  MacroButton macIb01 i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Mark Dow<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

OMC Ag Consulting

IN-10935

	EPA has received a pesticide petition (IN-10935) from OMC Ag Consulting
(828 Tanglewood Lane, East Lansing, MI 48823) on behalf of  Vive Crop
Protection, Inc. (700 Bay Street, Suite 1100, Toronto, Ontario, Canada,
M5G-1Z6) requesting, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180  to establish an exemption from the requirement of a tolerance for
acrylic polymers (CAS Reg. No.2156-97-0) and acrylamidopropyl (CAS Reg.
No. 15214-89-8) when used in pesticide formulations applied to growing
crops under 40 CFR 180.960. EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition to revise an existing exemption from the
requirement of a tolerance for modified acrylic polymers located in 40
CFR part 180.960

The existing tolerance exemption reads as follows: Acrylic polymers
composed of one or more of the following monomers: Acrylic acid, methyl
acrylate, ethyl acrylate, butyl acrylate, hydroxyethyl acrylate,
hydroxypropyl acrylate, hydroxybutyl acrylate, carboxyethyl acrylate,
methacrylic acid, methyl methacrylate, ethyl methacrylate, butyl
methacrylate, isobutyl methacrylate, hydroxyethyl methacrylate,
hydroxypropyl methacrylate, hydroxybutyl methacrylate, lauryl
methacrylate, and stearyl methacrylate; with none and/or one or more of
the following monomers: Acrylamide, N-methyl acrylamide, N,N-dimethyl
acrylamide, N-octylacrylamide, maleic anhydride, maleic acid, monoethyl
maleate, diethyl maleate, monooctyl maleate, dioctyl maleate; and their
corresponding sodium, potassium, ammonium, isopropylamine,
triethylamine, monoethanolamine, and/or triethanolamine salts; the
resulting polymer having a minimum number average molecular weight (in
amu), 1,200.  No CAS registry number is associated with the exemption.

Vive Crop Protection, Inc. is requesting that the exemption be revised
to include lauryl acrylate by inserting lauryl acrylate between
hydroxybutyl methacrylate and lauryl methacrylate, and by inserting
acrylamidopropyl methyl sulfonic acid after dioctyl maleate.

A. Residue Chemistry

	1. Plant metabolism. NA-Remove

	2. Analytical method. NA-Remove

	3. Magnitude of residues. Vive Crop Protection, Inc. is petitioning for
an exemption from the requirement of a tolerance based upon the
polymer’s compliance with the Low Risk Polymer criteria per 40 CFR
723.250.  Therefore, an analytical method to determine residues in raw
agricultural commodities has not been proposed.  No residue chemistry
data or environmental fate data are presented in the petition as the
Agency does not generally requires some or all of the listed studies to
rule on the exemption from the requirement of a tolerance for a low risk
polymer inert ingredient.

B. Toxicological Profile

1. Acute toxicity.

The Agency has established a set of criteria which identifies categories
of polymers that present low risk.  These criterial (described in 40 CFR
723.250) identify polymers that are relatively unreactive and stable
compared to other chemical substances, as well as, polymers that
typically are not readily absorbed.  Vive Crop Protection, Inc.,
believes that lauryl acrylate polymers and acrylamidopropyl methyl
sulfonic acid polymers conform to the definition of a polymer given in
40 CFR 723.250 and meets the criteria used to identify a low risk
polymer.  Vive Crop Protection, Inc., also believes that based on these
substances conformance to the above mentioned criteria, no mammalian
toxicity is anticipated from dietary, inhalation or dermal exposure to
polymers and that these polymers will present minimal or no risk.

1. These polymers are not cationic polymers.

2. They contain as an integral part of their composition the atomic
elements carbon, hydrogen, and oxygen.

3. They do not contain as an integral part of their composition, except
as impurities, any elements other than those listed in   HYPERLINK
"https://www.federalregister.gov/select-citation/2001/06/20/40-CFR-723.2
50"  40 CFR 723.250 (d)(2)(ii).

4. These polymers are not designed or reasonably anticipated to
substantially degrade, decompose, or depolymerize.

5. These polymers are not manufactured or imported from monomers and/or
other reactants that are not already on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.

6. They are not water absorbing polymers.

7. The minimum average molecular weight of the above-mentioned polymers
is greater than 1,000. Substances with molecular weights greater than
400 are generally not readily absorbed through the intact skin, and
substances with molecular weights greater than 1,000 are generally not
absorbed through the intact gastrointestinal (GI) tract. Chemicals not
absorbed through the GI tract are generally incapable of eliciting a
toxic response. These polymers have an oligomer content less than 10%
below molecular weight 500 and less than 25% molecular weight 1,000.

Vive Crop Protection, Inc. believes sufficient information was submitted
in the petition to assess the hazards of modified acrylic polymers. No
toxicology data were presented in the petition as the Agency does not
generally require that polymers conform to   HYPERLINK
"https://www.federalregister.gov/select-citation/2001/06/20/40-CFR-723.2
50"  40 CFR 723.250 . Based on these polymers conforming to the
definition of a polymer and meeting the criteria of a low risk polymer
under   HYPERLINK
"https://www.federalregister.gov/select-citation/2001/06/20/40-CFR-723.2
50"  40 CFR 723.250 , Vive Crop Protection, Inc. believes there are no
concerns for risks associated with toxicity.

	2. Genotoxicty. NA-Remove

	3. Reproductive and developmental toxicity. NA-Remove

	4. Subchronic toxicity. NA-Remove

	5. Chronic toxicity. NA-Remove

	6. Animal metabolism. NA-Remove

	7. Metabolite toxicology. NA-Remove

	8. Endocrine disruption.

Endocrine disrupter. There is no evidence that modified acrylic polymers
are endocrine disrupters. Substances with molecular weights greater than
400 generally are not absorbed through the intact skin, and substances
with molecular weights greater than 1,000 generally are not absorbed
through the GI tract. Chemicals not absorbed through the skin or GI
tract generally are incapable of eliciting a toxic response.

C. Aggregate Exposure

	1. Dietary exposure. Some modified acrylic polymers may be used in
contact with food as components of containers used to manufacture,
process, or store food when regulated for such use under the Federal
Food, Drug, and Cosmetic Act.  Modified acrylic polymers with a
molecular weight greater than 1,000 daltons are not readily absorbed
through the intact gastrointestinal track and are considered incapable
of eliciting a toxic response.

	i. Food. NA-Remove

	ii. Drinking water. NA-Remove

	2. Non-dietary exposure. NA-Remove

D. Cumulative Effects

	There is data to support a conclusion of negligible cumulative risk for
modified acrylic polymers.  Polymers with molecular weights greater than
400 generally are not absorbed through the intact skin, and substances
with molecular weights greater than 1,000 generally are not absorbed
through the intact gastrointestinal (GI) track.  Chemicals not absorbed
through the skin or GI track generally are incapable of eliciting a
toxic response.  Therefore, there is no reasonable expectation of
increased risk due to cumulative exposure.  Based on how these polymers
conform to the definition of a polymer and meeting the criteria of low
risk polymers under 40 CFR 723.250, Vive Crop Protection, Inc. believes
there are no concerns for risk associated with cumulative effects.

E. Safety Determination

	1. U.S. population. NA-Remove

	2. Infants and children. NA-Remove

F. International Tolerances

	NA-Remove

 PAGE

 PAGE   4


[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Notices]
[Page 48755]
[FR Doc No: 2020-17646]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. FAA-2020-61]

Petition for Exemption; Summary of Petition Received; Air Evac
EMS Inc.

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

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before September 1, 2020.

ADDRESSES: Send comments identified by docket number FAA-2017-1253
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Quentin Flinn<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 5, 2020.
Brandon Roberts,
Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2017-1253.
    Petitioner: Air Evac EMS Inc.
    Section(s) of 14 CFR Affected: 91.411(b) & 91.413(c).
    Description of Relief Sought: Air Evac EMS Inc., petitioned for an
exemption to perform air traffic control (ATC) transponder tests and
inspections and altimeter system and altimeter reporting equipment
tests and inspections for its 14 CFR part 135 aircraft maintained under
the Airbus manufacturers maintenance program.

[FR Doc. 2020-17646 Filed 8-11-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6759-6760]
[FR Doc No: 2023-02103]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2315]

Early Lyme Disease as Manifested by Erythema Migrans: Developing
Drugs for Treatment; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Early Lyme
Disease as Manifested by Erythema Migrans: Developing Drugs for
Treatment.'' The purpose of this draft guidance is to assist sponsors
in the clinical development of drugs for the treatment of early Lyme
disease as manifested by erythema migrans (EM).

DATES: Submit either electronic or written comments on the draft
guidance by April 3, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-2315 for ``Early Lyme Disease as Manifested by Erythema
Migrans: Developing Drugs for Treatment.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Shabnam Naseer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 22, Rm. 6239, Silver Spring, MD 20993, 301-796-
8539.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Early Lyme Disease as Manifested by Erythema Migrans:
Developing Drugs for Treatment.''
    The purpose of this draft guidance is to assist sponsors in the
clinical development of drugs for the treatment of early Lyme disease
as manifested by EM. Specifically, this guidance addresses FDA's
current thinking regarding clinical trial design considerations such as
trial populations, efficacy endpoints and clinical microbiology
considerations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Early Lyme
Disease as Manifested by Erythema Migrans: Developing Drugs for
Treatment.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information contained in 21 CFR part 312 relating to investigational
new drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to new
drug applications have been approved under OMB control number 0910-
0001. The collections of information contained in 21 CFR part 601
relating to biologics license applications have been approved under OMB
control number 0910-0338. The collections of information in 21 CFR part
201 relating to prescription product labeling requirements have been
approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02103 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Notices]
[Pages 24556-24557]
[FR Doc No: 2022-08792]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0163; FRL-9408-03-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Uses--March 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before May 26, 2022.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number and the File Symbol of the EPA registration
Number of interest as shown in the body of this document, through the
Federal eRulemaking Portal at https://www.regulations.gov. Follow the
online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting or visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets/about-epa-dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (BPPD)

(7511M), main telephone number:<PHONE_NUMBER>, email address:
[email protected]; or Marietta Echeverria, Registration Division
(RD) (7505P), main telephone number:<PHONE_NUMBER>, email address:
[email protected]. The mailing address for each contact person is:
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing
address, include the contact person's name, division, and mail code.
The division to contact is listed at the end of each application
summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

A. Notice of Receipt--New Uses

    1. EPA Registration Number: 352-555; 352-768. Docket ID number:
EPA-HQ-OPP-2021-0447. Applicant: E.I. du Pont de Nemours and Company,
9330 Zionsville Road Indianapolis, IN 46268. Active ingredient:
Rimsulfuron. Product type: Herbicide. Proposed uses: Pomegranates;
tropical and subtropical, small fruit, edible peel subgroup 23A.
Contact: RD.
    2. EPA Registration Number: 7969-311. Docket ID number: EPA-HQ-OPP-
2022-0234. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528. Active ingredient: Fluxapyroxad
and Pyraclostrobin. Product type: Fungicide. Proposed use: Coffee,
green bean; stevia, dried leaves; and stevia, fresh leaves. Contact:
RD.
    3. EPA Registration Number: 7969-312. Docket ID number: EPA-HQ-OPP-
2022-0234. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528. Active ingredient: Fluxapyroxad.
Product type: Fungicide. Proposed use: Coffee, green bean; stevia,
dried leaves; and stevia, fresh leaves. Contact: RD.
    4. EPA File Symbol: 7969-UIO. Docket ID number: EPA-HQ-OPP-2022-
0348. Applicant: BASF Corporation, 26 Davis Dr., Research Triangle, NC,
27709. Active ingredient: Broflanilide. Product type: Insecticide.
Proposed Use: Corn seed treatment. Contact: RD.
    5. EPA Registration Numbers: 86174-3 and 86174-4. Docket ID number:
EPA-HQ-OPP-2022-0305. Applicant: SAN Agrow Holding GmbH,
Industriestrasse 21, Herzogenburg 3130, Austria (c/o SciReg, Inc.,
12733 Director's Loop, Woodbridge, VA 22192). Active ingredients:
Aureobasidium pullulans strain DSM 14940 and Aureobasidium pullulans
strain DSM 14941. Product type: Fungicide. Proposed use: Aerial
application for numerous crops (e.g., legume, pome fruit, stone fruit,
and ornamentals) in agricultural settings. Contact: BPPD.
    6. EPA Registration Number: 91746-2. Docket ID number: EPA-HQ-OPP-
2022-0324. Applicant: Belchim Crop Protection US Corporation, 2751
Centreville Road, Suite 100, Wilmington, Delaware 19808. Active
ingredient: Pyridate. Product type: Herbicide. Proposed use: Turfgrass
and fallow. Contact: RD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: April 15, 2022.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2022-08792 Filed 4-25-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 15, 2008 (Volume 73, Number 241)]
[Notices]
[Page 76034-76037]
[DOCID:fr15de08-54]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0602]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of the Impact of Coupons Embedded
in Direct-to-Consumer Prescription Drug Print Advertisements on
Consumer Perceptions of Product Risks and Benefits

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for

public comment in response to the notice. This notice solicits comments
on a study of the impact of the presence of coupons offering price
incentives or rebates on consumers' perceptions of product risks and
benefits in direct-to-consumer (DTC) print ads.\1\ Notice of proposed
information collection for this project was previously published on
February 6, 2006 (71 FR 6077) and withdrawn. This revised notice
replaces the previous notice.
---------------------------------------------------------------------------

    \1\ While the Federal Food, Drug, and Cosmetic Act (the act)
provides FDA with authority to regulate prescription drug
advertisements that are false or misleading, the act does not
provide FDA with the authority to regulate the pricing of
prescription drugs. Thus, FDA is merely interested in studying the
impact, if any, of the presence of coupons in DTC advertisements on
consumers' perceptions of product risks and benefits, and recognizes
that it does not actually regulate the dollar or other incentive
amount of coupons, price incentives, or rebate offers with respect
to how they affect the price of prescription drugs or biological
products.

DATES: Submit written or electronic comments on the collection of
---------------------------------------------------------------------------
information by February 13, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Experimental Study of the Impact of Coupons Embedded in Direct-to-
Consumer Prescription Drug Print Advertisements on Consumer Perceptions
of Product Risks and Benefits

    FDA recognizes that the manufacturers, packers, and distributors
(sponsors) of prescription human and animal drugs, including biological
products for humans, have a First Amendment right to engage in the
truthful and non-misleading advertising of their products. An
advertisement is misleading, however, if it fails to disclose certain
information about the advertised product's uses and risks. Thus, for
prescription drugs and biologics, the act requires advertisements to
contain ``information in brief summary relating to side effects,
contraindications, and effectiveness'' (21 U.S.C. 352(n)). FDA is
responsible for enforcing the act and implementing regulations.
    FDA regulations require that prescription drug advertisements that
make claims about a product must also include risk information in a
``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the
content and presentation of the information. Advertisements that draw
attention to the name of the product but do not make representations
about the product's indication(s) or dosage recommendations are called
reminder advertisements. As a general matter, reminder ads may mention
the proprietary and established name of the product and (optionally)
contain information about the product's ingredients, dosage form,
quantity, price, and manufacturer (21 CFR 202.1(e)(2)(i)). Other
written, printed, or graphic information is not prohibited in reminder
ads as long as that information does not make a representation or
suggestion relating to the product beyond those permitted.
    Reminder ads allow sponsors to distribute price sheets, pens,
notepads and other minor giveaways featuring the name of the drug
product to physicians and other healthcare professionals without
requiring a full disclosure of the product's risks. As DTC promotion
has increased, sponsors have chosen to create reminder ads for
consumers.
    On November 1 and 2, 2005, the agency held a part 15 public hearing
(70 FR 54054, September 13, 2005) on the topic of direct-to-consumer
advertising of prescription drugs and restricted medical devices.
During the hearing, the agency received several comments in connection
with the potential impact of coupons and other price incentives on
consumer perceptions of DTC-advertised products. Sponsors may use ads
as a vehicle to offer price incentives to consumers (e.g., ``free
trial,'' ``buy six get one free''). Coupon promotions are widely used
in many product categories and have been the topic of many academic
studies. Certain types of coupons, most notably those that appear in
the body of an advertisement itself (i.e., are embedded in the
advertisement), can positively affect perceptions of the brand.\2\
---------------------------------------------------------------------------

    \2\ LeClerc, France and John D.C. Little, ``Can Advertising Copy
Make FSI Coupons More Effective?'' Journal of Marketing Research,
34(4), 473-484, 1997.
---------------------------------------------------------------------------

    People tend to rate owned objects more favorably than those they do
not own, even when those objects have been assigned to them at
random.\3\ This has been termed the ``mere ownership'' or ``mere
possession'' effect. An interesting extension of this effect is
provided in research by Sen and Johnson \4\ which has shown that
consumers rate a product more favorably when they are simply given a
gift certificate or a coupon for that product or service. Other
research has examined the effect of warranties. People who viewed an ad
with a high warranty perceived the product as being less risky compared
to people who saw an ad with a medium or low warranty.\5\
---------------------------------------------------------------------------

    \3\ Beggan, James K., ``On the Social Nature of Nonsocial
Perception: The Mere Ownership Effect,'' Journal of Personality and
Social Psychology, 62(2), 229-237, 1992.
    \4\ Sen, Sankar and Eric J. Johnson, ``Mere-Possession Effects
Without Possession in Consumer Choice,'' Journal of Consumer
Research, 24 (June), 105-117, 1997.
    \5\ Shimp, Terrence A. and William O. Bearden, ``Warranty and
Other Extrinsic Cue Effects on Consumers' Risk Perceptions,''
Journal of Consumer Research, 9 (June), 38-47, 1982.
---------------------------------------------------------------------------

    Based on this body of consumer research, the inclusion of a coupon
or other price incentive in the body of a DTC ad may affect consumers'
perceptions of the risks and benefits of

the prescription drug. For instance, consumers may assign more weight
to benefit claims in cases where a coupon or other price incentive is
embedded in the advertisement. For ``simple'' consumer products,
coupons and free trial offers may enable the customer to test new
products while minimizing their financial risk of testing the product.
For products that consumers can readily test and ones where performance
can be adequately verified (termed ``search'' goods by economists),
coupons and free trial offers provide both the consumer and
manufacturer an efficient mechanism for matching consumers and
products. For more complex products such as prescription drugs where
supervision of a physician is required to evaluate both appropriateness
and performance, coupons and free trial offers may send different
signals.
    The proposed exploratory study will examine what impact, if any,
the presence of coupons in DTC advertisements may have on consumers'
perceptions of product risks and benefits and the overall impression of
the product in DTC full-product and reminder advertisements.\6\
---------------------------------------------------------------------------

    \6\ As noted previously in this document, FDA does not have the
authority to regulate prescription drug pricing and we will not be
examining prescription drug prices.
---------------------------------------------------------------------------

Design Overview

    This study will employ a between-subjects crossed factorial design
and will focus on consumer print advertising. Fifteen print
advertisements will be created using three levels of ad type and five
levels of promotional offer. Thus, the factors will be ad type (DTC
print reminder; DTC print full product; over-the-counter (OTC) print
full product) and offer type (free trial offer; buy one, get one free;
money off prescription/purchase cost; money back guarantee; no
promotion). Product name and indication will be constant across
conditions. Side effect and risk information will be constant across
full product DTC ad conditions. Participants will be asked to read a
single print advertisement for a new drug. After reading the
advertisement, they will be asked questions about their evaluation of
the information presented in the advertisement.

Factors

    1. Participants: Consumers will be screened and recruited by the
contractor to be currently diagnosed with insomnia or at risk of
developing insomnia. Participants will be randomly assigned to
experimental cells. Each condition will be balanced with respect to
gender.
    Because this is the first investigation of this issue with DTC ads,
we chose to limit our investigation to one disease condition. We chose
to accept this decrease in generality to maximize our ability to detect
a subtle difference between promotion types. Participants will be
screened to represent a range of education levels (some college or less
vs. completed college or more). Because the task presumes basic reading
abilities, all participants will have English as their primary language
and, as appropriate, be required to have reading glasses when
participating in the study.
    2. Type of Ad: The following three types of ads will be tested: (1)
A full-product ad for a prescription drug, (2) a reminder ad for a
prescription drug, and (3) an ad for an OTC drug. An ad for an OTC
drug, which typically includes benefit but not risk information, is
included to see if prior research findings in the area of consumer
package goods can be replicated.
    3. Type of Promotion: The following five types of promotions will
be tested: (1) Free trial offer; (2) buy one, get one free; (3) money-
off prescription/purchase cost; (4) money back guarantee; and (5) a no
promotion condition. With the exception of buy one, get one free, these
are promotional variations that have been used in drug advertising. We
ask for comment on other promotional types that could be tested.

Procedure

    Participants will be shown one ad, for example, a reminder ad for a
prescription drug with a free-trial offer coupon embedded. Then the
participant will be asked to answer questions examining a number of
important perceptions about the product, including perceived riskiness
of the drug, likelihood of benefits, and behavioral intent (talking to
doctor, product purchase). Finally, demographic and health care
utilization information will be collected.
    Interviews are expected to last approximately 15 minutes. A total
of 1,350 participants will be involved. This will be a one-time (rather
than annual) collection of information.
    FDA estimates the burden of this collection of information as
follows:
    FDA estimates that 2,025 individuals will need to be screened to
obtain a respondent sample of 1,350. The screener is expected to take
30 seconds, for a total screener burden of 17 hours. The 1,350
respondents will then be asked to respond to a series of questions
about the advertisement. We estimate the response burden for the survey
to be 15 minutes, for a burden of 337.5 hours. The estimated total
burden for this data collection effort is 354.5 hours.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency     Total Annual        Hours per
         No. of  Respondents             per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
2,025 (screener)                                      1              2,025               .008                 17
----------------------------------------------------------------------------------------------------------------
1,350 (questionnaire)                                 1              1,350                .25              337.5
----------------------------------------------------------------------------------------------------------------
Total                                 .................              3,375  .................              354.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29517 Filed 12-12-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Notices]
[Pages 70623-70624]
[FR Doc No: 2013-28249]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2009-0203]

Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee
and the Liquid Pipeline Advisory Committee

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of advisory committee meeting.

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

SUMMARY: This notice announces a public meeting of the Gas Pipeline
Advisory Committee (GPAC) also known as the Technical Pipeline Safety
Standards Committee, and the Liquid Pipeline Advisory Committee (LPAC)
also known as the Technical Hazardous Liquid Pipeline Safety Standards
Committee. The committees will meet in a joint session to consider a
proposed rule to incorporate by reference two new standards (one
partially) and 21 updated editions of currently referenced standards in
49 CFR Parts 192, 193, and 195.

DATES: The meeting will be held on Tuesday, December 17, 2013, from
10:00 a.m. to 12:00 p.m. EST.

ADDRESSES: The committee members will take part in this joint meeting
by telephone conference call. The public may participate in the meeting
via telephone conference call, or at the U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, Room
E27-302. The conference call number and any additional information will
be published on the PHMSA Web site at http://www.phmsa.dot.gov/public,
under ``News and Updates'' on the homepage. Participants who plan to
attend in person should register in advance at https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=93.
    The meeting will not be webcast; however, presentations will be
available on the meeting Web site and posted in the E-Gov Web site at
http://www.regulations.gov under Docket Number PHMSA-2013-2003 within
30 days following the meeting.
    You may submit comments, identified by Docket Number PHMSA-2009-
0203, by any of the following methods:
    E-Gov Web: http://www.regulations.gov. This site allows the public
to enter comments on any Federal Register notice issued by any agency.
Follow the online instructions for submitting comments.
    Mail: Docket Management System: U.S. Department of Transportation,
1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140,
Washington, DC 20590-0001.
    Hand Delivery or Courier: U.S. Department of Transportation Docket
Management System: West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., between 9:00 a.m. and 5:00 p.m. EST, Monday through
Friday, except Federal holidays.
    Fax:<PHONE_NUMBER>.
    Instructions: Identify the Docket Number PHMSA-2009-0203, at the
beginning of your comments. If you submit your comments by mail, submit
two copies. If you wish to receive confirmation that PHMSA received
your comments, include a self-addressed stamped postcard. Internet
users may submit comments at http://www.regulations.gov.

    Note:  All comments received will be posted without edits to
http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.

    Privacy Act: Anyone is able to search the electronic comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000, (65 FR 19477-78) or you may visit http://docketsinfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. Follow the online
instructions for accessing the dockets. Alternatively, you may review
the documents in person at the street address listed above.

Information on Services for Individuals with Disabilities

    For information on facilities or services for individuals with
disabilities, or to seek special assistance at the meeting, please
contact Cheryl Whetsel at<PHONE_NUMBER> by December 10, 2013.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details

    Members of the public may participate via telephone conference or
make a statement during the advisory committee meeting. If you intend
to make a statement, please notify PHMSA in advance by forwarding an
email to<EMAIL_ADDRESS>by December 10, 2013.

II. Committee Background

    The GPAC and LPAC are statutorily-mandated advisory committees that
advise PHMSA on proposed safety standards, risk assessments, and safety
policies for natural gas pipelines and for hazardous liquid pipelines.
Both committees were established under the Federal Advisory Committee
Act (Pub. L. 92-463, 5 U.S.C. App. 1) and the pipeline safety law (49
U.S.C. Chap. 601). Each committee consists of 15 members--with
membership evenly divided among the Federal and state government, the
regulated industry, and the public. The committees advise PHMSA on the
technical feasibility, practicability, and cost-effectiveness of each
proposed pipeline safety standard.

III. Agenda

    On Tuesday, December 17, 2013, from 10:00 a.m. to 12:00 p.m. the
GPAC and LPAC will participate in a joint meeting. A detailed agenda
will be published on the PHMSA Web site at http://www.phmsa.dot.gov/.

    Authority: 49 U.S.C. 60102, 60115; 60118.

    Issued in Washington, DC on November 19, 2013.
Alan K. Mayberry,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2013-28249 Filed 11-25-13; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70622-70626]
[FR Doc No: 2019-27380]

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

DEPARTMENT OF TRANSPORTATION

Notice of Final Federal Agency Actions on Proposed Highway
Projects in Texas

AGENCY: Texas Department of Transportation (TxDOT), Federal Highway
Administration (FHWA), U.S. Department of Transportation.

ACTION: Notice of limitation on claims for judicial review of actions
by TxDOT and Federal Agencies.

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

SUMMARY: This notice announces actions taken by TxDOT and Federal
agencies that are final. The environmental review, consultation, and
other actions required by applicable Federal environmental laws for
these projects are being, or have been, carried-out by TxDOT pursuant
to an assignment agreement executed by FHWA and TxDOT. The actions
relate to various proposed highway projects in the State of Texas.
These actions grant licenses, permits, and approvals for the projects.

DATES: By this notice, TxDOT is advising the public of final agency
actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review
of TxDOT and Federal agency actions on the highway projects will be
barred unless the claim is filed on or before the deadline. For the
projects listed below, the deadline is May 21, 2020. If the Federal law
that authorizes judicial review of a claim provides a time period of
less than 150 days for filing such a claim, then that shorter time
period still applies.

FOR FURTHER INFORMATION CONTACT: Carlos Swonke, Environmental Affairs
Division, Texas Department of Transportation, 125 East 11th Street,
Austin, Texas 78701; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>TxDOT's normal business hours are 8:00 a.m.-
5:00 p.m. (central time), Monday through Friday.

SUPPLEMENTARY INFORMATION: The environmental review, consultation, and
other actions required by applicable Federal environmental laws for
these projects are being, or have been, carried-out by TxDOT pursuant
to 23 U.S.C. 327 and a Memorandum of Understanding dated December 16,
2014, and executed by FHWA and TxDOT.
    Notice is hereby given that TxDOT and Federal agencies have taken
final agency actions by issuing licenses, permits, and approvals for
the highway projects in the State of Texas that are listed below.
    The actions by TxDOT and Federal agencies and the laws under which
such actions were taken are described in the Categorical Exclusion
(CE), Environmental Assessment (EA), or Environmental Impact Statement
(EIS) issued in connection with the projects and in other key project
documents. The CE, EA, or EIS and other key documents for the listed
projects are available by contacting TxDOT at the address provided
above.
    This notice applies to all TxDOT and Federal agency decisions as of
the issuance date of this notice and all laws under which such actions
were taken, including but not limited to:
    1. General: National Environmental Policy Act (NEPA) [42 U.S.C.
4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109].
    2. Air: Clean Air Act, 42 U.S.C. 7401-7671(q).
    3. Land: Section 4(f) of the Department of Transportation Act of
1966 [49 U.S.C. 303]; Landscaping and Scenic Enhancement (Wildflowers),
23 U.S.C. 319.
    4. Wildlife: Endangered Species Act [16 U.S.C. 1531-1544 and
Section 1536], Marine Mammal Protection Act [16 U.S.C. 1361], Fish and
Wildlife Coordination Act [16 U.S.C. 661-667(d)], Migratory Bird Treaty
Act [16 U.S.C. 703-712].
    5. Historic and Cultural Resources: Section 106 of the National
Historic Preservation Act of 1966, as amended [54 U.S.C. 300101 et
seq.]; Archeological Resources Protection Act of 1977 [16 U.S.C.
470(aa)-11]; Archeological and Historic Preservation Act [54 U.S.C.
312501 et seq.]; Native American Grave Protection and Repatriation Act
(NAGPRA) [25 U.S.C. 3001-3013].
    6. Social and Economic: Civil Rights Act of 1964 [42 U.S.C.
2000(d)-2000(d)(1)]; American Indian Religious Freedom Act [42 U.S.C.
1996]; Farmland Protection Policy Act (FPPA) [7 U.S.C. 4201-4209].
    7. Wetlands and Water Resources: Clean Water Act, 33 U.S.C. 1251-
1377 (Section 404, Section 401, Section 319); Land and Water
Conservation Fund (LWCF), 16 U.S.C. 4601-4604; Safe Drinking Water Act
(SDWA), 42 U.S.C. 300(f)-300(j)(6); Rivers and Harbors Act of 1899, 33
U.S.C. 401-406; Wild and

Scenic Rivers Act, 16 U.S.C. 1271-1287; Emergency Wetlands Resources
Act, 16 U.S.C. 3921, 3931; TEA-21 Wetlands Mitigation, 23 U.S.C.
103(b)(6)(m), 133(b)(11); Flood Disaster Protection Act, 42 U.S.C.
4001-4128.
    8. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988
Floodplain Management; E.O. 12898, Federal Actions to Address
Environmental Justice in Minority Populations and Low Income
Populations; E.O. 11593 Protection and Enhancement of Cultural
Resources; E.O. 13007 Indian Sacred Sites; E.O. 13287 Preserve America;
E.O. 13175 Consultation and Coordination with Indian Tribal
Governments; E.O. 11514 Protection and Enhancement of Environmental
Quality; E.O. 13112 Invasive Species. (Catalog of Federal Domestic
Assistance Program Number 20.205, Highway Planning and Construction.)
    The projects subject to this notice are:
    1. FM 471 from SH 211 to Old FM 471, Bexar and Medina Counties,
Texas. The project would expand the existing FM 471 from a two-lane
roadway to a four-lane roadway with raised medians, turn lanes,
dedicated bike lanes and sidewalks. The project is approximately 4.44
miles in length. The actions by TxDOT and Federal agencies and the laws
under which such actions were taken are described in the Categorical
Exclusion Determination issued on July 8, 2019 and other documents in
the TxDOT project file. The Categorical Exclusion determination and
other documents in the TxDOT project file are available by contacting
TxDOT at the address provided above or the TxDOT San Antonio District
Office at 4615 NW Loop 410, San Antonio, TX 78229; telephone (210) 615-
5839.
    2. Business (BU) 71E over the Colorado River in LaGrange, Fayette
County, Texas. The proposed project consists of the construction of a
new concrete and steel girder bridge over the Colorado River
approximately 54 feet downstream (centerline to centerline) of the
existing historic truss bridge. The new bridge would be 1,400 feet long
and 53 feet wide and would carry two 12 feet travel lanes with 10 feet
shoulders and a 6 feet wide sidewalk. The purpose of the project is to
provide a bridge crossing that meets current design and safety
standards, as well as allow for the future rehabilitation and continued
use of the existing historic truss bridge. The actions by TxDOT and
Federal agencies and the laws under which such actions were taken are
described in the Categorical Exclusion Determination issued on July 10,
2019, and other documents in the TxDOT project file. The Categorical
Exclusion Determination and other documents in the TxDOT project file
are available by contacting TxDOT at the address provided above or the
TxDOT Yoakum District Office at 403 Huck St., Yoakum, TX 77995;
telephone<PHONE_NUMBER>.
    3. State Loop 250 at CR 1140, Midland County Texas. The proposed
improvements include the construction of main lanes through the
entirety of the project limits. An overpass would be constructed at the
intersection with CR 1140 with ramps to and from the bridge overpass.
Turnaround lanes would also be constructed at both bridges. The actions
by TxDOT and Federal agencies and the laws under which such actions
were taken are described in the Categorical Exclusion Determination
issued on July 12, 2019, and other documents in the TxDOT project file.
The Categorical Exclusion Determination and other documents in the
TxDOT project file are available by contacting TxDOT at the address
provided above or the TxDOT Odessa District Office at 3901 East Highway
80, Odessa, Texas 79761; telephone<PHONE_NUMBER>.
    4. SH 276 from FM 549 to CR 2472 in Rockwall County, Texas. The
proposed project would reconstruct and widen SH 276 from a two-lane
undivided rural roadway to a four-lane divided urban roadway within the
project limits. The proposed facility would include four lanes, two 12-
foot inside lanes and two 14-foot outside shared-use lanes, with a
raised median and two-foot inside and outside shoulders. Five-foot
sidewalks would be included on both sides of the roadway. The length of
the proposed project is approximately 7.22 miles. The purpose of the
proposed project is to improve traffic mobility and reduce congestion.
The actions by TxDOT and Federal agencies and the laws under which such
actions were taken are described in the Categorical Exclusion
Determination issued on July 31, 2019, and other documents in the TxDOT
project file. The Categorical Exclusion Determination and other
documents in the TxDOT project file are available by contacting TxDOT
at the address provided above or the TxDOT Dallas District Office at
4777 E Highway 80, Mesquite, TX 75150; telephone<PHONE_NUMBER>.
    5. Pellicano Drive from Joe Battle Blvd. to Darrington (Berryville
St.) in El Paso County, Texas. The project will reconstruct/widen from
a two-lane roadway to a six-lane divided facility with sidewalk,
illumination, landscaping, dedicated bicycle lanes and a shared-use
path. The actions by TxDOT and Federal agencies and the laws under
which such actions were taken are described in the Categorical
Exclusion Determination issued on August 7, 2019 and other documents in
the TxDOT project file. The Categorical Exclusion Determination and
other documents in the TxDOT project file are available by contacting
TxDOT at the address provided above or the TxDOT El Paso District
Office at 13301 Gateway West, El Paso, TX 79928; telephone (915) 790-
4340.
    6. Landing Boulevard from FM 518 to Interstate Highway 45 (I-45) in
Harris and Galveston Counties, Texas. The approximately 1.7-mile-long
project will extend Landing Boulevard and the NASA Road 1 Bypass (NASA
1) as a four-lane divided roadway to a proposed roundabout with the
proposed NASA 1 Bypass extension, which would connect to the existing
NASA 1 Bypass at I-45. The actions by TxDOT and Federal agencies and
the laws under which such actions were taken are described in the
Categorical Exclusion Determination approved on August 14, 2019 and
other documents in the TxDOT project file. The Categorical Exclusion
Determination and other documents in the TxDOT project file are
available by contacting TxDOT at the address provided above or the
TxDOT Houston District Office located at 7600 Washington Avenue,
Houston, Texas 77007; telephone<PHONE_NUMBER>.
    7. I-10 from Loop 1604 to US 90, Bexar and Guadalupe Counties,
Texas. The project includes widening the existing facility from four
lanes to six lanes and upgrading existing interchanges. The existing
two-way frontage roads would be modified to one-way on either side of
the I-10 main lanes. Continuous 6-foot sidewalks would be added
adjacent to the outside of the northern (westbound) and southern
(eastbound) frontage roads for the entire project length. The project
is approximately 13.35 miles in length. The actions by TxDOT and
Federal agencies and the laws under which such actions were taken are
described in the Categorical Exclusion Determination issued on August
15, 2019 and other documents in the TxDOT project file. The Categorical
Exclusion determination and other documents in the TxDOT project file
are available by contacting TxDOT at the address provided above or the
TxDOT San Antonio District Office at 4615 NW Loop 410, San Antonio, TX
78229; telephone<PHONE_NUMBER>.
    8. FM 2818 from 0.5 miles North of FM 60 to FM 2154 in Brazos
County, Texas. The proposed project would add capacity to FM 2818 by
constructing an

additional travel lane in each direction. Additionally, congestion
would be addressed at the intersections of FM 2347, Luther Street and
Holleman Drive by converting the corridor to a ``Super Street'' design.
The length of the project is approximately 3.25 miles. The purpose of
the proposed project is to relieve congestion by adding capacity and
improving safety. The actions by TxDOT and Federal agencies and the
laws under which such actions were taken are described in the
Categorical Exclusion Determination issued on August 28, 2019, and
other documents in the TxDOT project file. The Categorical Exclusion
Determination and other documents in the TxDOT project file are
available by contacting TxDOT at the address provided above or the
TxDOT Bryan District Office at 2591 North Earl Rudder Freeway, Bryan,
TX 77803; telephone<PHONE_NUMBER>.
    9. FM 565 from 0.30 miles West of FM 2354 to 0.16 miles East of FM
1405, Chambers County, Texas. The existing roadway consists of two 11-
foot lanes with 1-foot shoulders. The proposed roadway will be widened
to two 12-foot lanes with two 10-foot shoulders. From approximately
1.02 miles west of FM 2354 to 0.36 miles east of FM 1405, the roadway
will be realigned to eliminate an undesirable ``S'' curve that does not
meet current standards. The length of the proposed project is
approximately 1.86 miles. The purpose of the proposed project is to
improve traffic mobility, reduce congestion and bring the existing
roadway up to current safety standards by removing the ``s'' curve. The
actions by TxDOT and Federal agencies and the laws under which such
actions were taken are described in, the Categorical Exclusion
Determination issued on August 28, 2019, and other documents in the
TxDOT project file. The Categorical Exclusion Determination and other
documents in the TxDOT project file are available by contacting TxDOT
at the address provided above or the TxDOT Beaumont District Office at
8350 Eastex Freeway, Beaumont TX 77708; telephone<PHONE_NUMBER>.
    10. Interstate Highway 10 (I-10) at the San Jacinto River in Harris
County, Texas. The 0.5-mile-long project will complete an emergency
repair of the navigation system associated with the existing bridge
which was damaged as a result of Hurricane Harvey. The project would
replace the damaged dolphin structures and navigation fender system,
and add rip-rap to protect the navigation fender system and bridge
bents from future natural disasters or extreme high-water events. The
actions by TxDOT and Federal agencies and the laws under which such
actions were taken are described in the Categorical Exclusion
Determination approved on October 11, 2019 and other documents in the
TxDOT project file. The Categorical Exclusion Determination and other
documents in the TxDOT project file are available by contacting TxDOT
at the address provided above or the TxDOT Houston District Office
located at 7600 Washington Avenue, Houston, Texas 77007; telephone
(713) 802-5076.
    11. US 83 at FM 3034 in Jones County, Texas. The project will
consist of a new overpass on US 83 with a project length of 1 mile. FM
3034 will be realigned to the north of the existing alignment with a
project length of 0.27 miles. The actions by TxDOT and Federal agencies
and the laws under which such actions were taken are described in the
Categorical Exclusion approved on October 15, 2019, and other documents
in the TxDOT project file. The Categorical Exclusion Determination and
other documents in the TxDOT project file are available by contacting
TxDOT at the address provided above or the TxDOT Abilene District
Office at 4250 North Clack Street, Abilene, TX 79601; telephone (325)
643-6817.
    12. FM 2275 from FM 3272 to SH 300, in Gregg County, Texas. The
purpose of the proposed project is to improve safety and mobility by
reconstructing and widening the freeway from two to four lanes with
flush median (continuous left turn lane), including shared use paths,
bike lanes, and sidewalks. The proposed project length is approximately
4.04 miles in length. The actions by TxDOT and Federal agencies and the
laws under which such actions were taken are described in the final
Environmental Assessment (EA) approved on July 18, 2019, the Finding of
No Significant Impact (FONSI) issued on July 18, 2019, and other
documents in the TxDOT project file. The Final EA, FONSI, and other
documents in the TxDOT project file are available by contacting TxDOT
at the address provided above or the TxDOT Tyler District Office at
2709 West Front Street St., Tyler, TX 75702; telephone<PHONE_NUMBER>.
    13. US 59 from FM 2914 to south of SL 573, in San Jacinto and
Liberty Counties, Texas. The purpose of the proposed project is to
improve safety and mobility on US 59 between FM 2914 and SL 573 to
accommodate current and future traffic volumes by upgrading US 59 to
interstate standards which would include converting it to a controlled
access highway with frontage roads and two main lanes in each
direction, and frontage road shoulders to accommodate bicycles in the
Liberty County portion of the project. The proposed project length is
approximately 6.63 miles in length. The actions by TxDOT and Federal
agencies and the laws under which such actions were taken are described
in the Final Environmental Assessment (EA) approved on August 14, 2019,
the Finding of No Significant Impact (FONSI) issued on August 14, 2019,
and other documents in the TxDOT project file. The Final EA, FONSI, and
other documents in the TxDOT project file are available by contacting
TxDOT at the address provided above or the TxDOT Lufkin District Office
at 1805 North Timberland Dr., Lufkin, TX 75901; telephone (936) 633-
4395.
    14. US 183A Toll Road Phase III, From Hero Way to SH 29, Williamson
County, Texas. The build alternative would extend the six-lane,
controlled-access, grade separated 183A tolled main lanes from their
current terminus approximately 0.4 mile north of Hero Way to
approximately 0.4 mile north of SH 29. The 183A tolled main lanes would
be located in the median between the existing northbound and southbound
US 183 four-lane divided roadway. The existing US 183 four-lane divided
roadway within the project limits would serve as frontage roads north
to SH 29, and transition back to the existing, undivided US 183
approximately 1.1 miles north of SH 29. The project is approximately
5.63 miles in length. The actions by TxDOT and Federal agencies and the
laws under which such actions were taken are described in the Final EA
approved on August 19, 2019, the Finding of No Significant Impact
(FONSI) issued on August 19, 2019, and other documents in the TxDOT
project file. The Final EA, FONSI and other documents in the TxDOT
project file are available by contacting TxDOT at the address provided
above or the TxDOT Austin District Office at 7901 North I-35, Austin,
TX 78753; telephone<PHONE_NUMBER>.
    15. FM 552 from SH 205 to SH 66 in Rockwall County, Texas. The
proposed project would consist of widening FH 552 from a two-lane rural
section to a four-lane urban section. The two inside travel lanes would
be 12-foot wide and the outside travel lanes would be 14-foot wide to
accommodate shared-use of bicycles and vehicles. The length of the
proposed project is approximately 5.19 miles. The purpose of the
proposed project is to improve mobility and providing a facility that
meets current roadway design standards. The actions by TxDOT and
Federal agencies and the laws under which such actions were

taken are described in the Final Environmental Assessment (EA) approved
on August 23, 2019, Finding of No Significant Impact (FONSI) issued on
August 23, 2019 and other documents in the TxDOT project file. The
Final EA, FONSI, and other documents are available by contacting TxDOT
at the address provided above or the TxDOT Dallas District Office at
4777 E Highway 80, Mesquite, TX 75150; telephone<PHONE_NUMBER>.
    16. SH 286 from FM 43 to south of FM 2444, in Nueces County, Texas.
The purpose of the proposed project is to improve safety and mobility
on SH 286 between FM 43 and FM 2444 and to accommodate current and
future traffic volumes by reconstructing and widening SH 286 from a
two-lane undivided highway to a controlled access four-lane freeway,
including frontage roads with 12-foot shoulders, and sidewalks. The
proposed project length is approximately 3.2 miles. The actions by
TxDOT and Federal agencies and the laws under which such actions were
taken are described in the Final Environmental Assessment (EA) approved
on September 24, 2019, the Finding of No Significant Impact (FONSI)
issued on September 25, 2019 and other documents in the TxDOT project
file. The Final EA, FONSI, and other documents in the TxDOT project
file are available by contacting TxDOT at the address provided above or
the TxDOT Corpus Christi District Office at 1701 South Padre Island
Drive, Corpus Christi, TX 78416; telephone<PHONE_NUMBER>.
    17. US 82 from FM 1197/Bridge Street in Henrietta to SH 175/
Montague Street in Nocona in Clay and Montague Counties, Texas. The
proposed project would consist of widening the existing 2-lane
undivided highway to a 4-lane divided highway. Some areas of proposed
US 82 would be divided by a depressed grassy median and other areas
would be divided by a center left turn lane. The proposed project would
be approximately 26.6 miles in length. The actions by TxDOT and Federal
agencies and the laws under which such actions were taken are described
in the Final Environmental Assessment (EA) approved on September 24,
2019, the Finding of No Significant Impact (FONSI) issued on October 3,
2019, and other documents in the TxDOT project file. The Final EA,
FONSI, and other documents in the TxDOT project file are available by
contacting TxDOT at the address provided above or at the TxDOT Wichita
Falls District Office at 1601 Southwest Parkway, Wichita Falls, TX
76302; telephone<PHONE_NUMBER>.
    18. FM 1461 from SH 289 to CR 123 in Collin County, Texas. The
proposed improvements would consist of reconstructing and widening the
roadway from a two-lane rural highway to a four-lane urban highway.
Expansion would consist of one 12-foot wide travel lane and one 14-foot
wide outside shared-use lane in each direction, a proposed median to
accommodate a future ultimate six-lane facility, and sidewalks. The
length of the proposed project is approximately 7.10 miles. The purpose
of the proposed project is to accommodate expanding transportation
demands, increase mobility and accessibility in the region, and provide
an east-west transportation facility to serve the communities in the
project area. The actions by TxDOT and Federal agencies and the laws
under which such actions were taken are described in the Final
Environmental Assessment (EA) approved on October 1, 2019, Finding of
No Significant Impact (FONSI) issued on October 3, 2019 and other
documents in the TxDOT project file. The Final EA, FONSI, and other
documents are available by contacting TxDOT at the address provided
above or the TxDOT Dallas District Office at 4777 E Highway 80,
Mesquite, TX 75150; telephone:<PHONE_NUMBER>.
    19. IH 35 from US 380 to 0.7 Mile North of FM 3002 in Denton and
Cooke Counties, Texas. The proposed project would widen and reconstruct
IH 35 within the proposed limits. The proposed project would construct
three main lanes in each direction and two frontage road lanes in each
direction. Existing interchanges would be reconstructed and the
existing two-way frontage roads would be converted to one-way
operation. In addition, existing ramps would generally be configured
from a ``diamond'' to an ``X'' configuration. The length of the
proposed project is approximately 15.1 miles. The purpose of the
proposed project is to improve traffic mobility, enhance access, reduce
traffic congestion, and improve safety. The actions by TxDOT and
Federal agencies and the laws under which such actions were taken are
described in the Final Environmental Assessment (EA) approved on
October 3, 2019, Finding of No Significant Impact (FONSI) issued on
October 7, 2019 and other documents in the TxDOT project file. The EA
and other documents are available by contacting TxDOT at the address
provided above or the TxDOT Dallas District Office at 4777 E Highway
80, Mesquite, TX 75150; telephone:<PHONE_NUMBER>.
    20. Alliance Texas/Haslet Accessibility Improvement Project, from
approximately 3,500 feet west of FM 156 to I-35W, Tarrant County. TxDOT
proposes reconstructing and widening approximately 0.75 mile of
Avondale-Haslet Road to a 4-lane divided roadway. Also, the project
includes the extension of Avondale-Haslet Road (4-lane divided roadway)
from FM 156 to I-35W (Proposed Haslet Parkway) and the extension of
Intermodal Parkway (6-lane divided roadway) southward from its current
southern terminus to the proposed Haslet Parkway. The proposed right-
of-way (ROW) width varies between 120 to 170 feet. The actions by TxDOT
and Federal agencies and the laws under which such actions were taken
are described in the Final Environmental Assessment approved on October
28, 2019, the Finding of No Significant Impact issued on December 2,
2019, and other documents in the TxDOT project file. The Final
Environmental Assessment and other documents in the TxDOT project file
are available by contacting TxDOT at the address provided above or the
TxDOT Fort Worth District Office at 2501 S W Loop 820, Fort Worth,
Texas 76133; telephone<PHONE_NUMBER>.
    21. SH 21 Widening from 2.01 miles west of FM 2865 to Martin Luther
King, Jr. Street in the City of Madisonville, in Madison County, Texas.
The proposed project would widen SH 21 from 2.01 miles west of FM 2865
to Martin Luther King, Jr. Street in the City of Madisonville, and
construct a relief route on new location south of the community of
North Zulch. The section of SH 21 through North Zulch would not be
widened. Beginning 2.01 miles west of FM 2865, SH 21 would be widened
for approximately 5 miles before diverging south of North Zulch on new
location near County Road 439 (approximately 1 mile west of North
Zulch). The proposed relief route south of North Zulch would continue
on new location for approximately 3.2 miles before merging with the
existing SH 21 facility east of North Zulch approximately 0.75 mile
east of County Road 426 (Cleveland Road). From this point, the proposed
project would widen SH 21 for approximately 10 miles, ending at Martin
Luther King, Jr. Street in Madisonville. The proposed SH 21 facility,
including the new-location relief route, would consist of four 12-foot
wide travel lanes with a 56-foot to 68-foot wide median. The proposed
project would require approximately 384 acres of additional ROW,
including approximately 160 acres of ROW for the new location relief
route. The ROW width would vary from 100 feet to 324 feet wide, with a
typical

width of 224 feet. The actions by TxDOT and Federal agencies and the
laws under which such actions were taken are described in the Final
Environmental Assessment (EA) October 10, 2019, the Finding of No
Significant Impact (FONSI) was issued on December 6, 2019, and other
documents in the TxDOT project file. The EA, and FONSI, and other
documents in the TxDOT project file are available by contacting TxDOT
at the address provided above or the TxDOT Bryan District Office at
2591 North Earl Rudder Freeway, Bryan, TX 77803; telephone (979) 778-
9764.

(Authority: 23 U.S.C. 139(l)(1))

    Issued on: December 13, 2019.
Michael T. Leary,
Director, Planning and Program Development, Federal Highway
Administration.
[FR Doc. 2019-27380 Filed 12-20-19; 8:45 am]
 BILLING CODE 4910-22-P