[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10508-10510]
[FR Doc No: 2023-03033]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10658-01-R1]

Notice of Availability of Draft NPDES Potable Water Treatment
Facility General Permit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability of draft NPDES general permits MAG640000
and NHG640000.

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SUMMARY: The Director of the Water Division, U.S. Environmental
Protection Agency--Region 1 (EPA), is providing a Notice of
Availability for the Draft National Pollutant Discharge Elimination
System (NPDES) Potable Water Treatment Facility General Permit (Draft
PWTF GP) for discharges to certain waters of the Commonwealth of
Massachusetts and the State of New Hampshire. This Draft PWTF GP
establishes effluent limitations and requirements, effluent and ambient
monitoring requirements, reporting

requirements, and standard conditions for existing potable water
treatment facilities that discharge wastewater associated with common
water treatment processes (e.g., clarification, granular media
filtration, microfiltration, etc.). The Draft PWTF GP is available on
EPA Region 1's website at https://www.epa.gov/npdes-permits/potable-water-treatment-facility-general-permit-pwtf-gp-massachusetts-new-hampshire. The Fact Sheet for the Draft PWTF GP sets forth principal
facts and the significant factual, legal, methodological, and policy
questions considered in the development of the Draft Permit and is also
available at this website.

DATES: The public comment period will be open until April 24, 2023. See
EPA's web page for the applicable dates, https://www.epa.gov/npdes-permits/potable-water-treatment-facility-general-permit-pwtf-gp-massachusetts-new-hampshire.

ADDRESSES: Written comments on the Draft PWTF GP may be sent via email
to: [email protected]. If requesting to submit comments in hard copy
form, please reach out to the EPA contact above.

FOR FURTHER INFORMATION CONTACT: The administrative record and
additional information concerning the Draft PWTF GP may be obtained
from Nathan Chien via telephone:<PHONE_NUMBER> or email
[email protected].

SUPPLEMENTARY INFORMATION:
    Public Comment Information: Interested persons may submit written
comments on the Draft PWTF GP to EPA Region 1 at the address listed
above. In reaching a final decision on this Draft Permit, the Regional
Administrator will respond to all significant comments and make
responses available to the public on EPA Region 1's website. All
comments must be postmarked or delivered by the close of the public
comment period.
    General Information: The Draft PWTF GP includes effluent
limitations and requirements for eligible facilities based on
technology and/or water quality considerations of the unique discharges
from these facilities. The effluent limits established in the Draft
PWTF GP ensure that the surface water quality standards of the
receiving water(s) will be attained and/or maintained.
    Obtaining Authorization: To obtain coverage under the General
Permit, facilities meeting the eligibility requirements outlined in
part I of this General Permit may submit a notice of intent (NOI) in
accordance with part II of this General Permit and 40 CFR
122.28(b)(2)(i) & (ii). The contents of the NOI shall include at a
minimum, the legal name and address of the owner or operator, the
facility name and address, type of facility or discharges, the
receiving stream(s) and be signed by the operator in accordance with
the signatory requirements of 40 CFR 122.22. Alternately, based on 40
CFR 122.28(b)(2)(vi), the Director may notify a discharger that it is
covered by a general permit, even if the discharger has not submitted
an NOI to be covered. EPA has determined that the facilities identified
in appendix K of the Draft PWTF GP all meet the eligibility
requirements for coverage under the Draft General Permit and may be
authorized to discharge under the General Permit by this type of
notification.
    Other Legal Requirements: Endangered Species Act (ESA): In
accordance with the ESA, EPA has updated the provisions and necessary
actions and documentation related to potential impacts to endangered
species from PWTFs eligible for coverage under the Draft PWTF GP.
Concurrently with the public notice of the Draft PWTF GP, EPA plans to
initiate an informal consultation with the National Oceanic and
Atmospheric Administration, National Marine Fisheries Service (NOAA
Fisheries) under ESA section 7, through the submission of a letter and
biological assessment (BA) summarizing the results of EPA's assessment
of the potential effects to endangered and threatened species and their
critical habitats under NOAA Fisheries jurisdiction as a result of
EPA's issuance of the Draft PWTF GP. In this document, EPA has made a
preliminary determination that the proposed issuance of the Draft PWTF
GP is not likely to adversely affect the shortnose sturgeon, Atlantic
sturgeon, leatherback sea turtles, loggerhead sea turtles, Kemp's
ridley sea turtles, green sea turtles, North Atlantic right whales, and
fin whales. EPA plans to request that NOAA Fisheries review this
submittal and inform EPA whether it concurs with this preliminary
finding.
    In addition, EPA has initiated an informal consultation with the
U.S. Fish and Wildlife Service (USFWS) under ESA section 7, through the
submission of a letter summarizing the results of EPA's assessment of
the potential effects to endangered and threatened species and their
critical habitats under USFWS jurisdiction as a result of EPA's
issuance of the Draft PWTF GP. In this document, EPA has made a
preliminary determination that the proposed issuance of the Draft PWTF
GP is not likely to adversely affect the northern long-eared bat. EPA
has completed an informal consultation with USFWS regarding the
threatened northern long-eared bat, as activities conducted as part of
the PWTF GP are consistent with activities analyzed in the USFWS
January 5, 2016, Programmatic Biological Opinion (PBO).
    Essential Fish Habitat (EFH): Under the 1996 Amendments (Pub. L.
104-267) to the Magnuson-Stevens Fishery Conservation and Management
Act (16 U.S.C. 1801 et seq. (1998)), EPA is required to consult with
NOAA Fisheries if EPA's actions or proposed actions that it funds,
permits or undertakes ``may adversely impact any essential fish
habitat.'' 16 U.S.C. 1855(b). In the Fact Sheet accompanying the Draft
PWTF GP, EPA notes that the general permit action minimizes adverse
effects to aquatic organisms, including those with designated EFH in
the receiving waters. EFH species associated with the receiving waters
of facilities covered by the Draft PWTF GP may include Atlantic salmon
as well as the life stages of a number of coastal EFH designated
species, along with two habitat areas of particular concern. EPA has
made the determination that additional mitigation is not warranted
under section 305(b)(2) of the Magnuson-Stevens Act and has provided
this determination to NOAA Fisheries for their review.
    National Historic Preservation Act (NHPA): Facilities which
adversely affect properties listed or eligible for listing in the
National Registry of Historic Places under the NHPA are not authorized
to discharge under the Draft PWTF GP. EPA is requesting that facilities
certify, prior to obtaining coverage, that there are either no historic
properties present or that their discharge and related activities do
not have the potential to impact historic properties.
    Coastal Zone Management Act (CZMA): The CZMA, 16 U.S.C. 1451 et
seq., and its implementing regulations (15 CFR part 930) require a
determination that any federally licensed activity affecting the
coastal zone with an approved Coastal Zone Management Program (CZMP) is
consistent with the CZMA.
    Concurrent with the public notice EPA will request that the
Executive Office of Environmental Affairs, MA CZM, Project Review
Coordinator provide a consistency concurrence that the proposed Draft
PWTF GP is consistent with the MA CZMP.
    There are no eligible facilities that discharge to New Hampshire's
coastal zone. Therefore, additional CZMA federal consistency review by
the New

Hampshire Coastal Program is not required.
    Authority: This action is being taken under the Clean Water Act, 33
U.S.C. 1251 et seq.

David Cash,
Regional Administrator, EPA Region 1.
[FR Doc. 2023-03033 Filed 2-17-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15799-15800]
[DOCID:fr07ap09-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59683; File No. SR-NYSE-2009-12]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving a Proposed Rule Change Amending Its Limited Liability Company
Operating Agreement and the Bylaws of Its Wholly-Owned Subsidiary NYSE
Market, Inc. To Eliminate, in Each Case, a Requirement That Not Less
Than Two Members of the Board of Directors Must Qualify as ``Non-
Affiliated Directors'' and a Related Requirement That Not Less Than Two
Members of the Board of Directors Must Qualify as ``Fair Representation
Candidates''

April 1, 2009.

I. Introduction

    On February 2, 2009, the New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend: (i) its Second Amended and Restated
Operating Agreement (``NYSE Operating Agreement''); and (ii) the bylaws
of its wholly-owned subsidiary NYSE Market, Inc. (``NYSE Market'')
(``NYSE Market Bylaws''), to eliminate the requirement that not less
than two members of the board of directors of NYSE (``NYSE Board'') and
of NYSE Market (``NYSE Market Board''), respectively, must qualify as
``non-affiliated directors'' and the requirement that not less than two
members of such boards must qualify as ``fair representation
candidates'' (as each of those terms is defined in the NYSE Operating
Agreement and NYSE Market Bylaws, respectively). The requirements that
at least 20% of NYSE Board's directors and NYSE Market Board's
directors must be ``non-affiliated directors'' and ``fair
representation candidates'' would remain in place. The proposed rule
change was published for comment in the Federal Register on February
20, 2009.\3\ The Commission received no comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 59400 (February 12,
2009), 74 FR 7945.
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II. Description of the Proposal

    The Exchange proposes that its parent company, NYSE Group, Inc., as
the sole member of the Exchange, amend the NYSE Operating Agreement to
eliminate the requirements that: (i) not less than two members of NYSE
Board must be persons who are not members of the board of directors of
NYSE Euronext (``NYSE Euronext Board''), and who qualify as independent
under the independence policy of the NYSE Euronext Board (``NYSE non-
affiliated directors''); and (ii) not less than two members of the NYSE
Board must be ``fair representation candidates'' (as defined in the
NYSE Operating Agreement). In each case, however, the current
requirements that a minimum of 20% of NYSE Board's directors must be
NYSE non-affiliated directors and that a minimum of 20% of NYSE Board's
directors must be fair representation candidates would continue to
apply.\4\
---------------------------------------------------------------------------

    \4\ The Exchange has represented that fair representation
candidates on the NYSE Board qualify as NYSE non-affiliated
directors.
---------------------------------------------------------------------------

    The Exchange also proposes that the Exchange, as the sole
stockholder of NYSE Market, amend the NYSE Market Bylaws to eliminate
the requirements that: (i) not less than two members of the NYSE Market
Board must be persons who are not members of the NYSE Euronext Board,
although such directors need not be independent (``NYSE Market non-
affiliated directors''); and (ii) not less than two members of the NYSE
Market Board must be ``fair representation candidates'' (as defined in
the NYSE Market Bylaws). In each case, however, the current
requirements that a minimum of 20% of NYSE Market Board's directors
must be NYSE Market non-affiliated directors and that a minimum of 20%
of NYSE Market Board's directors must be fair representation candidates
would continue to apply.\5\
---------------------------------------------------------------------------

    \5\ The Exchange has represented that fair representation
candidates on the NYSE Market Board qualify as NYSE Market non-
affiliated directors.
---------------------------------------------------------------------------

    The Exchange also proposes to specify in the NYSE Operating
Agreement and the NYSE Market Bylaws that, for purposes of calculating
the minimum number of non-affiliated directors and

fair representation candidates for each the NYSE Board and the NYSE
Market Board, if the number that is equal to 20% of the total number of
directors on their respective boards is not a whole number, such number
would be rounded up to the next whole number.\6\
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    \6\ See Section 2.03(a)(i) and (iii) of the NYSE Operating
Agreement and Article III, Section 1(A) and (B) of the NYSE Market
Bylaws.
---------------------------------------------------------------------------

    The Exchange has stated that the practical effect of the proposed
rule change would be to enable the size of both the NYSE Board and the
NYSE Market Board to be reduced from ten members to five members. The
Exchange has represented that the initial implementation of the
proposed changes immediately following approval by the Commission would
be accomplished through the voluntary resignation of five of the ten
directors from the NYSE Board and NYSE Market Board, respectively,
including one ``fair representation'' director from each of the boards,
in connection with a reduction in the size of each board to five
directors. The Exchange's proposal would not revise the current fair
representation candidate selection and petition process for, or the
appointment or election of a fair representation candidate to, the NYSE
Board and the NYSE Market Board.\7\
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    \7\ As defined in the NYSE Operating Agreement, fair
representation candidates are NYSE Board members that are determined
by member organizations of the Exchange through a specified petition
process (``Petition Candidates'') or, in the absence of Petition
Candidates, candidates recommended jointly by the Director Candidate
Recommendation Committee (``DCRC'') of NYSE Market and of NYSE
Regulation, Inc. In the case of NYSE Market, fair representation
candidates on the Market Board are determined similarly except that,
in the absence of Petition Candidates, they are individuals
recommended by the DCRC of NYSE Market.
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    The Exchange has stated that its proposal is consistent with the
governance structures of other national securities exchanges that have
been approved by the Commission. The Exchange has noted, for example,
that The NASDAQ Stock Market LLC (``Nasdaq'') has a 20% fair
representation requirement, without specifying a minimum number of fair
representation directors,\8\ and that Nasdaq has complete discretion as
to the number of board members.\9\ The Exchange also has noted that in
the approval order relating to the acquisition of the American Stock
Exchange LLC by NYSE Euronext, the Commission similarly approved a
discretionary board size (noting that Amex intended to have a five-
member board), a 20% fair representation requirement, and no minimum
number of fair representation directors.\10\ The Exchange indicated
that, by eliminating, for itself and NYSE Market, the current
requirements for a minimum of two non-affiliated directors and two fair
representation candidates, it will be able to improve administrative
efficiency and effectiveness by operating with a smaller number of
directors, while continuing to fulfill its statutory obligations
regarding the fair representation of its members.
---------------------------------------------------------------------------

    \8\ See Article I, paragraph (q) of the By-Laws of the NASDAQ
Stock Market LLC, which states that, `` `Membership Representative
Director' means a Director who has been elected or appointed after
having been nominated by the Member Nominating Committee or by a
Nasdaq Member pursuant to these By-Laws.''
    \9\ See Section 9(a) of the NASDAQ Stock Market LLC Agreement.
    \10\ See Securities Exchange Act Release No. 58673 (September
29, 2008), 73 FR 57707 (October 3, 2008) (SR-Amex-2008-62).
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the Act and the rules and regulations thereunder applicable to a
national securities exchange.\11\ In particular, the Commission finds
that the proposal is consistent with the requirements of Section
6(b)(3) of the Act, which provides that the rules of an exchange must
assure a fair representation of its members in the selection of its
directors and administration of its affairs and provide that one or
more directors shall be representative of issues and investors and not
be associated with a member of the exchange, broker, or dealer.\12\
---------------------------------------------------------------------------

    \11\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78f(b)(3).
---------------------------------------------------------------------------

    The fair representation requirement in Section 6(b)(3) of the Act
is intended to give members a voice in the selection of the exchange's
directors and the administration of its affairs. Moreover, the Section
6(b)(3) requirement helps to ensure that members are protected from
unfair, unfettered actions by an exchange and that, in general, an
exchange is administered in a way that is equitable to all those who
trade on its market or through its facilities. The Commission notes
that the requirement that at least 20% of the directors on the NYSE and
NYSE Market boards be non-affiliated directors and fair representation
candidates is designed to ensure the fair representation of NYSE
members on the NYSE Board and the NYSE Market Board.\13\ The Commission
notes that, while the proposal eliminates the requirement regarding a
specific minimum number of non-affiliated directors and fair
representation candidates on the boards, it does not alter the minimum
20% requirement for non-affiliated directors or fair representation
candidates or the process by which members can directly petition and
vote for representatives on the boards. Moreover, the proposal adds to
the NYSE Operating Agreement and NYSE Market Bylaws a provision that:
whenever 20% of the board would not result in a whole number, such
number would in all cases be rounded up to the nearest whole number,
thus ensuring that the non-affiliated directors and fair representation
candidates never constitute less than 20% of the board. The Commission
further notes that the proposed changes to the NYSE Operating Agreement
and NYSE Market Bylaws are consistent with previous proposals approved
by the Commission for other exchanges, which also do not specify the
number of fair representation directors and which allow discretion as
to the size of their boards.\14\ The Commission therefore finds that
the Exchange's proposal is consistent with Section 6(b)(3) of the
Act.\15\
---------------------------------------------------------------------------

    \13\ See supra notes 4 and 5.
    \14\ See, e.g., Section 9(a) of the NASDAQ Stock Market LLC
Agreement and Article IV, Section 4-1 of the NASDAQ OMX PHLX, Inc.
By-Laws.
    \15\ 15 U.S.C. 78f(b)(3).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-NYSE-2009-12) is approved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Florence E. Harmon,
Deputy Secretary.
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    \17\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. E9-7834 Filed 4-6-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3303-3306]
[FR Doc No: 2022-01146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1137, FDA-2020-D-1138, FDA-2020-D-0987]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on January 21, 2022.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance

(see table 1). Received comments will be placed in the docket(s) and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, 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, or 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>.

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
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists'' (originally issued on January 31,
2020, and subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are available on
FDA's web pages entitled ``COVID-19-Related Guidance Documents for
Industry, FDA Staff, and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders)
and ``Search for FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
            Docket No.                      Center              Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137...................  CBER..................  Policy for Certain REMS    Office of Communication,
                                                             Requirements During the    Outreach and
                                                             Tocilizumab Shortage       Development, 10903 New
                                                             Related to the COVID-19    Hampshire Ave., Bldg.
                                                             Public Health Emergency    71, Rm. 3128, Silver
                                                             (December 2021).           Spring, MD 20993-0002, 1-
<PHONE_NUMBER> or 240-402-
                                                                                8010; email
                                                                                [email protected].

FDA-2020-D-1138...................  CDRH..................  Enforcement Policy for     CDRH-
                                                             Viral Transport Media      [email protected]
                                                             During the Coronavirus     Please include the
                                                             Disease (COVID-19)         document number 20038-R2
                                                             Public Health Emergency    and complete title of
                                                             (Revised November 2021).   the guidance in the
                                                                                request.
FDA-2020-D-0987...................  CDRH..................  Policy for Coronavirus     CDRH-
                                                             Disease-2019 Tests         [email protected]
                                                             During the Public Health   Please include the
                                                             Emergency (Revised         document number 20010-R4
                                                             November 2021).            and complete title of
                                                                                the guidance in the
                                                                                request.
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

                                     Table 2--CBER Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                        CFR cite referenced in        Another guidance title        OMB control
       COVID-19 guidance title             COVID-19 guidance     referenced in COVID-19 guidance      No(s).
----------------------------------------------------------------------------------------------------------------
Policy for Certain REMS Requirements   21 CFR part 314 (New      ...............................       0910-0001
 During the Tocilizumab Shortage        Drug Applications and
 Related to the COVID-19 Public         Abbreviated New Drug
 Health Emergency (December 2021).      Applications).
                                       21 CFR parts 210, 211     ...............................       0910-0139
                                        and 610 (Current Good
                                        Manufacturing
                                        Practices).
                                       21 CFR part 600 (Adverse  ...............................       0910-0308
                                        Experience Reports).
                                       21 CFR part 601           ...............................       0910-0338
                                        (Biologic License
                                        Applications).
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidances

    The guidances listed below refer to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in the following FDA regulations and guidances have been approved by
OMB as listed in the table below (table 3). These guidances also
contain a new collection of information not approved under a current
collection. These new collections of information have been granted a
public health emergency (PHE) waiver from the PRA by the Department of
Health and Human Services (HHS) on March 19, 2020, under section 319(f)
of the PHS Act. Information concerning the PHE PRA waiver can be found
on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 3--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                          Another guidance                      New Collection
     COVID-19 guidance title       CFR cite referenced  referenced in COVID-   OMB Control    covered by PHE PRA
                                       in COVID-19           19 guidance         No(s).             Waiver
-----------------------------------------guidance---------------------------------------------------------------
Enforcement Policy for Viral                            Emergency Use             0910-0595  ...................
 Transport Media During the                              Authorization of
 Coronavirus Disease 2019 (COVID-                        Medical Products
 19) Public Health Emergency                             and Related
 (Revised November 2021)                                 Authorities;
 (document number 20038-R2).                             Guidance for
                                                         Industry and Other
                                                         Stakeholders.
                                  ------------------------------------------------------------------------------
                                                        Administrative            0910-0607  ...................
                                                         Procedures for
                                                         Clinical
                                                         Laboratory
                                                         Improvement
                                                         Amendments of 1988
                                                         Categorization.
                                  ------------------------------------------------------------------------------
                                   800, 801, and 809..  ...................       0910-0485  ...................
                                   803................  ...................       0910-0437  ...................
                                   806................  ...................       0910-0359  ...................

                                   807, subparts A      ...................       0910-0625  ...................
                                    through D.
                                   807, subpart E.....  ...................       0910-0120  ...................
                                   820................  ...................       0910-0073  ...................
                                   830 and 801.20.....  ...................       0910-0720  ...................
                                  ------------------------------------------------------------------------------
                                                                                Manufacturer
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of viral transport
                                                                                media
                                                                                manufacturing
                                                                                capacity
                                                                                information.
----------------------------------------------------------------------------------------------------------------
                                                                                Manufacturer
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of sterile
                                                                                phosphate buffered
                                                                                saline/saline
                                                                                manufacturing
                                                                                capacity
                                                                                information.
----------------------------------------------------------------------------------------------------------------
Policy for Coronavirus Disease-
 2019 Tests During the Public
 Health Emergency (Revised
 November 2021) (document number
 20010-R4).
----------------------------------------------------------------------------------------------------------------
                                                        Emergency Use             0910-0595  ...................
                                                         Authorization of
                                                         Medical Products
                                                         and Related
                                                         Authorities;
                                                         Guidance for
                                                         Industry and Other
                                                         Stakeholders.
----------------------------------------------------------------------------------------------------------------
                                                        Administrative            0910-0607  ...................
                                                         Procedures for
                                                         Clinical
                                                         Laboratory
                                                         Improvement
                                                         Amendments of 1988
                                                         Categorization.
----------------------------------------------------------------------------------------------------------------
                                   803................  Medical Device            0910-0437  ...................
                                                         Reporting.
----------------------------------------------------------------------------------------------------------------
                                                                                Confirmation to FDA
                                                                                that the developer
                                                                                of a diagnostic or
                                                                                serology test on
                                                                                FDA's notification
                                                                                lists and for
                                                                                which an Emergency
                                                                                Use Authorization
                                                                                (EUA) request was
                                                                                submitted, wants
                                                                                FDA to continue
                                                                                reviewing its EUA
                                                                                request.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01146 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P