[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56605-56606]
[FR Doc No: 2017-25770]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2181]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
29, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 29, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 29, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-2181 for ''Determination of Regulatory Review Period for
Purposes of Patent Extension; XURIDEN.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469,

September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product XURIDEN
(uridine triacetate). XURIDEN is indicated for the treatment of
hereditary orotic aciduria. Subsequent to this approval, the USPTO
received a patent term restoration application for XURIDEN (U.S. Patent
No. 6,258,795) from Wellstat Therapeutics Corp., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated August 25, 2016, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the approval of XURIDEN represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
XURIDEN is 8,494 days. Of this time, 8,254 days occurred during the
testing phase of the regulatory review period, while 240 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: June 4, 1992. The applicant claims May 4, 1992, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was June 4,
1992, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: January 8,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for XURIDEN (NDA 208169) was initially submitted on
January 8, 2015.
    3. The date the application was approved: September 4, 2015. FDA
has verified the applicant's claim that NDA 208169 was approved on
September 4, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of 21 CFR 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with 21 CFR 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25770 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70873-70875]
[FR Doc No: 2014-28106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Quantitative Data on Tobacco Products and
Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
December 29, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Generic Clearance for the Collection of Quantitative Data on
Tobacco Products and Communications.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Generic Clearance for the Collection of Quantitative Data on Tobacco
Products and Communications--(OMB Control Number 0910--NEW)

    In order to conduct educational and public information programs
relating to tobacco use as authorized by section 1003(d)(2)(D) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's
Center for Tobacco Products (CTP) will create and use a variety of
media to inform and educate the public, tobacco retailers, and health
professionals about the risks of tobacco use, how to quit using tobacco
products, and FDA's role in regulating tobacco.
    To ensure that these health communication messages have the highest
potential to be received, understood, and accepted by those for whom
they are intended, the Center for Tobacco Products will conduct
research and studies relating to the control and prevention of disease.
In conducting such research, FDA will employ formative pretests.
Formative pretests are conducted on a small scale, and their focus is
on developing and assessing the likely effectiveness of communications
with specific target audiences. This type of research involves: (1)
Assessing audience knowledge, attitudes, behaviors, and other
characteristics for the purpose of determining the need for and
developing health messages, communication strategies, and public
information programs and (2) pretesting these health messages,
strategies, and program components while they are in developmental form
to assess audience comprehension, reactions, and perceptions.
    Formative pretesting is a staple of best practices in
communications research. Obtaining feedback from intended audiences
during the development of messages and materials is crucial for the
success of every communication program. The purpose of obtaining
information from formative pretesting is that it allows FDA to improve
materials and strategies while revisions are still affordable and
possible. Formative pretesting can also avoid potentially expensive and
dangerous unintended outcomes caused by audiences' interpreting
messages in a way that was not intended by the drafters. By maximizing
the effectiveness of messages and strategies for reaching targeted
audiences, the frequency with which tobacco communication messages need
to be modified should be greatly reduced.
    The information collected will serve the primary purpose of
providing FDA information about the perceived effectiveness of
messages, advertisements, and materials in reaching and successfully
communicating with their intended audiences. Quantitative testing
messages and other materials with a sample of the target audience will
allow FDA to refine messages, advertisements, and materials, including
questionnaires or images, directed at consumers while the materials are
still in the developmental stage.
    In the Federal Register of July 17, 2014 (79 FR 41696), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four comments were received, but only two
comments were PRA-related.
    (Comment 1) One comment was supportive of the information
collection, stating they ``support CTP's proposal to conduct formative
pretests to ensure that health communication messages are received,
understood and accepted by the intended audiences'' and that they
believe the proposed information collection is necessary and will have
practical utility. The comment also stated that CTP's projection of the
burden of the proposed collection effort seems reasonable. In addition,
the comment suggested that FDA consult with FDA's Risk Communication
Advisory Committee on proposed information collections.
    (Response) FDA agrees that the request in this collection of
information is necessary and that the proposed burden is reasonable.
Consultation with other U.S. Department of Health and Human Services
(HHS) Agencies, FDA advisory committees, and/or the public will occur
when appropriate.
    (Comment 2) One comment was supportive of the data collection
stating that the ``collections are, in fact, essential.'' That comment
also made suggestions about what the specific goals of messages tested
in information collections included under this generic collection
should focus on, and suggested that those collections be made available
for further public comments.
    (Response) FDA agrees that the request in this collection of
information is essential to the mission of FDA as a science-based
Agency in its implementation of the Tobacco Control Act. Although we
appreciate suggestions for the content of future submissions submitted
under this generic clearance, ultimately such decisions will be driven
by needs determined by the Agency in consultation with other HHS
Agencies and the public when appropriate.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                Number of
                 Activity                      Number of      responses per     Total annual          Average burden per response          Total hours
                                              respondents       respondent       responses
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Self-Administered Surveys.................          30,300                1           30,300   0.33 (20 minutes).......................           9,999
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents to be included in each new survey will
vary, depending on the nature of the material or message being tested
and the target audience.

    Dated: November 20, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28106 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P


DCTM_ ARP. xls Surface N Leached N Reg Scenari Operation lb/ yr lb/ yr BaselineCattle Baseline Beef 4,138,829 0 BaselinePoultry Baseline Broiler 829,724 0 BaselineDairy Baseline Dairy 1,487,802 0 BaselineDairy Baseline Heifer 209,063 0 BaselinePoultry Baseline Layers 649,178 0 BaselinePoultry ( wet) Baseline Layers ( wet) 10,426,018 0 BaselineSwine Baseline Swine combined 2,507,500 0 BaselineSwine Baseline Swine slaughter 3,826,253 0 BaselinePoultry Baseline Turkey 117,260 0 BaselineVeal Baseline Veal 0 0 BaselineTotal Baseline Total 24,191,628 0 Option 1Cattle Option 1 Beef 4,138,829 0 Option 1Poultry Option 1 Broiler 0 0 Option 1Dairy Option 1 Dairy 1,487,802 0 Option 1Dairy Option 1 Heifer 209,063 0 Option 1Poultry Option 1 Layers 0 0 Option 1Poultry ( wet) Option 1 Layers ( wet) 10,426,018 0 Option 1Swine Option 1 Swine combined 2,507,500 0 Option 1Swine Option 1 Swine slaughter 3,826,253 0 Option 1Poultry Option 1 Turkey 0 0 Option 1Veal Option 1 Veal 0 0 Option 1Total Option 1 Total 22,595,466 0 Option 2Cattle Option 2 Beef 4,138,829 0 Option 2Poultry Option 2 Broiler 0 0 Option 2Dairy Option 2 Dairy 1,487,802 0 Option 2Dairy Option 2 Heifer 209,063 0 Option 2Poultry Option 2 Layers 0 0 Option 2Poultry ( wet) Option 2 Layers ( wet) 10,426,018 0 Option 2Swine Option 2 Swine combined 2,507,500 0 Option 2Swine Option 2 Swine slaughter 3,826,253 0 Option 2Poultry Option 2 Turkey 0 0 Option 2Veal Option 2 Veal 0 0 Option 2Total Option 2 Total 22,595,466 0 Option 3Cattle Option 3 Beef 4,138,829 0 Option 3Poultry Option 3 Broiler 0 0 Option 3Dairy Option 3 Dairy 1,487,802 0 Option 3Dairy Option 3 Heifer 209,063 0 Option 3Poultry Option 3 Layers 0 0 Option 3Poultry ( wet) Option 3 Layers ( wet) 10,426,018 0 Option 3Swine Option 3 Swine combined 2,507,500 0 Option 3Swine Option 3 Swine slaughter 3,826,253 0 Option 3Poultry Option 3 Turkey 0 0 Option 3Veal Option 3 Veal 0 0 Option 3Total Option 3 Total 22,595,466 0 Option 5aCattle Option 5 Beef 1,738,308 0 Option 5aPoultry Option 5 Broiler 0 0 DCTM_ ARP. xls Option 5aDairy Option 5 Dairy 624,877 0 Option 5aDairy Option 5 Heifer 87,807 0 Option 5aPoultry Option 5 Layers 0 0 Option 5Poultry ( wet) Option 5 Layers ( wet) 0 0 Option 5Swine Option 5 Swine combined 0 0 Option 5Swine Option 5 Swine slaughter 0 0 Option 5aPoultry Option 5 Turkey 0 0 Option 5aVeal Option 5 Veal 0 0 Option 5Total Option 5 Total 2,450,992 0 Option 6Cattle Option 6 Beef 4,138,829 0 Option 6Poultry Option 6 Broiler 0 0 Option 6Dairy Option 6 Dairy 1,041,462 0 Option 6Dairy Option 6 Heifer 209,063 0 Option 6Poultry Option 6 Layers 0 0 Option 6Poultry ( wet) Option 6 Layers ( wet) 10,426,018 0 Option 6Swine Option 6 Swine combined 1,755,250 0 Option 6Swine Option 6 Swine slaughter 2,678,377 0 Option 6Poultry Option 6 Turkey 0 0 Option 6Veal Option 6 Veal 0 0 Option 6Total Option 6 Total 20,248,999 0 Option 7Cattle Option 7 Beef 4,132,678 0 Option 7Poultry Option 7 Broiler 0 0 Option 7Dairy Option 7 Dairy 446,440 0 Option 7Dairy Option 7 Heifer 209,063 0 Option 7Poultry Option 7 Layers 0 0 Option 7Poultry ( wet) Option 7 Layers ( wet) 10,426,018 0 Option 7Swine Option 7 Swine combined 25,176 0 Option 7Swine Option 7 Swine slaughter 23,985 0 Option 7Poultry Option 7 Turkey 0 0 Option 7Veal Option 7 Veal 0 0 Option 7Total Option 7 Total 15,263,361 0 DCTM_ ARP. xls N Surface P Leached P P Sediment Sed BOD lb/ yr lb/ yr tons/ yr lb/ yr 4 1,189,603 0 1 21,685 43 7,236,755 1 226,288 0 0 8,297 17 3,017,180 1 427,632 0 0 5,194 10 2,601,427 0 60,090 0 0 1,095 2 365,548 1 231,849 0 0 6,183 12 2,550,342 10 2,257,179 0 2 44,785 90 13,256,449 3 542,861 0 1 110 0 2,943,354 4 828,364 0 1 169 0 4,500,599 0 43,500 0 0 1,135 2 397,172 0 0 0 0 0 0 0 24 5,807,367 0 6 88,654 177 36,868,824 4 1,189,603 0 1 21,685 43 7,236,755 0 0 0 0 0 0 0 1 427,632 0 0 5,194 10 2,601,427 0 60,090 0 0 1,095 2 365,548 0 0 0 0 0 0 0 10 2,257,179 0 2 44,785 90 13,256,449 3 542,861 0 1 110 0 2,943,354 4 828,364 0 1 169 0 4,500,599 0 0 0 0 0 0 0 0 0 0 0 0 0 0 23 5,305,729 0 5 73,040 146 30,904,131 4 1,189,603 0 1 21,685 43 7,236,755 0 0 0 0 0 0 0 1 427,632 0 0 5,194 10 2,601,427 0 60,090 0 0 1,095 2 365,548 0 0 0 0 0 0 0 10 2,257,179 0 2 44,785 90 13,256,449 3 542,861 0 1 110 0 2,943,354 4 828,364 0 1 169 0 4,500,599 0 0 0 0 0 0 0 0 0 0 0 0 0 0 23 5,305,729 0 5 73,040 146 30,904,131 4 1,189,603 0 1 21,685 43 7,236,755 0 0 0 0 0 0 0 1 427,632 0 0 5,194 10 2,601,427 0 60,090 0 0 1,095 2 365,548 0 0 0 0 0 0 0 10 2,257,179 0 2 44,785 90 13,256,449 3 542,861 0 1 110 0 2,943,354 4 828,364 0 1 169 0 4,500,599 0 0 0 0 0 0 0 0 0 0 0 0 0 0 23 5,305,729 0 5 73,040 146 30,904,131 2 594,802 0 1 9,325 19 4,342,053 0 0 0 0 0 0 0 DCTM_ ARP. xls 1 213,816 0 0 2,233 4 1,560,856 0 30,045 0 0 471 1 219,329 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 838,663 0 1 12,029 24 6,122,238 4 1,189,603 0 1 21,685 43 7,236,755 0 0 0 0 0 0 0 1 149,671 0 0 779 2 390,214 0 60,090 0 0 1,095 2 365,548 0 0 0 0 0 0 0 10 2,257,179 0 2 44,785 90 13,256,449 2 190,001 0 0 17 0 441,503 3 289,927 0 0 25 0 675,090 0 0 0 0 0 0 0 0 0 0 0 0 0 0 20 4,136,473 0 4 68,387 137 22,365,558 4 1,187,836 0 1 21,653 43 7,225,999 0 0 0 0 0 0 0 0 128,318 0 0 1,559 3 780,602 0 60,090 0 0 1,095 2 365,548 0 0 0 0 0 0 0 10 2,257,179 0 2 44,785 90 13,256,449 0 5,451 0 0 4 0 101,768 0 5,193 0 0 6 0 148,197 0 0 0 0 0 0 0 0 0 0 0 0 0 0 15 3,644,066 0 4 69,102 138 21,878,562 DCTM_ ARP. xls BOD FC FC FS FS Zn Cu 10 10 cfu/ yr 10 10 cfu/ yr lb/ yr lb/ yr 7 374,983,708 375 168,096,145 168 14,224 4,008 3 452,577 0 392,987,640 393 2,715 739 3 32,754,778 33 191,069,538 191 8,189 2,047 0 18,941,438 19 8,490,989 8 718 202 3 5,796,233 6 12,365,296 12 14,684 641 13 56,429,478 56 120,382,886 120 142,955 6,245 3 54,286,083 54 1,598,423,549 1,598 15,079 3,619 5 82,836,413 83 2,439,072,147 2,439 23,010 5,522 0 264,781 0 564,866 1 2,837 134 0 0 0 0 0 0 0 37 626,745,487 627 4,931,453,057 4,931 224,411 23,159 7 374,983,708 375 168,096,145 168 14,224 4,008 0 0 0 0 0 0 0 3 32,754,778 33 191,069,538 191 8,189 2,047 0 18,941,438 19 8,490,989 8 718 202 0 0 0 0 0 0 0 13 56,429,478 56 120,382,886 120 142,955 6,245 3 54,286,083 54 1,598,423,549 1,598 15,079 3,619 5 82,836,413 83 2,439,072,147 2,439 23,010 5,522 0 0 0 0 0 0 0 0 0 0 0 0 0 0 31 620,231,897 620 4,525,535,255 4,526 204,175 21,644 7 374,983,708 375 168,096,145 168 14,224 4,008 0 0 0 0 0 0 0 3 32,754,778 33 191,069,538 191 8,189 2,047 0 18,941,438 19 8,490,989 8 718 202 0 0 0 0 0 0 0 13 56,429,478 56 120,382,886 120 142,955 6,245 3 54,286,083 54 1,598,423,549 1,598 15,079 3,619 5 82,836,413 83 2,439,072,147 2,439 23,010 5,522 0 0 0 0 0 0 0 0 0 0 0 0 0 0 31 620,231,897 620 4,525,535,255 4,526 204,175 21,644 7 374,983,708 375 168,096,145 168 14,224 4,008 0 0 0 0 0 0 0 3 32,754,778 33 191,069,538 191 8,189 2,047 0 18,941,438 19 8,490,989 8 718 202 0 0 0 0 0 0 0 13 56,429,478 56 120,382,886 120 142,955 6,245 3 54,286,083 54 1,598,423,549 1,598 15,079 3,619 5 82,836,413 83 2,439,072,147 2,439 23,010 5,522 0 0 0 0 0 0 0 0 0 0 0 0 0 0 31 620,231,897 620 4,525,535,255 4,526 204,175 21,644 4 161,242,994 161 72,281,342 72 14,224 4,008 0 0 0 0 0 0 0 DCTM_ ARP. xls 2 14,084,555 14 82,159,901 82 8,189 2,047 0 8,144,818 8 3,651,125 4 718 202 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 183,472,367 183 158,092,369 158 23,131 6,258 7 374,983,708 375 168,096,145 168 14,224 4,008 0 0 0 0 0 0 0 0 327,548 0 1,910,695 2 8,189 2,047 0 18,941,438 19 8,490,989 8 718 202 0 0 0 0 0 0 0 13 56,429,478 56 120,382,886 120 142,955 6,245 0 542,861 1 15,984,235 16 15,079 3,619 1 828,364 1 24,390,721 24 23,010 5,522 0 0 0 0 0 0 0 0 0 0 0 0 0 0 22 452,053,396 452 339,255,672 339 204,175 21,644 7 374,426,418 374 167,846,325 168 14,202 4,002 0 0 0 0 0 0 0 1 9,828,619 10 57,333,610 57 2,457 614 0 18,941,438 19 8,490,989 8 718 202 0 0 0 0 0 0 0 13 56,429,478 56 120,382,886 120 142,955 6,245 0 545,055 1 16,048,856 16 151 36 0 519,267 1 15,289,533 15 144 35 0 0 0 0 0 0 0 0 0 0 0 0 0 0 22 460,690,274 461 385,392,199 385 160,628 11,135 DCTM_ ARP. xls Cd Ni Pb As Metals lb/ yr lb/ yr lb/ yr lb/ yr 39 3,621 0 0 0.022 25 882 312 364 0.005 14 1,274 0 0 0.012 2 183 0 0 0.001 29 193 572 106 0.016 286 1,881 5,568 1,031 0.158 81 240 253 2,082 0.021 124 366 387 3,177 0.033 1 9 98 91 0.003 0 0 0 0 0.000 601 8,648 7,190 6,851 0.271 39 3,621 0 0 0.022 0 0 0 0 0.000 14 1,274 0 0 0.012 2 183 0 0 0.001 0 0 0 0 0.000 286 1,881 5,568 1,031 0.158 81 240 253 2,082 0.021 124 366 387 3,177 0.033 0 0 0 0 0.000 0 0 0 0 0.000 546 7,563 6,208 6,290 0.246 39 3,621 0 0 0.022 0 0 0 0 0.000 14 1,274 0 0 0.012 2 183 0 0 0.001 0 0 0 0 0.000 286 1,881 5,568 1,031 0.158 81 240 253 2,082 0.021 124 366 387 3,177 0.033 0 0 0 0 0.000 0 0 0 0 0.000 546 7,563 6,208 6,290 0.246 39 3,621 0 0 0.022 0 0 0 0 0.000 14 1,274 0 0 0.012 2 183 0 0 0.001 0 0 0 0 0.000 286 1,881 5,568 1,031 0.158 81 240 253 2,082 0.021 124 366 387 3,177 0.033 0 0 0 0 0.000 0 0 0 0 0.000 546 7,563 6,208 6,290 0.246 39 3,621 0 0 0.022 0 0 0 0 0.000 DCTM_ ARP. xls 14 1,274 0 0 0.012 2 183 0 0 0.001 0 0 0 0 0.000 0 0 0 0 0.000 0 0 0 0 0.000 0 0 0 0 0.000 0 0 0 0 0.000 0 0 0 0 0.000 54 5,077 0 0 0.035 39 3,621 0 0 0.022 0 0 0 0 0.000 14 1,274 0 0 0.012 2 183 0 0 0.001 0 0 0 0 0.000 286 1,881 5,568 1,031 0.158 81 240 253 2,082 0.021 124 366 387 3,177 0.033 0 0 0 0 0.000 0 0 0 0 0.000 546 7,563 6,208 6,290 0.246 39 3,615 0 0 0.022 0 0 0 0 0.000 4 382 0 0 0.003 2 183 0 0 0.001 0 0 0 0 0.000 286 1,881 5,568 1,031 0.158 1 2 3 21 0.000 1 2 2 20 0.000 0 0 0 0 0.000 0 0 0 0 0.000 332 6,066 5,573 1,071 0.185


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STANDARDS OF PERFORMANCE PHOSPHATE FERTILIZER INDUSTRY NSPS SUBPARTS T, U, V, W, AND X 1. Identification of the Information Collection 1( a) Title of the Information Collection ICR for NSPS Subpart T, U, V, W, and X B Phosphate Fertilizer Industry 1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS) for the Phosphate Fertilizer Industry were proposed on October 22, 1974 and promulgated on August 6 1975. These standards apply to each wet phosphoric acid plant, each super phosphoric acid plant, each granular diammonium phosphate plant, and each triple superphosphate plant, having a design capacity of more than 15 tons of equivalent phosphorous pentoxide ( P 2 O 5) feed per calendar day. These standards also apply to granular triple superphosphate storage facilities. Specific affected facilities for each subpart are found at 40 CFR. 60.200, 60.210, 60.220, 60.230 and 60.240. Eleven sources are currently subject to the standard, and it is estimated that no additional sources will become subject to the standard over the next three years. The average annual cost to industry over the next three years of the ICR is estimated to be $ 52,880. Fluorides are the pollutants regulated under this standard. Phosphate fertilizer plants shall not discharge gases to the atmosphere in excess of the following grams/ metric tone of equivalent P 2 O 5: 10/ 0 g/ ton for wet phosphoric acid, 5.0 g/ ton for super phosphoric acid, 30 g/ ton for diammonium phosphate plant, 100 g/ ton for triple superphosphate plant, and 0.25 g/ hours/ metric ton for granular triple superphosphate storage.

Owners or operators of the affected facilities described must make the following one timeonly reports: notification of the date of construction or reconstruction; notification of the anticipated and actual dates of startup; notification of any physical or operational change to an existing facility which may increase the regulated pollutant emission rate; notification of demonstration of the continuous monitoring system; the notification of the initial performance test; and results of the initial performance test.

Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility. These notifications, reports and records are required, in general, of all sources subject to NSPS.

Recordkeeping requirements specific to phosphate fertilizer industry provide information on the amount of fertilizer processed, and the operation of the emission control device ( scrubber system). Owners or operators of affected facilities ( excepting phosphate storage facilities) are required to install, calibrate, maintain, and operate a flow monitoring device which can be used to  2 determine the mass flow of phosphorous bearing feed material to the process. Owners or operators shall maintain a daily record of equivalent P 2 O 5 feed calculated from the mass rate measured by the CMS. Owners or operators of phosphate storage facilities are required to maintain an accurate account of triple superphosphate stored to permit the determination of the amount of equivalent P 2 O 5, and shall calculate and maintain daily records of the equivalent P 2 O 5 stored. Owners or operators of all affected facilities shall install, calibrate, maintain, and operate a monitoring device which continuously measures and permanently records the total pressure drop across the process scrubbing system.

Therefore, the recordkeeping requirements for phosphate fertilizer plants consist of the occurrence and duration of all start ups and malfunctions as described, the initial performance tests results, amount of phosphate feed material, equivalent calculated amounts of P 2 O 5, and the pressure drop across the scrubber system. Records of startups, shutdowns and malfunctions shall be noted as they occur. Records of the performance test should include information necessary to determine the conditions of the performance test, and performance test measurements ( including pressure drop across the scrubber system) and results ( specified in detail at 40 CFR 60.204, 60.214, 60.224, 60.234, and 60.244 Test Methods and Procedures and 60.8 Performance Test). The amount of equivalent P 2 O 5 stored or the amount of feed shall be calculated and recorded daily. The CMS shall record pressure drop across the scrubbers continuously and automatically.

The reporting requirements for this industry include the initial notifications listed, and the initial performance test results. Notifications shall be sent out prior to the specified events. Deadlines for notification are listed at 40 CFR 60.7. Requirements for the performance test reports are given at the sections above, and shall include the emissions of total fluorides in gram/ metric ton of equivalent P 2 O 5. This industry is not required to submit excess emission reports.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act, as amended, to establish standards of performance for new stationary sources that reflect:

. . . application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any nonair quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated [ Section lll( a)( l)].

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years. In addition, Section 114( a) states that:  3 . . . the Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C) install, use and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) provide such other information, as he may reasonably require.

In the Administrator's judgment, particulate emissions from the ammonium sulfate manufacturing industry cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NSPS were promulgated for this source category at 40 CFR Part 60 Subparts T, U, V, W, and X. . 2( b) Practical Utility/ Users of The Data Source data and information requirements for phosphate fertilizer plants are outlined in Table A. The standards require the initial reports required by the general provisions of 40 CFR 60.7. These initial reports include notification of construction or modification, reconstruction, and startup, shutdown, or malfunction. The standards also require recordkeeping to document information relating to the daily feed rate and storage of equivalent phosphorus pentoxide. Equivalent amounts of P 2 O 5 are determined from CMS records of phosphate bearing feed material or accounts for triple superphosphate stored. The standards are defined in terms of grams of fluorides emitted per metric ton of equivalent P 2 O 5 processed.

The standards are hourly emission standards and are a function of the hourly feed rate of phosphate bearing materials. As such, it is incumbent upon the personnel monitoring the source to determine the feed rate per hour in order to establish that the facility is in compliance. The regulations require recordation and maintenance of daily records for purposes of determining and verifying the feed rate factor used in the compliance equation. Requiring sources to record and retain hourly feed rate records would allow EPA to monitor compliance more precisely. However, the regulation requires daily rather than hourly recordkeeping because it is the least burdensome necessary for the proper performance of the agency's functions to comply with legal requirements and program objectives. Indeed, according to industry personnel surveyed in an informal poll, the daily feed rate recordation requirement places no additional burden on the industry. This is so because proper plant operation and industry practice include daily recordation of amounts of phosphate bearing feed processed. According to industry personnel, this practice predates the regulation and would continue in its absence. Because the daily recordation requirement places no additional burden on industry and because P 2 O 5 feed rates are essential to determining compliance with the standard, the regulation requires daily recordation of the amount of P 2 O 5 stored. The records must be retained at the facility for a minimum of two ( 2) years.

The information generated by the monitoring, recordkeeping, and reporting requirements described above is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment used to achieve compliance with the NSPS. Notification of construction and startup indicates to enforcement personnel when a new affected facility has been  4 constructed and therefore is subject to the standards. Under the standard, data collected by an affected facility is retained at the source for a minimum of two years and made available for inspection by the Administrator.

If the information required by the standards were not collected, the Agency would have no means for ensuring that compliance with the NSPS is achieved and maintained by new, modified, or reconstructed sources subject to the regulations. Under these circumstances, an owner or operator could elect to reduce operating expenses by not installing, maintaining, or otherwise operating the control technology required by the standards. In the absence of the information collection requirements, compliance with the standards could be ensured only through continuous on site inspections by regulatory agency personnel. Consequently, not collecting the information would result in either greatly increased expenditures of resources, or the inability to ensure compliance with the standards.

The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria 3( a) Nonduplication Certain reports or records required by State or local agencies may duplicate information required by this rule. In such cases, a copy of the report submitted to the State or local agency may be sent to the Administrator in lieu of the report required by these standards.

There are no other sources of similar information since the standards ask for records of daily feed rate and storage unique to each phosphate fertilizer plant.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on January 21, 2000.

3( c) Consultations No comments were received in response to the published federal register notice. In addition to soliciting public comment, Agency program personnel with expertise in this industry were consulted.  5 3( d) Effects of less Frequent Collection If the information required by these standards was collected less frequently, the main consequence would be that the chances of detecting poor operation and maintenance of control equipment would decrease. Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met.

3( e) General Guidelines None of the reporting or recordkeeping requirements contained in 40 CFR Part 60 or otherwise pertinent to this request violate any of the regulations established by OMB in 5 CFR 1320.6.

3( f) Confidentiality and Sensitive Questions Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contained in 40 CFR Part 60 or otherwise pertinent to this request contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping requirements are phosphate fertilizer plants ( SIC Code 2874).

4( b) INFORMATION REQUESTED i. Data Items Reporting Provide notification of  construction/ reconstruction  anticipated startup  actual startup  6  initial performance test Record  daily feed rate and storage  initial performance test results  startups, shutdowns, and malfunctions  control device operating parameters ( continuous)

ii. Respondent Activities  read instructions  perform initial performance test, and repeat performance tests  write the notifications listed above  enter information required to be recorded above 5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts no activities in connection with the acquisition, analysis, storage, and distribution of the information required under 40 CFR Subparts T, U, V, W, and X. No new facilities are anticipated to open during the next three years. The only requirement for existing facilities is recordkeeping by the respondents, which does not require activity by the Agency.

5( b) Collection Methodology and Management All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office. Notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may inspect the source to check if the pollution control devices are properly operated.

Information contained in the reports is entered into the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by EPA's Office of Air Quality Planning and Standards. The AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, EPA Regional Offices and Headquarters. EPA can edit, store, retrieve and analyze the data via PC terminals.

The records required by this NSPS must be retained by the owner or operator for ( two) years.  7 5( c) Small Entity Flexibility Currently the number of employees at a typical fertilizer plant exceeds the criterion for small business, and no new facilities are expected within the next three years, so this information collection requirement is not anticipated to impact small businesses. The recordkeeping requirements were selected within the context of a small collection of process equipment and reflect the burden on either small or larger businesses should they fall under the recordkeeping requirements of this rule. To the extent that larger businesses can use economies of scale to reduce their burden, their overall burden will be reduced. However, even though the recordkeeping requirements are the same for small and larger businesses, the Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.

5( d) Collection Schedule The information collection activity within this request consists of daily ( 350 per year) recordkeeping occurrences of 0.25 hours each.

6. Estimating the Burden and Cost of the Collection Table 2 documents the computation of individual burdens for each of the recordkeeping and reporting requirements applicable to the industry. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory as required at 40 CFR Part 60 Subparts T, U, V, W, and X. The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated at 962.5 ( total from industry table) person hours. These hours are based on Agency studies and background documents from the development of the standards or test methods, Agency knowledge and experience with the ( NSPS, NESHAP, MACT) program, the previously approved ICR, and any comments received about time to prepare reports.

6( b) Estimating Respondent Costs This ICR uses a technical labor rate of $ 54.94 per hour including110 per cent overhead to determine the cost to respondents. This rate is from the United States Department of Labor  8 Bureau of Labor Statistics, March 1999, Table 10: Employment Costs for Private Industry by Occupational and Industry Group. The rates are from column 1: Total compensation. The wage rates have been loaded by adding 110% overhead. The average annual cost to industry over the next three years of the ICR is estimated to be $ 52,880.

The only type of industry costs associated with the information collection activity in the standards are labor costs.

6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information. Publication and distribution of the information are part of the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by the EPA's Office of Air Quality Planning and Standards with the result that no Federal costs can be directly attributed to the ICR. Examination of records to be maintained by the respondents will occur incidentally as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

Since the Agency burden is associated with the analysis of reported information, and reporting is only associated with the construction or reconstruction of facilities, and no such construction or reconstruction is anticipated in the next three years, no Agency burden is anticipated in this ICR.

6( d) Estimating the Respondent Universe and Total Burden and Costs The number of existing sources subject to 40 CFR Part 60 Subparts T, U, V, W, and X is 11. No new sources are anticipated. The total annual labor costs are $ 52,880. There are no annual capital and operating/ maintenance costs to the regulated entity. Details upon which this estimate is based appear in Table 1: Industry Burden.

6( e) Bottom Line Burden Hours And Cost Tables ( See Table 1, attached)

6( f) Reasons for Change in Burden There is no change in burden from the existing ICR.

6( g) Burden Statement Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to  9 comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, Office of Environmental Information ( OEI), U. S. Environmental Protection Agency, Mail code 2822, 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1061.08 and OMB control number 2060 0037 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Rules and Regulations]
[Pages 34520-34522]
[FR Doc No: 2020-12245]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0264]
RIN 1625-AA87

Security Zone; HMS MEDWAY, St. Johns River, Jacksonville, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving security
zone for navigable waters 500 yards around the HMS MEDWAY during the
vessel's transit from the St. Johns River Sea Buoy until BAE Systems
Shipyard, and while it remains docked at BAE Systems Shipyard, Mayport,
FL starting May 17, 2020. The security zone is needed to protect
personnel and government property from potential hazards associated
with waterborne security incidents and recreational marine traffic
while the vessel transits to their assigned berth space at BAE Systems
Shipyard, Mayport, FL and while docked at BAE Systems Shipyard. Entry
of vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Jacksonville.

DATES: This rule is effective without actual notice from June 5, 2020
until 4 p.m. on June 14, 2020. For purposes of enforcement, actual
notice will be used from 4 a.m. May 17, 2020 until June 5, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0264 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Emily Sysko, Sector Jacksonville, Waterways
Management, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. The Coast Guard
was notified of the vessel arrival on May 8, 2020. The Royal Navy
vessel and personnel will be entering the area and immediate action is
needed to respond to the potential security hazards associated with
their visit. It is impracticable to publish an NPRM because we must
establish this security zone by May 17, 2020.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential hazards associated with waterborne security
threats.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Jacksonville (COTP) has determined that
potential hazards associated with waterborne threats as a result of the
HMS MEDWAY entering the St. Johns River starting May 17, 2020, will be
a potential security concern for the Royal Navy vessel as it passes the
St. Johns River Sea Boy, while transits to their assigned berth at BAE
Systems Shipyard, and while docked at the BAE Systems Shipyard in
Mayport, FL. This rule is needed to protect personnel and government
officials from potential hazards associated with vessels coming within
500 yards of the HMS MEDWAY.

IV. Discussion of the Rule

    This rule establishes a temporary moving security zone from 4 a.m.
May 17, 2020 until June 14, 2020. The security zone will encompass
navigable waters within a 500 yard radius around the HMS MEDWAY as the
vessel transits the St. Johns River to BAE Systems Shipyard, MAYPORT,
FL and while docked at the BAE Systems Shipyard. The duration of the
zone is intended to protect personnel and government property during
the vessel's transit from the St. Johns River Sea Buoy to BAE Systems
Shipyard, and while docked at BAE Systems Shipyard, Mayport, FL. No
vessel or person will be permitted to enter the security zone without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the time and
duration the HMS MEDWAY's anticipated transit time in the St. Johns
River. Vessel traffic will be able to safely transit around this
security zone which would impact a small area of the St. Johns River
while the HMS MEDWAY transits the waterway and is docked at their
assigned berth at BAE Systems Shipyard, Mayport, FL. Moreover, the
Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone, and the rule would allow vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
security zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship

between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
We have analyzed this rule under that order and have determined that it
is consistent with the fundamental federalism principles and preemption
requirements described in Executive Order 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
security zone that will prohibit entry within navigable waters outlined
in the Discussion of the Rule above. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For insturctions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6
and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T07-0264 to read as follows:

Sec.  165.T07-0264  Security Zone; HMS MEDWAY, St. Johns River,
Jacksonville, FL.

    (a) Location. The following is a security zone: The security zone
will encompass navigable waters within a 500 yard radius around HMS
MEDWAY during the vessel's transit from the St. Johns River Entrance
Buoy to it's assigned berth at BAE Systems Shipyard, Mayport, FL, and
will remain around the vessel while docked at BAE Systems Shipyard.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and
Federal, State, and local officers designated by or assisting the
Captain of the Port Jacksonville (COTP) in the enforcement of the
security zone.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port
Jacksonville or a designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Jacksonville by telephone at<PHONE_NUMBER>, or a designated
representative via VHF-FM radio on channel 16, to request
authorization. If authorization is granted, all persons and vessels
receiving such authorization must comply with the instructions of the
COTP Jacksonville or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area
through Broadcast Notice to Mariners via VHF-FM channel 16 or by on-
scene designated representatives.
    (d) Enforcement period. This section will be enforced from 4 a.m.
May 17, 2020 until 4 p.m. on June 14, 2020.

    Dated: May 15, 2020.
M.R. Vlaun,
Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
[FR Doc. 2020-12245 Filed 6-4-20; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78356-78357]
[FR Doc No: 2013-30884]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0025; FRL-9904-60]

Notice of Receipt of Pesticide Products; Registration
Applications To Register New Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This
notice provides the public with an opportunity to comment on the
applications.

DATES: Comments must be received on or before January 27, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the EPA Registration Number or EPA File Symbol of
interest as shown in the body of this document, by one of the following
methods:
     Federal eRulemaking Portal: http://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.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), telephone number: (703)
305-7090, email address<EMAIL_ADDRESS>or Lois Rossi,
Registration Division (RD) (7505P), telephone number:<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>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).
     Pesticide manufacturing (NAICS code 32532).

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 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.

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), 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. For actions being evaluated under the
Agency's public participation process for registration actions, there
will be an additional opportunity for a 30-day public comment period on
the proposed decision. Please see the Agency's public participation Web
site for additional information on this process (http://www.epa.gov/pesticides/regulating/registration-public-involvement.html). EPA
received the following applications to register new uses for pesticide
products containing currently registered active ingredients:
    1. EPA Registration Numbers: 1021-1795 and 1021-2562. Docket ID
number: EPA-HQ-OPP-2013-0659. Applicant: McLauglin Gormley King
Company, 8810 Tenth Avenue North, Minneapolis, MN 55427. Active
ingredient: Prallethrin. Product type: Insecticide. Proposed uses:
Wide-area applications to control adult mosquitoes on, over, or near
agricultural lands. (RD)
    2. EPA Registration Numbers: 4787-55, 4787-61, 67760-75, and 67760-
120. Docket ID number: EPA-HQ-OPP-2013-0655. Applicant: Cheminova A/S,
c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-
2510. Active ingredient: Flutriafol. Product type: Fungicide. Proposed
uses: Cucurbit vegetables, fruiting vegetables, strawberries, tree
nuts, and wheat. (RD)
    3. EPA Registration Number: 7969-278. Docket ID number: EPA-HQ-OPP-
2013-0622. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528. Active ingredient: Saflufenacil.
Product type: Herbicide. Proposed uses: Postemergent applications to
wheat and barley for dessication/harvest aid treatments. (RD)
    4. EPA Registration Numbers: 7969-275, 7969-278, and 7969-297.
Docket ID Number: EPA-HQ-OPP-2013-0622. Applicant: BASF Corporation, 26
Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528.
Active ingredient: Saflufenacil. Product type: Herbicide. Proposed
uses: Grass forage, fodder and hay, including grass grown for seed
(Crop Group 17). (RD)
    5. EPA Registration Numbers: 7969-283 and 7969-284. Docket ID
number: EPA-HQ-OPP-2013-0255. Applicant: BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. Active
ingredient: Metrafenone. Product type: Fungicide. Proposed use:
Vegetable, fruiting, Group 8-10. (RD)
    6. EPA Registration Number: 84059-15. Docket ID Number: EPA-HQ-OPP-
2011-0568. Applicant: Marrone Bio Innovations, 2121 Second St., Suite
B-107, Davis, CA 95618. Active ingredient: Pseudomonas fluorescens
strain CL145A cells and spent fermentation media. Product type:
Molluscicide. Proposed uses: Application to listed water bodies and
sites for recreational and environmental rehabilitation. (BPPD)
    7. EPA Registration File Symbol: 88306-G. Docket ID Numbers: EPA-
HQ-OPP-2013-0277 and EPA-HQ-OPP-2013-0278. Applicant: Amy Plato
Roberts, Regulatory Consultant, Technology Sciences Group, Inc., 712
Fifth Street, Suite A, Davis, CA 95616, on behalf of Agri-Neo, Inc.,
3485 Ashby Saint-Laurent (Quebec), H4R 2K3, Canada. Active ingredient:
Tetraacetylethylenediamine (TAED) and its degradation product
diacetylethylenediamine (DAED) in and on all food commodities. Product
type: Biochemical pesticide and fungicide. Proposed uses: Granular
fungicide to control bacterial and fungal pathogens both on greenhouse
and field grown fruits and vegetables, row crops, seeds, and
ornamentals. (BPPD)

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: December 16, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-30884 Filed 12-24-13; 8:45 am]
BILLING CODE 6560-50-P