[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7979-7981]
[FR Doc No: 2023-02498]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-5658 and FDA-2019-E-5659]

Determination of Regulatory Review Period for Purposes of Patent
Extension; YUPELRI

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for YUPELRI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by April 10, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 7, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 10, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as

well as any attachments, except for information submitted, marked and
identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-5658; FDA-2019-E-5659 for Determination of Regulatory Review
Period for Purposes of Patent Extension; YUPELRI. Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, YUPELRI
(revefenacin) indicated for maintenance treatment of patients with
chronic obstructive pulmonary disease. Subsequent to this approval, the
USPTO received patent term restoration applications for YUPELRI (U.S.
Patent Nos. 7,288,657 and 7,585,879) from Theravance Biopharma R&D IP,
LLC and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
December 26, 2019, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
YUPELRI represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
YUPELRI is 1,724 days. Of this time, 1,362 days occurred during the
testing phase of the regulatory review period, while 362 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
February 21, 2014. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
February 21, 2014.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: November 13,
2017. FDA has verified the applicant's claim that new drug application
(NDA) for YUPELRI (NDA 210598) was initially submitted on November 13,
2017.
    3. The date the application was approved: November 9, 2018. FDA has
verified the applicant's claim that NDA 210598 was approved on November
9, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,042 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at
Docket Nos. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02498 Filed 2-6-23; 8:45 am]
BILLING CODE 4164-01-P


Date Time 11/ 7/ 03 11: 30 a. m.

Project Name CONTACT REPORT RICE NESHAP Project Number ESD3 B 1 4 Alpha Gamma Originator Contact Phone Number Jennifer Snyder Mike Wyatt, Johnson Matthey 610 341 3429 General Subject I called Mike Wyatt at Johnson Matthey in response to this public comment made on catalyst deactivation:

" Typically, oxidation catalysts undergo two stages of deactivation: a period of rapid deactivation as the catalyst adjust to the thermal and gas conditions, typically over a period on the order of 100 hours; followed by a period of slow deactivation that occurs over thousands or tens of thousands of hours."

He verified that there are two periods of deactivation, as was described in the comment. He said the first would best be described as " stabilization," and would be more on the order of 20 hours, but this depends on a number of variables, of course. The longer term deactivation rate depends a lot on oil consumption. If you have an engine which burns a lot of oil, then your deactivation will be more rapid. They design the catalyst to have the guaranteed percent reduction at the end of its useful life ( i. e. they have a warranty period). I asked him what these typically were, and he said for a natural gas fired engine, 2 years, and for a turbine, which burns no oil, 3 to 5 years. He gave the example of a guarantee for 90% CO reduction to have an efficiency of 93% after its degreening period, to be eventually degraded to 90%. He said CO deactivation was relatively flat, while HC deactivation has more of a slope to it. He did say that they have a catalyst installation on a turbine in California which was installed in 1988, which is still in operation and has had no problems. I asked him if this is typical and he said it was not unusual, but this is the oldest installation he knows of. It has run for over 100,000 hours, and has not had to be regenerated or remanufactured. It has been washed many times on site, but this is a simple wash procedure performed by the operators.

Signed


[Federal Register: December 4, 2007 (Volume 72, Number 232)]
[Proposed Rules]
[Page 68108-68111]
[DOCID:fr04de07-22]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28246; Directorate Identifier 2007-CE-048-AD]
RIN 2120-AA64

Airworthiness Directives; Cirrus Design Corporation Models SR20
and SR22 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); Reopening of
the comment period.

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

SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) that applies to certain Cirrus Design Corporation (CDC) Models
SR20 and SR22 airplanes. The earlier NPRM would have required you to
inspect and, as necessary, adjust the aileron and rudder rigging and
would have required you to modify, inspect, and, as necessary, adjust
the rudder-aileron interconnect system. The earlier NPRM resulted from
a jamming of the aileron and rudder controls on a Model SR20 airplane,
which resulted in loss of rudder and aileron flight controls. Since
issuance of the NPRM, CDC revised the service information as a result
of comments received on the NPRM, and the FAA has determined the
changes to the service information are necessary to address the unsafe
condition. The changes in the revised service information include the
addition of airplanes to the Applicability; a requirement to check
rudder, aileron, and rudder-aileron interconnect rigging; a requirement
to replace the attaching hardware and clamp at the end of the rudder-
aileron interconnect arm; and an increase in work-hours to do the
proposed actions. This proposed AD would require you to use the revised
service information and would require you to report any out-of-rig
condition found. Since these actions impose an additional burden over
that proposed in the NPRM, we are reopening the comment period to allow
the public the chance to comment on these additional actions.

DATES: We must receive comments on this proposed AD by January 3, 2008.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD:
     Federal eRulemaking Portal: Go to http://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: U.S. Department of Transportation, Docket
Operations, M-30, 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 service information identified in this proposed AD, contact
Cirrus Design Corporation, 4515 Taylor Circle, Duluth, Minnesota 55811;
telephone:<PHONE_NUMBER>; Internet address: http://www.cirrusdesign.com
.

FOR FURTHER INFORMATION CONTACT: Wess Rouse, Aerospace Engineer, 2300
East Devon Avenue, Room 107, Des Plaines, Illinois 60018; telephone:
(847) 294-8113; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include the docket number, ``FAA-
2007-28246; Directorate Identifier 2007-CE-048-AD'' at the beginning of
your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of the proposed
AD. We will consider all comments received by the closing date and may
amend the proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov
, including any personal information you provide. We

will also post a report summarizing each substantive verbal contact we
receive concerning this proposed AD.

Discussion

    On June 14, 2007, we issued a proposal to amend part 39 of the
Federal Aviation Regulations (14 CFR part 39) to include an AD that
would apply to certain CDC Models SR20 and SR22 airplanes. This
proposal was published in the Federal Register as a notice of proposed
rulemaking (NPRM) on June 21, 2007 (72 FR 34198). The NPRM proposed to
require you to inspect and, as necessary, adjust the aileron and rudder
rigging and would require you to modify, inspect, and, as necessary,
adjust the rudder-aileron interconnect system.

Comments

    We provided the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and FAA's response to each comment:

Comment Issue No. 1: Language in the Summary of the NPRM Implies That
the Control Jamming Event Only Occurs on the Ground

    Mr. Gene Hudson and Ms. Bridgette Doremire state that language in
the Summary of the NPRM improperly implies that the control jamming
event only occurs on the ground. They contend that such language might
encourage owners and operators to underestimate the risk. Hudson
recommends deleting the language from the Summary.
    We agree that the language of the Summary could imply that the
control jamming event only occurs on the ground. To eliminate this
implication, we will delete the language in the Summary that implies
that the control jamming event only occurs on the ground.

Comment Issue No. 2: Remove Text From the Service Information That
States the Control Jamming Event Has Not Been Seen on Aircraft With
Flight Control Systems Rigged to Specifications

    Hudson and Doremire state the service information text is
misleading and implies that the jamming of the flight controls will
only occur if the flight controls have been improperly rigged after
leaving the factory. They claim that evidence exists of airplanes being
improperly rigged at the factory or of flight controls jamming in the
field after aircraft are rigged at the factory. Hudson recommends
deleting the text from the service information or not referencing the
service information in the proposed AD if the service information
includes the misleading text.
    We do not agree with the commenters. Although it is not known how
the controls became improperly rigged, this is the reason the jamming
occurred. The aileron and rudder controls have not jammed on a properly
rigged airplane. The CDC has changed the rigging procedure to give more
detailed instructions regarding the rigging procedure.
    We are not changing the proposed AD as a result of this comment.

Comment Issue No. 3: Include Text in the Proposed AD That the Jamming
Condition Can Occur at Positions Other Than Full Cross Control

    Hudson and Doremire contend that the jamming condition can occur at
positions other than full cross control.

The commenters claim that they have inspected several airplanes and
have noted interference conditions during cross-control deflections at
less than half-travel. We infer that the commenters want language in
the proposed AD to reflect that the jamming condition can occur at
positions other than full cross control.
    There has been no evidence provided to show that there is a problem
until full cross-control. The airplane that we inspected showed no
interference until full cross control. One of the airplanes that the
commenters discussed was reviewed by representatives of the FAA, CDC,
and the National Transportation Safety Board (NTSB). It was determined
that the airplane's rudder was improperly rigged. The CDC has revised
procedures for rudder rigging to give more detailed instructions in the
manufacturer's service bulletin.
    We are not changing the proposed AD as a result of this comment.

Comment Issue No. 4: Proposed AD Gives the False Impression That the
Jamming Condition Has Been Identified on Only One Airplane

    Hudson and Doremire state that the proposed AD gives the impression
that the jamming condition has been identified on only 1 airplane.
Doremire claims to have seen the jamming condition on 12 airplanes.
Hudson also states that a posting on an Internet Web site indicates
that aircraft owners believe that the problem has only been found on 1
airplane.
    The jammed condition initially occurred on 1 airplane. However,
subsequent inspections have shown improper rigging on other airplanes.
    We will revise the proposed AD to identify the occurrence of
improper rigging on several airplanes.

Comment Issue No. 5: Issue the Proposed AD as an Emergency AD and
Ground Any Airplane That Has Not Incorporated the Modifications
Required by the AD

    Hudson and Doremire contend that the urgency of the rudder-aileron
interconnect problem has been understated. They want this AD action to
be an Emergency AD and include the immediate grounding of any airplane
that has not incorporated the modifications required by the AD.
    Our risk assessment shows the rudder-aileron interconnect problem
warrants NPRM AD action.
    We are not changing the proposed AD as a result of this comment.

Comment Issue No. 6: Inspect for Clamp and Bungee Clamp Interference
With Adjacent Control Cables; Implement a Solution to the Control
System Interference

    Hudson and Doremire state that there is a significant risk for
flight control cable fraying with repeated clamp chafing, especially in
airplanes used in flight training. Further, airplanes have potentially
experienced chafing while doing normal crosswind takeoffs and landings.
They recommend revising the proposed AD to require an inspection for
clamp and bungee clamp interference with adjacent control cables,
including a specific check for rudder, aileron, and elevator control
cable fraying in the 12 inches adjacent to the forward and aft bungee
clamps and the interconnect arm rudder clamp.
    The commenters also recommend revising the proposed AD to implement
a solution to the control system interference to prevent possible
contact between the moving parts of the system throughout the full
range of possible control travel.
    We agree with the commenters that interference of the control cable
mechanism should not occur. The manufacturer's service bulletin has
been revised to add design changes to further increase clearances. In
addition, more detailed rigging and inspection instructions have been
added. Additionally, the revised service bulletin adds a redesigned
clamp for the end of the interconnect arm.
    We are incorporating the revised service bulletin into the proposed
AD.

Comment Issue No. 7: Restrict Affected Aircraft From Forward and Side
Slips, Power On and Off Stalls, Unusual Attitudes, Steep Turns, Slow
Flight, and Any Takeoffs or Landings in Crosswind Conditions

    Doremire strongly recommends restricting all affected aircraft from
forward slips, side slips, power on and off stalls, unusual attitudes,
steep turns, slow flight, and any takeoffs or landings in crosswind
conditions. The commenter states that such restrictions would prevent
in-flight loss of control.
    The FAA disagrees with the recommendation. The restrictions that
the commenter proposes will ground all CDC airplanes until
incorporation of the AD actions. The data submitted so far shows that
the binding of the controls has only occurred on misrigged airplanes
and can be overcome by additional control forces. The risk assessment
performed does not support these proposed restrictions.
    We are not changing the proposed AD as a result of this comment.

Comment Issue No. 8: Special Flight Permit Limitations

    Hudson recommends removal of the interconnect bungee as a condition
for the issuance of a special flight permit. We conclude that the
commenter recommends the requirement of a special flight permit with
the above restriction.
    We disagree that the restriction should be added to the AD.
Evidence warranting this restriction for a special flight permit has
not been shown. In the event that an aircraft has experienced a binding
event, the aircraft should not be flown until the binding event is
addressed/corrected. The Principal Inspector and/or Flight Standards
District Office (FSDO) may always add this restriction on a case-by-
case basis when issuing a special flight permit.
    We are not changing the proposed AD as a result of this comment.

Comment Issue No. 9: Require Incorporation of Service Bulletin No. SB
2X-27-14 R3 Within the Listed Compliance Time and Allow an Extended
Compliance Time for Those Who Have Already Done Service Bulletin No.
SB2X-27-14 R2

    CDC comments that aircraft complying with Service Bulletin No.
SB2X-27-14 R2 minimizes the probability for the locking condition and
meets the primary objective of the proposed AD. They request the
proposed AD allow for an extended compliance period for those who have
already done Service Bulletin No. SB2X-27-14 R2.
    We disagree with CDC. The instructions listed in Service Bulletin
No. SB2X-27-14 R2 do not include adequate rigging instructions for the
rudder. Further, it is not known if the modified airplanes were rigged
correctly. Also, additional improvements to the rudder/ailerons
interconnect system were made that were not included in Service
Bulletin No. SB2X-27-14 R2. The FAA has determined that the changes
incorporated into Service Bulletin No. SB 2X-27-14 R3 are necessary to
address the unsafe condition.
    We are not changing the proposed AD as a result of this comment.

FAA's Determination and Requirements of This Proposed AD

    We have carefully reviewed the available data and determined that
the unsafe condition referenced in this document exists or could
develop on other products of the same type design; and we should take
AD action to correct this unsafe condition.

    Certain changes described above in the comments expand the scope of
the earlier NPRM. As a result, we have determined that it is necessary
to reopen the comment period to provide additional opportunity for the
public to comment on the proposed AD.

The Supplemental NPRM

    Since issuance of the NPRM, CDC has issued Cirrus Service Bulletin
No. SB 2X-27-14 R3, Revised: October 10, 2007.
    The revised service information includes instructions that add new
attaching parts, including an improved bungee clamp that replaces the
existing Adel clamp at the end of the rudder-aileron interconnect arm;
re-orient existing cable clamps 180 degrees at the RH rudder cable;
clarify security of attaching parts and orientation of bungee cord
ends; change the serial number effectivity for the Model SR20 airplane;
and increase work-hours necessary to do the proposed action.
    The FAA has determined that the changes incorporated into the
service bulletin are necessary to address the unsafe condition. The
added proposed AD actions following the revised service bulletin go
beyond the scope of what was originally proposed in the NPRM.
Therefore, we are reopening the comment period and allowing the public
the chance to comment on these additional actions.

Costs of Compliance

    We estimate that this proposed AD affects 2,435 airplanes in the
U.S. registry.
    We estimate the following costs to do the proposed check of the
rudder, aileron, and rudder-aileron interconnect rigging, and
replacement of the attaching hardware for the rudder-aileron
interconnect arm and RH aileron cable clamps:

----------------------------------------------------------------------------------------------------------------
                                                                                Total cost per   Total cost on
                          Labor cost                              Parts cost        airplane      U.S. operators
----------------------------------------------------------------------------------------------------------------
1.5 work-hours x $80 per hour = $120.........................             $18             $138         $336,030
----------------------------------------------------------------------------------------------------------------

    CDC will provide warranty credit to the extent noted in Service
Bulletin SB 2X-27-14 R3, Issued: May 9, 2007, Revised: October 10,
2007.

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.
    We are 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

    We have 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 that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket that contains the proposed AD, the
regulatory evaluation, any comments received, and other information on
the Internet at http://dms.dot.gov; or in person at the Docket

Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Docket Office (telephone<PHONE_NUMBER>)
is located at the street address stated in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Cirrus Design Corporation: Docket No. FAA-2007-28246; Directorate
Identifier 2007-CE-048-AD.

Comments Due Date

    (a) We must receive comments on this airworthiness directive
(AD) action by January 3, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model SR20 airplanes, serial numbers (SN)
1005 through 1861, and Model SR22 airplanes, SN 0002 through 2333,
SN 2335 through 2419, and SN 2421 through 2437, that are
certificated in any category.

Unsafe Condition

    (d) This AD results from an incident of jamming of the aileron
and rudder controls on a Model SR20 airplane and the possibility of
the occurrence on other airplanes. In addition, other Models SR20
and SR22 airplanes have been found with misrigging of the flight
controls that could lead to jamming. We are issuing this AD to
prevent the possibility of jamming of the rudder-aileron
interconnect system, which may result in loss of rudder and aileron
flight controls.

Compliance

    (e) To address this problem, you must do the following, unless
already done:

----------------------------------------------------------------------------------------------------------------
               Actions                             Compliance                            Procedures
----------------------------------------------------------------------------------------------------------------
(1) Inspect/check the rudder,         At whichever occurs first:            Follow Cirrus Service Bulletin No.
 aileron, and rudder-aileron          (i) Within the next 25 hours time-in-  SB 2X-27-14 R3, Issued: May 9,
 interconnect rigging; correct any     service (TIS) after the effective     2007, Revised: October 10, 2007.
 out-of-rig condition; and replace     date of this AD; or
 the attaching hardware for the       (ii) Within the next 3 months after
 rudder-aileron interconnect arm.      the effective date of this AD.
(2) Only if you find an out-of-rig    At whichever occurs later:            Send the form (Figure 1 of this AD)
 condition: Report to the FAA any     (i) Within 10 days after the           to FAA, Manufacturing Inspection
 out-of-rig conditions discovered as   inspection required in paragraph      District Office, 6020 28th Avenue
 a result of the inspection required   (e)(1) of this AD; or                 South, Room 103, Minneapolis,
 by paragraph (e)(1) of this AD on    (ii) Within 10 days after the          Minnesota, 55450-2700; telephone
 the form in Figure 1 of this AD.      effective date of this AD.<PHONE_NUMBER>; facsimile (612) 713-
 The Office of Management and Budget                                         4365.
 (OMB) approved the information
 contained in this regulation under
 the provisions of the Paperwork
 Reduction Act and assigned OMB
 Control Number 2120-0056.
----------------------------------------------------------------------------------------------------------------

    Note: Temporary revisions to the airplane maintenance manuals
(AMM), SR20 AMM Temporary Revision No. 27-1 and SR22 AMM Temporary
Revision No. 27-1, both dated October 10, 2007, contain information
pertaining to this subject.

               Docket No. FAA-2007-28246 Inspection Report
            [Report only if you find an out-of-rig condition]
------------------------------------------------------------------------

------------------------------------------------------------------------
1. Inspection Performed By:          2. Telephone:

------------------------------------------------------------------------
3. Aircraft Model:                   4. Airplane Serial Number:
------------------------------------------------------------------------
5. Aircraft Total Hours Time-in-     6. Date of inspection required in
 Service:                             paragraph (e)(1) of this AD:
------------------------------------------------------------------------
7a. Do any of the aircraft logs      7b. If Yes, copy the log book
 contain entries describing flight    entry(s) and include the date of
 control system maintenance,          the entry.
 preventative maintenance, or
 alteration:

----Yes ----No

------------------------------------------------------------------------
8. Inspection Results: (Report only if an out-of-rig condition is found,
 and describe the out-of-rig condition as accurate and detailed as
 possible):

------------------------------------------------------------------------
9. Corrective Action Taken:

------------------------------------------------------------------------
Send to:

Federal Aviation Administration
Manufacturing Inspection District Office 6020 28th Avenue South, Room
 103
Minneapolis, Minnesota 55450-2700

Telephone<PHONE_NUMBER>
Facsimile<PHONE_NUMBER>
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (g) The Manager, Chicago Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Wess Rouse, Aerospace Engineer, 2300 East Devon Avenue, Room
107, Des Plaines, Illinois 60018; telephone:<PHONE_NUMBER>; fax:
(847) 294-7834. Before using any approved AMOC on any airplane to
which the AMOC applies, notify your appropriate principal inspector
(PI) in the FAA Flight Standards District Office (FSDO), or lacking
a PI, your local FSDO.

Related Information

    (h) To get copies of the service information referenced in this
AD, contact Cirrus Design Corporation, 4515 Taylor Circle, Duluth,
Minnesota 55811; telephone:<PHONE_NUMBER>; Internet address: http://www.cirrusdesign.com.
 To view the AD docket, go 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, or on the Internet at http://dms.dot.gov. The docket

number is Docket No. FAA-2007-28246; Directorate Identifier 2007-CE-
048-AD.

    Issued in Kansas City, Missouri, on November 28, 2007.
Patrick R. Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-23456 Filed 12-3-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Page 19284]
[FR Doc No: 2012-7682]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9654-5]

Proposed CERCLA Administrative Settlement; George L. Gomez and
Patricia A. Gomez.

AGENCY: Environmental Protection Agency

ACTION: Notice; request for public comment

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

SUMMARY: In accordance with Section 122(h)(1) of the Comprehensive
Environmental Response, Compensation, and Liability Act, as amended
(CERCLA), 42 U.S.C. 9622(h)(1), notice is hereby given of a proposed
administrative settlement for the Terrible Mine Site, Isle Mining
District, Custer County, Colorado with George L. Gomez and Patricia A.
Gomez based upon an inability to pay settlement. The settlement
includes a covenant not to sue the settling party pursuant to Section
107(a) of CERCLA, 42 U.S.C. 9607(a), and provides that the settling
parties will sign and execute an environmental covenant on the Site.
For thirty (30) days following the date of publication of this notice,
the agency will receive written comments relating to the settlement.
The agency will consider all comments received and may modify or
withdraw its consent to the settlement if comments received disclose
facts or considerations which indicate that the settlement is
inappropriate, improper, or inadequate. The agency's response to any
comments received will be available for public inspection at the EPA
Region 8 Records Center, 1595 Wynkoop Street, Denver, Colorado 80202.

DATES: Comments must be submitted on or before April 30, 2012.

ADDRESSES: The proposed settlement is available for public inspection
at the EPA Region 8 Records Center, 1595 Wynkoop Street, Denver,
Colorado 80202. A copy of the proposed settlement may be obtained from
John Works, EPA Technical Enforcement Officer, EPA Region 8, 1595
Wynkoop Street, Denver, CO 80202,<PHONE_NUMBER>. Comments should
reference the Terrible Mine Site, Isle Mining District, Custer County,
Colorado and EPA Docket No. 08-2012-0003 and should be addressed to
John Works, EPA Technical Enforcement Officer, EPA Region 8, 1595
Wynkoop Street, Denver, CO 80202.

FOR FURTHER INFORMATION CONTACT: John Works, EPA Technical Enforcement
Officer, EPA Region 8, 1595 Wynkoop Street, Denver, CO 80202, 303-312-
6196.

    Dated: March 21, 2012.
Andrew M. Gaydosh,
Assistant Regional Administrator, Office of Enforcement and Compliance
and Environmental Justice, U. S. Environmental Protection Agency,
Region 8, Denver, CO.
[FR Doc. 2012-7682 Filed 3-29-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Page 16469]
[FR Doc No: 2011-6814]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket DOT-OST-2010-0260]

Application of Air Charter, Inc. D/B/A Air Flamenco for Commuter
Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause (Order 2011-3-21), Docket DOT-
OST-2010-0260.

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

SUMMARY: The Department of Transportation is directing all interested
persons to show cause why it should not issue an order finding Air
Charter, Inc. d/b/a Air Flamenco fit, willing, and able, and awarding
it Commuter Air Carrier Authorization.

DATES: Persons wishing to file objections should do so no later than
March 31, 2011.

ADDRESSES: Objections and answers to objections should be filed in
Docket DOT-OST-2010-0260 and addressed to U.S. Department of
Transportation, Docket Operations, (M-30, Room W12-140), 1200 New
Jersey Avenue, SE., West Building Ground Floor, Washington, DC 20590,
and should be served upon the parties listed in Attachment A to the
order.

FOR FURTHER INFORMATION CONTACT: Scott A. Faulk, Air Carrier Fitness
Division (X-56, Room W86-487), U.S. Department of Transportation, 1200
New Jersey Avenue, SE., Washington, DC 20590,<PHONE_NUMBER>.

    Dated: March 17, 2011.
Susan L. Kurland,
Assistant Secretary for Aviation and International Affairs.
[FR Doc. 2011-6814 Filed 3-22-11; 8:45 am]
BILLING CODE P