[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15417-15422]
[FR Doc No: 2023-05094]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2007-D-0369, FDA-2008-D-0610, FDA-2015-D-1211, FDA-
2021-D-0409, FDA-2020-D-0987, FDA-2020-D-1057, FDA-2020-D-1106, FDA-
2020-D-1106-0002, FDA-2020-D-1108, FDA-2020-D-1136, FDA-2020-D-1137,
FDA-2020-D-1138, FDA-2020-D-1139, FDA-2020-D-1140, FDA-2020-D-1304,
FDA-2020-D-1370, FDA-2020-D-1386, FDA-2020-D-1414, FDA-2020-D-1824,
FDA-2020-D-1825, FDA-2020-D-2016, FDA-2021-D-1311]

Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: On February 9, 2023, the Secretary of Health and Human
Services (HHS) renewed the Coronavirus Disease 2019 (COVID-19) public
health emergency declaration issued under section 319 of the Public
Health Service Act (PHS Act) (``PHE declaration''), effective February
11, 2023. The declaration is expected to expire at the end of the day
on May 11, 2023. The Food and Drug Administration (FDA, Agency, or we)
has issued guidance documents to address the circumstances of the
public health emergency and, more generally, COVID-19. Many of those
guidance documents are tied to the duration of the PHE declaration.
This notice is intended to provide clarity to stakeholders with respect
to the guidance documents that will no longer be effective with the
expiration of the PHE declaration and the guidances that FDA is
revising to continue in effect after the expiration of the PHE
declaration.

FOR FURTHER INFORMATION CONTACT: Diane Maloney, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Kimberly
Thomas, Center for Drug Evaluation and Research, Food and Drug
Administration (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 6282,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Philip Chao, Center for
Food Safety and Applied Nutrition (CFSAN), CPK1 Rm. 1C001, HFS-024,
Food and Drug Administration, College Park, MD 20740,<PHONE_NUMBER>;
Diane Heinz, Center for Veterinary Medicine (CVM), Food and Drug
Administration, 7500 Standish Pl., HFV-6, Rockville, MD 20855, 240-402-
5692; Amanda Wulf, Office of Regulatory Affairs (ORA), Food and Drug
Administration, 12420 Parklawn Dr., ELEM-4044, Rockville, MD 20857,
301-796-8856.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
prior Secretary of HHS, pursuant to the authority under section 319 of
the PHS Act (42 U.S.C. 247d), determined that a PHE existed (COVID-19
PHE) and had existed since January 27, 2020, nationwide.\1\ On February
9, 2023, the Secretary of HHS renewed the COVID-19 PHE declaration,
effective February 11, 2023. On February 9, based on current COVID-19
trends, HHS announced that it is planning for the declaration to expire
at the end of the day on May 11, 2023. (HHS, Fact Sheet: COVID-19
Public Health Emergency Transition Roadmap (February 9, 2023),
available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-
covid-19-public-health-emergency-transition-
roadmap.html#:~:text=Based%20on%20current%20COVID%2D19,day%20on%20May%20
11%2C%202023).
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    \1\ Secretary of HHS, ``Determination that a Public Health
Emergency Exists'' (originally issued on January 31, 2020, and
subsequently renewed, pursuant to the authority under section 319 of
the PHS Act), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. There are additional types of
determinations and declarations related to emergencies, including
public health emergencies, that are distinct from a PHE declared
pursuant to section 319 of the PHS Act. For instance, the
determination and declarations made under section 564 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), which enable the issuance
of Emergency Use Authorizations (EUAs), are independent from a
declaration under section 319 of the PHS Act.
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    Since the start of the COVID-19 pandemic in 2020, FDA has issued
more than 80 COVID-19-related guidances (not including revisions). In
the Federal Register of March 25, 2020 (85 FR 16949) (available at
https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf),
FDA announced general procedures for making available FDA guidances
related to the COVID-19 PHE. We have updated or otherwise modified our
COVID-19-related guidances in response to comments received, as
appropriate, and as relevant needs and circumstances evolved throughout
the COVID-19 PHE. We have withdrawn, and announced the

withdrawal of, several COVID-19-related guidances after determining
that the policies no longer represented the Agency's current
thinking.\2\ In December 2021, we issued a draft guidance ``Transition
Plan for Medical Devices That Fall Within Enforcement Policies Issued
During the COVID-19 Public Health Emergency'' (``draft device
enforcement policy transition guidance'') that describes FDA's proposed
plans for devices that fall within the enforcement policies of certain
device guidances issued during the COVID-19 PHE.\3\ FDA intends to
finalize the draft guidance as soon as practicable. In the Federal
Register of December 8, 2022 (87 FR 75275), FDA announced the
availability of a final guidance ``Recommendations to Reduce the Risk
of Transfusion-Transmitted Malaria,'' which replaced the COVID-19-
related guidance FDA issued in April 2020, and is available at https://www.fda.gov/media/163737/download.
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    \2\ See 86 FR 55620 (October 6, 2021), available at https://www.federalregister.gov/documents/2021/10/06/2021-21798/guidance-documents-related-to-coronavirus-disease-2019-availability; 86 FR
56960 (October 13, 2021), available at https://www.federalregister.gov/documents/2021/10/13/2021-22108/alcohol-based-hand-sanitizer-products-withdrawal-of-three-temporary-guidance-documents-issued-during; 87 FR 34691 (June 7, 2022),
available at https://www.federalregister.gov/documents/2022/06/07/2022-12176/effects-of-the-covid-19-public-health-emergency-on-formal-meetings-and-user-fee-applications-for; 87 FR 78111 (December
21, 2022), available at https://www.federalregister.gov/documents/2022/12/21/2022-27673/enforcement-policy-regarding-federal-veterinarian-client-patient-relationship-requirements-to; 88 FR 8872
(February 10, 2023), available at https://www.federalregister.gov/documents/2023/02/10/2023-02809/temporary-policy-on-repackaging-or-combining-propofol-drug-products-during-the-covid-19-public. In
addition, one guidance document entitled ``Policy for Certain REMS
Requirements During the Tocilizumab Shortage Related to the COVID-19
Public Health Emergency'' stated it would ``remain in effect for the
duration of the tocilizumab shortage''; because the tocilizumab
shortage resolved on March 30, 2022, the guidance is no longer in
effect (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/withdrawn-guidances-biologics).
    \3\ See 86 FR 72973 (December 23, 2021). Concurrent with
issuance of the draft device enforcement policy transition guidance,
FDA also issued ``Transition Plan for Medical Devices Issued
Emergency Use Authorizations (EUAs) During the COVID-19 Public
Health Emergency,'' which described and sought comment on FDA's
general recommendations for a transition for devices issued EUAs.
See 86 FR 72978 (December 23, 2021). FDA also intends to finalize
this guidance as soon as practicable.
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    Circumstances have changed since 2020 when FDA first began issuing
guidances to support COVID-19 response efforts. For example, several
COVID-19 guidances were developed to help address supply chain
disruptions. In several instances, supply chains have stabilized and
the relevant COVID-19 guidances are no longer needed. Some COVID-19
guidances were issued to clarify previously issued recommendations by
tailoring them to specific considerations for the pandemic. Because
these COVID-19 guidances will not be needed when the PHE declaration
expires, FDA is not extending them. In other instances, the science
behind certain recommendations has advanced, and FDA may want to update
certain guidances to reflect new data.
    This notice addresses the 72 COVID-19-related guidance documents
that are currently in effect and listed below. Most of these COVID-19-
related guidances state that they are intended to remain in effect only
for the duration of the COVID-19 PHE declaration. In light of HHS's
recent announcement that the PHE declaration is expected to expire on
May 11, 2023, FDA has reviewed these COVID-19-related guidance
documents and has examined whether any of the guidances should be
continued past expiration of the PHE declaration--for example, to
provide stakeholders including industry, healthcare providers,
patients, consumers, and FDA time to transition from policies adopted
and operations implemented during the COVID-19 PHE.
    Based on this review, in this notice, FDA is announcing that the
COVID-19-related guidances listed in section II, table 1 will no longer
be in effect when the PHE declaration expires. FDA also is announcing
that the COVID-19-related guidance documents listed in section III,
table 2 of this notice are being revised to continue in effect for 180
days after the PHE declaration expires, then will no longer be in
effect. The guidance documents listed in section IV, table 3 of this
notice are being revised to continue in effect for 180 days after the
PHE declaration expires, during which time FDA plans to further revise
these guidances. Finally, this notice lists, in section V, table 4,
COVID-19-related guidance documents whose intended duration is not tied
to the COVID-19 PHE and that will remain in effect when the COVID-19
PHE declaration expires.
    FDA's revision of the guidances in section III, table 2 and section
IV, table 3 so that they continue in effect for a brief period after
expiration of the PHE declaration constitutes a minor change under 21
CFR 10.115(c)(2) and (g)(4). Even if these revisions were not minor
changes, FDA has determined that obtaining comment prior to
implementation is not feasible or appropriate, given the need for an
orderly transition and given that the PHE declaration is anticipated to
expire on May 11, 2023. Moreover, FDA already has solicited comments on
these policies, through dockets for the guidances, and we have taken
the comments received into account in issuing this notice. This period
of time will provide an opportunity for stakeholders to transition from
policies adopted and operations implemented during the COVID-19 PHE
(see section III, table 2 below) or for FDA to further revise or
otherwise update the guidance (see section IV, table 3 below). Although
the changes to continue the guidances in section III, table 2 and
section IV, table 3 for a brief period after the PHE declaration
expires are being implemented immediately without prior comment, FDA
will consider all comments received and revise the guidances as
appropriate.
    As the COVID-19 pandemic evolves, FDA continues to assess the needs
and circumstances related to the policies in our COVID-19-related
guidances, and we may alter our approach for individual guidances
listed in this notice. For instance, FDA could withdraw a guidance
before the COVID-19 PHE declaration expires should reassessment show
policy reflected in a particular guidance document is no longer needed.
However, should FDA alter our approach for particular guidances, we
will do so consistent with our good guidance practices regulation (21
CFR 10.115).

II. COVID-19 Guidance Documents That Will No Longer Be in Effect Upon
Expiration of the COVID-19 PHE Declaration

    FDA has identified 22 COVID-19-related guidances that should no
longer be in effect upon expiration of the COVID-19 PHE declaration.
Most of these guidances state that they are intended to remain in
effect only for the duration of the declared COVID-19 PHE. FDA has
assessed the needs and circumstances related to the policies
articulated in the 22 guidances listed in table 1. FDA also has
considered comments submitted to the dockets for these guidances, and
our experience with implementation. Upon review, FDA continues to
believe that it is appropriate for these guidances to end when the PHE
declaration expires.
    While generally intended to be in effect for the duration of the
COVID-19 PHE declaration, five guidances listed in table 1 also
indicated that FDA expected their recommendations would continue to
assist the Agency and/or stakeholders outside the expiration of the PHE
declaration, otherwise reflected FDA's current thinking, or were
proposed to be extended in the draft device enforcement policy
transition guidance.

Upon assessment of these guidances, FDA has found that these will no
longer be needed because the recommendations are described in other
guidance documents or the conditions related to the COVID-19 PHE as
outlined in the guidances have changed and stakeholders have resumed or
adjusted operations and are no longer relying on the guidances.
Therefore, FDA has concluded it is appropriate for these five
guidances, marked with an asterisk in table 1, to end upon expiration
of the PHE declaration.
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    \4\ While the guidance document entitled ``Exemption and
Exclusion from Certain Requirements of the Drug Supply Chain
Security Act During the COVID-19 Public Health Emergency'' will no
longer be in effect when the COVID-19 PHE declared under section 319
of the PHS Act expires, the Agency retains authority under section
582(a) of the FD&C Act (21 U.S.C. 360eee-1(a)) to grant waivers,
exemptions, and exceptions to allow for continued distribution of
covered COVID-19 Drug Supply Chain Security Act products, as
appropriate, which may be used to avoid disruption beyond the
expiration of such declaration.

  Table 1--Guidance Documents That Will No Longer Be in Effect Upon Expiration of the COVID-19 PHE Declaration
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
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FDA-2020-D-1137............................  CBER......................  Manufacturing Considerations for
                                                                          Licensed and Investigational Cellular
                                                                          and Gene Therapy Products During COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1136............................  CDER......................  COVID-19 Public Health Emergency Policy
                                                                          on COVID-19-Related Sanitation
                                                                          Tunnels.
FDA-2021-D-1311............................  CDER......................  Nonclinical Considerations for
                                                                          Mitigating Nonhuman Primate Supply
                                                                          Constraints Arising from the COVID-19
                                                                          Pandemic.*
FDA-2020-D-1136............................  CDER......................  Development of Abbreviated New Drug
                                                                          Applications During the COVID-19
                                                                          Pandemic--Questions and Answers.
FDA-2020-D-1136............................  CDER......................  Protecting Participants in
                                                                          Bioequivalence Studies for Abbreviated
                                                                          New Drug Applications During the COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1136............................  CDER......................  Review Timelines for Applicant
                                                                          Responses to Complete Response Letters
                                                                          When a Facility Assessment Is Needed
                                                                          During the COVID-19 Public Health
                                                                          Emergency Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Resuming Normal Drug and Biologics
                                                                          Manufacturing Operations During the
                                                                          COVID-19 Public Health Emergency.*
FDA-2020-D-1136............................  CDER......................  Good Manufacturing Practice
                                                                          Considerations for Responding to COVID-
                                                                          19 Infection in Employees in Drug and
                                                                          Biological Products Manufacturing.*
FDA-2020-D-1136............................  CDER......................  Statistical Considerations for Clinical
                                                                          Trials During the COVID-19 Public
                                                                          Health Emergency.
FDA-2020-D-1136............................  CDER......................  Effects of the COVID-19 Public Health
                                                                          Emergency on Formal Meetings and User
                                                                          Fee Applications--Questions and
                                                                          Answers.
FDA-2020-D-1136............................  CDER......................  Temporary Policy for Compounding of
                                                                          Certain Drugs for Hospitalized
                                                                          Patients by Outsourcing Facilities
                                                                          During the COVID-19 Public Health
                                                                          Emergency.
FDA-2020-D-1136............................  CDER......................  Temporary Policy for Compounding of
                                                                          Certain Drugs for Hospitalized
                                                                          Patients by Pharmacy Compounders not
                                                                          Registered as Outsourcing Facilities
                                                                          During the COVID-19 Public Health
                                                                          Emergency Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Temporary Policy Regarding Non-Standard
                                                                          PPE Practices for Sterile Compounding
                                                                          by Pharmacy Compounders not Registered
                                                                          as Outsourcing Facilities During the
                                                                          COVID-19 Public Health Emergency.
FDA-2020-D-1136............................  CDER......................  Temporary Policy on Prescription Drug
                                                                          Marketing Act Requirements for
                                                                          Distribution of Drug Samples During
                                                                          the COVID-19 Public Health Emergency.*
FDA-2020-D-1136............................  CDER......................  COVID-19 Public Health Emergency:
                                                                          General Considerations for Pre-IND
                                                                          Meeting Requests for COVID-19 Related
                                                                          Drugs and Biological Products.
FDA-2020-D-1136............................  CDER......................  Exemption and Exclusion from Certain
                                                                          Requirements of the Drug Supply Chain
                                                                          Security Act During the COVID-19
                                                                          Public Health Emergency.\4\
FDA-2020-D-1138............................  CDRH......................  Notifying CDRH of a Permanent
                                                                          Discontinuance or Interruption in
                                                                          Manufacturing of a Device Under
                                                                          Section 506J of the FD&C Act During
                                                                          the COVID-19 Public Health Emergency
                                                                          (Revised).
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for the Quality
                                                                          Standards of the Mammography Quality
                                                                          Standards Act During the COVID-19
                                                                          Public Health Emergency.*
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Enforcement
                                                                          of 21 CFR Part 118 (the Egg Safety
                                                                          Rule) During the COVID-19 Public
                                                                          Health Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Packaging
                                                                          and Labeling of Shell Eggs Sold by
                                                                          Retail Food Establishments During the
                                                                          COVID-19 Public Health Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Nutrition
                                                                          Labeling of Certain Packaged Food
                                                                          During the COVID-19 Public Health
                                                                          Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Reporting a Temporary Closure or
                                                                          Significantly Reduced Production by a
                                                                          Human Food Establishment and
                                                                          Requesting FDA Assistance During the
                                                                          COVID-19 Public Health Emergency.
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III. COVID-19 Guidance Documents That FDA Is Revising To Continue in
Effect for 180 Days After the PHE Declaration Expires To Provide a
Period for Stakeholder Transition

    Based on our review, FDA has identified 22 COVID-19-related
guidances that, similar to the guidances previously discussed, can be
discontinued in connection with expiration of the COVID-19 PHE
declaration but for which an additional wind-down period is appropriate
to allow for an orderly transition. In general, these guidances were
intended to be in effect for the duration of the declared COVID-19 PHE.
However, FDA has considered the circumstances surrounding the current
phase of the COVID-19 pandemic, comments submitted to the dockets for
these guidances, and our experience with implementation, and has
determined that for these guidances, stakeholders such as industry,
healthcare providers, patients, consumers, and FDA would benefit from
additional time to

transition from the policies adopted during the COVID-19 PHE. Thus, FDA
is revising the 22 guidances listed in table 2 to continue in effect
for 180 days after the expiration of the PHE declaration--i.e., after
November 7, 2023, they will no longer be in effect. We note that some
of these guidances are addressed in the draft device enforcement policy
transition guidance, which, when finalized, may specify a duration
period for these guidances that is longer than the time period
described here. Therefore, the guidances listed in table 2 are being
revised to reflect that they continue in effect for 180 days after the
COVID-19 PHE declaration expires, with the exception of guidances
covered under the draft device enforcement policy transition guidance.
Those device guidances, which are identified in table 2 with an
asterisk, are being revised to reflect that they continue in effect for
180 days after expiration of the PHE declaration unless a different
intended duration for the guidance is set forth in the final device
transition guidance.
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    \5\ FDA is revising the guidance ``Enforcement Policy for Face
Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and
Respirators During the Coronavirus Disease (COVID-19) Public Health
Emergency (Revised)'' to split it into two separate guidance
documents, each with identical policies to the corresponding parts
of the September 2021 version. Concurrent with issuance of this
guidance addressing face shields, surgical masks, and respirators,
FDA also is issuing ``Enforcement Policy for Face Masks and Barrier
Face Coverings During the Coronavirus Disease (COVID-19) Public
Health Emergency.'' That guidance is listed in table 3 of this
notice.

      Table 2--Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the COVID-19 PHE
                                               Declaration Expires
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
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FDA-2020-D-1136............................  CDER......................  Policy for the Temporary Use of
                                                                          Portable Cryogenic Containers Not in
                                                                          Compliance With 21 CFR 211.94(e)(1)
                                                                          For Oxygen and Nitrogen During the
                                                                          COVID-19 Public Health Emergency
                                                                          Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Manufacturing, Supply Chain, and Drug
                                                                          and Biological Product Inspections
                                                                          During COVID-19 Public Health
                                                                          Emergency Questions and Answers.
FDA-2020-D-1106............................  CDER......................  Policy for Certain REMS Requirements
                                                                          During the COVID-19 Public Health
                                                                          Emergency Guidance for Industry and
                                                                          Health Care Professionals.
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Remote Digital
                                                                          Pathology Devices During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Imaging Systems
                                                                          During the Coronavirus Disease 2019
                                                                          (COVID-19) Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Non-Invasive
                                                                          Fetal and Maternal Monitoring Devices
                                                                          Used to Support Patient Monitoring
                                                                          During the Coronavirus Disease 2019
                                                                          (COVID-19) Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for
                                                                          Telethermographic Systems During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Digital Health
                                                                          Devices for Treating Psychiatric
                                                                          Disorders During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Extracorporeal
                                                                          Membrane Oxygenation and
                                                                          Cardiopulmonary Bypass Devices During
                                                                          the Coronavirus Disease 2019 (COVID-
                                                                          19) Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Remote
                                                                          Ophthalmic Assessment and Monitoring
                                                                          Devices During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Infusion Pumps
                                                                          and Accessories During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Face Shields,
                                                                          Surgical Masks, and Respirators During
                                                                          the Coronavirus Disease 2019 (COVID-
                                                                          19) Public Health Emergency.* \5\
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Gowns, Other
                                                                          Apparel, and Gloves During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Sterilizers,
                                                                          Disinfectant Devices, and Air
                                                                          Purifiers During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Ventilators and
                                                                          Accessories and Other Respiratory
                                                                          Devices During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Modifications to
                                                                          FDA Cleared Molecular Influenza and
                                                                          RSV Tests During the Coronavirus
                                                                          Disease 2019 (COVID-19) Public Health
                                                                          Emergency.*
FDA-2020-D-1138............................  CDRH......................  Coagulation Systems for Measurement of
                                                                          Viscoelastic Properties: Enforcement
                                                                          Policy During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency (Revised).*
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Viral Transport
                                                                          Media During the Coronavirus Disease
                                                                          2019 (COVID-19) Public Health
                                                                          Emergency (Revised).*
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Nutrition
                                                                          Labeling of Standard Menu Items in
                                                                          Chain Restaurants and Similar Retail
                                                                          Food Establishments During the COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1139............................  CFSAN.....................  Temporary Policy Regarding Certain Food
                                                                          Labeling Requirements During the COVID-
                                                                          19 Public Health Emergency: Minor
                                                                          Formulation Changes and Vending
                                                                          Machines.
FDA-2020-D-1386............................  CFSAN.....................  Temporary Policy During the COVID-19
                                                                          Public Health Emergency Regarding the
                                                                          Qualified Exemption from the Standards
                                                                          for the Growing, Harvesting, Packing,
                                                                          and Holding of Produce for Human
                                                                          Consumption.
FDA-2020-D-1140............................  CVM.......................  CVM GFI #270--Guidance on the Conduct
                                                                          and Review of Studies to Support New
                                                                          Animal Drug Development during the
                                                                          COVID-19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------

IV. COVID-19 Guidance Documents FDA Is Revising To Continue in Effect
for 180 Days After Expiration of the PHE Declaration, During Which Time
FDA Plans to Further Revise the Guidances

    Based on our review, FDA has identified 24 COVID-19-related
guidances that we intend to retain with appropriate changes after
expiration of the COVID-19 PHE declaration. Therefore, FDA is revising
the 24 guidances listed in table 3 to continue in effect for 180 days
after the COVID-19 PHE declaration expires. During that time, FDA plans
to further revise each of these guidances with any appropriate changes
based on comments received and the Agency's experience with
implementation. For example, FDA could revise a guidance so its
duration aligns with an applicable declaration made under section 564
of the FD&C Act enabling the issuance of EUAs, or by removing language
describing intended duration. Once a revised final guidance is issued,
which could occur sooner than 180 days after the PHE declaration
expires, it will supersede the guidance listed in table 3.
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    \6\ FDA is revising the guidance ``Enforcement Policy for Face
Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and
Respirators During the Coronavirus Disease (COVID-19) Public Health
Emergency (Revised)'' to split it into two separate guidance
documents, each with identical policies to the corresponding parts
of the September 2021 version. Concurrent with issuance of this
guidance addressing face masks and barrier face coverings, FDA also
is issuing ``Enforcement Policy for Face Shields, Surgical Masks,
and Respirators During the Coronavirus Disease (COVID-19) Public
Health Emergency.'' That guidance is listed in table 2 of this
notice.

    Table 3--Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the PHE Declaration
                      Expires, During Which Time FDA Plans to Further Revise the Guidances
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137............................  CBER......................  Emergency Use Authorization for
                                                                          Vaccines to Prevent COVID-19.
FDA-2020-D-1825............................  CBER......................  Investigational COVID-19 Convalescent
                                                                          Plasma.
FDA-2015-D-1211............................  CBER......................  Revised Recommendations for Reducing
                                                                          the Risk of Human Immunodeficiency
                                                                          Virus Transmission by Blood and Blood
                                                                          Products.
FDA-2020-D-1137............................  CBER......................  Development and Licensure of Vaccines
                                                                          to Prevent COVID-19.
FDA-2020-D-1137............................  CBER......................  Alternative Procedures for Blood and
                                                                          Blood Components During the COVID-19
                                                                          Public Health Emergency.
FDA-2020-D-1106-0002.......................  CDER......................  FDA Guidance on Conduct of Clinical
                                                                          Trials of Medical Products during
                                                                          COVID-19 Public Health Emergency.
FDA-2020-D-1370............................  CDER......................  COVID-19: Developing Drugs and
                                                                          Biological Products for Treatment or
                                                                          Prevention.
FDA-2020-D-2016............................  CDER......................  Policy for Testing of Alcohol (Ethanol)
                                                                          and Isopropyl Alcohol for Methanol,
                                                                          Including During the COVID-19 Public
                                                                          Health Emergency (COVID-19).
FDA-2020-D-1136............................  CDER......................  COVID-19: Potency Assay Considerations
                                                                          for Monoclonal Antibodies and Other
                                                                          Therapeutic Proteins Targeting SARS-
                                                                          CoV-2 Infectivity.
FDA-2020-D-1824............................  CDER......................  Assessing COVID-19-Related Symptoms in
                                                                          Outpatient Adult and Adolescent
                                                                          Subjects in Clinical Trials of Drugs
                                                                          and Biological Products for COVID-19
                                                                          Prevention or Treatment.
FDA-2020-D-1414............................  CDER......................  Institutional Review Board (IRB) Review
                                                                          of Individual Patient Expanded Access
                                                                          Requests for Investigational Drugs and
                                                                          Biological Products During the COVID-
                                                                          19 Public Health Emergency Guidance
                                                                          for IRBs and Clinical Investigators.
FDA-2020-D-1057............................  CDER......................  Notifying FDA of a Permanent
                                                                          Discontinuance or Interruption in
                                                                          Manufacturing Under Section 506C of
                                                                          the FD&C Act Guidance for Industry
FDA-2021-D-0409............................  CDER......................  COVID-19: Master Protocols Evaluating
                                                                          Drugs and Biological Products for
                                                                          Treatment or Prevention.
FDA-2020-D-1136............................  CDER......................  Remote Interactive Evaluations of Drug
                                                                          Manufacturing and Bioresearch
                                                                          Monitoring Facilities During the COVID-
                                                                          19 Public Health Emergency Guidance
                                                                          for Industry.
FDA-2020-D-1136............................  CDER......................  COVID-19 Container Closure System and
                                                                          Component Changes: Glass Vials and
                                                                          Stoppers Guidance for Industry.
FDA-2020-D-1136............................  CDER......................  Development of Monoclonal Antibody
                                                                          Products Targeting SARS-CoV-2,
                                                                          Including Addressing the Impact of
                                                                          Emerging Variants, During the COVID 19
                                                                          Public Health Emergency.
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Face Masks and
                                                                          Barrier Face Coverings During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.\6\
FDA-2020-D-1138............................  CDRH......................  Supplements for Approved Premarket
                                                                          Approval (PMA) or Humanitarian Device
                                                                          Exemption (HDE) Submissions During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency (Revised).
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Clinical
                                                                          Electronic Thermometers During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency.
FDA-2020-D-1138............................  CDRH......................  Enforcement Policy for Non-Invasive
                                                                          Remote Monitoring Devices Used to
                                                                          Support Patient Monitoring During the
                                                                          Coronavirus Disease 2019 (COVID-19)
                                                                          Public Health Emergency (Revised).
FDA-2020-D-1139............................  CFSAN.....................  Returning Refrigerated Transport
                                                                          Vehicles and Refrigerated Storage
                                                                          Units to Food Uses After Using Them to
                                                                          Preserve Human Remains During the
                                                                          COVID-19 Pandemic.
FDA-2020-D-1108............................  CFSAN.....................  Temporary Policy Regarding Preventive
                                                                          Controls and FSVP Food Supplier
                                                                          Verification Onsite Audit Requirements
                                                                          During the COVID-19 Public Health
                                                                          Emergency.
FDA-2020-D-1304............................  CFSAN.....................  Temporary Policy Regarding Accredited
                                                                          Third-Party Certification Program
                                                                          Onsite Observation and Certificate
                                                                          Duration Requirements During the COVID-
                                                                          19 Public Health Emergency.
FDA-2020-D-1140............................  CVM.......................  CVM GFI #271 Reporting and Mitigating
                                                                          Animal Drug Shortages during the COVID-
                                                                          19 Public Health Emergency.
----------------------------------------------------------------------------------------------------------------

V. Other COVID-19 Related Guidance Documents

    FDA also has issued the four guidance documents listed in table 4
whose policies and recommendations have supported COVID-19 response
efforts, but whose duration is not tied to the COVID-19 PHE
declaration, and will remain in effect after expiration of the COVID-19
PHE declaration. In January 2023, FDA revised the two guidances marked
with an asterisk in table 4 to state their policies are intended to
remain in effect only for the duration of the declaration under section
564 of the FD&C Act by the Secretary of HHS on February 4, 2020,
declaring that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
the novel coronavirus (2019-nCoV) (85 FR 7316). These guidances
previously stated that they were intended to remain in effect only for
the duration of the PHE declaration.

                               Table 4--Other COVID-19-Related Guidance Documents
----------------------------------------------------------------------------------------------------------------
                 Docket No.                          Lead center                    Title of guidance
----------------------------------------------------------------------------------------------------------------
FDA-2007-D-0369............................  CDER......................  Product-Specific Guidances for
                                                                          Chloroquine and Hydroxychloroquine.
FDA-2008-D-0610............................  CDER......................  Postmarketing Adverse Event Reporting
                                                                          for Medical Products and Dietary
                                                                          Supplements During a Pandemic.
FDA-2020-D-0987............................  CDRH......................  Policy for Coronavirus Disease-2019
                                                                          Tests (Revised).*
FDA-2020-D-0987............................  CDRH......................  Policy for Evaluating Impact of Viral
                                                                          Mutations on COVID-19 Tests.*
----------------------------------------------------------------------------------------------------------------

VI. Electronic Access

    Persons with access to the internet may obtain the guidances listed
in this notice at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: March 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05094 Filed 3-10-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19256-19262]
[FR Doc No: 2021-07562]

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

ENVIRONMENTAL PROTECTION AGENCY

[See Item Specific ICR Titles Provided in the Text; FRL-10022-42-OAR]

Proposed Information Collection Request; Comment Request; 41
Source Categories

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency is planning to submit
the below listed information collection requests (ICR) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. These are proposed extensions of the currently
approved ICRs. An agency may not conduct or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be submitted on or before June 14, 2021.

ADDRESSES: Submit your comments, referencing the Docket ID numbers
provided for each item in the text, online using https://www.regulations.gov/ (our preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.
    The EPA's policy is that all relevant comments received will be
included in the public docket without change including any personal
information provided, unless the comment includes profanity, threats,
information claimed to be Confidential Business Information or other
information whose disclosure is restricted by statute. Out of an
abundance of caution for members of the public and our staff, the EPA
Docket Center and Reading Room are closed to the public, with limited
exceptions, to reduce the risk of transmitting COVID-19. Our Docket
Center staff will continue to provide remote customer service via
email, phone, and webform. We encourage the public to submit comments
via https://www.regulations.gov/ or email, as there may be a delay in
processing mail and

faxes. Hand deliveries and couriers may be received by scheduled
appointment only. For further information on EPA Docket Center services
and the current status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Mr. Muntasir Ali, Sector Policies and
Programs Division, (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at https://www.regulations.gov/ or in person at the EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The
telephone number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit https://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. Burden
is defined at 5 CFR 1320.03(b). EPA will consider the comments received
and amend the ICR as appropriate. The final ICR package will then be
submitted to OMB for review and approval. At that time, EPA will issue
another Federal Register notice to announce the submission of the ICR
to OMB and the opportunity to submit additional comments to OMB.
    General Abstract: For the first ICR in this notice (item (1)
below), regulated entities are required to submit initial notifications
when an aerosol coating is manufactured and notification of changes in
the initial report, to report formulation data and exemptions claimed,
and to maintain records. In addition, regulated entities are required
to submit triennial reports that include formulation data and VOC
usage. The reports required enable the EPA to determine compliance with
the national VOC emission standards for aerosol coatings. For the
remaining listed ICRs in this notice, owners and operators of affected
facilities are required to comply with reporting and record keeping
requirements for the general provisions of 40 CFR part 60, subpart A or
part 63, subpart A, as well as the applicable specific standards. This
includes submitting initial notifications, performance tests and
periodic reports and results, and maintaining records of the occurrence
and duration of any startup, shutdown, or malfunction in the operation
of an affected facility, or any period during which the monitoring
system is inoperative. These reports are used by EPA to determine
compliance with the standards.
    (1) Docket ID Number: EPA-HQ-OAR-2006-0971; National Volatile
Organic Compound Emission Standards for Aerosol Coatings (40 CFR part
59, subpart E) (Renewal); EPA ICR Number 2289.05; OMB Control Number
2060-0617; Expiration date November 30, 2021.
    Respondents: Manufacturers, distributors, and importers of aerosol
coatings.
    Respondent's obligation to respond: Mandatory (40 CFR part 59,
subpart E).
    Estimated number of respondents: 65.
    Frequency of response: Annually, triennially.
    Estimated Annual burden: 12,259 hours.
    Estimated Annual cost: $855,113, includes no annualized capital or
operations & maintenance (O&M) costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (2) Docket ID Number: EPA-HQ-OAR-2021-0085; New Source Performance
Standards (NSPS) for New Residential Wood Heaters (40 CFR part 60,
subpart AAA) (Renewal); EPA ICR Number 1176.14; OMB Control Number
2060-0161; Expiration date March 31, 2022.
    Respondents: Residential wood heaters.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart AAA).
    Estimated number of respondents: 45.
    Frequency of response: Annually.
    Estimated Annual burden: 4,320 hours.
    Estimated Annual cost: $1,210,000, includes $740,000 annualized
capital or operations & maintenance (O&M) costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (3) Docket ID Number: EPA-HQ-OAR-2021-0087; National Emission
Standards for Hazardous Air Pollutants (NESHAP) for Benzene Waste
Operations (40 CFR part 61, subpart FF) (Renewal); EPA ICR Number
1541.13; OMB Control Number 2060-0183; Expiration date March 31, 2022.
    Respondents: Facilities that generate waste containing benzene.
    Respondent's obligation to respond: Mandatory (40 CFR part 61,
subpart FF).
    Estimated number of respondents: 270.
    Frequency of response: Quarterly and annually.
    Estimated Annual burden: 19,500 hours.
    Estimated Annual cost: $2,130,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (4) Docket ID Number: EPA-HQ-OAR-2021-0089; NESHAP for Chromium
Emissions from Hard and Decorative Chromium Electroplating and Chromium
Anodizing Tanks (40 CFR part 63, subpart N) (Renewal); EPA ICR Number
1611.13; OMB Control Number 2060-0327; Expiration date March 31, 2022.
    Respondents: Hard and decorative chromium electroplating and
chromium anodizing tanks.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart N).
    Estimated number of respondents: 1,343.
    Frequency of response: Quarterly, semiannually, and annually.
    Estimated Annual burden: 242,000 hours.
    Estimated Annual cost: $46,900,000, includes $20,400,000 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (5) Docket ID Number: EPA-HQ-OAR-2021-0090; NESHAP for Flexible
Polyurethane Foam Product (40 CFR part 63, subpart III) (Renewal); EPA
ICR Number 1783.10; OMB Control Number 2060-0357; Expiration date March
31, 2022.
    Respondents: Flexible polyurethane foam production facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart III).
    Estimated number of respondents: 12.
    Frequency of response: Semiannually and annually.
    Estimated Annual burden: 869 hours.
    Estimated Annual cost: $94,700, includes no annualized capital or
O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.

    (6) Docket ID Number: EPA-HQ-OAR-2021-0091; NESHAP for Pesticide
Active Ingredient Production (40 CFR part 63, subpart MMM) (Renewal);
EPA ICR Number 1807.10; OMB Control Number 2060-0370; Expiration date
March 31, 2022.
    Respondents: Pesticide active ingredient production facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart MMM)
    Estimated number of respondents: 18.
    Frequency of response: Quarterly and semiannually.
    Estimated Annual burden: 12,100 hours.
    Estimated Annual cost: $1,350,000, includes $26,500 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (7) Docket ID Number: EPA-HQ-OAR-2021-0093; NESHAP for Ferroalloys
Production: Ferromanganese and Silicomanganese (40 CFR part 63, subpart
XXX) (Renewal); EPA ICR Number 1831.08; OMB Control Number 2060-0391;
Expiration date March 31, 2022.
    Respondents: Facilities that produce ferroalloys.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart XXX).
    Estimated number of respondents: 2.
    Frequency of response: Quarterly, semiannually, and annually.
    Estimated Annual burden: 1,170 hours.
    Estimated Annual cost: $133,000, includes no annualized capital or
O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to incorporation of burden from previously promulgated rule amendments.
    (8) Docket ID Number: EPA-HQ-OAR-2021-0108; NESHAP for Metal Coil
Surface Coating Plants (40 CFR part 63, subpart SSSS) (Renewal); EPA
ICR Number 1957.11; OMB Control Number 2060-0487; Expiration date March
31, 2022.
    Respondents: Metal coil surface coating facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart SSSS).
    Estimated number of respondents: 48.
    Frequency of response: Semiannually and occasionally.
    Estimated Annual burden: 16,100 hours.
    Estimated Annual cost: $1,820,000, includes $57,600 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to incorporation of burden from previously promulgated rule amendments.
    (9) Docket ID Number: EPA-HQ-OAR-2021-0111; NESHAP for Industrial,
Commercial, and Institutional Boilers and Process Heaters (40 CFR part
63, subpart DDDDD) (Renewal); EPA ICR Number 2028.12; OMB Control
Number 2060-0551; Expiration date March 31, 2022.
    Respondents: Industrial, commercial, and institutional boilers and
process heaters.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart DDDDD).
    Estimated number of respondents: 2,012.
    Frequency of response: Semiannually, annually, biennially, and
five-year.
    Estimated Annual burden: 199,000 hours.
    Estimated Annual cost: $196,000,000, includes $131,000,000
annualized capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (10) Docket ID Number: EPA-HQ-OAR-2021-0112; NESHAP for Printing,
Coating and Dyeing of Fabrics and Other Textiles (40 CFR part 63,
subpart OOOO) (Renewal); EPA ICR Number 2071.10; OMB Control Number
2060-0522; Expiration date March 31, 2022.
    Respondents: Printing, coating, slashing, dyeing, or finishing of
fabric and other textiles facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart OOOO).
    Estimated number of respondents: 43.
    Frequency of response: Semiannually.
    Estimated Annual burden: 7,248 hours.
    Estimated Annual cost: $160,000, includes $110,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected decrease in burden
following implementation of previously promulgated rule amendments.
    (11) Docket ID Number: EPA-HQ-OAR-2021-0113; NESHAP for Coal- and
Oil-fired Electric Utility Steam Generating Units (40 CFR part 63,
subpart UUUUU) (Renewal); EPA ICR Number 2137.10; OMB Control Number
2060-0567; Expiration date March 31, 2022.
    Respondents: Coal- and oil-fired electric utility steam generating
units.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart UUUUU).
    Estimated number of respondents: 322.
    Frequency of response: Semiannually.
    Estimated Annual burden: 284,000 hours.
    Estimated Annual cost: $132,000,000, includes $104,000,000
annualized capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (12) Docket ID Number: EPA-HQ-OAR-2021-0114; NESHAP for Gasoline
Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities and
Gasoline Dispensing Facilities (40 CFR part 63, subparts BBBBBB and
CCCCCC) (Renewal); EPA ICR Number 2237.06; OMB Control Number 2060-
0620; Expiration date March 31, 2022.
    Respondents: Gasoline distribution facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subparts BBBBBB and CCCCCC).
    Estimated number of respondents: 19,120.
    Frequency of response: Semiannually.
    Estimated Annual burden: 214,000 hours.
    Estimated Annual cost: $23,500,000, includes $110,000 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (13) Docket ID Number: EPA-HQ-OAR-2021-0115; NESHAP for Paint
Stripping and Miscellaneous Surface Coating at Area Sources (40 CFR
part 63, subpart HHHHHH) (Renewal); EPA ICR Number 2268.06; OMB Control
Number 2060-0607; Expiration date March 31, 2022.
    Respondents: Paint stripping operations using methylene chloride
(MeCl)-containing paint strippers, motor vehicle and mobile equipment
surface coating operations, and miscellaneous surface coating
operations.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart HHHHHH).
    Estimated number of respondents: 39,812.
    Frequency of response: Initially and annually.
    Estimated Annual burden: 169,000 hours.
    Estimated Annual cost: $18,500,000, includes $117,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (14) Docket ID Number: EPA-HQ-OAR-2021-0116; NESHAP for Plating and
Polishing Area Sources (40 CFR part 63, subpart WWWWWW) (Renewal); EPA
ICR Number 2294.06; OMB Control Number 2060-0623; Expiration date March
31, 2022.
    Respondents: Plating and polishing facilities.

    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart WWWWWW).
    Estimated number of respondents: 2,900.
    Frequency of response: Annually.
    Estimated Annual burden: 67,700 hours.
    Estimated Annual cost: $7,410,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (15) Docket ID Number: EPA-HQ-OAR-2021-0084; NESHAP for Mercury (40
CFR part 61, subpart E) (Renewal); EPA ICR Number 0113.14; OMB Control
Number 2060-0097; Expiration date April 30, 2022.
    Respondents: Mercury ore processing facilities, mercury cell chlor-
alkali plants, sludge incineration plants, and sludge drying plants.
    Respondent's obligation to respond: Mandatory (40 CFR part 61,
subpart E).
    Estimated number of respondents: 107.
    Frequency of response: Semiannually and annually.
    Estimated Annual burden: 20,600 hours.
    Estimated Annual cost: $2,260,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (16) Docket ID Number: EPA-HQ-OAR-2021-0086; NESHAP for Coke Oven
Batteries (40 CFR part 63, subpart L) (Renewal); EPA ICR Number
1362.12; OMB Control Number 2060-0253; Expiration date April 30, 2022.
    Respondents: Coke oven batteries.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart L).
    Estimated number of respondents: 19.
    Frequency of response: Semiannually.
    Estimated Annual burden: 79,800 hours.
    Estimated Annual cost: $8,730,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (17) Docket ID Number: EPA-HQ-OAR-2021-0092; NESHAP for Steel
Pickling, HCI Process Facilities and Hydrochloric Acid Regeneration
Plants (40 CFR part 63, subpart CCC) (Renewal); EPA ICR Number 1821.10;
OMB Control Number 2060-0419; Expiration date April 30, 2022.
    Respondents: Steel pickling, HCl process facilities and
hydrochloric acid regeneration plants
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart CCC)
    Estimated number of respondents: 100.
    Frequency of response: Semiannually.
    Estimated Annual burden: 35,000 hours.
    Estimated Annual cost: $3,840,000, includes $10,600 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (18) Docket ID Number: EPA-HQ-OAR-2021-0094; NESHAP for Source
Categories: Generic Maximum Achievable Control Technology Standards (40
CFR part 63, subpart YY) (Renewal); EPA ICR Number 1871.11; OMB Control
Number 2060-0420; Expiration date April 30, 2022.
    Respondents: Polycarbonate, acrylic and modacrylic fiber, acetal
resin, and hydrogen fluoride production facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart YY).
    Estimated number of respondents: 7.
    Frequency of response: Semiannually.
    Estimated Annual burden: 2,910 hours.
    Estimated Annual cost: $361,000, includes $43,100 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (19) Docket ID Number: EPA-HQ-OAR-2021-0106; NESHAP for Paper and
Other Web Coating (40 CFR part 63, subpart JJJJ) (Renewal); EPA ICR
Number 1951.10; OMB Control Number 2060-0511; Expiration date April 30,
2022.
    Respondents: Paper and other web coating facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart JJJJ)
    Estimated number of respondents: 170.
    Frequency of response: Semiannually.
    Estimated Annual burden: 17,300 hours.
    Estimated Annual cost: $2,735,000, includes $765,000 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (20) Docket ID Number: EPA-HQ-OAR-2021-0107; NESHAP for Metal
Furniture Surface Coating (40 CFR part 63, subpart RRRR) (Renewal); EPA
ICR Number 1952.10; OMB Control Number 2060-0518; Expiration date April
30, 2022.
    Respondents: Metal furniture surface coating facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart RRRR).
    Estimated number of respondents: 16.
    Frequency of response: Semiannually.
    Estimated Annual burden: 190,000 hours.
    Estimated Annual cost: $17,200,000, includes $700,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected decrease in burden
following implementation of previously promulgated rule amendments.
    (21) Docket ID Number: EPA-HQ-OAR-2021-0109; NESHAP for Reinforced
Plastic Composites Production (40 CFR part 63, subpart WWWW) (Renewal);
EPA ICR Number 1976.10; OMB Control Number 2060-0509; Expiration date
April 30, 2022.
    Respondents: Reinforced plastic composites production facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart WWWW)
    Estimated number of respondents: 448.
    Frequency of response: Semiannually.
    Estimated Annual burden: 38,125 hours.
    Estimated Annual cost: $3,749,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is a projected decrease in burden
following implementation of previously promulgated rule amendments.
    (22) Docket ID Number: EPA-HQ-OAR-2021-0110; NESHAP for Coke Oven
Pushing, Quenching, and Battery Stacks (40 CFR part 63, subpart CCCCC)
(Renewal); EPA ICR Number 1995.08; OMB Control Number 2060-0521;
Expiration date April 30, 2022.
    Respondents: Coke oven batteries.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart CCCCC).
    Estimated number of respondents: 16.
    Frequency of response: Quarterly and semiannually.
    Estimated Annual burden: 27,200 hours.
    Estimated Annual cost: $3,240,000, includes $143,000 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (23) Docket ID Number: EPA-HQ-OAR-2021-0101; NESHAP for Integrated
Iron and Steel Manufacturing (40 CFR part 63, subpart FFFFF) (Renewal);
EPA ICR Number 2003.10; OMB Control Number 2060-0517; Expiration date
April 30, 2022.
    Respondents: Sinter plants, blast furnaces, and basic oxygen
process furnace shops at integrated iron and steel manufacturing
facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart FFFFF).
    Estimated number of respondents: 11.
    Frequency of response: Semiannually.
    Estimated Annual burden: 6,500 hours.

    Estimated Annual cost: $800,000, includes $50,300 annualized
capital or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (24) Docket ID Number: EPA-HQ-OAR-2021-0102; NESHAP for Flexible
Polyurethane Foam Fabrication (40 CFR part 63, subpart MMMMM)
(Renewal); EPA ICR Number 2027.11; OMB Control Number 2060-0516;
Expiration date April 30, 2022.
    Respondents: Flexible polyurethane foam fabrication facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart MMMMM)
    Estimated number of respondents: 18.
    Frequency of response: Semiannually.
    Estimated Annual burden: 22,200 hours.
    Estimated Annual cost: $2,560,000, includes $34,500 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected decrease in burden due
to anticipated shutdown of existing sources.
    (25) Docket ID Number: EPA-HQ-OAR-2021-0104; NESHAP for Refractory
Products Manufacturing (40 CFR part 63, subpart SSSSS) (Renewal); EPA
ICR Number 2040.11; OMB Control Number 2060-0515; Expiration date April
30, 2022.
    Respondents: Refractory products manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart SSSSS).
    Estimated number of respondents: 8.
    Frequency of response: Semiannually.
    Estimated Annual burden: 306 hours.
    Estimated Annual cost: $37,800, includes $3,040 annualized capital
or O&M costs.
    Changes in Estimates: There is a projected decrease in burden due
to anticipated shutdown of existing sources.
    (26) Docket ID Number: EPA-HQ-OAR-2021-0121; NESHAP for Industrial,
Commercial, and Institutional Boilers Area Sources (40 CFR part 63,
subpart JJJJJJ) (Renewal); EPA ICR Number 2253.05; OMB Control Number
2060-0668; Expiration date April 30, 2022.
    Respondents: Industrial, commercial, and institutional boilers
designed to burn biomass, coal, or liquid fuels.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart JJJJJJ).
    Estimated number of respondents: 100,344.
    Frequency of response: Annually and biennially.
    Estimated Annual burden: 1,830,000 hours.
    Estimated Annual cost: $340,000,000, includes $132,000,000
annualized capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (27) Docket ID Number: EPA-HQ-OAR-2021-0122; NESHAP for Nine Metal
Fabrication and Area Finishing Source (40 CFR part 63, subpart XXXXXX)
(Renewal); EPA ICR Number 2298.06; OMB Control Number 2060-0622;
Expiration date April 30, 2022.
    Respondents: Metal fabrication and finishing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart XXXXXX).
    Estimated number of respondents: 5,800.
    Frequency of response: Annually.
    Estimated Annual burden: 39,000 hours.
    Estimated Annual cost: $4,440,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (28) Docket ID Number: EPA-HQ-OAR-2021-0125; NESHAP for Polyvinyl
Chloride and Copolymer Production (40 CFR part 63, subpart HHHHHHH)
(Renewal); EPA ICR Number 2432.07; OMB Control Number 2060-0666;
Expiration date April 30, 2022.
    Respondents: Polyvinyl chloride and copolymer production
facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart HHHHHHH).
    Estimated number of respondents: 15.
    Frequency of response: Semiannually.
    Estimated Annual burden: 338,000 hours.
    Estimated Annual cost: $45,500,000, includes $7,060,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected decrease in burden due
to anticipated shutdown of existing sources.
    (29) Docket ID Number: EPA-HQ-OAR-2021-0096; NESHAP for Asbestos
(40 CFR part 61, subpart M) (Renewal); EPA ICR Number 0111.16; OMB
Control Number 2060-0101; Expiration date May 31, 2022.
    Respondents: Demolition and renovation facilities; asbestos waste
disposal; asbestos milling, manufacturing and fabricating; the use of
asbestos on roadways; asbestos waste converting facilities; and the use
of asbestos insulation and sprayed-on materials.
    Respondent's obligation to respond: Mandatory (40 CFR part 61,
subpart M).
    Estimated number of respondents: 9,687.
    Frequency of response: Quarterly, semiannually, and annually.
    Estimated Annual burden: 287,000 hours.
    Estimated Annual cost: $32,700,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (30) Docket ID Number: EPA-HQ-OAR-2021-0098; NESHAP for the Surface
Coating of Large Household and Commercial Appliances (40 CFR part 63,
subpart NNNN) (Renewal); EPA ICR Number 1954.10; OMB Control Number
2060-0457; Expiration date May 31, 2022.
    Respondents: Large household and commercial appliance surface
coating facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart NNNN)
    Estimated number of respondents: 10.
    Frequency of response: Semiannually.
    Estimated Annual burden: 3,870 hours.
    Estimated Annual cost: $429,000, includes $5,400 annualized capital
or O&M costs.
    Changes in Estimates: There is a projected decrease in burden
following implementation of previously promulgated rule amendments.
    (31) Docket ID Number: EPA-HQ-OAR-2021-0100; NESHAP for Rubber Tire
Manufacturing (40 CFR part 63, subpart XXXX) (Renewal); EPA ICR Number
1982.05; OMB Control Number 2060-0449; Expiration date May 31, 2022.
    Respondents: Rubber processing, tire production, tire cord
production, and puncture sealant application facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart XXXX)
    Estimated number of respondents: 23.
    Frequency of response: Semiannually and annually.
    Estimated Annual burden: 6,520 hours.
    Estimated Annual cost: $910,000, includes no annualized capital or
O&M costs.
    Changes in Estimates: There is a projected decrease in burden due
to anticipated shutdown of existing sources.
    (32) Docket ID Number: EPA-HQ-OAR-2021-0103; NESHAP for Asphalt
Processing and Asphalt Roofing Manufacturing (40 CFR part 63, subpart
LLLLL) (Renewal); EPA ICR Number 2029.09; OMB Control Number 2060-0520;
Expiration date May 31, 2022.

    Respondents: Asphalt processing and asphalt roofing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart LLLLL)
    Estimated number of respondents: 8.
    Frequency of response: Semiannually.
    Estimated Annual burden: 3,970 hours.
    Estimated Annual cost: $472,000, includes $20,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to incorporation of burden from previously promulgated rule amendments.
    (33) Docket ID Number: EPA-HQ-OAR-2021-0105; NESHAP for
Semiconductor Manufacturing (40 CFR part 63, subpart BBBBB) (Renewal);
EPA ICR Number 2042.08; OMB Control Number 2060-0519; Expiration date
May 31, 2022.
    Respondents: Semiconductor manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart BBBBB).
    Estimated number of respondents: 1.
    Frequency of response: Semiannually.
    Estimated Annual burden: 41 hours.
    Estimated Annual cost: $5,270, includes $550 annualized capital or
O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (34) Docket ID Number: EPA-HQ-OAR-2021-0123; NESHAP for Chemical
Manufacturing Area Sources (40 CFR part 63, subpart VVVVVV) (Renewal);
EPA ICR Number 2323.08; OMB Control Number 2060-0621; Expiration date
May 31, 2022.
    Respondents: Chemical manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart VVVVVV).
    Estimated number of respondents: 528.
    Frequency of response: Semiannually.
    Estimated Annual burden: 10,200 hours.
    Estimated Annual cost: $2,650,000, includes $1,490,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (35) Docket ID Number: EPA-HQ-OAR-2021-0124; NESHAP for Aluminum,
Copper, and Other Non-Ferrous Foundries (40 CFR part 63, subpart
ZZZZZZ) (Renewal); EPA ICR Number 2332.06; OMB Control Number 2060-
0630; Expiration date May 31, 2022.
    Respondents: Aluminum, copper, and other non-ferrous metals
foundries.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart ZZZZZZ).
    Estimated number of respondents: 318.
    Frequency of response: Semiannually.
    Estimated Annual burden: 11,900 hours.
    Estimated Annual cost: $1,360,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (36) Docket ID Number: EPA-HQ-OAR-2021-0126; Title: NESHAP for
Polyvinyl Chloride and Copolymers Production Area Sources (40 CFR part
63, subpart DDDDDD) (Renewal); EPA ICR Number 2454.06; OMB Control
Number 2060-0684; Expiration date May 31, 2022.
    Respondents: Polyvinyl chloride and copolymer production
facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart DDDDDD).
    Estimated number of respondents: 4.
    Frequency of response: Semiannually.
    Estimated Annual burden: 92,300 hours.
    Estimated Annual cost: $1,360,000, includes no annualized capital
or O&M costs.
    Changes in Estimates: There is a projected decrease in burden due
to anticipated shutdown of existing sources.
    (37) Docket ID Number: EPA-HQ-OAR-2021-0118; NESHAP for Mercury
Cell Chlor-Alkali Plants (40 CFR part 63, subpart IIIII) (Renewal); EPA
ICR Number 2046.11; OMB Control Number 2060-0542; Expiration date June
30, 2022.
    Respondents: Mercury cell chlor-alkali facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart IIIII).
    Estimated number of respondents: 2.
    Frequency of response: Semiannually.
    Estimated Annual burden: 3,760 hours.
    Estimated Annual cost: $444,000, includes $16,400 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected decrease in burden due
to anticipated shutdown of existing sources.
    (38) Docket ID Number: EPA-HQ-OAR-2021-0119; NESHAP for Taconite
Iron Ore Processing (40 CFR part 63 subpart RRRRR) (Renewal); EPA ICR
Number 2050.10; OMB Control Number 2060-0538; Expiration date June 30,
2022.
    Respondents: Taconite iron ore processing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63
subpart RRRRR).
    Estimated number of respondents: 8.
    Frequency of response: Semiannually.
    Estimated Annual burden: 483 hours.
    Estimated Annual cost: $576,000, includes $521,000 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (39) Docket ID Number: EPA-HQ-OAR-2021-0120; NESHAP for Primary
Magnesium Refining (40 CFR part 63, subpart TTTTT) (Renewal); EPA ICR
Number 2098.11; OMB Control Number 2060-0536; Expiration date June 30,
2022.
    Respondents: Primary magnesium refining facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart TTTTT).
    Estimated number of respondents: 1.
    Frequency of response: Semiannually.
    Estimated Annual burden: 611 hours.
    Estimated Annual cost: $70,900, includes $1,200 annualized capital
or O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.
    (40) Docket ID Number: EPA-HQ-OAR-2021-0097; NESHAP for Municipal
Solid Waste Landfills (40 CFR part 63, subpart AAAA) (Renewal); EPA ICR
Number 1938.08; OMB Control Number 2060-0505; Expiration date July 31,
2022.
    Respondents: Municipal solid waste landfills.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart AAAA).
    Estimated number of respondents: 1,151.
    Frequency of response: Semiannually.
    Estimated Annual burden: 35,200 hours.
    Estimated Annual cost: $3,170,000, includes $10,800 annualized
capital or O&M costs.
    Changes in Estimates: There is a projected increase in burden due
to an increase in the number of sources subject to the regulation.
    (41) Docket ID Number: EPA-HQ-OAR-2021-0099; NESHAP for Wet-Formed
Fiberglass Mat Production (40 CFR part 63, subpart HHHH) (Renewal); EPA
ICR Number 1964.10; OMB Control Number 2060-0496; Expiration date
September 30, 2022.
    Respondents: Wet-formed fiberglass mat production facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart HHHH).

    Estimated number of respondents: 7.
    Frequency of response: Semiannually.
    Estimated Annual burden: 1,470 hours.
    Estimated Annual cost: $95,500, includes no annualized capital or
O&M costs.
    Changes in Estimates: There is no change in burden from the
previous ICR.

    Dated: April 5, 2021.
Penny Lassiter,
Director, Sector Policies and Programs Division.
[FR Doc. 2021-07562 Filed 4-12-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Notices]
[Pages 78129-78130]
[FR Doc No: 2020-26618]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12514-086]

Northern Indiana Public Service Company; Notice of Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.

    a. Application Type: Temporary Variance from Reservoir Elevation.
    b. Project No.: 12514-086.
    c. Date Filed: November 2, 2020 and supplemented on November 24,
2020.
    d. Applicant: Northern Indiana Public Service Company.
    e. Name of Project: Norway Oakdale Hydroelectric Project.
    f. Location: The Norway Oakdale Hydroelectric Project is located on
the Tippecanoe River in Carroll and White Counties, Indiana.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: M. Bryan Little, Senior Counsel, NiSource
Corporate Services, 150 West Market Street, Ste. 600, Indianapolis, IN
46204,<PHONE_NUMBER>.
    i. FERC Contact: Zeena Aljibury,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: 14 days from the issuance date of this notice by the
Commission.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/doc-sfiling/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER>

(TTY). In lieu of electronic filing, please mail a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing
should include docket number P-12514-086. Comments emailed to
Commission staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The applicant requests Commission
approval for a temporary variance from the reservoir elevation
requirements at Lake Shafer. Due to the sever regional drought
conditions and low river flow on the Tippecanoe River, the applicant is
operating the project under abnormal river conditions and requests a
variance from the allowable elevation at Lake Shafer (maintain
fluctuation within of 0.25 feet below elevation 647.47 feet NGVD) so
that it can continue to meet the flow requirements from the downstream
Lake Freeman development to protect the federally endangered mussel
species. Although the duration of drought conditions are difficult to
predict, the applicant requests the temporary variance to remain into
effect until March 31, 2021, which is when winter weather conditions
typically begin to subside and will produce sufficient flow from
melting snow and ice to allow Lake Shafer to return to its normal
elevation.
    l. Locations of the Application: In addition to publishing the full
text of this document in the Federal Register, the Commission provides
all interested persons an opportunity to view and/or print the contents
of this document via the internet through the Commission's Home Page
(http://ferc.gov) using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. At this time, the Commission has suspended access to the
Commission's Public Reference Room, due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact the
Federal Energy Regulatory Commission at<EMAIL_ADDRESS>or
call toll-free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Motions to Intervene, or Protests: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person commenting, protesting or intervening; and (4)
otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, motions to intervene, or protests must set
forth their evidentiary basis. Any filing made by an intervenor must be
accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 385.2010.

    Dated: November 25, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-26618 Filed 12-2-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Page 11705]
[FR Doc No: 2013-03829]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting.

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
February 21, 2013 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Other matters relating to enforcement proceedings; and
An adjudicatory matter.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: February 14, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-03829 Filed 2-14-13; 4:15 pm]
BILLING CODE 8011-01-P