[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19271-19272]
[FR Doc No: 2021-07548]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0318]

Development Considerations of Antimicrobial Drugs for the
Treatment of Gonorrhea; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, National Institute of Allergy and
Infectious Diseases, Centers for Disease Control and Prevention, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we), the
National Institute of Allergy and Infectious Diseases (NIAID), and the
Centers for Disease Control and Prevention (CDC) are announcing the
following public workshop entitled ``Development Considerations of
Antimicrobial Drugs for the Treatment of Gonorrhea.'' The purpose of
the public workshop is to discuss the nonclinical and clinical
pharmacology data and clinical trial design considerations regarding
developing antimicrobial drugs for the treatment of gonorrhea.

DATES: The public workshop will be held virtually on April 23, 2021,
from 9 a.m. to 5 p.m., Eastern Time. Submit either electronic or
written comments on this public workshop by June 1, 2021. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held in virtual format only.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 1, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 1, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0318 for ``Development Considerations of Antimicrobial Drugs
for the Treatment of Gonorrhea.'' 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,<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>.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Antoinette
Ziolkowski, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

I. Background

    FDA, NIAID, and CDC are announcing a public workshop regarding the
development considerations of antimicrobial drugs for the treatment of
gonorrhea. As such, discussions will focus on the current state of
diagnosis and treatment of gonorrhea and nonclinical and clinical trial
design considerations for drug development.

II. Topics for Discussion at the Public Workshop

    The workshop will focus on discussing challenges and clinical trial

considerations regarding antimicrobial drug development for gonorrhea.
    Discussions are planned around the following topic areas:
     Animal models;
     Clinical pharmacology considerations; and
     Trial design considerations for gonorrhea, such as
enrollment strategies, choice of comparators, and site of infection.
    The Agency encourages healthcare providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders to attend
this public workshop.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop
must register online, using the internet link noted in the Transcripts
section below, by April 21, 2021, 11:59 p.m. Eastern Time. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Registrants will receive confirmation when
they have been accepted.
    If you need special accommodations due to a disability, please
contact Antoinette Ziolkowski or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) no later than April 20, 2021.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the virtual public comment
session and which topic(s) you wish to address. All requests to make
oral presentations must be received by April 15, 2021. We will do our
best to accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations and request time for a joint
presentation. We will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin
and will select and notify participants by April 16, 2021. If selected
for presentation, any presentation materials must be emailed to
<EMAIL_ADDRESS>no later than April 19, 2021. No
commercial or promotional material will be permitted to be presented or
distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at the following site: https://collaboration.fda.gov/cderond042321/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/drugs/news-events-human-drugs/development-considerations-antimicrobial-drugs-treatment-gonorrhea-04232021-04232021.

    Dated: April 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07548 Filed 4-12-21; 8:45 am]
BILLING CODE 4164-01-P


Page 1 of 17 Screening Level Exposure Assessments Propylene Carbonate Note to the READER:

As explained in the final rule the Agency determined as part of its Safety Assessment of propylene carbonate to perform a qualitative assessment. The screening level assessments in this document were used to bound the risk. Page 2 of 17 Dietary ( Food) Modeling ( performed using an Agency developed screening tool) Page 3 of 17 Model Assumptions  Actual crop specific residue data for active ingredients can be utilized as surrogate data for inert ingredient residue levels ( including secondary residues in meat, milk, poultry and eggs)  Inert ingredients are used on all crops and 100% of all crops are " treated" with inert ingredients  No adjustment made for % of inert in formulation, application rate, or multiple applications of different active ingredient formulations  Considers only preharvest applications Dietary modeling was performed utilizing the highest established tolerance level residue for each commodity.

Table 1. Estimated Chronic Dietary Exposure1 for a Generic Inert Ingredient Population Subgroup2 Estimated Exposure, mg/ kg/ day U. S. Population ( total) 0.120 All infants (< 1 year) 0.245 Children ( 1 2 years) 0.422 Children ( 3 5 years) 0.310 Children ( 6 12 years) 0.174 Youth ( 13 19 years) 0.100 Adults ( 20 49 years) 0.087 Adults ( 50+ years) 0.086 Females ( 13 49 years) 0.087 1Exposure estimates are based on highest tolerance level residues of high use active ingredients for all food forms, including meat, milk, poultry, and eggs. 2Only representative population subgroups are shown. Page 4 of 17 Table 2. Estimated Acute Dietary Exposure1 for a Generic Inert Ingredient Population Subgroup2 Estimated Exposure, mg/ kg/ day 95th Percentile 99th Percentile 99.9th Percentile U. S. Population ( total) 0.336 0.643 1.164 All infants (< 1 year) 0.701 1.060 2.056 Children ( 1 2 years) 0.939 1.382 2.106 Children ( 3 5 years) 0.683 1.010 1.476 Children ( 6 12 years) 0.395 0.563 0.827 Youth ( 13 19 years) 0.239 0.357 0.815 Adults ( 20 49 years) 0.199 0.295 0.468 Adults ( 50+ years) 0.191 0.263 0.357 Females ( 13 49 years) 0.198 0.287 0.415 1Exposure estimates are based on highest tolerance level residues of high use active ingredients for all food forms, including meat, milk, poultry, and eggs. 2Only representative population subgroups are shown. Page 5 of 17 Drinking Water Exposure ( modeled using FIRST) Page 6 of 17 Model Assumptions  1 lb/ acre application rate and 15 lb/ acre application rates to bracket  Koc of 24 ( degradation does occur)

 Half life of 18 days  Consumption ( 2L/ day for adults, 1L/ day for child)

 Body weights ( 70 kg adult, 10 kg child)

Propylene Carbonate Chronic Acute 1 lb application concentration = 4 ppb 1 lb application concentration = 82 ppb chronic exposure ( adult) = 0.0001 mg/ kg/ day acute exposure ( adult) = 0.002 mg/ kg/ day chronic exposure ( child) = 0.0004 mg/ kg/ day acute exposure ( child) = 0.0082 mg/ kg/ day 15 lb application concentration = 60 ppb 15 lb application concentration = 1200 ppb chronic exposure ( adult) = 0.0017 mg/ kg/ day acute exposure ( adult) = 0.035 mg/ kg/ day chronic exposure ( child) = 0.006 mg/ kg/ day acute exposure ( child) = 0.012 mg/ kg/ day Note: These estimates are based on the following document Risk Assessment for Propylene and Butylene Carbonate as an Inert Ingredient ( DP Barcode D276674 and D2500272) ( Lucy Shanaman and Henry Craven, December 12, 2002) Page 7 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: 8/ 15/ 03 SUBJECT: Propylene Carbonate Exposure Analysis FROM: Tom Brennan, Chemist Registration Division ( 7505C)

TO: Kathryn Boyle Registration Division ( 7505C)

Executive Summary:

The Office of Pesticide Programs has completed the exposure and risk assessment process for the propylene carbonate for the Lower Toxicity Pesticide Chemical Focus Group. This following scenarios were assessed using the Pesticide Handlers Exposure Database V1.1, and the E FAST model developed by the Office of Pollution Prevention and Toxics.

° Adult exposures from mixing loading and application to lawns using a hose end sprayer and low pressure handwand; ° Adult exposures from using a general purpose cleaner in the residence; and, ° Adult exposures from using liquid laundry detergent in the residence.

Attached are the residential assessments developed for this project. Page 8 of 17 Residential Exposure ( as a result of application to a lawn) Page 9 of 17 Model Assumptions  Outdoor, low pressure handwand or hose end sprayer ( both M/ L/ A)

 100% inhalation exposure factor  75% dermal exposure factor( estimated from physical/ chemical data)

 used Residential SOPs  application rate is 1 lb/ acre to 15 lb/ acre to bracket potential exposure Application rate = 1 lb/ acre mixer/ leader/ applicator ( m/ l/ a), low pressure handwand, dermal 0.025 m/ l/ a, low pressure handwand, inhalation 0.0000099 Total = 0.025 m/ l/ a, hose end sprayer, dermal 0.059 m/ l/ a, hose end sprayer, inhalation 0.00011 Total = 0.059 Application Rate = 15 lb/ acre m/ l/ a, low pressure handwand, dermal 0.375 m/ l/ a, low pressure handwand, inhalation 0.00015 Total = 0.375 m/ l/ a, hose end sprayer, dermal 0.885 m/ l/ a, hose end sprayer, inhalation 0.0017 Total = 0.886 Note: These estimates are based on the following document Residential Exposure Assessment for the Inert Ingredients, Propylene and Butylene Carbonate ( DP Barcode D281386) ( Jack Arthur, March 6, 2002) Page 10 of 17 E Fast Modeling General Purpose Cleaner Page 11 of 17 CEM Inputs ID Number: Unknown Product: Unknown Chemical Name: propylene carbonate Scenario: General Purpose Cleaner Population: Adult Molecular Weight ( g/ mole): 102.1 Vapor Pressure ( torr): 0.045 Weight Fraction  Median ( unitless): 0.988 Weight Fraction  90% ( unitless): 0.988 Inhalation Inputs Frequency of Use ( events/ yr): 300 Years of Use: 57 Mass of Product Used per Event  Median ( g): 61.5 Mass of Product Used per Event  90% ( g): 123 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.667 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 1.42 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111221542467422744411 Start Time: 7 Non User: Room of Use: 2. Kitchen Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 300 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 3.6e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADDpot, ADCpot ( days): 2.08e+ 04 Avg. Time, ADRpot, Cppot ( days): 1.00e+ 00 Page 12 of 17 CEM Inhalation Exposure Estimates ID Number: Unknown Scenario: General Purpose Cleaner Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 2.16e+ 00 2.74e+ 04 LADCpot ( mg/ m3) 1.17e+ 01 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 2.84e+ 00 2.08e+ 04 ADCpot ( mg/ m3) 1.54e+ 01 2.08e+ 04 Acute ADRpot ( mg/ kg day) 5.07e+ 00 1.00e+ 00 Cppot ( mg/ m3) 9.73e+ 01 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADD  Average Daily Dose ( mg/ kg day) ADC  Average Daily Concentration ( mug/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 Page 13 of 17 CEM Dermal Exposure Estimates ID Number: Unknown Scenario: General Purpose Cleaner Population: Adult Years of Use ( years): 57 SA/ BW Body ( cm2/ kg): 15.6 Frequency of Use ( events/ year): 300 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 3.47e 01 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 4.56e 01 2.08e+ 04 Acute ADRpot ( mg/ kg day) 5.55e 01 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADD  Average Daily Dose ( mg/ kg day)

ADR  Acute Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 acute dermal exposure = 0.55 mg/ kg/ day acute inhalation exposure = 5.07 mg/ kg/ day total exposure = 5.62 mg/ kg/ day Page 14 of 17 E Fast Modeling Laundry Detergent Page 15 of 17 CEM Inputs ID Number: Unknown Product: Unknown Chemical Name: propylene carbonate Scenario: Laundry Detergent Population: Adult Molecular Weight ( g/ mole): 102.1 Vapor Pressure ( torr): 0.045 Weight Fraction  Median ( unitless): 0.988 Weight Fraction  90% ( unitless): 0.988 Inhalation Inputs Frequency of Use ( events/ yr): 312 Years of Use: 57 Mass of Product Used per Event  Median ( g): 200 Mass of Product Used per Event  90% ( g): 400 Inhalation Rate During Use ( m3/ hr): 0.55 Duration of Use  Median ( hours/ event): 0.333 Inhalation Rate After Use ( m3/ hr): 0.55 Duration of Use  90% ( hours/ event): 0.667 Zone 1 Volume ( m3): 20 Whole House Volume ( m3): 369 Air Exchange Rate ( air exchanges/ hr): 0.45 Body Weight ( kg): 71.8 Activity Patterns User: 1111111235542467422744411 Start Time: 9 Non User: 1111111132442477422744411 Room of Use: 5. Utility Room Hour: 0 6 12 18 Dermal Inputs Frequency of Use  Body ( events/ yr): 52 SA/ BW  Body ( cm2/ kg): 15.6 Amount Retained / Absorbed to Skin ( g/ cm2 event): 1.13e 05 Avg. Time, LADDpot, LADCpot ( days): 2.74e+ 04 Avg. Time, ADDpot, ADCpot ( days): 2.08e+ 04 Avg. Time, ADRpot, Cppot ( days): 1.00e+ 00 Page 16 of 17 CEM Inhalation Exposure Estimates ID Number: Unknown Scenario: Laundry Detergent Population: Adult Inhalation Rate ( m3/ day): 0.55 Years of Use ( years): 57 Body Weight ( kg): 71.8 Frequency of Use ( events/ year): 312 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.48e 01 2.74e+ 04 LADCpot ( mg/ m3) 8.07e 01 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 1.95e 01 2.08e+ 04 ADCpot ( mg/ m3) 1.06e+ 00 2.08e+ 04 Acute ADRpot ( mg/ kg day) 9.25e 01 1.00e+ 00 Cppot ( mg/ m3) 1.29e+ 02 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day) LADC  Lifetime Average Daily Concentration ( mg/ m3)

ADD  Average Daily Dose ( mg/ kg day) ADC  Average Daily Concentration ( mug/ m3)

ADR  Acute Dose Rate ( mg/ kg day) Cp  Peak Concentration ( mg/ m3)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 Page 17 of 17 CEM Dermal Exposure Estimates ID Number: Unknown Scenario: Laundry Detergent Population: Adult Years of Use ( years): 57 SA/ BW Body ( cm2/ kg): 15.6 Frequency of Use ( events/ year): 52 Exposure Units Result AT ( days)

Chronic Cancer LADDpot ( mg/ kg day) 1.89e 02 2.74e+ 04 Chronic Non Cancer ADDpot ( mg/ kg day) 2.48e 02 2.08e+ 04 Acute ADRpot ( mg/ kg day) 1.74e 01 1.00e+ 00 LADD  Lifetime Average Daily Dose ( mg/ kg day)

ADD  Average Daily Dose ( mg/ kg day)

ADR  Acute Dose Rate ( mg/ kg day)

Note: 75 years = 2.738e+ 04 days pot  potential dose Note: The general Agency guidance for assessing short term, infrequent events ( for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. Thus, estimates of long term average exposure like ADD or ADC may not be appropriate for use in assessing risks associated with this type of exposure pattern. ( Methods for Exposure Response Analysis for Acute Inhalation Exposure to Chemicals ( External Review Draft). EPA/ 600/ R 98/ 051. April 1998 acute dermal exposure = 0.17 mg/ kg/ day acute inhalation exposure = 0.92 mg/ kg/ day total exposure = 1.1 mg/ kg/ day


[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27533-27535]
[FR Doc No: E9-13475]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0298; FRL-8419-9]

Pesticide Experimental Use Permit; Receipt of Application;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's receipt of an application 62719-
EUP-AE from Dow AgroSciences requesting an experimental use permit
(EUP) for sulfuryl fluoride. The Agency has determined that the permit
may be of regional and national significance. Therefore, in accordance
with 40 CFR

172.11(a), the Agency is soliciting comments on this application.

DATES: Comments must be received on or before July 10, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0298, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington,VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0298. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to agricultural producers, food manufacturers,
pesticide manufacturers, or those persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

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 e-mail. 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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What Action is the Agency Taking?

    Under section 5 of FIFRA, 7 U.S.C. 136c, EPA can allow
manufacturers to field test pesticides under development. Manufacturers
are required to obtain an EUP before testing new pesticides or new uses
of pesticides if they conduct experimental field tests on 10 acres or
more of land or one acre or more of water.

    Pursuant to 40 CFR 172.11(a), the Agency has determined that the
following EUP application may be of regional and national significance,
and therefore is seeking public comment on the EUP application:
    Submitter: Dow AgroSciences, (62719-EUP-AE).
    Pesticide Chemical: Sulfuryl fluoride.
    Summary of Request: Dow AgroSciences is requesting an EUP for
sulfuryl fluoride, a pesticide fumigant. The product is intended to be
applied as a pre-plant soil fumigant to areas where tomato, pepper,
squash, and cucurbits are typically grown. The proposed EUP program
would be initiated on August 1, 2009 and finalized on August 1, 2012.
The amount of pesticide product proposed for use is 32,500 lbs of the
product, which equals 32,435 lbs of the active ingredient. The total
proposed acreage is 65 acres. The states in which the proposed program
will be conducted include California, Florida, Georgia, and Texas.
    A copy of the application and any information submitted is
available for public review in the docket established for this EUP
application as described under ADDRESSES.
    Following the review of the application and any comments and data
received in response to this solicitation, EPA will decide whether to
issue or deny the EUP request, and if issued, the conditions under
which it is to be conducted. Any issuance of an EUP will be announced
in the Federal Register.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: May 29, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E9-13475 Filed 6-9-09; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: December 4, 2009 (Volume 74, Number 232)]
[Notices]
[Page 63759]
[DOCID:fr04de09-87]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0542]

Draft Guidance for Industry: Factors That Distinguish Liquid
Dietary Supplements From Beverages, Considerations Regarding Novel
Ingredients, and Labeling for Beverages and Other Conventional Foods;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Factors that Distinguish Liquid Dietary Supplements from Beverages,
Considerations Regarding Novel Ingredients, and Labeling for Beverages
and Other Conventional Foods.'' The draft guidance describes factors
that can be used to identify liquid products that are excluded from
being dietary supplements because they are represented as conventional
foods. Further, the draft guidance reminds manufacturers and
distributors of beverages and other conventional foods, particularly
those that contain novel ingredients, about the requirements of the
Federal Food, Drug, and Cosmetic Act (the act) regarding ingredients
and labeling.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
the draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by February 2, 2010.

ADDRESSES:  Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Office of Nutrition, Labeling, and Dietary Supplements, Center for Food
Safety and Applied Nutrition (HFS-800), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT:  Robert Moore, Center for Food Safety
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Factors that Distinguish Liquid Dietary
Supplements from Beverages, Considerations Regarding Novel Ingredients,
and Labeling for Beverages and Other Conventional Foods.'' The draft
guidance is intended to assist dietary supplement and beverage
manufacturers and distributors in reaching a determination as to
whether a liquid product may be labeled and marketed as a dietary
supplement. The draft guidance describes factors that manufacturers and
distributors can use to identify liquid products that are excluded from
being dietary supplements because they are represented as conventional
foods. Further, the draft guidance reminds manufacturers and
distributors of beverages and other conventional foods, particularly
those that contain novel ingredients, about the requirements of the act
regarding ingredients and labeling.
    FDA is issuing this draft guidance as Level 1 guidance consistent
with FDA's good guidance practices regulation (21 CFR 10.115). The
draft guidance, when finalized, will represent the agency's current
thinking on the topics discussed. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternate approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding the draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28926 Filed 12-3-09; 8:45 am]

BILLING CODE 4160-01-S


BEFORE THE

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON D.C.

________________________________________

IN THE MATTER OF INTRA-ALASKA            )             Docket
OST-07-14694

BUSH CLASS SERVICE MAIL RATES             )

_______________________________________ )

RATE EQUALIZATION NOTICE

of

Arctic Transportation Services, Inc.

Communication with respect to the document should be sent to:

Wilfred P. Ryan, President

Arctic Transportation Services, Inc.

5701 Silverado Way, Unit L

Anchorage, AK  99518

Arctic Transportation Services, Inc., (7S), an Alaskan incorporated air
carrier currently authorized to transport United States mail, hereby
gives notice of its intent to equalize its mail rates to the lowest
authorized rates legally in effect between:

	KOTZEBUE (OTZ), Alaska and NOORVIK (ORV), Alaska

	KOTZEBUE (OTZ), Alaska and SELAWIK (WLK), Alaska

With the lower levels paid to other carriers or combinations of other
carriers in these markets effective March 1, 2007.

1.	Order 90-10-34 provides that an air carrier may elect to establish a
reduced charge equal to the charges prescribed for mail transportation
actually being performed between the same origin and destination points
by any other certificated air carrier or combination of carriers,
regardless of routing.

2.	Subject to the conditions below, Arctic Transportation Services,
Inc., (7S), gives this notice of its election to equalize its rates for
small aircraft in the Kotzebue, Alaska (OTZ) to Noorvik, Alaska (ORV)
and the Kotzebue, Alaska (OTZ) to Selawik, Alaska (WLK) on a total rate
per pound basis, the lower rate or combination of rates now in effect or
hereafter determined and paid to Frontier Flying Service for each
category of mail Frontier Flying Service transports in these markets to
any lower rate or combination of rates paid in the future to any other
carrier in these markets.

3.	Arctic Transportation Services, Inc., (7S), offer of equalization
results from the implementation of the Rural Service Improvement Act of
2002, and the assertion by the United States Postal Service that air
carriers operating under FAR Part 135 would not be tendered mail in
markets served by carriers operating under FAR Part 121 unless the FAR
Part 135 carrier equalized to the new FAR Part 121 bush passenger mail
rate.

4.	Equalization under this notice is effective immediately and is
effective for an indefinite period.  This notice will remain in effect
until terminated by written notice filed at least end days in advance.

WHEREFORE, Arctic Transportation Services, Inc., (7S) gives this notice
of equalization of its mail rates and requests equitable tender of main
in these markets pursuant to the practices and procedures of the United
States Department of Transportation and the United States Postal
Service.

Respectfully Submitted,

Wilfred P. Ryan, President

Arctic Transportation Services

February 20, 2007

Service List

Postmaster General

c/o Assistant General Council-Transportation

United States Post Office

475 Le Enfant Plaza, S.W.

Washington, D.C. 20260-7130

Mr. Steven R. Deaton

Western District Network

4141 Postmark Drive

Anchorage, Alaska  99502-9781

Documentary Services Division (C-55)

DOT/OST Room PL 401

400 7th Street, S.W.

Washington, D.C. 20590-1801

Mr. Bob Hajdukovich

Frontier Flying Service, Inc.

5245 Airport Industrial Rd.

Fairbanks, Alaska 99704

Mr. Mike Hageland

Hageland Aviation

P. O. Box 220610

Anchorage, Alaska 99522

Mr. Al Haddadi

General Manager

Bering Air, Inc.

P. O. Box 1650

Nome, Alaska 99762


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36548-36551]
[FR Doc No: 2022-13042]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95093; File No. SR-NYSE-2022-11]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Instituting Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change, as Modified by Amendment No. 1, To Amend the NYSE
Listed Company Manual To Provide a Limited Exemption From the
Shareholder Approval Requirements for Closed-End Management Investment
Companies With Equity Securities Listed Under Section 102.04 of the
Listed Company Manual

June 13, 2022.

I. Introduction

    On February 23, 2022, New York Stock Exchange LLC (``Exchange'' or
``NYSE'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend Section 312.03 of the
NYSE Listing Company Manual (``LCM'' or ``Manual'') to provide an
exemption from certain shareholder approval requirements of that rule
for listed registered closed-end management investment companies
(``closed-end funds'') and business development companies (``BDCs'')
under certain circumstances. On March 8, 2022, the Exchange filed
Amendment No. 1 to the proposed rule change, which amended and replaced
the proposed rule change in its entirety. The proposed rule change, as
amended by Amendment No. 1, was published for comment in the Federal
Register on March 15, 2022.\3\ The Commission has received no comments
on the proposed rule change. On April 26, 2022, pursuant to Section
19(b)(2) of the Exchange Act,\4\ the Commission designated a longer
period within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ This order institutes
proceedings pursuant to Section 19(b)(2)(B) of the Exchange Act \6\ to
determine whether to approve or disapprove the proposed rule change, as
modified by Amendment No. 1.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 94388 (March 9,
2022), 87 FR 14589 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 94795, 87 FR 25689
(May 2, 2022). The Commission designated June 13, 2022, as the date
by which the Commission shall approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change, as modified by Amendment No. 1.
    \6\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

II. Description of the Proposal, as Modified by Amendment No. 1

    Section 312.03(b)(i) of the Manual requires listed issuers to
obtain shareholder approval prior to the issuance of common stock, or
of securities convertible into or exercisable for common stock, in any
transaction or series of related transactions, to a director, officer
or substantial security holder of the company (each a ``Related
Party'') if the number of shares of common stock to be issued, or if
the number of shares of common stock into which the securities may be
convertible or exercisable, exceeds either one percent of the number of
shares of common stock or one percent of the voting power outstanding
before the issuance.\7\ However, shareholder approval will not be
required if such transaction is a cash sale for a price that is at
least the Minimum Price.\8\
---------------------------------------------------------------------------

    \7\ See NYSE LCM Section 312.03(b)(i).
    \8\ See id. ``Minimum Price'' means a price that is the lower
of: (i) the Official Closing Price immediately preceding the signing
of the binding agreement; or (ii) the average Official Closing Price
for the five trading days immediately preceding the signing of the
binding agreement. See NYSE LCM Section 312.04(h). ``Official
Closing Price'' of the issuer's common stock means the official
closing price on the Exchange as reported to the Consolidated Tape
immediately preceding the signing of a binding agreement to issue
the securities. See NYSE LCM Section 312.04(i).
---------------------------------------------------------------------------

    According to the Exchange, Section 312.03(b)(ii) of the Manual
provides that shareholder approval is also required prior to the
issuance of common stock, or of securities convertible into or
exercisable for common stock, where such securities are issued as
consideration in a transaction or series of related transactions in
which a Related Party has a five percent or greater interest (or such
persons collectively have a ten percent or greater interest), directly
or indirectly, in the company or assets to be acquired or in the
consideration to be paid in the transaction or series of related
transactions and the present or potential issuance of common stock, or
securities convertible into common stock, could result in an issuance
that exceeds either five percent of the number of shares of common
stock or five percent of the voting power outstanding before the
issuance.\9\
---------------------------------------------------------------------------

    \9\ See Notice, supra note 3, at 14590; NYSE LCM Section
312.03(b)(ii).
---------------------------------------------------------------------------

    The Exchange further states that Section 312.03(b)(iii) of the
Manual provides that any sale of stock to an

employee, director or service provider is also subject to the equity
compensation rules in Section 303A.08 of the Manual.\10\ For example,
according to the Exchange, a sale of stock to any such parties at a
discount to the then market price would be treated as equity
compensation under Section 303A.08 notwithstanding that shareholder
approval may not be required under Section 312.03(b) or 312.03(c) of
the Manual.\11\
---------------------------------------------------------------------------

    \10\ See Notice, supra note 3, at 14590; NYSE LCM Section
312.03(b)(iii).
    \11\ See id. Consequently, the company would be required to
either: (i) obtain shareholder approval of such sale, or (ii) issue
such shares under an equity compensation plan that had previously
been approved by shareholders and for which shareholder approval
under Section 303A.08 of the Manual is not otherwise required.
Moreover, shareholder approval is required if any of the
subparagraphs of Section 312.03 require such approval,
notwithstanding the fact that the transaction does not require
approval under Section 312.03(b) or one or more of the other
subparagraphs of Section 312.03. See NYSE LCM Section
312.03(b)(iii).
---------------------------------------------------------------------------

    According to the Exchange, Section 312.03(c) of the Manual also
requires listed issuers to obtain shareholder approval prior to the
issuance of common stock, or of securities convertible into or
exercisable for common stock, in any transaction or series of related
transactions if: (1) the common stock has, or will have upon issuance,
voting power equal to or in excess of 20 percent of the voting power
outstanding before the issuance of such stock or of securities
convertible into or exercisable for common stock; or (2) the number of
shares of common stock to be issued is, or will be upon issuance, equal
to or in excess of 20 percent of the number of shares of common stock
outstanding before the issuance of the common stock or of securities
convertible into or exercisable for common stock.\12\
---------------------------------------------------------------------------

    \12\ See Notice, supra note 3, at 14590; NYSE LCM Section
312.03(c). However, shareholder approval will not be required for
any such issuance involving: any public offering for cash; or any
other financing (that is not a public offering for cash) in which
the company is selling securities for cash, if such financing
involves a sale of common stock, or securities convertible into or
exercisable for common stock, at a price at least as great as the
Minimum Price, provided that if the securities in such financing are
issued in connection with an acquisition of the stock or assets of
another company, shareholder approval will be required if the
issuance of such securities alone or when combined with any other
present or potential issuance of common stock, or securities
convertible into common stock in connection with such acquisition,
is equal to or exceeds either 20 percent of the number of shares of
common stock or 20 percent of the voting power outstanding before
the issuance. See NYSE LCM Section 312.03(c).
---------------------------------------------------------------------------

    The Exchange states that it proposes to exempt closed-end funds and
BDCs with equity securities listed under Section 102.04 of the Manual
\13\ from having to comply with the shareholder approval requirements
in Sections 312.03(b) and (c) of the Manual in connection with the
acquisition of the stock or assets of an affiliated registered
investment company in a transaction that complies with Rule 17a-8 under
the 1940 Act (``Rule 17a-8'') \14\ and does not otherwise require
shareholder approval under the 1940 Act or the rules thereunder or any
other Exchange rule.\15\ In support of its proposal, the Exchange
states it believes Rule 17a-8 provides protections that obviate the
need for a shareholder approval requirement in these circumstances.\16\
---------------------------------------------------------------------------

    \13\ See NYSE LCM Section 102.04 (providing minimum numerical
standards for closed-end management investment companies registered
under the Investment Company Act of 1940 (``1940 Act'') and closed-
end management investment companies that have filed an election to
be treated as a BDC under the 1940 Act).
    \14\ 17 CFR 270.17a-8.
    \15\ See Notice, supra note 3, at 14590; proposed NYSE LCM
Section 312.03(f).
    \16\ See Notice, supra note 3, at 14590.
---------------------------------------------------------------------------

    Sections 17(a)(1) and (2) of the 1940 Act prohibit, among other
things, certain transactions between registered investment companies
and affiliated persons.\17\ Rule 17a-8 \18\ provides an exemption from
Sections 17(a)(1) and (2) of the 1940 Act for certain mergers of
affiliated companies, provided, among other things, the board of
directors of each investment company, including a majority of the
directors that are not interested persons of the respective investment
company or of any other company or series participating in the
transaction, must determine that (i) participation in the merger is in
the best interests of its respective investment company, and (ii) the
interests of the company's existing shareholders will not be diluted as
a result of the transaction.\19\ In addition, under Rule 17a-8, an
affiliated merger must be approved by a majority of the outstanding
voting securities of the merging company that is not the surviving
company unless certain conditions are met.\20\ The Exchange states in
its filing that Rule 17a-8 does not require the surviving company to
obtain shareholder approval in connection with the merger of an
affiliated company.\21\
---------------------------------------------------------------------------

    \17\ See 15 U.S.C. 80a-17(a)(1)-(2). See also the definition of
``affiliated person'' in the 1940 Act, 15 U.S.C. 80a-2(a)(3).
    \18\ Section 57(i) of the 1940 Act makes Rule 17a-8 applicable
to BDCs. See 15 U.S.C. 80a-56(i) (providing that ``. . . the rules
and regulations of the Commission under subsections (a) and (d) of
section 17 applicable to registered closed-end investment companies
shall be deemed to apply to transactions subject to subsections (a)
and (d) of this section''); see also Investment Company Act Release
No. 26520 (July 27, 2004), 69 FR 46378 at nn. 9 & 27 (noting that
certain rules, including Rule 17a-8, ``apply to investment
companies, including registered investment companies and business
development companies, if they rely on these rules'').
    \19\ 17 CFR 270.17a-8(a)(2).
    \20\ 17 CFR 270.17a-8(a)(3).
    \21\ See Notice, supra note 3, at 14590.
---------------------------------------------------------------------------

    The Exchange asserts that, because the board of each merging
company must make an affirmative decision that the transaction is in
the best interest of its respective company and that the transaction
will not result in dilution for existing shareholders, the Exchange
believes the provisions of Rule 17a-8 protect against dilution and also
provide safeguards for existing shareholders when the transaction
involves a director, officer, or substantial shareholder of the listed
company that has a significant interest in the company or assets to be
acquired or the consideration to be paid and therefore may benefit from
the transaction.\22\
---------------------------------------------------------------------------

    \22\ See id.
---------------------------------------------------------------------------

    Notwithstanding the proposed exemption, the Exchange states that if
other provisions of Exchange rules and the 1940 Act and the rules
thereunder require shareholder approval, those will still apply.\23\
The Exchange also states that the adopting release for Rule 17a-8
specifically noted that nothing in Rule 17a-8 relieves a fund of its
obligation to obtain shareholder approval as may be required by state
law or a fund's organizational documents.\24\
---------------------------------------------------------------------------

    \23\ See id. at 14591.
    \24\ See id. at 14591, n.10 (citing Investment Company Act
Release No. 25666 (July 18, 2002), 67 FR 48512 (July 24, 2002) at
n.18).
---------------------------------------------------------------------------

III. Proceedings To Determine Whether To Approve or Disapprove SR-NYSE-
2022-11, as Modified by Amendment No. 1, and Grounds for Disapproval
Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Exchange Act \25\ to determine whether the proposed
rule change, as modified by Amendment No. 1, should be approved or
disapproved. Institution of such proceedings is appropriate at this
time in view of the legal and policy issues raised by the proposed rule
change, as modified by Amendment No. 1. Institution of proceedings does
not indicate that the Commission has reached any conclusions with
respect to any of the issues involved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Exchange Act,\26\ the
Commission is providing notice of the grounds for disapproval under
consideration. The

Commission is instituting proceedings to allow for additional analysis
of the proposed rule change's consistency with the Exchange Act, and,
in particular, with Section 6(b)(5) of the Exchange Act, which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest and not be designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.\27\
---------------------------------------------------------------------------

    \26\ Id.
    \27\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As discussed above, the Exchange is proposing to exempt closed-end
funds and BDCs from the requirement to obtain shareholder approval
prior to issuances of securities in connection with the acquisition of
stock or assets of an affiliated company, provided that the transaction
complies with Rule 17a-8, which requires, among other things, that the
board of directors of each company participating in such a merger
determines that participation in the merger is in the best interests of
the company and that the interests of the company's shareholders will
not be diluted as a result of the merger. Although the Commission
previously approved a similar exemption for exchange-traded funds
(``ETFs''),\28\ there are differences between ETFs and closed-end funds
and BDCs. Shares of closed-end funds and BDCs often trade at prices
that are less than, or at a ``discount'' to, the fund's net asset value
per share. In contrast, ETFs may trade at a discount but often to a
much lesser degree than closed-end funds and BDCs. Due to these
circumstances, shareholders of closed-end funds and BDCs may have an
interest in expressing their views on a proposal by management to merge
the closed-end fund or BDC into an affiliated fund. In addition, unlike
shareholders of ETFs,\29\ shareholders of closed-end funds and BDCs
typically participate in annual shareholder meetings with respect to
the election of directors and other matters. The Exchange's proposal
therefore raises questions as to whether the elimination of the current
ability of shareholders of closed-end funds and BDCs to vote on mergers
with affiliated companies is consistent with Section 6(b)(5) of the
Exchange Act, which requires the rules of the Exchange to, among other
relevant provisions, protect investors and the public interest.\30\
---------------------------------------------------------------------------

    \28\ The Commission previously approved NYSE Arca, Inc.'s
proposal to exempt issuers of Unit Investment Trusts, Investment
Company Units, Exchange-Traded Fund Shares, Portfolio Depositary
Receipts, Managed Fund Shares, Active Proxy Portfolio Shares, and
Managed Portfolio Shares from the requirement to obtain shareholder
approval prior to the issuance of securities in connection with
certain acquisitions of the stock or assets of an affiliated
registered investment company in a transaction that complies with
Rule 17a-8. See Securities Exchange Act Release No. 91901 (May 14,
2021), 86 FR 27487 (May 20, 2021).
    \29\ See id. at n.18.
    \30\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Under the Commission's Rules of Practice, the ``burden to
demonstrate that a proposed rule change is consistent with the Exchange
Act and the rules and regulations thereunder . . . is on the self-
regulatory organization [`SRO'] that proposed the rule change.'' \31\
The description of a proposed rule change, its purpose and operation,
its effect, and a legal analysis of its consistency with applicable
requirements must all be sufficiently detailed and specific to support
an affirmative Commission finding,\32\ and any failure of an SRO to
provide this information may result in the Commission not having
sufficient basis to make an affirmative finding that a proposed rule
change is consistent with the Exchange Act and the applicable rule and
regulations.\33\
---------------------------------------------------------------------------

    \31\ Rule 700(b)(3), Commission Rules of Practice, 17 CFR
201.700(b)(3).
    \32\ See id.
    \33\ See id.
---------------------------------------------------------------------------

    For these reasons, the Commission believes it is appropriate to
institute proceedings pursuant to Section 19(b)(2)(B) of the Exchange
Act \34\ to determine whether the proposal should be approved or
disapproved.
---------------------------------------------------------------------------

    \34\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposed rule
change, as modified by Amendment No. 1, is consistent with Section
6(b)(5) or any other provision of the Exchange Act, or the rules and
regulations thereunder. Although there do not appear to be any issues
relevant to approval or disapproval that would be facilitated by an
oral presentation of views, data, and arguments, the Commission will
consider, pursuant to Rule 19b-4, any request for an opportunity to
make an oral presentation.\35\
---------------------------------------------------------------------------

    \35\ Section 19(b)(2) of the Exchange Act, as amended by the
Securities Act Amendments of 1975, Public Law 94-29 (June 4, 1975),
grants the Commission flexibility to determine what type of
proceeding--either oral or notice and opportunity for written
comments--is appropriate for consideration of a particular proposal
by a self-regulatory organization. See Securities Act Amendments of
1975, Senate Comm. on Banking, Housing & Urban Affairs, S. Rep. No.
75, 94th Cong., 1st Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule change, as modified by
Amendment No. 1, should be approved or disapproved by July 8, 2022. Any
person who wishes to file a rebuttal to any other person's submission
must file that rebuttal by July 22, 2022.
    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of the proposal, which are set forth
in Notice,\36\ in addition to any other comments they may wish to
submit about the proposed rule change.
---------------------------------------------------------------------------

    \36\ See Notice, supra note 3.
---------------------------------------------------------------------------

    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSE-2022-11 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2022-11. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE,

Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2022-11 and should be
submitted on or before July 8, 2022. Rebuttal comments should be
submitted by July 22, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\37\
---------------------------------------------------------------------------

    \37\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13042 Filed 6-16-22; 8:45 am]
BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                              WASHINGTON, D.C. 20460

  SEQ CHAPTER \h \r 1 OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 								Chemical: MCPB (and Salt)

								PC Code: 019201

								DP barcode:  343745

February 27, 2008

MEMORANDUM

Subject:	Drinking Water Assessment for MCPB Use on Mint

To:		Susan Stanton

		Risk Manager Reviewer

Registration Division (7508P)

From:		James Lin, Environmental Engineer

		Nancy Andrews, Branch Chief

		Environmental Risk Branch I

Environmental Fate and Effects Division (7507P)

A previous drinking water assessment for MCPB was completed August 3, 2005 (DP 314053).  The assessment was targeted for uses on peas with a single maximum application rate of 1.5 lb. ae/A).  Both monitoring analysis and modeling approach were applied in the assessment.  The complete drinking water assessment is attached (pages 7 – 16).

This new IR-4 tolerance petition for EFED is to assess drinking water impacts associated with use on Mint.  The standard EFED Oregon Mint scenario is used for this assessment.  The scenario describes the mint growing in Marion County, Oregon within the Major Land Resource Area (MLRA) – A2.  The timings of mint growing are April 15, July 25, and August 1, respectively for the emergence date, maturation date, and harvest date.  The 30 years of weather records are from weather station - 24232.

All the modeling inputs of physical chemical parameters and environmental fate study parameters are adopted from the previous assessment (see pages 9 and 10).  The only exception is the use rate which is based on the proposed label.  The recommended Thistrol® herbicide label language for mint uses are as follows.

For suppression of field bindweed and other broadleaf weeds listed on this label: apply early post-emergence at the rate of 1 to 2 pints per acre (0.25 to 0.5 lb. acid equivalent/acre (lb. ae/A)) in sufficient water for coverage.

Field bindweed suppression improves as the runners begin to exceed 6 to 8 inches in length.  Mint oil yield may be reduced if applications are made when the crop is 6 inches or more tall.  Mint may be discolored or twisted, but the production benefits gained from suppressing bindweed typically far exceeds the risk of mint injury.

For control of winter annual weeds listed, a fall application at 1 to 2 pints per acre (0.25 to 0.5 lb. ae/A) may be applied.  A single spring application works best for field bindweed suppression.

Based on two applications of 0.5 lb. ae/A, one for the spring application and the other for fall application, the Oregon Mint modeling scenario predicts the drinking water concentrations after PCA (0.87) correction of 8.32 ug/L, 4.31 ug/L, and 3.22 ug/L, respectively for the 1-in-10 years acute (peak), chronic (annual average) and cancer (30-year average).  The PE5 output is included in Appendix 1.  These values are less than the previous estimates, therefore, for the drinking water assessment purpose, the previous estimated drinking water concentrations for use on peas should be used as the representative drinking water concentrations.

The recommended estimated drinking water concentrations (EDWCs) for the human health risk assessment are as follows:

	Surface water (PRZM/EXAMS)

Acute (peak)				54.7 ug/L

Chronic (annual average)		13.5 ug/L

Cancer (30-year average)		7.3 ug/L

Groundwater (SCI-GROW)			2.1 ug/L

Appendix 1.  PE5 output of Oregon Mint Scenario.

stored as MCPORMT.out

stored as MCPORMT.out

Chemical: MCPB

PRZM environment: ORmintSTD.txt	modified Tueday, 29 May 2007 at 12:00:46

EXAMS environment: ir298.exv	modified Thuday, 29 August 2002 at 14:34:12

Metfile: w24232.dvf	modified Wedday, 3 July 2002 at 08:06:10

Water segment concentrations (ppb)

Year	Peak	96 hr	21 Day	60 Day	90 Day	Yearly

1961	5.928	5.878	5.677	5.311	4.948	2.459

1962	9.697	9.604	9.394	8.047	6.975	4.72

1963	8.394	8.274	7.796	6.916	6.629	4.728

1964	6.589	6.545	6.383	5.934	5.212	4.156

1965	6.027	5.987	5.857	5.459	4.808	2.942

1966	5.704	5.66	5.513	5.104	4.546	3.121

1967	5.977	5.917	5.668	5.038	4.623	3.247

1968	10.18	10.02	9.278	7.864	6.881	3.776

1969	6.744	6.696	6.447	5.755	5.082	3.595

1970	5.648	5.611	5.376	5.075	4.441	2.859

1971	6.86	6.737	6.423	6.155	5.645	3.252

1972	6.258	6.205	5.986	5.799	5.458	3.576

1973	6.313	6.265	6.195	5.293	4.796	3.689

1974	5.25	5.207	5.049	4.653	4.103	2.397

1975	5.94	5.893	5.609	5.037	4.533	3.305

1976	5.948	5.904	5.752	5.517	5.351	3.544

1977	7.075	7.021	6.757	6.349	6.053	4.981

1978	6.004	5.956	5.793	5.471	5.17	3.65

1979	12.81	12.6	11.82	10.58	9.264	5.314

1980	7.182	7.037	6.867	6.378	5.829	5.046

1981	7.975	7.887	7.387	6.165	5.251	3.259

1982	5.661	5.619	5.465	5.043	4.509	3.052

1983	5.354	5.315	5.175	4.825	4.299	2.825

1984	7.03	6.97	6.725	5.802	4.982	3.784

1985	7.133	7.069	6.829	6.306	6.01	4.021

1986	7.229	7.173	6.93	6.413	5.799	4.557

1987	6.091	6.046	5.879	5.721	5.224	3.878

1988	6.562	6.419	5.823	5.648	5.169	3.472

1989	7.259	7.185	6.843	6.431	5.908	4.333

1990	6.135	6.086	5.703	5.11	4.641	3.576

Sorted results

Prob.	Peak	96 hr	21 Day	60 Day	90 Day	Yearly

0.032258064516129	12.81	12.6	11.82	10.58	9.264	5.314

0.0645161290322581	10.18	10.02	9.394	8.047	6.975	5.046

0.0967741935483871	9.697	9.604	9.278	7.864	6.881	4.981

0.129032258064516	8.394	8.274	7.796	6.916	6.629	4.728

0.161290322580645	7.975	7.887	7.387	6.431	6.053	4.72

0.193548387096774	7.259	7.185	6.93	6.413	6.01	4.557

0.225806451612903	7.229	7.173	6.867	6.378	5.908	4.333

0.258064516129032	7.182	7.069	6.843	6.349	5.829	4.156

0.290322580645161	7.133	7.037	6.829	6.306	5.799	4.021

0.32258064516129	7.075	7.021	6.757	6.165	5.645	3.878

0.354838709677419	7.03	6.97	6.725	6.155	5.458	3.784

0.387096774193548	6.86	6.737	6.447	5.934	5.351	3.776

0.419354838709677	6.744	6.696	6.423	5.802	5.251	3.689

0.451612903225806	6.589	6.545	6.383	5.799	5.224	3.65

0.483870967741936	6.562	6.419	6.195	5.755	5.212	3.595

0.516129032258065	6.313	6.265	5.986	5.721	5.17	3.576

0.548387096774194	6.258	6.205	5.879	5.648	5.169	3.576

0.580645161290323	6.135	6.086	5.857	5.517	5.082	3.544

0.612903225806452	6.091	6.046	5.823	5.471	4.982	3.472

0.645161290322581	6.027	5.987	5.793	5.459	4.948	3.305

0.67741935483871	6.004	5.956	5.752	5.311	4.808	3.259

0.709677419354839	5.977	5.917	5.703	5.293	4.796	3.252

0.741935483870968	5.948	5.904	5.677	5.11	4.641	3.247

0.774193548387097	5.94	5.893	5.668	5.104	4.623	3.121

0.806451612903226	5.928	5.878	5.609	5.075	4.546	3.052

0.838709677419355	5.704	5.66	5.513	5.043	4.533	2.942

0.870967741935484	5.661	5.619	5.465	5.038	4.509	2.859

0.903225806451613	5.648	5.611	5.376	5.037	4.441	2.825

0.935483870967742	5.354	5.315	5.175	4.825	4.299	2.459

0.967741935483871	5.25	5.207	5.049	4.653	4.103	2.397

0.1	9.5667	9.471	9.1298	7.7692	6.8558	4.9557

					Average of yearly averages:	3.7038

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run:

Output File: MCPORMT

Metfile:	w24232.dvf

PRZM scenario:	ORmintSTD.txt

EXAMS environment file:	ir298.exv

Chemical Name:	MCPB

Description	Variable Name	Value	Units	Comments

Molecular weight	mwt	228.6	g/mol

Henry's Law Const.	henry	3.42e-9	atm-m^3/mol

Vapor Pressure	vapr	4e-7	torr

Solubility	sol	600	mg/L

Kd	Kd	0.85	mg/L

Koc	Koc		mg/L

Photolysis half-life	kdp	2.6	days	Half-life

Aerobic Aquatic Metabolism	kbacw	156	days	Halfife

Anaerobic Aquatic Metabolism	kbacs	68	days	Halfife

Aerobic Soil Metabolism	asm	78	days	Halfife

Hydrolysis:	pH 7	0	days	Half-life

Method:	CAM	1	integer	See PRZM manual

Incorporation Depth:	DEPI	0	cm

Application Rate:	TAPP	0.56	kg/ha

Application Efficiency:	APPEFF	0.95	fraction

Spray Drift	DRFT	0.16	fraction of application rate applied to pond

Application Date	Date	20-04	dd/mm or dd/mmm or dd-mm or dd-mmm

Interval 1	interval	160	days	Set to 0 or delete line for single app.

app. rate 1	apprate	0.56	kg/ha

Record 17:	FILTRA

	IPSCND	1

	UPTKF

Record 18:	PLVKRT

	PLDKRT

	FEXTRC	0.5

Flag for Index Res. Run	IR	Reservoir

Flag for runoff calc.	RUNOFF	monthly	none, monthly or total(average of entire run)

Appendix 2.  Drinking Water Assessment for MCPB (DP 314053)

 PAGE

 PAGE   16


[Federal Register Volume 82, Number 222 (Monday, November 20, 2017)]
[Notices]
[Pages 55109-55110]
[FR Doc No: 2017-25076]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0957]

Cooperative Research and Development Agreement--Robotic Aircraft
for Sensors Program for Maritime

AGENCY: Coast Guard, DHS.

ACTION: Notice of intent; request for comments.

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

SUMMARY: The Coast Guard announces its intent to enter into a
cooperative research and development agreement (CRADA) with several
companies to evaluate small unmanned aircraft systems (SUAS) sensors or
payloads, to determine their potential use in a maritime environment by
first responders and DHS operational components. The Coast Guard will
conduct flight testing and evaluations of SUAS under a wide variety of
simulated but realistic and relevant real-world maritime operational
scenarios, such as: law enforcement; search and rescue; and maritime
environmental responses. From our previous solicitations, the Coast
Guard is currently considering partnering with AeroVironment, Inc. and
solicits public comment on the possible participation of other parties
in the proposed CRADA, and the nature of that participation. The Coast
Guard also invites other potential non-Federal participants, who have
the interest and capability to bring similar contributions to this type
of research, to consider submitting proposals for consideration in
similar CRADAs.

DATES: Comments must reach the Coast Guard on or before December 20,
2017. Synopses of proposals regarding future CRADAs must also reach the
Coast Guard on or before December 20, 2017.

ADDRESSES: Submit comments online at http://www.regulations.gov
following Web site instructions. Submit synopses of proposals regarding
future CRADAs to Mr. Steve Dunn at his address listed in the FOR
FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
or wish to submit proposals for future CRADAs, contact Mr. Steve Dunn,
Project Official, Systems Branch, U.S. Coast Guard Research and
Development Center, 1 Chelsea Street, New London, CT 06320, telephone
860-271-2789, email [email protected].

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We request public comments on this notice. Although we do not plan
to publish responses to comments in the Federal Register, we will
respond directly to commenters and may modify our proposal in light of
comments.
    Comments should be marked with docket number USCG-2017-0957 and
should provide a reason for each suggestion or recommendation. You
should provide personal contact information so that we can contact you
if we have questions regarding your comments; but please note that all
comments will be posted to the online docket without change and that
any personal information you include can be searchable online. For more
about privacy and the docket, visit http://www.regulations.gov/privacyNotice. We do accept anonymous comments.
    We encourage you to submit comments through the Federal Portal at
http://www.regulations.gov. If your material cannot be submitted using
http://www.regulations.gov, contact the Coast Guard (see FOR FURTHER
INFORMATION CONTACT). Documents mentioned in this notice and all public
comments will be in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    Do not submit detailed proposals for future CRADAs to http://www.regulations.gov. Instead, submit them directly to the Coast Guard
(see FOR FURTHER INFORMATION CONTACT).

Discussion

    CRADAs are authorized under 15 U.S.C. 3710(a).\1\ A CRADA promotes
the transfer of technology to the private sector for commercial use, as
well as specified research or development efforts that are consistent
with the mission of the Federal parties to the CRADA. The Federal party
or parties

agree with one or more non-Federal parties to share research resources,
but the Federal party does not contribute funding.
---------------------------------------------------------------------------

    \1\ The statute confers this authority on the head of each
Federal agency. The Secretary of DHS's authority is delegated to the
Coast Guard and other DHS organizational elements by DHS Delegation
No. 0160.1, para. II.B.34.
---------------------------------------------------------------------------

    CRADAs are not procurement contracts. Care is taken to ensure that
CRADAs are not used to circumvent the contracting process. CRADAs have
a specific purpose and should not be confused with procurement
contracts, grants, and other type of agreements.
    Under the proposed CRADA, the Coast Guard's Research and
Development Center (R&DC) will collaborate with one or more non-Federal
participants. Together, the R&DC and the non-Federal participants will
evaluate SUAS and their airborne sensors to determine their potential
for use in a maritime environment by a first responder and DHS
operational components.
    We anticipate that the Coast Guard's contributions under the
proposed CRADA will include the following:
    (1) Develop the demonstration test plan to be executed under the
CRADA;
    (2) Provide the SUAS test range, test range support, facilities,
and all approvals required for a 5 day demonstration under the CRADA;
    (3) Conduct the privacy threshold analysis required for the
demonstration;
    (4) Conduct the privacy impact assessment required for the
demonstration;
    (5) Coordinate any required spectrum approval for the SUAS;
    (6) Coordinate and receive any required interim flight clearance
for the demonstration;
    (7) Provide any required airspace coordination and de-confliction
for the demonstration test plan;
    (8) Collect and analyze demonstration test plan data; and
    (9) Develop a demonstration final report documenting the
methodologies, findings, conclusions, and recommendations of this CRADA
work.
    We anticipate that the non-Federal participants' contributions
under the proposed CRADA will include the following:
    (1) Provide SUAS and all other equipment to conduct the
demonstration described in the demonstration test plan;
    (2) Provide all required operators and technicians to conduct the
demonstration;
    (3) Provide technical data for the SUAS to be utilized;
    (4) Provide shipment and delivery of all SUAS equipment required
for the demonstration; and
    (5) Provide travel and associated personnel and other expenses as
required.
    The Coast Guard reserves the right to select for CRADA participants
all, some, or no proposals submitted for this CRADA. The Coast Guard
will provide no funding for reimbursement of proposal development
costs. Proposals and any other material submitted in response to this
notice will not be returned. Proposals submitted are expected to be
unclassified and have no more than five single-sided pages (excluding
cover page, DD 1494, JF-12, etc.). The Coast Guard will select
proposals at its sole discretion on the basis of:
    (1) How well they communicate an understanding of, and ability to
meet, the proposed CRADA's goal; and
    (2) How well they address the following criteria:
    (a) Technical capability to support the non-Federal party
contributions described; and
    (b) Resources available for supporting the non-Federal party
contributions described.
    Currently, the Coast Guard is considering AeroVironment, Inc. for
participation in this CRADA, because they have demonstrated the ability
to operate SUAS in a maritime environment. However, we do not wish to
exclude other viable participants from this or future similar CRADAs.
    This is a technology demonstration effort. The goal of this CRADA
is to identify and investigate the potential of the SUAS and their
airborne sensors to determine their potential use in a maritime
environment by the first responder and the DHS operational components.
Special consideration will be given to small business firms/consortia,
and preference will be given to business units located in the U.S.
    This notice is issued under the authority of 5 U.S.C. 552(a) and 15
U.S.C. 3710(a).

    Dated: November 2, 2017.
Gregory C. Rothrock,
Captain, USCG, Commanding Officer, U.S. Coast Guard Research and
Development Center.
[FR Doc. 2017-25076 Filed 11-17-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32901-32902]
[FR Doc No: 2019-14644]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR19-29-000]

SFPP, LP; Notice of Petition for Declaratory Order

    Take notice that on June 27, 2019, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2018), SFPP, LP filed a
petition for Declaratory Order seeking approval of the overall tariff
rate structure, as well as terms of service including prorationing, and
open season procedures, for a proposed expansion service on SFPP's East
line, in order to serve the Mexican market with Mexican grade gasoline
and diesel,

all as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    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 5 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
website that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time on July 26, 2019.

    Dated: July 2, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-14644 Filed 7-9-19; 8:45 am]
BILLING CODE 6717-01-P