[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Rules and Regulations]
[Pages 49248-49249]
[FR Doc No: 2021-18887]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2021-0176; FRL-8759-02-R9]

Air Plan Approval; California; Imperial County Air Pollution
Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the Imperial County Air Pollution
Control District (ICAPCD or ``District'') portion of the California
State Implementation Plan (SIP). The revision concerns emissions of
volatile organic compounds (VOCs) from gasoline transfers at bulk
gasoline terminals storage. We are approving a local rule to regulate
these emission sources under the Clean Air Act (CAA or the Act).

DATES: This rule is effective on October 4, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2021-0176. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through https://www.regulations.gov, or please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section for
additional availability information. 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: Donnique Sherman, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On May 10, 2021 (86 FR 24835), the EPA proposed to approve the
following rule into the California SIP.

----------------------------------------------------------------------------------------------------------------
          Local agency               Rule #                 Rule title                Revised        Submitted
----------------------------------------------------------------------------------------------------------------
ICAPCD.........................             415  Transfer and Storage of              11/03/2020      02/19/2021
                                                  Gasoline.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complies with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, the EPA is fully approving this rule into the
California SIP. The November 3, 2020, version of Rule 415 will replace
the previously approved version of this rule in the SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
ICAPCD rules described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under

Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by November 1, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: August 26, 2021.
Elizabeth Adams,
Acting Regional Administrator, Region IX.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends part 52, chapter I, title 40 of the Code of
Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(332)(i)(A)(5) and
(c)(562)to read as follows:

Sec.  52.220   Identification of plan-in part.

* * * * *
    (c) * * *
    (332) * * *
    (i) * * *
    (A) * * *
    (5) Previously approved on February 22, 2005 in paragraph
(c)(332)(i)(A)(2) of this section and now deleted with replacement in
(c)(562)(i)(A)(1), Rule 415, ``Transfer and Storage of Gasoline,''
amended on May 18, 2004.
* * * * *
    (562) Amended regulations for the following APCDs were submitted on
February 19, 2021 by the Governor's designee as an attachment to a
letter dated February 18, 2021.
    (i) Incorporation by reference. (A) Imperial County Air Pollution
Control District. (1) Rule 415, ``Transfer and Storage of Gasoline,''
amended on November 3, 2020.
    (2) [Reserved]
    (B) [Reserved]
    (ii) [Reserved]

[FR Doc. 2021-18887 Filed 9-1-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Page 21843]
[FR Doc No: 2020-08261]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-49-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of Revised
Schedule for Environmental Review of a Proposed Amendment of the
Northeast Supply Enhancement Project

    This notice identifies the Federal Energy Regulatory Commission
staff's revised schedule for the completion of the environmental
assessment (EA) for Transcontinental Gas Pipe Line Company, LLC's
Northeast Supply Enhancement Project Amendment. The first notice of
schedule, issued on March 25, 2020, identified May 15, 2020 as the EA
issuance date. However, we received few comments regarding the access
road that is the subject of the amendment. As a result, staff has
revised the schedule for issuance of the EA.

Schedule for Environmental Review

Issuance of the EA April 24, 2020
90-day Federal Authorization Decision Deadline July 23, 2020

    If a schedule change becomes necessary, an additional notice will
be provided so that the relevant agencies are kept informed of the
project's progress.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP20-49), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: April 14, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-08261 Filed 4-17-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Notices]
[Pages 24239-24242]
[FR Doc No: 2012-9629]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66821; File No. SR-NYSE-2012-10]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Amending NYSE Rule 107B To Add
a Class of Supplemental Liquidity Providers That Are Registered as
Market Makers at the Exchange

April 17, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 4, 2012, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Rule 107B to add a class of
Supplemental Liquidity Providers (``SLP'') that are registered as
market makers at the Exchange. The text of the proposed rule change is
available at the Exchange, the Commission's Public Reference Room, and
www.nyse.com.

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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE Rule 107B, which currently
operates on a pilot basis, to add a class of SLPs that are registered
as market makers at the Exchange.
Background
    Rule 107B, which was adopted as a pilot program in October 2008,
established a new class of off-Floor market participants referred to as
Supplemental Liquidity Providers or ``SLPs.'' \3\ Approved Exchange
member organizations are eligible to be an SLP. SLPs supplement the
liquidity provided by Designated Market Makers (``DMM''). SLPs have
monthly quoting requirements that may qualify them to receive SLP
rebates, which are larger than the general rebate available to non-SLP
market participants.
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    \3\ See Securities Exchange Act Release No. 58877 (October 29,
2008), 73 FR 65904 (November 5, 2008) (SR-NYSE-2008-108)
(establishing pilot program for market participants referred to as
``Supplemental Liquidity Providers'' or ``SLPs.''). The pilot is
currently scheduled to end on July 31, 2012.
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    The goal of the SLP program is to encourage participants to quote
more often and to add displayed liquidity to the market. Thus, Rule
107B(a) requires that an SLP maintain a bid and/or an offer at the NBB
or NBO averaging at

least 10% of the trading day for each assigned security. In addition,
an SLP must provide an average daily volume (``ADV'') of more than 10
million shares for all assigned SLP securities on a monthly basis.
Meeting this volume requirement will enable an SLP to receive the basic
SLP rebate (currently $0.0020 per executed share) on security-by-
security basis and to maintain their SLP status.\4\
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    \4\ The Exchange may, from time to time, change the amounts of
the scaled SLP rebates by filing a proposed rule change under Rule
19b-4(f)(2) of the Act. 17 CFR 240.19b-4(f)(2).
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    To qualify as an SLP under Rule 107B(c), a member organization is
subject to a number of conditions, including adequate trading
infrastructure to support SLP trading activity, quoting and volume
performance that demonstrates an ability to meet the 10% ADV
requirement, and use of specified SLP mnemonics. In addition, the
business unit of the member organization acting as an SLP must enter
proprietary orders only and have adequate information barriers between
the SLP unit and any member organization's customer, research, and
investment-banking business. Pursuant to Rule 107B(h)(2)(A), a DMM may
also be an SLP, but not in the same securities in which it is
registered as a DMM.
    Rule 107B(d) and (e) currently set forth the application process
and voluntary withdrawal process for SLPs. Rule 107B(f) sets forth how
the quoting requirements are calculated and Rule 107B(g) sets forth how
the monthly volume requirement is calculated. The assignment of SLP
securities is set forth in Rule 107B(h). Rule 107B(i) specifies the
entry of orders by SLPs, which may only be entered electronically from
off the Floor of the Exchange from the proprietary account of the
member organization.
    Rule 107B(j) imposes certain non-regulatory penalties if an SLP
fails to meet the quoting requirements. Specifically, an SLP would not
be able to earn a rebate unless it maintained a quote at the NBB or NBO
an average of 10% of the trading day. Pursuant to Rule 107B(j)(1)(A),
to be eligible for a financial rebate for an SLP security for which the
SLP has met the 10% quoting requirement, the SLP would first need to
meet the minimum 10 million share ADV requirement for all assigned
securities. If the SLP fails to meet the volume requirement, it would
not be eligible for any rebates, notwithstanding that it may have met
the quoting requirement for one or more assigned SLP securities. If the
SLP meets the volume requirement for all assigned securities, but does
not meet the 10% quoting requirement in any securities, the SLP would
not receive any financial rebates. An SLP is also at risk of losing its
SLP status if it fails to meet the 10% quoting requirement for three
consecutive months. Rule 107B(k) specifies the process for the appeal
of any non-regulatory penalties.
Proposed SLP Market Makers
    The Exchange proposes to amend Rule 107B to add a category of SLPs
that would be registered as market makers at the Exchange. As proposed,
the term ``SLP'' would refer to member organizations that provide
supplemental liquidity and there would be two classes of SLP. The
existing SLP member organizations and associated requirements would
continue unchanged and would be applicable to a new class of SLPs
referred to as ``SLP-Prop.''
    The Exchange proposes to add a new class of SLP, referred to as
``SLMM'', which would be registered as market makers at the Exchange.
As proposed, the SLMMs would have differing qualification requirements
and increased regulatory obligations as compared to SLP-Props, but
would otherwise be subject to the existing SLP program. Because the
Exchange proposes that the SLMMs would be subject to specified
regulatory obligations, including the requirement to maintain a
continuous two-sided quote, the Exchange believes that this class of
registered market makers could be eligible for market maker treatment
under federal rules,\5\ such as the close-out requirements for fail-to-
deliver positions applicable to market makers under Rule 204 of
Regulation SHO.\6\
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    \5\ Among other things, a ``market maker'' is defined under the
Securities Exchange Act of 1934 (the ``Act'') as ``any dealer who,
with respect to a security, holds himself out (by entering
quotations in an inter-dealer communication system or otherwise) as
being willing to buy and sell such security for his own account on a
regular or continuous basis.'' 15 U.S.C. 78c(a)(38).
    \6\ 17 CFR 242.204(a)(3).
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    As with the SLP program in general, SLMMs are intended to
supplement the liquidity provided by DMMs, and are not intended to
replace DMMs.\7\ The Exchange proposes to add SLMMs in order to assist
in the maintenance of a fair and orderly market, as reasonably
practicable. While all securities that trade at the Exchange are
required to be assigned to a DMM, not all securities would be required
to be assigned to an SLMM, which is how the SLP program operates today.
The Exchange believes that the proposed rule change would expand the
number of member organizations eligible to participate in the SLP
program. In particular, it would enable member organizations that are
registered as market makers on other exchanges that are not interested
in joining the existing proprietary-only SLP program to join the SLP
program.
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    \7\ The Exchange notes that NYSE Arca, Inc. (``NYSE Arca'') has
two classes of market makers: lead market makers and regular market
makers. The proposed SLMM class would have obligations similar to
those applicable to NYSE Arca regular market makers.
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    As set forth in the proposed amendment to Rule 107B(a), an SLP can
choose to be either an SLP-Prop or an SLMM. As proposed, SLMMs would
have different qualification requirements, specified regulatory
obligations, expanded entry of order requirements, and a security-by-
security withdrawal ability. SLP-Props and SLMMs would be subject to
the same application and overall program withdrawal process, ADV and
quoting requirements, manner by which SLP securities are assigned, and
non-regulatory penalties. The Exchange does not propose to amend those
aspects of the SLP program that would be applicable to both SLP-Props
and SLMMs.\8\ For these purposes, the rule would continue to refer to
``SLPs,'' which refers to both SLP-Prop and SLMM.
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    \8\ As part of the application process, a prospective SLP would
make an election of whether it is seeking to be an SLP-Prop or SLMM.
Based on this election, the Exchange would review the application
for whether the SLP applicant meets the qualification requirements
of Rule 107B(c) or proposed Rule 107B(d), as applicable. Current
SLPs may also apply with the Exchange to convert to be an SLMM,
provided that they meet proposed Rule 107B(d) qualification
requirements.
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    As proposed, the qualification requirements specified in Rule
107B(c) would be applicable and unchanged to SLP-Props. The Exchange
proposes to add Rule 107B(d) to specify the qualification requirements
of SLMMs, and re-number the rest of Rule 107B accordingly. As proposed,
to be approved, an SLMM would need to meet the qualification
requirements currently set forth in Rule 107B(c)(1), and (3)-(5),
relating to requirements for adequate technology and performance
history.
    If approved as an SLMM, an SLMM must meet specified regulatory
obligations, which are set forth in proposed Rule 107B(d). Because
these are regulatory obligations, failure to comply with these
obligations could result in disciplinary action. First, pursuant to
proposed Rule 107B(d)(1), the SLMM must maintain a continuous two-sided
quotation in those securities in which the SLMM is registered to

trade as an SLP (``Two-Sided Obligation''). As proposed, the Two-Sided
Obligation applicable to SLMMs would be virtually identical to the
market-maker two-sided obligations adopted by the equities markets in
2010.\9\ Second, pursuant to proposed Rule 107B(d)(2), the SLMM would
be required to maintain net capital in accordance with the provisions
of Rule 15c3-1 under the Act, which specifies the capital requirements
for market makers.\10\ Finally, pursuant to proposed Rule 107B(d)(3),
the SLMM would be required to maintain unique mnemonics specifically
dedicated to SLMM activity. Use of these unique mnemonics will enable
SLMMs to meet their requirement under proposed Rule 107B(d)(1)(A) to
identify their market-making activity to the Exchange. As proposed,
such mnemonics may not be used for trading in securities other than SLP
Securities assigned to the SLMM.\11\
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    \9\ See Securities Exchange Act Release No. 63255 (Nov. 5,
2010), 75 FR 69484 (Nov. 12, 2010) (SR-BATS-2010-025; SR-BX-2010-66;
SR-CBOE-2010-087; SR-CHX-2010-22; SR-FINRA-2010-049; SR-NASDAQ-2010-
115; SR-NSX-2010-12; SR-NYSE-2010-69; SR-NYSEAmex-2010-96; and SR-
NYSEArca-2010-83) (order approving enhanced quoting requirements for
market makers).
    \10\ 17 CFR 240.15c3-1. For purposes of that rule, the term
``market maker'' is defined as ``a dealer who, with respect to a
particular security, (i) Regularly publishes bona fide, competitive
bid and offer quotations in a recognized interdealer quotation
system; or (ii) furnishes bona fide competitive bid and offer
quotations on request; and (iii) is ready, willing and able to
effect transactions in reasonable quantities at his quoted prices
with other brokers or dealers.'' 17 CFR 240.15c3-1(c)(8).
    \11\ Because of the regulatory obligations associated with the
SLMM Two-Sided Obligations, the Exchange believes that requiring
dedicated, unique mnemonics for SLMM trading activity will enable
SLMMs to comply with the proposed Rule 107B(d)(1)(A) requirement to
identify such market-making quotes to the Exchange. The use of
unique mnemonics will also facilitate the review by FINRA, on behalf
of the Exchange and NYSE Regulation, Inc., of SLMM compliance with
the Two-Sided Obligation.
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    Pursuant to Rule 107B(c)(6), SLPs must currently maintain adequate
information barriers between the SLP unit and the member organization's
customer, research and investment-banking business. This requirement
ensures that the orders submitted by SLPs are proprietary only, and are
not related to any customer-facing business, including potentially
market-making businesses. The Exchange proposes to maintain this
requirement for SLP-Props. However, because market making sometimes
involves a customer-facing business, the Exchange does not believe that
the information barrier requirement is necessary for the proposed
SLMMs.\12\ Accordingly, the Exchange proposes that this qualification
requirement be applicable only to the SLP-Prop class of SLPs.
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    \12\ The Exchange notes that other exchanges do not require
information barriers for equities market makers. See, e.g., The
NASDAQ Stock Market LLC (``Nasdaq'') Rules Series 4600 (Requirements
for Nasdaq Market Makers and Other Nasdaq Market Center
Participants) and NYSE Arca Equities Rule 7, Section 2 (Market
Makers).
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    As a related matter, the Exchange proposes to amend Rule 107B(i)
(as proposed Rule 107B(j)) to modify the entry of order requirements.
SLP-Prop would continue to be required to enter proprietary orders
only. As proposed, SLMMs would similarly be required to enter orders
for their own account, however, they could be entered in either a
proprietary capacity or a principal capacity on behalf of an affiliated
or unaffiliated person. Accordingly, an SLMM could be submitting SLMM
quotes to the Exchange on behalf of customers, or other unaffiliated or
affiliated persons.
    The Exchange proposes to add an additional ability for SLMMs to
voluntarily withdraw from registration as a market maker in a
particular security. In proposed Rule 107B(f)(2), the Exchange proposes
that an SLMM may withdraw its registration in a security by giving
written notice to the SLP Liaison Committee and FINRA. As proposed, the
Exchange may require a certain minimum notice period for withdrawal,
and may place such other conditions on withdrawal and re-registration
following withdrawal, as it deems appropriate in the interests of
maintaining fair and orderly markets. An SLMM that fails to give
advanced written notice of termination to the Exchange may be subject
to formal disciplinary action.
    The Exchange believes that the security-by-security withdrawal
provision will enable SLMMs to comply with legal or regulatory
requirements that may conflict with meeting the SLMM requirements. For
example, permitting an SLMM to withdraw its quotations may enable it to
meet otherwise conflicting obligations under Rule 104 of Regulation
M.\13\ In particular, because the Exchange will always have a DMM
assigned to a security, the Exchange believes that having a flexible
policy toward withdrawal of registration in a security will not harm
investors. Moreover, the proposed rule is identical to that of another
exchange.\14\
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    \13\ 17 CFR 242.104 (setting forth restrictions on entering
stabilizing bids or penalty bids in connection with an offering of
any security).
    \14\ The proposed rule is based on BATS Exchange, Inc.
(``BATS'') Rule 11.7(b). As noted below, a number of self-regulatory
organizations have similar provisions, with varying language.
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    The final proposed change to the SLP rule is to add to Rule 107B(h)
(as proposed Rule 107B(i)) that an SLP-Prop may not also act as an SLMM
in the same securities in which it is registered as an SLP-Prop and
vice versa. The Exchange believes that under the SLP program, a member
organization should be either an SLP-Prop or SLMM. However, if a member
organization has more than one business unit, and the SLP-Prop business
unit is walled off from the SLMM business unit, the member organization
may engage in both an SLP-Prop and SLMM business from those different
business units. Provided there is no coordinated trading between the
SLP-Prop and SLMM business units, they may be assigned the same
securities.
    The Exchange proposes to implement the changes to the SLP program
by adding the SLMM class effective on the first day of the month
following Commission approval of this proposal.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange. In particular,
the Exchange believes that its proposal is consistent with Section 6(b)
of the Act,\15\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\16\ in particular, because it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that adding an additional registered market
maker program to the Exchange will promote just and equitable
principles of trade as it could potentially expand the number of market
participants trading at the Exchange that would be required to assist
in the maintenance of a fair and orderly market, as reasonably
practicable. In particular, the current SLP program is limited solely
to member organizations that trade for their own account, and that are
walled off from any customer-facing business. With the proposed rule
change, additional market participants, including member organizations
that are registered as market makers on other exchanges that engage in
a customer-

facing business, would be able to participate in the SLP program.
    As noted above, the Exchange would continue to require that a DMM
be registered in every security at the Exchange, and similar to NYSE
Arca's market maker program, which has two classes of market maker, the
SLMMs would provide supplemental liquidity in addition to the DMMs.
Because the proposed SLMMs would be required to meet the Two-Sided
Obligation applicable to all equities market makers, the Exchange
believes that the proposed rule change would also remove impediments to
and perfect the mechanism of a free and open market and a national
market system by increasing the number of market participants that are
required to maintain a continuous two-sided quotation in the securities
in which they are registered. The Exchange further believes that adding
additional registered market makers would protect investors and the
public interest by providing additional sources of liquidity for
trading.
    In addition, the Exchange believes that the proposed rule change is
consistent with the requirements of the Act because the proposed
requirements for the SLMMs are based on existing, approved requirements
for registered market makers on other exchanges. In addition to the
Two-Sided Obligation, the proposed SLMMs would also be required to
assist in the maintenance of a fair and orderly market, as reasonably
practicable, and maintain net capital consistent with federal
requirements for market makers.

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 purposes of the Act.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

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_ADDRESS>Please include
File Number SR-NYSE-2012-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2012-10. 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 Web site (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 Web site 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NYSE-2012-10 and should be
submitted on or before May 14, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-9629 Filed 4-20-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 29, 2010 (Volume 75, Number 209)]
[Rules and Regulations]
[Page 66655-66657]
[DOCID:fr29oc10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0849; Directorate Identifier 2010-CE-043-AD;
Amendment 39-16488; AD 2010-22-09]
RIN 2120-AA64

Airworthiness Directives; PILATUS Aircraft Ltd. Model PC-7
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    This Airworthiness Directive (AD) is prompted due to an
occurrence when an aircraft had a partial in-flight separation of
the aileron outboard bearing support.
    The aileron outboard bearing supports are attached with two
forward attachment bolts and two aft attachment bolts. The forward
attachment bolts are approximately 3.2 mm (0.125 inch) longer than
the aft attachment bolts. If the aileron outboard bearing supports
have been removed, it is possible that during the reinstallation of
the aileron outboard bearing supports, the attachment bolts can be
installed in wrong positions. Bolts that are installed in wrong
positions can damage the threads in the rear attachment anchor nuts.
    Such a condition, if left uncorrected, could lead to in-flight
separation of the aileron outboard bearing support, and as a
consequence, the loss or limited controllability of the aircraft.

    We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective December 3, 2010.
    On December 3, 2010, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590.
    For service information identified in this AD, contact Pilatus
Aircraft Ltd.,

Customer Service Manager, CH-6371 STANS, Switzerland; telephone: +41
(0) 41 619 62 08; fax: +41 (0) 41 619 73 11; Internet: http://
www.pilatus-aircraft.com. You may review copies of the referenced
service information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on August 26, 2010 (75
FR 52482). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    This Airworthiness Directive (AD) is prompted due to an
occurrence when an aircraft had a partial in-flight separation of
the aileron outboard bearing support.
    The aileron outboard bearing supports are attached with two
forward attachment bolts and two aft attachment bolts. The forward
attachment bolts are approximately 3.2 mm (0.125 inch) longer than
the aft attachment bolts. If the aileron outboard bearing supports
have been removed, it is possible that during the reinstallation of
the aileron outboard bearing supports, the attachment bolts can be
installed in wrong positions. Bolts that are installed in wrong
positions can damage the threads in the rear attachment anchor nuts.
    Such a condition, if left uncorrected, could lead to in-flight
separation of the aileron outboard bearing support, and as a
consequence, the loss or limited controllability of the aircraft.
    In order to correct and control the situation, this AD requires
a one time inspection to verify that the bolts are installed in the
correct positions and the threads of the anchor nuts are in good
condition. The replacement of the attachment hardware is required if
any damage on the anchor nut threads or a bolt at the wrong location
is found.

    You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. Pilatus Aircraft Ltd.
supports the NPRM and its adoption as a final rule AD action.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed except for minor editorial changes. We have determined
that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 12 products of U.S. registry.
We also estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $2,040, or $170 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 25 work-hours and require parts costing $200, for a cost of
$2,325 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD Docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-22-09 Pilatus Aircraft Ltd.: Amendment 39-16488; Docket No.
FAA-2010-0849; Directorate Identifier 2010-CE-043-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
3, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to PILATUS Aircraft Ltd. Model PC-7
airplanes, manufacturer serial numbers (MSN) 101 through 618,
certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 57: Wings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    This Airworthiness Directive (AD) is prompted due to an
occurrence when an aircraft had a partial in-flight separation of
the aileron outboard bearing support.
    The aileron outboard bearing supports are attached with two
forward attachment bolts and two aft attachment bolts. The forward
attachment bolts are approximately 3.2 mm (0.125 inch) longer than
the aft attachment bolts. If the aileron outboard bearing supports
have been removed, it is possible that during the reinstallation of
the aileron outboard bearing supports, the attachment bolts can be
installed in wrong positions. Bolts that are installed in wrong
positions can damage the threads in the rear attachment anchor nuts.
    Such a condition, if left uncorrected, could lead to in-flight
separation of the aileron outboard bearing support, and as a
consequence, the loss or limited controllability of the aircraft.
    In order to correct and control the situation, this AD requires
a one time inspection to verify that the bolts are installed in the
correct positions and the threads of the anchor nuts are in good
condition. The replacement of the attachment hardware is required if
any damage on the anchor nut threads or a bolt at the wrong location
is found.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within 1 month after December 3, 2010 (the effective date of
this AD), check the airplane maintenance records to determine if the
left and/or right aileron outboard bearing supports have been
removed at any time during the life of the airplane. Do this check
following paragraph 3.A. of Pilatus Aircraft Ltd. PC-7 Service
Bulletin No. 57-015, Rev. No. 1, dated July 23, 2010.
    (2) If an entry is found during the airplane maintenance records
check required in paragraph (f)(1) of this AD or it is unclear
whether or not the left and/or right aileron outboard bearing
supports have been removed at any time during the life of the
airplane, before further flight, do the actions specified in
paragraphs 3.A.(2) through paragraph 3.E of Pilatus Aircraft Ltd.
PC-7 Service Bulletin No. 57-015, Rev. No. 1, dated July 23, 2010.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave., SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

Special Flight Permit

    (h) Special flight permits will not be issued.

Related Information

    (i) Refer to MCAI Federal Office of Civil Aviation (FOCA) AD HB-
2010-010, dated July 29, 2010; and Pilatus Aircraft Ltd. PC-7
Service Bulletin No. 57-015, Rev. No. 1, dated July 23, 2010, for
related information.

Material Incorporated by Reference

    (j) You must use Pilatus Aircraft Ltd. PC-7 Service Bulletin No.
57-015, Rev. No. 1, dated July 23, 2010, to do the actions required
by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Pilatus Aircraft Ltd., Customer Service Manager, CH-6371 STANS,
Switzerland; telephone: +41 (0) 41 619 62 08; fax: +41 (0) 41 619 73
11; Internet: http://www.pilatus-aircraft.com.
    (3) You may review copies of the referenced service information
at the FAA, Small Airplane Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Kansas City, Missouri, on October 21, 2010.
Christina L. Marsh,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-27214 Filed 10-28-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Proposed Rules]
[Pages 18490-18496]
[FR Doc No: 2020-06821]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2020-N-1082]

Microbiology Devices; Reclassification of Certain Hepatitis C
Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody
Tests

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed amendment; proposed order; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to reclassify certain hepatitis C virus (HCV) antibody assay devices
intended for the qualitative detection of HCV, postamendments class III
devices (product code MZO) into class II (general controls and special
controls), subject to premarket notification. FDA is also proposing a
new device classification regulation with the name ``hepatitis C virus
(HCV) antibody tests'' along with the special controls that the Agency
believes are necessary to provide a reasonable assurance of safety and
effectiveness for these devices. FDA is proposing this reclassification
on its own initiative. If finalized, this order will reclassify these
types of devices from class III (general controls and premarket
approval) to class II (general controls and special controls) and
reduce the regulatory burdens associated with these devices, as these
types of devices will no longer be required to submit a premarket
approval application (PMA), but can instead submit a premarket
notification under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
and obtain clearance before marketing their device.

DATES: Submit either electronic or written comments on the proposed
order by June 1, 2020. Please see section XI of this document for the
proposed effective date when the new requirements apply and for the
proposed effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 1, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 1, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1082 for ``Reclassification of Certain Hepatitis C Virus
Antibody Assay Devices, To Be Renamed Hepatitis C Virus Antibody
Tests.'' Received comments, those filed in a timely manner (see
ADDRESSES) will be placed in the docket and, except for

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

FOR FURTHER INFORMATION CONTACT: Maria Ines Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3104, Silver Spring, MD 20993-0002, 301-
796-7017<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended by the Medical Device Amendments of 1976
(Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-
629), Food and Drug Administration Modernization Act of 1997 (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), among other amendments, establishes a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (general controls and special controls), and class
III (general controls and premarket approval).
    Section 513(a)(1) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under sections 501,
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h,
360i, or 360j) or any combination of such sections) are sufficient to
provide reasonable assurance of safety and effectiveness; or those
devices for which insufficient information exists to determine that
general controls are sufficient to provide reasonable assurance of
safety and effectiveness or to establish special controls to provide
such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for
which general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, and for which there
is sufficient information to establish special controls to provide such
assurance, including the promulgation of performance standards,
postmarket surveillance, patient registries, development and
dissemination of guidelines, recommendations, and other appropriate
actions the Agency deems necessary to provide such assurance (section
513(a)(1)(B) of the FD&C Act). Class III devices are those devices for
which insufficient information exists to determine that general
controls and special controls would provide a reasonable assurance of
safety and effectiveness, and are purported or represented to be for a
use in supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury (section
513(a)(1)(C) of the FD&C Act).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until, (1) FDA
reclassifies the device into class I or class II, or (2) FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval. FDA determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act and part 807
(21 CFR part 807), subpart E, of the regulations.
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA, acting by administrative
order, can reclassify the device into class I or class II on its own
initiative, or in response to a petition from the manufacturer or
importer of the device. To change the classification of the device, the
proposed new class must have sufficient regulatory controls to provide
a reasonable assurance of the safety and effectiveness of the device
for its intended use.
    FDA relies upon ``valid scientific evidence,'' as defined in
section 513(a)(3) and 21 CFR 860.7(c)(2), in the classification process
to determine the level of regulation for devices. To be considered in
the reclassification process, the ``valid scientific evidence'' upon
which the Agency relies must be publicly available (see section 520(c)
of the FD&C Act). Publicly available information excludes trade secret
and/or confidential commercial information, e.g., the contents of a
pending PMA (see section 520(c) of the FD&C Act).
    In accordance with section 513(f)(3) of the FD&C Act, the Agency is
issuing this proposed order to reclassify hepatitis C virus (HCV)
antibody tests intended for the qualitative detection of HCV,
postamendment class III devices, into class II (general controls and
special

controls), subject to premarket notification because the Agency
believes the standard in section 513(a)(1)(B) of the FD&C Act is met as
there is sufficient information to establish special controls, which,
in addition to general controls, will provide reasonable assurance of
the safety and effectiveness of the device.\1\
---------------------------------------------------------------------------

    \1\ In December 2019, FDA began adding the term ``Proposed
amendment'' to the ``ACTION'' caption for these documents, typically
styled ``Proposed order'', to indicate that they ``propose to
amend'' the Code of Federal Regulations. This editorial change was
made in accordance with the Office of Federal Register's (OFR)
interpretations of the Federal Register Act (44 U.S.C. chapter 15),
its implementing regulations (1 CFR 5.9 and parts 21 and 22), and
the Document Drafting Handbook.
---------------------------------------------------------------------------

    Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. FDA has determined that
premarket notification is necessary to reasonably assure the safety and
effectiveness of HCV antibody tests intended for the qualitative
detection of HCV. Therefore, the Agency does not intend to exempt these
proposed class II devices from premarket notification requirements. If
this proposed order is finalized, persons who intend to market this
type of device must submit to FDA a premarket notification under
section 510(k) of the FD&C Act.

II. Regulatory History of the Devices

    This proposed order applies to HCV antibody assay device for use as
a prescription device as an aid in the diagnosis of HCV infection.
These are prescription devices that are assigned product code MZO. On
August 30, 2001, FDA approved its first HCV antibody test (Ortho-
Clinical Diagnostics, Inc.'s VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV
REAGENT PACK AND CALIBRATOR) intended for use as a prescription device
as an aid in the diagnosis of HCV infection by a qualified licensed
healthcare professional in conjunction with other relevant clinical and
laboratory findings through its PMA process under section 515 of the
FD&C Act (21 U.S.C. 360e). In a May 22, 2002, Federal Register notice
(67 FR 36009), FDA announced the PMA approval order and the
availability of the Summary of Safety and Effectiveness Data (SSED) for
this device.
    Since the first approval order, FDA has approved nine additional
original PMAs for HCV antibody tests that are prescription devices
intended for use as an aid in the diagnosis of HCV infection by a
qualified licensed healthcare professional in conjunction with other
relevant clinical and laboratory findings (hereafter referred to as
``HCV antibody test'').
    A review of the medical device reporting databases indicates that
there is a low number of reported events for HCV antibody tests
relative to the number of tests conducted using these devices. Events
reported included false positive results, low test results, false
negative results, unspecified incorrect or inadequate results,
mechanical problems, and leak/splash. As of the date of this proposed
order, FDA is aware of two class III recalls, \2\ two class II recalls,
\3\ and no class I recalls for these devices.\4\ The class II recalls
occurred in 2007 and 2014, and were related to: (1) Sporadic lower than
expected anti-HCV test results, and (2) failure of the instrument to
open (actuate) some reagent packs from certain lots. All recalls have
been resolved and no patient harm has been identified. These facts,
coupled with the low number of reported events, indicate a good safety
record for this device class. These recall events reflect the risks to
health identified in section V below, and FDA believes the special
controls proposed herein, in addition to general controls, can
effectively mitigate the risks identified in these recalls.
---------------------------------------------------------------------------

    \2\ Class III recalls are defined in 21 CFR 7.3(m)(3).
    \3\ Class II recalls are defined in 21 CFR 7.3(m)(2).
    \4\ Class I recalls are defined in 21 CFR 7.3(m)(1).
---------------------------------------------------------------------------

III. Device Description

    HCV antibody tests are postamendments prescription devices for the
qualitative detection of HCV and are classified into class III under
section 513(f)(1) of the FD&C Act. HCV antibody tests are described in
FDA's SSEDs and product code database (assigned product code MZO) as
devices for the qualitative detection of antibodies to HCV in human
serum and plasma. HCV antibodies, when present in samples, bind to HCV
antigens to form a complex that is bound to a solid phase (e.g.
microparticles, microtiter plate or else). Detection of the complexes
can be performed using different methods that measure the presence/
absence of HCV antibodies in the sample. HCV antibody tests are
intended for use as aids in the presumptive diagnosis of HCV infection
in persons with signs and symptoms of hepatitis and in persons at risk
of acquiring HCV infection. These devices are not intended for
screening blood, plasma, cell or tissue donors. This proposed order
does not apply to HCV antibody tests that are intended for home use or
over-the-counter use.
    FDA is proposing to reclassify HCV antibody tests from class III
(general controls and premarket approval) to class II (general controls
and special controls) and to establish a new name for the device type
that will be within the classification regulation; i.e., hepatitis C
virus (HCV) antibody tests. FDA believes that this name and proposed
identification language most accurately describes these devices. An HCV
antibody test is tentatively identified as a device intended for use
with human serum, plasma, or other matrices as a prescription device
that aids in the diagnosis of HCV infection in persons with signs and
symptoms of hepatitis and in persons at risk for hepatitis C infection.
The test is intended as an aid in the diagnosis of HCV infection in
specified populations, and/or as an aid in the management of HCV-
infected patients including guiding the selection of genotype-specific
treatment in individuals with chronic HCV infection. The test is not
intended for screening blood, plasma, cell, or tissue donors.
    Based upon our review experience and consistent with the FD&C Act
and FDA's regulations in 21 CFR 860.134, FDA believes that these
devices should be reclassified from class III into class II with
special controls because there is sufficient information to establish
special controls that, along with general controls, can provide
reasonable assurance of the devices' safety and effectiveness.

IV. Proposed Reclassification

    FDA is proposing to reclassify HCV antibody tests. On March 22,
2018, FDA held a public meeting of the Microbiology Devices Panel
(Panel) of the Medical Devices Advisory Committee convened to discuss
and make recommendations regarding the reclassification of HCV antibody
tests from class III (general controls and premarket approval) into
class II (general controls and special controls) (Ref. 1). Panel
members unanimously agreed that special controls, in addition to
general controls, are necessary and sufficient to mitigate the risks to
health of patients presented by these devices and to provide reasonable
assurance of the safety and effectiveness of these devices (Ref. 2). In
addition, Panel members generally agreed with the development of
special controls as presented by FDA.
    FDA agrees and believes that at this time, sufficient data and
information exist such that the risks identified in section V below can
be mitigated by

establishing special controls that, together with general controls, can
provide a reasonable assurance of the safety and effectiveness of these
devices and therefore proposes these devices to be reclassified from
class III (general controls and premarket approval) to class II
(general controls and special controls).
    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR
part 860, subpart C, FDA is proposing to reclassify postamendments HCV
antibody tests to be renamed ``hepatitis C virus (HCV) antibody
tests,'' from class III into class II. FDA believes that, at this time,
there are sufficient data and information available to FDA through
FDA's accumulated experience with these devices from review submissions
and from published peer-reviewed literature, as well as the
recommendations provided by the Panel, to demonstrate that the proposed
special controls, along with general controls, would effectively
mitigate the risks to health identified in section V below and provide
a reasonable assurance of the safety and effectiveness of these
devices. Absent the special controls identified in this proposed order,
general controls applicable to the device type are insufficient to
provide reasonable assurance of the safety and effectiveness of these
devices. FDA expects that the reclassification of these devices would
enable more manufacturers to develop HCV antibody tests such that
patients would benefit from increased access to safe and effective
tests.
    FDA is proposing to create a classification regulation for HCV
antibody tests that will be reclassified from class III to class II.
Under this proposed order, if finalized, HCV antibody tests will be
identified as prescription devices. As such, the prescription device
must satisfy prescription labeling requirements for in vitro diagnostic
products (See 21 CFR 809.10(a)(4) and (b)(5)(ii)). In this proposed
order, if finalized, the Agency has identified the special controls
under section 513(a)(1)(B) of the FD&C Act that, together with general
controls, will provide a reasonable assurance of the safety and
effectiveness for HCV antibody tests.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For HCV antibody tests, FDA has determined
that premarket notification is necessary to provide reasonable
assurance of the safety and effectiveness of these devices. Therefore,
FDA does not intend to exempt this proposed class II devices from the
510(k) requirements. If this proposed order is finalized, persons who
intend to market this type of device must submit a 510(k) to FDA and
receive clearance prior to marketing the device.
    This proposed order, if finalized, will decrease regulatory burden
on industry, as manufacturers will no longer have to submit a PMA for
these types of devices but can instead submit a 510(k) to the Agency
for review prior to marketing their device. A 510(k) typically results
in a shorter premarket review timeline compared to a PMA, which
ultimately provides more timely access of these types of devices to
patients.
    In addition, the Agency believes that certain changes could be made
to HCV antibody tests that could significantly affect the safety and
effectiveness of those devices and for which a new 510(k) is likely
required.\5\ Based on FDA's accumulated experience with these devices,
changes that likely could significantly affect the safety and
effectiveness of these devices include, but are not limited to, changes
to critical reagents, changes to final release specifications, and
changes in shelf-life of the device. For more information about when to
submit a new 510(k), manufacturers should refer to FDA's guidance
entitled ``Deciding When to Submit at 510(k) for a Change to an
Existing Device'' (Ref. 3).
---------------------------------------------------------------------------

    \5\ See 21 CFR 807.81(a)(3)(i).
---------------------------------------------------------------------------

V. Risks to Health

    It is estimated by the Centers for Disease Control and Prevention
that chronic HCV infection in the United States affects at least
between 2.7 and 3.9 million people (Ref. 4). HCV infection can be
asymptomatic, and accordingly, many HCV-infected individuals are
unaware of their HCV infection. Between 20 percent and 30 percent of
patients with acute infection, defined as the first 6 months after
infection, clear the virus spontaneously while the other 70 percent to
80 percent of individuals become chronically infected with HCV (Ref.
5). Later diagnosis can lead to a more severe disease outcome and
premature death among those who are chronically infected (Ref. 6).
Patients who are tested and become aware that they are HCV infected may
modify risk behaviors to prevent transmission to others and can be
referred for treatment.
    If left untreated, patients with chronic HCV infection have a
significant risk of developing severe liver disease and/or
hepatocellular cancer. Treatment of chronic HCV is highly effective,
resulting in a sustained virological response (SVR) considered
synonymous with cure. SVR is associated with improved clinical outcome,
and a decrease in HCV-associated mortality (Ref. 7). Therefore,
diagnosis of patients with chronic HCV infection through devices such
as hepatitis C virus antibody tests is essential to ensure that
patients are linked to the appropriate care (Ref. 6).
    After consideration of FDA's accumulated experience with these
devices from FDA review submissions, recommendations of the Panel for
the classification of these devices (Ref. 2), and published literature,
FDA has identified the following probable risks to health associated
with HCV Antibody Tests:
     Inaccurate interpretation of test results. Inaccurate
interpretation of test results by clinicians may negatively influence
patient management decisions. A reactive test result misinterpreted as
non-reactive may delay or prevent a patient with HCV infection from
being identified and linked to care. Missed identification of patients
with chronic HCV infection could lead to adverse effects on patient
health such as progressive liver disease, cirrhosis and/or
hepatocellular cancer, all of which are known to contribute to patient
morbidity and mortality (Ref. 6). A reactive test incorrectly
interpreted as non-reactive also may contribute to public health risk
by leading to inadvertent transmission of virus by an infected person.
A non-reactive test result incorrectly identified as reactive may
contribute to unnecessary additional patient testing to exclude active
HCV infection or potentially delay diagnosis of alternative causes of
liver disease when present.
     Failure of the device to perform as indicated (e.g., false
negative results or false positive results). A false negative test
result due to failure of the device to perform may delay or prevent a
patient with HCV infection from being identified and linked to care.
Missed identification of patients with chronic HCV infection could lead
to adverse effects on patient health such as progressive liver disease,
cirrhosis and/or hepatocellular cancer, all of which are known to
contribute to patient morbidity and mortality (Ref. 6). A false
negative/false non-reactive test result also may contribute to public
health risk by leading to inadvertent transmission of virus by an
infected person. Factors that may cause decreased test sensitivity and/
or an increased rate of false

negative results include, but are not limited to, the presence of
interfering substances in the sample, acute infection at a stage that
is too early for a device to detect the infection, and antibody
concentrations that are too low to be detected by the device. They also
can be caused by misinterpretation of invalid results as negative. A
false positive test result may contribute to unnecessary additional
patient testing to exclude active HCV infection or potentially delay
diagnosis of alternative causes of liver disease when present. Factors
that may lead to false positive results include device contamination
from positive samples, cross-reactivity with other antibodies, or
misinterpretation of invalid results as positive.

VI. Summary of the Reasons for Reclassification

    FDA believes that HCV antibody tests should be reclassified from
class III (general controls and premarket approval) into class II
(general controls and special controls) because special controls, in
addition to general controls, can be established to mitigate the risks
to health identified in section V and provide a reasonable assurance of
the safety and effectiveness of these devices. The proposed special
controls are identified by FDA in section VII.
    Taking into account the probable health benefits of the use of
theses device and the nature and known incidence of the risks of the
devices, FDA, on its own initiative, is proposing to reclassify these
postamendments class III devices into class II. FDA believes that, when
used as indicated, HCV antibody tests can provide significant benefits
to clinicians and patients.
    FDA's reasons for reclassification are based on the substantial
scientific and medical information available regarding the nature,
complexity, and risks associated with HCV antibody tests in the
identified intended use populations (Ref. 1). The safety and
effectiveness of this device type has become well-established since the
initial approval of the first HCV antibody test for the qualitative
detection of HCV in 2001.

VII. Proposed Special Controls

    FDA believes that these devices can be classified into class II
with the establishment of special controls. FDA believes that the
following special controls, together with general controls, will
provide a reasonable assurance of the safety and effectiveness of HCV
antibody tests. Table 1 demonstrates how these proposed special
controls will mitigate each of the identified risks to health in
section V.
    The risk of inaccurate interpretation of test results can be
mitigated by special controls requiring certain labeling, including
providing clearly stated warnings and limitations and information on
principles of operation and procedures in performing the test.
    Risks associated with the failure of the device to perform as
indicated (e.g., false negative and false positive test results) can be
mitigated through a combination of special controls including certain
labeling requirements, certain design verification and validation
information, and performance studies. Examples of verification and
validation information to be included in the design of the device
includes documentation of performance specifications including
analytical and clinical performance criteria. In addition, design
verification and validation activities must include documentation of a
complete device description, critical reagents, risk analysis
strategies, lot release criteria, stability studies and protocols.
Required statements in labeling can aid in mitigating the failure of
the device to perform as indicated, for example including a statement
that use of the test with specimen types other than those specifically
identified for use with this device may cause inaccurate test results.

 Table 1--Risks to Health and Mitigation Measures for HCV Antibody Tests
------------------------------------------------------------------------
  Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Inaccurate interpretation of   Certain labeling warnings, limitations,
 test results.                  and explanation of procedures.
Failure of the device to       Certain labeling warnings, limitations,
 perform as indicated.          and explanation of procedures.
                               Performance specifications including
                                analytical and clinical performance
                                criteria.
                               Certain design verification and
                                validation information including
                                documentation of device description,
                                critical reagents, risk analysis
                                strategies, lot release criteria,
                                stability studies and protocols.
------------------------------------------------------------------------

    If this proposed order is finalized, HCV antibody tests will be
reclassified into class II (general controls and special controls) and
would be subject to premarket notification requirements under section
510(k) of the FD&C Act. As discussed below, the intent is for the
reclassification to be codified in 21 CFR 866.3169. Firms submitting a
premarket notification under section 510(k) of the FD&C Act for HCV
antibody tests will be required to comply with the particular
mitigation measures set forth in the special controls. Adherence to the
special controls, in addition to the general controls, is necessary to
provide a reasonable assurance of the safety and effectiveness of these
devices.

VIII. Analysis of Environmental Impact

    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.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed order contains no new
collections of information. 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. This proposed order refers
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 21 CFR part 820 have been approved
under OMB control number 0910-0073; the collections of information in
21 CFR parts 807, subpart E, have been approved under OMB control
number 0910-0120; and the collections of information in 21 CFR parts
801 and 809 have been approved under OMB control number 0910-0485.

X. Codification of Orders

    Under section 513(f)(3) of the FD&C Act, FDA may issue final orders
to reclassify devices. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as newly codified
orders. Therefore,

under section 513(f)(3), in the proposed order, we are proposing to
codify HCV antibody tests in the new 21 CFR 866.3169, under which
certain HCV antibody tests would be reclassified from class III to
class II.

XI. Proposed Effective Date

    FDA proposes that any final order based on this proposed order
become effective 30 days after its date of publication in the Federal
Register.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

* 1. Executive Summary of the FDA Microbiology Devices Panel
Meeting, March 22, 2018 (available at https://www.fda.gov/media/111502/download).
* 2. Transcript of the FDA Microbiology Devices Panel Meeting, March
22, 2018 (available at https://www.fda.gov/media/119966/download).
* 3. ``Deciding When to Submit a 510(k) for a Change to an Existing
Device--Guidance for Industry and Food and Drug Administration
Staff,'' issued October 25, 2017 (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device).
* 4. Department of Health and Human Services--Viral Hepatitis Action
Plan for 2017-2020 (available at https://www.hhs.gov/sites/default/files/National%20Viral%20Hepatitis%20Action%20Plan%202017-2020.pdf).
5. Aisyah, D.N., L. Shallcross, A.J. Hully, et al., ``Assessing
Hepatitis C Spontaneous Clearance and Understanding Associated
Factors--A Systematic Review and Meta-Analysis.'' Journal of Viral
Hepatitis, 25(6): 680-698, 2018.
6. Moorman, A.C., J. Xing, S. Ko, et al., ``Late Diagnosis of
Hepatitis C Virus Infection in the Chronic Hepatitis Cohort Study
(CHeCS): Missed Opportunities for Intervention.'' Hepatology, 61(5):
1479-1484, 2015.
7. Ioannou, G.N., P.K. Green, and K. Berry, ``HCV Eradication
Induced by Direct-Acting Antiviral Agents Reduces the Risk of
Hepatocellular Carcinoma.'' Journal of Hepatology, 68(1): 25-33,
2018.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

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

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

0
2. Add Sec.  866.3169 to subpart D to read as follows:

Sec.  866.3169   Hepatitis C Virus Antibody Tests.

    (a) Identification. A hepatitis C virus (HCV) antibody test is
identified as an in vitro diagnostic device intended for use with human
serum, plasma, or other matrices as a prescription device that aids in
the diagnosis of HCV infection in persons with signs and symptoms of
hepatitis and in persons at risk for hepatitis C infection. The test is
not intended for screening blood, plasma, cell, or tissue donors.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The labeling required under 21 CFR 809.10(b) must include:
    (i) A prominent statement that the test is not intended for the
screening of blood, plasma, and cell or tissue donors.
    (ii) Limitations, which must be updated to reflect current clinical
practice and disease presentation and management. The limitations must
include, but are not limited to, statements that indicate:
    (A) When appropriate, the performance characteristics of the test
have not been established in populations of immunocompromised or
immunosuppressed patients or, other special populations where test
performance may be affected.
    (B) The detection of HCV antibodies indicates a present or past
infection with hepatitis C virus, but does not differentiate between
acute, chronic, or resolved infection.
    (C) The specimen types for which the device has been cleared, and
that use of the test with specimen types other than those specifically
cleared for this device may result in inaccurate test results.
    (D) Test results are to be interpreted by qualified licensed
healthcare professionals in conjunction with the individual's clinical
presentation, history, and other laboratory results.
    (E) A non-reactive test result may occur early during acute
infection, prior to development of a host antibody response to
infection, or when analyte levels are below the limit of detection of
the test.
    (iii) A detailed explanation of the principles of operation and
procedures for performing the test.
    (2) Design verification and validation must include the following:
    (i) A detailed device description, including all parts that make up
the device, ancillary reagents required but not provided, an
explanation of the device methodology, and design of the antigen(s) and
capture antibody(ies) sequences, rationale for the selected epitope(s),
degree of amino acid sequence conservation of the target, and the
design and nature of all primary, secondary, and subsequent standards
used for calibration.
    (ii) Documentation and characterization (e.g., supplier,
determination of identity, and stability) of all critical reagents
(including description of the antigen(s) and capture antibody(ies)),
and protocols for maintaining product integrity throughout its labeled
shelf life.
    (iii) Risk analysis and management strategies, such as Failure
Modes Effects Analysis and/or Hazard Analysis and Critical Control
Points summaries and their impact on test performance.
    (iv) Final release criteria to be used for manufactured test lots
with appropriate evidence that lots released at the extremes of the
specifications will meet the claimed analytical and clinical
performance characteristics as well as the stability claims.
    (v) Stability studies for reagents must include documentation of an
assessment of real-time stability for multiple reagent lots using the
indicated specimen types and must use acceptance criteria that ensure
that analytical and clinical performance characteristics are met when
stability is assigned based on the extremes of the acceptance range.
    (vi) All stability protocols, including acceptance criteria.
    (vii) Final release test results for each lot used in clinical
studies.
    (viii) Multisite reproducibility study that includes the testing of
three independent production lots.
    (ix) Analytical performance studies and results for determining the
limit of blank (LoB), limit of detection (LoD), cutoff, precision
(reproducibility) including lot-to-lot and/or instrument-to-instrument
precision, interference, cross reactivity, carry-over, hook effect,

seroconversion panel testing, matrix equivalency, specimen stability,
reagent stability, and cross-genotype antibody detection sensitivity,
when appropriate.
    (x) Analytical sensitivity of the test is the same or better than
that of other cleared or approved tests.
    (xi) Detailed documentation of clinical performance testing from a
multisite clinical study. Performance must be analyzed relative to an
FDA cleared or approved HCV antibody test, or a comparator that FDA has
determined is appropriate. This study must be conducted using
appropriate patient samples, with an acceptable number of HCV positive
and negative samples in applicable risk categories. Additional relevant
patient groups must be validated as appropriate. The samples may be a
combination of fresh and repository samples, sourced from
geographically diverse areas. The study designs, including number of
samples tested, must be sufficient to meet the following criteria:
    (A) Clinical sensitivity of the test must have a lower bound of the
95 percent confidence interval of greater than or equal to 95 percent.
    (B) Clinical specificity of the test must have a lower bound of the
95 percent confidence interval of greater than or equal to 96 percent.
    (3) For any HCV antibody test intended for Point of Care (PoC) use,
the following special controls, in addition to those listed in
paragraphs (b)(1) and (2) of this section, apply:
    (i) Clinical studies must be conducted at PoC sites.
    (ii) Additional labeling must include a brief summary of the
instructions for use that are appropriate for use in a PoC environment.

    Dated: March 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06821 Filed 4-1-20; 8:45 am]
 BILLING CODE 4164-01-P