[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73819-73822]
[FR Doc No: 2020-25502]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90415; File No. SR-DTC-2020-013]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend the Reorganizations Service Guide

November 13, 2020.
    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 November 12, 2020, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by the clearing agency. DTC filed the proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(4) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4).
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The purpose of the proposed rule change \5\ is to amend the
Reorganizations Guide to (1) establish November 16, 2020 as the date
for the retirement of the Reorganization Inquiry for Participants
(``RIPS'') \6\ function for mandatory corporate action events,\7\ and
(2) make clarifying and technical changes, as more fully described
below.
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    \5\ Each term not otherwise defined herein has its respective
meaning as set forth in the Rules, By-Laws and Organization
Certificate of DTC (the ``Rules'') and the Reorganizations Service
Guide (``Reorganizations Guide''), available at http://www.dtcc.com/legal/rules-and-procedures.aspx.
    \6\ The RIPS function on the Participant Terminal System
(``PTS'') is the functional equivalent of the Reorganizations and
Redemptions function on the Participant Browser Service System
(``PBS''). The PBS Reorganizations and Redemptions function will be
retired concurrently with the RIPS function for mandatory
reorganizations events. PTS and PBS are user interfaces for DTC's
settlement and asset services functions. PTS is mainframe-based and
PBS is web-based with a mainframe back-end. Participants may use
either PTS or PBS, as they are functionally equivalent. References
to a particular PTS function in this rule filing include the
corresponding PBS function.
    \7\ RIPS will continue to be available for voluntary
reorganizations events. See Important Notice 13116-20 (August 3,
2020), available at https://www.dtcc.com/legal/important-notices.

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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend the
Reorganizations Guide to (1) establish November 16, 2020 as the date
for the retirement of the RIPS function for mandatory corporate action
events, and (2) make clarifying and technical changes, as more fully
described below.
(i) RIPS (Reorganization Inquiry for Participants) Retirement
    On May 21, 2019, DTC filed with the Commission a proposed rule
change to, among other things, update its corporate action service by
transitioning certain corporate action functions on PTS and PBS for the
processing of Reorganizations to the Corporate Action Web (``CA Web'')
\8\ system.\9\ The rule change provided that, at the conclusion of the
pilot test phase in Q2 of 2019, Reorganizations activity within the
ADJI (Adjustment Inquiries) function, the RIPS function for mandatory
reorganizations, and the SDAR Dept. C (Reorg/Redemptions/Dividend
Allocations) function would be retired from PTS/PBS and the equivalent
functionality would only be available on CA Web.
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    \8\ In PTS/PBS, corporate actions are announced using DTC
proprietary codes to signify event types. CA Web replaces DTC's
proprietary codes with market standard language. For example, a cash
dividend payment that PTS/PBS identifies as a ``08'' function code
is identified in CA Web as a ``Cash Dividend'' event. Additionally,
CA Web incorporates the entire lifecycle of an event into one
platform with a unique corporate action identifier that follows the
event through its lifecycle. CA Web gives Participants the ability
to customize screen displays and offers flexible methods for event
search, neither of which is available in the PTS/PBS systems.
    \9\ See Securities Exchange Act Release No. 85986 (May 31,
2019), 84 FR 26466 (June 6, 2019) (SR-DTC-2019-003).
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    Subsequent to the May 21, 2019 rule filing, DTC had received
feedback from Participants indicating that they needed additional time
to test the parallel RIPS functionality on CA Web, the
``Reorganizations Announcements'' function. DTC postponed the
retirement of the RIPS function for mandatory corporate actions events
from PTS to an unspecified future date in order to provide Participants
with the additional time for testing.\10\
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    \10\ See Securities Exchange Act Release No. 86255 (July 1,
2019), 84 FR 32508 (July 8, 2019) (SR-DTC-2019-004).
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    DTC understands that the Participants have completed their testing.
Thus, pursuant to this proposed rule change, DTC would retire the RIPS
function for mandatory corporate actions events from PTS on November
16, 2020. In addition, DTC would amend the Reorganizations Guide to
reference the retirement and to remove references to RIPS for mandatory
corporate actions events.
(ii) Clarifying and Technical Changes
    Pursuant to the proposed rule change, DTC would make other
technical and clarifying changes to the Reorganizations Guide, as
described below.
1. ``Important Legal Information'' Section
    Pursuant to the proposed rule change, DTC would update the
copyright date from 2019 to 2020.
2. ``About Reorganization Services'' Section
    In the ``Preparing to Use the Services'' subsection, DTC is
proposing to remove the chart of PTS/PBS functions that were retired in
2019. These functions have since been replaced by CA Web functionality.
    In the ``How Reorganizations Work'' subsection, DTC is proposing to
delete ``Participant Terminal System (PTS) functions'' and
``Participant Browser Service (PBS)'' from the list of delivery
mechanism that DTC uses to provide Participants with information
pertaining to their entitlements. The PTS/PBS functions that had been
used for this purpose were retired.
    In the ``Associated PTS/PBS and CA Web Functions'' subsection, DTC
is proposing to delete the ART, POS, SDAR, ADJI rows from the table, as
these functions were retired in 2019.\11\ In addition, DTC is proposing
to delete the row for LENP, which was replaced by the Legal Notice
System (LENS).\12\ Further, pursuant to the proposed rule change, DTC
would delete the ``X'' in the Mand column for the RIPS row, to reflect
the retirement of RIPS for mandatory reorganizations. DTC would also
delete the ``X'' in the PXY column for RIPS because Proxy announcements
are not viewed in RIPS, but rather are viewed in PTS PXY and announced
in PTS PANS.
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    \11\ See Securities Exchange Act Release No. 85986 (May 31,
2019), 84 FR 26466 (June 6, 2019) (SR-DTC-2019-003).
    \12\ See Important Notice 6525-10 (March 31, 2010), supra note
7.
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3. ``Announcements'' Section
    In the ``How the Announcement Service Works'' subsection, DTC is
proposing to update the final sentence in the subsection to reflect
that announcement information is also delivered electronically via ISO
20022 messaging.
    In the ``How to View Mandatory and Voluntary Reorganization
Announcements'' subsection, DTC is proposing to amend the first
sentence and insert a footnote to reflect that, after the RIPS function
for mandatory reorganizations announcements is retired on November 16,
2020, the RIPS function would only be available for voluntary
reorganizations announcements.
4. ``Processing'' Section
    In the ``Mandatory Reorganizations'' subsection, in the ``Various
Types of Mandatory Reorganizations'' table, DTC is proposing to edit
the description for the Liquidation event by deleting ``securities and/
or.'' The reference to securities is incorrect because DTC does not
distribute securities under a Liquidation event type. Securities are
distributed under a plan of reorganization.
    In the ``Reorganization (RRG) Segregated Account'' subsection, for
consistency, DTC is proposing to move the sentence ``Contra-CUSIP
numbers are used to segregate your position (representing instructions
submitted) for voluntary offers and put bond options.'' to the ``About
Contra-CUSIPs'' subsection.
    In the ``About Contra-CUSIPs'' subsection, DTC is proposing to
streamline the description of contra-CUSIPs to enhance readability,
and, for accuracy, to update the description to reflect that a contra-
CUSIP contains the same first three digits of the issuer number
assigned to the subject security. Further, DTC is proposing to simplify
the description of a contra-CUSIP by removing text and examples that
address the specific numerical construction of a contra-CUSIP. In
addition to the three issuer digits, DTC generates the other digits of
a contra-CUSIP on the basis of multiple factors, including, but not
limited to, security characteristics, event types, and

currency. These other digits are used by DTC for internal tracking and
accounting purposes and are not intended to provide information to
Participants about the offer or event. The current language of the
Reorganizations Guide does not reflect the full scope of the DTC
process. In addition, because it is an internal DTC process for
internal DTC use, DTC believes that Participants do not need, and may
be confused by, information about how DTC generates the specific digits
in a contra-CUSIP.
5. ``Instructions/Expirations'' Section
    In the second paragraph of the ``Accepting an ATOP-Eligible Offer''
subsection, DTC is proposing to insert ``ISO 20022'' in the list of
interfaces through which a Participant can view a notice of a tender
offer.-
    In the ``Submitting a Protect for an ATOP-Eligible Offer''
subsection, DTC is proposing to insert additional language into the
Warning! paragraph to clarify that DTC will only accept cover of
protect instructions outside of PTS PTOP or PBS Voluntary Tenders and
Exchanges when the window for submitting instructions through PTS PTOP
or PBS Voluntary Tenders and Exchanges has closed, and only if the
Participant contacted the agent before the offer had actually expired.
If the offer expired prior to the Participant contacting the agent, any
agreements to handle the protect will be required to be completed
outside DTC. Further, DTC is proposing to clarify that if the
Participant contacts the agent before the actual expiration of the
offer and the agent agrees to accept an email submission directly, the
agent will notify DTC and the Participant should email a Protect
Submission Form to DTC. Once the communication from both the agent and
Participant has been received by DTC, with each having provided the
appropriate indemnification language, DTC will then input the protect
submission on behalf of the Participant.
    In the ``Submitting a Cover of Protect via PTS PTOP or PBS
Voluntary Tenders and Exchanges for an ATOP-Eligible Offer''
subsection, DTC is proposing to insert additional language into the
Warning! paragraph to clarify that DTC will not accept cover of protect
instructions outside of PTS PTOP or PBS Voluntary Tenders and Exchanges
(i) if the window for submitting instructions through PTS PTOP or PBS
Voluntary Tenders and Exchanges is still open, or (ii) if the original
protect was not accepted in PTS PTOP or PBS Voluntary Tenders and
Exchanges. In the paragraph below the Warning! paragraph, DTC is
proposing to insert ``ISO 20022 message'' in the lists of interfaces
through which a Participant can view the notice of a tender offer.
    In the ``Submitting a Cover of Protect via PTS PTOP or PBS
Voluntary Tenders and Exchanges on Behalf of Another Participant''
subsection, DTC is proposing to insert additional language into the
Warning! paragraph to clarify that in order for one Participant to
cover a protect on behalf of a second Participant, the second
Participant must have either (i) submitted its protect via PTS/PBS, or
(ii) submitted a protect to the agent via email that was subsequently
communicated to DTC and input into PTS PTOP by DTC.
    In the ``Procedures for Submitting Instructions Outside of PTS/
PBS''/''Submitting the Instruction'' subsection, in the fifth Warning!
paragraph, DTC is proposing to insert ``CA Web and ISO 20022 messages''
as interfaces through which a Participant can view information about a
tender offer.
2. Statutory Basis
    Section 17A(b)(3)(F) of the Act requires, inter alia, that the
Rules be designed to promote the prompt and accurate clearance and
settlement of securities transactions.\13\
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    \13\ 15 U.S.C. 78q-1(b)(3)(F).
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    DTC believes that the proposed rule change with respect to
establishing November 16, 2020 as the date for the retirement of the
RIPS function for mandatory corporate actions events is consistent with
Section 17(A)(b)(3)(F) of the Act referenced above. By requiring
Participants to utilize the more flexible and robust CA Web interface,
DTC would be promoting more efficient access to reorganization services
and a broader view of a reorganization event for Participants.
Therefore, DTC believes that the proposed rule change would promote the
prompt and accurate clearance and settlement of securities transactions
relating to mandatory corporate actions events, consistent with Section
17A(b)(3)(F) of the Act, cited above.
    DTC believes that the proposed rule change to amend the
Reorganizations Guide to make technical and clarifying changes is
consistent with Section 17(A)(b)(3)(F) of the Act referenced above
because it would enhance the clarity and transparency of the
Reorganizations Guide. By enhancing the clarity and transparency of the
Reorganizations Guide, the proposed rule change would allow
Participants to more efficiently and effectively conduct their business
in connection with processing reorganization events and settling
related securities transactions. Therefore, DTC believes that the
proposed rule change is designed to promote the prompt and accurate
clearance and settlement of securities transactions related to
Reorganizations, consistent with Section 17A(b)(3)(F) of the Act, cited
above.

(B) Clearing Agency's Statement on Burden on Competition

    DTC believes that the proposed rule change with respect to amending
the Reorganizations Guide to establish November 16, 2020 as the date
for the retirement of the RIPS function for mandatory corporate actions
events would not have any impact on competition. As discussed above,
DTC had originally postponed the retirement date to allow Participants
additional time to test the parallel functionality on CA Web. As
Participants' testing is now complete, the retirement of RIPS for
mandatory corporate actions, which applies to all Participants equally,
can proceed. Therefore, DTC believes that the proposed rule change with
respect to amending the Reorganizations Guide to establish November 16,
2020 as the date for the retirement of the RIPS function for mandatory
corporate actions events would not have any impact on competition.\14\
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    \14\ 15 U.S.C. 78q-1(b)(3)(I).
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    DTC believes that the proposed rule change to amend the
Reorganizations Guide to make technical and clarifying changes would
not have any impact on competition because it merely would enhance the
clarity and transparency of the Reorganizations Guide, and therefore
would not affect the rights and obligations of any party.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been
solicited or received. DTC will notify the Commission of any written
comments received by DTC.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) \15\ of the Act and paragraph (f) \16\ of Rule 19b-4
thereunder. 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.
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f).
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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-DTC-2020-013 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2020-013. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of DTC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). 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-DTC-2020-013 and should be submitted on
or before December 10, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-25502 Filed 11-18-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6415-6417]
[FR Doc No: 2022-02368]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2021-N-0807]

Medical Devices; Immunology and Microbiology Devices;
Classification of the System for Detection of Microorganisms and
Antimicrobial Resistance Using Reporter Expression

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the system for detection of microorganisms and antimicrobial resistance
using reporter expression into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the system for detection of
microorganisms and antimicrobial resistance using reporter expression's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective February 4, 2022. The classification was
applicable on December 5, 2019.

FOR FURTHER INFORMATION CONTACT: Tobin Hellyer, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3272, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the system for detection of
microorganisms and antimicrobial resistance using reporter expression
as class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation by placing the device into a lower device class than the
automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a

common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)s (see
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or premarket approval application to
market a substantially equivalent device (see 21 U.S.C. 360c(i),
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On March 19, 2019, FDA received Roche Molecular Systems, Inc.'s
request for De Novo classification of the cobas vivoDx MRSA. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 5, 2019, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
866.1655.\1\ We have named the generic type of device system for
detection of microorganisms and antimicrobial resistance using reporter
expression, and it is identified as an in vitro diagnostic device
intended for the detection and identification of live microorganisms
and the detection of associated antimicrobial drug susceptibility or
resistance in specimens from patients at risk of colonization or
suspected of infection.
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    \1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The 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.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

    Table 1--System for Detection of Microorganisms and Antimicrobial
   Resistance Using Reporter Expression Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Failure to use the device correctly....  Certain labeling information
                                          identified in special controls
                                          (b)(1) and (3), and Certain
                                          design verification and
                                          validation identified in
                                          special control (b)(4)(vii).
False positive or negative results.....  Certain labeling information
                                          identified in special controls
                                          (b)(1) and (3), Use of certain
                                          specimen collection and
                                          transport devices identified
                                          in special control (b)(2), and
                                          Certain design verification
                                          and validation identified in
                                          special control (b)(4).
Failure to interpret results correctly.  Certain labeling information
                                          identified in special controls
                                          (b)(1) and (3), and Certain
                                          design verification and
                                          validation identified in
                                          special control (b)(4)(vii).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget

(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The collections of information in the guidance document ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801 and 809 regarding labeling, have been
approved under OMB control number 0910-0485.

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, 21 CFR part
866 is 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.  866.1655 to subpart B to read as follows:

Sec.  866.1655  System for detection of microorganisms and
antimicrobial resistance using reporter expression.

    (a) Identification. A system for detection of microorganisms and
antimicrobial resistance using reporter expression is an in vitro
diagnostic device intended for the detection and identification of live
microorganisms and the detection of associated antimicrobial drug
susceptibility or resistance in specimens from patients at risk of
colonization or suspected of infection.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The intended use for the device in the labeling required under
Sec.  809.10 of this chapter must include a detailed description of the
targets the device detects, the type of results provided to the user,
the clinical indications appropriate for test use, and the specific
population(s) for which the device is intended.
    (2) Any device used for specimen collection and transport must be
FDA-cleared, approved, or -classified as 510(k) exempt (standalone or
as part of a test system) for the collection of the specimen types
claimed by this device and for the maintenance of viability of the
targeted microorganisms; alternatively, the specimen collection device
must be cleared in a premarket submission as a part of this device.
    (3) The labeling required under Sec.  809.10(b) of this chapter
must include:
    (i) A detailed description of the device, including reagents,
instruments, ancillary materials, applicable specimen collection and
transport device(s) and control elements, and a detailed explanation of
the methodology, including all pre-analytical methods for handling and
processing of specimens and controls to maintain organism viability;
    (ii) Detailed descriptions of the test procedure, including the
preparation and maintenance of quality controls and the interpretation
of test results;
    (iii) Detailed discussion of the performance characteristics of the
device for all claimed organisms and specimen types based on analytical
studies, including evaluation of analytical sensitivity, inclusivity,
cross-reactivity, potentially interfering substances and
microorganisms, contamination, specimen stability, precision, and
reproducibility;
    (iv) Detailed discussion of the performance characteristics of the
device observed in a clinical study performed on a population that is
consistent with the intended use population in comparison to the
results obtained by a reference or comparator method determined to be
acceptable by FDA, for microbial detection, identification, and
antimicrobial susceptibility testing; and
    (v) A limiting statement indicating that a negative test result
does not preclude colonization or infection with organisms that do not
express detectable levels of the reporter that is identified by the
device.
    (4) Design verification and validation must include:
    (i) A detailed description of the device, including an explanation
of the technology, hardware, software, and consumables, as well as an
explanation of the result algorithms and method(s) of data processing
from signal acquisition to result assignment;
    (ii) A detailed description of the impact of any software,
including software applications and hardware-based devices that
incorporate software, on the device's functions;
    (iii) Detailed documentation of the analytical and clinical studies
required in paragraphs (b)(3)(iii) and (iv) of this section, including
the study protocols containing descriptions of the test methods,
prescribed methods of data analysis and acceptance criteria, final
study reports, and data line listings;
    (iv) Detailed documentation of quality control procedures,
including an explanation of how quality control materials were
selected, the recommended frequency of testing, methods of control
preparation, acceptance criteria for performance and the results from
quality control testing performed during the analytical and clinical
studies required under paragraphs (b)(3)(iii) and (iv) of this section;
    (v) Detailed documentation of studies performed to establish
onboard and in-use reagent stability, including the test method(s),
data analysis plans, acceptance criteria, final study reports, and data
line listings;
    (vi) Detailed documentation of studies to establish reagent shelf-
life for the assay kit and each applicable specimen collection and
transport device, including study protocols containing descriptions of
the test method(s), data analysis plans, and acceptance criteria; and
    (vii) Documentation of an appropriate end user device training
program that will be offered as part of efforts to assure appropriate
conduct of the assay and to mitigate the risk associated with false
results, including failure to use the device correctly or correctly
interpret results.

    Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02368 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Page 45842]
[FR Doc No: 2017-20997]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-144-000.
    Applicants: Noble Americas Gas & Power Corp., Mercuria Energy
America, Inc.
    Description: Supplement to July 31, 2017 Joint Application for
Authorization under Section 203 of the Federal Power Act by Mercuria
Energy America, Inc.
    Filed Date: 9/22/17.
    Accession Number: 20170922-5179.
    Comments Due: 5 p.m. ET 9/27/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-2336-002.
    Applicants: Shoreham Solar Commons LLC.
    Description: Tariff Amendment: Second Supplement to Market-Based
Rate Application to be effective 11/22/2017.
    Filed Date: 9/22/17.
    Accession Number: 20170922-5165.
    Comments Due: 5 p.m. ET 10/13/17.

    Docket Numbers: ER17-2337-002.
    Applicants: Shoreham Solar Commons Holdings LLC.
    Description: Tariff Amendment: Second Supplement to Market-Based
Rate Application to be effective 11/22/2017.
    Filed Date: 9/22/17.
    Accession Number: 20170922-5166.
    Comments Due: 5 p.m. ET 10/13/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 25, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-20997 Filed 9-29-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Page 31347]
[FR Doc No: 2012-12706]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR12-17-000]

High Prairie Pipeline, LLC v. Enbridge Energy, Limited
Partnership; Notice of Complaint

    Take notice that on May 17, 2012, pursuant to section 206 of the
Rules of Practice and Procedure of the Federal Energy Regulatory
Commission (Commission), 18 CFR 385.206; section 13(1) of the
Interstate Commerce Act (ICA), 49 U.S.C. 13(1); and section 343.2(c)(3)
of the Commission's Procedural Rules Applicable to Oil Pipeline
Proceedings, High Prairie Pipeline, LLC (Complainant) filed a formal
complaint against Enbridge Energy, Limited Partnership (Respondent) for
violations of sections 3(6), 1(6), 6(1), 1(4) and 6(7) of the ICA and
sections 341.0 and 341.8 of the Commission's regulations.
    The Complainant states that a copy of the Complaint has been served
on the contact for the Respondent as listed on the Commission list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on June 6, 2012.

    Dated: May 18, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-12706 Filed 5-24-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Notices]
[Pages 7866-7867]
[FR Doc No: 2021-02154]

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

[FRL-10019-95-OP]

Notification of Request for Nominations to the National
Environmental Justice Advisory Council

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for Nominations to the National Environmental Justice
Advisory Council (NEJAC).

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) invites
nominations from a diverse range of qualified candidates to be
considered for appointment to its National Environmental Justice
Advisory Council (NEJAC). The NEJAC was chartered to provide advice
regarding broad, cross-cutting issues related to environmental justice.
This notice solicits nominations to fill approximately seven (7) new
vacancies for terms through September 2022. To maintain the
representation outlined by the charter, nominees will be selected to
represent: Academia (1 vacancy); community-based organizations (2
vacancies); non-governmental organizations (1 vacancy); state and local
governments (2 vacancies); and tribal governments and indigenous
organizations (1 vacancy). We are interested in adding members located
in EPA regions 1, 2, 7, 8, 9, 10. Vacancies are anticipated to be
filled by September 2021. Sources in addition to this Federal Register
Notice will be utilized in the solicitation of nominees.

DATES: Nominations should be submitted in time to arrive no later than
Wednesday, March 24, 2021.

ADDRESSES: Submit nominations electronically with the subject line
NEJAC Membership 2021 to<EMAIL_ADDRESS>The Office of Environmental
Justice will acknowledge receipt of nominations.

FOR FURTHER INFORMATION CONTACT: Karen L. Martin, NEJAC Designated
Federal Officer, U.S. EPA; email<EMAIL_ADDRESS>telephone: (202) 564-
0203.

SUPPLEMENTARY INFORMATION: The NEJAC is a federal advisory committee
chartered under the Federal Advisory Committee Act (FACA), Public Law
92-463. EPA established the NEJAC in 1993 to provide independent
consensus advice to the EPA Administrator about a broad range of
environmental issues related to environmental justice. The NEJAC
conducts business in accordance with the Federal Advisory Committee Act
(FACA) (5 U.S.C. App. 2) and related regulations.

    The Council consists of 30 members (including a Chairperson and two
Vice-Chairpersons) appointed by EPA's Administrator. Members serve as
non-federal stakeholders representing: Six (6) from academia, four (4)
from business and industry; seven (7) from community based
organizations; six (6) from non-governmental/environmental
organizations; four (4) from state and local governments; and three (3)
from tribal governments and indigenous organizations, of which one
member serves as a liaison to the National Tribal Caucus. Members are
appointed for one (1); two (2) or three (3)-year terms with the
possibility of reappointment for another term.
    The NEJAC usually meets face-to-face twice a year, generally in the
Spring and the Fall. Additionally, members may be asked to participate
in teleconference meetings or serve on work groups to develop
recommendations, advice letters, and reports to address specific policy
issues. The average workload for members is approximately 5 to 8 hours
per month. EPA provides reimbursement for travel and other incidental
expenses associated with official government business.
    Nominations: Any interested person and/or organization may nominate
qualified individuals for membership. Individuals are encouraged to
self-nominate. The EPA values and welcomes diversity. In an effort to
obtain nominations of diverse candidates, the Agency encourages
nominations of women and men of all racial and ethnic groups from all
geographic locations of the United States of America. All nominations
will be fully considered, but applicants need to be aware of the
specific representation sought as outlined in the summary above. In
addition, EPA is seeking nominees with knowledge in youth perspectives
and youth development; environmental measures; public health/health
disparities; water infrastructure and other water concerns; farmworkers
and pesticides; community sustainability and resiliency; green jobs and
green infrastructure; land use and equitable development; and emerging
inclusion of sub-populations such as the homeless, veterans, prisoners,
etc.
    Other criteria used to evaluate nominees will include:
     The background and experience that would help members
contribute to the diversity of perspectives on the committee (e.g.,
geographic, economic, social, cultural, educational background,
professional affiliations, and other considerations;
     demonstrated experience with environmental justice and
community sustainability issues at the national, state, or local level;
     excellent interpersonal and consensus-building skills;
     ability to volunteer time to attend meetings 2-3 times a
year, participate in teleconference meetings, attend listening sessions
with the Administrator or other senior-level officials, develop policy
recommendations to the Administrator, and prepare reports and advice
letters; and
     willingness to commit time to the committee and
demonstrated ability to work constructively and effectively on
committees.
    How To Submit Nominations: Any interested person or organization
may nominate qualified persons to be considered for appointment to this
advisory committee. Individuals are encouraged to self-nominate.
Nominations will be submitted in electronic format following the
template available at https://www.epa.gov/environmentaljustice/nominations-nejac. To be considered, all nominations should include:
     Current contact information for the nominee/applicant,
including the nominee's/applicant's name, organization (and position
within that organization), current business address, email address,
telephone numbers and the stakeholder category position you are
interested in.
     Brief Statement describing the nominee's/applicant's
interest in serving on the NEJAC.
     R[eacute]sum[eacute] and a short biography describing the
professional and educational qualifications of the nominee, including a
list of relevant activities, and any current or previous service on
advisory committees.
     Brief statements describing experience as it relates to
engaging affected communities, understanding environmental justice/
relevant issues, consensus building, communication skills and
availability.
     Letter[s] of recommendation from a third party supporting
the nomination. Letter[s] should describe how the nominee's experience
and knowledge will bring value to the work of the NEJAC.

Matthew Tejada,
Director Office of Environmental Justice.
[FR Doc. 2021-02154 Filed 2-1-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Page 64140]
[FR Doc No: 2020-22448]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-3037-000]

Vopak Industrial Infrastructure Americas; St. Charles, LLC;
Supplemental Notice That Initial Market-Based Rate Filing Includes
Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Vopak Industrial Infrastructure Americas St. Charles, LLC's application
for market-based rate authority, with an accompanying rate tariff,
noting that such application includes a request for blanket
authorization, under 18 CFR part 34, of future issuances of securities
and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 26, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: October 5, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-22448 Filed 10-8-20; 8:45 am]
BILLING CODE 6717-01-P


EO12866 Interagency Review Briefings on the Draft Final Emission Standards and RIA for New and Modified Sources in the Oil and Natural Gas Sector
List of Attachments
 EO 12866 Oil and Gas NSPS Interagency Review Introductory Briefing, April 6, 2016.
 EO 12866 Oil and Gas NSPS Regulatory Impacts Analysis Interagency Review Introductory Briefing, April 7, 2016.


[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Page 57422]
[FR Doc No: 2021-22517]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1388-081]

Southern California Edison; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 1388-081.
    c. Dated Filed: August 12, 2021.
    d. Submitted By: Southern California Edison.
    e. Name of Project: Lee Vining Hydroelectric Project.
    f. Location: Approximately 9 miles upstream of Mono Lake and the
Town of Lee Vining, in Mono County, California. The project occupies
land within the Inyo National Forest administered by the U.S. Forest
Service.
    g. Filed Pursuant to: 18 CFR 5.5 of the Commission's regulations.
    h. Applicant Contact: Matthew Woodhall, Relicensing Project
Manager, Southern California Edison, Southern California Edison Company
1515 Walnut Grove Avenue, Rosemead, CA 91770,<PHONE_NUMBER>,
[email protected].
    i. FERC Contact: Kelly Wolcott at<PHONE_NUMBER> or
[email protected].
    j. Southern California Edison (SCE) filed its request to use the
Traditional Licensing Process on August 12, 2021. YCWA provided public
notice of its request on September 7, 2021. In a letter dated October
8, 2021, the Director of the Division of Hydropower Licensing approved
YCWA's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the California State Historic Preservation Officer,
as required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating SCE as the Commission's
non-federal representative for carrying out informal consultation,
pursuant to section 7 of the Endangered Species Act and section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act; and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. SCE filed a Pre-Application Document (PAD; including a proposed
process plan and schedule) with the Commission, pursuant to 18 CFR 5.6
of the Commission's regulations.
    n. A copy of the PAD may be viewed on the Commission's website
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. At this time, the Commission has suspended access
to the Commission's Public Reference Room, due to the proclamation
declaring a National Emergency concerning the Novel Coronavirus Disease
(COVID-19), issued by the President on March 13, 2020. For assistance,
contact FERC Online Support at [email protected], (866) 208-
3676 (toll free), or<PHONE_NUMBER> (TTY).
    o. The applicant states its unequivocal intent to submit an
application for a new license for Project No.1388-081. Pursuant to 18
CFR 16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by January 31,
2024.
    p. Register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: October 8, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-22517 Filed 10-14-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Notices]
[Page 53312-53313]
[DOCID:fr16oc09-147]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Bird/Other Wildlife Strike Report

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. Wildlife strike data are collected to develop
standards and monitor hazards to aviation.

DATES: Please submit comments by December 15, 2009.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Bird/Other Wildlife Strike Report.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0045.
    Form(s): 5200-7.
    Affected Public: A total of 7,133 respondents.
    Frequency: The information is collected on occasion.

    Estimated Average Burden per Response: Approximately 5 minutes per
response.
    Estimated Annual Burden Hours: An estimated 592 hours annually.
    Abstract: Wildlife strike data are collected to develop standards
and monitor hazards to aviation. Data identify wildlife strike control
requirements and provide in service data on aircraft component failure.
The FAA form 5200-7, Bird/Other Wildlife Strike Report, is most often
completed by the pilot-in-charge of an aircraft involved in a wildlife
collision or by Air Traffic Control Tower personnel, or other airline
or airport personnel who have knowledge of the incident.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility the accuracy of the Department's estimates of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on October 8, 2009.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E9-24755 Filed 10-15-09; 8:45 am]

BILLING CODE 4910-13-M