[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49828-49830]
[FR Doc No: 2022-17481]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R09-OAR-2022-0705; FRL-10086-01-R9]

Clean Air Act Grant; Hawaii Department of Health; Opportunity for
Public Hearing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed action; determination with request for comments and
notice of opportunity for public hearing.

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SUMMARY: The EPA is proposing to determine that the reduction in
expenditures of recurrent non-Federal funds for the Hawaii Department
of Health (HDOH) in support of its

continuing air program under section 105 of the Clean Air Act (CAA) for
the fiscal year (FY) 2022 is a result of non-selective reductions in
expenditures. This determination, when final, will permit the HDOH to
receive grant funding for FY2023 from the EPA under section 105 of the
CAA.

DATE: Comments and/or requests for a public hearing must be received by
the EPA at the address stated below on or before September 12, 2022 .

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2022-0705 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Proprietary Business Information (PBI) or Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (e.g., on the web,
cloud, or other file sharing system). For additional submission
methods, please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section. For the full EPA public comment policy,
information about PBI/CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Asia Yeary, EPA Region IX, Pacific
Islands Contact Office, Prince Kuhio Federal Building, 300 Ala Moana
Blvd., Suite 5-152, Honolulu, HI 96850; phone at<PHONE_NUMBER> or
email at [email protected].

SUPPLEMENTARY INFORMATION: Section 105 of the CAA provides grant
funding to air pollution control agencies for the prevention and
control of air pollution or implementation of national primary and
secondary ambient air quality standards. In accordance with 40 CFR
35.145(a), the Regional Administrator may provide air pollution control
agencies up to three-fifths of the approved costs of implementing
programs for the prevention and control of air pollution. CAA section
105 grants require a cost share (also referred to as a match
requirement) of 40%. Program activities relevant to the match consist
of both recurring and non-recurring (unique, one-time only) expenses.
In addition, air pollution control agencies must meet a maintenance of
effort (MOE) requirement in accordance with section 105(c)(1) of the
CAA, 42 U.S.C. 7405(c)(1).
    The MOE provision requires that an eligible agency spend at least
the same dollar level of funds as it did in the previous grant year for
the costs of recurring activities. Specifically, section 105(c)(1) of
the CAA provides that, ``No agency shall receive any grant under this
section during any fiscal year when its expenditures of non-Federal
funds for recurrent expenditures for air pollution control programs
will be less than its expenditures were for such programs during the
preceding fiscal year.'' However, pursuant to CAA section 105(c)(2), 42
U.S.C. 7405(c)(2), the EPA may still award a grant to an agency not
meeting the requirements of section 42 U.S.C. 7405(c)(1), ``. . . if
the Administrator, after notice and opportunity for public hearing,
determines that a reduction in expenditures is attributable to a non-
selective reduction in the expenditures in the programs of all
Executive branch agencies of the applicable unit of Government.'' These
statutory requirements are repeated in the EPA's implementing
regulations at 40 CFR 35.140-35.148. The EPA issued a memorandum dated
September 30, 2011, entitled ``Updated Information for Determining a
Non-Selective Reduction'' with guidance to recipients on what
constitutes a nonselective reduction. In consideration of the
legislative history, the guidance clarified that a non-selective
reduction does not necessarily mean that each executive branch agency
needs to be reduced in equal proportion. However, it must be clear to
the EPA, from the weight of evidence, that a recipient's CAA-related
air program is not being disproportionately impacted or singled out for
a reduction.
    A section 105 grant recipient must submit a final federal financial
report no later than 120 days from the close of its grant period that
documents all of its federal and non-federal expenditures for the
completed period. The recipient seeking an adjustment to its MOE for
that period must provide the rationale and the documentation necessary
to enable the EPA to determine that a nonselective reduction has
occurred. In order to expedite that determination, the recipient must
provide details of the budget action and the comparative fiscal impacts
on all the jurisdiction's executive branch agencies, and the
recipient's air program. The recipient needs to identify any executive
branch agencies or programs that should be excepted from comparison and
explain why. The recipient must provide evidence that the air program
is not being singled out for a reduction or being disproportionately
reduced. Documentation in key areas will be needed: budget data
specific to the recipient's air program; and comparative budget data
between the recipient's air program, the agency containing the air
program, and the other executive branch agencies. The EPA may also
request information from the recipient about how impacts on its program
operations will affect its ability to meet its CAA obligations and
requirements, and documentation that explains the cause of the
reduction, such as legislative changes or the issuance of a new
executive order.
    In FY2021, the EPA awarded the HDOH $781,332, which represented
approximately 29% of the HDOH budget. In FY2022, the EPA awarded the
HDOH $884,194, which represented approximately 31% of the HDOH budget.
    HDOH's final federal financial report for FY2021 indicated that
HDOH's MOE level was $1,918,582. HDOH expects their FY2022 expenditures
to be approximately $1,645,864, which indicates that HDOH's
expenditures of non-federal funded recurring activities is not
sufficient to meet the MOE requirements for FY2022 under section 105 of
the CAA because it is not equal to or greater than the MOE for the
previous fiscal year.
    The EPA must make a determination (after notice and an opportunity
for a public hearing) that the reduction in expenditures from 2021 to
2022 is attributable to a non-selective reduction in the expenditures
in the programs of all executive branch agencies of Hawaii's State
government.
    The HDOH is a department organizationally within the Hawaii State
government, which is the unit of government for CAA section 105(c)(2)
purposes.
    On July 5, 2022, the HDOH submitted a request to the EPA seeking a
reduction for the required MOE for FY2022 due to a non-selective
reduction in expenditures. The HDOH explained that it will be unable to
meet its MOE

requirement due to the significant economic and health impacts from the
COVID pandemic. This reduction in recurring expenditures is the result
of HDOH experiencing significant payroll changes impacting its overall
budget. Not only are senior level employees retiring, with some
positions filled by entry level staff at lower starting salaries, other
positions remain vacant due to the conditions caused by the COVID-19
pandemic.
    HDOH explained that the reduction is non-selective because the air
program is not being disproportionately impacted or singled out as the
reduction of expenditures due to increased vacancies and inability to
replace staff is occurring throughout the State government, and not
exclusively to the air program. Hawaii is currently experiencing one of
the highest rates of out-migration of its work-age population. State
agencies have lost staff and have struggled to hire new staff to
replace them.
    The vacancy data provided by Hawaii's Department of Human Resources
Development (DHRD) and HDOH's Human Resources (HR) shown below supports
the requested MOE reduction by demonstrating that a non-selective
reduction in the expenditures of all executive branch agencies has
occurred. The air program's vacancy rate increased by 3.23%, from
27.42% in 2021 to 30.65% in 2022 and the majority of HDOH's
environmental programs' vacancy rates also increased anywhere from
1.69% to 30.95% during this same time frame. In line with the air
program and the other environmental program vacancy increases, the
vacancy rate for the entire HDOH (which contains the air program and
other environmental programs) increased by 3.88% (from 17.38% to
21.25%) during this period. Overall statewide (executive branch
agencies) position vacancy rates showed an even larger increase of
7.88% from 2021 to 2022. Trends in the HDOH and executive branch agency
data show steady increases in vacancy rates with the largest increase
occurring over the last year. The air program's vacancy rate increase
of 3.23% is slightly smaller than the HDOH's increase of 3.88% and less
than half of the executive branch agency increase of 7.88% over the
past year.
    The EPA proposes to find that the request for a reset of HDOH's MOE
meets the requirements for a non-selective reduction under CAA section
105. The HDOH's reduction in personnel expenses and significant cut
back on expenditures caused by the COVID-19 pandemic contributed to the
reduction in expenditures.
    The EPA proposes that the MOE for HDOH's FY2022 CAA section 105
grant be reduced to $1,645,864 to address the non-selective reduction
of recurrent expenditures discussed above.
    This notice constitutes a request for public comment and an
opportunity for public hearing as required by the CAA. All written
substantive comments received by September 12, 2022 on this proposal
will be considered. The EPA will conduct a public hearing on this
proposal only if a written request for such is received by the EPA by
September 12, 2022. If no written request for a hearing is received or
if the EPA determines that the issues raised are insubstantial, the EPA
will proceed to reduce HDOH's MOE for FY2022.

    Dated: August 9, 2022.
Elizabeth Adams,
Director, Air and Radiation Division, Region IX.
[FR Doc. 2022-17481 Filed 8-11-22; 8:45 am]
BILLING CODE 6560-50-P


DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Oxide Pesticide Products

Please note that all times are approximate (see note at end of Agenda).

Tuesday, November 3, 2009

1:30   P.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

1:35   P.M. 	Introduction and Identification of Panel Members – Carey
Pope, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

1:40   P.M.	Welcome and Opening Remarks – Steven Bradbury, Ph.D.,
Deputy Director, Office of Pesticide Programs, EPA

1:45   P.M.	Goals and Objectives – William Jordan, Senior Advisor to
the Office Director, Office of Pesticide Programs, EPA

2:00   P.M.	Evaluation of Hazard and Exposure Associated with Nanosilver
and Other Nanometals –  Office of Pesticide Programs, EPA

3:30 P.M.	Break

3:45 P.M.	EPA presentation (continued)

5:00 P.M.	Adjourn

DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Oxide Pesticide Products

Please note that all times are approximate (see note at end of Agenda).

Wednesday, November 4, 2009

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members – Carey
Pope, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

8:45 A.M.	Public Comment

10:00 A.M.	Break

10:15 A.M.	Public Comment (continued)

11:00 A.M.	Panel Discussion of Charge

Charge Question 1.  Potential Risks from Nanosilver Materials Issue:
Whether pesticide products containing nanosilver as the active
ingredient pose potential hazards and exposures to humans and the
environment that are different from those associated with products
containing conventional silver.

A.  Available scientific literature indicates that nanosilver products
may exert an antimicrobial effect by releasing silver ions, and that
these ions may pose potential hazards to humans and the environment.
The Agency is unaware on any information that would suggest exposures to
silver ions released from nanosilver products differ from the hazards of
silver ions released by non-nanosilver (hereafter referred to as silver)
based products and, therefore, might present a different hazard profile.
 Is the Panel aware of any information inconsistent with this
determination?

B.  Available scientific literature also indicates that, in addition to
any hazards resulting from the release of silver ions, nanosilver
particles themselves may present hazards that differ from those of
silver particles. What, if anything, does the existing scientific
literature indicate about the potential for nanosilver materials with
specific particle sizes in the range of 1 to 20 nm, 21 to 50 nm, and 51
to 100 nm to pose different hazards than those of larger-sized particles
of the same material, particularly nanosilver vs. silver?  What does the
existing scientific literature indicate about the potential for
particular physicochemical properties of nanosilver materials (e.g.,
shape, surface characteristics, composition, etc.) to pose hazards that
are different from larger-sized particles of the same material?  Does
existing literature support “bridging” data?  In other words, can
hazard or exposure data developed on 1 to 20 nm silver particles or
silver composites be used to assess the risks for 51 to 100 nm silver
particles or silver composites?

C.  What, if anything, does the existing scientific literature indicate
about the potential for nanosilver particles in the range of 100 nm –
1000 nm (or “agglomerated” nanosilver or nanometals/nanometal
oxides) to pose hazards that are different from larger-sized particles
of the same material?

D.  If nanosilver particles present different hazards than either silver
or agglomerated nanosilver, the potential risks to human health and the
environment will depend on the extent of exposure.  Several types of
nanosilver pesticide products are described in the attached Background
Paper, and other types seem possible in the near future (e.g.,
sanitizers and disinfectants; and chemicals used in or on industrial,
commercial or residential systems, such as slimicides, preservatives,
antifoulants, metal working fluids, etc.).  What do available data on
the release, fate, transport and transformation of nanosilver particles
suggest regarding potential human or ecological systems exposure to
nanosilver particles (individual or agglomerated) under realistic use
scenarios?

E.  The Agency would like the Panel’s advice as to whether the models
currently used by the Agency would be appropriate to predict potential
environmental exposures to nanosilver and if not, what, if any,
modifications would be necessary.

12:00 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge Question 1 (continued)

2:00 P.M.	Panel Discussion of Charge

Charge Question 2.   Data Requirements Issue:  If the panel believes
that nanosilver is different in terms of hazard/exposure what type of
data (studies) would EPA need to adequately assess the potential risks
associated with the use of an antimicrobial pesticide containing
nanosilver particles, when the product is intended for use as an
additive to various substrates (e.g., textiles, plastics, ceramics) to
impart antimicrobial properties to the treated substrate?  In liquid,
spray form?

A.  What types of data on the nanoscale material would be sufficient to
adequately evaluate whether the hazard and exposure properties of the
nanoscale material were comparable to that of a macroscale/bulk form of
the same material?  Could EPA rely on toxicity data for the bulk
material to assess the risk of the nanoscale material?

B.  What types of data would be sufficient to:

1)  Evaluate whether the nanoscale material, once it has been applied to
or incorporated within a substrate, remains associated with the
substrate through the whole-life cycle of that substrate to such an
extent that there would be essentially no human or environmental
exposure to the nanoscale material or nanosized composite, and

2) Measure and characterize exposures to nanomaterials that may leach
from treated materials?

C.  Assuming appropriate studies could adequately show that nanosilver,
which is applied to a substrate, would bind with that substrate to such
an extent that there is essentially no exposure to the nanosilver, does
the Panel think that other types of data (such as toxicity studies on
the nanosilver particles or composite) would be needed?  Similarly, if
only silver ions are released from substrate containing nanosilver,
would consideration of the potential risks associated with the silver
ions be sufficient or would additional data be needed to assess hazards
and exposure to human health and the environment from nanosilver?

3:30 P.M.	Break

3:45 P.M.	Panel Discussion of Charge

Charge Question 3. Other Risk Assessment Issues.

A.  Products developed using nanotechnology may contain a distribution
of particle sizes.  Please comment on how information concerning the
percentage of the particles in a product falling within the nanoscale
range (e.g., 1 - ~100 nm) could affect the risks of a product.  Are
particles at the lower end of the range (e.g., 1 nm) likely to behave
like particles at the upper end of the range (e.g., 100 nm)?

B.  Please comment on the extent to which the scientific literature
indicates that data on one form of a nanosilver particle or other
nanometal/nanometal oxide particle can be used to assess the potential
hazards and exposures of another form of nanosilver that has different
physicochemical properties (e.g., is a different size or shape or has
different surface properties).  For example, if nanosilver is reacted
with a non-metal material to form a nanosilver complex or composite, to
what extent could data developed for the nanosilver be used to predict
the toxicity of the complex or composite?

C.  Please comment on the extent to which the scientific literature
indicates that nanosilver physicochemical properties change under
different environmental or physiological conditions, what those
conditions are, and how this variation could be best addressed.

5:00 P.M.      ADJOURN

DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Oxide Pesticide Products

Please note that all times are approximate (see note at end of Agenda).

Thursday, November 5, 2009

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:40 A.M. 	Introduction and Identification of Panel Members – Carey
Pope, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

8:50 A.M.	Panel Discussion of Charge

Charge Question 4.  Research Needs.

A. In the next year, what types of new information on individual
products would be most useful to EPA for assessing potential risks of
antimicrobial pesticides containing nanosilver or nanosilver composites,
such as toxicity studies, exposure studies, etc.

B. What types of long term research would be most helpful for improving
the assessment of the potential risks of antimicrobial pesticide
products containing nanosilver or nanosilver composites?

10:00 A.M.	Break

10:15 A.M.	Panel Discussion of Charge (continued as needed)

12:00 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge (continued as needed)

2:45 P.M.	Break

3:00 P.M.	Panel Discussion of Charge (continued as needed)

5:00 P.M.      ADJOURN

DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN CONSULTATION MEETING

November 3 - 6, 2009

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2009-0683

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

Evaluation of Hazard and Exposure Associated with Nanosilver and Other
Nanometal Oxide Pesticide Products

Please note that all times are approximate (see note at end of Agenda).

Friday, November 6, 2009

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:40 A.M. 	Introduction and Identification of Panel Members – Carey
Pope, Ph.D., Session Chair, FIFRA Scientific Advisory Panel

8:50 A.M.	Panel Discussion of Charge (continued as needed)

10:00 A.M.	Break

10:15 A.M.	Panel Discussion of Charge (continued as needed)

12:00 P.M.	Lunch

1:15 P.M.	Panel Discussion of Charge (continued as needed)

2:45 P.M.	Break

3:00 P.M.	Panel Discussion of Charge (continued as needed)

5:00 P.M.      ADJOURN

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Joseph Bailey, via telephone:<PHONE_NUMBER>; fax:
(202) 564-8382; or email<EMAIL_ADDRESS>
 PAGE

 PAGE   4


[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Page 873]
[FR Doc No: 2019-00467]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84954; File No. SR-DTC-2018-010]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Designation of Longer Period for Commission Action on
Proposed Rule Change To Amend the Settlement Guide Procedures To
Provide Status Information for Institutional Transactions to a Matching
Utility

December 26, 2018.
    On November 29, 2018, The Depository Trust Company (``DTC''), filed
with the Securities and Exchange Commission (``Commission'') a proposed
rule change, to allow DTC to share status information with matching
utilities (SR-DTC-2018-010), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The proposed rule change was published for comment in
the Federal Register on December 12, 2018.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 84751 (December 7,
2018), 83 FR 63948 (December 12, 2018) (SR-DTC-2018-010).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for the proposed rule change
is January 25, 2019.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the proposed rule change.
    Accordingly, pursuant to Section 19(b)(2) of the Act \5\ and for
the reasons stated above, the Commission designates March 12, 2019 as
the date by which the Commission shall either approve, disapprove, or
institute proceedings to determine whether to disapprove proposed rule
change SR-DTC-2018-010.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-00467 Filed 1-30-19; 8:45 am]
BILLING CODE P


[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40795-40797]
[FR Doc No: 2018-17629]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83822; File No. SR-NYSEAMER-2018-37]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Change To Amend Section
140 and Section 142 of the NYSE American Company Guide To Eliminate the
Initial Application Fee for SPACs Applying To List and Amend the
Additional Shares Fee for Shares Issued in Conjunction With a Business
Combination if the SPAC Remains Listed After Such Business Combination

August 10, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on July 31, 2018, NYSE American LLC (the ``Exchange'' or
``NYSE American'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Section 140 of the NYSE American
Company Guide to provide that a company applying to list as a special
purpose acquisition company (``SPAC'') under Section 119 of the Company
Guide will not be required to pay an Initial Application Fee. The
Exchange also proposes to amend Section 142 of the Company Guide to
provide that a SPAC remaining listed after consummation of the Business
Combination will not be required to pay listing fees in relation to the
issuance of any additional shares (i) in connection with the
consummation of the Business Combination; or (ii) in a transaction that
occurs at the same time as the Business Combination with a closing
contractually contingent on the consummation of the Business
Combination. The proposed change is available on the Exchange's website
at www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Section 119 of the Company Guide provides for the listing of
companies with no prior operating history (``SPACs'') that conduct an
initial public offering for the purpose of engaging in a merger or
acquisition with one or more unidentified companies within a specific
period of time (not to exceed 36 months) (the ``Business
Combination''). At least 90% of the gross proceeds of a SPAC's IPO and
any concurrent sale by the company of equity securities must be
deposited in a trust account maintained by an independent trustee, an
escrow account maintained by an ``insured depository institution,'' as
that term is defined in Section 3(c)(2) of the Federal Deposit
Insurance Act, or in a separate bank account established by a
registered broker or dealer (collectively, a ``deposit account'')
pending completion of the Business Combination or dissolution of the
SPAC. The Business Combination must have an aggregate fair market value
of at least 80% of the value of the deposit account (excluding any
deferred underwriter's fees and taxes payable on the income earned on
the deposit account) at the time of the agreement. A listed SPAC may
remain listed upon consummation of its Business Combination, provided
it

meets the criteria for initial listing of an operating company.
Proposed Waiver of the Initial Application Fee for SPACs
    Pursuant to Section 140 of the Company Guide, issuers applying for
initial listing on the Exchange must (subject to enumerated exceptions)
pay a $5,000 initial application fee (the ``Initial Application Fee'').
The Initial Application Fee is deducted from the amount of initial
listing fees payable by an applicant at the time of its initial
listing. The Exchange proposes to amend Section 140 to provide that
companies listed as SPACs under Section 119 of the Company Guide would
not be charged the Initial Application Fee. SPACs applying to list
almost always complete their offerings and the Exchange is therefore
unlikely to incur unreimbursed costs in reviewing their applications,
which was the concern the Exchange was addressing when it adopted the
Initial Application Fee.
Proposed Waiver of Additional Listing Fees in Connection With SPAC
Business Combinations
    The Exchange has observed that a SPAC will frequently reconsider
its listing venue in connection with the consummation of its Business
Combination. The Business Combination is a transformative event in the
life cycle of a SPAC, when it becomes an operating company instead of a
blank check company. In connection with that transformation, a SPAC
will frequently put in place a new management team and significantly
change its board of directors and it will often have a significantly
different shareholder base after the Business Combination than it had
as a SPAC. In effect, a SPAC after its Business Combination is a
completely different company and it is for this reason that the board
and management of the company after the transaction would want to
reconsider the positioning of the company in many respects, including
its listing venue.
    The market for the retention or transfer to another exchange of
these companies is very competitive and a number of transfers to a new
listing venue have occurred in connection with the completion of a
SPAC's Business Combination. The listing rules of the Exchange,\4\ the
New York Stock Exchange \5\ and NASDAQ Stock Market \6\ all provide for
a waiver of all initial listing fees in connection with a transfer from
another national securities exchange, so a SPAC moving its listing upon
consummation of its Business Combination does not pay any listing fees
in connection with such transfer or the issuance of any new shares at
the time of its Business Combination. However, pursuant to the
provisions of Section 142 of the Company Guide, a SPAC remaining listed
on the Exchange upon consummation of its Business Combination must pay
additional listing fees in relation to any additional shares issued in
connection with the Business Combination. In such a case, the SPAC
would be faced with the anomalous situation where there would be no
listing fee burden associated with a transfer to another exchange but
it would be required to pay significant additional listing fees if it
remained on its incumbent exchange. Consequently, to eliminate this
disparate treatment of companies listing after a Business Combination,
the Exchange proposes to amend Section 142 to provide that any SPAC
remaining listed on the Exchange upon consummation of its Business
Combination would no longer be subject to any additional listing fees
with respect to any shares issued in connection with such Business
Combination.
---------------------------------------------------------------------------

    \4\ See Section 140 of the NYSE American Company Guide.
    \5\ See Section 902.02 of the NYSE Listed Company Manual.
    \6\ See NASDAQ Marketplace Rule 5910(a)(7)(i).
---------------------------------------------------------------------------

    In addition, the Exchange has observed that it is not uncommon for
a SPAC to raise capital by selling shares in a private placement in
conjunction with the consummation of its Business Combination to fund
its new business after the Business Combination. The private placement
generally closes at the same time as the consummation of the Business
Combination and the closing of the private placement is contractually
conditioned on such consummation.
    Under current Exchange rules, the SPAC would be required to pay
listing fees with respect to the shares issued in any such private
placement. By contrast, if the SPAC chose to transfer to another
listing venue at the time of consummation of its Business Combination,
the other market would charge no listing fees on those shares as they
would be subject to the listing fee exemption, which all of the
exchanges have, for shares outstanding at the time of transfer. As this
anomaly would impose a cost on the SPAC if it remained on the Exchange
where none would be incurred if the company chose to transfer, the
Exchange proposes to amend Section 142 to provide that a SPAC that
remains listed after consummation of its Business Combination would not
be required to pay listing fees in relation to the issuance of any
additional shares in a transaction that occurs at the same time as the
Business Combination with a closing contractually contingent on the
consummation of the Business Combination.\7\
---------------------------------------------------------------------------

    \7\ The Exchange believes that it is appropriate to provide this
waiver to a SPAC at the time of its Business Combination and not to
an operating company that would also be subject to additional
listing fees in connection with a share issuance subsequent to
listing. In the Exchange's experience, there is generally no
parallel to the Business Combination in the life cycle of an
operating company that would cause it to reconsider its listing
venue at the time it issued additional shares, so the anomaly the
Exchange seeks to address in relation to SPACs is not relevant to
operating companies.
---------------------------------------------------------------------------

    The Exchange does not expect the revenues it forgoes as a result of
the proposed amendments to Sections 140 and 142 to negatively affect
its ability to conduct its regulatory program.
    The Exchange also proposes to remove some text from Section 140
that is no longer applicable as it refers to the implantation of the
Initial Application Fee as of January 1, 2013. Additionally, the
Exchange proposes to amend Section 142 to remove text relating to fee
rates that are no longer applicable as they expired by their terms on
December 31, 2014.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\8\ in general, and furthers the
objectives of Sections 6(b)(4) \9\ and 6(b)(5) \10\ of the Act, in
particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges and is not
designed to permit unfair discrimination among its members and issuers
and other persons using its facilities.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed amendment to Section 140 is not unfairly
discriminatory and represents an equitable allocation of reasonable
fees, because SPACs applying to list almost always complete their
offerings and the Exchange is therefore unlikely to incur unreimbursed
costs in reviewing their applications, which was the concern the
Exchange was addressing when it adopted the Initial Application Fee. In
addition, the proposed amendment would represent an equitable
allocation of reasonable fees as the Initial Listing Application Fee is
offset against fees payable upon listing and almost all SPACs applying
to list would benefit from this discount to their initial listing fees,
while operating company

applicants are much more likely not to complete the listing process.
    The proposed amendment to Section 142 is not unfairly
discriminatory and represents an equitable allocation of reasonable
fees, as it will result in a SPAC that remains listed on the Exchange
after its Business Combination being treated the same as a SPAC that
transfers to the Exchange from another listing venue. The Exchange also
believes the proposed amendment to Section 142 is not unfairly
discriminatory and represents an equitable allocation of reasonable
fees with respect to listed operating companies, as operating companies
generally do not have an event in their life cycle parallel to the
Business Combination for a SPAC which would normally give rise to a
reconsideration of the company's listing venue.
    The proposed removal of text relating to fees that are no longer
applicable is ministerial in nature and has no substantive effect.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Act. The proposed amendment to
Section 140 does not impose and burden on competition as it merely will
allow the Exchange to better compete with other exchanges for initial
listing of SPACs. In addition, the proposed amendment to Section 142
does not impose any burden on competition, as it will have the effect
of treating a SPAC that remains listed on the Exchange after its
Business Combination the same for fee purposes as a SPAC that transfers
to the Exchange from another listing venue or transfers to another
listing venue at that time.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \11\ of the Act and subparagraph (f)(2) of Rule
19b-4 \12\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2018-37 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2018-37. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2018-37 and should be submitted
on or before September 6, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2018-17629 Filed 8-15-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 9, 2009 (Volume 74, Number 195)]
[Rules and Regulations]
[Page 52136-52138]
[DOCID:fr09oc09-7]

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

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2009-N-0119]

Medical Devices; Immunology and Microbiology Devices;
Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
classification of the respiratory viral panel multiplex nucleic acid
assay into class II (special controls). The special controls that will
apply to the device are three guidance documents entitled: ``Class II
Special Controls Guidance Document: Respiratory Viral Panel Multiplex
Nucleic Acid Assay,'' as applicable, ``Class II Special Controls
Guidance Document: Testing for Human Metapneumovirus (hMPV) Using
Nucleic Acid Assays,'' and as applicable,``Class II Special Controls
Guidance Document: Testing for Detection and Differentiation of
Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' The
agency classified the device into class II (special controls) in order
to provide a reasonable assurance of safety and effectiveness of the
device. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the guidance documents that will serve
as the special controls for this device.

DATES: This final rule is effective November 9, 2009. The
classification was effective January 3, 2008.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5550, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of This Rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in
commercial distribution before May 28, 1976, the date of enactment of
the Medical Device Amendments of 1976 (the amendments), generally
referred to as postamendments devices, are classified automatically by
statute into class III without any FDA rulemaking process. These
devices remain in class III and require premarket approval, unless and
until the device is classified or reclassified into class I or II, or
FDA issues an order finding the device to be substantially equivalent,
in accordance with section 513(i) of the act, to a predicate device
that does not require premarket approval. The agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k) and part 807 (21 CFR part 807) of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act for a device
that has not previously been classified may, within 30 days after
receiving an order classifying the device in class III under section
513(f)(1), request FDA to classify the device under the criteria set
forth in section 513(a)(1). FDA shall, within 60 days of receiving such
a request, classify the device by written order. This classification
shall be the initial classification of the device. Within 30 days after
the issuance of an order classifying the device, FDA must publish a
notice in the Federal Register announcing such classification (section
513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an
order on November 30, 2007, classifying the Luminex Molecular
Diagnostics, Inc., xTAG\TM\ RVP (Respiratory Viral Panel) as class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device that was
subsequently reclassified into class I or class II. On December 1,
2007, Luminex Molecular Diagnostics, Inc., submitted a petition
requesting classification of the xTAG\TM\ RVP under section 513(f)(2)
of the act. The manufacturer recommended that the device be classified
into class II.
    In accordance with section 513(f)(2) of the act, FDA reviewed the
petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the act. Devices are
to be classified into class II if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the Luminex
Molecular Diagnostics, Inc., xTAG\TM\ RVP can be classified in class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of safety and effectiveness of the device.
    The device is assigned the generic name ``respiratory viral panel
multiplex nucleic acid assay.'' It is identified as a qualitative in
vitro diagnostic device that is intended to simultaneously detect and
identify multiple viral nucleic acids extracted from human respiratory
specimens or viral culture. The detection and identification of a
specific viral nucleic acid from individuals exhibiting signs and
symptoms of respiratory infection aids in the diagnosis of respiratory
viral infection when used in conjunction with other clinical and
laboratory findings.

    Respiratory illness caused by various commonly circulating
respiratory viruses (e.g., Influenza A, RSV) can cause high morbidity
and mortality, particularly in at-risk populations such as the elderly
and the very young. Therefore, FDA has identified the following issues
of safety or effectiveness requiring special controls for a respiratory
viral panel multiplex nucleic acid assay, i.e. potential risks to
health associated with this assay. These include (1) Failure of the
device to perform as indicated, leading to inaccurate results or lack
of results and (2) incorrect interpretation of results; both of these
potential risks may lead to incorrect patient management decisions. For
example, a false positive result could lead to unnecessary or
inappropriate treatment for the misidentified viral illness, as well as
delayed treatment of the actual infection, which may potentially be a
more serious infection caused by bacteria or other pathogens. A false
negative result could lead to failure to provide a diagnosis and the
correct treatment, and may contribute to unnecessary treatment. A lack
of result could lead to delayed diagnosis and inadequate treatment.
Additionally, for assays that both detect Influenza A and differentiate
between Influenza A subtypes, if a specimen yields a positive test
result for Influenza A, but produces negative test results for all
specific influenza A subtypes intended to be differentiated (i.e., H1
or H3), then local, state or federal public health authorities should
be notified to determine whether the specimen represents a novel strain
of Influenza A, in accordance with the Morbidity and Mortality Weekly
Report (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5613a4.htm and
http://www.cste.org/ps/2007pdfs/novelfluanndssjan10final23.pdf).\1\
Therefore, inaccurate results for influenza types and subtypes included
in the respiratory viral panel may lead to inappropriate public health
responses. Failure to interpret assay results in the context of the
other laboratory results and the clinical presentation could lead to
inappropriate or delayed treatment. The virus or viruses detected may
not necessarily be the cause of the clinical symptoms, therefore
positive assay results do not rule out bacterial co-infection, or co-
infection with other viruses.
---------------------------------------------------------------------------

    \1\ (FDA has verified the Web site addresses, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
---------------------------------------------------------------------------

    FDA believes the class II special controls guidance documents will
help mitigate potential risks by providing recommendations for
performance evaluation, labeling, and measures to address the effects
of ancillary reagents (specific reagents required under instructions
for use of the assay but not provided) on safety and effectiveness of
respiratory viral panel multiplex nucleic acid assays. The guidance
documents also provide information on how to meet premarket (510(k))
submission requirements for the device. FDA believes that following the
class II special controls guidance documents generally addresses the
risks to health identified in the previous paragraph. Therefore, on
January 3, 2008, FDA issued an order to the petitioner classifying the
device into class II. FDA is codifying this classification by adding 21
CFR 866.3980.
    Any firm submitting a 510(k) premarket notification for a
respiratory viral panel multiplex nucleic acid assay will need to
address the issues covered in the special controls guidances. However,
the firm need only show that its device meets the recommendations of
the guidances, or in some other way provides equivalent assurance of
safety and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, however, FDA has
determined that premarket review of the system's key performance
characteristics, test methodology, labeling, and other requirements as
outlined in Sec.  807.87, will provide reasonable assurance that
acceptable levels of performance for both safety and effectiveness will
be addressed before marketing clearance. Thus, persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
respiratory viral panel multiplex nucleic acid assay they intend to
market.

II. What Is the Environmental Impact of This Rule?

    The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. What Is the Economic Impact of This Rule?

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because classification of these devices into class
II will relieve manufacturers of the device of the cost of complying
with the premarket approval requirements of section 515 of the act (21
U.S.C. 360e), and may permit small potential competitors to enter the
marketplace by lowering their costs, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Does This Final Rule Have Federalism Implications?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the

exercise of State authority conflicts with the exercise of Federal
authority under the Federal statute.'' Federal law includes an express
preemption provision that preempts certain state requirements
``different from or in addition to'' certain federal requirements
applicable to devices. 21 U.S.C. 360k; Medtronic v. Lohr, 518 U.S. 470
(1996); Riegel v. Medtronic, 128 S. Ct. 999 (2008). The special
controls established by this final rule create ``requirements'' for
specific medical devices under 21 U.S.C. 360k, even though product
sponsors have some flexibility in how they meet those requirements.
(Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)).

V. How Does This Rule Comply With the Paperwork Reduction Act of 1995?

    This final rule establishes as special controls three guidance
documents that refer to previously approved collections of information
found in other FDA regulations. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control no.
0910-0120. The collections of information in 21 CFR part 801 and 21 CFR
809.10, regarding labeling, have been approved under OMB control no.
0910-0485.

VI. What References Are on Display?

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Petition from Luminex Molecular Diagnostics, Inc., dated
December 1, 2007.

List of Subjects in 21 CFR Part 866

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 866.3980 is added to subpart D to read as follows:

Sec.  866.3980   Respiratory viral panel multiplex nucleic acid assay.

    (a) Identification. A respiratory viral panel multiplex nucleic
acid assay is a qualitative in vitro diagnostic device intended to
simultaneously detect and identify multiple viral nucleic acids
extracted from human respiratory specimens or viral culture. The
detection and identification of a specific viral nucleic acid from
individuals exhibiting signs and symptoms of respiratory infection aids
in the diagnosis of respiratory viral infection when used in
conjunction with other clinical and laboratory findings. The device is
intended for detection and identification of a combination of the
following viruses:
    (1) Influenza A and Influenza B;
    (2) Influenza A subtype H1 and Influenza A subtype H3;
    (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial
Virus subtype B;
    (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
    (5) Human Metapneumovirus;
    (6) Rhinovirus; and
    (7) Adenovirus.
    (b) Classification. Class II (special controls). The special
controls are:
    (1) FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid
Assay;''
    (2) For a device that detects and identifies Human Metapneumovirus,
FDA's guidance document entitled ``Class II Special Controls Guidance
Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid
Assays;'' and
    (3) For a device that detects and differentiates Influenza A
subtype H1 and subtype H3, FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Testing for Detection and
Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic
Acid Assays.'' See Sec.  866.1(e) for the availability of these
guidance documents.

    Dated: October 1, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24432 Filed 10-8-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Page 36280]
[FR Doc No: 2021-14618]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9057-3]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed June 28, 2021 10 a.m. EST Through July 2, 2021 10 a.m. EST
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20210087, Draft, USFS, OR, Youngs Rock Rigdon, Comment Period
Ends: 08/23/2021, Contact: Hilary Krieger<PHONE_NUMBER>.
EIS No. 20210088, Final, USFS, CO, Berlaimont Estates Access Route,
Review Period Ends: 08/09/2021, Contact: Leanne Veldhuis<PHONE_NUMBER>.
EIS No. 20210089, Final, FRA, GA, Atlanta to Charlotte Rail Corridor
Investment Plan, Contact: John Winkle<PHONE_NUMBER>.

    Under 23 U.S.C. 139(n)(2), FRA has issued a single document that
consists of a final environmental impact statement and record of
decision. Therefore, the 30-day wait/review period under NEPA does not
apply to this action.

EIS No. 20210090, Draft, NOAA, NY, Proposed Lake Ontario National
Marine Sanctuary Draft Environmental Impact Statement and Draft
Management Plan, Comment Period Ends: 09/10/2021, Contact: Ellen Brody
734-276-6387.
EIS No. 20210091, Third Final Supplemental, USFS, AK, Kensington Gold
Mine Plan of Operations Amendment 1, Review Period Ends: 08/23/2021,
Contact: Matthew Reece<PHONE_NUMBER>.
EIS No. 20210092, Draft, USAF, ID, Airspace Optimization for Readiness
for Mountain Home Air Force Base, Comment Period Ends: 08/23/2021,
Contact: Robin Divine<PHONE_NUMBER>.
EIS No. 20210093, Final Supplement, USFS, ID, Clear Creek Integrated
Restoration Project, Review Period Ends: 08/09/2021, Contact: Karen
Ritland<PHONE_NUMBER>.
EIS No. 20210094, Draft, FERC, PA, East 300 Upgrade Project, Comment
Period Ends: 08/23/2021, Contact: Office of External Affairs 866-208-
3372.

    Dated: July 2, 2021.
Candi Schaedle,
Acting Director, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2021-14618 Filed 7-8-21; 8:45 am]
BILLING CODE 6560-50-P