      2,309,079
School Bus
                                      43
                                                                     25,201,662
                                                                     32,497,370
Refuse Truck
                                      51
                                                                      2,897,462
                                                                      2,074,341
Single Unit Shorthaul Truck
                                      52
                                                                    198,308,587
                                                                    249,731,833
Single Unit Longhaul Truck
                                      53
                                                                     25,487,609
                                                                     39,169,765
Motor Home
                                      54
                                                                     45,859,407
                                                                     59,508,279
Combination Short-haul Truck
                                      61
                                                                    166,694,865
                                                                    222,336,742
Combination Long-haul Truck
                                      62
                                                                    199,421,654
                                                                    316,912,033
Total

                                                                  8,670,156,620
                                                                 10,490,033,832

TDEC 7. What version of the MOVES database was used?

Shelby County Response to TDEC 7. - MOVES2010b.

TDEC 8. How was the source type population developed and adjusted over time?

Shelby County Response to TDEC 8. - The MOVES Technical Guidance offers direction on how to leverage default population and VMT data alongside local VMT data to arrive at an estimate of the local population. This guidance suggests comparing the ratio of default source type population to default VMT to the local VMT to arrive at an estimate of local source type population. This methodology was applied for all analysis years. A growth rate was not applied, since growth is inherently built in through this methodology.

TDEC 9. How were the compliance factors in the IM inputs calculated?

Shelby County Response to TDEC 9.  -  The compliance factors for the revised ozone maintenance plan for Shelby County were developed as discussed in the document titled "MOVES2010b Compliance Factor for Shelby County Tennessee" found in Attachment VIII - Supplemental Support Documents.

TDEC 10. Why is the endModelYear 2002 in the 2006 IM input file? Did the 4 year exemption apply then? When did the change to the ordinance for the 4 year exemption take effect?

Shelby County Response to TDEC 10.  -  2002 should not be used as the endModelYear in the 2006 IM input file, MOVES has been rerun to correct this using 2005 as the end year. The 4 year exemption should not be used in the 2006 IM input file, MOVES has been rerun to correct this using 2005, a one-year exemption. The 4 year exemption took effect January 3, 2011, however this was an incorrect application of this exemption and should not have been used in the MOVES I/M input for 2006.

TDEC 11. The last paragraph on page 9 seems to indicate that the MVEBs did not change as provided in the 2010 ozone maintenance plan. Is this true? Table III and subsequent discussion do not agree with this statement.

Shelby County Response to TDEC 11.  -  the second sentence of the referenced paragraph has been restructured to provide clarity.

TDEC 12. Table III has a column indicating `On-Road Allocation Percent'  -  these values appears to be a fraction, not a percent. The last column states that this is the "On-Road Safety Margin"; the safety margin identified in 40 CFR 93.101 indicates that any safety margin is not explicitly for on-road  -  it is the overall safety margin, some of which (95% in this case) is being applied towards the MVEB. The column headings are somewhat confusing.

Shelby County Response to TDEC 12.  -  The values referenced in Table III have been corrected to show percent.

The Code of Federal Regulations (CFR), 40 CFR 93.101, defines "safety margin" to mean "the amount by which the total projected emissions from all sources of a given pollutant are less than the total emissions that would satisfy the applicable requirement for . . . maintenance." Subpart 93.101 also states that the "motor vehicle emissions budget" (MVEB) is that " . . . portion of the total allowable emissions defined in the submitted or approved . . . maintenance plan for a certain date for the purpose of . . . demonstrating . . . maintenance of the NAAQS, for any criteria pollutant or its precursors, allocated (emphasis added) to highway and transit vehicle use and emissions." As used in Table III (which has been restructured to add clarity), the "safety margin" is the difference between "baseline" emissions in 2006 and "total" emissions in 2021, which has occurred in the summation of the increases and decreases in emissions from the five categories of area, non-road, on-road, point, and Cleo, Inc Offsets at 1.1 to 1, in Table III. Considering VOC emissions specifically, as the method would be the same for NOx emissions, "Total" emissions of 93.433 tpd in 2021 evidence a reduction of emissions from 2006 (98.061 tpd) of 4.628 tpd (98.061 tpd minus 93.433 tpd) which is the "safety margin". Ninety-five percent (95%) of the "safety margin", 4.396 tpd, which is termed the "motor vehicle safety margin", is allocated to the MVEB (as provided for by the definition of MVEB in 40 CFR 93.100) which is a summation of the emissions expected to occur in 2021 from on-road sources plus the "motor vehicle safety margin" of 4.396 tpd. To further clarify the intent and use of Table III, a column has been added which is labeled "Safety Margin" and, the former "On-Road Safety Margin" column has been repositioned and is now termed "Motor Vehicle Safety Margin". As was discussed and implemented in response to EPA 2., a Table IV has been added to the revised maintenance plan to better clarify the MVEBs for VOC and NOx.

Commenter 3  -  MPO
The MPO submitted a letter dated March 6, 2014 by email on March 10, 2014. The letter contained two (2) numbered comments.

MPO 1. Under Section 11 Public Comment, please list the public hearing that will be held on March 6, 2014. The draft document only lists the public hearing on March 4, 2014.

Shelby County Response to MPO 1. - March 6, 2014 has been added to the document.

MPO 2. Under Section IIA, Regulatory Portion: Revised Maintenance Plan Projects, if discontinuing the I/M program resulted in 129 tpy of VOCs and if 224.4 tpy are available from the closure of the Cleo plant, the remaining emission bank would seem to be 104.94 when the two are subtracted and multiplied by 1.1. Under the section it states that there would be 105.5 tpy in banked emissions. We would like to get a clarification on the remaining banked emissions.

Shelby County Response to MPO 2. - The actual emissions increase that must be offset is 128.48 tons per year (tpy) (0.352 tons per day times 365 days per year) of VOC. This has been corrected in the document.


[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Proposed Rules]
[Pages 54124-54126]
[FR Doc No: 2021-21102]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 86, No. 187 / Thursday, September 30, 2021 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0834; Project Identifier MCAI-2021-00298-R]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Leonardo S.p.a. Model A109S and AW109SP helicopters. This
proposed AD was prompted by the discovery that rubber protection of
certain electrical wiring had not been installed in the baggage
avionics bay during production. This proposed AD would require
installing protective rubber borders on the edge of the baggage
avionics bay frames, as specified in a European Union Aviation Safety
Agency (EASA) AD, which is proposed for incorporation by reference
(IBR). 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 November
15, 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 EASA material that is proposed for IBR in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find the EASA material on the EASA website at https://ad.easa.europa.eu. For Leonardo Helicopters service information
identified in this NPRM, contact Leonardo S.p.A. Helicopters, Emanuele
Bufano, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di
Samarate (Va) Italy; telephone +39-0331-225074; fax +39-0331-229046; or
at https://customerportal.leonardocompany.com/en-US/. You may view this
material at the FAA, Office of the Regional Counsel, Southwest Region,
10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For
information on the availability of this material at the FAA, call (817)
222-5110. The EASA material is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0834.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0834; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the EASA AD,
any comments received, and other information. The street address for
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-
9167; email<EMAIL_ADDRESS>
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-2021-0834; Project Identifier
MCAI-2021-00298-R'' 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 Hal
Jensen, Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives that is not specifically designated as
CBI will be placed in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0065, dated March 8, 2021 (EASA
AD 2021-0065), to correct an unsafe condition for certain serial-
numbered Leonardo S.p.A. Helicopters, formerly Finmeccanica S.p.A.,
AgustaWestland S.p.A., Agusta S.p.A., Model A109S and AW109SP
helicopters.
    This proposed AD was prompted by the discovery that rubber
protection of

certain electrical wiring had not been installed in the baggage
avionics bay during production. The FAA is proposing this AD to prevent
chafing of electrical wiring, which could result in fire ignition and
smoke in the baggage compartment and subsequent loss of control of the
helicopter. See EASA AD 2021-0065 for additional background
information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0065 requires installing rubber protections on the
electrical wiring in the baggage/avionics compartment.
    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.

Other Related Service Information

    The FAA reviewed Leonardo Helicopters Alert Service Bulletin (ASB)
No. 109S-100, dated February 2, 2021, for Model A109S helicopters, and
Leonardo Helicopters ASB No. 109SP-142, also dated February 2, 2021,
for Model AW109SP helicopters. This service information specifies
procedures for installing protective rubber borders on the edge of the
baggage avionics bay frames.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that
the unsafe condition described previously is likely to exist or develop
on other helicopters of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0065, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0065 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0065 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0065 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0065. Service information referenced in EASA AD 2021-0065 for
compliance will be available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0834 after the FAA final
rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 3 helicopters of U.S. Registry. Labor rates are estimated at $85
per work-hour. Based on these numbers, the FAA estimates the following
costs to comply with this proposed AD.
    Installing protective rubber borders on the edge of the baggage
avionics bay frames would take about 2 work-hours and parts would cost
about $24 for an estimated cost of $194 per helicopter and $582 for the
U.S. fleet.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Leonardo S.p.a.: Docket No. FAA-2021-0834; Project Identifier MCAI-
2021-00298-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by November 15, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model A109S and AW109SP
helicopters, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) AD 2021-0065, dated March 8,
2021 (EASA AD 2021-0065).

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 2497, Electrical
Power System Wiring.

(e) Unsafe Condition

    This AD was prompted by the discovery that rubber protection of
certain electrical wiring had not been installed in the baggage
avionics bay during production. The FAA is issuing this AD to
prevent chafing of electrical wiring. The unsafe condition, if not
addressed, could result in fire ignition and smoke in the baggage
compartment and subsequent loss of control of the helicopter.

(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 2021-0065.

(h) Exceptions to EASA AD 2021-0065

    (1) Where EASA AD 2021-0065 requires compliance in terms of
flight hours, this AD requires using hours time-in-service.
    (2) Where EASA AD 2021-0065 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2021-0065.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0065
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Special Flight Permit

    Special flight permits are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (l)(2) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (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.

(l) Related Information

    (1) For EASA AD 2021-0065, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may view this
material at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For
information on the availability of this material at the FAA, call
(817) 222-5110. This material may be found in the AD docket at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0834.
    (2) For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on September 23, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-21102 Filed 9-29-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Page 64180]
[FR Doc No: 2016-22376]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2489]

Receipt of Notice That a Patent Infringement Complaint Was Filed
Against a Biosimilar Applicant

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing notice
that an applicant for a proposed biosimilar product notified FDA that a
patent infringement action was filed in connection with the applicant's
biologics license application (BLA). Under the Public Health Service
Act (PHS Act), an applicant for a proposed biosimilar product or
interchangeable product must notify FDA within 30 days after the
applicant was served with a complaint in a patent infringement action
described under the PHS Act. FDA is required to publish notice of the
complaint in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
The BPCI Act amended the PHS Act and created an abbreviated licensure
pathway for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological reference product.
Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a BLA for a proposed biosimilar
product or a proposed interchangeable product (351(k) BLA). Section
351(l) of the PHS Act, also added by the BPCI Act, describes certain
procedures for exchanging patent information and resolving patent
disputes between a 351(k) BLA applicant and the holder of the BLA
reference product. If a 351(k) applicant is served with a complaint for
a patent infringement described in section 351(l)(6) of the PHS Act,
the applicant is required, under section 351(l)(6)(C) of the PHS Act,
to provide the FDA with notice and a copy of the complaint within 30
days of service. FDA is required to publish notice of a complaint
received under section 351(l)(6)(C) of the PHS Act in the Federal
Register.
    FDA has received notice of the following complaint under section
351(l)(6)(C) of the PHS Act: Amgen v. Sandoz, 3:16-cv-02581 (N.D. Cal.,
filed May 12, 2015).
    FDA has only a ministerial role in publishing notice of a complaint
received under section 351(l)(6)(C) of the PHS Act, and does not
perform a substantive review of the complaint.

    Dated: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22376 Filed 9-16-16; 8:45 am]
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[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Proposed Rules]
[Pages 38226-38227]
[FR Doc No: 2012-15748]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0538; Airspace Docket No. 12-ANM-8]

Proposed Amendment of Class E Airspace; Lewistown, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace at Lewistown
Municipal Airport, Lewistown, MT. Controlled airspace is necessary to
accommodate aircraft using Area Navigation (RNAV) Global Positioning
System (GPS) standard instrument approach procedures at Lewistown
Municipal Airport, Lewistown, MT. The FAA is proposing this action to
enhance the safety and management of aircraft operations at the
airport.

DATES: Comments must be received on or before August 13, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2012-
0538; Airspace Docket No. 12-ANM-8, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2012-0538 and Airspace Docket No. 12-ANM-8) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2012-0538 and Airspace Docket No. 12-ANM-8''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and

5 p.m., Monday through Friday, except federal holidays. An informal
docket may also be examined during normal business hours at the
Northwest Mountain Regional Office of the Federal Aviation
Administration, Air Traffic Organization, Western Service Center,
Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class E surface airspace and
Class E airspace extending upward from 700 feet above the surface at
Lewistown Municipal Airport, Lewistown, MT. Controlled airspace is
necessary to accommodate aircraft using RNAV (GPS) standard instrument
approach procedures at Lewistown Municipal Airport and would enhance
the safety and management of aircraft operations at the airport.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.9V, dated August 9, 2011, and
effective September 15, 2011, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designation listed in this document will
be published subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would modify controlled airspace at Lewistown Municipal Airport,
Lewistown, MT.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ANM MT E2 Lewistown, MT [Modified]

Lewistown Municipal Airport, MT
    (Lat. 47[deg]02'57'' N., long. 109[deg]28'00'' W.)

    Within a 6.8-mile radius of the Lewistown Municipal Airport.
This Class E airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM MT E5 Lewistown, MT [Modified]

Lewistown Municipal Airport
    (Lat. 47[deg]02'57'' N., long. 109[deg]28'00'' W.)

    That airspace extending upward from 700 feet above the surface
within 9.3-mile radius of the Lewistown Municipal Airport, and
within 4.5 miles each side of the Lewistown Municipal Airport
269[deg] bearing extending from the 9.3-mile radius to 14.5 miles
west of the airport, and within 2.5 miles south and 4 miles north of
the Lewistown Municipal Airport 258[deg] bearing extending from the
9.3-mile radius to 20.5 miles west of the airport; that airspace
extending upward from 1,200 feet above the surface bounded by a line
beginning at lat. 47[deg]21'00'' N., long. 110[deg]33'00'' W.; to
lat. 47[deg]30'00'' N., long. 110[deg]00'00'' W.; to lat.
47[deg]16'00'' N., long. 109[deg]44'00'' W.; to lat. 47[deg]11'33''
N., long. 108[deg]46'00'' W.; to lat. 46[deg]43'40'' N., long.
108[deg]48'22'' W.; to lat. 46[deg]43'40'' N., long. 109[deg]32'14''
W., to lat. 46[deg]32'19'' N., long. 109[deg]32'14'' W.; to lat.
46[deg]32'19'' N., long. 110[deg]06'30'' W.; thence to the point of
origin.

    Issued in Seattle, Washington, on June 18, 2012.
Vered Lovett,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-15748 Filed 6-26-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Rules and Regulations]
[Page 66544]
[FR Doc No: 2022-23990]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 13

[Docket No.: FAA-2018-1051; Amdt. No.: 13-40A]
RIN 2120-AL00

Update to Investigative and Enforcement Procedures and Part 11;
Correction

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Final rule; correction.

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SUMMARY: On October 11, 2022, the FAA published a final rule titled
``Update to Investigative and Enforcement Procedures and Part 11;
Technical Amendments.'' That document made technical amendments to the
Update to Investigative and Enforcement Procedures final rule, which
was published on October 1, 2021. The technical amendments rule
inadvertently identified the Rulemaking Identification Number (RIN).

DATES: Effective November 4, 2022.

FOR FURTHER INFORMATION CONTACT: Cole R. Milliard, Office of the Chief
Counsel, AGC-300, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591; telephone<PHONE_NUMBER>; email
[email protected], or Jessica E. Kabaz-Gomez, Office of the Chief
Counsel, AGC-300, Federal Aviation Administration,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of October 11, 2022, in FR Doc. 2022-21354,
on page 61232, in the first column, correct the RIN to read: RIN 2120-
AL00.

    Issued in Washington, DC, under the authority provided by 49
U.S.C. 106(f), 40101 note and 44807, on October 21, 2022.
Brandon Roberts,
Executive Director, Office of Rulemaking.
[FR Doc. 2022-23990 Filed 11-3-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 229 (Wednesday, November 27, 2019)]
[Notices]
[Pages 65382-65383]
[FR Doc No: 2019-25763]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0041; FRL-10002-20-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; RadNet (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), RadNet (EPA ICR Number 0877.14,
OMB Control Number 2060-0015) 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 January 31, 2020. Public comments were
previously requested via the Federal Register on May 13, 2019 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 December 27,
2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2003-0041, to (1) EPA online using www.regulations.gov (our preferred
method<EMAIL_ADDRESS>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_ADDRESS>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: John Griggs, OAR/ORIA/NAREL, 540 South
Morris Ave., Montgomery, AL 36115; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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: RadNet is a national network of stations collecting
sampling media that include air, precipitation, and drinking water.
Samples are sent to EPA's National Analytical Radiation Environmental
Lab (NAREL) in Montgomery, Alabama, where they are analyzed for
radioactivity. RadNet provides emergency response/homeland security and
ambient monitoring information on levels of environmental radiation
across the nation. All stations, usually operated by state and local
personnel, participate in RadNet voluntarily. Station operators
complete information forms that accompany the samples. The forms
request information pertaining to sample type, sample location, start
and stop date and times for sampling, length of sampling period, and
volume represented. Data from RadNet are made available regularly on
the Agency website--https://www.epa.gov/radnet.
    Form Numbers: 5900-23, 5900-24, 5900-27, 5900-29.
    Respondents/affected entities: Primarily State and Local Officials.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 237 (total).
    Frequency of response: Biweekly, monthly, quarterly.
    Total estimated burden: 3,722 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $2,510,235 (per year), includes $2,363,476
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 5 hours in the
total

estimated respondent burden compared with the ICR currently approved by
OMB. This decrease shows the program is in maturity and is expected to
operate with minimal change.

Courtney Kerwin,
Director, Collection Strategies Division.
[FR Doc. 2019-25763 Filed 11-26-19; 8:45 am]
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