[Federal Register Volume 88, Number 8 (Thursday, January 12, 2023)]
[Notices]
[Pages 2172-2173]
[FR Doc No: 2023-00638]

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UNIFIED CARRIER REGISTRATION PLAN

Sunshine Act Meetings

TIME AND DATE: January 19, 2023, 12 p.m. to 3 p.m., Eastern Time.

PLACE: This meeting will be accessible via conference call and via Zoom
Meeting and Screenshare. Any interested person may call (i) 1-929-205-
6099 (US Toll) or 1-669-900-6833 (US Toll) or (ii) 1-877-853-5247 (US
Toll Free) or 1-888-788-0099 (US Toll Free), Meeting ID: 921 0221 1185,
to listen and participate in this meeting. The website to participate
via Zoom Meeting and Screenshare is https://kellen.zoom.us/meeting/register/tJYsd-uqrzorEtGskEIbjjq1h4Qxy3jsUawP.

MATTERS TO BE CONSIDERED: Proposed Agenda

I. Welcome and Call to Order--UCR Board Chair

    The UCR Board Chair will welcome attendees, call the meeting to
order, call roll for the Board, confirm the presence of a quorum, and
facilitate self-introductions.

II. Verification of Publication of Meeting Notice--UCR Executive
Director

    The UCR Executive Director will verify publication of the meeting
notice on the UCR website and distribution to the UCR contact list via
email, followed by subsequent publication of the notice in the Federal
Register.

III. Review and Approval of Board Agenda--UCR Board Chair

For Discussion and Possible Board Action

    The proposed Agenda will be reviewed, and the Board will consider
adoption.
Ground Rules
[rtarr8] Board actions taken only in designated areas on agenda

IV. Approval of Minutes of the December 8, 2022, UCR Board Meeting--UCR
Board Chair

For Discussion and Possible Board Action

    Draft Minutes from the December 8, 2022 UCR Board meeting will be
reviewed. The Board will consider action to approve.

V. Report of FMCSA--FMCSA Representative

    The Federal Motor Carrier Safety Administration (FMCSA) will
provide a report on relevant activity.

VI. Engagement Letter Between the UCR Plan and the Bradley Law Firm--
UCR Executive Director and UCR Board Chair

For Discussion and Possible Board Action

    An engagement letter between the UCR Plan and the Bradley Law Firm
covering legal services performed by Bradley Law Firm on behalf of the
UCR Plan during 2023 will be presented to the UCR Board for its
consideration and approval.

VII. Subcommittee Reports

Audit Subcommittee--UCR Audit Subcommittee Chair

A. Discuss Options to Replace the Retreat Audit program With a Program
That Relies on Roadside Inspection Data--UCR Audit Subcommittee Chair,
UCR Audit Subcommittee Vice-Chair, and DSL Transportation
    The UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-
Chair, and DSL Transportation will lead a discussion on options to
replace the Retreat Audit Program currently utilized by the States with
a roadside inspection data driven audit for non-IRP plated commercial
motor vehicles and the motor carriers operating this type of registered
equipment.
B. Discuss Options to Limit SHB Reporting to Current Registration
Year--The UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-
Chair, and DSL Transportation
    The UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-
Chair, and DSL Transportation will lead discussion on limiting the SHB
reporting period to the current registration year.
C. Update for Hosting a Monthly Question and Answer Session for State
Auditors--UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-
Chair, and Executive Director
    The UCR Audit Subcommittee Chair, UCR Audit Subcommittee Vice-Chair
and UCR Executive Director will lead a discussion regarding the value
of a series of 60-minute virtual question and answer sessions for state
auditors.
D. Review Snapshot of State Audit Compliance Rates--UCR Audit
Subcommittee Chair
    The UCR Audit Subcommittee Chair will review audit compliance rates
for the states for registration years 2021 and 2022 and related
compliance percentages for FARs, retreat audits, and registration
compliance percentages.

Finance Subcommittee--UCR Finance Subcommittee Chair

Distribution From the UCR Depository for 2023 Registration Year--UCR
Depository Manager and UCR Finance Subcommittee Chair
    The UCR Finance Subcommittee Chair and the UCR Depository Manager
will provide an update on the timing for a distribution of fees from
the UCR Depository to states that have not yet

reached their revenue entitlements for the 2023 registration year.

Education and Training Subcommittee--UCR Education and Training
Subcommittee Chair

Update on Current and Future Training Initiatives--UCR Education and
Training Subcommittee Chair
    The Education and Training Subcommittee Chair will provide an
update on current and planned future training initiatives and the E-
Certificate program.

Industry Advisory Subcommittee--UCR Industry Advisory Subcommittee
Chair

Update on Current Initiatives--UCR Industry Advisory Subcommittee Chair
    The UCR Industry Advisory Subcommittee Chair will provide an update
on current and planned initiatives regarding motor carrier industry
concerns.

Enforcement Subcommittee--UCR Enforcement Subcommittee Chair

    Update on Current Initiatives--The UCR Enforcement Subcommittee
Chair will provide an update on current and planned initiatives.

VIII. Contractor Reports--UCR Board Chair

 UCR Executive Director's Report

    The UCR Executive Director will provide a report covering recent
activity for the UCR Plan.

 DSL Transportation Services, Inc.

    DSL Transportation Services, Inc. will report on the latest data
from the Focused Anomaly Reviews (FARs) program, discuss motor carrier
inspection results, pilot projects and other matters.

 Seikosoft

    Seikosoft will provide an update on recent/new activity related to
the National Registration System (NRS).

 UCR Administrator Report (Kellen)

    The UCR Chief of Staff will provide a management report covering
recent activity for the Depository, Operations, and Communications.

IX. Other Business--UCR Board Chair

    The UCR Board Chair will call for any other business, old or new,
from the floor.

X. Adjournment--UCR Board Chair

    The UCR Board Chair will adjourn the meeting.
    The agenda will be available no later than 5:00 p.m. Eastern time,
January 10, 2023, at: https://plan.ucr.gov.

CONTACT PERSON FOR MORE INFORMATION: Elizabeth Leaman, Chair, Unified
Carrier Registration Plan Board of Directors,<PHONE_NUMBER>,
[email protected].

Alex B. Leath,
Chief Legal Officer, Unified Carrier Registration Plan.
[FR Doc. 2023-00638 Filed 1-10-23; 4:15 pm]
BILLING CODE 4910-YL-P


[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25054-25055]
[FR Doc No: 2023-08689]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2023-0011]

Request for Information Regarding Uses for Used Creosote-Treated
Railroad Ties

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Request for information (RFI).

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SUMMARY: The Federal Railroad Administration is seeking information on
potential uses and options for disposal or repurposing used creosote-
treated railroad ties (CTRTs), which are the wooden rail crossties that
support the rail track. Every year, approximately 23 million CTRTs are
replaced along the nation's rail network. Because a number of FRA's
grant programs fund rail infrastructure projects, which may include the
replacement of worn CTRTs, understanding the options to dispose of
CTRTs will assist FRA and its grantees from the implementation of FRA's
grant programs and assessing the impacts of such disposition (e.g.,
life-cycle maintenance impacts). Depending on the responses, FRA may
develop a best practices document for rail tie disposal.

DATES: Written comments on this RFI must be received on or before June
26, 2023. FRA will consider comments filed after this date to the
extent practicable in the development of any potential best practices.

ADDRESSES: Comments: Comments should refer to docket number FRA-2023-
0011 and be submitted at https://www.regulations.gov. Search by using
the docket number and follow the instructions for submitting comments.
    Instructions: All submissions must include the agency name and
docket number (FRA-2023-0011) for this RFI. Please note that comments
submitted online via www.regulations.gov are not immediately posted to
the docket. Several business days may elapse after a comment has been
submitted online before it is posted to the docket.
    Privacy Act: DOT solicits comments from the public to better inform
its regulatory process. DOT posts these comments, without edit, to
www.regulations.gov, as described in the system of records notice, DOT/
ALL- 14 FDMS, accessible through www.dot.gov/privacy. To facilitate
comment tracking and response, commenters are encouraged to provide
their name, or the name of their organization; however, submission of
names is completely optional. Whether or not commenters identify
themselves, all timely comments will be fully considered. If you wish
to provide comments containing proprietary or confidential information,
please contact the agency for alternate submission instructions.
    Docket: For access to the docket to read comments received, please
visit https://www.regulations.gov and follow the online instructions
for accessing the docket.

FOR FURTHER INFORMATION CONTACT: For further information related to
this RFI, please contact Michael Johnsen, Senior Advisor for Climate
and Sustainability, Office of Environmental Program Management, at
telephone:<PHONE_NUMBER>, email: [email protected].

SUPPLEMENTARY INFORMATION: Crossties support the metal rails upon which
trains run and the majority of them are made of creosote-treated wood.
Creosote is an oil-based preservative allowing the ties to maintain a
lifespan of about 30 years. There are approximately 207,000 miles of
rail track in the U.S. requiring about 620 million crossties. About 23
million crossties are replaced every

year. Traditionally, end of life disposal of CTRTs primarily involved
burning in waste-to-energy (or energy conversion) facilities to produce
electricity. However, recent changes in Environmental Protection Agency
(EPA) regulations and policy limit the options for disposing CTRTs
through those facilities.
    Recent research points to a pyrolysis process than can recover
creosote and produce a material called biochar from CTRTs. Biochar is a
residue of carbon and ashes from specific burning processes of biomass,
such as rail crossties, and has a number of potential uses. These uses
include filtration and use as a soil amendment to improve soil quality
and to reduce acidity and nutrient leaching. In addition, converting
used rail crossties to biochar can also sequester carbon, providing an
option to help remove carbon dioxide from the atmosphere. In the August
2020 Journal of Analytical and Applied Pyrolysis (Vol 149, August 2020,
104826), a research paper entitled ``Pyrolysis of creosote-treated
railroad ties to recover creosote and produce biochar'' found that
CTRTs pyrolyzed to 700 [deg]C resulted in residual creosote of 0.06% by
weight of the original CTRT. This residual level would meet the
qualification of a soil amendment under the European Biochar
Certificate as no trace metals were found. This indicates there could
be potential benefits and sustainable uses for used CTRTs.
    FRA manages a number of grant programs that fund rail
infrastructure improvements, including the Consolidated Rail
Infrastructure and Safety Improvement grant program. Those FRA-funded
rail activities under these grant programs include track and tie
projects that replace worn CTRTs. Understanding the disposition of worn
CTRTs will assist FRA in complying with the direction in E.O. 14008 to
assess the climate impacts of these grant programs, and in researching
greenhouse gas emissions from rail projects.\1\ This information may
also provide FRA with opportunities to offer technical assistance to
grantees relating to the various options to dispose of CTRTs.
---------------------------------------------------------------------------

    \1\ See also DOT's Climate Plan, available at https://www.transportation.gov/sites/dot.gov/files/2022-04/Climate_Action_Plan.pdf.
---------------------------------------------------------------------------

    FRA is therefore seeking any information, public comment, or
feedback, including information about initiatives and pilot studies, on
how CTRTs could be reused or repurposed as an alternative to
landfilling, including information regarding the biochar process. FRA
is also interested in potential uses for CTRT-sourced biochar as well
as other legal and potentially commercially viable options for used
CTRTs. Where available and appropriate, FRA requests that respondents
provide relevant technical information, statutory or regulatory
citations, data, or other evidence to support their comments.
    Interested parties are invited to submit comments to the electronic
docket in response to this RFI. Please refer to the ADDRESSES section
above for guidance on how to submit comments to the electronic docket.

    Issued in Washington, DC.
Marlys Ann Osterhues,
Director, Office of Environmental Program Management.
[FR Doc. 2023-08689 Filed 4-24-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: October 19, 2006 (Volume 71, Number 202)]
[Notices]
[Page 61742]
[DOCID:fr19oc06-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-17-000]

Colorado Interstate Gas Company; Notice of Proposed Changes in
FERC Gas Tariff

October 12, 2006.
    Take notice that on October 10, 2006, Colorado Interstate Gas
Company (CIG) tendered for filing as part of its FERC Gas Tariff, First
Revised Volume No. 1, one firm transportation service agreement (FTSA)
with Public Service Company of Colorado.
    CIG states that the FTSA is being submitted to update a previously
approved non-conforming agreement.
    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 and 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 in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-17458 Filed 10-18-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Rules and Regulations]
[Pages 7996-7999]
[FR Doc No: 2016-03231]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-8421]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Patricia Suber, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this

rule is exempt from the requirements of the Regulatory Flexibility Act
because the National Flood Insurance Act of 1968, as amended, Section
1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an
appropriate public body adopts adequate floodplain management measures
with effective enforcement measures. The communities listed no longer
comply with the statutory requirements, and after the effective date,
flood insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.
    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain Federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region I

Massachusetts:
    Boston, City of, Suffolk          250286  July 7, 1975,       March 16, 2016........  March 16, 2016
     County.                                   Emerg; April 1,
                                               1982, Reg; March
                                               16, 2016, Susp.
    Chelsea, City of, Suffolk         250287  May 26, 1972,       ......do *............   Do.
     County.                                   Emerg; August 2,
                                               1982, Reg; March
                                               16, 2016, Susp.
    Revere, City of, Suffolk          250288  December 29, 1972,  ......do..............   Do.
     County.                                   Emerg; October
                                               16, 1984, Reg;
                                               March 16, 2016,
                                               Susp.
    Winthrop, Town of, Suffolk        250289  November 3, 1972,   ......do..............   Do.
     County.                                   Emerg; October 8,
                                               1976, Reg; March
                                               16, 2016, Susp.

           Region IV

Alabama:
    Anniston, City of, Calhoun        010020  December 10, 1974,  ......do..............   Do.
     County.                                   Emerg; September
                                               15, 1983, Reg;
                                               March 16, 2016,
                                               Susp.
    Attalla, City of, Etowah          010079  July 1, 1975,       ......do..............   Do.
     County.                                   Emerg; December
                                               1, 1981, Reg;
                                               March 16, 2016,
                                               Susp.
    Calhoun County,                   010013  September 22,       ......do..............   Do.
     Unincorporated Areas.                     1975, Emerg;
                                               September 15,
                                               1983, Reg; March
                                               16, 2016, Susp.
    Centre, City of, Cherokee         010233  December 27, 1976,  ......do..............   Do.
     County.                                   Emerg; March 14,
                                               1980, Reg; March
                                               16, 2016, Susp.
    Cherokee County,                  010234  June 24, 1986,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; June 17,
                                               1991, Reg; March
                                               16, 2016, Susp.
    Childersburg, City of,            010197  April 23, 1975,     ......do..............   Do.
     Talladega County.                         Emerg; December
                                               17, 1987, Reg;
                                               March 16, 2016,
                                               Susp.
    Etowah County,                    010077  N/A, Emerg;         ......do..............   Do.
     Unincorporated Areas.                     February 27,
                                               1990, Reg; March
                                               16, 2016, Susp.
    Gadsden, City of, Etowah          010080  April 12, 1976,     ......do..............   Do.
     County.                                   Emerg; April 4,
                                               1983, Reg; March
                                               16, 2016, Susp.
    Glencoe, City of, Etowah          010081  May 13, 1975,       ......do..............   Do.
     County.                                   Emerg; December
                                               1, 1981, Reg;
                                               March 16, 2016,
                                               Susp.
    Hobson City, Town of,             010021  April 16, 1975,     ......do..............   Do.
     Calhoun County.                           Emerg; September
                                               30, 1983, Reg;
                                               March 16, 2016,
                                               Susp.
    Hokes Bluff, Town of,             010254  September 1, 1976,  ......do..............   Do.
     Etowah County.                            Emerg; March 28,
                                               1980, Reg; March
                                               16, 2016, Susp.
    Jacksonville, City of,            010022  December 31, 1974,  ......do..............   Do.
     Calhoun County.                           Emerg; July 5,
                                               1982, Reg; March
                                               16, 2016, Susp.
    Lincoln, City of,                 010198  May 16, 1975,       ......do..............   Do.
     Talladega County.                         Emerg; July 18,
                                               1983, Reg; March
                                               16, 2016, Susp.
    Ohatchee, Town of, Calhoun        010232  N/A, Emerg; August  ......do..............   Do.
     County.                                   18, 2004, Reg;
                                               March 16, 2016,
                                               Susp.
    Oxford, City of, Calhoun          010023  April 3, 1975,      ......do..............   Do.
     and Talladega Counties.                   Emerg; January
                                               18, 1984, Reg;
                                               March 16, 2016,
                                               Susp.
    Piedmont, City of, Calhoun        010024  June 25, 1975,      ......do..............   Do.
     County.                                   Emerg; June 15,
                                               1984, Reg; March
                                               16, 2016, Susp.
    Rainbow City, City of,            010351  September 15,       ......do..............   Do.
     Etowah County.                            1975, Emerg;
                                               January 6, 1982,
                                               Reg; March 16,
                                               2016, Susp.
    Reece City, Town of,              010253  April 27, 1990,     ......do..............   Do.
     Etowah County.                            Emerg; February
                                               1, 1991, Reg;
                                               March 16, 2016,
                                               Susp.

    Sardis City, Town of,             010361  April 7, 1978,      ......do..............   Do.
     Etowah County.                            Emerg; January 1,
                                               1987, Reg; March
                                               16, 2016, Susp.
    Southside, City of, Etowah        010082  August 21, 1975,    ......do..............   Do.
     County.                                   Emerg; July 2,
                                               1987, Reg; March
                                               16, 2016, Susp.
    Sylacauga, City of,               010199  February 18, 1975,  ......do..............   Do.
     Talladega County.                         Emerg; December
                                               17, 1987, Reg;
                                               March 16, 2016,
                                               Susp.
    Talladega, City of,               010200  June 27, 1974,      ......do..............   Do.
     Talladega County.                         Emerg; April 15,
                                               1980, Reg; March
                                               16, 2016, Susp.
    Talladega County,                 010297  October 3, 1975,    ......do..............   Do.
     Unincorporated Areas.                     Emerg; July 2,
                                               1980, Reg; March
                                               16, 2016, Susp.
    Weaver, City of, Calhoun          010025  June 27, 1975,      ......do..............   Do.
     County.                                   Emerg; September
                                               30, 1983, Reg;
                                               March 16, 2016,
                                               Susp.

           Region V

Indiana:
    Gary, City of, Lake County        180132  March 17, 1975,     ......do..............   Do.
                                               Emerg; March 16,
                                               1981, Reg; March
                                               16, 2016, Susp.
    Griffith, Town of, Lake           185175  February 26, 1971,  ......do..............   Do.
     County.                                   Emerg; April 14,
                                               1972, Reg; March
                                               16, 2016, Susp.
    Highland, Town of, Lake           185176  May 21, 1971,       ......do..............   Do.
     County.                                   Emerg; May 19,
                                               1972, Reg; March
                                               16, 2016, Susp.
    Lake County,                      180126  July 25, 1973,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               2, 1981, Reg;
                                               March 16, 2016,
                                               Susp.
    Munster, Town of, Lake            180139  November 11, 1974,  ......do..............   Do.
     County.                                   Emerg; May 16,
                                               1983, Reg; March
                                               16, 2016, Susp.
    Schererville, Town of,            180142  March 17, 1975,     ......do..............   Do.
     Lake County.                              Emerg; May 1,
                                               1980, Reg; March
                                               16, 2016, Susp.
Minnesota: Hastings, City of,         270105  March 9, 1973,      ......do..............   Do.
 Dakota and Washington                         Emerg; July 16,
 Counties.                                     1980, Reg; March
                                               16, 2016, Susp.
Ohio:
    Holland, Village of, Lucas        390659  March 13, 1975,     ......do..............   Do.
     County.                                   Emerg; September
                                               22, 1978, Reg;
                                               March 16, 2016,
                                               Susp.
    Lucas County,                     390359  March 9, 1977,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; March 16,
                                               1983, Reg; March
                                               16, 2016, Susp.
    Ottawa Hills, Village of,         390362  October 24, 1975,   ......do..............   Do.
     Lucas County.                             Emerg; June 4,
                                               1980, Reg; March
                                               16, 2016, Susp.
    Sylvania, City of, Lucas          390364  February 18, 1972,  ......do..............   Do.
     County.                                   Emerg; July 5,
                                               1977, Reg; March
                                               16, 2016, Susp.
    Toledo, City of, Lucas            395373  December 18, 1970,  ......do..............   Do.
     County.                                   Emerg; June 4,
                                               1980, Reg; March
                                               16, 2016, Susp.

          Region VII

Kansas: Bourbon County,               200022  December 22, 1986,  ......do..............   Do.
 Unincorporated Areas.                         Emerg; June 1,
                                               1988, Reg; March
                                               16, 2016, Susp.

          Region VIII

Colorado:
    Castle Rock, Town of,             080050  April 22, 1975,     ......do..............   Do.
     Douglas County.                           Emerg; August 15,
                                               1978, Reg; March
                                               16, 2016, Susp.
    Douglas County,                   080049  August 28, 1974,    ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               3, 1980, Reg;
                                               March 16, 2016,
                                               Susp.
    Larkspur, Town of, Douglas        080309  March 27, 1987,     ......do..............   Do.
     County.                                   Emerg; September
                                               30, 1987, Reg;
                                               March 16, 2016,
                                               Susp.
    Lone Tree, City of,               080319  N/A, Emerg; April   ......do..............   Do.
     Douglas County.                           8, 2005, Reg;
                                               March 16, 2016,
                                               Susp.
    Parker, Town of, Douglas          080310  March 12, 1986,     ......do..............   Do.
     County.                                   Emerg; September
                                               30, 1987, Reg;
                                               March 16, 2016,
                                               Susp.
----------------------------------------------------------------------------------------------------------------
* -do- = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: January 15, 2016.
Roy E. Wright,
Deputy Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2016-03231 Filed 2-16-16; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Rules and Regulations]
[Page 68442]
[FR Doc No: 2015-28122]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Docket No. FAA-2015-0842; Airspace Docket No. 15-ACE-2

Amendment of Class E Airspace for the Following Missouri Towns:
Chillicothe, MO; Cuba, MO; Farmington, MO; Lamar, MO; Mountain View,
MO; Nevada, MO; and Poplar Bluff, MO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction.

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

SUMMARY: This action corrects an error in a final rule published in the
Federal Register of October 19, 2015, by amending the magnetic bearing
to a true bearing in the Class E surface area airspace description for
Farmington Regional Airport, Farmington, MO.

DATES: Effective 0901 UTC, December 10, 2015. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Jim Pharmakis, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone: 817-
222-5855.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register amending
Class E surface area airspace at multiple airports in Missouri,
including Farmington Regional Airport, Farmington, MO (80 FR 63085
October 19, 2015). Subsequent to publication the FAA identified that a
magnetic bearing was used to describe parameters of the Class E surface
area airspace for Farmington Regional Airport, Farmington, MO. This
action replaces the magnetic bearing with a true bearing.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of October 19, 2015 (80 FR 63085) FR Doc. 2015-26273,
the bearing in the regulatory text on page 63086, column 3, line 9, is
corrected as follows:

Sec.  71.1  [Amended]

ACE MO E2 Farmington, MO (Corrected)

0
Remove ``202[deg] bearing'' and add in its place ``204[deg] bearing''

    Issued in Fort Worth, Texas, on October 26, 2015.
Walter Tweedy,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-28122 Filed 11-4-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]
[Page 42177]
[DOCID:fr20jy10-115]

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SECURITIES AND EXCHANGE COMMISSION

[Form N-SAR; SEC File No. 270-292; OMB Control No. 3235-0330]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form N-SAR, SEC File No. 270-292, OMB Control No. 3235-0330.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Form N-SAR (OMB Control No. 3235-0330, 17 CFR 249.330) is the form
used by all registered investment companies with the exception of face
amount certificate companies, to comply with the periodic filing and
disclosure requirements imposed by Section 30 of the Investment Company
Act of 1940 (15 U.S.C. 80a-1 et seq.) (``Investment Company Act''), and
of rules 30a-1 and 30b1-1 thereunder (17 CFR 270.30a-1 and 17 CFR
270.30b1-1). The information required to be filed with the Commission
assures the public availability of the information and permits
verification of compliance with Investment Company Act requirements.
Registered unit investment trusts are required to provide this
information on an annual report filed with the Commission on Form N-SAR
pursuant to rule 30a-1 under the Investment Company Act, and registered
management investment companies must submit the required information on
a semi-annual report on Form N-SAR pursuant to rule 30b1-1 under the
Investment Company Act.
    The Commission estimates that the total number of respondents is
3,480 and the total annual number of responses is 6,180 ((2,700
management investment company respondents x 2 responses per year) +
(780 unit investment trust respondents x 1 response per year)). The
Commission estimates that each registrant filing a report on Form N-SAR
would spend, on average, approximately 14.31 hours in preparing and
filing reports on Form N-SAR and that the total hour burden for all
filings on Form N-SAR would be 88,436 hours.
    The collection of information under Form N-SAR is mandatory.
Responses to the collection of information will not be kept
confidential. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, VA 22312; or send an email to: PRA_
<EMAIL_ADDRESS>
    Dated: July 14, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-17639 Filed 7-19-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Notices]
[Pages 68930-68931]
[FR Doc No: 2019-27086]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2712-092]

Black Bear Hydro Partners, LLC, Black Bear Development Holdings,
LLC, and Black Bear SO, LLC; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Capacity Amendment of License.

    b. Project No: 2712-092.
    c. Date Filed: November 8, 2019.
    d. Applicant: Black Bear Hydro Partners, LLC.
    e. Name of Project: Stillwater Project.
    f. Location: The Project is located on the Stillwater Branch of the
Penobscot River in Penobscot County, Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Kevin Bernier, Senior Compliance Specialist
(207) 723-4341<EMAIL_ADDRESS>1024 Central
Street, Millinocket, Maine 04462.
    i. FERC Contact: Holly Frank;<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance date of this notice by the Commission.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-2712-092. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Black Bear Hydro Partners, LLC
(applicant) requests an amendment of the minimum flow requirement
pursuant to Article 402 of the Stillwater license. The current minimum
flow requirement is 70 cubic feet per second (cfs), allocated such that
a minimum flow of 20 cfs is conveyed to the west bypass channel and 50
cfs is conveyed to the east bypass channel. In order to facilitate
upstream eel passage and protect downstream migrating fish, the
applicant requests an amendment which would eliminate the specific
minimum flow conveyance locations. The total minimum flow of 70 cfs
would not be changed.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', ``MOTION TO
INTERVENE'', as applicable; (2) set forth in the heading the name of
the applicant and the project number of the application to which the
filing responds; (3) furnish the name, address, and telephone number of
the person commenting, protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: December 9, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-27086 Filed 12-16-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85291-85293]
[FR Doc No: 2023-26885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-2136]

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

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 Truseltiq and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application 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 February 5, 2024.
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 June 4, 2024. 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 February 5, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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 No.
FDA-2022-E-2136 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TRUSELTIQ.'' 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, Truseltiq
(infigratinib) indicated for the treatment of adults with previously
treated, unresectable locally advanced or metastatic cholangiocarcinoma
with a fibroblast growth factor receptor 2

fusion or other rearrangement as detected by an FDA-approved test. This
indication is approved under accelerated approval based on overall
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trial(s). Subsequent to this approval,
the USPTO received a patent term restoration application for Truseltiq
(U.S. Patent No. 8,552,002) from QED Therapeutics, Inc. (agent of
Novartis AG), and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated January 18, 2023, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of Truseltiq 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
Truseltiq is 4,258 days. Of this time, 4,016 days occurred during the
testing phase of the regulatory review period, while 242 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:
October 2, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
October 2, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: September 29,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Truseltiq (NDA 214622) was initially submitted on
September 29, 2020.
    3. The date the application was approved: May 28, 2021. FDA has
verified the applicant's claim that NDA 214622 was approved on May 28,
2021.
    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 application for patent extension,
this applicant seeks 1,516 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: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26885 Filed 12-6-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 191 (Thursday, October 2, 2014)]
[Notices]
[Page 59489]
[FR Doc No: 2014-23539]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[A-1-FRL-9917-37-Region-1]

Notice of Decision To Issue a Clean Air Act PSD Permit for Salem
Harbor Redevelopment Project

AGENCY: Environmental Protection Agency.

ACTION: Notice of final action.

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

SUMMARY: This notice announces that the Massachusetts Department of
Environmental Protection (MassDEP) issued a final permit decision for a
Clean Air Act Prevention of Significant Deterioration (PSD) permit
(Transmittal Number X254064) to Footprint Power Salem Harbor
Development, LP for the construction of the Salem Harbor Redevelopment
(SHR) Project.

DATES: MassDEP issued a final PSD permit decision for the SHR on
September 11, 2014. The PSD permit for SHR became final and effective
on September 11, 2014. Pursuant to Section 307(b)(1) of the Clean Air
Act, 42 U.S.C. 7607(b)(1), judicial review of this final permit
decision, to the extent it is available, may be sought by filing a
petition for review in the United States Court of Appeals for the First
Circuit within 60 days of October 2, 2014.

ADDRESSES: Documents relevant to the above-referenced permit are
available for public inspection during normal business hours at the
following address: Massachusetts Department of Environmental
Protection, Northeast Regional Office, 205B Lowell Street, Wilmington,
MA 01887.

FOR FURTHER INFORMATION CONTACT: Ida E. McDonnell, Manager, Air
Permits, Toxics and Indoor Programs Unit, Environmental Protection
Agency, EPA New England Regional Office,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Key portions of the administrative record for
this permit decision (including the final permit, all public comments,
MassDEP's responses to the public comments, and additional supporting
information) are available through a link at MassDEP's Web site at:
http://www.mass.gov/eea/agencies/massdep/air/approvals/footprint.html.
Anyone who wishes to review the Environmental Appeals Board (EAB or
Board) decisions described below or the documents in the EAB's
electronic docket for its decision related to this matter can obtain
them at http://www.epa.gov/eab/.

SUPPLEMENTARY INFORMATION: The MassDEP, acting under authority of an
April 11, 2011 PSD delegation agreement with EPA Region 1, issued a
final PSD permit decision on January 30, 2014 to the Footprint Power
Salem Harbor Development, LP authorizing construction and operation of
the SHR project. Four commenters jointly filed a petition seeking
review of MassDEP's January 30, 2014 permit decision for the SHR
project with the EPA EAB. On September 2, 2014, the Board issued an
order denying review. See In re Footprint Power Salem Harbor
Development, LP, PSD Appeal No. 14-02, Slip opinion (EAB September 2,
2014), 16E.A.D_. Following denial of review, pursuant to 40 CFR
124.19(l)(2), MassDEP issued a final permit decision to the SHR project
on September 11, 2014. All conditions of the SHR PSD permit,
Transmittal No. X254064, became final and effective on September 11,
2014.

    Dated: September 18, 2014.
Deborah A. Szaro,
 Acting Regional Administrator, EPA New England.
[FR Doc. 2014-23539 Filed 10-1-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 223 (Thursday, November 19, 2015)]
[Notices]
[Pages 72483-72484]
[FR Doc No: 2015-29473]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0103; Notice 1]

Michelin North America, Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: Michelin North America, Inc. (MNA), has determined that
certain Michelin heavy truck tires do not fully comply with paragraphs
S6.5(a) and (j) of Federal Motor Vehicle Safety Standard (FMVSS) No.
119, New Pneumatic Tires for Motor Vehicles With a GVWR of More than
4,536 kilograms (10,000 pounds) and Motorcycles. MNA has filed an
appropriate report dated September 18, 2015, pursuant to 49 CFR part
573, Defect and Noncompliance Responsibility and Reports.

DATES: The closing date for comments on the petition is December 21,
2015.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: 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 Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: Logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated above will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see
implementing rule at 49 CFR part 556), MNA submitted a petition for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential to
motor vehicle safety.
    This notice of receipt of MNA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Affected are approximately 247 Michelin X Works
XZY size 315/80R22.5 156/150K heavy truck tires that were manufactured
between January 1, 2011 and July 31, 2015.
    III. Noncompliance: MNA describes the noncompliance's as the
inadvertent omission from the tires sidewall of the letter marking that
designates the tire load range as required by paragraph S6.5(j) and the
symbol ``DOT'' confirming certification as required by paragraph
S6.5(a) of FMVSS No. 119.
    IV. Rule Text: Paragraph S6.5 of FMVSS No. 119 requires in
pertinent part:
    S6.5 Tire Markings. Except as specified in this paragraph, each
tire shall be marked on each sidewall with the information specified in
paragraphs (a) through (j) of this section. . . .
    (a) The symbol DOT, which shall constitute a certification that the
tire conforms to applicable Federal Motor Vehicle Safety standards.
This symbol may be marked on only one sidewall. . . .
    (j) The letter designating the tire Load Range.
    V. Summary of MNA's Petition: MNA believes that while it did not
intend to release the subject tires for sale in the U.S. market, and
therefore did not mark the tires accordingly, it believes that the
subject noncompliance is inconsequential to motor vehicle safety for
the following reasons:
    (1) Maximum Load Rating: The subject tires are marked on both
sidewalls with the European Tyre and Rim Technical Organization (ETRTO)
published load capacities in pounds and kilograms for single and dual
application in the format specified by FMVSS No. 119. MNA believes that
this marking provides sufficient information to ensure the proper
application of the tire.
    (2) Load Index: The subject tire is marked with the [International
Organization for Standardization] ISO load indices for single and dual
application as specified by the ETRTO standard. MNA believes that ISO
load indices are widely recognized within the industry and thus provide
additional information to ensure the proper application of the tire.
    (3) Other Markings: All other markings specified by FMVSS No. 119
are present on the tire including the full tire identification number
(TIN).
    (4) Performance: The subject tire meets all performance
requirements of FMVSS No. 119. MNA believes that the subject
noncompliances have no impact on the load carrying capacity of the tire
on a motor vehicle, nor on motor vehicle safety itself.

    (5) Vehicle Fitment: Paragraph S6 of FMVSS No. 119 requires that
the marking should contain load capacity values in pounds and kilograms
as well as a letter designating the load range. This information is
used by vehicle owners to ensure adequate tire load capacity for the
specific vehicle configuration. Although the subject tire lacks the
letter designating the load range, MNA believes that the ETRTO standard
load capacity values and ISO load indices for single and dual
application which are widely recognized in the industry are present to
ensure proper application.
    MNA has additionally informed NHTSA that it has corrected its
internal systems error to prevent similar tires from being released for
sale in the U.S. market in the future.
    In summation, MNA believes that the described noncompliances of the
subject tires is inconsequential to motor vehicle safety, and that its
petition, to exempt MNA from providing recall notification of
noncompliances as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that MNA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after MNA
notified them that the subject noncompliance existed.

    Authority: (49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8)

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2015-29473 Filed 11-18-15; 8:45 am]
 BILLING CODE 4910-59-P


1
5
,142
0
.
1
5
%
K
Unable to determine the registration number of the manufacturer
16
6,647
1.
70
%
L
Unable to determine identity of the manufacturer--providing identity of
manufacturer’s headquarters
1
5
,674
0.
16
%
M
Unable to determine identity of manufacturer or headquarters providing
invoicing firms identity
1
5
,839
0.
16
%
O
Gift pack for non-business purposes--providing single prior notice and
identity of packer
3
2
,371
0.
33
%
Total times a reason code was given (includes submission for PNSI and ABI/ACS)
for fiscal year 2007
63
7,153 7.51%
FDA posits that larger entities (e.g., medium to large importers) that deal directly with
foreign manufacturers will not be impacted by this IFR requirement (are not part of the 2.91
percent) as they will be able to obtain the manufacturers’ registration numbers and facility
addresses for the products they are importing. Therefore, it is mostly the small U.S. retailers or
individuals that buy from other wholesalers or retailers in foreign countries that may have a
problem obtaining the registration number, city, and country of the actual food manufacturing
facility.
Using data from the U.S. Census Bureau, FDA was able to determine that for 2006, about
$64.8 billion foods, feeds, and beverages were imported into the United States.  We subtract
from the $64.8 billion import value the categories of imported food products that are not
regulated by FDA and therefore prior notice is not required (i.e., meat products, poultry products,

357
and egg products).  The new, reduced imported food value represents the value of imported food
that could be affected by the IFR requirement that the registration number, city, and country of
the manufacturer be provided on prior notice.
Next, we present the best and worst case scenarios to represent the possible range of
imported foods value that may be affected by this IFR requirement.
In our best case scenario, few imported foods would be affected by manufacturer
registration number, name and partial address being required on prior notice.  For our best case
scenario we subtract the full import value of the potentially “unaffected” categories listed in table
5 of this document from $64.8 billion, the total value of food, feeds, and beverages imported into
the United States in 2006. (Ref. 3)  In essence, we subtract out those food categories that are
likely comprised of foods that are still in their natural state such that a manufacturer is not
required for the prior notice (e.g., green coffee).  This is our “best case” scenario because not all
foods imported from the categories below will come from facilities that are not required to be
registered (i.e. vegetables could be farm commodities or could be processed).  The remaining
imported foods value, about $29 billion, represents the value of alcoholic beverages, bakery
products, non-agricultural, and “other” imported foods; which are products more likely to be
required to have a manufacturing facility’s registration number.
About 2.91 percent of the prior notice submissions for fiscal year 2007 indicated that the
importer could not provide the registration number, city, and country of the actual manufacturing
facility.  While we do not know the value of imported foods for each of the prior notice
submissions in the 2.91 percent affected, in the absence of better information, for our best case
scenario we reduce the value of imported foods affected to $843 million, or 2.91 percent of $29
billion.

358
The estimated $843 million affected by the facility name, registration number, and partial
address requirement is an overestimate of the imported value likely affected.  The 2.91 percent of
prior notice submissions that could not supply the information required by the codified of the
IFR are most likely goods imported by small or very small U.S. retailers or individuals.  These
goods are likely purchased for import not through the manufacturer but through middlemen, thus
the importers often do not have access to, or knowledge of, the manufacturer registration number
and facility address.  These small U.S. retailers or individuals would not be importing large
quantities of food; therefore, the value of their imported shipments should be small, much
smaller in total than the $843 million estimate.  In other words, the 2.91 percent of prior notice
submissions affected by the identity of the manufacturer requirement of the IFR likely represent
much less than 2.91 percent of the total value of foods imported into the United States.
For the worst case scenario, we apply the 2.91 percent of import lines for 2007 that could
not provide the registration number, city, and country of the actual manufacturer to the entire
value of FDA-regulated imported food shipments, $59 billion, giving us a possible $1.7 billion in
imported foods value that could be affected by the prior notice IFR requiring the facility name,
registration number, and partial address on most prior notices.  The “worst case” scenario likely
includes some food that would not be affected by this requirement, and as with the best case
scenario, the value affected is likely overestimated because the persons most likely to be affected
by the manufacturer identity requirement will not be importing large quantities of goods.
Table 7 of this document thus estimates that the value of imported food affected by the
IFR requirement to be $843 million to $1.7 billion. These values represent the range of imported
food value affected by the requirement, not the actual size of the effect (the marginal increase in
prices importers will have to pay or pass along to consumers in order to still be able to offer

359
certain products in the U.S.). The size of the effect is best measured as the increased cost
associated with importers switching to other foreign or domestic suppliers or the costs of ceasing
to have certain products available for sale. For example, if alternative suppliers’ prices are on
average 10 percent higher than the prices of the suppliers that can no longer be used, the actual
range of costs of the registration number and full address requirement of the IFR is $84.3 million
to $172.2 million.
The final row in table 7 of this document estimates the marginal cost of the IFR
manufacturer registration number and full facility address requirement by assuming that costs of
imported food products that are likely to be affected by this IFR requirement undergo a 50
percent mark-up if importers wish to still continue supplying these products in the U.S. market.
This is likely an overestimate of the mark-up suppliers will have to pay to continue securing
certain imported food products, but the overestimate also compensates for those products that
may no longer be available to consumers at all.  Thus, the costs of requiring manufacturer
registration number and full facility address on prior notice are estimated to be $421.5 to $861
million.

360
TABLE 7.--IMPORTS OF GOODS BY END USE CATEGORY AND COMMODITY (2006 SEASONALLY ADJUSTED DATA)
Best Case Scenario
(Millions)
Worst Case Scenario
(Millions)
Foods, feeds, and beverages (FFB) total
<s>1</s>
$64,782
$64,782
Categories of imported food products subtracted
Meat products
$5,611
$5,611
Fish and shellfish
$9,867
Vegetables $4,943
Cane and beet sugar
$1,121
Cocoa beans
$520
Tea, spices, etc.
$715
Food oils, oilseeds
$1,999
Feedstuff and food grains
$1,577
Fruits, frozen juices
$5,503
Nuts $856
Green coffee
$2,035
Dairy products and eggs
$1,070
Remaining value of imports that may be affected by the IFR
identity of the manufacturer requirement
$28,965
$59,171
Imported value reduced further to represent that 2.91% of prior
notice submissions could not provide registration number
and site-specific information on prior notice for fiscal year
2
007
$843
$1,722
Size of the effect--the marginal cost of the registration number
and address requirement (assume 50% increase in prices
for the likely affected products)
$421.5
$861
1
Source of original data: U.S. Census Bureau, U.S. Bureau of Economic Analysis, US DOC News, November 9,
20
0
7
, pages 12 and 15, available online at
http://www.bea.gov/newsreleases/international/trade/2007/pdf/trad0907.pdf.
Table 8 of this document presents a summary of the revised estimated costs associated
with Option 1, including the marginal costs ($641.25 million, the average of the best ($421.5
million) and worst ($861 million) case scenarios) to importers who may be affected by the IFR
requirement that a facility’s name, registration number and partial address be provided on prior
notice.  Also included in the summary table 8 of this document are the discounted present value
of the costs at the OMB-recommended discount rates of 3 and 7 percent.

361
TABLE 8.--SUMMARY OF UPDATED COSTS FOR OPTION 1--BASELINE AND IFR
(In Thousands of Dollars)
Learning costs
$66,240
Coordination costs
$31,095
Computer acquisition costs
$7,600
FDA prior notice system cost
$13,000
Annual costs to fill out prior notice screens
$202,500
Additional costs for BRASS users
$48,462
Lost value for produce
$4,261
Lost value for seafood
$11,533
Cost for truck time
$0
Costs of manufacturer registration number and full facility address
requirement $641,250
Total first year costs for Option 1
$1,025,941
Annual costs after first year
<s>1</s>
$919,800
PV of costs at 7% for 20 years
$9,843,567
PV of costs at 3% for 20 years
$13,787,344
<s>1</s>
Annual costs include the start-up costs of prior notice to the estimated 10 percent of new businesses
that enter the market each year.
Benefits of Option 1 (Baseline and IFR)
FDA’s prior notice system provides us with enhanced knowledge
of what articles of food are being imported or offered for import into the United States.
Requiring prior notice of imported food shipments and defining the required data information
improves our ability to detect accidental and deliberate contamination of food and to deter
deliberate contamination.
Before prior notice was required, FDA received almost no advance notice information
about food products entering the United States from foreign sources, or the location of the food’s
anticipated port of arrival.  With the information required by prior notice, FDA does know what
articles of food are being imported or offered for import before they arrive at the port.  In the
event of a credible threat for a specific product or a specific manufacturer or processor, for
example, FDA will be able to mobilize and assist in the detention and removal of products that
may pose a serious health threat to humans or animals.

362
FDA’s PNC reviews prior notices and assesses the risk related to imported food
shipments. Personnel at the PNC decide on a case-by-case basis whether the article of food needs
to be held for examination upon arrival at the port. Having notice of an article of food imported
or offered for import into the United States before it reaches a U.S. port allows FDA personnel to
be ready at any time to respond to shipments that appear to pose a significant health risk to
humans or animals.
Cost Benefit Summary Table
We now estimate that the costs of the IFR (Option 1) will be about $1 billion in the first
year and $920 million in later years. At a 7-percent discount rate, the present value of the costs
of the IFR, discounted 20 years into the future, would be about $9.8 billion; for a discount rate of
3 percent, the present value costs would be about $13.8 billion.
TABLE 9.--UPDATED COST BENEFIT SUMMARY TABLE FOR OPTION 1
Annualized Costs Over
20
Years at 7% Discount
Rate (Millions)
Annualized Costs Over
20
Years at 3% Discount
Rate (Millions)
Option 1--2 hour prior notice for vehicle, 4 hour for rail
and air, 8 hour for vessels (IFR)
$931
$928
Benefits--FDA will know what articles of food are being imported or offered for import, before they arrive at
the port.  In the event of a threat of significant public health risk to humans or animals, FDA and CBP
will be able to mobilize and assist each other in the detention and removal of those products.

363
Option 2 (A and B): Minimum prior notice time frame would be 1 hour before arrival for articles
of food arriving by land by road or 30 minutes for FAST participants, 2 hours before arrival for
articles of food arriving by land by rail, “wheels-up” for flights originating in North and Central
America, South America (north of the equator only), the Caribbean, and Bermuda; 4 hours for all
other flights, and 8 hours before arrival for vessels; information would be submitted
electronically, most changes in information would require resubmission
This option coordinates FDA minimum prior notice times with those of CBP for imports
arriving by land by road, by land by rail, and by air.
15
For this option’s time frames we present
two scenarios: (1) The costs and benefits of Option 2 when FDA’s PNC is staffed at its current
level and must review and respond to prior notices received within the minimum time frame
required; and (2) the costs and benefits of Option 2 when the PNC has increased its staff to
review and respond to prior notices received within the minimum time frame required.
Option 2A-PNC is Staffed at its Current Level and Must Review and Respond to Prior Notices
within the Minimum Time Frame Required
Costs of Option 2A
1-hour or 30 minute minimum prior notice time for food arriving by land by road
A significant portion (approximately 31 percent) of the prior notices reviewed by the
PNC on a daily basis is for articles of food that arrive in the United States by land by road. The
PNC conducts a more intensive security review on at least 225 to 250 prior notices per day.  Of
these prior notices that are flagged as potentially high-risk and require a more intensive security
15
We do not examine or integrate timeframes for products arriving by water. Persons that use vessels to import
their products are usually dealing with merchandise that is not highly perishable in nature and thus less time-
sensitive. FDA did not receive comments requesting the coordination of FDA and CBP timeframes for food arriving
by water.  FDA’s current minimum prior notice timeframe for notification of food being imported by water is 8
hours before arrival; CBP’s current minimum prior notice timeframe for articles being imported by water is 24 hours
before arrival.

364
review, about 77 (31 percent of 250) are for articles of food arriving by land by road.
Complicating matters further is that prior notice submissions and expiration times are not evenly
distributed over an 8-hour shift or 24-hour day; an overwhelming majority of prior notice
submissions arrive during a certain 12 hour time period.
The PNC has estimated using 2007 data that most prior notices submitted for land border
entries took between 30 and 110 minutes to review.  This range indicates that if the prior notice
minimum submission time frames were reduced from 2 hours to 1 hour, approximately 27
percent of those high risk prior notices for articles of food arriving by land by road that are
selected for a more intensive review would exceed the minimum prior notice timeframe and
would have to be delayed at the port of arrival while the PNC completes its review and risk
assessment, as discussed earlier in this preamble.
If the minimum prior notice submission time for articles of food arriving by land by road
is shortened to 30 minutes, the intensive security reviews (described previously) on
approximately 69 percent of the high-risk targeted land border prior notices would not be
completed within the prior notice timeframe.  Again, as a result of the shorter timeframe, it
would be necessary for the PNC to delay the movement of these shipments at the port of arrival
in order to complete their review and risk assessment.
The synopsis stated in the previous paragraph implies that the PNC likely will not be able
to review and respond to all prior notices received for articles of food arriving by land by road
within the minimum time if the minimum prior notice submission time for articles of food
arriving by land by road is either one hour or 30 minutes.  The loss of value to fresh produce and
seafood calculated in table 8 of this document reflects that some articles of food (about 27 to 69

365
percent of high risk prior notices) will be held at the port of arrival past the 30 minutes or 1 hour
minimum prior notice submission time frame while the PNC completes its review.
In table 10 of this document, we first calculate the lost value to fresh produce and seafood
as if FDA had the additional staff necessary to receive, review, and respond to prior notices
within the minimum prior notice submission time
16
and then increase those costs (in terms of lost
value to perishable produce and seafood arriving in the United States by land by road by 48
percent-the average of 27 and 69 percent) to account for the fact that some of these articles of
food will be held up at the port pending prior notice review completion given the current PNC
staffing level.
We note that we base this analysis on the typical (average) prior notice review time.
Given that most prior notices for land border entries took between 30 and 110 minutes to review,
the typical article of food arriving by land by road should not have to wait longer than 2 hours to
enter; which is equivalent to the time that articles of food arriving by land by road will have to
wait to enter the United States under Option 1.  However, no matter what the minimum prior
notice submission time frames are, there will always be some articles of food whose review will
take longer than the minimum allotted prior notice review time frames.
16
We use the same probability of resubmission structure established in the analysis of the IFR, (68 FR 58974 at
5
902
5).  This minimum submission time should eliminate the probability of having to resubmit prior notice for all
but 2.5 percent of those perishable products imported from Canada and Mexico by land by road.

366
TABLE 10.--LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 2A FOR SHIPMENTS
ARRIVING BY LAND BY ROAD (1-HOUR OR 30-MINUTE MINIMUM NOTICE REQUIREMENT)
Perishable Produce
Dollars
2
001
Imported Mexican produce total retail value
$3,458,525,000
94
% of total retail value for Mexican produce
$3,251,014,000
0.
6% Reduction in value for 2.5% of Mexican produce
$488,000
48% Increase in lost value due wait time past minimum submission time frame
$234,000
Total lost value for Mexican produce
$722,000
2
001
Imported Canadian produce total retail value
$401,826,000
85
% of total retail value for Canadian produce
$341,552,000
0.
6% Reduction in value for 2.5% of Canadian produce
$51,000
48
% Increase in lost value due wait time past minimum submission time frame
$24,000
Total lost value for Canadian produce
$75,000
Total lost value for produce
$797,000
Perishable Seafood
Dollars
2
001
Imported Mexican seafood total retail value
$112,277,000
94