[Federal Register Volume 78, Number 203 (Monday, October 21, 2013)]
[Notices]
[Page 62361]
[FR Doc No: 2013-24518]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2277-023]

Union Electric Company (dba Ameren Missouri); Missouri; Taum Sauk
Pumped Storage Project; Notice of Proposed Restricted Service List for
a Programmatic Agreement for Managing Properties Included in or
Eligible for Inclusion in the National Register of Historic Places

    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure \1\ provides that, to
eliminate unnecessary expense or improve administrative efficiency, the
Secretary may establish a restricted service list for a particular
phase or issue in a proceeding. The restricted service list should
contain the names of persons on the service list who, in the judgment
of the decisional authority establishing the list, are active
participants with respect to the phase or issue in the proceeding for
which the list is established.
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    \1\ 18 CFR 385.2010.
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    The Commission staff is consulting with the Missouri State Historic
Preservation Office (Missouri SHPO) and the Advisory Council on
Historic Preservation (Advisory Council) pursuant to the Advisory
Council's regulations, 36 CFR Part 800, implementing section 106 of the
National Historic Preservation Act, as amended, (16 U.S.C. 470f), to
prepare a Programmatic Agreement for managing properties included in,
or eligible for inclusion in, the National Register of Historic Places
that could be affected by issuance of a new license for the Taum Sauk
Pumped Storage Project No. 2277.
    The programmatic agreement, when executed by the Commission and the
Missouri SHPO, would satisfy the Commission's section 106
responsibilities for all individual undertakings carried out in
accordance with the license until the license expires or is terminated
(36 CFR 800.13(e)). The Commission's responsibilities pursuant to
section 106 for the project would be fulfilled through the Programmatic
Agreement, which the Commission staff proposes to draft in consultation
with certain parties listed below. The executed Programmatic Agreement
would be incorporated into any Order issuing a license.
    Union Electric Company (doing business as Ameren Missouri), as
applicant for the Taum Sauk Pumped Storage Project and the Osage Nation
have expressed an interest in this proceeding and are invited to
participate in consultations to develop the Programmatic Agreement. For
purposes of commenting on the programmatic agreement, we propose to
restrict the service list for Project No. 2277 as follows:

John Eddins or Representative, Advisory Council on Historic
Preservation, The Old Post Office Building, Suite 803, 1100
Pennsylvania Avenue NW., Washington, DC 20004.
Judith Deel or Representative, Missouri State Historic Preservation
Office, 1101 Riverside Dr., Jefferson City, MO 65101.
Dr. Andrea A. Hunter or Representative, Osage Nation, Tribal Historic
Preservation Office, 627 Grandview, Pawhuska, Oklahoma 74056.
Michael Lobbig, P.E., PMP or Representative, Managing Supervisor, Hydro
Licensing, Dam Safety & Hydro Engineering Department, Ameren Missouri,
Power Operations Services, 3700 S. Lindbergh Blvd., St. Louis, Missouri
63127.

    Any person on the official service list for the above-captioned
proceeding may request inclusion on the restricted service list, or may
request that a restricted service list not be established, by filing a
motion to that effect within 15 days of this notice date. In a request
for inclusion, please identify the reason(s) why there is an interest
to be included. Also please identify any concerns about historic
properties, including Traditional Cultural Properties. If historic
properties are to be identified within the motion, please use a
separate page, and label it NON-PUBLIC Information.
    The Commission strongly encourages electronic filing. Please file
motions using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-2277-023.
    If no such motions are filed, the restricted service list will be
effective at the end of the 15 day period. Otherwise, a further notice
will be issued ruling on any motion or motions within the 15-day
period.

    Dated: October 11, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24518 Filed 10-18-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58803-58806]
[FR Doc No: 2022-20828]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0987]

Policy for Coronavirus Disease--2019 Tests During the Public
Health Emergency (Revised); Immediately in Effect Guidance for
Commercial Manufacturers 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 a final guidance document related to the
Coronavirus Disease 2019 (COVID-19) public health emergency (PHE)
entitled ``Policy for Coronavirus Disease--2019 Tests During the Public
Health Emergency (Revised).'' FDA is issuing this guidance to provide
FDA's revised enforcement policies and review priorities regarding
certain novel coronavirus (COVID-19) tests for the duration of the
public health emergency. Rapid detection of COVID-19 cases in the
United States requires wide availability of testing to control the
spread of this highly contagious infection. This document supersedes
``Policy for Coronavirus Disease--2019 Tests During the Public Health
Emergency (Revised)'' issued November 15, 2021. The guidance identified
in this notice addresses issues related to the COVID-19 PHE and has
been issued in accordance with the expedited process FDA announced in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. This guidance has been implemented
without prior comment, but it remains subject to comment in accordance
with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on September 28, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0987 for ``Policy for Coronavirus Disease--2019 Tests During
the Public Health Emergency (Revised).'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for a single hard copy of the guidance
document entitled ``Policy for Coronavirus Disease--2019 Tests During
the Public Health Emergency (Revised)'' to the Office of Policy, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Toby Lowe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance entitled
``Policy for Coronavirus Disease--2019 Tests During the Public Health
Emergency (Revised),'' which supersedes the guidance of the same title
issued November 15, 2021. FDA is issuing this guidance to provide FDA's
updated enforcement policies and review priorities regarding certain
novel coronavirus (COVID-19) tests for the duration of the public
health emergency. Rapid detection of COVID-19 cases in the United
States requires wide availability of testing to control the spread of
this highly contagious infection.
    Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360bbb-3), the FDA Commissioner may authorize the use
of unapproved medical products, or unapproved uses of approved medical
products, in certain emergency circumstances, after the HHS Secretary
has made a declaration of emergency or threat justifying authorization
of emergency use, to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by chemical, biological,
radiological, and nuclear threat agents when certain criteria are met
(emergency use authorization (EUA)). As of August 15, 2022, FDA has
authorized under EUA more than 439 tests for COVID-19, including more
than 354 diagnostic and 85 serology or other immune response tests.
Further, two molecular diagnostic COVID-19 tests have been granted
marketing authorization through the traditional device premarket review
pathways.
    In the context of a public health emergency involving pandemic
infectious disease, it is critically important that tests are validated
because false results not only can negatively impact the individual
patient but also can have a broad public health impact. False positive
results for diagnostic tests, for example, can lead to unnecessary
quarantine and potential further spread when presumed positive
individuals are quarantined together, wasted contact tracing and
testing resources, and delay in accurate diagnosis and appropriate
treatment for the individual. False negative results can lead to lack
of appropriate treatment for the individual and further spread of the
disease.
    FDA has continued to closely monitor the COVID-19 testing landscape
and believes it is appropriate to update its policies to reflect the
current needs of the pandemic. As explained throughout this updated
guidance, FDA intends to review the EUA requests for a smaller subset
of tests. Traditional marketing pathways remain available to all
developers and FDA encourages developers of tests that fall outside the
scope of the priorities outlined in this updated guidance to pursue
those routes. In sum, FDA has revised this guidance to update the types
of COVID-19 tests for which the Agency intends to review EUA requests,
to discuss the use of the traditional premarket review pathways for
other types of COVID-19 tests for which the Agency does not intend to
review EUA requests, and to make minor updates to the enforcement
policies.
    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
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    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.

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    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced various procedures for
making available FDA guidances related to the COVID-19 PHE. The March
25, 2020, notice stated that due to the need to act quickly and
efficiently to respond to the COVID-19 PHE and to allow FDA to rapidly
disseminate Agency recommendations and policies related to COVID-19 to
industry, FDA staff, and other stakeholders, prior public participation
would not be feasible or appropriate before FDA implemented COVID-19-
related guidances. FDA will continue to issue COVID-19-related
guidances for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and
Sec.  10.115(g)(2)). The guidances are available on FDA's web pages
entitled ``COVID-19-Related Guidance Documents for Industry, FDA Staff,
and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and ``Search for
FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.) Although this guidance has
been implemented immediately without prior comment, FDA will consider
all comments received and revise the guidance as appropriate (see Sec.
10.115(g)(3)).
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). The guidance represents the
current thinking of FDA. 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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (PRA). The collections of
information in the following FDA regulations and guidances have been
approved by OMB as listed in the table below. This guidance also
contains a new collection of information not approved under a current
collection. The new collection of information has been granted a public
health emergency (PHE) waiver from the PRA by the Department of Health
and Human Services (HHS) on March 19, 2020, under section 319(f) of the
PHS Act. Information concerning the PHE PRA waiver can be found on the
HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

----------------------------------------------------------------------------------------------------------------
                                                                                New collection covered by
        21 CFR part or guidance                    Topic             OMB control No.         PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization of Medical   Emergency Use                      0910-0595  .........................
 Products and Related Authorities;        Authorization.
 Guidance for Industry and Other
 Stakeholders.
``Administrative Procedures for CLIA     Administrative Procedures          0910-0607  .........................
 Categorization; Guidance for Industry    for Clinical Laboratory
 and Food and Drug Administration         Improvement Amendments
 Staff'' and ``Recommendations for        of 1988 Categorization.
 Clinical Laboratory Improvement
 Amendments of 1988 (CLIA) Waiver
 Applications for Manufacturers of In
 Vitro Diagnostic Devices; Guidance for
 Industry and Food and Drug
 Administration Staff''.
803....................................  Medical devices; medical           0910-0437  .........................
                                          device reporting;
                                          manufacturer reporting,
                                          importer reporting, user
                                          facility reporting,
                                          distributor reporting.
807, subpart E.........................  Premarket notification...          0910-0120  .........................
814, subparts A through E..............  Premarket approval.......          0910-0231  .........................
860, subpart D.........................  De Novo classification             0910-0844  .........................
                                          process.
``Requests for Feedback and Meetings     Q-submissions; pre-                0910-0756  .........................
 for Medical Device Submissions: The Q-   submissions.
 Submission Program''.
                                                                                Voluntary templates to
                                                                                facilitate the
                                                                                preparation and
                                                                                submission of an
                                                                                Emergency Use
                                                                                Authorization request
                                                                                for various types of
                                                                                COVID-19 tests.
----------------------------------------------------------------------------------------------------------------

III. Electronic Access

    Persons with access to the internet may obtain the guidance at:
     FDA web page entitled ``Guidance Documents (Medical
Devices and Radiation-Emitting Products)'' available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products;
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/
covid-19-

related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: September 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20828 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 102 (Wednesday, May 27, 2020)]
[Notices]
[Pages 31783-31785]
[FR Doc No: 2020-11306]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1875]

Financial Transparency and Efficiency of the Prescription Drug
User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee
Amendments; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
hosting a virtual public meeting entitled ``Financial Transparency and
Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee
Act, and Generic Drug User Fee Amendments,'' and an opportunity for
public comment. This public meeting will take place virtually due to
extenuating circumstances and will be held by webcast only.

DATES: The public meeting will take place remotely on June 22, 2020,
from 9 a.m. to 11 a.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 22, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 22, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1875 for ``Financial Transparency and Efficiency of
Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic
Drug User Fee Amendments; Public Meeting; Request for Comments.''
Received comments, those filed in a timely manner, will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Monica Ellerbe, Office of Finance,
Budget and Acquisitions, 4041 Powder Mill Rd., Rm. 72044, Beltsville,
MD 20750,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The public meeting will include presentations from FDA on: (1) The
5-year plans for the Prescription Drug User Fee Act (PDUFA) VI,
Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee
Amendments (GDUFA) II; (2) the Agency's progress in implementing
resource capacity planning and modernized time reporting; and (3) the
Agency's progress in addressing the findings from the independent third
party evaluation of the resource management associated with PDUFA,
BsUFA, and GDUFA that concluded and was published in fiscal year (FY)
2019. This meeting is intended to satisfy FDA's commitment to host an
annual public meeting in the third quarter of each fiscal year
beginning in FY 2019 and can be found in the Commitment letters listed
below (II.B.3 of PDUFA VI (p. 38), IV.B.3 of BsUFA II (p. 28), and
VI.B.4 of GDUFA II (p.22)).
    This public meeting is intended to meet performance commitments
included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs
were reauthorized as part of the FDA Reauthorization Act of 2017
(FDARA) (Pub. L. 115-52) signed by the President on August 18, 2017.
The complete set of performance goals for each program are available
at:
     PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf;
     BsUFA II program: https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf; and
     GDUFA II program: https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf.
    Each of these user fee programs included a set of commitments
related to financial management. These included commitments to publish
a 5-year financial plan that should be updated annually, develop
resource capacity planning capability and to modernize time reporting
practices, and have a third-party evaluation of resource management
practices for these user fee programs. In addition, each user fee
program includes a commitment to host a public meeting in the third
quarter of each fiscal year, beginning in FY 2019, to discuss specific
topics.

II. Topics for Discussion at the Public Meeting

    This public meeting will provide FDA the opportunity to update
interested public stakeholders on topics related to the financial
management of PDUFA VI, BsUFA II, and GDUFA II. FDA will present the 5-
year financial plans for each of these programs and update participants
on the progress towards implementing resource capacity planning and
modernizing its time reporting approach. In addition, FDA will provide
an update on the Agency's progress in addressing the findings from the
independent third party evaluation of the resource management
associated with PDUFA, BsUFA, and GDUFA that concluded and was
published in FY 2019. To view the evaluation assessment report, please
visit here: https://www.fda.gov/media/127605/download.

III. Attending the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://www.eventbrite.com/e/public-meeting-financial-transparency-and-efficiency-of-user-fee-programs-registration-101672491158. Please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone.
    Persons interested in attending this public meeting must register
by June 19, 2020, at 11:59 p.m. Eastern Time. Registrants will receive
confirmation once they have been accepted. We will let registrants know
if registration closes before the day of the public meeting.
    If you need special accommodations due to a disability, please
contact Monica Ellerbe no later than June 15, 2020, 11:59 p.m. Eastern
Time.
    Streaming Webcast of the Public Meeting: The webcast for this
public meeting is https://collaboration.fda.gov/fdafinancial062220/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/

help/en/support/meeting_test.htm. To get a quick overview of the
Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

    Dated: May 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11306 Filed 5-26-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Page 13709]
[FR Doc No: 2017-05012]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Certification
and Operation FAR 125

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a previously approved
information collection. 14 CFR 125 prescribes requirements for issuing
operating certificates and for appropriate operating rules. In addition
to the statutory basis, the collection of this information is necessary
to issue, reissue, or amend applicant's operating certificates and
operations specifications.

DATES: Written comments should be submitted by May 15, 2017.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Room 441, Federal Aviation Administration, ASP-110, 950
L'Enfant Plaza SW., Washington, DC 20024.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson by email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0085.
    Title: Certification and Operation FAR 125.
    Form Numbers: None.
    Type of Review: Renewal of an information collection.
    Background: 14 CFR part 125 prescribes requirements for leased
aircraft, aviation service firms, and air travel. A letter of
application and related documents which set forth an applicant's
ability to conduct operations in compliance with the provisions of 14
CFR part 125 are submitted to the appropriate Flight Standards District
Office (FSDO). Inspectors in FAA FSDO's review the submitted
information to determine certificate eligibility.
    Respondents: Approximately 163 certificated operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1.33 hours.
    Estimated Total Annual Burden: 61,388 hours.

    Issued in Washington, DC, on February 1, 2017.
Ronda L. Thompson,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2017-05012 Filed 3-13-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 11, 2007 (Volume 72, Number 69)]
[Notices]
[Page 18230-18231]
[DOCID:fr11ap07-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP01-205-014]

Southern Natural Gas Company; Notice of Negotiated Rate Tariff
Filing

April 5, 2007.
    Take notice that on March 30, 2007, Southern Natural Gas Company
(Southern) tendered for filing as part of its FERC Gas Tariff, Seventh
Revised Volume No. 1, Eleventh Revised Sheet No. 23, with an effective
date of May 1, 2007.
    Southern states that the filing is being filed to reflect two
negotiated rate transactions are between BG Energy Merchants LLC and
Florida Power Corporation d/b/a Progress Energy Florida, Inc.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the 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

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6799 Filed 4-10-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11193-11194]
[FR Doc No: 2018-05107]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR18-17-000]

TransMontaigne Product Services LLC v. Colonial Pipeline Company;
Notice of Complaint

    Take notice that on March 1, 2018, pursuant to Rule 206 of the
Rules of the Practice and Procedure of the Federal Energy Regulatory
Commission (Commission) 18 CFR 385.206 (2017), Part 343 of the
Commission's Rules and Regulations, 18 CFR 343 et seq. (2017) and
sections 1(5), 6, 8, 9, 13, 15 and 16 of the Interstate Commerce Act,
49 U.S.C. App 1(5), 6, 8, 9, 13,15, and 16 and Section 1803 of the
Energy Policy Act of 1992, TransMontaigne Product Services LLC
(TransMontaigne or Complainant) filed a complaint against Colonial
Pipeline Company (Colonial or Respondent) challenging that the justness
and reasonableness of the rates charged by Colonial for transportation
service pursuant to certain tariffs on file with the Commission, all as
more fully explained in the complaint.
    TransMontaigne certifies that copies of the complaint were served
on the contacts for Colonial as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the

website that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email [email protected], or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 2, 2018.

    Dated: March 6, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-05107 Filed 3-13-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Page 21702]
[FR Doc No: 2013-08498]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-02]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before May 1, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2012-
1348 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tyneka Thomas ARM-105,<PHONE_NUMBER>,
FAA, Office of Rulemaking, 800 Independence Ave. SW., Washington, DC
20591. This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on April 8, 2013.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2012-1348.
    Petitioner: Flight Safety International, Inc.
    Section of 14 CFR Affected: 14 CFR 60.17(c)(ii).
    Description of Relief Sought: The relief sought would allow Flight
Safety International, Inc., to re-qualify an Embraer Flight Simulation
Training Device under the qualification basis to which it was
originally qualified.

[FR Doc. 2013-08498 Filed 4-10-13; 8:45 am]
BILLING CODE 4910-13-P


production during the 12 months before the compliance deadline for the
affected source under this rule. The determination may take into
account requirements under a legally and practicably enforceable limit
in an operating permit or other federally enforceable requirement. You
must reevaluate the source-wide VOC emissions from the collection of
all storage vessels, glycol dehydrators and pneumatic pumps for each
modification to an existing source; or
    (2) For oil and natural gas sources that began operations on or
after February 6, 2023, the VOC emissions control requirements of this
section apply upon startup of operation.
    (3) Modification to an oil and natural gas source requires a re-
evaluation of the source-wide VOC emissions from the collection of all
storage vessels, glycol dehydrators and pneumatic pumps. Adding
production from a new well or increasing production at an existing well
is considered a modification of a well site. Increasing maximum
throughput at a tank battery, compressor station or natural gas
processing plant is considered a modification.
    (b) Exemptions. (1) This section does not apply to storage vessels
located at an oil and natural gas source that are subject to the
emissions control requirements for storage vessels in 40 CFR part 60,
subparts OOOO or OOOOa, or 40 CFR part 63, subpart HH.
    (2) This section does not apply to an emergency storage vessel
located at an oil and natural gas source, if it meets the following
requirements:
    (i) The emergency storage vessel is not used as an active storage
vessel;
    (ii) The owner or operator empties the emergency storage vessel no
later than 15 days after receiving fluids;
    (iii) The emergency storage vessel is equipped with a liquid level
gauge or equivalent device; and
    (iv) Records are kept of the usage of each emergency storage vessel
as required in Sec.  49.4183(a)(3), including the date the vessel
received fluids, the volume of fluids received in barrels, the date the
vessel was emptied, and the volume of fluids emptied in barrels.
    (3) This section does not apply to storage vessels that are removed
from service. If you remove a storage vessel from service, you must
comply with paragraphs (b)(3)(i) through (iii) of this section.

    (i) For a storage vessel to be removed from service, you must
comply with the requirements of paragraphs (b)(3)(i)(A) and (B) of this
section.
    (A) You must completely empty and degas the storage vessel, such
that the storage vessel no longer contains crude oil, condensate,
intermediate hydrocarbon liquids or produced water. A storage vessel
where liquid is left on walls, as bottom clingage, or in pools due to
floor irregularity is considered to be completely empty.
    (B) You must keep records as required in Sec.  49.4183(a)(4),
identifying each storage vessel removed from service and the date of
its removal from service.
    (ii) If a storage vessel identified in paragraph (b)(3)(i)(B) of
this section is returned to service, you must determine its
applicability as provided in paragraph (a) of this section, and you
must keep records as required in Sec.  49.4183(a)(4), identifying the
storage vessel and the date of its return to service.
    (c) VOC emission control requirements. For each storage vessel, you
must comply with the VOC emissions control requirements of paragraph
(c)(1) or (c)(2) of this section.
    (1) You must reduce VOC emissions from each storage vessel by at
least 95.0 percent on a continuous basis according to paragraph
(c)(1)(i) or (ii) of this section. You must equip each storage vessel
with a cover that meets the conditions specified in Sec.  49.4176(c),
and must route all flashing, working, standing and breathing losses
from the storage vessels through a closed-vent system that meets the
conditions specified in Sec.  49.4176(d) to:
    (i) An operating system designed to recover 100 percent of the
emissions and recycle them for use in a process unit or incorporate
them into a product; or
    (ii) An enclosed combustor or flare that is designed to reduce the
mass content of VOC in the natural gas emissions vented to the device
by at least 95.0 percent and that is operated as specified in Sec.
49.4177;
    (2) You must maintain the source-wide uncontrolled actual VOC
emissions from the collection of all storage vessels, glycol
dehydrators, and pneumatic pumps at an oil and natural gas source at
less than 4 tpy. Before using the uncontrolled actual VOC emission rate
for compliance purposes, you must demonstrate that the uncontrolled
actual VOC emissions have remained at less than 4 tpy, as determined
monthly for 12 consecutive months. After such demonstration, you must
determine the uncontrolled actual VOC emission rate each month. The
uncontrolled actual VOC emissions must be calculated using a generally
accepted model or calculation methodology. Monthly calculations must be
based on the average throughput of the source for the month. Monthly
calculations must be separated by at least 14 days. You must comply
with paragraph (c)(1) of this section within 30 days of the monthly
emissions determination required in this section if the determination
indicates that VOC emissions from the collection of all storage
vessels, glycol dehydrators, and pneumatic pumps at your oil and
natural gas source increased to 4 tpy or greater.
    (3) Except as provided in paragraph (c)(4) of this section, if you
use a control device to reduce emissions from your storage vessels, you
must equip each storage vessel with a cover that meets the requirements
of Sec.  49.4176(c).
    (4) If you use a floating roof to reduce emissions, you must meet
the requirements of Sec.  60.112b(a)(1) or (2) and the relevant
monitoring, inspection, recordkeeping, and reporting requirements in 40
CFR part 60, subpart Kb.
    (5) After a minimum of 12 consecutive months of operation at a
source that begins operation on or after February 6, 2023, controls may
be removed if the source-wide uncontrolled actual VOC emissions from
the collection of all storage vessels, glycol dehydrators, and
pneumatic pumps has been maintained at a rate less than 4 tpy, as
determined according to paragraph (c)(2) of this section.

Sec.  49.4174   VOC emissions control requirements for dehydrators.

    (a) Applicability. The VOC emissions control requirements of this
section apply to each glycol dehydration unit located at an oil and
natural gas source as identified in Sec.  49.4169(b) where the source-
wide potential for VOC emissions from the collection of all storage
vessels, glycol dehydrators, and pneumatic pumps is equal to or greater
than 4 tpy, as determined according to Sec.  49.4173. You must
reevaluate the source-wide VOC emissions from the collection of all
storage vessels, glycol dehydrators and pneumatic pumps for each
modification to an existing source, as described in Sec.
49.4173(a)(3). Applicability for glycol dehydrators that began
operation before February 6, 2023 must be determined using uncontrolled
actual emissions. Applicability for glycol dehydrators that began
operation on or after February 6, 2023 must be determined using
potential to emit.
    (b) Exemptions. This section does not apply to glycol dehydration
units subject to the emissions control requirements for glycol
dehydration unit process vents in 40 CFR part 63, subpart HH.
    (c) VOC emissions control requirements. For each glycol dehydration
unit, you must comply with the VOC emissions control requirements of
paragraphs (c)(1) or (2) of this section.
    (1) You must reduce VOC emissions from each glycol dehydration unit
process vent by at least 95.0 percent on a continuous basis according
to paragraphs (c)(1)(i) and (ii) of this section. You must route all
glycol dehydration unit process vent emissions through a closed-vent
system that meets the conditions specified in Sec.  49.4176(d) to:
    (i) An operating system designed to recover 100 percent of the
emissions and recycle them for use in a process unit or incorporate
them into a product; or
    (ii) An enclosed combustor or flare designed to reduce the mass
content of VOC in the emissions vented to the device by at least 95.0
percent and operated as specified in Sec.  49.4177; or
    (2) You must maintain the source-wide uncontrolled actual VOC
emissions from the collection of all storage vessels, glycol
dehydrators, and pneumatic pumps at an oil and natural gas source at
less than 4 tpy for 12 consecutive months in accordance with the
procedures specified in Sec.  49.4173(c)(2).

Sec.  49.4175  VOC emissions control requirements for pneumatic pumps.

    (a) Applicability. The requirements of this section apply to each
pneumatic pump located at an oil and natural gas source as identified
in Sec.  49.4169(b) where the source-wide potential for VOC emissions
from the collection of all storage vessels, glycol dehydrators, and
pneumatic pumps is equal to or greater than 4 tpy, as determined
according to Sec.  49.4173. You must reevaluate the source-wide VOC
emissions from the collection of all storage vessels, glycol
dehydrators and pneumatic pumps for each modification to an existing
source, as described in Sec.  49.4173(a)(3). Applicability for
pneumatic pumps that began operation before February 6, 2023 must be
determined using uncontrolled actual emissions. Applicability for
pneumatic pumps that began operation on or after February 6, 2023 must
be determined using potential to emit.
    (b) Exemptions. This section does not apply to pneumatic pumps
subject to the emissions control requirements for pneumatic pumps in 40
CFR part 60, subpart OOOOa.

    (c) VOC Emission Control Requirements. For each pneumatic pump, you
must comply with the VOC emissions control requirements of paragraph
(c)(1) or (2) of this section.
    (1) You must reduce VOC emissions from each pneumatic pump by at
least 95.0 percent on a continuous basis according to paragraph
(c)(1)(i) or (ii) of this section. You must route all pneumatic pump
emissions through a closed-vent system that meets the conditions
specified in Sec.  49.4176(d) to:
    (i) An operating system designed to recover 100 percent of the
emissions and recycle them for use in a process unit or incorporate
them into a product; or
    (ii) An enclosed combustor or flare designed to reduce the mass
content of VOC in the emissions vented to the device by at least 95.0
percent and operated as specified in Sec.  49.4177; or
    (2) You must maintain the source-wide uncontrolled actual VOC
emissions from the collection of all storage vessels, glycol
dehydrators, and pneumatic pumps at an oil and natural gas source at
less than 4 tpy for any 12 consecutive months in accordance with the
procedures specified in Sec.  49.4173(c)(2).

Sec.  49.4176  VOC emissions control requirements for covers and
closed-vent systems.

    (a) Applicability. The VOC emissions control requirements in this
section apply to each cover on a storage vessel that is subject to
Sec.  49.4173, and to each closed-vent system that is used to convey
VOC emissions from the collection of all storage vessels, glycol
dehydration units, or pneumatic pumps (to a vapor recovery system or
control device) that are subject to Sec. Sec.  49.4173 through 49.4175.
    (b) Exemptions. This section does not apply to covers and closed-
vent systems that are subject to the requirements for covers and
closed-vent systems in 40 CFR part 60, subparts OOOO or OOOOa, or 40
CFR part 63, subpart HH.
    (c) Covers. Each owner or operator must equip all openings on each
storage vessel with a cover to ensure that all flashing, working,
standing and breathing loss emissions are routed through a closed-vent
system to a vapor recovery system, an enclosed combustor, or a flare.
    (1) Each cover and all openings on the cover (e.g., access hatches,
sampling ports, pressure relief valves (PRV), and gauge wells) must
form a continuous impermeable barrier over the entire surface area of
the crude oil, condensate, intermediate hydrocarbon liquids, or
produced water in the storage vessel.
    (2) Each cover opening must be secured in a closed, sealed position
(e.g., covered by a gasketed lid or cap) whenever material is in the
unit on which the cover is installed except when it is necessary to use
an opening as follows:
    (i) To add fluids to, or remove fluids from the unit (this includes
openings necessary to equalize or balance the internal pressure of the
unit following changes in the level of the material in the unit);
    (ii) To inspect or sample the fluids in the unit; or
    (iii) To inspect, maintain, repair, or replace equipment located
inside the unit.
    (3) Each thief hatch cover must be weighted and properly seated to
ensure that flashing, working, standing, and breathing loss emissions
are routed through the closed-vent system to the vapor recovery system,
the enclosed combustor, or the flare under normal operating conditions.
    (4) Each PRV must be set to release at a pressure that will ensure
that flashing, working, standing, and breathing loss emissions are
routed through the closed-vent system to the vapor recovery system, the
enclosed combustor, or the flare under normal operating conditions.
    (d) Closed-vent systems. Each owner or operator must meet the
following requirements for closed-vent systems:
    (1) Each closed-vent system must route all captured storage vessel
emissions from flashing, working, standing, and breathing losses;
glycol dehydration unit process vent emissions; and pneumatic pump
emissions from the oil and natural gas source to a gathering pipeline
system for sale, use in a process unit, incorporation into a product,
or other beneficial purpose, or to a VOC emission control device, as
specified in Sec. Sec.  49.4173 through 49.4175.
    (2) All vent lines, connections, fittings, valves, relief valves,
and any other appurtenances employed to collect or contain captured
storage vessel emissions from flashing, working, standing, and
breathing losses; glycol dehydration unit process vent emissions; or
pneumatic pump emissions; or to transport such emissions to a gathering
pipeline system for sale, use in a process unit, incorporation into a
product, or other beneficial purpose, or to a VOC emission control
device, as specified in Sec. Sec.  49.4173 through 49.4175, must be
maintained and operated properly at all times.
    (3) Each closed-vent system must be designed to operate with no
detectable emissions, as demonstrated by the closed-vent system
monitoring requirements in Sec.  49.4182(c).
    (4) If any closed-vent system contains one or more bypass devices
that could be used to divert all or a portion of the captured storage
vessel flashing, working, standing, and breathing losses; glycol
dehydration unit process vent emissions; or pneumatic pump emissions
from entering a gathering pipeline system for sale, use in a process
unit, incorporation into a product, or other beneficial purpose, or
from being transferred to the VOC emissions control device, the owner
or operator must meet one of the requirements in paragraphs (d)(4)(i)
or (ii) of this section for each bypass device. Low leg drains, high
point bleeds, analyzer vents, open-ended valves or lines, and safety
devices are not subject to the requirements applicable to bypass
devices.
    (i) At the inlet to a bypass device the owner or operator must
properly install, calibrate, maintain, and operate a flow indicator
that is capable of taking continuous readings and sounding an alarm
when the bypass device is open such that emissions are being, or could
be, diverted away from a gathering pipeline system for sale, use in a
process unit, incorporation into a product, or other beneficial
purpose, or the VOC emission control device and into the atmosphere; or
    (ii) The owner or operator must secure the bypass device valve
installed at the inlet to the bypass device in the non-diverting
position using a car-seal or a lock-and-key type configuration.

Sec.  49.4177   VOC emissions control devices.

    (a) Applicability. The requirements in this section apply to all
flares and enclosed combustors used to control VOC emissions at an oil
and natural gas source, as identified in Sec.  49.4169(b), in order to
meet the requirements specified in Sec. Sec.  49.4173 through 49.4176,
as applicable.
    (b) Exemptions. This section does not apply to VOC emission control
devices that are subject to the requirements for control devices used
to comply with the emissions standards in 40 CFR part 60, subparts OOOO
or OOOOa; or 40 CFR part 63, subpart HH.
    (c) Enclosed combustors and flares. Each owner or operator must
meet the following requirements for enclosed combustors and flares:
    (1) For each enclosed combustor or flare, the owner or operator
must follow the manufacturer's written operating instructions,
procedures, and

maintenance schedule to ensure good air pollution control practices for
minimizing emissions;
    (2) The owner or operator must ensure that each enclosed combustor
or flare is designed to have sufficient capacity to reduce the mass
content of VOC in the captured emissions routed to it by at least 95.0
percent for the minimum and maximum natural gas volumetric flow rate
and BTU content routed to the device;
    (3) Each enclosed combustor or flare must be operated to reduce the
mass content of VOC in the captured emissions routed to it by
continuously meeting at least 95.0 percent VOC control efficiency;
    (4) The owner or operator must ensure that each flare is designed
and operated in accordance with the requirements of 40 CFR 60.18(b) for
such flares;
    (5) The owner or operator must ensure that each enclosed combustor
is:
    (i) A model that is:
    (A) Demonstrated by a manufacturer to meet the VOC control
efficiency requirements of Sec. Sec.  49.4173 through 49.4176 using
EPA-approved performance test procedures specified in 40 CFR 60.5413;
or
    (B) Demonstrated by the owner or operator to meet the VOC control
efficiency requirements of Sec. Sec.  49.4173 through 49.4176 according
to the procedures and schedule specified in Sec.  49.4182(d)(1);
    (ii) Operated properly at all times that captured emissions are
routed to it;
    (iii) Operated with a liquid knock-out system to collect any
condensable vapors (to prevent liquids from going through the control
device);
    (iv) Equipped and operated with a flash-back flame arrestor;
    (v) Equipped and operated with one of the following:
    (A) A continuous burning pilot; or
    (B) An operational electronically controlled automatic ignition
device;
    (vi) Equipped with a monitoring system for continuous measuring and
recording of the parameters that indicate proper operation of each
enclosed combustor or flare, including each continuous burning pilot
flame or electronically controlled automatic ignition device, to
monitor and document proper operation of the enclosed combustor or
flare. Examples of such continuous monitoring systems may include a
thermocouple and a chart recorder, data logger or similar device, or
connection to a SCADA system;
    (vii) Maintained in a leak-free condition; and
    (viii) Operated with no visible smoke emissions.
    (d) Other control devices. Upon prior written approval by the EPA,
the owner or operator may use control devices other than those listed
above that are determined by the EPA to be capable of reducing the mass
content of VOC in the natural gas routed to it by at least 95.0
percent, provided that:
    (1) In operating such control devices, the owner or operator must
follow the manufacturer's written operating instructions, procedures
and maintenance schedule to ensure good air pollution control practices
for minimizing emissions; and
    (2) The owner or operator must ensure there is sufficient capacity
to reduce the mass content of VOC in the produced natural gas and
natural gas emissions routed to such other control devices by at least
95.0 percent for the minimum and maximum natural gas volumetric flow
rate and BTU content routed to each device.
    (3) The owner or operator must operate such a control device to
reduce the mass content of VOC in the produced natural gas and natural
gas emissions routed to it by at least 95.0 percent.

Sec.  49.4178   VOC emissions control requirements for fugitive
emissions.

    (a) Applicability. The requirements of this section apply to all
owners or operators of the collection of fugitive emissions components,
as defined in Sec.  49.4171, located at any oil and natural gas source,
as identified in Sec.  49.4169(b), except that this section does not
apply to owners or operators of the collection of fugitive emissions
components at an oil and natural gas source that is subject to the
fugitive emissions monitoring requirements in 40 CFR part 60, subpart
OOOOa.
    (b) Owners or operators of the collection of fugitive emissions
components must comply with paragraph (d) of this section if either of
the following is true:
    (1) The collection of fugitive emissions components is located at
an oil and natural gas source that is required to control VOC emissions
according to Sec. Sec.  49.4173 through 49.4177 of this section (i.e.,
the source-wide potential for VOC emissions from the collection of all
storage vessels, glycol dehydrators, and pneumatic pumps is equal to or
greater than 4 tpy, as determined according to Sec.  49.4173(a)(1)); or
    (2) The collection of fugitive emissions components is located at a
well site, as defined in 40 CFR 60.5430a, that at any time has total
production greater than 15 barrels of oil equivalent (boe) per day
based on a rolling 12-month average.
    (c) Owners or operators of the collection of fugitive emissions
components for which neither (b)(1) nor (b)(2) is true must comply with
either paragraph (c)(1) or paragraph (c)(2) of this section.
    (1) You must monitor all fugitive emissions components and repair
all sources of fugitive emissions in accordance with paragraph (d) of
this section. You must keep records in accordance with Sec.  49.4183
and report in accordance with Sec.  49.4184; or
    (2) You must maintain the total production for the well site at or
below 15 boe per day based on a rolling 12-month average. You must
demonstrate that the total daily oil and natural gas production from
the collection of all wells producing to the well site is at or below
15 boe per day, based on a 12-month rolling average, according to the
procedures in paragraph (e) of this section. You must maintain records
as specified in Sec.  49.4183(a)(11).
    (d) Monitoring requirements. (1) Each owner or operator must
develop and implement a fugitive emissions monitoring plan to reduce
emissions from fugitive emissions components at all of their oil and
natural gas sources on Indian country lands within the U&O Reservation.
This Reservation-wide monitoring plan must include the following
elements, at a minimum:
    (i) A requirement to perform an initial monitoring of the
collection of fugitive emissions components at each oil and natural gas
source by February 6, 2024;
    (ii) A requirement to perform subsequent monitoring of the
collection of fugitive emissions components at each oil and natural gas
source once every 6 months after the initial monitoring survey, with
consecutive monitoring surveys conducted at least 4 months apart and no
more than 7 months apart.
    (iii) A description of the technique used to identify leaking
fugitive emission components, which must be limited to:
    (A) Onsite EPA Reference Method 21, 40 CFR part 60, appendix A,
where an analyzer reading of 500 parts per million volume (ppmv) VOC or
greater is considered a leak in need of repair;
    (B) Onsite optical gas imaging instruments, as defined in 40 CFR
60.18(g)(4), where any visible emissions are considered a leak in need
of repair, unless the owner or operator evaluates the leak with an
analyzer meeting EPA Reference Method 21 at 40 CFR part 60, appendix A,
and the concentration is less than 500 ppmv. The optical gas imaging
instrument must be capable of meeting the optical gas imaging

equipment requirements specified in 40 CFR part 60, subpart OOOOa; or
    (C) Another method approved by the Administrator to demonstrate
compliance with the fugitive emissions monitoring requirements. To be
approved, you must demonstrate that the alternative method achieves
emissions reductions that equal or exceed those that would result from
the application of either Method 21 or optical gas imaging instruments.
Approval of an alternative method will be subject to public notice and
comment.
    (iv) The manufacturer and model number of any fugitive emissions
monitoring device to be used;
    (v) Procedures and timeframes for identifying and repairing
components from which leaks are detected, including:
    (A) A requirement to repair any leaks identified from components
that are safe to repair and do not require source shutdown as soon as
practicable, but no later than 30 calendar days after discovering the
leak;
    (B) Timeframes for inspecting and repairing leaking components that
are difficult-to-monitor, unsafe-to-monitor, or require source
shutdown, to be no later than the next required monitoring event, as
noted in paragraphs (c)(1)(v)(B)(1) through (3) of this section:
    (1) If using Method 21, fugitive emissions components that cannot
be monitored without elevating the monitoring personnel more than 2
meters above the surface may be designated as difficult-to-monitor and
must meet the specifications in paragraphs (c)(1)(v)(B)(1)(i) through
(iv) of this section:
    (i) For all fugitive emissions components designated difficult-to-
monitor, a written plan must be developed and incorporated into the
fugitive emissions monitoring plan.
    (ii) The plan must include the identification and location of each
fugitive emissions component designated difficult-to-monitor.
    (iii) The plan must include an explanation of why each fugitive
emissions component designated as difficult-to-monitor is difficult-to-
monitor.
    (iv) The plan must include a schedule for monitoring the difficult-
to-monitor fugitive emissions components at least once per calendar
year and a schedule for repairing such fugitive emissions components
according to paragraph (c)(1)(v)(B)(3) of this section;
    (2) Fugitive emissions components that cannot be monitored because
monitoring personnel would be exposed to an immediate danger while
conducting a monitoring survey may be designated as unsafe-to-monitor
and must meet the specification in paragraphs (c)(1)(v)(B)(2)(i)
through (iv) of this section:
    (i) A written plan must be developed for all of the fugitive
emissions components designated unsafe-to-monitor and incorporated into
the fugitive emissions monitoring plan;
    (ii) The plan must include the identification and location of each
fugitive emissions component designated unsafe-to-monitor.
    (iii) The plan must include an explanation of why each fugitive
emissions component designated as unsafe-to-monitor is unsafe-to-
monitor.
    (iv) The plan must include a schedule for monitoring the unsafe-to-
monitor fugitive emissions components as frequently as practicable
during safe to inspect times and for repairing such fugitive emissions
components according to paragraph (c)(1)(v)(B)(3) of this section;
    (3) If the repair or replacement of a fugitive emissions component
designated difficult-to-monitor or unsafe-to-monitor is technically
infeasible; would require a vent blowdown, a compressor station
shutdown, a well shutdown, or well shut-in; or would be unsafe to
repair during operation of the unit, the repair or replacement must be
completed during the next scheduled compressor station shutdown, well
shutdown, or well shut-in; after a planned vent blowdown; or within 2
years, whichever is earlier; and
    (C) Procedures for verifying leaking component repairs, no more
than 30 calendar days after repairing the leak;
    (vi) Training and experience needed before performing surveys;
    (vii) Procedures for calibration and maintenance of any fugitive
emissions monitoring device to be used; and
    (viii) Standard monitoring protocols for each type of typical oil
and natural gas source (e.g., well site, tank battery, compressor
station), including a general list of component types that will be
inspected and what supporting data will be recorded (e.g., wind speed,
detection method device-specific operational parameters, date, time,
and duration of inspection).
    (2) The owner or operator is exempt from inspecting and repairing a
fugitive emissions component under any of the following circumstances:
    (i) The contacting process stream only contains glycol, amine,
methanol, or produced water; or
    (ii) The component to be inspected is buried, insulated in a manner
that prevents access to the components by a monitor probe or optical
gas imaging device, or obstructed by equipment or piping that prevents
access to the components by a monitor probe or optical gas imaging
device.
    (e) Procedures for determining total well site production. The
total well site production must be determined according to the
following procedures:
    (1) Calculate the total average boe per day for each calendar month
using:
    (i) For existing well sites, the records of production for the
first 30 days after becoming subject to this section.
    (ii) For well sites that commence construction, reconstruction or
modification on or after February 6, 2023, the first 30 days of
production, performing the calculation within 45 days of the end of the
first 30 days of production.
    (2) Determine the daily oil and natural gas production for each
individual well at the well site for the month. To convert gas
production to equivalent barrels of oil, divide the cubic feet of gas
produced by 6,000.
    (3) Sum the daily production for each individual well at the well
site to determine the total well site production and divide by the
total number of days in the calendar month. This is the average daily
total well site production for the month.
    (4) Use the result determined in paragraph (e)(2) of this section
and average with the daily average well site production values
determined for each of the preceding 11 months to calculate the rolling
12-month average of the total well site production.

Sec.  49.4179   VOC emissions control requirements for tank truck
loading.

    (a) Applicability. The requirements in this section apply to each
owner or operator who loads or permits the loading of any intermediate
hydrocarbon liquid or produced water at an oil and natural gas source
as identified in Sec.  49.4169(b).
    (b) Tank truck loading requirements. Tank trucks used for
transporting intermediate hydrocarbon liquid or produced water must be
loaded and unloaded using measures to minimize VOC emissions. These
measures must include, at a minimum, bottom filling or a submerged fill
pipe, as defined in Sec.  49.4171(b).

Sec.  49.4180   VOC emissions control requirements for pneumatic
controllers.

    (a) Applicability. The VOC emissions control requirements in this
section apply to each owner or operator of any existing pneumatic
controller located at an oil and natural gas source as identified in
Sec.  49.4169(b).

    (b) Exemptions. This section does not apply to pneumatic
controllers subject to and controlled in accordance with the
requirements for pneumatic controllers in 40 CFR part 60, subparts OOOO
or OOOOa.
    (c) Retrofit requirements. All existing pneumatic controllers must
meet the standards established for pneumatic controllers that are
constructed, modified, or reconstructed on or after October 15, 2013,
as specified in 40 CFR part 60, subpart OOOO.
    (d) Documentation requirements. The owner or operator of any
existing pneumatic controllers must meet the tagging requirements in 40
CFR 60.5390(a), except that the month and year of installation,
reconstruction or modification is not required.

Sec.  49.4181   Other combustion devices.

    (a) Applicability. The VOC emission control requirements in this
section apply to each owner or operator of any existing enclosed
combustor or flare located at an oil and natural gas source as
identified in Sec.  49.4169(b) that is used to control VOC emissions,
but that is not required under Sec. Sec.  49.4173 through 49.4175 of
this rule.
    (b) Retrofit requirements. All existing enclosed combustors and
flares must be equipped with an operational electronically controlled
automatic ignition device.

Sec.  49.4182   Monitoring and testing requirements.

    (a) Applicability. The monitoring and testing requirements in
paragraphs (c) and (d) of this section apply, as appropriate, to each
oil and natural gas source as identified in Sec.  49.4169(b) with
equipment or activities that are subject to Sec. Sec.  49.4173 through
49.4177.
    (b) Exemptions. Paragraphs (c) and (d) of this section do not apply
to any storage vessels, glycol dehydration units, pneumatic pumps,
covers, or closed-vent systems, or to VOC emission control devices
subject to and monitored in accordance with the monitoring requirements
for such equipment and activities in 40 CFR part 60, subparts OOOO or
OOOOa, or 40 CFR part 63, subpart HH.
    (c) Each owner or operator must inspect each cover and closed-vent
system as specified in paragraphs (c)(1) or (2).
    (1) Conduct olfactory, visual, and auditory inspections at least
once every calendar month, separated by at least 15 days between each
inspection, of each cover and closed-vent system, including each bypass
device, and each storage vessel thief hatch, seal, and pressure relief
valve, to ensure proper condition and functioning of the equipment to
identify defects that can result in air emissions according to the
procedures. Examples of defects are visible cracks, holes, or gaps in
the cover or piping, or between the cover and the separator wall; loose
connections; liquid leaks; and broken, cracked, or otherwise damaged
seals or gaskets on closure devices, caps, or other closure devices. If
the storage vessel is partially or entirely buried, you must inspect
only those portions of the cover that extend to or above the ground
surface, and those connections that are on such portions of the cover
(e.g., fill ports, access hatches, gauge wells) and can be opened to
the atmosphere. The inspector should note whether there are signs of
oil releases around storage vessel thief hatches, seals and pressure
relief valves (e.g., staining on the storage vessel), which may
indicate over-pressure events that occurred when the storage vessel was
being filled. Any defects identified must be corrected or repaired
within 30 days of identification.
    (2) Conduct optical gas imaging inspections of each cover and
closed vent system for any visible emissions at the same frequency as
the frequency for the collection of fugitive emissions components
located at the oil and natural gas source, as specified in Sec.
49.4178(d)(1).
    (d) Each owner or operator must monitor the operation of each
enclosed combustor and flare to confirm proper operation and
demonstrate compliance with the requirements of Sec.  49.4177(c), as
follows and as applicable:
    (1) Demonstrate compliance with the requirement of Sec.
49.4177(c)(5)(i)(B) that each enclosed combustor must be demonstrated
by the owner or operator to meet the VOC control efficiency
requirements of Sec. Sec.  49.4173 through 49.4176, by conducting
performance tests using EPA-approved performance test methods and
procedures specified in 40 CFR 60.5413 and according to the schedule
specified in paragraphs (d)(1)(i) and (ii) of this section.
    (i) You must conduct an initial performance test within 180 days
after the effective date of this rule for existing enclosed combustors,
and within 180 days after initial startup for new enclosed combustors.
You must submit the performance test results as specified in Sec.
49.4184(a) within 60 days of completing the test.
    (ii) You must conduct periodic performance tests for all enclosed
combustors required to conduct initial performance tests. You must
conduct the first periodic performance test no later than 60 months
after the initial performance test required in paragraph (d)(1)(i) of
this section. You must conduct subsequent periodic performance tests at
intervals no longer than 60 months following the previous periodic
performance test or whenever you desire to establish a new operating
limit. You must submit the periodic performance test results as
specified in Sec.  49.4184(a) within 60 days of completing each test.
    (iii) The owner or operator of an enclosed combustor whose model is
tested under, and meets the criteria of, Sec.  49.4177(c)(5)(i)(A) is
not required to conduct performance testing.
    (2) Conduct inspections of each enclosed combustor or flare at
least once every calendar month, separated by at least 15 days between
each inspection, to confirm proper operation of the device, as follows:
    (i) Demonstrate that each enclosed combustor or flare is operated
with no visible smoke emissions, except for periods not to exceed a
total of 1 minute during any 15-minute period, by conducting a visible
emissions test using section 11 of EPA Method 22 of appendix A-7 of 40
CFR part 60. The observation period must be of sufficient length to
meet the requirement for determining compliance with this visible
emissions standard. Devices failing the visible emissions test must
follow manufacturer's repair instructions, if available, or best
combustion engineering practice as outlined in the unit inspection and
maintenance plan, to return the unit to compliant operation. All
inspection, repair, and maintenance activities for each unit must be
recorded in a maintenance and repair log and must be available for
inspection. Following return to operation from maintenance or repair
activity, each device must pass a Method 22 of Appendix A-7 of 40 CFR
part 60 visual observation as described in this paragraph.
    (ii) Conduct visual inspections to confirm that the pilot is lit
when vapors are being routed to the device and that the continuous
burning pilot or electronically controlled automatic ignition device
and the continuous parameter monitoring system is operating properly;
    (iii) Conduct olfactory, visual and auditory inspections of all
other equipment associated with the combustion device to ensure system
integrity; and
    (iv) Respond to any indication of pilot flame failure and ensure
that the pilot flame is relit as soon as practically and safely
possible after discovery.
    (e) Where sufficient to meet the monitoring requirements in this
section,

the owner or operator may use a SCADA system to monitor and record the
required data.

Sec.  49.4183   Recordkeeping requirements.

    (a) Each owner or operator of an oil and natural gas source as
identified in Sec.  49.4169(b) must maintain the following records, as
applicable:
    (1) Monthly calculations, as specified in Sec.  49.4173(c)(2),
demonstrating that the uncontrolled actual VOC emissions from the
collection of all storage vessels, glycol dehydrators, and pneumatic
pumps at an oil and natural gas source, as identified in Sec.
49.4169(b), have been maintained at less than 4 tpy;
    (2) Records of monthly and rolling 12-month crude oil, condensate,
intermediate hydrocarbon liquids, produced water or natural gas
throughput;
    (3) For each emergency storage vessel that is exempted from the
control requirements of Sec.  49.4173(b)(2), records of usage
including:
    (i) The date the vessel received fluids;
    (ii) The volume of fluids received in barrels;
    (iii) The date the overflow vessel was emptied; and
    (iv) The volume of fluids emptied in barrels.
    (4) Identification of each storage vessel that is removed from
service or returned to service as specified in Sec.  49.4173(b)(3),
including the date the storage vessel was removed from service or
returned to service.
    (5) For storage vessels that are skid-mounted or permanently
attached to something that is mobile (such as trucks, railcars, barges
or ships), records indicating the number of consecutive days that the
vessel is located at an oil and natural gas source. If a storage vessel
is removed from an oil and natural gas source and, within 30 days, is
either returned to the source or replaced by another storage vessel at
the source to serve the same or similar function, then the entire
period since the original storage vessel was first located at the
source, including the days when the storage vessel was removed, must be
added to the count of the number of consecutive days.
    (6) For each enclosed combustor or flare at an oil and natural gas
source required under Sec. Sec.  49.4173 through 49.4177:
    (i) Manufacturer-written, site-specific designs, operating
instructions, operating procedures and maintenance schedules, including
those of any operation monitoring systems;
    (ii) Date of installation;
    (iii) Records of required monitoring of operations in Sec.
49.4182(d)(1);
    (iv) Records of any instances in which the pilot flame is not
present or the monitoring equipment is not functioning in the enclosed
combustor or flare, the date and times of the occurrence, the
corrective actions taken, and any preventative measures adopted to
prevent recurrence of the occurrence; and
    (v) Records of any visible emissions tests conducted according to
Sec.  49.4182(d)(3), including any time periods in which visible smoke
emissions are observed emanating from the enclosed combustor or flare.
    (7) For each closed-vent system:
    (i) The date of installation; and
    (ii) Records of any instances in which any closed-vent system or
control device was bypassed or down, the reason for each incident, its
duration, and the corrective actions taken, and any preventative
measures adopted to avoid such bypasses or downtimes.
    (8) Documentation of all storage vessel and closed-vent system
inspections required in Sec.  49.4182(c). All inspection records must
include the following information:
    (i) The date of the inspection;
    (ii) The findings of the inspection;
    (iii) Any adjustments or repairs made as a result of the
inspection, and the date of the adjustment or repair; and
    (iv) The inspector's name or identification number;
    (9) The Uinta Basin-wide fugitive emissions monitoring plan for the
Indian country lands within the U&O Reservation, including all elements
required by Sec.  49.4178(d).
    (10) Documentation of each fugitive emissions inspection conducted
in accordance with Sec.  49.4178(d). All inspection records must
include the following information:
    (i) The date of the inspection;
    (ii) The identification of any component that was determined to be
leaking;
    (iii) The identification of any component designated difficult-to-
monitor or unsafe-to-monitor that was not inspected, and the reason it
was not inspected;
    (iv) The date of the first attempt to repair the leaking component;
    (v) The identification of any leaking component with a delayed
repair and the reason for the delayed repair:
    (A) For unavailable parts:
    (1) The date of ordering a replacement component; and
    (2) The date the replacement component was received; and
    (B) For a shutdown:
    (1) The reason the repair is technically infeasible;
    (2) The date of the shutdown;
    (3) The date of subsequent startup after a shutdown; and
    (4) Emission estimates of the shutdown and the repair if the delay
is longer than 6 months;
    (vi) The date and description of any corrective action taken,
including the date the component was verified to no longer be leaking;
    (vii) The identification of each component exempt under Sec.
49.4178(d)(2), including the type of component and a description of the
qualifying exemption; and
    (viii) The inspector's name or identification number.
    (11) For each well site complying with either Sec.  49.4178(b)(2)
or Sec.  49.4178(c)(2), you must maintain records of the rolling 12-
month average daily production no later than 12 months before complying
with Sec.  49.4178(b)(2) or Sec.  49.4178(c)(2).
    (12) For each electronically controlled automatic ignition system
required under Sec.  49.4181, records demonstrating the date of
installation and manufacturer specifications; and
    (13) For each retrofitted pneumatic controller, the records
required in 40 CFR 60.5420(c)(4)(i).
    (b) Each owner or operator must keep all records required by this
section onsite at the source or at the location that has day-to-day
operational control over the source and must make the records available
to the EPA upon request.
    (c) Each owner or operator must retain all records required by this
section for a period of at least 5 years from the date the record was
created.

Sec.  49.4184   Notification and reporting requirements.

    (a) Unless otherwise specified, each owner or operator must submit
any documents required under this rule to: U.S. EPA Region 8,
Enforcement and Compliance Assurance Division, Air and Toxics
Enforcement Branch, 8ENF-AT, 1595 Wynkoop St., Denver, CO 80202, or
documents may be submitted electronically to
[email protected] and/or to the EPA's Compliance and
Emissions Data Reporting Interface (CEDRI). Information on CEDRI is
available at https://www.epa.gov/electronic-reporting-air-emissions/cedri; CEDRI can be accessed directly through the EPA's Central Data
Exchange (CDX) at https://cdx.epa.gov/. The EPA will make all the
information submitted through CEDRI available to the public without
further notice to you. Do not use CEDRI to submit information you claim
as confidential business information (CBI). Anything submitted using
CEDRI cannot

later be claimed CBI. Although we do not expect persons to assert a
claim of CBI, if you wish to assert a CBI claim, you must submit a
complete file, including the information claimed to be CBI, on a
compact disc, flash drive, or other commonly used electronic storage
media to the EPA, and the electronic media must be clearly marked as
CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group
Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd.,
Durham, NC 27703. The same information, with the CBI omitted, must be
submitted to the EPA via [email protected] or the EPA's
CDX as described earlier in this paragraph. All claims of CBI must be
asserted at the time of submission. Furthermore, under CAA section
114(c), emissions data is not entitled to confidential treatment, and
the EPA is required to make emissions data available to the public.
Thus, emissions data will not be protected as CBI and will be made
publicly available.
    (b) Each owner and operator of an affected oil and natural gas
source as identified in Sec.  49.4169(b) must submit an annual report
containing the information specified in paragraphs (b)(1) through (3)
of this section, as applicable. The annual report must cover affected
operations for the previous calendar year. The initial annual report is
due April 1st of the calendar year following February 6, 2023 and must
cover all affected operations for the previous calendar year on and
after February 6, 2023. Subsequent annual reports are due on the same
date each year as the date the initial annual report was submitted. If
you own or operate more than one oil and natural gas source, you may
submit one report for multiple oil and natural gas sources, provided
the report contains all of the information required as specified in
paragraphs (b)(1) through (3) of this section. Annual reports may
coincide with title V, NSPS OOOO or OOOOa, or NESHAP HH reports as long
as all the required elements of the annual report are included. An
alternative schedule on which the annual report must be submitted will
be allowed as long as the schedule does not extend the reporting
period. The annual report must include:
    (1) The owner or operator name, and the name and location (decimal
degree latitude and longitude location indicating the datum used in
parentheses) of each oil and natural gas source being included in the
annual report.
    (2) The beginning and ending dates of the reporting period.
    (3) For each oil and natural gas source, a summary of the required
records specified in Sec.  49.4183 that are identified in paragraphs
(b)(3)(i) through (iv) of this section as they relate to the source's
compliance with the requirements of Sec. Sec.  49.4173 through 49.4183.
    (i) For each enclosed combustor or flare at an oil and natural gas
source required under Sec. Sec.  49.4173 through 49.4177:
    (A) Records of any instances in which the pilot flame is not
present or the monitoring equipment is not functioning, the date and
times of the occurrence, the corrective actions taken, and any
preventative measures adopted to prevent recurrence of the occurrence;
and
    (B) Records of any time periods in which visible smoke emissions
are observed emanating from the enclosed combustor or flare.
    (ii) For each closed-vent system:
    (A) Records of any instances in which any closed-vent system or
control device was bypassed or down, the reason for each incident, its
duration, the corrective actions taken, and any preventative measures
adopted to avoid such bypasses or downtimes; and
    (B) Records of any instances of defects identified during the
monthly inspection required in Sec.  49.4182(c), including:
    (1) The date of the inspection;
    (2) The findings of the inspection;
    (3) Date and description of corrective adjustments or repairs made
as a result of the inspection or reason for delay of repair; and
    (iii) For Fugitive Emissions Monitoring, records documenting each
fugitive emissions inspection, including:
    (A) The date of the inspection;
    (B) Identification of any component that was determined to be
leaking;
    (C) Identification of any component designated difficult-to-monitor
or unsafe-to-monitor that was not inspected and the reason it was not
inspected;
    (D) The date of repair of each leaking component;
    (E) Identification of any leaking component with a delayed repair,
the reason for the delayed repair and the emission estimates associated
with any shutdown and repair if the delay is longer than 6 months;
    (F) The date and description of any corrective action taken,
including the date the component was verified to no longer be leaking;
    (G) The inspector's name or identification number;
    (H) For each well site complying with Sec.  49.4178(c)(2), you must
specify that the well site is exempt from the requirements of Sec.
49.4178(d) and submit the average daily production for the well site;
and
    (iv) For each pneumatic controller with a natural gas bleed rate
greater than the applicable standard, records of the reason for the use
of the controller.

[FR Doc. 2022-24677 Filed 12-7-22; 8:45 am]
BILLING CODE 6560-50-P