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[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39927-39929]
[FR Doc No: 2016-14461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0734]

Evaluation and Reporting of Age, Race, and Ethnicity Data in
Medical Device Clinical Studies; Draft Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Evaluation and
Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical
Studies.'' The purpose of this document is to outline FDA's proposed
recommendations and expectations for the evaluation and reporting of
age, race, and ethnicity data in medical device clinical studies. The
primary intent of these recommendations is to improve the quality,
consistency, and transparency of data regarding the performance of
medical devices within specific age, race, and ethnic groups. This
draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0734 for ``Evaluation and Reporting of Age, Race, and
Ethnicity Data in Medical Device Clinical Studies.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical
Device Clinical Studies'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and

Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5428, Silver Spring, MD 20993-0002,
301-796-6349; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 907 of the Food and Drug Administration Safety and
Innovation Act (Pub. L 112-144) (FDASIA) directed the Agency to publish
and provide to Congress a report describing the extent to which
clinical trial participation and safety and effectiveness data by
demographic subgroups, including sex, age, race, and ethnicity, is
included in applications submitted to FDA (Ref 1). Section 907 also
directed FDA to publish and provide to Congress an action plan
outlining recommendations for improving the completeness and quality of
analyses of data on demographic subgroups in summaries of product
safety and effectiveness data and in labeling; on the inclusion of such
data, or the lack of availability of such data, in labeling; and on
improving the public availability of such data to patients health care
providers and researchers, and to indicate the applicability of these
recommendations to the types of medical products addressed in section
907. In the Action Plan, FDA committed to developing this draft
guidance as part of the strategy to fulfill FDASIA requirements (Ref.
2).
    This guidance outlines FDA's recommendations and expectations for
patient enrollment, data analysis, and reporting of age, race, and
ethnicity data in medical device clinical studies. Specific objectives
of this guidance are to (1) encourage the collection and consideration
of age, race, ethnicity, and associated covariates (e.g., body size,
biomarkers, bone density) during the study design stage; (2) outline
recommended analyses of study subgroup data with a framework for
considering demographic data when interpreting overall study outcomes;
and (3) specify FDA's recommendations for reporting age, race, and
ethnicity-specific information in summaries and labeling for approved
or cleared medical devices. FDA believes these recommendations will
help improve the quality, consistency, and transparency of data
regarding the performance of medical devices within specific age, race,
and ethnic groups as well as encourage appropriate enrollment of
diverse populations including relevant age, race, and ethnic groups.
Proper evaluation and reporting of these data can benefit patients,
clinicians, researchers, regulators, and other stakeholders.
    This document extends the policy established in FDA's guidance
entitled ``Evaluation of Sex-Specific Data in Medical Device Clinical
Studies'' to additional demographic subgroups of age, race, and
ethnicity (Ref. 3). Upon finalization of this draft guidance, FDA
intends to integrate the content of both guidances into one document.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the evaluation
and reporting of age, race, and ethnicity data in medical device
clinical studies. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Evaluation and Reporting of Age, Race,
and Ethnicity Data in Medical Device Clinical Studies'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1500026 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). These
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts A
through E, have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H, have been
approved under OMB control number 0910-0332; the collections of
information in 21 CFR part 822 have been approved under OMB control
number 0910-0449; and the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485.

V. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA Report: Collection, Analysis, and Availability of Demographic
Subgroup Data for FDA-Approved Medical Products, issued August 2013,
required under FDASIA section 907, available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf.
2. FDA's Action Plan to Enhance the Collection and Availability of
Demographic Subgroup Data (August, 2014), available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf.
3. FDA's guidance entitled ``Evaluation of Sex-Specific Data in
Medical Device Clinical Studies'' (August 22, 2014), available at
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283707.pdf.

    Dated: June 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14461 Filed 6-17-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 6, 2008 (Volume 73, Number 194)]
[Notices]
[Page 58248]
[DOCID:fr06oc08-88]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0098] (formerly Docket No. 2005N-0349)

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Survey of Current Manufacturing
Practices in the Food Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Survey of Current Manufacturing
Practices in the Food Industry'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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

SUPPLEMENTARY INFORMATION: In the Federal Register of May 8, 2007 (72
FR 26132), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0628.
The approval expires on August 31, 2011. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23606 Filed 10-3-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: September 29, 2010 (Volume 75, Number 188)]
[Notices]
[Page 60117-60119]
[DOCID:fr29se10-66]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0118; FRL-8846-5]

Registration Review; Biopesticides Dockets Opened for Review and
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has established registration review dockets for the
pesticides listed in the table in Unit III.A. With this document, EPA
is opening the public comment period for these registration reviews.
Registration review is EPA's periodic review of pesticide registrations
to ensure that each pesticide continues to satisfy the statutory
standard for registration, that is, the pesticide can perform its
intended function without unreasonable adverse effects on human health
or the environment. Registration review dockets contain information
that will assist the public in understanding the types of information
and issues that the Agency may consider during the course of
registration reviews. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before November 29, 2010.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID numbers listed
in the table in Unit III.A. for the pesticides you are commenting on.
EPA's policy is that all comments received will be included in the
docket without change and may be made available on-line at http://
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM

you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For pesticide-specific information
contact: The Regulatory Action Leader (RAL) identified in the table in
Unit III.A. for the pesticide of interest.
    For general information contact: Kevin Costello, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address: costello.kevin @epa.gov.

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, farmworker, 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. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Submitting CBI
    Do not submit this information to EPA through regulations.gov or e-
mail. Clearly mark the part or all of the information that you claim to
be CBI. For CBI information in a disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for Preparing Your Comments
    When submitting comments, remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
3. Environmental Justice
    EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of any group, including minority and/or low
income populations, in the development, implementation, and enforcement
of environmental laws, regulations, and policies. To help address
potential environmental justice issues, the Agency seeks information on
any groups or segments of the population who, as a result of their
location, cultural practices, or other factors, may have atypical or
disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticides discussed in this
document, compared to the general population.

II. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations
for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of
FIFRA provides, among other things, that the registrations of
pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide
product may be registered or remain registered only if it meets the
statutory standard for registration given in FIFRA section 3(c)(5).
When used in accordance with widespread and commonly recognized
practice, the pesticide product must perform its intended function
without unreasonable adverse effects on the environment; that is,
without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

A. What action is the agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations identified in the table in this unit to assure that they
continue to satisfy the FIFRA standard for registration--that is, they
can still be used without unreasonable adverse effects on human health
or the environment. A pesticide's registration review begins when the
Agency establishes a docket for the pesticide's registration review
case and opens the docket for public review and comment. At present,
EPA is opening registration review dockets for the cases identified in
the following table.

------------------------------------------------------------------------
                                                     Regulatory action
 Registration review case name    Docket ID No.      leader, telephone
            and No.                                 No., e-mail address
------------------------------------------------------------------------
Beauveria bassiana (6057).....  EPA-HQ-OPP-2010-0  Shanaz Bacchus, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                    ov.
Egg Solids (4079).............  EPA-HQ-OPP-2010-0  Cheryl Greene, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                    v.

Indole-3-butyric acid (IBA)     EPA-HQ-OPP-2010-0  Colin G. Walsh, (703)
 (2330).<PHONE_NUMBER>,
<EMAIL_ADDRESS>Phenethyl propionate (3110)...  EPA-HQ-OPP-2010-0  Cheryl Greene, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                    v.
------------------------------------------------------------------------

B. Docket Content

1. Review Dockets
    The registration review dockets contain information that the Agency
may consider in the course of the registration review. The Agency may
include information from its files including, but not limited to, the
following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
2. Other Related Information
    More information on these cases, including the active ingredients
for each case, may be located in the registration review schedule on
the Agency's Web site at http://www.epa.gov/oppsrrd1/registration_
review/schedule.htm. Information on the Agency's registration review
program and its implementing regulation may be seen at http://
www.epa.gov/oppsrrd1/registration_review.
3. Information Submission Requirements
    Anyone may submit data or information in response to this document.
To be considered during a pesticide's registration review, the
submitted data or information must meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 23, 2010.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2010-24436 Filed 9-28-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)]
[Notices]
[Pages 17876-17877]
[FR Doc No: 2018-08555]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent of Waiver With Respect to Land; Willoughby Lost
Nation Municipal Airport, Willoughby, Ohio

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA is considering a proposal to change 10.667 acres of
airport land from aeronautical use to non-aeronautical use and to
authorize the sale of airport property located at Willoughby Lost
Nation Municipal Airport, Willoughby, Ohio. The aforementioned land is
not needed for aeronautical use.
    The proposed non-aeronautical use of the property is for a
compatible 120,000 square foot manufacturing facility and office space
development. The property has been appraised and the airport will
receive Fair Market Value for the land to be sold.

DATES: Comments must be received on or before May 24, 2018.

ADDRESSES: Documents are available for review by appointment at the FAA
Detroit Airports District Office, Evonne M. McBurrows, Program Manager,
11677 South Wayne Road, Suite 107, Romulus, Michigan 48174 Telephone:
(734) 229-2945/Fax:<PHONE_NUMBER> and Lake County Ohio Port and
Economic Development Authority, One Victoria Place, Painesville, Ohio
44077 and<PHONE_NUMBER>.
    Written comments on the Sponsor's request must be delivered or
mailed to: Evonne M. McBurrows, Program Manager, Federal Aviation
Administration, Detroit Airports District Office, 11677 South Wayne
Road, Suite 107, Romulus, Michigan 48174, Telephone Number: (734) 229-
2945/FAX Number:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Evonne M. McBurrows, Program Manager,
Federal Aviation Administration, Detroit Airports District Office,
11677 South Wayne Road, Suite 107, Romulus, Michigan 48174. Telephone
Number:<PHONE_NUMBER>/FAX Number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with section 47107(h) of Title
49, United States Code, this notice is required to be published in the
Federal Register 30 days before modifying the land-use assurance that
requires the property to be used for an aeronautical purpose.
    The 10.667 acre parcel is located east of Lost Nation Road and
North of Jet Drive adjacent to the westerly airport

property boundary line. The property is currently undeveloped land and
was acquired by the City of Willoughby under Federal grant 8-1-3-39-
0090-0185. The proposed non-aeronautical use of the land will be for a
120,000 square foot manufacturing facility and office space. The
property is not needed for aeronautical purposes. The release of the
property and use of the property will be in conformity with local and
state laws. The property has a proposed developer identified and it has
been appraised. The airport will receive Fair Market Value for the land
to be sold.
    The disposition of proceeds from the sale of the airport property
will be in accordance with FAA's Policy and Procedures Concerning the
Use of Airport Revenue, published in the Federal Register on February
16, 1999 (64 FR 7696).
    This notice announces that the FAA is considering the release of
the subject airport property at the Willoughby Lost Nation Municipal
Airport, City of Willoughby, Ohio from federal land covenants, subject
to a reservation for continuing right of flight as well as restrictions
on the released property as required in FAA Order 5190.6B section
22.16. Approval does not constitute a commitment by the FAA to
financially assist in the disposal of the subject airport property nor
a determination of eligibility for grant-in-aid funding from the FAA.

Legal Description 10.667 Acres

    Situated in the City of Willoughby, County of Lake, and State of
Ohio and known as being part of Original Lot No. 6, Douglas Tract, and
is further bounded and described as follows:
    Beginning at an iron pin found at the southeasterly corner of land
conveyed to Halabar Enterprises, LLC by deed recorded in Document No.
970032610 of Lake County Records in the northerly sideline of Jet
Center Place, where it is 70.00 feet wide, at a point located South
88[deg]15'30'' East 14.98 feet from an angle point in said sideline,
said point being further located 4 + 19.98, 35.00 feet left as appears
by plat recorded in Vol.16, Page 34 of Lake County Plat Records,
    Thence North 1[deg]44'30'' East, along the easterly line of said
land of Halabar Enterprises, 753.23 feet to an iron pin found at the
northeasterly corner of said land;
    Thence South 88[deg]43'30'' West, along the northerly line of said
land, 60.56 feet to an iron pin found at the southeasterly corner of
land conveyed to Authur P. Armington by deed recorded in Vol. 704, Page
163 of Lake County Official Records;
    Thence, North 1[deg]44'30'' East along the easterly line of
Armington, 240.00 feet to an iron pin found at the southerly line of
land conveyed to Frank R. Farroni by deed recorded in Volume 759, Page
634 of Lake County Records.
    Thence North 88[deg]43'30'' East along the southerly said land of
Farroni, 3.00 feet to an iron pin found at the southeasterly corner of
said land,
    Thence North 01[deg]44'30'' East, along the easterly line of said
land of Farroni 28.00 feet to an iron pin found at the southwesterly
corner of land conveyed to Lost Nation Parkway, I Ltd by Document No.
980042081 of Lake County Records.
    Thence South 88[deg]15'30'' East along the southerly line of said
land of Lost Nation Parkway 1, Ltd., 499.92 feet to an iron pin set;
    Thence South 1[deg]44'30'' West, 903.33 feet to an iron pin found
at the northwesterly corner of land conveyed to the City of Willoughby
by deed recorded in Vol. 680 Page 252 of Lake County Official Records;
    Thence South 0[deg]14'52'' West, along the westerly line of said
land of the City, 82.96 feet to an iron pin found at the curved
northerly, sideline of Jet Center Place;
    Thence westerly along said sideline on an arc deflecting to the
left, said arc having a radius of 68.50 feet and a chord of 59.34 feet
which bears South 78[deg]13'00'' West, a distance of 61.38 feet to a
point of reverse curve;
    Thence westerly continuing along said sideline on an arc deflecting
to the right said arc having a radius of 81.50 feet and a chord of
54.47 feet which bears South 72[deg]3'11'' West a distance of 55.54
feet to a point.
    North 88[deg]15'30'' West along said sideline of Jet Center Place
335.53 feet to the place of beginning and containing 10.667 acres of
land according to a survey made in August 1999 by Richard J. Bislki,
registered surveyor No. 5244 of CT Consultants, Inc., Registered
Engineers and Surveyors, be the same more or less, but subject to all
legal highways.
    The bearings stated herein are based upon the recorded bearings as
shown on the dedication plat of Jet Center Place, Vol. 16 Page 34 and
are for the sole purpose of indicating relative angular values between
lines.

    Issued in Romulus, Michigan on April 16, 2018.
John L. Mayfield, Jr.,
Manager, Detroit Airports District Office, FAA, Great Lakes Region.
[FR Doc. 2018-08555 Filed 4-23-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Page 47222]
[FR Doc No: 2011-19762]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4001-DR; Docket ID FEMA-2011-0001]

Vermont; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Vermont (FEMA-4001-DR), dated July 8, 2011, and
related determinations.

DATES: Effective Date: July 25, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Vermont is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of July 8, 2011.

    Essex and Orange Counties for Public Assistance. Washington
County for Public Assistance (already designated for Individual
Assistance).

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-19762 Filed 8-3-11; 8:45 am]
BILLING CODE 9110-23-P


[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Notices]
[Page 26082-26083]
[DOCID:fr03my06-67]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0237; FRL-8061-6]

Geologics; Transfer of Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be tranferred to Geologics in accordance with 40
CFR 2.307(h)(3) and 2.308(i)(2). Geologics has been awarded multiple
contracts to perform work for OPP, and access to this information will
enable Geologics to fulfill the obligations of the contract.

DATES:  Geologics will be given access to this information on or before
May 8, 2006.

FOR FURTHER INFORMATION CONTACT: Felicia Croom, Information Technology
and Resources Management Division (7502P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. i. EPA has established a docket for this action under
Docket identification (ID) number EPA-HQ-OPP-2006-0237. Publicly
available docket materials are available electronically at http://www.regulations.gov
.

    ii. Important Note: OPP will be moving to a new location the first
week of May 2006. As a result, from Friday, April 28 to Friday, May 5,
2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall 2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number ((703) 305-5805) and
hours of operation (8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays) will remain the same after the move.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr.

II. Contractor Requirements

    Under these contract numbers, the contractor will perform the
following:
    1. Under Contract No.GS-10F-0452M, enter data for DMR-QA Studies 25
and 26.
    2. Perform data entry analysis of DMR-QA Study 25 trends, provide
suggestions and editorial comments to improve instructions and format
of the DMR-QA notice, and
    3. Enter data of Laboratory inspections and data audits conducted
by the Laboratory Data Integrity Branch.
    This contract involves no subcontractors.
    The OPP has determined that the contracts described in this
document involve work that is being conducted in connection with FIFRA,
since pesticide chemicals will be the subject of certain evaluations to
be made under this contract. These evaluations may be used in
subsequent regulatory decisions under FIFRA.
    Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under sections 3, 4, 6, and 7
of FIFRA and under sections 408 and 409 of FFDCA.
    In accordance with the requirements of 40 CFR 2.307(h)(3), the
contracts with Geologics, prohibits use of the information for any
purpose not specified in these contracts; prohibits disclosure of the
information to a third party without prior written approval from the
Agency; and requires that each official and employee of the contractor
sign an agreement to protect the information from unauthorized release
and to handle it in accordance with the FIFRA Information Security
Manual. In addition, Geologics is required to submit for EPA approval a
security plan under which any CBI will be secured and protected against
unauthorized release or compromise. No information will be provided to
Geologics until the requirements in this document have been fully
satisfied. Records of information provided to Geologics will be
maintained by EPA Project Officers for these contracts. All information
supplied to Geologics by EPA for use in connection with these contracts
will be returned to EPA when Geologics has completed its work.

List of Subjects

    Environmental protection, Business and industry, Government
contracts, Government property, Security measures.

    Dated: April 25, 2006.
Robert A. Forrest,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.

[FR Doc.E6-6611 Filed 5-2-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Rules and Regulations]
[Page 18990]
[FR Doc No: 2014-07702]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2014-N-0002]

Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug
Applications for Combination Drug Medicated Feeds Containing an
Arsenical Drug; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval; correction.

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

SUMMARY: The Food and Drug Administration (FDA) published a document in
the Federal Register of February 27, 2014, concerning the voluntary
withdrawal of approval of new animal drug applications (NADAs). The
document contained an incorrect list of NADAs.

DATES: This correction is effective April 7, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In FR Doc. 2014-02616, appearing on page
10974 in the Federal Register of February 27, 2014, the following
corrections are made:
    On page 10974, in the third column, in the 2d line of the
``SUMMARY'' section remove ``69'' and add in its place ``68''.
    On page 10975, the first bulleted text ``Huvepharma AD, 5th Floor,
3A Nikolay Haitov Str., 1113 Sofia, Bulgaria has requested that FDA
withdraw approval of the following 16 NADAs and 8 ANADAs'' is corrected
to read ``Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia,
Bulgaria, has requested that FDA withdraw approval of the following 15
NADAs and 8 ANADAs''; and on the same page in the table, the entry
``013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).''
is removed.

    Dated: April 2, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-07702 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P


Government Agency Debt, if categorized as no-coupon discount notes;
Non-U.S. Sovereign, Sub-Sovereign and Supra-National debt; Certificate
of Deposit; Non-Negotiable Time Deposit; Variable Rate Demand Note;
Other Municipal Security; Asset Backed Commercial Paper; Other Asset
Backed Securities; U.S. Treasury Repurchase Agreement, if
collateralized only by U.S. Treasuries (including Strips) and cash;
U.S. Government Agency Repurchase Agreement, collateralized only by
U.S. Government Agency securities, U.S. Treasuries, and cash; Other
Repurchase Agreement, if any collateral falls outside Treasury,
Government Agency and cash; Insurance Company Funding Agreement;
Investment Company; Financial Company Commercial Paper; Non-Financial
Company Commercial Paper; and Other Instrument. If Other Instrument,
include a brief description);
* * * * *
    (iii) A schedule, chart, graph, or other depiction showing the
money market fund's net asset value per share (which the fund must
calculate based on current market factors before applying the amortized
cost or penny-rounding method, if used), rounded to the fourth decimal
place in the case of funds with a $1.0000 share price or an equivalent
level of accuracy for funds with a different share price (e.g., $10.000
per share), as of the end of each business day during the preceding six
months, which must be updated each business day as of the end of the
preceding business day.
    (iv) A link to a website of the Securities and Exchange Commission
where a user may obtain the most recent 12 months of publicly available
information filed by the money market fund pursuant to Sec.  270.30b1-
7.
    (v) For a period of not less than one year, beginning no later than
the same business day on which the money market fund files an initial
report on Form N-CR (Sec.  274.222 of this chapter) in response to the
occurrence of any event specified in Part C of Form N-CR, the same
information that the money market fund is required to report to the
Commission on Part C (Items C.1, C.2, C.3, C.4, C.5, C.6, and C.7) of
Form N-CR concerning such event, along with the following statement:
``The Fund was required to disclose additional information about this
event on Form N-CR and to file this form with the Securities and
Exchange Commission. Any Form N-CR filing submitted by the Fund is
available on the EDGAR Database on the Securities and Exchange
Commission's internet site at https://www.sec.gov.''
* * * * *
    (j) Delegation. The money market fund's board of directors may
delegate to the fund's investment adviser or officers the
responsibility to make any determination required to be made by the
board of directors under this section other than the determinations
required by paragraphs (c)(1) (board findings), (c)(3) (share
cancellation), (f)(1) (adverse events), (g)(1) and (2) (amortized cost
and penny rounding procedures), and (g)(8) (stress testing procedures)
of this section.
    (1) Written guidelines. The board of directors must establish and
periodically review written guidelines

(including guidelines for determining whether securities present
minimal credit risks as required in paragraphs (d)(2) and (g)(3) of
this section and guidelines for determining the application and size of
liquidity fees as required in paragraph (c)(2) of this section) and
procedures under which the delegate makes such determinations.
    (2) Oversight. The board of directors must take any measures
reasonably necessary (through periodic reviews of fund investments and
the delegate's procedures in connection with investment decisions,
periodic review of the delegate's liquidity fee determinations under
paragraph (c)(2) of this section, and prompt review of the adviser's
actions in the event of the default of a security or event of
insolvency with respect to the issuer of the security or any guarantee
or demand feature to which it is subject that requires notification of
the Commission under paragraph (f)(2) of this section by reference to
Form N-CR (Sec.  274.222 of this chapter) to assure that the guidelines
and procedures are being followed.

0
3. Amend Sec.  270.31a-2 by revising paragraph (a)(2) to read as
follows:

Sec.  270.31a-2  Records to be preserved by registered investment
companies, certain majority-owned subsidiaries thereof, and other
persons having transactions with registered investment companies.

    (a) * * *
    (2) Preserve for a period not less than six years from the end of
the fiscal year in which any transaction occurred, the first two years
in an easily accessible place, all books and records required to be
made pursuant to Sec.  270.31a-1(b)(5) through (12) and all vouchers,
memoranda, correspondence, checkbooks, bank statements, cancelled
checks, cash reconciliation, cancelled stock certificates, and all
schedules evidencing and supporting each computation of net asset value
of the investment company shares, including schedules evidencing and
supporting each computation of an adjustment to net asset value of the
investment company shares based on swing pricing policies and
procedures established and implemented pursuant to Sec.  270.22c-
1(a)(3), all schedules evidencing and supporting each computation of a
liquidity fee by a money market fund pursuant to Sec.  270.2a-7(c)(2),
and other documents required to be maintained by Sec.  270.31a-1(a) and
not enumerated in Sec.  270.31a-1(b).
* * * * *

PART 274--FORMS PRESCRIBED UNDER THE INVESTMENT COMPANY ACT OF 1940

0
4. The general authority citation for part 274 continues to read as
follows:

    Authority:  15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m,
78n, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and 80a-37 unless
otherwise noted.
* * * * *

0
5. Amend Form N-1A (referenced in Sec. Sec.  239.15A and 274.11A) by:
0
a. Revising Item 4(b)(1)(ii);
0
b. Revising Item 16(g);
0
c. Removing instructions 2 and 3 to Item 16(g)(1); and
0
d. Revising Item 27A(i).

    Note:  Form N-1A is attached as Appendix A to this document.
Form N-1A does not appear in the Code of Federal Regulations.

0
6. Amend Form N-CSR (referenced in Sec. Sec.  249.331 and 274.128) by:
0
a. Revising the header to the instruction to paragraph (a) and (b) of
Item 7 to read ``Instructions to paragraphs (a) and (b)'';
0
b. Redesignating the current instruction to Item 7 as Instruction 1;
and
0
c. Adding Instruction 2 to Item 7.

    Note:  Form N-CSR is attached in Appendix B to this document.
Form N-CSR does not appear in the Code of Federal Regulations.

0
7. Revise Form N-MFP (referenced in Sec.  274.201).

    Note:  Form N-MFP is attached as Appendix C to this document.
Form N-MFP does not appear in the Code of Federal Regulations.

0
8. Amend Form N-CR (referenced in Sec.  274.222) by:
0
a. Revising the General Instructions in Sections A, C, D, and F, and
Parts A and C;
0
b. Removing Parts E, F, and G and replacing them with new Part E; and
0
c. Redesignating Part H to Part F.

    Note:  Form N-CR is attached as Appendix D to this document.
Form N-CR does not appear in the Code of Federal Regulations.

PART 279--FORMS PRESCRIBED UNDER THE INVESTMENT ADVISERS ACT OF
1940

0
9. The authority citation for part 279 continues to read as follows:

    Authority:  The Investment Advisers Act of 1940, 15 U.S.C. 80b-
1, et seq., Pub. L. 111-203, 124 Stat. 1376.

0
10. Amend Form PF (referenced in Sec.  279.9) by revising section 3 and
the Glossary of Terms.

    Note:  Form PF is attached as Appendix E to this document. Form
PF does not appear in the Code of Federal Regulations.

    By the Commission.

    Dated: July 12, 2023.
Vanessa A. Countryman,
Secretary.

    Note:  The following appendices will not appear in the Code of
Federal Regulations.

Appendix A--Form N-1A

Form N-1A

* * * * *

Item 4. Risk/Return Summary: Investments, Risks, and Performance

* * * * *
    (b) * * *
    (1) * * *
    (ii)(A) If the Fund is a Money Market Fund that is not a
government Money Market Fund, as defined in Sec.  270.2a-7(a)(14) or
a retail Money Market Fund, as defined in Sec.  270.2a-7(a)(21),
include the following statement:
    You could lose money by investing in the Fund. Because the share
price of the Fund will fluctuate, when you sell your shares they may
be worth more or less than what you originally paid for them. The
Fund may impose a fee upon sale of your shares. The Fund generally
must impose a fee when net sales of Fund shares exceed certain
levels. An investment in the Fund is not a bank account and is not
insured or guaranteed by the Federal Deposit Insurance Corporation
or any other government agency. The Fund's sponsor is not required
to reimburse the Fund for losses, and you should not expect that the
sponsor will provide financial support to the Fund at any time,
including during periods of market stress.
    (B) If the Fund is a Money Market Fund that is a government
Money Market Fund, as defined in Sec.  270.2a-7(a)(14), or a retail
Money Market Fund, as defined in Sec.  270.2a-7(a)(21), and that is
subject to the requirements of Sec.  270.2a-7(c)(2)(i) of this
chapter or is not subject to the requirements of Sec.  270.2a-
7(c)(2)(i) pursuant to Sec.  270.2a-7(c)(2)(i)(B) of this chapter,
but has chosen to rely on the ability to impose liquidity fees
consistent with the requirements of Sec.  270.2a-7(c)(2)(i), include
the following statement:
    You could lose money by investing in the Fund. Although the Fund
seeks to preserve the value of your investment at $1.00 per share,
it cannot guarantee it will do so. The Fund may impose a fee upon
sale of your shares. An investment in the Fund is not a bank account
and is not insured or guaranteed by the Federal Deposit Insurance
Corporation or any other government agency. The Fund's sponsor is
not required to reimburse the Fund for losses, and you should not
expect that the sponsor will provide financial support to the Fund
at any time, including during periods of market stress.
    (C) If the Fund is a Money Market Fund that is a government
Money Market Fund, as defined in Sec.  270.2a-7(a)(14), that is not
subject to the requirements of Sec.  270.2a-

7(c)(2)(i) of this chapter pursuant to Sec.  270.2a-7(c)(2)(i)(B) of
this chapter, and that has not chosen to rely on the ability to
impose liquidity fees consistent with the requirements of Sec.
270.2a-7(c)(2)(i), include the following statement:
    You could lose money by investing in the Fund. Although the Fund
seeks to preserve the value of your investment at $1.00 per share,
it cannot guarantee it will do so. An investment in the Fund is not
a bank account and is not insured or guaranteed by the Federal
Deposit Insurance Corporation or any other government agency. The
Fund's sponsor is not required to reimburse the Fund for losses, and
you should not expect that the sponsor will provide financial
support to the Fund at any time, including during periods of market
stress.
    Instruction. If an affiliated person, promoter, or principal
underwriter of the Fund, or an affiliated person of such a person,
has contractually committed to provide financial support to the
Fund, and the term of the agreement will extend for at least one
year following the effective date of the Fund's registration
statement, the statement specified in Item 4(b)(1)(ii)(A), Item
4(b)(1)(ii)(B), or Item 4(b)(1)(ii)(C) may omit the last sentence
(``The Fund's sponsor is not required to reimburse the Fund for
losses, and you should not expect that the sponsor will provide
financial support to the Fund at any time, including during periods
of market stress.''). For purposes of this Instruction, the term
``financial support'' includes any capital contribution, purchase of
a security from the Fund in reliance on Sec.  270.17a-9, purchase of
any defaulted or devalued security at par, execution of letter of
credit or letter of indemnity, capital support agreement (whether or
not the Fund ultimately received support), performance guarantee, or
any other similar action reasonably intended to increase or
stabilize the value or liquidity of the fund's portfolio; however,
the term ``financial support'' excludes any routine waiver of fees
or reimbursement of fund expenses, routine inter-fund lending,
routine inter-fund purchases of fund shares, or any action that
would qualify as financial support as defined above, that the board
of directors has otherwise determined not to be reasonably intended
to increase or stabilize the value or liquidity of the fund's
portfolio.
* * * * *

Item 16. Description of the Fund and Its Investments and Risks

* * * * *
    (g) Money Market Fund Material Events. If the Fund is a Money
Market Fund disclose, as applicable, the following events:
    (1) Imposition of Liquidity Fees. During the last 10 years, any
occasion on which the Fund has imposed a liquidity fee pursuant to
Sec.  270.2a-7(c)(2).

Instructions

    1. With respect to each such occasion, disclose: the dates the
Fund imposed a liquidity fee pursuant to Sec.  270.2a-7(c)(2) and
the size of the liquidity fee imposed on each of those dates.
* * * * *

Item 27A. Annual and Semi-Annual Shareholder Report

* * * * *
    (i) Availability of Additional Information. Provide a brief,
plain English statement that certain additional Fund information is
available on [the Fund's] website. Include plain English references
to, as applicable, the Fund's prospectus, financial information,
holdings, and proxy voting information, including the information
described in Instructions 2 and 3 to Item 17(f) of Form N-1A. A Fund
also may refer to other information available on this website,
including the information described in Instruction 2 to paragraphs
(a) and (b) of Item 7 of Form N-CSR, if it reasonably believes that
shareholders likely would view the information as important.

Instructions

* * * * *
    3. If a Fund (or financial intermediary through which shares of
the Fund may be purchased or sold) receives a request for the Fund's
proxy voting record by phone or email, the Fund (or financial
intermediary) must send the information disclosed in the Fund's most
recently filed report on Form N-PX in a human-readable format,
within three business days of receipt of the request, by first-class
mail or other means designed to ensure equally prompt delivery.
    4. If a Fund has a website, it must make publicly available free
of charge the information disclosed in the Fund's most recently
filed report on Form N-PX on or through its website as soon as
reasonably practicable after filing the report with the Commission.
The information disclosed in the Fund's most recently filed report
on Form N-PX must be in a human-readable format and remain available
on or through the Fund's website for as long as the Fund remains
subject to the requirements of rule 30b1-4 (17 CFR 270.30b1-4). A
Fund may satisfy the requirement to provide this information in a
human-readable format by providing a direct link to the relevant
HTML-rendered Form N-PX report on EDGAR.
* * * * *

Appendix B--Form N-CSR

FORM N-CSR

* * * * *

Item 7. Financial Statements and Financial Highlights for Open-End
Management Investment Companies.

* * * * *
    Instructions to paragraphs (a) and (b).
    1. The financial statements and financial highlights filed under
this Item must be audited and be accompanied by any associated
accountant's report, as defined in rule 1-02(a) of Regulation S-X
[17 CFR 210.1-02(a)], except that in the case of a report on this
Form N-CSR as of the end of a fiscal half-year, the financial
statements and financial highlights need not be audited.
    2. In the case of a Money Market Fund, Schedule I--Investments
in securities of unaffiliated issuers [17 CFR 210.12-12B] may be
omitted from its financial statements, provided that: (a) the Fund
states in the report that the Fund's complete schedule of
investments in securities of unaffiliated issuers is available (i)
without charge, upon request, by calling a specified toll-free
telephone number; (ii) on the Fund's website, if applicable; and
(iii) on the Commission's website at http://www.sec.gov; and (b)
whenever the Fund (or financial intermediary through which shares of
the Fund may be purchased or sold) receives a request for the Fund's
schedule of investments in securities of unaffiliated issuers, the
Fund (or financial intermediary) sends a copy of Schedule I--
Investments in securities of unaffiliated issuers within 3 business
days of receipt by first-class mail or other means designed to
ensure equally prompt delivery.
* * * * *

Appendix C--Form N-MFP

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BILLING CODE 8011-01-C

Form N-MFP

Monthly Schedule of Portfolio Holdings of Money Market Funds

    Form N-MFP is to be used by registered open-end management
investment companies, or series thereof, that are regulated as money
market funds pursuant to rule 2a-7 under the Investment Company Act of
1940 (``Act'') (17 CFR 270.2a-7) (``money market funds''), to file
reports with the Commission pursuant to rule 30b1-7 under the Act (17
CFR 270.30b1-7). The Commission may use the information provided on
Form N-MFP in its regulatory, disclosure review, inspection, and
policymaking roles.

General Instructions

A. Rule as to Use of Form N-MFP

    Form N-MFP is the public reporting form that is to be used for
monthly reports of money market funds required by section 30(b) of the
Act and rule 30b1-7 under the Act (17 CFR 270.30b1-7). A money market
fund must report information about the fund and its portfolio holdings
as of the last business day or any subsequent calendar day of the
preceding month. The Form N-MFP must be filed with the Commission no
later than the fifth business day of each month, but may be filed any
time beginning on the first business day of the month. Each money
market fund, or series of a money market fund, is required to file a
separate form. If the money market fund does not have any classes, the
fund must provide the information required by Part B for the series. A
money market fund is not required to respond to an item that is wholly
inapplicable. If an item requests information that is not applicable
(for example, a company does not have an LEI), respond N/A.
    A money market fund may file an amendment to a previously filed
Form N-MFP at any time, including an amendment to correct a mistake or
error in a previously filed form. A fund that files an amendment to a
previously filed form must provide information in response to all items
of Form N-MFP, regardless of why the amendment is filed.

B. Application of General Rules and Regulations

    The General Rules and Regulations under the Act contain certain
general requirements that are applicable to reporting on any form under
the Act. These general requirements should be carefully read and
observed in the preparation and filing of reports on this form, except
that any provision in the form or in these instructions shall be
controlling.

C. Filing of Form N-MFP

    A money market fund must file Form N-MFP in accordance with rule
232.13 of Regulation S-T. Form N-MFP must be filed electronically using
the Commission's EDGAR system.

D. Paperwork Reduction Act Information

    A registrant is not required to respond to the collection of
information contained in Form N-MFP unless the Form displays a
currently valid Office of Management and Budget (``OMB'') control
number. Please direct comments concerning the accuracy of the
information collection burden estimate and any suggestions for reducing
the burden to the Secretary, Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090.
    The OMB has reviewed this collection of information under the
clearance requirements of 44 U.S.C. 3507.

E. Definitions

    References to sections and rules in this Form N-MFP are to the
Investment Company Act of 1940 [15 U.S.C. 80a] (the ``Investment
Company Act''), unless otherwise indicated. Terms used in this Form N-
MFP have the same meaning as in the Investment Company Act or related
rules, unless otherwise indicated.
    As used in this Form N-MFP, the terms set out below have the
following meanings:
    ``Cash'' means demand deposits in depository institutions and cash
holdings in custodial accounts.
    ``Class'' means a class of shares issued by a Multiple Class Fund
that represents interests in the same portfolio of securities under
rule 18f-3 [17 CFR 270.18f-3] or under an order exempting the Multiple
Class Fund from sections 18(f), 18(g), and 18(i) [15 U.S.C. 80a-18(f),
18(g), and 18(i)].
    ``Fund'' means the Registrant or a separate Series of the
Registrant. When an item of Form N-MFP specifically applies to a
Registrant or a Series, those terms will be used.
    ``Government Money Market Fund'' means a money market fund as
defined in 17 CFR 270.2a-7(a)(14).
    ``LEI'' means, with respect to any company, the ``legal entity
identifier'' assigned by or on behalf of an internationally recognized
standards setting body and required for reporting purposes by the U.S.
Department of the Treasury's Office of Financial Research or a
financial regulator.
    ``Master-Feeder Fund'' means a two-tiered arrangement in which one
or more Funds (or registered or unregistered pooled investment
vehicles) (each a ``Feeder Fund'') holds shares of a single Fund (the
``Master Fund'') in accordance with section 12(d)(1)(E) [15 U.S.C. 80a-
12(d)(1)(E)].
    ``Money Market Fund'' means a registered open-end management
investment company, or series thereof, that is regulated as a money
market fund pursuant to rule 2a-7 (17 CFR 270.2a-7) under the
Investment Company Act of 1940.
    ``Retail Money Market Fund'' means a money market fund as defined
in 17 CFR 270.2a-7(a)(21).
    ``RSSD ID'' means the identifier assigned by the National
Information Center of the Board of Governors of the Federal Reserve
System, if any.
    ``Securities Act'' means the Securities Act of 1933 [15 U.S.C. 77a-
aa].
    ``Series'' means shares offered by a Registrant that represent
undivided interests in a portfolio of investments and that are
preferred over all other series of shares for assets specifically
allocated to that series in accordance with rule 18f-2(a) [17 CFR
270.18f-2(a)].
    ``Value'' has the meaning defined in section 2(a)(41) of the Act
(15 U.S.C. 80a-2(a)(41)).

Appendix D--Form N-CR

Form N-CR

* * * * *

General Instructions

A. Rule as to Use of Form N-CR

    Form N-CR is the public reporting form that is to be used for
current reports of money market funds required by section 30(b) of
the Act and rule 30b1-8 under the Act. A money market fund must file
a report on Form N-CR upon the occurrence of any one or more of the
events specified in Parts B-F of this form. Unless otherwise
specified, a report is to be filed within one business day after
occurrence of the event. A report will be made public immediately
upon filing. If the event occurs on a Saturday, Sunday, or holiday
on which the Commission is not open for business, then the report is
to be filed on the first business day thereafter.
* * * * *

C. Information To Be Included in Report Filed on Form N-CR

    Upon the occurrence of any one or more of the events specified
in Parts B-F of Form N-CR, a money market fund must file a report on
Form N-CR that includes information in response to each of the items
in Part A of the form, as well as each of the items in the
applicable Parts B-F of the form.

D. Filing of Form N-CR

    A money market fund must file Form N-CR in accordance with rule
232.13 of Regulation S-T. Reports on Form N-CR must be filed
electronically using the Commission's Electronic Data Gathering,
Analysis, and Retrieval (``EDGAR'') system in accordance with
Regulation S-T. Consult the EDGAR Filer Manual and Appendices for
EDGAR filing instructions.
* * * * *

F. Definitions

    References to sections and rules in this Form N-CR are to the
Investment Company Act (15 U.S.C. 80a), unless otherwise indicated.
Terms used in this Form N-CR have the same meaning as in the
Investment Company Act or rule 2a-7 under the Investment Company
Act, unless otherwise indicated.
    In addition, the following definitions apply:
    ``Fund'' means the registrant or a separate series of the
registrant.
    ``LEI'' means, with respect to any company, the ``legal entity
identifier'' as assigned by a utility endorsed by the Global LEI
Regulatory Oversight Committee or accredited by the Global LEI
Foundation.
    ``Registrant'' means the investment company filing this report
or on whose behalf the report is filed.
    ``Series'' means shares offered by a Registrant that represent
undivided interests in a portfolio of investments and that are
preferred over all other series of shares for assets specifically
allocated to that series in accordance with rule 18f-2(a) (17 CFR
270.18f-2(a)).
* * * * *

Part A: General Information

* * * * *
    Item A.2 Name of registrant.
    Item A.3 CIK Number of registrant.
    Item A.4 LEI of registrant.
    Item A.5 Name of series.
    Item A.6 EDGAR Series Identifier.
    Item A.7 LEI of series.
    Item A.8 Securities Act File Number.
    Item A.9 Provide the name, email address, and telephone number
of the person authorized to receive information and respond to
questions about this Form N-CR.
* * * * *

Part C: Provision of Financial Support to Fund

* * * * *
    Item C.6 Security supported (if applicable). Disclose the name
of the issuer, the title of the issue (including coupon or yield, if
applicable), at least two identifiers,

if available (e.g., CUSIP, ISIN, CIK, LEI), and the date the fund
acquired the security.
* * * * *

Part E: Liquidity Threshold Event

    If a fund has invested less than: (i) 25% of its total assets in
weekly liquid assets or (ii) 12.5% of its total assets in daily
liquid assets, disclose the following information:
    Item E.1 Initial date on which the fund invested less than 25%
of its total assets in weekly liquid assets, if applicable.
    Item E.2 Initial date on which the fund invested less than 12.5%
of its total assets in daily liquid assets, if applicable.
    Item E.3 Percentage of the fund's total assets invested in both
weekly liquid assets and daily liquid assets as of any dates
reported in Items E.1 or E.2.
    Item E.4 Brief description of the facts and circumstances
leading to the fund investing less than 25% of its total assets in
weekly liquid assets or less than 12.5% of its total assets in daily
liquid assets, as applicable.
    Instruction. A report responding to Items E.1, E.2, and E.3 is
to be filed within one business day after occurrence of an event
contemplated in this Part E. An amended report responding to Item
E.4 is to be filed within four business days after occurrence of an
event contemplated in this Part E.

Part F: Optional Disclosure

    If a fund chooses, at its option, to disclose any other events
or information not otherwise required by this form, it may do so
under this Item F.1.
    Item F.1 Optional disclosure.
    Instruction. Item F.1 is intended to provide a fund with
additional flexibility, if it so chooses, to disclose any other
events or information not otherwise required by this form, or to
supplement or clarify any of the disclosures required elsewhere in
this form. Part F does not impose on funds any affirmative
obligation. A fund may file a report on Form N-CR responding to Part
F at any time.
* * * * *

Appendix E-Form PF

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[FR Doc. 2023-15124 Filed 8-2-23; 8:45 am]
BILLING CODE 8011-01-C


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Rules and Regulations]
[Pages 11875-11878]
[FR Doc No: 2021-04066]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2020-0186; FRL-10019-56-Region 4]

Air Plan Approval; North Carolina; Revisions to Construction and
Operation Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the North Carolina State Implementation
Plan (SIP) submitted by the State of North Carolina through the North
Carolina Department of Environmental Quality, Division of Air Quality
(DAQ), on July 10, 2019. The SIP revision seeks to modify the State's
construction and operation permitting regulations by making minor
changes that do not significantly alter the meaning of the regulations.
EPA is approving this revision pursuant to the Clean Air Act (CAA or
Act).

DATES: This rule is effective March 31, 2021.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2020-0186. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 can either
be retrieved electronically via www.regulations.gov or in hard copy at
the Air Regulatory Management Section, Air Planning and Implementation
Branch, Air and Radiation Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960.
EPA requests that if at all possible, you contact the person listed in
the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Pearlene Williams, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Williams can also
be reached via phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 10, 2019, the State of North Carolina submitted changes to
the North Carolina SIP for EPA approval. EPA is finalizing changes to
the following regulations under 15A North Carolina Administrative Code
(NCAC) Subchapter 02Q,\1\ Section .0300, Construction and Operation
Permits: Section .0301, Applicability; Section .0303, Definitions;
Section .0304, Applications; Section .0305, Application Submittal
Content; Section .0307, Public Participation Procedures; Section .0308,
Final Action on Permit Applications; Section .0309, Termination,
Modification and Revocation of Permits; Section .0310, Permitting of
Numerous Similar Facilities; Section .0311, Permitting of Facilities at
Multiple Temporary Sites; Section .0312, Application Processing
Schedule; Section .0313, Expedited Application Processing Schedule;
Section .0314, General Requirements for All Permits; Section .0315,
Synthetic Minor Facilities; Section .0316, Administrative Permit
Amendments; and Section .0317, Avoidance Conditions.\2\
---------------------------------------------------------------------------

    \1\ In the table of North Carolina regulations federally
approved into the SIP at 40 CFR 52.1770(c), 15A NCAC 02Q is referred
to as ``Subchapter 2Q Air Quality Permits.''
    \2\ The State submitted the SIP revision following the
readoption of several air regulations, including .0301, .0303,
.0304, .0305, .0307, .0308, .0309, .0310, .0311, .0312, .0313,
.0314, .0315, .0316, and .0317, pursuant to North Carolina's 10-year
regulatory readoption process at North Carolina General Statute
150B-21.3A.
---------------------------------------------------------------------------

II. Analysis of North Carolina's SIP Revision

    The revision that is the subject of this final rulemaking makes
changes to construction and operating permitting regulations under
Subchapter 2Q of the North Carolina SIP. These changes revise the
applicability of permit exemptions, permit application and processing
procedures, and revise related definitions. Details regarding the
background for these changes may be found in the proposed rulemaking
that published October 19, 2020 (85 FR 66296). The comment period for
this rulemaking closed on November 18, 2020. No adverse comments were
received. EPA finds that the changes do not interfere with any
applicable requirement concerning attainment and reasonable further
progress, or any other applicable CAA requirement.
    EPA has determined that the changes to the regulations above
provide clarity to the applicability of permit exemptions, permit
application and processing procedures, and definitions. The changes are
minor changes that do not significantly alter the meaning of the
regulations. The changes to the SIP satisfy CAA section 110(l) and do
not interfere with attainment and maintenance of the national ambient
air quality standards or any other applicable requirement of the Act.
Therefore, EPA is approving the changes to these regulations.

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 following
sections of 15A NCAC Subchapter 2Q with a state-effective date of April
1, 2018: Section .0301, Applicability; Section .0303, Definitions;
Section .0304, Applications; Section .0305, Application Submittal
Content; Section .0307, Public Participation Procedures; Section .0308,
Final Action on Permit Applications; Section .0309, Termination,
Modification and Revocation of Permits; Section .0310, Permitting of
Numerous Similar Facilities; Section .0311, Permitting of Facilities at
Multiple Temporary Sites; Section .0312, Application Processing
Schedule; Section .0313, Expedited Application Processing Schedule;
Section .0314, General Requirements for All Permits; Section .0315,
Synthetic Minor Facilities; Section .0316, Administrative Permit
Amendments; and Section .0317, Avoidance Conditions. This finalization
revises the applicability of permit exemptions, revises permit
application and processing procedures, and amends definitions. EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 4 office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

IV. Final Action

    EPA is approving North Carolina's July 10, 2019, SIP revision,
which contains changes to the following regulations under 15A NCAC
Subchapter 02Q, Section .0300, Construction and Operation Permits:
Section .0301, Applicability; Section .0303, Definitions; Section
.0304, Applications; Section .0305, Application Submittal Content;
Section .0307, Public Participation Procedures; Section .0308, Final
Action on Permit Applications; Section .0309, Termination, Modification
and Revocation of Permits; Section .0310, Permitting of Numerous
Similar Facilities; Section .0311, Permitting of Facilities at Multiple
Temporary Sites; Section .0312, Application Processing Schedule;
Section .0313, Expedited Application Processing Schedule; Section
.0314, General Requirements for All Permits; Section .0315, Synthetic
Minor Facilities; Section .0316, Administrative Permit Amendments; and
Section .0317, Avoidance Conditions. EPA has concluded that these
changes are consistent with the CAA.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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. 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 CAA; 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).
    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 as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 30, 2021. 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

Signing Statement

    This document of the Environmental Protection Agency was signed on
January 7, 2021, by Mary Walker, Regional Administrator, pursuant to
the Statutory Deadline of the Clean Air Act. That document with the
original signature and date is maintained by EPA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned EPA Official re-signs the document
for publication, as an official document of the Environmental
Protection Agency. This administrative process in no way alters the
legal effect of this document upon publication in the Federal Register.

    Dated: February 23, 2021.
John Blevins,
Acting Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 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.

Subpart II--North Carolina

0
2. In 52.1770 amend table 1 in paragraph (c) under Subchapter 02Q Air
Quality Permits under Section .0300, Construction and Operation Permits
by revising the entries for ``Section .0301'', ``Section .0303'',
``Section .0304'', ``Section .0305'', ``Section .0307'', ``Section
.0308'', ``Section .0309'', ``Section .0310'', ``Section .0311'',
``Section .0312'', ``Section .0313'', ``Section .0314'', ``Section
.0315'', ``Section .0316'', and ``Section .0317'' to read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (c) * * *

                                   (1) EPA Approved North Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                                            State
         State citation              Title/subject     effective date   EPA approval date       Explanation
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Subchapter 2Q Air Quality Permits
                                Section .0300 Construction and Operating Permits
----------------------------------------------------------------------------------------------------------------
Section .0301...................  Applicability......        4/1/2018  3/1/2021, [Insert   .....................
                                                                        citation of
                                                                        publication].
Section .0303...................  Definitions........        4/1/2018  3/1/2021, [Insert   .....................
                                                                        citation of
                                                                        publication].
Section .0304...................  Applications.......        4/1/2018  3/1/2021, [Insert   .....................
                                                                        citation of
                                                                        publication].
Section .0305...................  Application                4/1/2018  3/1/2021, [Insert   .....................
                                   Submittal Content.                   citation of
                                                                        publication].

                                                  * * * * * * *
Section .0307...................  Public                     4/1/2018  3/1/2021, [Insert   .....................
                                   Participation                        citation of
                                   Procedures.                          publication].
Section .0308...................  Final Action on            4/1/2018  3/1/2021, [Insert   .....................
                                   Permit                               citation of
                                   Applications.                        publication].

Section .0309...................  Termination,               4/1/2018  3/1/2021, [Insert   .....................
                                   Modification and                     citation of
                                   Revocation of                        publication].
                                   Permits.
Section .0310...................  Permitting of              4/1/2018  3/1/2021, [Insert   .....................
                                   Numerous Similar                     citation of
                                   Facilities.                          publication].
Section .0311...................  Permitting of              4/1/2018  3/1/2021, [Insert   .....................
                                   Facilities at                        citation of
                                   Multiple Temporary                   publication].
                                   Sites.
Section .0312...................  Application                4/1/2018  3/1/2021, [Insert   .....................
                                   Processing                           citation of
                                   Schedule.                            publication].
Section .0313...................  Expedited                  4/1/2018  3/1/2021, [Insert   .....................
                                   Application                          citation of
                                   Processing                           publication].
                                   Schedule.
Section .0314...................  General Permitting         4/1/2018  3/1/2021, [Insert   .....................
                                   for All                              citation of
                                   Requirements.                        publication].
Section .0315...................  Synthetic Minor            4/1/2018  3/1/2021, [Insert   .....................
                                   Facilities.                          citation of
                                                                        publication].
Section .0316...................  Administrative             4/1/2018  3/1/2021, [Insert   .....................
                                   Permit Amendments.                   citation of
                                                                        publication].
Section .0317...................  Avoidance                  4/1/2018  3/1/2021, [Insert   .....................
                                   Conditions.                          citation of
                                                                        publication].

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

* * * * *
[FR Doc. 2021-04066 Filed 2-26-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 7, 2007 (Volume 72, Number 151)]
[Notices]
[Page 44129]
[DOCID:fr07au07-33]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-139-002]

Algonquin Gas Transmission, LLC.; Notice of Compliance Filing

July 31, 2007.
    Take notice that on July 27, 2007, Algonquin Gas Transmission, LLC.
(Algonquin) tendered for filing as part of its FERC Gas Tariff, Fifth
Revised Volume No. 1, the following tariff sheets to become effective
on July 19, 2007:

Substitute Second Revised Sheet No. 512
Substitute Second Revised Sheet No. 513
Substitute Second Revised Sheet No. 514

    Algonquin states that it is making this filing in compliance with
an order issued by the Commission in the captioned docket on July 19,
2007.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15286 Filed 8-6-07; 8:45 am]

BILLING CODE 6717-01-P