( 2) An emissions unit is physically incapable of operating at the post change emissions rate, if operations at the major stationary source could not supply material or accept material from the emissions unit due to inherent capacity constraints at the major stationary source, and there is no market from which or to which the major stationary source could purchase or sell the material, or if there is no other reasonable means of disposing of the material.

( 3) An emissions unit is economically incapable of operating at the post change Draft: Deliberative and Privileged; do not cite, quote, or distribute. March 14, 2006 73 emissions rate, if a market exists from which or to which the major stationary source could purchase or sell the material, or if there is a reasonable means of disposing of the material, but the cost of such a transaction is so unreasonable that it would preclude the major stationary source from engaging in the transaction.

* * * * *

( 51) Project means a physical change in, or change in the method of operation of, an existing major stationary source.

( i) Projects occurring at the same major stationary source that are dependent on each other to be economically or technically viable are considered a single project.

( ii) For purposes of determining whether a project results in a significant emissions increase under paragraph ( b)( 39) of this section, include the emissions increases from:

( a) Any new emissions unit;

( b) Any emissions unit that undergoes a physical change in or change in the method of operation; and ( c) Any emissions unit that does not undergo a physical change in or change in the method of operation at the major stationary source but whose emissions result from the physical change in or change in the method of operation.

( d) For purposes of paragraph ( b)( 51)( ii)( c) of this section, emissions of a specific pollutant at an emissions unit result from the project according to paragraph ( b)( 40)( ii)( e) of this section.

* * * * *

PART 52 [ AMENDED] Draft: Deliberative and Privileged; do not cite, quote, or distribute. March 14, 2006 74 4. The authority citation for part 52 continues to read as follows:

Authority: 42 U. S. C. 7401, et seq.

Subpart A [ Amended]

5. Section 52.21 is amended:

a. By revising paragraph ( a)( 2)( iv)( f);

b. By adding paragraph ( a)( 2)( iv)( g);

c. By adding paragraph ( b)( 41)( ii)( e); and d. By revising paragraph ( b)( 52).

The revisions and additions read as follows:

§ 52.21 Prevention of significant deterioration of air quality.

( a) * * *

( 2) * * *

( iv) * * *

( f) Hybrid test for projects that involve multiple types of emissions units. A significant emissions increase of a regulated NSR pollutant is projected to occur if the sum of the difference between the projected actual emissions and the baseline actual emissions for each emissions unit,

using the method specified in paragraphs ( a)( 2)( iv)( c) through ( d) of this section as applicable to each type of emissions unit, equals or exceeds the significant amount for that pollutant ( as defined in paragraph ( b)( 23) of this section). For example, if a project involves both an existing emissions unit and a new emissions unit, the projected increase is determined by summing the values determined using the method specified in paragraph ( a)( 2)( iv)( c) of this section for the existing unit and the method specified in paragraph ( a)( 2)( iv)( d) of this section for the new unit. Draft: Deliberative and Privileged; do not cite, quote, or distribute. March 14, 2006 75 ( g) Project netting. ( 1) Emissions decreases resulting from a project shall be calculated using the procedures contained in paragraphs ( a)( 2)( iv)( c), ( d), and ( f) of this section.

( 2) Decreases must be creditable according to all of the requirements of paragraph ( b)( 3)

of this section, or otherwise enforceable as a practical matter.

( 3) Emissions decreases cannot be used in both project netting and contemporaneous netting.

* * * * *

( b) * * *

( 41) * * *

( ii) * * *

( e) For purposes of paragraph ( b)( 41)( ii)( c) of this section, an emissions increase results from a project if, before the project, the emissions unit was legally, physically and/ or economically incapable of operating at the post change emissions rate.

( 1) An emissions unit is legally incapable of operating at the post change emissions rate,

if such emissions would violate a legally and practically enforceable term or condition of any previously issued air quality permit.

( 2) An emissions unit is physically incapable of operating at the post change emissions rate, if operations at the major stationary source could not supply material or accept material from the emissions unit due to inherent capacity constraints at the major stationary source, and there is no market from which or to which the major stationary source could purchase or sell the material, or if there is no other reasonable means of disposing of the material.

( 3) An emissions unit is economically incapable of operating at the post change Draft: Deliberative and Privileged; do not cite, quote, or distribute. March 14, 2006 76 emissions rate, if a market exists from which or to which the major stationary source could purchase or sell the material, or if there is a reasonable means of disposing of the material, but the cost of such a transaction is so unreasonable that it would preclude the major stationary source from engaging in the transaction.

* * * * *

( 52) Project means a physical change in, or change in the method of operation of, an existing major stationary source.

( i) Projects occurring at the same major stationary source that are dependent on each other to be economically or technically viable are considered a single project.

( ii) For purposes of determining whether a project results in a significant emissions increase under paragraph ( b)( 40) of this section, include the emissions increases from:

( a) Any new emissions unit;

( b) Any emissions unit that undergoes a physical change in or change in the method of operation; and ( c) Any emissions unit that does not undergo a physical change in or change in the method of operation at the major stationary source but whose emissions result from the physical change in or change in the method of operation.

( d) For purposes of paragraph ( b)( 52)( ii)( c) of this section, emissions of a specific pollutant at an emissions unit result from the project according to paragraph ( b)( 41)( ii)( e) of this section.

* * * * *


[Federal Register Volume 86, Number 62 (Friday, April 2, 2021)]
[Notices]
[Pages 17380-17381]
[FR Doc No: 2021-06808]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0144; FRL-10021-76]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Table 1 of Unit II, pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation
order follows a July 30, 2020 Federal Register Notice of Receipt of
Requests from the registrants listed in Table 2 of Unit II to
voluntarily cancel these product registrations. In the July 30, 2020
notice, EPA indicated that it would issue an order implementing the
cancellations, unless the Agency received substantive comments within
the 180-day comment period that would merit its further review of these
requests, or unless the registrants withdrew their requests. The Agency
received two anonymous public comments on the notice, but none merited
its further review of the requests. Further, the registrants did not
withdraw their requests. Accordingly, EPA hereby issues in this notice
a cancellation order granting the requested cancellations. Any
distribution, sale, or use of the products subject to this cancellation
order is permitted only in accordance with the terms of this order,
including any existing stocks provisions.

DATES: The cancellations are applicable April 2, 2021.

FOR FURTHER INFORMATION CONTACT: Christopher Green, Registration
Division (7502P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2020-0144, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This notice announces the cancellation, as requested by
registrants, of products registered under FIFRA section 3 (7 U.S.C.
136a). These registrations are listed in sequence by registration
number in Table 1 of this unit.

                                         Table 1--Product Cancellations
----------------------------------------------------------------------------------------------------------------
        Registration No.           Company No.             Product name                 Active ingredients
----------------------------------------------------------------------------------------------------------------
228-619........................             228  NuFarm Sethoxydim SPC Herbicide  Sethoxydim.
1258-1265......................            1258  Baquacil Ultra Swimming Pool     Poly(iminoimidocarbonyliminoim
                                                  Sanitizer & Fungicide.           idocarbonyliminohexamethylene
                                                                                ) hydrochloride.
62719-397......................           62719  Kerb 50-W......................  Propyzamide.
CA-960008......................           62719  Kerb 50W Herbicide in WSP......  Propyzamide.
FL-910007......................           62719  Kerb 50W Herbicide.............  Propyzamide.
ID-020020......................           62719  Kerb 50W Herbicide in WSP......  Propyzamide.
----------------------------------------------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed in Table 1 of this
unit.

               Table 2--Registrants of Cancelled Products
------------------------------------------------------------------------
           EPA company No.                  Company name and address
------------------------------------------------------------------------
228..................................  NuFarm Americas, Inc., 4020
                                        Aerial Center Pkwy., Ste. 101,
                                        Morrisville, NC 27560.
1258.................................  Arch Chemicals, Inc., 1200
                                        Bluegrass Lakes Parkway,
                                        Alpharetta, GA 30004.
62719................................  Dow Agrosciences, LLC, 9330
                                        Zionsville Rd., 308/2E,
                                        Indianapolis, IN 46268-1054.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    The Agency received two anonymous public comments on the notice.
For these reasons, the Agency does not believe that the comments
submitted during the comment period merit further review or a denial of
the requests for voluntary cancellation.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), EPA hereby
approves the requested cancellations of the registrations identified in
Table 1 of Unit II. Accordingly, the Agency hereby orders that the
product registrations identified in Table 1 of Unit II are canceled.
The applicable date of the cancellations that are the subject of this
notice is April 2, 2021. Any distribution, sale, or use of existing
stocks of the products identified in Table 1 of Unit II in a manner
inconsistent with any of the provisions for disposition of existing
stocks set forth in Unit VI will be a violation of FIFRA.

V. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a
registrant of a pesticide product may at any time request that any of
its pesticide registrations be canceled or amended to terminate one or
more uses. FIFRA further provides that, before acting on the request,
EPA must publish a notice of receipt of any such request in the Federal
Register. Thereafter, following the public comment period, the EPA
Administrator may approve such a request. The notice of receipt for
this action was published for comment in the Federal Register of July
30, 2020 (85 FR 45881) (FRL-10012-41). The comment period closed on
January 26, 2021.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the applicable date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows.
    The registrants may continue to sell and distribute existing stocks
of products listed in Table 1 of Unit II until April 4, 2022, which is
1 year after the publication of the Cancellation Order in the Federal
Register. Thereafter, the registrants are prohibited from selling or
distributing products listed in Table 1, except for export in
accordance with FIFRA section 17 (7 U.S.C. 136o), or proper disposal.
Persons other than the registrants may sell, distribute, or use
existing stocks of products listed in Table 1 of Unit II until existing
stocks are exhausted, provided that such sale, distribution, or use is
consistent with the terms of the previously approved labeling on, or
that accompanied, the canceled products.

    Authority: 7 U.S.C. 136 et seq.

    Dated: March 26, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2021-06808 Filed 4-1-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 5, 2009 (Volume 74, Number 191)]
[Rules and Regulations]
[Page 51082-51083]
[DOCID:fr05oc09-6]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2008-0020; Internal Agency Docket No. FEMA-8097]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed within this rule because of noncompliance with the
floodplain management requirements of the program. If the Federal
Emergency Management Agency (FEMA) receives documentation that the
community has adopted the required floodplain management measures prior
to the effective suspension date given in this rule, the suspension
will not occur and a notice of this will be provided by publication in
the Federal Register on a subsequent date.

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

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

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59. Accordingly, the communities will be
suspended on the effective date in the third column. As of that date,
flood insurance will no longer be available in the community. However,
some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of the communities will be published in the Federal
Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022,

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

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

0
Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

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

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

Sec.  64.6  [Amended]

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

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

Virginia:
    Farmville, Town of, Prince         510118  November 9, 1973,  Oct. 2, 2009..........  Oct. 2, 2009.
     Edward and Cumberland                      Emerg; September
     Counties.                                  1, 1978, Reg;
                                                October 2, 2009,
                                                Susp.
    Prince Edward County,              510239  April 11, 1974,    ......do*.............   do.
     Unincorporated Areas.                      Emerg; September
                                                1, 1978, Reg;
                                                October 2, 2009,
                                                Susp.
           Region IV

North Carolina:
    Brevard, City of,                  370231  January 17, 1974,  ......do..............   do.
     Transylvania County.                       Emerg; September
                                                29, 1978, Reg;
                                                October 2, 2009,
                                                Susp.
    Rosman, Town of,                   375358  December 30,       ......do..............   do.
     Transylvania County.                       1971, Emerg;
                                                June 2, 1972,
                                                Reg; October 2,
                                                2009, Susp.
    Transylvania County,               370230  January 21, 1974,  ......do..............   do.
     Unincorporated Areas.                      Emerg; January
                                                2, 1980, Reg;
                                                October 2, 2009,
                                                Susp.
            Region V

Wisconsin:
    Delavan, City of, Walworth         550463  October 18, 1974,  ......do..............   do.
     County.                                    Emerg; September
                                                1, 1983, Reg;
                                                October 2, 2009,
                                                Susp.
    East Troy, Village of,             550464  December 12,       ......do..............   do.
     Walworth County.                           1975, Emerg;
                                                December 1,
                                                1982, Reg;
                                                October 2, 2009,
                                                Susp.
    Fontana-on-Geneva Lake,            550592  NA, Emerg; March   ......do..............   do.
     Village of, Walworth                       23, 2006, Reg;
     County.                                    October 2, 2009,
                                                Susp.
    Mukwonago, Village of,             550485  February 18,       ......do..............   do.
     Walworth and Waukesha                      1975, Emerg;
     Counties.                                  July 5, 1982,
                                                Reg; October 2,
                                                2009, Susp.
Walworth County, Unincorporated        550462  June 10, 1975,     ......do..............   do.
 Areas.                                         Emerg; August
                                                15, 1983, Reg;
                                                October 2, 2009,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: September 22, 2009.
Edward L. Connor,
Acting Assistant Administrator, Mitigation Directorate, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. E9-23960 Filed 10-2-09; 8:45 am]

BILLING CODE 9110-12-P


Vince Helwig
 Michigan Department of Environmental Quality (DEQ)
Steve Lee Hensley
USA Rice Federation
Susana Hildebrand
Texas Council on Environmental Quality (CEQ)
Dan Johnson
WESTAR Council
Gary Jones
Printing Industries of America Graphic Arts Technical Foundation
Robert Kaufman
Koch Companies Public Sector, LLC
Lee Kindberg
Maersk Line
Jerry Kurtzweg
 USEPA
Tim Larson
Ross and Associates
Gay MacGregor
 USEPA
Mark MacLeod
Environmental Defense Fund
Keith Mason
 USEPA
Janet McCabe
 USEPA
Liz Naess
 USEPA
Don Neal
Calpine Corporation
Robert O'Keefe
The Health Effects Institute
John Paul
Regional Air Pollution Control Agency
Lorie Schmidt
 USEPA
Conrad Schneider
Clean Air Task Force
Julie Simpson
Nez Perce Tribe
Chris Stoneman
 USEPA
Eric Svenson
PSEG Services Corporation
Elineth Torres
 USEPA
Gene Trisko
International Brotherhood of Electrical Workers (IBEW)
Mary Turner
Waste Management
Philip Wakelyn
Texas Cotton Ginners' Association
John Walke
Natural Resources Defense Council
Jason Walker
Northwestern Band of Shoshone Nation
Matthew Watkins
National Association of Home Builders
Chet Wayland
 USEPA
Lewis Weinstock
 USEPA
Joy Wiecks
Fond du Lac Reservation


[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83409-83410]
[FR Doc No: 2023-26246]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0671]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by May 27, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-E-0671 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; AZSTARYS.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The

Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Azstarys
(serdexmethylphenidate and dexmethylphenidate), which is indicated for
the treatment of attention deficit hyperactivity disorder in patients 6
years of age and older. Subsequent to this approval, the USPTO received
a patent term restoration application for Azstarys (U.S. Patent No.
9,079,928) from KemPharm, Inc., and the USPTO requested FDA's
assistance in determining the patent's eligibility for patent term
restoration. In a letter dated September 28, 2022, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of Azstarys 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
Azstarys is 1,676 days. Of this time, 1,244 days occurred during the
testing phase of the regulatory review period, while 432 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 6, 2016. The applicant claims September 19, 2016, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was October
6, 2016, 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 of the FD&C Act: March 2,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Azstarys (NDA 212994) was initially submitted on
March 2, 2020.
    3. The date the application was approved or the effective date of
approval for a drug product recommended for control under section
201(j) of the Controlled Substances Act: May 7, 2021. FDA has verified
the applicant's claim that NDA 212994 was approved on March 2, 2021;
however, the Drug Enforcement Agency issued an interim final rule
controlling the product under section 201(j) of the Controlled
Substances Act on May 7, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 948 days of patent term extension.

III. Petitions

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

    Dated: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26246 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P


Memorandum To: Docket From: EPA, Clean Air Markets Division Subject: References for the NOx and SO2 Control Design and Performance Levels Used in the Proposed IAQR Date: January 28, 2004 The purpose of this memo is to record references to the technical publications that support the design and performance levels for the NOx and SO2 control technologies used in the proposed IAQR. These design and performance levels are described in the IAQR Section " Performance and Applicability of Pollution Control Technologies for EGUs." A considerable amount of published technical literature is available in the industry that supports these design and performance levels. References to some of this literature are provided below:

1. Electric Power Annual 2000, Volume II, Table 27, DOE/ EIA 0348( 00) 12, November 2002 2. J. Smolenski, et. al., " Tampa Electric Company Phase II FGD System Big Bend Station Units 1& 2, Advanced Design   Low Cost," The MEGA Symposium, Atlanta, GA, August 1999 3. C. Wedig, et. al., " Petersburg Units 1 and 2 Flue Gas Desulfurization System Process Design and Operation Experience," The MEGA Symposium, Washington, DC, August 1997 4. R. Richard, et. al., " A Performance Review of Unit 4 FGD System at Cinergy's Gibson Station," The MEGA Symposium, Washington, DC, August 1997 5. J. Klingspor, et. al., " LS 2 Two Years of Operating Experience," The MEGA Symposium, Washington, DC, August 1997 6. K. Frizzell, et. al., " Results of High Velocity Single Absorber Operation at OMU's Elmer Smith Station," The MEGA Symposium, Washington, DC, August 1997 7. Controlling SO2 Emissions: A Review of Technologies, EPA 600/ R 00 093, October 2000 8. R. McIlvaine, et. al., " SCR Operating Experience of German Power Plant Owner As Applied to Challenging, U. S., High Sulfur Service, The MEGA Symposium, Washington, D. C., May 2003 9. " SCR Keynote Address," McIlvaine Company's Website, www. mcilvainecompany. com 10. C. Erickson, et. al., " Coal Fired SCR Operating Experience With High Removal Efficiency and Low NOx Firing System," The MEGA Symposium, Washington, D. C., May 2003 11. A. Favale, et. al., " Critical Design Issues for Selective Catalytic Reduction for AES Cayuga, LLC," Power Gen International Conference, Las Vegas, NV, December 2001 12. Public Service of New Hampshire Factsheet, www. psnh. com 13. Nischt, et. al., " Update of Selective Catalytic Reduction Retrofit on a 675 MW Boiler at AES Somerset," ASME International Joint Power Generation Conference, July 2000 14. Cochran, et. al., " Design and Initial Startup Results from the New Madrid SCR Retrofit Project," ICAC Forum 2000, March 2000 15. AECI News Release, " Coal Keeps Costs Low, Environmental Quality High," www. aeci. org 16. R. Glaser, et. al., " The SCR Retrofit at the Montour Steam Electric Station," The MEGA Symposium, Chicago, IL, August 2001


[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90895-90896]
[FR Doc No: 2016-30095]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79523; File No. SR-BatsBZX-2016-84)

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
21.5 of Bats BZX Exchange, Inc. To Extend Through June 30, 2017, the
Penny Pilot Program in Options Classes in Certain Issues

December 9, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 30, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated this proposal as a ``non-controversial''
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
Rule 19b-4(f)(6)(iii) thereunder,\4\ which renders it effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to extend through June 30, 2017, the
Penny Pilot Program (``Penny Pilot'') in options classes in certain
issues (``Pilot Program'') previously approved by the Commission.\5\
The text of the proposed rule change is available at the Exchange's Web
site at www.batstrading.com, at the principal office of the Exchange,
and at the Commission's Public Reference Room.
---------------------------------------------------------------------------

    \5\ The rules of BZX Options, including rules applicable to BZX
Options' participation in the Penny Pilot, were approved on January
26, 2010. See Securities Exchange Act Release No. 61419 (January 26,
2010), 75 FR 5157 (February 1, 2010) (SR-BATS-2009-031). BZX Options
commenced operations on February 26, 2010. The Penny Pilot was most
recently extended for BZX Options through December 31, 2016. See
Securities Exchange Act Release No. 78032 (June 10, 2016), 81 FR
39307 (June 16, 2016) (SR-BatsBZX-2016-23).
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to extend the Penny Pilot, which was
previously approved by the Commission, through June 30, 2017, and to
provide revised dates for adding replacement issues to the Pilot
Program. The Exchange proposes that any Pilot Program issues that have
been delisted may be replaced on the second trading day following
January 1, 2017. The replacement issues will be selected based on
trading activity for the most recent six month period excluding the
month immediately preceding the replacement (i.e., beginning June 1,
2016, and ending November 30, 2016).
    The Exchange represents that the Exchange has the necessary system
capacity to continue to support operation of the Penny Pilot. The
Exchange believes the benefits to public customers and other market
participants who will be able to express their true prices to buy and
sell options have been demonstrated to outweigh the increase in quote
traffic.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\6\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act \7\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system. The Exchange believes that the Pilot
Program promotes just and equitable principles of trade by enabling
public customers and other market participants to express their true
prices to buy and sell options. Accordingly, the Exchange believes that
the proposal is consistent with the Act because it will allow the
Exchange to extend the Pilot Program prior to its expiration on
December 31, 2016. The Exchange notes that this proposal does not
propose any new policies or provisions that are unique or unproven, but
instead relates to the continuation of an existing program that
operates on a pilot basis.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. In this regard, the Exchange
notes that the rule change is being proposed in order to continue the
Pilot Program, which is a

competitive response to analogous programs offered by other options
exchanges. The Exchange believes this proposed rule change is necessary
to permit fair competition among the options exchanges.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (A)
Significantly affect the protection of investors or the public
interest; (B) impose any significant burden on competition; and (C) by
its terms, become operative for 30 days from the date on which it was
filed or such shorter time as the Commission may designate it has
become effective pursuant to Section 19(b)(3)(A) of the Act \8\ and
paragraph (f)(6) of Rule 19b-4 thereunder,\9\ the Exchange has
designated this rule filing as non-controversial. The Exchange has
given the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal is
consistent with the Act. 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_ADDRESS>Please include
File No. SR-BatsBZX-2016-84 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 No. SR-BatsBZX-2016-84. 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 Web site (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 Web site 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 such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BatsBZX-2016-84 and should be
submitted on or before January 5, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-30095 Filed 12-14-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Proposed Rules]
[Pages 3740-3742]
[FR Doc No: 2019-02215]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0126; FRL-9989-32-Region 5]

Air Plan Approval; Indiana; Proposed Approval of a Revision to
the Sulfur Dioxide State Implementation Plan for United States Steel-
Gary Works

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a March 6, 2018 request by the Indiana Department of
Environmental Management (IDEM) to revise its State Implementation Plan
(SIP) for the United States Steel-Gary Works (US Steel-Gary Works). The
proposed SIP revision pertains to the removal of all sulfur dioxide
(SO2) emission limitations for the facility's coke plant,
which permanently ceased operation on March 30, 2015, and other
administrative changes. The SIP revision provides for an overall
reduction in SO2 emissions at the facility.

DATES: Comments must be received on or before March 15, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2018-0126 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment.

The written comment is considered the official comment and should
include discussion of all points you wish to make. EPA will generally
not consider comments or comment contents located outside of the
primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the ``For Further Information Contact'' section. For the
full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Emily Crispell, Environmental
Scientist, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. Background
II. Summary of Changes to Existing Rule
III. Summary of 110(l) Analysis
IV. What action is EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Background

    US Steel-Gary Works is an integrated steel mill located in Gary,
Indiana. On March 30, 2015, the facility permanently ceased the
operation of its entire coke plant. The coke plant consisted of the
coal handling facilities, coke oven batteries, coke byproducts recovery
plant, coke oven desulfurization facility, and #2 coke plant boiler
house.
    IDEM amended 326 Indiana Administrative Code (326 IAC) 7-4.1-20 to
remove SO2 emission limitations applicable to the coke
plant. IDEM held a public hearing on October 11, 2017 and received one
question regarding whether US Steel-Gary Works would be required to
reapply for permits if they chose to reopen the coke plant facility.
IDEM confirmed that US Steel-Gary Works would have to reapply for
permits if they chose to reopen the coke plant.
    IDEM adopted the revised rule on October 11, 2017, which became
effective on February 21, 2018.

II. Summary of Changes to Existing Rule

    The existing rule 326 IAC 7-4.1-20 contained the SO2
emission limitations for various emission units at US Steel-Gary Works,
depending on the operation status of the coke oven gas desulfurization
unit. The sole purpose of the coke oven gas desulfurization unit was to
control coke oven gas emissions from the coke plant. IDEM revised 326
IAC 7-4.1-20 to remove all SO2 sources and emission limits
associated with the coke plant. IDEM renumbered and retained the
remainder of the rule which contains SO2 emission
limitations for other operating units at the facility such as the
turboblower boiler house units, number 4 boiler house units, blast
furnace stove stacks, 84-inch hot strip mill units, number 3 sinter
plant windbox gas cleaning systems, and baghouses.

III. Summary of 110(l) Analysis

    According to Clean Air Act (CAA) Section 110(l), EPA cannot approve
a revision of a SIP if the revision would interfere with any applicable
requirement concerning attainment of the National Ambient Air Quality
Standards and Reasonable Further Progress (as defined in Section 171 of
the CAA). Indiana's submission is consistent with CAA Section 110(l)
because the changes to the facility will result in a decrease in
SO2 emissions in excess of 3792.2 tons per year.

IV. What action is EPA taking?

    EPA is proposing to approve IDEM's March 6, 2018 submittal as a
revision to its existing SIP for US Steel-Gary Works. EPA is requesting
comments on the proposed approval.

V. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference revisions to Indiana rule 326 IAC 7-4.1-20 U.S. Steel-Gary
Works Sulfur Dioxide Emission Limitations, effective on February 21,
2018. EPA has made, and will continue to make, these documents
generally available through www.regulations.gov and at the EPA Region 5
Office (please contact the person identified in the ``For Further
Information Contact'' section of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides.

    Dated: December 21, 2018.
James O. Payne
Acting Regional Administrator, Region 5.
[FR Doc. 2019-02215 Filed 2-12-19; 8:45 am]
BILLING CODE 6560-50-P


Atrazine Human Health Re-Evaluation

Conference Call with Technical Registrants

October 7, 2009

10:30 – 11:00 a.m. EDT

Call Requested By: EPA Office of Pesticide Programs

Participants:

Office of Pesticide Programs, EPA – Robert McNally, Steven Bradbury,
Peter Caulkins, Catherine Eiden, and Carol Stangel

Atrazine Technical Registrants –

SYNGENTA

Dan Campbell

1-336-632-7627

[Also on the call: Janis McFarland]

AGAN CHEM MFG, LTD

MAKHTESHIM-AGAN OF NORTH AMERICA INC

Jennifer Yentel,<PHONE_NUMBER>

Ephi Gur,<PHONE_NUMBER>,   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

DREXEL CHEMICAL COMPANY

Luz G. Chan

(901) 774-4370

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

OXON ITALIA S.P.A.

SIPCAM AGRO USA, INC

Joseph W. Burley

(770) 594-6356

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Meeting Summary:

EPA discussed with the atrazine technical registrants the Agency’s
announcement that it is launching a comprehensive new evaluation of the
pesticide atrazine based on transparency and sound science, including
independent scientific peer review by the FIFRA Scientific Advisory
Panel (SAP).  The evaluation will help determine whether a change in
EPA’s regulatory position on atrazine is appropriate.  At the end of
this process, the Agency will decide whether to revise its current
atrazine risk assessment and whether new restrictions are necessary to
better protect public health.

EPA explained that the Agency will engage the SAP to reevaluate the
human health effects of atrazine over the coming year, including an
informational presentation in November 2009 and three meetings with the
Panel in February, April and September 2010.  The SAP meetings will be
open to the public.  At the conclusion of this evaluation of
atrazine’s human health effects, EPA will ask the SAP to review
atrazine’s potential effects on amphibians and aquatic ecosystems.

In addition to conducting this science evaluation, EPA will be exploring
better ways to inform the public more quickly about results of atrazine
drinking water monitoring.  Also, EPA briefly discussed some potential
changes to the 2003 Memorandum of Agreement that would address some
concerns raised in recent media reports.

Specifically, concern has been expressed about single day spikes of
atrazine in drinking water that could present a potential health
concern.  A one-day level of concern (LOC) of 298 ppb was established in
the 2003 risk assessment.  (Currently, the highest one-day level of
atrazine in drinking water that EPA is aware of is 89 ppb).  EPA would
like to modify the Atrazine Memorandum of Agreement (MOA) to include the
following:

1) exceedance of the 298 ppb one-day level of concern in raw or finished
drinking would result in prohibition of atrazine use in the watershed
associated with the drinking water system.

2) in a subset of Community Water Systems (CWS) in the current
monitoring program, during a period of high atrazine use, pilot daily
monitoring over a finite period -- maybe a month -- to see if higher
spikes are occurring that the current monitoring is missing.  These data
might be useful for SAP consideration regarding the monitoring
frequency.

Concern also has been expressed about drinking water monitoring data
being available to local communities in a timely fashion.  EPA would
like to discuss ways to provide these data to interested parties more
quickly.

Concern has been expressed about whether EPA's performance standard for
drinking water is sufficiently protective, since EPA is regulating on an
intermediate-term exposure effect.  The Atrazine MOA currently states
that atrazine use is prohibited in the watershed associated with a CWS
when 2 exceedances of 37.5 ppb as a 90 day rolling average in raw
drinking water have occurred in that CWS.  Rather than prohibiting
atrazine use in the watershed after 2 exceedances in a 5 year period,
EPA would like to modify this provision to prohibit atrazine use in the
watershed after one exceedance in a 5 year period.  (There has not been
any exceedance of 37.5 ppb as a 90 day rolling average since the
monitoring program was established in 2003).

EPA will schedule follow-up meetings with the technical registrants in
the near future to continue this discussion of potential changes to the
MOA.

Meeting Summary Prepared by:  Robert McNally

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