[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Page 38803]
[FR Doc No: 2012-16056]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9695-7]

Request for Nominations to the Great Lakes Advisory Board (GLAB)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for nominations to the Great Lakes Advisory Board
(GLAB).

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is seeking
nominations from a diverse range of qualified candidates to be
considered for appointment as members of its Great Lakes Advisory Board
(GLAB). The GLAB will provide advice and recommendations to the EPA
Administrator, in her capacity as Chair of the Great Lakes Interagency
Task Force, on matters pertaining to Great Lakes restoration and
protection. Vacancies are expected to be filled by September 2012.
Sources in addition to this Federal Register Notice may be used in the
solicitation of nominees.

DATES: Nominations must be postmarked by July 30, 2012.

ADDRESSES: Submit nominations electronically with the subject line
``GLAB Nomination 2012'' to<EMAIL_ADDRESS>You may also submit
nominations by mail to: Rita Cestaric, Designated Federal Officer, US
Environmental Protection Agency, Great Lakes National Program Office,
77 W. Jackson Boulevard, Chicago, Illinois 60604.

FOR FURTHER INFORMATION CONTACT: Rita Cestaric, Designated Federal
Officer, US Environmental Protection Agency, 77 W. Jackson, Chicago, IL
60604; email address<EMAIL_ADDRESS>telephone number: (312)
886-6815.

SUPPLEMENTARY INFORMATION: On May 31, 2012, EPA published in the
Federal Register a notice of intent to establish the GLAB under the
authority of the Federal Advisory Committee Act (FACA), Public Law 92-
463. The GLAB will provide advice and recommendations to the EPA
Administrator, in her capacity as Chair of the Great Lakes Interagency
Task Force, on matters pertaining to Great Lakes restoration and
protection. The GLAB will conduct business in accordance with FACA and
related regulations.
    The GLAB will be composed of approximately 15 members appointed by
the EPA Administrator. In selecting members, EPA will consider
candidates representing or serving as liaison to a broad range of
interests across the Great Lakes, that may include, but are not limited
to, environmental groups, business, agricultural groups, youth groups,
foundations, environmental justice groups, academia and state, local
and tribal governments. Members will be appointed for two year terms
and are eligible for reappointment.
    The GLAB will meet approximately two times a year. Additionally,
members may be asked to participate in teleconference meetings. The
average workload for members will be approximately 4 to 6 hours per
month. We are unable to provide honoraria or compensation for service
on the GLAB. However, you may receive travel and per diem allowances
where appropriate and according to applicable federal travel
regulations.
    Nominations: The EPA welcomes and values diversity. In an effort to
obtain nominations of diverse candidates, the agency encourages
nominations of women and men of all racial and ethnic groups. All
nominations will be fully considered, but applicants need to be aware
of the specific representation sought as outlined in the SUPPLEMENTARY
INFORMATION section above.
    Other criteria used to evaluate nominees will include:
     The background and experiences that would help members
contribute to the diversity of perspectives on the GLAB (e.g.,
economic, social, cultural, educational background, professional
affiliations and other considerations);
     Demonstrated experience with Great Lakes issues;
     Leadership experience in Great Lakes organizations,
businesses and workgroups;
     Excellent interpersonal and consensus-building skills;
     Ability to volunteer time to attend approximately two in-
person meetings a year, participate in teleconference meetings, attend
listening sessions with senior-level federal officials, develop policy
recommendations and prepare reports and letters of advice; and
     Willingness to commit time to the committee and
demonstrated ability to work constructively and effectively on
committees.
    How to Submit Nominations: Any interested person or organization
may nominate qualified persons to be considered for appointment to the
GLAB. Individuals may self-nominate. Nominations can be submitted in
electronic format (preferred) or in hard copy format (see ADDRESSES
section above). To be considered, nominations should include:
     Current contact information for the nominee, including the
nominee's name, organization (and position within that organization),
current business address, email address and daytime phone number;
     Brief statement describing the nominee's interest in
serving on the GLAB;
     Resume and a short biography (no more than two paragraphs)
describing the professional and educational qualifications of the
nominee, including a list of relevant activities and any current or
previous service on advisory committees; and
     Letter(s) of recommendation from a third party supporting
the nomination. Letter(s) should describe how the nominee's experience
and knowledge will bring value to the work of the GLAB.

    To help the Agency in evaluating the effectiveness of its outreach
efforts, please tell us how you learned of this opportunity.

    Dated: June 21, 2012.
Susan Hedman,
Great Lakes National Program Manager.
[FR Doc. 2012-16056 Filed 6-28-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 26, 2009 (Volume 74, Number 57)]
[Notices]
[Page 13275-13276]
[DOCID:fr26mr09-118]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 6c-7, SEC File No. 270-269, OMB Control No. 3235-0276.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 6c-7 (17 CFR 270.6c-7) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) (``1940 Act'') provides exemption from
certain provisions of Sections 22(e) and 27 of the 1940 Act for
registered separate accounts offering variable annuity

contracts to certain employees of Texas institutions of higher
education participating in the Texas Optional Retirement Program. There
are approximately 100 registrants governed by Rule 6c-7. The burden of
compliance with Rule 6c-7, in connection with the registrants obtaining
from a purchaser, prior to or at the time of purchase, a signed
document acknowledging the restrictions on redeemability imposed by
Texas law, is estimated to be approximately 3 minutes of professional
time per response for each of approximately 3000 purchasers annually
(at an estimated $63 per hour),\1\ for a total annual burden of 150
hours (at a total annual cost of $9,450).
---------------------------------------------------------------------------

    \1\ $63/hour figure for a Compliance Clerk is from SIFMA's
Office Salaries in the Securities Industry 2008, modified by
Commission staff to account for an 1800-hour work-year and
multiplied by 2.93 to account for bonuses, firm size, employee
benefits and overhead.
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules or forms. The Commission does not include in the
estimate of average burden hours the time preparing registration
statements and sales literature disclosure regarding the restrictions
on redeemability imposed by Texas law. The estimate of burden hours for
completing the relevant registration statements are reported on the
separate PRA submissions for those statements. (See the separate PRA
submissions for Form N-3 (17 CFR 274.11b) and Form N-4 (17 CFR
274.11c).)
    The Commission requests written comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (b) the accuracy of the
agency's estimate of the burden of the collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, VA 22312; or send an e-mail to: PRA_
<EMAIL_ADDRESS>
    Dated: March 20, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-6723 Filed 3-25-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: March 9, 2009 (Volume 74, Number 44)]
[Proposed Rules]
[Page 9974-9975]
[DOCID:fr09mr09-16]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0115; Airspace Docket No. 09-AGL-3]

Proposed Amendment of Class E Airspace; Mount Sterling, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Mount
Sterling, IL. Additional controlled airspace is necessary to
accommodate new Standard Instrument Approach Procedures (SIAPs) at
Mount Sterling Municipal Airport, Mount Sterling, IL. The FAA is taking
this action to enhance the safety and management of Instrument Flight
Rules (IFR) aircraft operations at Mount Sterling Municipal Airport.

DATES: 0901 UTC. Comments must be received on or before April 23, 2009.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2009-0115/Airspace Docket No. 09-
AGL-3, at the beginning of your comments. You may also submit comments
on the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through

Friday, except Federal holidays. The Docket Office (telephone 1-800-
647-5527), is on the ground floor of the building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone: (817)
321-7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2009-0115/
Airspace Docket No. 09-AGL-3.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration (FAA),
Office of Air Traffic Airspace Management, ATA-400, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Communications must identify both docket numbers for this notice.
Persons interested in being placed on a mailing list for future NPRMs
should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by adding additional Class E airspace for SIAPs
operations at Mount Sterling Municipal Airport, Mount Sterling, IL. The
area would be depicted on appropriate aeronautical charts.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9S, dated October 3, 2008, and effective October 31, 2008, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 describes the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it would add
additional controlled airspace at Mount Sterling Municipal Airport,
Mount Sterling, IL.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS;
AIRWAYS; ROUTES; AND REPORTING POINTS

    1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, dated October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700 feet
or more above the surface of the earth.
* * * * *

AGL IL E5 Mount Sterling, IL [Amended]

Mount Sterling Municipal Airport, IL
    (Lat. 39[deg]59'07'' N., long. 90[deg]48'15'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Mount Sterling Municipal Airport.
* * * * *

    Issued in Fort Worth, TX, on February 23, 2009.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
 [FR Doc. E9-4937 Filed 3-9-09; 8:45 am]

BILLING CODE 4901-13-P


[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Rules and Regulations]
[Pages 11957-11959]
[FR Doc No: 2022-04071]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2020-0504; FRL-9202-02-R5]

Air Plan Approval; Wisconsin; Permit Streamlining Updates

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing an
approval of revisions to the Wisconsin State Implementation Plan (SIP).
These changes include defining and removing terms, creating a more
streamlined process for permit applications and reports submitted
electronically, and clarifying rules to create a more efficient permit
issuance process. Approving this revision also makes Wisconsin rules
consistent with Federal rules.

DATES: This final rule is effective on April 4, 2022.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2020-0504. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays and facility
closures due to COVID-19. We recommend that you telephone Susan Kraj,
Environmental Engineer, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Susan Kraj, Environmental Engineer,
Air Permits Section, Air Programs Branch (AR18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background

    This final rule addresses the April 6, 2021, SIP revisions
submitted by the Wisconsin Department of Natural Resources (WDNR). This
submittal includes revisions to the definitions in Chapter NR 400, to
the minor construction permit program in Chapter NR 406, and to the
operating permit program in Chapter NR 407. Specifically, Wisconsin is
requesting to repeal NR 406.03(1e)(a), (b), and (j), NR 406.04(1f)(c)
and (Note), NR 407.02(6)(a)3.(Note), NR 407.11(1)(e) and (3)(c), and NR
407.12(1)(b)(Note) and (e); and to amend and create NR 400.02(130),
(136m), (136r), and (162), NR 406.02(6), NR 406.03(1e), (1m), and
(2)(b), NR 406.04(1)(a)4m., (bm), (i), (m), (zg), (1f), (1k), (1q),
(2)(h), (4)(a), (b), (e)3., (h), (j), and (7), NR 406.17(3)(d), NR
407.03(1)(intro.), (a), (bm), (1m), (2)(ba), (f) and (g), NR 407.05(2)
and (6), NR 407.105(3)(b), and NR 407.15(5).
    On December 6, 2021, EPA published a notice of proposed rulemaking
(NPRM) proposing approval of Wisconsin's April 6, 2021, submittal (86
FR 68954). The specific details of these SIP revisions and the
rationale for EPA's proposed approval are discussed in the NPRM and
will not be restated here. The NPRM provided a 30-day public comment
period which ended on January 5, 2022.
    No comments were received on the proposed rule during the public
comment process.

II. What action is EPA taking?

    For the reasons set forth in the proposed rulemaking, EPA is
approving the requested revisions to Wisconsin's SIP as submitted on
April 6, 2021. These revisions were included in the certified Board
Order AM-24-12b and published in the Wisconsin Administrative Register
#777 on September 28, 2020.

III. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Wisconsin
Regulations described in the amendments to 40 CFR part 52 set forth
below. 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).
    Also in this document, as described in the proposed amendments to
40 CFR

part 52 set forth below, EPA is proposing to remove provisions of the
EPA-Approved Wisconsin Regulations from the Wisconsin SIP, which is
incorporated by reference in accordance with the requirements of 1 CFR
part 51.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act (Act), the Administrator is required to
approve a SIP submission that complies with the provisions of the Act
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 Act. 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);
     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 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).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Act, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 2, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: February 22, 2022.
Debra Shore,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

0
2. Section 52.2570 is amended by:
0
a. Revising paragraphs (c)(76)(i)(A) and adding (c)(76)(i)(B);
0
b. Revising (c)(120)(i)(B); and
0
c. Adding paragraph (c)(145).
    The additions and revisions read as follows:

Sec.  52.2570  Identification of plan.

* * * * *
    (c) * * *
    (76) * * *
    (i) * * *
    (A) NR 407--Wisconsin Administrative Code, Operating Permits,
Effective date January 1, 1994. Sections NR 407.11(3)(c) and NR
407.12(1)(b)(Note) were rescinded in 2020 and are removed without
replacement; see paragraph (c)(145) of this section.
    (B) [Reserved].
* * * * *
    (120) * * *
    (i) * * *
    (B) NR 406.04 Direct sources exempt from construction permit
requirements. NR 406.04(1f) and NR 406.04(1k), as published in the
Wisconsin Administrative Register, June 30, 2007, No. 618, effective
July 1, 2007. Sections NR 406.04(1f)(c) and (Note) were rescinded in
2020 and are removed without replacement; see paragraph (c)(145) of
this section.
* * * * *
    (145) On April 6, 2021, WDNR submitted a request to revise portions
of its Air Pollution Control Definitions, Minor Construction Permit
Program, and Operating Permit Program. The changes include defining and
removing terms, creating a more streamlined process for permit
applications and reports submitted electronically, and clarifying rules
to create a more efficient permit issuance process. WDNR submitted
revisions to its rules NR 400, NR 406 and NR 407 of the Wisconsin
Administrative Code.
    (i) Incorporation by reference. (A) Wisconsin Administrative Code,
NR 400 Air Pollution Control Definitions. NR 400.02(130); NR
400.02(136m), (136r), (162), as published in the Wisconsin Register,
September 2020, No. 777, effective October 1, 2020.
    (B) Wisconsin Administrative Code, NR 406 Construction Permits. NR
406.02(6); NR 406.03(1e), (1m), and (2)(b); NR 406.04(1)(a)4m., (bm),
(i), (m)), (zg), (1f), (1k), (1q), (2)(h), (4)(a), (b), (e), (h), (j),
and (7); NR 406.17(3)(d), as published in the Wisconsin Register,
September 2020, No. 777, effective October 1, 2020.
    (C) Wisconsin Administrative Code, NR 407 Operation Permits. NR
407.03(1)(intro.), (a), (bm), (1m), (2)(ba), (f) and (g); NR 407.05(2)
and (6); NR 407.105(3)(b); and NR 407.15(5), as published in the
Wisconsin Register,

September 2020, No. 777, effective October 1, 2020.
    (ii) [Reserved].

[FR Doc. 2022-04071 Filed 3-2-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56244-56245]
[FR Doc No: 2017-25676]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-0533 and FDA-2016-E-0534]

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

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 RAPIVAB and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications 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 Nos.
FDA-2016-E-0533 and FDA-2016-E-0534 for ''Determination of Regulatory
Review Period for Purposes of Patent Extension; RAPIVAB.'' 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 RAPIVAB
(peramivir). RAPIVAB is indicated for the treatment of acute
uncomplicated influenza in patients 18 years and older who have been
symptomatic for no more than two days. Subsequent to this approval, the
USPTO received patent term restoration applications for RAPIVAB (U.S.
Patent Nos. 6,503,745 and 6,562,861) from BioCryst Pharmaceuticals,
Inc., and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
April 29, 2016, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of RAPIVAB
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
RAPIVAB is 3,287 days. Of this time, 2,925 days occurred during the
testing phase of the regulatory review period, while 362 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: December 21, 2005. FDA has verified the BioCryst
Pharmaceuticals, Inc. claims that December 21, 2005, is the date the
investigational new drug application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
23, 2013. FDA has verified the applicant's claims that the new drug
application (NDA) for RAPIVAB (NDA 206426) was initially submitted on
December 23, 2013.
    3. The date the application was approved: December 19, 2014. FDA
has verified the applicant's claim that NDA 206426 was approved on
December 19, 2014.
    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 applications for patent extension,
this applicant seeks 1,824 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 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25676 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 55039-55041]
[FR Doc No: 2021-21625]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93195; File No. SR-OCC-2021-009]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Revise the Options Clearing Corporation's Schedule of Fees

September 29, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'' or ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on September 28, 2021, The Options Clearing
Corporation (``OCC'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared primarily by
OCC. OCC filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) \3\ of the Act and Rule 19b-4(f)(2) \4\ thereunder so
that the proposal was 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)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change by OCC would revise OCC's schedule of fees
to implement a fee holiday for the period beginning November 1, 2021,
and ending December 31, 2021. OCC's schedule of fees is included as
Exhibit 5 to File No. SR-OCC-2021-009. Material proposed to be added to
OCC's schedule of fees as currently in effect is underlined and
material proposed to be deleted is marked in strikethrough text. All
capitalized terms not defined herein have the same meaning as set forth
in the OCC By-Laws and Rules.\5\
---------------------------------------------------------------------------

    \5\ OCC's By-Laws and Rules can be found on OCC's public
website: https://www.theocc.com/Company-Information/Documents-and-Archives/By-Laws-and-Rules.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, OCC 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. OCC has
prepared summaries, set forth in sections (A), (B), and (C) below, of
the most significant aspects of these statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(1) Purpose
    The purpose of this proposed rule change is to revise OCC's
schedule of fees to implement a fee holiday for the period beginning
November 1, 2021, and ending December 31, 2021. OCC's Capital
Management Policy (``Policy'') provides that OCC reviews its fee
schedule on a periodic basis in consideration of factors including, but
not limited to, projected operating expenses, projected volumes,
anticipated cash flows, and capital needs.\6\ Provided that OCC's
shareholders' equity (``Equity''), less the minimum persistent amount
of capital that OCC maintains exclusively to address losses or
liquidity shortfalls arising from member defaults (the ``Minimum
Corporate Contribution''),\7\ exceeds 110% of the Target Capital
Requirement \8\ (``Early Warning'') \9\ plus any amount approved for
capital expenditures, OCC's Board, or a Committee the Board has
delegated, may use tools as it considers appropriate to lower costs for
Clearing Members. Such tools for reducing the cost of clearing include
lowering fees, declaring a fee holiday, or issuing refunds.\10\
---------------------------------------------------------------------------

    \6\ See Exchange Act Release No. 88029 (Jan. 24, 2020), 85 FR
5500, 5502 (Jan. 30, 2020) (File No. SR-OCC-2019-007) (``Order
Approving Policy''); Exchange Act Release No. 87257 (Oct. 8, 2019),
84 FR 55194, 55196 (Oct. 15, 2019) (File No. SR-OCC-2019-805)
(``Notice of No-Objection to Policy'').
    \7\ See Exchange Act Release No. 92038 (May 27, 2021), 86 FR
29861 (Jun. 3, 2021) (File No. SR-OCC-2021-003) (order approving
proposed rule change to establish OCC's persistent minimum skin-in-
the-game); Exchange Act Release No. 91491 (Apr. 7, 2021), 86 FR
19061 (Apr. 12, 2021) (File No. SR-OCC-2021-801) (notice of no
objection to advance notice relating to OCC's establishment of
persistent minimum skin-in-the-game).
    \8\ The Target Capital Requirement is the amount of Equity
recommended by Management and approved by the Board to ensure
compliance with regulatory capital requirements and to keep such
additional amount the Board may approve for capital expenditures.
See OCC Rule 101.
    \9\ The Early Warning is one of the thresholds under OCC's plan
for replenishing capital in the event OCC's Equity falls close to or
below OCC's regulatory capital requirements, as required by SEC Rule
17Ad-22(e)(15)(iii). See 17 CFR 17Ad-22(e)(15)(iii).
    \10\ See Order Approving Policy, 85 FR at 5502; Notice of No-
Objection to Policy, 84 FR at 55196.
---------------------------------------------------------------------------

    OCC has experienced record volumes in 2021 while maintaining
expenses at or around the budgeted amount. These strong financial
results put OCC in a position to continue to invest resources in OCC's
initiative to update and upgrade its technology infrastructure for
critical clearing and settlement services, risk systems and data
management,\11\ while at the same time lowering the cost of clearing
for the users of the markets OCC serves. Accordingly, effective June 1,
2021, OCC lowered its clearing fee from $0.045 per contract to $0.02
per contract.\12\
---------------------------------------------------------------------------

    \11\ See OCC Technology Changes + Enhancements Reference Guide,
available at https://www.theocc.com/Participant-Resources (last
updated July 21, 2021).
    \12\ Exchange Act Release No. 91920 (May 18, 2021), 86 FR 27916
(May 24, 2021) (File No. SR-OCC-2021-006).
---------------------------------------------------------------------------

    As of June 30, 2021, OCC maintained Equity of approximately $693
million, or approximately $418 million more than the Early Warning.\13\
Based on projections of contract volume and expenses, OCC believes that
it can implement a two-month fee holiday while maintaining sufficient
revenue to support OCC's operations and capital needs, including 2021
cash needs related to OCC's technology infrastructure
transformation.\14\ Accordingly, OCC proposes to modify its fee
schedule to decrease both its per contract and per trade clearing fees
to $0 for the last two months of 2021.\15\
---------------------------------------------------------------------------

    \13\ See OCC Schedule of Fees, available at https://www.theocc.com/Company-Information/Schedule-of-Fees (under OCC
Capital Management Reporting, unaudited as of June 30, 2021).
    \14\ OCC has provided confidential data and analysis to the
Commission in Exhibit 3 to File No. SR-OCC-2021-009.
    \15\ These changes are also reflected in Exhibit 5 to File No.
SR-OCC-2021-009.

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

----------------------------------------------------------------------------------------------------------------
Fee schedule                          Proposed fee holiday from November 1, 2021 to
                                                     December 31, 2021
----------------------------------------------------------------------------------------------------------------
                         Clearing Fees                Clearing Fees
----------------------------------------------------------------------------------------------------------------
Trades with contracts of 0-2,750..  $0.02/contract............  Trades with contracts  $0/contract.
                                                                 of 0-2,750.
Trades with contracts of more than  $55/trade.................  Trades with contracts  $0/trade.
 2,750.                                                          of more than 2,750.
----------------------------------------------------------------------------------------------------------------

    OCC proposes to make the fee change effective November 1, 2021,
because OCC believes that this date is the first date that the industry
could be prepared to process the new fee without disruption based on
consultations with market participants.\16\ Effective the first trading
day of 2022, clearing fees will revert to the fee schedule in effect
before November 1, 2021 and OCC will remove the fee holiday from its
schedule of fees.
---------------------------------------------------------------------------

    \16\ OCC notes that a mid-month change to clearing fees could
introduce operational disruption to Clearing Members due to the
impact on their billing processes.
---------------------------------------------------------------------------

(2) Statutory Basis
    Section 17A(b)(3)(D) of the Act \17\ requires that the rules of a
clearing agency provide for the equitable allocation of reasonable
dues, fees, and other charges among its participants. OCC believes that
the proposed fee holiday is reasonable because it is designed to
decrease the cost of clearing while maintaining sufficient reserves in
the form of liquid net assets to cover OCC's operating expenses and
address potential business or operational losses so that OCC can
continue to meet its obligations as a systemically important financial
market utility to Clearing Members and the general public if such
losses were to materialize (including through a recovery or orderly
wind-down of critical operations and services) and thereby facilitating
compliance with certain requirements of Rule 17Ad-22(e)(15)(ii).\18\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78q-1(b)(3)(D).
    \18\ 17 CFR 240.17Ad-22(e)(15)(ii).
---------------------------------------------------------------------------

    In determining the appropriateness of a fee holiday, the CPC
considered a variety of factors, including the projected revenue loss
that would result from a two-month fee holiday, projected expenses,
projected average daily volume, and a scenario analysis modeling the
sensitivity of operating income, adjusting for different clearing fee
levels.\19\ The CPC also considered OCC's cash needs through 2021 to
support its technology transformation initiative. OCC believes that the
proposed fee holiday is reasonable and consistent with its existing By-
Laws and Rules. OCC also believes that the proposed fee holiday would
result in an equitable allocation of fees among its participants
because it would be equally applicable to all market participants. As a
result, OCC believes that the proposed fee holiday provides for the
equitable

allocation of reasonable fees in accordance with Section 17A(b)(3)(D)
of the Act.\20\
---------------------------------------------------------------------------

    \19\ A summary of the analyses is included in confidential
Exhibit 3 to File No. SR-OCC-2021-009.
    \20\ 15 U.S.C. 78q-1(b)(3)(D).
---------------------------------------------------------------------------

    The proposed rule change is not inconsistent with the existing
rules of OCC, including any other rules proposed to be amended.

(B) Clearing Agency's Statement on Burden on Competition

    Section 17A(b)(3)(I) of the Act \21\ requires that the rules of a
clearing agency not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act. OCC does not
believe that the proposed rule change would have any impact or impose a
burden on competition. Although this proposed rule change affects
clearing members, their customers, and the markets that OCC serves, OCC
believes that the proposed rule change would not disadvantage or favor
any particular user of OCC's services in relationship to another user
because the proposed fee holiday applies equally to all users of OCC.
Accordingly, OCC does not believe that the proposed rule change would
have any impact or impose a burden on competition.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

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

    Pursuant to Section 19(b)(3)(A)(ii) \22\ of the Act, and Rule 19b-
4(f)(2) thereunder,\23\ the proposed rule change is filed for immediate
effectiveness as it constitutes a change in fees charged to OCC's
members. 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 necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. The proposal shall
not take effect until all regulatory actions required with respect to
the proposal are completed.\24\
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \23\ 17 CFR 240.19b-4(f)(2).
    \24\ Notwithstanding its immediate effectiveness, implementation
of this rule change will be delayed until this change is deemed
certified under CFTC Regulation 40.6.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change 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 Number SR-OCC-2021-009 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2021-009. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of OCC.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-OCC-2021-009 and should be
submitted on or before October 26, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21625 Filed 10-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Rules and Regulations]
[Pages 56653-56656]
[FR Doc No: 2021-22104]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2020-0511; FRL-8667-01-OCSPP]

Clothianidin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of the
insecticide clothianidin in or on food and feed commodities (other than
those covered by a higher tolerance) in food/feed handling
establishments. McLaughlin Gormley King Company D/B/A MGK requested
tolerances for these commodities under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective October 12, 2021. Objections and
requests for hearings must be received on or before December 13, 2021
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0511, 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. 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
(703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; main telephone number:<PHONE_NUMBER>; email
address: [email protected].

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. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0511 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 13, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b), although at this
time, EPA strongly encourages those interested in submitting objections
or a hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal deliver,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
deliver, EPA intends to treat submissions filed via electronic means as
properly filed submissions during this time that the Agency continues
to maximize telework due to the pandemic; therefore, EPA believes the
preference for submission via electronic means will not be prejudicial.
If it is impossible for a person to submit documents electronically or
receive service electronically, e.g., the person does not have any
access to a computer, the person shall so advise OALJ by contacting the
Hearing Clerk at<PHONE_NUMBER>. If a person is without access to a
computer and must file documents by U.S. Mail, the person shall notify
the Hearing Clerk every time it files a document in such a manner. The
address for mailing documents is U.S. Environmental Protection Agency,
Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-

2020-0511, 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 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.
     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.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 27, 2020 (85 FR 68030) (FRL-
10015-86), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F8869) by McLaughlin Gormley King Company D/B/A MGK, 7325 Aspen Lane
N, Minneapolis, MN 55428. The petition requested that 40 CFR
180.586(a)(1) be amended by establishing tolerances for residues of the
insecticide clothianidin, (E)-N-[(2-Chloro-5-thiazolyl)methyl]-N'-
methyl-N''-nitroguanidine, in or on all food items in food handling
establishments where food and food products are held, processed,
prepared, and/or served at 0.01 parts per million (ppm). That document
referenced a summary of the petition prepared by McLaughlin Gormley
King Company D/B/A MGK, the registrant, which is available in the
docket, http://www.regulations.gov. There was one, non-substantive
comment received on November 8, 2020, in response to the notice of
filing.
    Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is establishing tolerances that vary from what the petitioners sought.
The reasons for these changes are explained in detail in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D) and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for clothianidin in or on food and feed commodities
(other than those covered by a higher tolerance).
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings and republishing the same sections is
unnecessary; EPA considers referral back to those sections as
sufficient to provide an explanation of the information EPA considered
in making its safety determination for the new rulemaking.
    EPA has recently published a tolerance rulemaking for clothianidin,
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to clothianidin and established tolerances for residues of
that chemical. EPA is incorporating previously published sections from
those rulemakings as described further in this rulemaking, as they
remain unchanged.
    Toxicological Profile. For a discussion of the Toxicological
Profile of clothianidin, see Unit III.A. of the November 25, 2019
rulemaking (84 FR 64772) (FRL-10000-64).
    Toxicological Points of Departure/Levels of Concern. A summary of
the toxicological effects of clothianidin, including the specific
information on the studies received, the nature of the adverse effects
caused by clothianidin, the no observed adverse effects level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov in the document
entitled ``Clothianidin: Draft Human Health Risk Assessment in Support
of Registration Review,'' dated September 7, 2017. This document can be
found in docket ID number EPA-HQ-OPP-2011-0865.
    Exposure Assessment. EPA has updated the exposure assessments of
clothianidin to include the petitioned-for tolerances in addition to
exposures associated with existing tolerances for clothianidin in 40
CFR 180.586. The acute and chronic dietary exposure assessments for
clothianidin were conducted using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database DEEM-
FCIDTM, Version 3.16, which incorporates consumption data
from USDA's National Health and Nutrition Examination Survey, What We
Eat in America, (NHANES/WWEIA). This dietary survey was conducted from
2003 to 2008.
    The acute dietary exposure assessment is based on tolerance-level
residues for all commodities since EPA typically does not include FHE
uses in acute dietary assessments. In addition, the acute dietary
exposure assessment assumes 100% crop treated (PCT) and incorporates
the modeled EDWCs. Therefore, the resulting exposure and risk estimates
are conservative.
    The partially refined chronic dietary exposure assessment is based
on average field trial residues and assumes 100 PCT. Average residues
from representative commodities were extrapolated to similar
commodities. Because thiamethoxam, which also breaks down into
clothianidin residues, is also registered for FHE use, EPA accounts for
clothianidin residues from both thiamethoxam and clothianidin FHE uses
in the chronic assessment. For these analyses, a residue input value
for FHE use was entered for all other commodities in DEEM-
FCIDTM not registered for direct use. Default processing
factors were used, except where empirical factors derived from
processing studies were available.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years

after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    EPA also used the same estimates for potential drinking water
exposures as reflected in the November 25, 2019, rulemaking. Since the
proposed use is for indoor applications, a new drinking water
assessment was not needed.
    Clothianidin is registered for uses that may result in residential
(non-occupational) exposures. EPA has assessed the potential for short-
term post-application exposure; other exposures are not expected. No
residential risks of concern were identified. For aggregate risk
assessment, EPA used the risk estimates from the combined dermal and
inhalation exposures for adults from indoor aerosol can usage and from
the combined dermal, inhalation, and incidental oral exposures for
children 1 to less than 2 years old from treated indoor surfaces.
    Safety Factor for Infants and Children. Section 408(b)(2)(C) of the
FFDCA provides that EPA shall apply an additional tenfold (10x) margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure unless EPA determines based on
reliable data that a different margin of safety will be safe for
infants and children. This additional margin of safety is commonly
referred to as the FQPA Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10 times, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    EPA determined reliable data show the safety of infants and
children would be adequately protected if the FQPA SF were reduced to
1x because: (1) The toxicology data base is complete and includes
developmental neurotoxicity (DNT), adult immunotoxicity and
developmental immunotoxicity studies; (2) EPA characterized the degree
of concern for the quantitative susceptibility observed in the
clothianidin 2-generation reproduction and DNT studies as low based on
the clear NOAELs for the offspring effects and the selection of
regulatory doses that are protective of those effects; (3) the rat is
the most sensitive species tested, and the NOAEL and LOAEL selected
from the two-generation reproduction study in rats are protective of
effects observed in the toxicology database, including the DNT and
developmental immunotoxicity studies; (4) there are no residual
uncertainties for pre- and/or post-natal toxicity; (5) EPA is
regulating the use of clothianidin based upon the most sensitive
offspring effects observed in the reproduction toxicity study, and
therefore the risk assessment is protective of these and other effects
that occurred at higher doses; (6) the exposure databases (e.g.,
dietary food, drinking water, and residential) are complete; and (7)
the risk assessment for each potential exposure scenario does not
underestimate potential exposure and risk for infants or children.
    Aggregate Risks and Determination of Safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate points of departure (PODs)
to ensure that an adequate margin of exposure (MOE) exists. For linear
cancer risks, EPA calculates the lifetime probability of acquiring
cancer given the estimated aggregate exposure.
    The acute dietary risk estimates for clothianidin are 9.5% of the
aPAD for the U.S. general population, and 29% of the aPAD for children
1 to 2 years old (the most highly exposed population subgroup). The
chronic dietary risk estimates are 3.9% of the cPAD for the U.S.
general population, and 9.4% of the cPAD for infants less than 1-year
old (the most highly exposed population subgroup). Because both are
below the 100% of the relevant PAD, these risk estimates are not of
concern.
    The short-term aggregate risk assessments resulted in MOEs of 150
to 490. For clothianidin, the LOC for short-term risk is an MOE of 100.
As the resulting aggregate MOEs exceed the LOC of 100, short-term
aggregate risk estimates are not of concern. Intermediate-term and
long-term residential exposures are not expected.
    Clothianidin is classified as ``Not Likely to be Carcinogenic to
Humans;'' therefore, cancer risk is not a concern and cancer risks are
not quantified.
    Based on the risk assessments and information described above, EPA
concludes there is a reasonable certainty that no harm will result to
the U.S. general population, or to infants and children, from aggregate
exposure to clothianidin residues. More detailed information on the
subject action to establish a tolerance in or on food and feed
commodities (other than those covered by a higher tolerance) can be
found at http://www.regulations.gov in the document entitled
``Clothianidin. Petition for the Establishment of Permanent Tolerances
and Registration for Use in Food Handling Establishment,'' dated July
15, 2021. This document can be found in docket ID number EPA-HQ-OPP-
2020-0511.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate Liquid Chromatograph/Mass Spectrometer/Mass Spectrometer
(LC/MS/MS) methods are available for enforcing tolerances of
clothianidin residues in/on crop (Morse Method #Meth-164--modified, RM-
39C-1, or Bayer Method 00552) and livestock (Bayer Method 00624)
matrices.
    These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
Although EPA may establish a tolerance that is different from a Codex
MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for
departing from the Codex level.
    Codex has not established MRLs for food commodities based on the
petitioned-for use in food handling establishments.

C. Revisions to Petitioned-For Tolerances

    The petition described the use of clothianidin in or on ``all food
items in food handling establishments where food and food products are
held, processed, prepared and/or served.''

EPA has revised this language for the requested tolerance to read
``Food and feed commodities (other than those covered by a higher
tolerance) in food/feed handling establishments.''

V. Conclusion

    Tolerances are established for residues of the insecticide
clothianidin in or on food and feed commodities (other than those
covered by a higher tolerance) at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 5, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.586, amend paragraph (a)(1) by
0
a. Designating the table as table 1; and
0
b. In newly redesignated table 1, adding in alphabetical order an entry
for ``Food and feed commodities (other than those covered by a higher
tolerance) in food/feed handling establishments''.
    The additions read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                              * * * * * * *
Food and feed commodities (other than those covered by a            0.01
 higher tolerance) in food/feed handling establishments....

                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-22104 Filed 10-8-21; 8:45 am]
BILLING CODE 6560-50-P