[Federal Register: July 15, 2009 (Volume 74, Number 134)]
[Notices]
[Page 34336-34337]
[DOCID:fr15jy09-88]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1312-000; Docket No. ER09-1313-000]

Riverside Energy Center, LLC; RockGen Energy, LLC; Notice
Suspending Due Date for Interventions, Protests and Comments

July 8, 2009.
    On July 7, 2009, Riverside Energy Center, LLC and RockGen Energy,
LLC (collectively the Applicants) filed a motion to hold the above-
referenced proceedings in abeyance and to suspend the July 7, 2009 due
date for filing comments and protests in this proceeding. The motion
states that the Applicants and Interested Parties \1\ from the of the
approved 2005 Settlement Agreement in Docket Nos. ER04-1055-000 and
ER04-1059-000,\2\ are currently involved in informal settlement
negotiations. The Applicants specifically request the Commission to
hold the above-referenced proceeding in abeyance for a period of two
months, until September 8, 2009, and to suspend the July 7, 2009
comment date for protests and comments. However, the Applicants seek to
have the July 7, 2009 date remain in effect for submitting
interventions during the current settlement negotiations. In the event
the Applicants and Interested Parties do not settle, the Applicants
request that the parties that have intervened as of the July 7, 2009
date should be afforded additional time to file protests and/or
comments on the proposed revised rate schedules in the above-referenced
proceedings and the Commission can then process and consider the
filings in the usual manner. The Applicants also state that the
Interested Parties and the Original Parties \3\ either support this
motion or do not oppose this motion.
---------------------------------------------------------------------------

    \1\ Interested Parties: Alliant Energy Corporate Services, Inc.
(AECS), American Transmission Company, LLC (ATCLLC), Madison Gas &
Electric Company (MGE), Midwest Independent Transmission System
Operator, Inc. (MISO), Wisconsin Public Power Inc. (WPPI), Wisconsin
Public Service Corporation (WPSC); and Upper Peninsula Power Company
(UPPCo).
    \2\ Riverside Energy Center, LLC and RockGen Energy, LLC, 111
FERC ] 61,429 (2005).
    \3\ Original Parties to the 2005 Settlement Agreement: AECS on
behalf of itself and its utility operating companies Interstate
Power and Light Company and Wisconsin Power and Light Company;
ATCLLC; Consumers Energy Company; The Detroit Edison Company; LG&E
Energy LLC, on behalf of its utility operating companies, Louisville
Gas and Electric Company and Kentucky Utilities Company; Madison Gas
& Electric Co.; the MISO.; WPPI.; Wisconsin Electric Power Company;
WPSC; and UPPCo.

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

    Upon consideration, notice is hereby given that the previously
established July 7, 2009 due date for filing interventions, protests
and/or comments is hereby suspended. A new due date for interventions,
---------------------------------------------------------------------------
protests and/or comments will be established upon further notice.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-16716 Filed 7-14-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Proposed Rules]
[Pages 3250-3257]
[FR Doc No: 2022-01156]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2021-N-0851]

Medical Devices; Immunology and Microbiology Devices;
Classification of Human Leukocyte, Neutrophil and Platelet Antigen and
Antibody Tests

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to classify Human Leukocyte Antigen (HLA), Human Platelet
Antigen (HPA), and Human Neutrophil Antigen (HNA) devices, a generic
type of device, into class II (special controls). FDA is identifying
proposed special controls for HLA, HPA, and HNA devices that are
necessary to provide a reasonable assurance of safety and
effectiveness. FDA is also giving notice that we do not intend to
exempt these device types from premarket notification requirements of
the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is publishing
in this document the recommendations of the Blood Products Advisory
Committee, serving as a device classification panel, regarding the
classification of these devices. After considering public comments on
the proposed classification, FDA will publish a final regulation
classifying these device types.

DATES: Submit either electronic or written comments on the proposed
rule by April 21, 2022.

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 April 21, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0851 for ``Medical Devices; Immunology and Microbiology
Classification of Human Leukocyte, Neutrophil and Platelet Antigen and
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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The

second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Statutory and Regulatory Authorities
    B. Regulatory History of the Devices
IV. Legal Authority
V. Description of the Proposed Rule and Panel Recommendations
    A. Identification
    B. Recommended Classification of the Panel
    C. Risks to Health and Special Controls
VI. Proposed Classification and FDA's Findings
VII. Proposed Effective Date
VIII. Preliminary Economic Analysis of Impacts
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to classify HLA, HPA, and HNA devices, a generic
type of device, into class II (special controls). The Agency believes
that the special controls established by this proposed rule, together
with general controls, would provide reasonable assurance of the safety
and effectiveness of these devices. FDA is also giving notice that we
do not intend to exempt HLA, HPA, and HNA devices from premarket
notification requirements of the FD&C Act.

B. Summary of the Major Provisions of the Proposed Rule

    FDA is proposing to classify HLA, HPA, and HNA devices, a generic
type of device, into class II with special controls. This proposed rule
provides device descriptions that include indications for use of the
devices and the special controls that will provide reasonable assurance
of the safety and effectiveness of these devices.

C. Legal Authority

    FDA is proposing this action under the device provisions of the
FD&C Act including section 513 of the FD&C Act (21 U.S.C. 360c).

D. Costs and Benefits

    The benefits of this proposed rule consist of the cost savings
resulting from the reduction in regulatory and economic burden that
accompanies the decrease in the number of information requests and
incomplete submissions submitted by manufacturers and handled by FDA;
however, we lack the information needed that would allow us to quantify
these benefits. The number of requests for additional information
following manufacturers' 510(k) submissions is small and widely
dispersed over the duration of time these devices have been marketed.
The classification procedure and outlined special controls will be
helpful for HLA, HPA, and HNA manufacturers in preparing their
submissions. Further benefits may be derived from the decreased time a
notification submission will need to be reviewed and the subsequent
potential benefits realized by consumers and manufacturers.
    The costs of this proposed rule include one-time upfront labeling
redesigns, in addition to initial learning and reading costs. The total
estimated one-time costs of this proposed rule are $434,885 (in 2020
dollars). The present value of these costs is $434,885 because they are
one-time costs that are expected to occur in the first year. The
annualized cost of this proposed rule over 10 years is $54,201 at a
seven percent discount rate and $45,632 at a three percent discount
rate.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

----------------------------------------------------------------------------------------------------------------
     Abbreviation/acronym                                        What it means
----------------------------------------------------------------------------------------------------------------
510(k).......................  Premarket Notification.
BPAC.........................  Blood Products Advisory Committee.
CFR..........................  Code of Federal Regulations.
FDA..........................  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
HLA..........................  Human Leukocyte Antigen.
HPA..........................  Human Platelet Antigen.
HNA..........................  Human Neutrophil Antigen.
MAUDE........................  Manufacturer and User Facility Device Experience.
MDR..........................  Medical Device Report.
Ref..........................  Reference.
TRALI........................  Transfusion-Related Acute Lung Injury.
U.S.C........................  United States Code.
----------------------------------------------------------------------------------------------------------------

III. Background

A. Statutory and Regulatory Authorities

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical
Device Amendments of 1976, establishes a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act establishes three categories (classes) of devices
depending on 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 (special controls),
and class III (premarket approval).
    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 of the device; 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, but 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 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).
    Under section 513(d)(1) of the FD&C Act, devices that were in
commercial distribution before the enactment of the Medical Device
Amendments of 1976 (1976 amendments) on May 28, 1976 (generally
referred to as ``preamendments devices''), are classified after FDA:
(1) Receives a recommendation from a device classification panel (an
FDA advisory committee); (2) publishes the panel's recommendation,
along with a proposed regulation classifying the device, and provides
an opportunity for interested persons to submit comments; and (3)
publishes a final regulation classifying the device.
    FDA has classified most preamendments devices under these
procedures, relying upon valid scientific evidence as described in
section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c), to determine
that there is reasonable assurance of the safety and effectiveness of a
device under its conditions of use.
    Devices that were not in commercial distribution before May 28,
1976 (generally referred to as ``postamendments devices''), are
classified automatically by section 513(f) 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
classifies or reclassifies the device into class I or 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.
    The Agency determines whether new devices are substantially
equivalent to previously marketed devices by means of premarket
notification procedures in section 510(k) of the FD&C Act and part 807
of the regulations (21 CFR part 807). The 510(k) premarket notification
is a submission made to FDA to demonstrate that the device to be
marketed is at least as safe and effective as (i.e., substantially
equivalent to) a legally U.S. marketed class I or II device of that
same generic type. A generic type of device is a grouping of devices
that do not differ significantly in purpose, design, materials, energy
source, function, or any other feature related to safety and
effectiveness, and for which similar regulatory controls are sufficient
to provide reasonable assurance of safety and effectiveness (21 CFR
860.3(i)). When determined to be substantially equivalent, the subject
device may be legally marketed in the United States. The legally
marketed device to which substantial equivalence is determined is known
as the predicate device. A predicate device can be a preamendments
device or a postamendments device.
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures without
submission of a premarket approval application until FDA issues a final
order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval.

B. Regulatory History of the Devices

    The first product license for Leukocyte Typing Serum was issued in
December 1974, by the Bureau of Biologics, FDA. An FDA guideline for
the production, testing, and lot release of Leukocyte Typing Serum was
issued in 1977 and subsequently codified as Additional Standards in the
biologics regulations under 21 CFR 660.10 through 660.15.
    In the Federal Register of August 1, 1980 (45 FR 51226), FDA
published a proposed rule recommending that the Additional Standards
for Leukocyte Typing Serum be removed with the subsequent revocation of
the existing product licenses. The proposed rule was prompted by the
realization of the growing complexities of the HLA system and the
difficulty in achieving standardization. The proposed rule was
supported by the argument that the products, while biologics, were also
medical devices that could be appropriately and efficiently regulated
under the FD&C Act as amended by the Medical Device Amendments of 1976
(21 U.S.C 301 et seq). The Agency's intent to classify HLA reagents and
kits was described in the preamble to the 1980 proposed rule.
    In the Federal Register of August 10, 1982 (47 FR 34532), FDA
issued a final rule revoking the additional standards for Leukocyte
Typing Serum. The final regulation instructed all manufacturers of
Leukocyte Typing Serum to register and list under part 807. For those
products not currently licensed, manufacturers would be required to
submit premarket notifications (510(k) submissions). The first 510(k)
cleared HLA device used a preamendment HLA device as predicate.
    Since 1982, FDA has cleared approximately 100 HLA device premarket
notifications (510(k)) submissions. Since 1993, FDA has cleared seven
HPA assays through the 510(k) premarket notifications pathway. Five
devices were cleared for the detection of antibodies against HPA and
two were cleared for HPA typing. Since 2006, FDA has cleared four HNA
devices through the 510(k) premarket

notifications pathway. Two devices were cleared for the detection of
antibodies against HNA and two were cleared for HNA typing.
    On September 15, 2000, the Blood Products Advisory Committee (BPAC)
(2000 BPAC), serving as a device classification panel, provided
recommendations to FDA regarding the classification of in vitro
diagnostic reagents and kits for use in determining the HLA phenotype
or genotype of an individual, or for detecting antibodies to HLA
antigens (Ref. 1). The scope of the discussion included devices that
are used to support platelet and leukocyte transfusions, or organ and
stem cell transplantation. The classification of HLA kits used to
predict disease was not discussed at the meeting. The 2000 BPAC agreed
unanimously that HLA devices should be classified as class II medical
devices. The panel did not agree that the devices should be exempt from
the requirement to submit a 510(k). Although the 2000 BPAC recommended
classification of the HLA devices as class II, the classification was
not finalized by FDA because of competing priorities.
    On November 30, 2017, FDA sought recommendations from the BPAC,
serving as a device classification panel (the Panel) (Refs. 2 and 3),
to discuss the classification of HLA, HPA, and HNA devices. FDA
proposed to the Panel that HLA, HPA, and HNA devices be classified as a
generic device type. The rationale to classify these devices together
was based on the similarities in the biological properties of the three
antigen systems, the use of similar technologies for the detection of
antigens and antibodies, the clinical use of the test results, and the
special controls required to mitigate risks. FDA proposed that these
are devices that do not differ significantly in purpose, design,
materials, energy source, function, or other features related to safety
and effectiveness, and for which similar regulatory controls are
sufficient to provide reasonable assurance of safety and effectiveness.
The Panel recommended that these devices be classified into class II
(special controls) with premarket review. FDA is not aware of new
information that has arisen since the Panel meeting that would provide
a basis for different recommendations or finding. The recommendations
of the Panel are summarized in Section V.

IV. Legal Authority

    We are issuing this proposed rule under section 513(a) of the FD&C
Act. FDA has authority under this provision of the FD&C Act to issue a
regulation to establish special controls for class II devices for which
general controls by themselves are insufficient to provide reasonable
assurance of safety and effectiveness of the device, and for which
there is sufficient information to establish special controls to
provide such assurance. Under this authority, FDA is establishing
special controls for HLA, HPA, and HNA devices.

V. Description of the Proposed Rule and Panel Recommendations

    This section summarizes the Panel's deliberations on November 30,
2017.

A. Identification

    FDA described HLA, HNA, and HPA devices for the Panel's
consideration:
    Human Leukocyte, Neutrophil and Platelet antigen and antibody
devices consist of HLA, HNA, and HPA typing and antibody detection
devices.
     HLA typing devices are used to determine HLA types, to aid
in transfusion or transplantation donor and recipient matching, or to
aid in the diagnosis of diseases.
     HLA antibody detection devices are used to detect
antibodies to HLA antigens to aid in donor and recipient matching in
transfusion or transplantation.
     HPA typing devices are used for the detection of human
platelet antigens to aid in donor and recipient matching in blood
transfusion or to aid in the diagnosis of diseases.
     HPA antibody detection devices are used to detect
autoantibodies and alloantibodies against platelet glycoproteins to aid
in donor and recipient matching in blood transfusion or to aid in the
diagnosis of diseases.
     HNA typing devices are used for the detection of human
neutrophil antigens to aid in donor and recipient matching in blood
transfusion or to aid in the diagnosis of diseases.
     HNA antibody detection devices are used to detect
autoantibodies and alloantibodies against neutrophil antigens to aid in
donor and recipient matching in blood transfusion or to aid in the
diagnosis of diseases.
    FDA clarified the following devices are not included in the
proposed classification:
     HLA, HPA, or HNA devices used as a companion diagnostic
device, a device that provides information that is essential for the
safe and effective use of a corresponding therapeutic product.
     HLA, HPA, or HNA assays that are intended for clinical use
and designed, manufactured, and used within a single laboratory.

B. Recommended Classification of the Panel

    The Panel recommended that HLA, HNA, and HPA devices be classified
into class II with special controls with premarket review. The Panel
agreed that general controls were not sufficient to provide reasonable
assurance of safety and effectiveness of HLA, HPA, and HNA devices. The
Panel believed that HLA, HPA, and HNA devices present a potentially
unreasonable risk of illness, injury, or death. Considering these
risks, the Panel agreed that sufficient information exists to establish
special controls for these devices. Consequently, the consensus of the
Panel was that class II classification (special controls) and premarket
review would provide reasonable assurance of safety and effectiveness
of these devices.
    The Panel considered the following valid scientific evidence to
make their recommendation regarding the safety and effectiveness of
these devices under its conditions of use. Specifically, the Panel
considered the history of safety and effectiveness of HLA, HPA, and HNA
devices over many years of use; the results of an FDA review of the
scientific literature; medical device reports (MDRs) of adverse events
or malfunctions; device recalls, and FDA's regulatory experiences with
the devices.

C. Risks to Health and Special Controls

    As required by section 513(d)(1) of the FD&C Act, FDA provided to
the Panel the following summary of valid scientific evidence regarding
the benefits and risks of HLA, HPA, and HNA devices. A systemic
literature review indicates that the use of these devices has improved
patient care in transfusion and transplantation, and in disease
diagnosis. HLA matching between the donor and recipient is a key
strategy to reduce rejection. The presence of anti-HLA antibodies,
especially donor-specific antibodies, has been associated with worse
outcomes after transplantation or transfusion. Identification of HLA
antibodies allows for informed decisions regarding whether to accept
and transplant an organ for a specific recipient. In similar fashion,
HPA and HLA devices provide a means to detect and identify related
antigens and antibodies facilitating transfusion with compatible blood
(platelet) products. In addition, HNA and HLA devices provide
laboratorians and clinicians tools to investigate transfusion-related
acute lung injury (TRALI) reactions and/or mitigate the risk of future
TRALI reactions associated with implicated blood donors.

    However, available literature, MDRs, and medical device recall data
indicate that HLA, HPA, and HNA devices can malfunction. These devices
may generate false positive, false negative, or inconsistent results
and have the potential to cause adverse health consequences. Suspected
device-associated deaths, serious injuries, and malfunctions are
reported to FDA through the Manufacturer and User Facility Device
Experience (MAUDE) database. Prior to the Panel meeting, FDA conducted
queries of the MAUDE database to identify MDRs related to the use of
HLA, HPA, and HNA devices. The search was restricted to reports that
FDA received and entered into the database before May 1, 2017. There
were 477 MDRs for HLA devices. Most MDRs (464) were reported for HLA
genotyping devices, while 13 MDRs were reported for HLA antibody
detection devices. All MDRs with reportable category information are
malfunctions. The most frequent malfunctions are incorrect reactivity
assignments that lead to mistype or no type HLA results. There have
been no reported deaths or serious injuries related to these
malfunctions. These medical device reports suggest that 510(k)
premarket notification of HLA devices is a necessary means to minimize
adverse health consequences that may result from HLA device
malfunctions. Compared to HLA devices, there are few HPA and HNA
devices in the U.S. market and few reported MDRs. The queries of the
MAUDE database prior to the Panel meeting identified only two MDRs for
HPA devices and no MDRs for HNA devices. However, these devices share
similar technologies and clinical applications to HLA devices and have
the potential for malfunctions that may cause adverse health
consequences. Therefore, 510(k) premarket notification of HPA and HNA
devices is needed to minimize adverse health consequences that may
result from HPA or HNA device malfunction.
    Similarly, prior to the Panel meeting, FDA searched the Medical
Device Recalls database for all recalls received before May 1, 2017,
for these devices. Of the total 37 HLA device recalls, none were
classified as class I recalls, in which the violative product could
cause serious adverse health consequences or death. A total of 19
recalls were classified as class II, and 18 were classified as class
III. Most of the recalls (32 of 37) were for products that failed to
provide correct testing results (false negative, false positive,
mistype, or no type). The root causes leading to incorrect HLA typing
results include incorrect reactivity assignments, lack of testing
sample(s) with specific allele before releasing, and manufacturing
errors. The HLA antibody device recalls were due to manufacturing
errors during the production of recombinant HLA proteins, such as
unstable transfectant. No recalls were reported for HPA and HNA
devices. However, these devices share similarities with the HLA devices
and are likely prone to similar malfunctions.
    FDA presented the following risks to health associated with HLA,
HPA, and HNA devices: Patient injury or death due to: (1) Poor graft
survival or function due to transplantation of incompatible
hematopoietic cells, tissue, or organ; (2) graft rejection because of
the transplantation of incompatible hematopoietic cells, tissue, or
organ; (3) graft-versus-host disease because of the transplantation of
incompatible immune system cells; (4) incorrect or delayed diagnosis of
medically related conditions or assessment of future risk of adverse
outcomes because of incorrect HLA, HPA, or HNA test results; (5)
transfusion reaction (e.g., transfusion associated lung injury, post
transfusion purpura) due to incorrect HLA, HPA, or HNA test results;
and, (6) platelet refractoriness because of incorrect HLA or HPA typing
or antibody detection results.
    FDA next proposed to the Panel measures to mitigate the risks to
health associated with HLA, HNA, and HPA devices. The identified risks
to health and the special controls to mitigate these risks (explained
in the paragraph immediately after the table) are summarized in the
following table:

                        Table 1--Summary of Risks to Health and Proposed Special Controls
----------------------------------------------------------------------------------------------------------------
               Risk to health                            Method of mitigation (i.e., special control)
----------------------------------------------------------------------------------------------------------------
Inaccurate test results (i.e., false         Special controls (1) and (2).
 positive or false negative results) can
 result in adverse health consequences.
Failure of software to correctly interpret   Special controls (1)(e) and (1)(f).
 test results can result in adverse health
 consequences.
----------------------------------------------------------------------------------------------------------------

    FDA proposed the following special controls (cross-referenced in
the table above) to the Panel for HLA, HPA, and HNA devices: (1)
Premarket submissions must include detailed documentation of the
following information: (a) Device accuracy study using well-
characterized samples representing as many targets as possible; (b)
precision studies to evaluate possible sources of variation that may
affect test results; (c) comparison studies to evaluate the device's
performance compared to a predicate; (d) specific information that
addresses or mitigates risks associated with false positive antibody
reactivity e.g., reactivity with denatured/cryptic epitopes, if
applicable; (e) description of how the assay cutoff was established and
validated as well as supporting data; (f) documentation for device
software, including, but not limited to, software requirement
specifications, software design specification, e.g., algorithms, alarms
and device limitations; hazard analysis, traceability matrix,
verification and validation testing, unresolved anomalies, hardware and
software specifications; electromagnetic compatibility and wireless
testing; (g) for multiplex assays in which large numbers of probes and/
or primers are handled during manufacturing process, premarket
submissions should provide the design specifications that are in place
to prevent incorrect reactivity assignment; (h) description of a plan
on how to ensure the performance characteristics of the device remain
unchanged over time when new HLA alleles are identified, and/or
reactivity assignments are changed from the assignments at the time the
device was evaluated; and (2) device labeling must include: (a) A
limitation statement that reads, ``The results should not be used as
the sole basis for making a clinical decision;'' and (b) a warning that
reads ``The device has not been cleared or approved for use as a
companion diagnostic.''
    The Panel members agreed with the special controls proposed by FDA.

VI. Proposed Classification and FDA's Findings

    After considering the recommendations of the Panel and the valid
scientific evidence, including the

published literature, MDRs, recall information, and FDA's regulatory
experience with these device types, FDA proposes to classify HLA, HPA,
and HNA devices as class II devices (special controls) with premarket
review. FDA believes general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness for these
devices and there is sufficient information to establish special
controls to provide such assurance. FDA believes that special controls,
in addition to general controls, would provide reasonable assurance of
the safety and effectiveness of HLA, HPA, and HNA devices and would,
therefore, mitigate the risks to health associated with their use.
    We are proposing to classify the devices as a generic type of
device because of the similarities in the biological properties of the
three antigen systems, the use of similar technologies for the
detection of antigens and antibodies, the clinical use of the test
results, and the special controls required to mitigate risks. The
proposed device identification includes the indications for use of HLA,
HPA, and HNA devices subject to the classification. The following
devices are not included in the proposed classification: HLA, HPA, or
HNA devices used as a companion diagnostic device, a device that
provides information that is essential for the safe and effective use
of a corresponding therapeutic product.
    The proposed regulation also includes special controls that are
necessary to provide a reasonable assurance of the safety and efficacy
of the devices. When developing the special controls, we considered the
recommendations provided in the FDA guidance document entitled
``Recommendations for Premarket Notification (510(k)) Submissions for
Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for
Matching of Donors and Recipients in Transfusion and Transplantation''
(Ref. 4).
    Section 510(m) of the FD&C Act provides that a class II device may
be exempted from premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to assure the safety and effectiveness of
the device. The Agency does not intend to exempt HNA, HPA, and HNA
devices from 510(k) premarket notification as allowed under section
510(m) of the FD&C Act. FDA believes premarket notification is
necessary for these devices to assure their safety and effectiveness.

VII. Proposed Effective Date

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

VIII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because of the limited impact of this proposed rule, we
propose to certify that the proposed rule will not have a significant
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    If finalized, the proposed rule would classify HLA, Human HPA, and
HNA devices as a generic group of devices into class II (special
controls). The Agency believes that the special controls included in
this proposed rule, together with general controls, are necessary to
provide reasonable assurance of the safety and effectiveness of these
devices. The special controls in the proposed rule are already
generally practiced by manufacturers of currently cleared devices; the
primary change consists of a labeling update. FDA is also giving notice
that we do not intend to exempt HLA, HPA, and HNA devices from
premarket notification requirements of the FD&C Act.
    The proposed rule's costs are summarized in table 2; we are unable
to quantify benefits for this proposed rule. Costs are calculated as
the one-time costs of relabeling affected devices to comply with the
proposed rule and costs associated with reading and understanding the
proposed rule. The total estimated one-time costs of this rule are
$434,885 (in 2020 dollars). The present value of these costs is
$443,885 because they are one-time costs that are expected to occur in
the first year. The annualized cost of this proposed rule over 10 years
is $54,201 at a seven percent discount rate and $45,632 at a three
percent discount rate.
    The benefits of this proposed rule consist of the cost savings
resulting from the reduction in regulatory and economic burden that
accompanies the decrease in the number of information requests and
incomplete submissions submitted by manufacturers and handled by FDA;
however, we lack the information needed that would allow us to quantify
these benefits. The number of requests for additional information
following manufacturers' 510(k) submissions is small and widely
dispersed over the duration of time these devices have been marketed.
The classification procedure and outlined special controls would be
helpful for HLA, HPA, and HNA manufacturers in preparing their
submissions. Further benefits may be derived from the decreased time a
notification submission would need to be reviewed and the subsequent
potential benefits realized by consumers and manufacturers. The costs
of this proposed rule include one-time upfront labeling redesigns, in
addition to initial learning and reading costs.
    Consistent with Executive Order 12866, table 2 provides the costs
and a description of benefits for this proposed rule.

                                   Table 2--Summary of Benefits and Costs in 2020 Dollars Over a 10-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                          Primary       Low        High    ------------------------------------
               Category                  estimate    estimate    estimate      Year      Discount     Period                      Notes
                                                                              dollars    rate (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year.......  ..........  ..........  ..........        2020           7          10  ........................................
                                        ..........  ..........  ..........        2020           3          10  ........................................
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........  ........................................
                                        ..........  ..........  ..........  ..........           3  ..........  ........................................
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........  Improved labeling and enhanced certainty
                                                                                for 510(k) submissions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $/year.......     $54,201  ..........  ..........        2020           7          10  ........................................
                                           $45,632  ..........  ..........        2020           3          10  ........................................
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........  ........................................
                                        ..........  ..........  ..........  ..........           3  ..........  ........................................
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........  ........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $/     ..........  ..........  ..........  ..........           7  ..........  ........................................
     year.
                                        ..........  ..........  ..........  ..........           3  ..........  ........................................
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................                 From:
                                                        To:                 ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $/year.  ..........  ..........  ..........  ..........           7  ..........  ........................................
                                        ..........  ..........  ..........  ..........           3  ..........  ........................................
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................                 From:
                                                        To:                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:
    Small Business:
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
analysis of economic impacts is available in the docket for this
proposed rule (Ref. 5) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

IX. Analysis of Environmental Impact

    We have 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.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

XI. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the proposed rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the proposed rule does not contain policies that would
have a substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XIII. References

    The following references 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 are also
available electronically at https://www.regulations.gov. 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. Blood Products Advisory Committee Meeting transcript--
September 15, 2000 (pp. 209-220), available at: https://wayback.archive-it.org/7993/20170404105835/https:/www.fda.gov/ohrms/dockets/ac/00/transcripts/3649t2c.pdf.
    2. Blood Products Advisory Committee Meeting transcript--
November 30, 2017, available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM590282.pdf .
    3. FDA Executive Summary. Classification of Human Leukocyte,
Neutrophil and Platelet Antigen or Antibody Tests--November 30,
2017, available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM586203.pdf.
    4. ``Recommendations for Premarket Notification (510(k))
Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA)
Test Kits Used for Matching of Donors and Recipients in Transfusion
and Transplantation: Guidance for Industry,'' July 2015, available
at: https://www.fda.gov/

regulatory-information/search-fda-guidance-documents/
recommendations-premarket-notification-510k-submissions-nucleic-
acid-based-human-leukocyte-antigen.
    5. FDA, ``Medical Devices; Immunology and Microbiology Devices;
Classification of Human Leukocyte, Neutrophil and Platelet Antigen
and Antibody Tests,'' Preliminary Regulatory Impact Analysis Initial
Regulatory Flexibility Analysis Unfunded Mandates Reform Act
Analysis,'' 2019 (available at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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, we
propose 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.  866.5960 to subpart F to read as follows:

Sec.  866.5960  Human Leukocyte, Human Neutrophil, and Human Platelet
antigen and antibody devices.

    (a) Identification. Human Leukocyte, Human Neutrophil, and Human
Platelet antigen and antibody devices consist of Human Leukocyte
Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil
Antigen (HNA) typing and antibody detection devices.
    (1) HLA typing devices are used to determine HLA types, to aid in
transfusion or transplantation donor and recipient matching, or to aid
in the diagnosis of diseases.
    (2) HLA antibody detection devices are used to detect antibodies to
HLA antigens to aid in donor and recipient matching in transfusion or
transplantation.
    (3) HPA typing devices are used for the detection of human platelet
antigens to aid in donor and recipient matching in blood transfusion or
to aid in the diagnosis of diseases.
    (4) HPA antibody detection devices are used to detect
autoantibodies and alloantibodies against platelet glycoproteins to aid
in donor and recipient matching in blood transfusion or to aid in the
diagnosis of diseases.
    (5) HNA typing devices are used for the detection of human
neutrophil antigens to aid in donor and recipient matching in blood
transfusion or to aid in the diagnosis of diseases.
    (6) HNA antibody detection devices are used to detect
autoantibodies and alloantibodies against neutrophil antigens to aid in
donor and recipient matching in blood transfusion or to aid in the
diagnosis of diseases.
    (b) Classification. Class II (special controls). HLA, HPA, and HNA
typing devices must comply with the following special controls:
    (1) Premarket submissions must include detailed documentation of
the following:
    (i) Device accuracy study using well-characterized samples
representing as many targets as possible.
    (ii) Precision studies to evaluate possible sources of variation
that may affect test results.
    (iii) Comparison studies to evaluate the device's performance
compared to a predicate.
    (iv) Specific information that addresses or mitigates risks
associated with false positive antibody reactivity, e.g., reactivity
with denatured/cryptic epitopes, if applicable.
    (v) Description of how the assay cutoff was established and
validated as well as supporting data.
    (vi) Documentation for device software, including, but not limited
to, software requirement specifications, software design
specifications, e.g., algorithms, alarms, and device limitations;
hazard analysis, traceability matrix, verification and validation
testing, unresolved anomalies, hardware and software specifications;
electromagnetic compatibility and wireless testing.
    (vii) Design specifications that are in place to prevent incorrect
reactivity assignment or multiplex assays in which large numbers of
probes and/or primers are handled during manufacturing process.
    (viii) Description of a plan on how to ensure the performance
characteristics of the device remain unchanged over time when new HLA
alleles are identified and/or reactivity assignments are changed from
the assignments at the time the device was evaluated.
    (2) The device labeling must include:
    (i) A limitation statement that reads, ``The results should not be
used as the sole basis for making a clinical decision.''
    (ii) A warning that reads ``The device has not been cleared or
approved for use as a companion diagnostic.''

    Dated: January 11, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-01156 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Pages 6462-6463]
[FR Doc No: 2019-03434]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Cancellation of Environmental Impact Statement for
Proposed Capacity Enhancements and Other Improvements at Charlotte
Douglas International Airport, Charlotte, Mecklenburg County, NC

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

ACTION: Notice of Cancellation of Preparation of Environmental Impact
Statement (EIS) by the Federal Aviation Administration (FAA) for
proposed capacity enhancements and other improvements (Proposed Action)
at Charlotte Douglas International Airport, Charlotte, NC.

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

SUMMARY: The Federal Aviation Administration (FAA) announces that it
has discontinued preparation of an Environmental Impact Statement (EIS)
for proposed capacity enhancements and other improvements (Proposed
Action) at Charlotte Douglas International Airport (CLT), Charlotte,
NC. The Proposed Action initially presented to the FAA entailed: (1) A
Fourth 12,000-foot Parallel Runway 1-19 and End-Around Taxiways; (2)
Concourse B and Ramp Expansion; (3) Concourse C and Ramp Expansion; and
(4) Daily North Parking Deck. Based on developments during the National
Environmental Policy Act, 42 U.S.C. 4321 et seq. (NEPA), review
process, the project now subject to environmental review includes a
fourth parallel runway of only 10,000 feet. The FAA determined that
this was a sufficient change to one of the proposed capacity
enhancements, as described in greater detail below in the Supplementary
Information section of this Notice, to warrant cancellation of the EIS
and conversion to an Environmental Assessment (EA).

DATES: Cancellation of this EIS is immediate.

ADDRESSES: Mail all comments, statements, or questions concerning this
notice to: Mr. Tommy L. Dupree, Assistant Manager, Memphis Airports
District Office, 2600 Thousand Oaks Blvd., Suite 2250, Memphis, TN
38118. You may also send comments to<EMAIL_ADDRESS>    In addition, one copy of any comment submitted to the FAA should be
mailed or delivered to Mr. Jack Christine, Chief Operating Officer,
City of Charlotte Aviation Department, 5601 Wilkinson Boulevard,
Charlotte, NC 28208.

SUPPLEMENTARY INFORMATION: On March 22, 2018, the FAA published in the
Federal Register a Notice of Intent (NOI) to prepare an EIS and to
conduct public and agency scoping meetings (Volume 83, Number 05583, FR
12369-12640). The FAA held two governmental agency scoping meetings for
Federal, state, and local regulatory agencies in Raleigh, NC, on April
24, 2018 and Charlotte, NC, on April 25, 2018, in addition to two
public scoping meetings for the general public in Charlotte, NC, on
April 24 and 26, 2018. FAA issued a Notice to Proceed for the EIS April
24, 2017.
    In October 2018, FAA conducted an EIS runway length analysis for
the proposed 12,000-foot runway, and the

analysis determined that only a 10,000-foot runway was required to meet
the purpose and need. The analysis was coordinated with the City of
Charlotte and its airline tenants. Given this change to a major element
of the sponsor's Proposed Action, the FAA began a process of
reevaluating the appropriate level of environmental documentation for
compliance with NEPA, the Council on Environmental Quality Regulations
for Implementing the Procedural Provisions of NEPA (40 Code of Federal
Regulations parts 1500-1508), FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, and FAA Order 5050.4B, National Environmental
Policy Act (NEPA) Implementing Instructions for Airport Actions. This
evaluation focused on likely changes to environmental impacts
anticipated to occur as a result of the runway length change.
    In determining the appropriate level of environmental review going
forward, the sponsor, at the request of the FAA, has performed a
preliminary noise analysis of the revised Proposed Action. In addition,
the FAA has evaluated potential changes in other anticipated
environmental impact categories. The FAA has also considered potential
mitigation for such impacts. In light of this review, the FAA
anticipates that compliance with NEPA can adequately be achieved by
preparation of an EA. The City of Charlotte will be responsible for the
development of the EA in accordance with NEPA, all applicable federal
regulations, and FAA guidance. In addition, the FAA will work with the
City of Charlotte to ensure an appropriate level of public involvement
is provided as part of the EA process. Once completed, the City will
forward the environmental document to the FAA. The FAA remains the
responsible Federal agency for compliance with the requirements of
NEPA. In this capacity, FAA will make its own independent evaluation of
the environmental issues and take responsibility for the scope and
content of the EA. The FAA also will make a final decision on whether
it can issue a satisfactory environmental finding based upon the EA.
The FAA will thereafter determine whether it may take the federal
actions necessary to allow implementation of the project. All questions
concerning the development, commencement, and public notices related to
the EA, should be directed to The City of Charlotte Aviation
Department, Mr. Jack Christine, Chief Operating Officer, 5601 Wilkinson
Boulevard, Charlotte, NC 28208.
    More information on the Proposed Action and the NEPA process is
available on the project website at: www.clteis.com.

    Issued in Memphis, Tennessee on February 21, 2019.
Phillip J. Braden,
Manager, Memphis Airports District Office, Southern Region.
[FR Doc. 2019-03434 Filed 2-26-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: November 19, 2007 (Volume 72, Number 222)]
[Notices]
[Page 65127]
[DOCID:fr19no07-118]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fourth Meeting, Special Committee 212, Helicopter Terrain
Awareness and Warning System (HTWAS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 212, Helicopter Terrain
Awareness and Warning System (HTWAS).

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

SUMMARY: The FAA is issuing this notice to advise the public of RTCA
Special Committee 212, Helicopter Terrain Awareness and Warning System
(HTWAS).

DATES: The meeting will be held December 5, 2007, from 9 a.m.-12 p.m.

ADDRESSES: The meeting will be held RTCA, Inc., 1828 L Street, NW.,
Suite 805, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 212 meeting. The agenda will
include:
     December 5:
     Opening Plenary Session (Welcome, Introductions, and
Administrative Remarks, Agenda Overview).
     Resolve comments ont he draft HTAWS MOPS document.
     Consider and approve the draft HTAWS MOPS document for
final review and comment (FRAC).
     Closing Plenary Session (Other Business, Establish Agenda,
Date and Place of Next Meeting, Adjourn).
    Attendance is open to the interested public but limited to space
availability. Pre-Registration for this meeting is not required for
attendance but is desired and can be done through the RTCA secretariat.
With the approval of the chairmen, members of the public may present
oral statements at the meeting. Persons wishing to present statements
or obtain information should contact the person listed in FOR FURTHER
INFORMATION CONTACT Section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC on November 8, 2007.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 07-5723 Filed 11-16-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34632-34635]
[FR Doc No: 2018-15504]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83646; File No. SR-MRX-2018-24]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change to Amend MRX Rule
723

July 16, 2018,
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 5, 2018, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``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.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend MRX Rule 723, entitled ``Price
Improvement Mechanism for Crossing Transactions.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqmrx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    MRX proposes to amend Rule 723, entitled ``Price Improvement
Mechanism for Crossing Transactions.'' Specifically, the Exchange
proposes to amend Rule 723(c)(2) to expand the types of Improvement
Orders \3\ that may be entered into the Price Improvement Mechanism or
``PIM.'' The Exchange also proposes to amend Rule 723(d)(1)-(3) to more
specifically clarify terms such as ``orders'' and ``responses'' in that
section.
---------------------------------------------------------------------------

    \3\ Rule 723(c)(1) defines an Improvement Order. The Exchange
will designate via circular a time of no less than 100 milliseconds
and no more than 1 second for Members to indicate the size and price
at which they want to participate in the execution of the Agency
Order (``Improvement Orders'').
---------------------------------------------------------------------------

Background
    The Exchange adopted PIM as part of its application to be
registered as a national securities exchange.\4\ In approving PIM, the
Commission noted that it was largely based on a similar functionality
offered by the International Securities Exchange, LLC (now Nasdaq ISE,
LLC) (``ISE'').\5\ ISE received approval to establish its PIM in 2004
that would allow an ISE Electronic Access Member (``EAM'') to enter
matched trades (``Crossing Transactions'').\6\ As noted in the Adopting
Filing, a Crossing Transaction would be comprised of an order that the
EAM represents as agent (``Agency Order'') and an order that is
executable against the Agency Order for the full size of the Agency
Order (the ``Counter-Side Order'').\7\ In the Adopting Filing, ISE
specified in Rule 723(c)(2) that Improvement Orders may be for the
account of a Public Customer or for the Member's own account.\8\ The
Adopting Filing noted that ISE would broadcast

Crossing Orders to all Members.\9\ Further, it was noted in the
Adopting Filing that during a three second auction, all ISE Members
could enter ``Improvement Orders,'' in penny increments, to improve the
price of the Agency Order.\10\ The Adopting Filing stated that
Improvement Orders may be for the account of a Public Customer or for
the Member's own account.\11\ Finally, the Adopting Filing noted that
during the exposure period, the aggregate size of the best prices,
including the Counter-Side Order, Improvement Orders, and any change to
either, would continually be updated and broadcast to all Members.\12\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 76998 (January 29,
2016), 81 FR 6066 (February 4, 2016) (File No. 10-221) (Exchange
Approval Order).The Exchange subsequently changed its name to ISE
Mercury and then later Nasdaq MRX.
    \5\ Id.
    \6\ See Securities Exchange Act Release No. 50819 (December 8,
2004), 69 FR 75093 (December 15, 2004) (SR-ISE-2003-06) (Order
Granting Approval of Proposed Rule Change and Amendment No. 1
Thereto and Notice of Filing and Order Granting Accelerated Approval
to Amendments No. 2 and 3 Thereto by the International Securities
Exchange, Inc. To Establish Rules Implementing a Price Improvement
Mechanism) (``Adopting Filing'').
    \7\ The Counter-Side Order may represent interest for the EAM's
own account, or interest the EAM has solicited from one or more
other parties, or a combination of both.
    \8\ Id.
    \9\ The broadcast message would include the series, price, and
size of the Agency Order and whether it is to buy or sell.
    \10\ The ISE would broadcast Improvement Orders to all Members.
Crossing Transactions and Improvement Orders would not be displayed
in the ISE BBO and would not be disseminated to the Options Price
Reporting Authority.
    \11\ MRX Rule 723(c)(2).
    \12\ MRX Rule 723(c)(4).
---------------------------------------------------------------------------

Rule 723(c)(2)
    With respect to the current limitation of Improvement Orders for
the account of a Public Customer or for the Member's own account, ISE
noted in its Adopting Filing that ``all ISE Members would be permitted
to participate in a PIM . . . unrelated orders could compete in
standard increments to trade with the Agency Order in the PIM. Such
unrelated orders could include agency orders on behalf of Public
Customers, market makers on other exchanges, and non-ISE member broker-
dealers, as well as non-Improvement orders submitted by ISE members.''
    At this time, the Exchange proposes to permit any MRX Member to
enter an Improvement Order marked as a response to a PIM auction
similar to Nasdaq PHLX LLC (``Phlx'') \13\ and Nasdaq BX, Inc. (``BX'')
\14\ rules. The Exchange no longer desires to limit Members who may
enter Improvement Orders into PIM to simply those orders for the
account of a Public Customer or for the Member's own account. The
Exchange desires to expand the types of orders that may be entered as
Improvement Orders similar to Phlx and BX. The Exchange is therefore
removing this limitation in Rule 723(c)(2) so that the proposed rule
text would read: ``Improvement Orders may be entered by all Members in
one-cent increments at the same price as the Crossing Transaction or at
an improved price for the Agency Order, and for any size up to the size
of the Agency Order.''
---------------------------------------------------------------------------

    \13\ Phlx Rule 1087 permits any member to submit for execution
an order it represents as agent on behalf of a public customer,
broker-dealer, or any other entity (``PIXL Order'').
    \14\ BX Rules at Chapter VI, Section 9 provides that ``A
Participant may electronically submit for execution an order it
represents as agent on behalf of a Public Customer, broker dealer,
or any other entity (``PRISM Order'').
---------------------------------------------------------------------------

Rule 723(d)(1)-(3)
    The Exchange proposes to amend MRX Rule 723(d)(1), which explains
the manner in which a PIM Order shall be allocated to conform this text
to the change which is proposed in Rule 723(c)(2). Rule 723(d)(1)
currently provides, ``At a given price, Priority Customer interest is
executed in full before Professional Orders \15\ and any other interest
of Members (i.e., proprietary interest from Electronic Access Members
and Exchange market makers).'' The Exchange proposes to expand upon the
term interest by adopting the defined terms ``Priority Customer
Interest'' for Priority Customer Orders and Improvement Orders from
Priority Customers, and ``Professional Interest'' for Professional
Orders, Improvement Orders from non-Priority Customers, and Market
Maker quotes. The Exchange believes that adding these defined terms
would clarify what is meant by interest. As proposed, Professional
Interest identifies all orders (including Improvement Orders) that are
not for the account of a Priority Customer as well as Market Maker
quotes, thereby incorporating the current reference to ``Professional
Orders'' within its terms and eliminating the necessity to include the
current rule text which provides, ``any other interest of Members
(i.e., proprietary interest from Electronic Access Members and Exchange
market makers).''
---------------------------------------------------------------------------

    \15\ MRX Rule 100(a)(54) provides the term ``Professional
Order'' means an order that is for the account of a person or entity
that is not a Priority Customer.
---------------------------------------------------------------------------

    The Exchange proposes to amend Rule 723(d)(2) which currently
provides, ``After Priority Customer interest at a given price,
Professional Orders and Members' interest will participate in the
execution of the Agency Order based upon the percentage of the total
number of contracts available at the price that is represented by the
size of the Members' interest.'' The Exchange proposes to replace the
reference to ``Priority Customer interest'' with the defined term
``Priority Customer Interest'' proposed to be added in Rule 723(d)(1),
as described above. The Exchange also proposes to change ``Professional
Orders'' to ``Professional Interest'' which will be defined in Rule
723(d)(1) to include Professional Orders as well as Improvement Orders
from non-Priority Customers and Market Maker quotes. Since Professional
Interest is defined in this manner, the Exchange also proposes to
remove the language referring to ``Members' interest'' from the
sentence because Professional Interest would include all orders from
non-Priority Customers and Market Maker quotes.
    The Exchange proposes to amend Rule 723(d)(3) to again remove the
rule text relating to ``Members' interest'' and instead utilize the
defined ``Professional Interest'' term consistent with proposed changes
to Rule 723(d)(1) and (2). The Exchange also proposes to make similar
changes to add the term ``Professional Interest'' to the sentence in
Rule 723(d)(3) that currently reads: ``Thereafter, all other orders,
Responses, and quotes at the price point will participate in the
execution of the Agency Order based upon the percentage of the total
number of contracts available at the price that is represented by the
size of the order, Response or quote.'' In particular, the language
related to ``other orders, Responses, and quotes'' in this sentence
will be replaced with ``Professional Interest'' since this term
includes all orders from non-Priority Customers and Market Maker
quotes, as described above. The Exchange notes that the references in
this sentence to ``Responses,'' currently an undefined term, should
instead refer to the defined term ``Improvement Orders,'' and the
proposed changes should therefore clarify how Rule 723(d)(3) will
apply. Finally, the Exchange proposes to replace the word ``Priority
Customer Orders'' with ``Priority Customer Interest'' as defined in
proposed Rule 723(d)(1) to clarify that those orders as well as
responses (i.e., Improvement Orders from Priority Customers) are
applicable. The proposed amendments add more specificity to the exact
order/quotes and responses which apply in this section.
    The amendments to Rule 723(d)(1)-(3) conform to the proposed
amendment to Rule 723(c)(2) and other proposed amendments as described
above which do not change the manner in which PIM operates today,
rather the other word changes seek to bring specificity to the manner
in which order, quotes and responses are treated.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the

objectives of Section 6(b)(5) of the Act,\17\ in particular, in that it
is designed 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.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange's proposal to amend Rule 723(c)(2) seeks to broaden
the types of orders that may be submitted as Improvement Orders into
PIM. As ISE previously noted, in its Adopting Filing, all Members are
able to participate in a PIM today as an unrelated order that rests on
the Order Book. Unrelated orders that rest on the Order Book can
participate in PIM and trade with the Agency Order in the PIM. The
Exchange proposes to allow all Members to submit Improvement Orders
directly into PIM to provide an even greater number of MRX Members to
more directly participate in PIM and provide price improvement. The
Exchange's proposal is consistent with the Act because allowing a
greater number of Members to directly respond with an Improvement Order
in a PIM will increase the likelihood of price improvement in that
auction thereby removing impediments to and perfecting the mechanism of
a free and open market and a national market system. This approach will
enable greater participation in PIM auctions.
    The Exchange's proposal to amend Rule 723(d) conforms the text with
changes made with respect to the proposal to amend Rule 723(c)(2) for
consistency. The proposed changes to remove the more generic ``Members'
interest'' and instead substitute very specific terms to define
interest and add quotes provide more specificity as to the manner in
which interest entered into PIM will be allocated. The Exchange's
proposed amendments to Rule 723(d)(1)-(3) are consistent with the Act
because the amendments seek to conform the rule text to the proposed
Rule 723(c)(2) amendment and describe in greater detail how interest
will be allocated by defining terms and eligible interest and this
transparency benefits investors and the public interest.

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 not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to
amend Rule 723(c)(2) to broaden the types of orders that may be
submitted as Improvement Orders into PIM does not unduly burden
competition because all Members will be permitted to submit Improvement
Orders directly into PIM to provide an even greater number of MRX
Members to more directly participate in PIM. The amendments to Rule
723(d) will conform the rule text and bring clarity to the allocation
method for PIM.

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

    No written comments were either solicited or received.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \18\ and Rule 19b-4(f)(6) thereunder.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \20\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \21\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that it
may allow all Members to submit Improvement Orders directly into PIM to
provide an even greater number of MRX Members an opportunity to more
directly participate in PIM and provide price improvement. The Exchange
states that it will issue an Options Trader Alert to notify Members of
the date within which this functionality will be implemented. The
Commission believes the waiver of the operative delay is consistent
with the protection of investors and the public interest. Accordingly,
the Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\22\
---------------------------------------------------------------------------

    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
    \22\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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 protected]. Please include
File Number SR-MRX-2018-24 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2018-24. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of 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. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-MRX-2018-24, and should be
submitted on or before August 10, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-15504 Filed 7-19-18; 8:45 am]
 BILLING CODE 8011-01-P