[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Rules and Regulations]
[Pages 4994-4995]
[FR Doc No: 2019-02678]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31239; Amdt. No. 3840]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective February 20, 2019. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of February 20, 2019.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73125. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.

    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on February 8, 2019.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

Effective Upon Publication

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    AIRAC date         State           City             Airport         FDC No.      FDC date        Subject
----------------------------------------------------------------------------------------------------------------
28-Mar-19.........  CA          Santa Rosa.......  Charles M Schulz--      8/0432      1/28/19  RNAV (GPS) RWY
                                                    Sonoma County.                               32, Amdt 1D.
28-Mar-19.........  CA          El Monte.........  San Gabriel             8/2453      1/28/19  VOR-A, Orig.
                                                    Valley.
28-Mar-19.........  KY          Lewisport........  Hancock Co-Ron          8/5973      1/28/19  RNAV (GPS) RWY
                                                    Lewis Field.                                 23, Amdt 1A.
28-Mar-19.........  WY          Newcastle........  Mondell Field....       8/8536      1/28/19  RNAV (GPS) RWY
                                                                                32, Amdt 1.
28-Mar-19.........  WY          Newcastle........  Mondell Field....       8/8538      1/28/19  RNAV (GPS) RWY
                                                                                14, Amdt 1.
28-Mar-19.........  CA          Santa Rosa.......  Charles M Schulz--      8/8919      1/28/19  ILS OR LOC/DME
                                                    Sonoma County.                               RWY 32, Amdt
                                                                                19A.
28-Mar-19.........  CA          Santa Rosa.......  Charles M Schulz--      8/8932      1/28/19  RNAV (GPS) RWY
                                                    Sonoma County.                               2, Orig-D.
28-Mar-19.........  CA          Santa Rosa.......  Charles M Schulz--      8/8942      1/28/19  RNAV (GPS) RWY
                                                    Sonoma County.                               14, Amdt 2A.
28-Mar-19.........  TN          Knoxville........  Knoxville               9/2426      1/28/19  RNAV (GPS) RWY
                                                    Downtown Island.                             26, Orig-D.
28-Mar-19.........  TN          Knoxville........  Knoxville               9/2427      1/28/19  LOC RWY 26, Amdt
                                                    Downtown Island.                             4B.
28-Mar-19.........  NY          Farmingdale......  Republic.........       9/3105      1/28/19  RNAV (RNP) Z RWY
                                                                                14, Orig-A.
28-Mar-19.........  NY          Farmingdale......  Republic.........       9/3108      1/28/19  RNAV (GPS) RWY
                                                                                32, Orig-A.
28-Mar-19.........  NY          Farmingdale......  Republic.........       9/3109      1/28/19  RNAV (GPS) RWY
                                                                                19, Amdt 2D.
28-Mar-19.........  NY          Farmingdale......  Republic.........       9/3110      1/28/19  RNAV (GPS) RWY
                                                                                1, Amdt 2C.
28-Mar-19.........  NY          Farmingdale......  Republic.........       9/3111      1/28/19  NDB RWY 1, Amdt
                                                                                14C.
28-Mar-19.........  NJ          Newark...........  Newark Liberty          9/8682       2/1/19  RNAV (GPS) Z RWY
                                                    Intl.                                        22L, Amdt 2B.
28-Mar-19.........  NJ          Newark...........  Newark Liberty          9/8690       2/1/19  RNAV (GPS) RWY
                                                    Intl.                                        4L, Amdt 2D.
28-Mar-19.........  FL          Wauchula.........  Wauchula Muni....       9/8691       2/1/19  RNAV (GPS) RWY
                                                                                18, Amdt 1B.
28-Mar-19.........  FL          Wauchula.........  Wauchula Muni....       9/8692       2/1/19  RNAV (GPS) RWY
                                                                                36, Amdt 1B.
28-Mar-19.........  ID          Blackfoot........  Mccarley Fld.....       9/8913       2/5/19  RNAV (GPS)-B,
                                                                                Orig-A.
28-Mar-19.........  ID          Blackfoot........  Mccarley Fld.....       9/8914       2/5/19  RNAV (GPS)-A,
                                                                                Orig-A.
28-Mar-19.........  ID          Blackfoot........  Mccarley Fld.....       9/8915       2/5/19  VOR/DME-C, Orig-
                                                                                A.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-02678 Filed 2-19-19; 8:45 am]
 BILLING CODE 4910-13-P


1 United States Prevention, Pesticides August 31, 2004 Environmental Protection and Toxic Substances Agency ( 7508C)

Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision ( TRED) for Trifluralin 2 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant:

This is the Environmental Protection Agency's ( hereafter referred to as EPA or the Agency) " Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision for Trifluralin," which was approved on August 31, 2004. This document is also known as a Tolerance Reassessment Decision, or TRED. A Notice of Availability of this tolerance reassessment decision will be published shortly. Additionally, the Agency will be proposing to establish a tolerance for trifluralin in mint oil.

The Federal Food, Drug and Cosmetic Act ( FFDCA), as amended by FQPA, requires EPA to reassess all the tolerances for registered chemicals in effect on or before the enactment of the FQPA on August 3, 1996. In reassessing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. Once a safety finding has been made, the tolerances are considered reassessed. Existing tolerances and exemptions associated with trifluralin must be reassessed in accordance with FFDCA, as amended by FQPA.

The Agency has completed the human health risk assessment for trifluralin and has determined that there is a reasonable certainty that no harm to any population subgroup will result from exposure to trifluralin when considering dietary exposure and all other non occupational sources of pesticide exposure for which there is reliable information. Therefore, no mitigation measures are needed, and the current tolerances at 40 CFR 180.207 for residues of trifluralin are now considered reassessed under section 408( q) of the FFDCA. Accordingly, the Agency will be proposing to establish a permanent tolerance at 2.0 ppm for mint oil.

Trifluralin is used as a pre emergence herbicide to control annual grasses and broadleaf weeds on a variety of food crops as well as for non food uses, including residential use sites. Taking into consideration available information on trifluralin and its expected use pattern, there is reasonable certainty of no harm from exposure to trifluralin through its use in pesticides. Available data show that residues of trifluralin in foods prepared with mint oil will not exceed the existing raw agricultural commodity tolerance. As a result, the Agency, using a qualitative approach to assessing human health risks from exposure to trifluralin, has made a safety finding that trifluralin is safe as currently used in pesticide products. 3 FQPA requires that EPA consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." The Agency considers other substances because low level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect, as would a higher level of exposure to any of the other substances individually.

The Agency has not yet determined whether the chemical class which includes trifluralin exhibits a common mechanism of toxicity. Therefore, the Agency defers any cumulative risk assessment to a later date. For the purposes of tolerance reassessment of trifluralin, EPA is assuming no common mechanism with other compounds. Therefore, a cumulative assessment was not conducted for this TRED.

Based on currently available data, trifluralin does not appear to be an endocrine disruptor. However, when the appropriate screening and/ or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, trifluralin may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption.

Trifluralin is classified as a skin sensitizer. However, EPA has no method of quantifying risk due to skin sensitization and remains concerned about dermal sensitization reactions to adults and children who are exposed to trifluralin in residential settings. Therefore, it is recommended that all products containing trifluralin be labeled as " SENSITIZER" and state that " skin contact should be avoided".

Currently, there is no tolerance for trifluralin in or on raw agricultural commodities for mint oil. Therefore, a permanent tolerance of 2.0 ppm for mint oil will be proposed for trifluralin at 40 CFR 180.207 and is now considered reassessed under section 408( q) of the FFDCA.

This document summarizes the Agency's decision on the tolerance reassessment for trifluralin and the establishment of a permanent tolerance for mint oil. Please contact John W. Pates, Jr. of my staff with any questions regarding this decision. He may be reached by phone at ( 703 308 8195) or via e mail at Pates. john@ epa. gov.

Sincerely,

Debra Edwards, Ph. D. Director Special Review and Reregistration Division Enclosures: Trifluralin Risk Assessment Overview


[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Page 14011]
[FR Doc No: 2012-5617]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL12-41-000; QF11-44-001; QF11-45-001]

Rainbow Ranch Wind, LLC, Rainbow West Wind, LLC; Notice of
Petition for Enforcement

    Take notice that on March 1, 2012, pursuant to section 210(h) of
the Public Utility Regulatory Policies Act of 1978 (PURPA), 16 USA
8242-3(h), Rainbow Ranch Wind, LLC (Rainbow Ranch) and Rainbow West
Wind, LLC (Rainbow West) (collectively, Petitioners) filed a petition
requesting the Federal Energy Regulatory Commission (Commission)
initiate an enforcement action against the Idaho Public Utilities
Commission (Idaho PUC) to remedy the rejection of (1) a Firm energy
Sales Agreement between Rainbow Ranch and Idaho Power Company (IPC) and
(2) a Firm Energy Sales Agreement between Rainbow West and IPC. In the
alternative, Petitioners request that the Commission make specific
findings with respect to Idaho PUC Order Nos. 32256 and 32300, as would
allow Petitioners to pursue enforcement action in a U.S. Federal
District Court.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 22, 2012.

    Dated: March 2, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-5617 Filed 3-7-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4223-4224]
[FR Doc No: 2018-01641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2476; FDA-2016-E-2472]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for LONSURF 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
2, 2018. 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 July 30, 2018. 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. Electronic comments
must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. 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-2016-E-2476 and FDA-2016-E-2472 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; LONSURF.'' 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.
     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.gpo.gov/fdsys/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.

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 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 LONSURF
(trifluridine and tipiracil hydrochloride). LONSURF is indicated for
the treatment of patients with metastatic colorectal cancer who have
been previously treated with fluoropyrimidine-, oxalplatin- and
irinotecan-based chemotherapy, an anti-vascular endothelial growth
factor biological therapy, and if RAS wild-type, an anti-epidermal
growth factor receptor therapy. Subsequent to this approval, the USPTO
received patent term restoration applications for LONSURF (U.S. Patent
Nos. 6,479,500 and 7,799,783) from Taiho Pharmaceutical Co., Ltd., and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 14,
2016, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of LONSURF 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
LONSURF is 6,083 days. Of this time, 5,805 days occurred during the
testing phase of the regulatory review period, while 278 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 (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 28, 1999. FDA has verified the Taiho Pharmaceutical
Co., Ltd. claim that January 28, 1999, is the date the investigational
new drug application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b)/507 of the FD&C Act:
December 19, 2014. FDA has verified the applicant's claim that the new
drug application (NDA) for LONSURF (NDA 207981) was initially submitted
on December 19, 2014.
    3. The date the application was approved: September 22, 2015. FDA
has verified the applicant's claim that NDA 207981 was approved on
September 22, 2015.
    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 1,827 days or 1,013 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 No. 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: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01641 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Proposed Rules]
[Pages 59449-59451]
[FR Doc No: 2020-20657]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0844; Product Identifier 2020-NM-100-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all The Boeing Company Model 737-100, -200, -200C, -300, -400, and
-500 series airplanes. This proposed AD was prompted by a report of
cracks found in fastener holes at a certain station of the center wing
box. This proposed AD would require repetitive external surface high
frequency eddy current inspections (HFEC) and repetitive external
surface ultrasonic inspections; or repetitive internal detailed
inspections; of a certain station of the center wing box for any
cracking, and repair if necessary. 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 6,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this referenced service information at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0844.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0844; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wayne Ha, Aerospace Engineer, Airframe
Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard,
Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; 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 the ADDRESSES section. Include ``Docket No. FAA-2020-0844;
Product Identifier 2020-NM-100-AD'' 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 proposed AD.

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 Wayne
Ha, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    The FAA has received a report of cracks found in fastener holes at
the center wing box, station 663.75 rear spar, of the lower skin
located at left buttock line 6.50. The lower skin cracks were hidden
between the center wing box lower chord on the upper surface and the
keel beam upper chord on the lower surface. A crack in the center wing
box, rear spar lower skin, or lower chord could go undetected. This
condition, if not addressed, could result in inability of a principal
structural element to sustain limit load and could adversely affect the
structural integrity of the airplane.

Explanation of Applicability

    The Boeing Company Model 737 airplanes having line numbers 1
through 291 have a limit of validity (LOV) of 34,000 total flight
cycles, and the actions proposed in this NPRM, as specified in Boeing
Alert Requirements Bulletin 737-57A1348 RB, dated June 1, 2020, would
be required at a compliance time occurring after that LOV. Although
operation of an airplane beyond its LOV is prohibited by 14 CFR
121.1115 and 129.115, this NPRM would include those airplanes in the
applicability so that these airplanes are tracked in the event the LOV
is extended in the future.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin 737-57A1348 RB,
dated June 1, 2020. The service information describes procedures for
repetitive external surface HFEC inspections and repetitive external
surface ultrasonic inspections; or repetitive internal detailed
inspections; of the center wing box, station 663.75 rear spar, lower
skin, and lower chord

between left buttock line 31.83 and right buttock line 31.83, for any
cracking, and repair if necessary.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    The FAA is proposing this AD because the agency evaluated all the
relevant information and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishment of the actions
identified in Boeing Alert Requirements Bulletin 737-57A1348 RB, dated
June 1, 2020, described previously, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-0844.

Explanation of Requirements Bulletin

    The FAA worked in conjunction with industry, under the
Airworthiness Directive Implementation Aviation Rulemaking Committee
(AD ARC), to enhance the AD system. One enhancement is a process for
annotating which steps in the service information are ``required for
compliance'' (RC) with an AD. Boeing has implemented this RC concept
into Boeing service bulletins.
    In an effort to further improve the quality of ADs and AD-related
Boeing service information, a joint process improvement initiative was
worked between the FAA and Boeing. The initiative resulted in the
development of a new process in which the service information more
clearly identifies the actions needed to address the unsafe condition
in the ``Accomplishment Instructions.'' The new process results in a
Boeing Requirements Bulletin, which contains only the actions needed to
address the unsafe condition (i.e., only the RC actions).

Costs of Compliance

    The FAA estimates that this proposed AD affects 141 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
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                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost    Cost per product          operators
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Repetitive external HFEC and       3 work-hours x $85             $0  $255 per inspection   Up to $35,955 per
 external ultrasonic inspections.   per hour = $255 per                cycle.                inspection cycle.
                                    inspection cycle.
Repetitive internal detailed       28 work-hours x $85            $0  $2,380 per            Up to $335,580 per
 inspections.                       per hour = $2,380                  inspection cycle.     inspection cycle.
                                    per inspection
                                    cycle.
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    The FAA has received no definitive data that would enable providing
cost estimates for the on-condition actions specified in this proposed
AD.

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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The 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 (AD):

The Boeing Company: Docket No. FAA-2020-0844; Product Identifier
2020-NM-100-AD.

(a) Comments Due Date

    The FAA must receive comments by November 6, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 737-100, -200, -
200C, -300, -400, and -500 series airplanes, certificated in any
category.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by a report of cracks found in fastener
holes at the center wing box, station 663.75 rear spar, of the

lower skin located at left buttock line 6.50. The FAA is issuing
this AD to address such cracking, which could result in inability of
a principal structural element to sustain limit load and could
adversely affect the structural integrity of the airplane.

(f) Compliance

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

(g) Actions for Group 1

    For airplanes identified as Group 1 in Boeing Alert Requirements
Bulletin 737-57A1348 RB, dated June 1, 2020: Within 120 days after
the effective date of this AD, inspect the airplane and do all
applicable on-condition actions using a method approved in
accordance with the procedures specified in paragraph (j) of this
AD.

(h) Required Actions

    For airplanes identified as Group 2 in Boeing Alert Requirements
Bulletin 737-57A1348 RB, dated June 1, 2020, except as specified by
paragraph (i) of this AD: At the applicable times specified in the
``Compliance'' paragraph of Boeing Alert Requirements Bulletin 737-
57A1348 RB, dated June 1, 2020, do all applicable actions identified
in, and in accordance with, the Accomplishment Instructions of
Boeing Alert Requirements Bulletin 737-57A1348 RB, dated June 1,
2020.

    Note 1 to paragraph (h): Guidance for accomplishing the actions
required by this AD can be found in Boeing Alert Service Bulletin
737-57A1348, dated June 1, 2020, which is referred to in Boeing
Alert Requirements Bulletin 737-57A1348 RB, dated June 1, 2020.

(i) Exceptions to Service Information Specifications

    (1) Where Boeing Alert Requirements Bulletin 737-57A1348 RB,
dated June 1, 2020, uses the phrase ``the original issue date of
Requirements Bulletin 737-57A1348 RB,'' this AD requires using ``the
effective date of this AD,'' except where Boeing Alert Requirements
Bulletin 737-57A1348 RB, dated June 1, 2020, uses the phrase ``the
original issue date of Requirements Bulletin 737-57A1348 RB'' in a
note or flag note.
    (2) Where Boeing Alert Requirements Bulletin 737-57A1348 RB,
dated June 1, 2020, specifies contacting Boeing for repair
instructions: This AD requires doing the repair using a method
approved in accordance with the procedures specified in paragraph
(j) of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the manager of the certification office, send it to the attention of
the person identified in paragraph (k)(1) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Los
Angeles ACO Branch, FAA, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

(k) Related Information

    (1) For more information about this AD, contact Wayne Ha,
Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5238; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on September 11, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-20657 Filed 9-21-20; 8:45 am]
BILLING CODE 4910-13-P