[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68493-68495]
[FR Doc No: 2016-23904]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78964; File No. SR-BatsBZX-2016-59]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Update
BZX Rules 21.1, 21.7 and 21.9 To Align the Exchange's Rules and
Functionality Applicable to the Exchange's Options Platform, BZX
Options, With the Exchange's Affiliated Options Platform, EDGX Options,
Which Is Operated by Bats EDGX Exchange, Inc.

September 28, 2016.
    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 September 19, 2016, Bats BZX Exchange, Inc. (the ``Exchange''
or ``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. 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)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to update Rules 21.1, 21.7 and 21.9
to align the Exchange's rules and functionality applicable to the
Exchange's options platform (``BZX Options'') with the Exchange's
affiliated options platform (``EDGX Options''), which is operated by
Bats EDGX Exchange, Inc. (``EDGX''). The Exchange has designated this
proposal as a non-controversial filing and requests that the Commission
waive the 30-day operative delay contained in Rule 19b-4(f)(6)(iii)
under the Act.\5\ If such waiver is granted by the Commission, the
Exchange shall implement this rule proposal immediately.
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    \5\ 17 CFR 240.19b-4(f)(6)(iii).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to make two changes to the Exchange's rules
and functionality applicable to the BZX Options as described below. The
changes are being proposed in order to allow the Exchange to conform
certain

functionality between BZX Options and EDGX Options.
    First, the Exchange proposes to eliminate ``WAIT'' orders, which
are orders that that when entered into the System,\6\ the order is held
for one second without processing for potential display and/or
execution. After one second, an order designated as ``WAIT'' is
processed for potential display and/or execution in accordance with all
order entry instructions as determined by the entering party. WAIT
orders were originally adopted by the Exchange based on similar
functionality available on other options exchanges and were intended to
enhance compliance with the order exposure requirement set forth in
Rule 22.12 (Order Exposure Requirements). Rule 22.12 prohibits Options
Members \7\ from executing as principal on BZX Options orders they
represent as agent unless (i) agency orders are first exposed on BZX
Options for at least one (1) second or (ii) the Options Member has been
bidding or offering on BZX Options for at least one (1) second prior to
receiving an agency order that is executable against such bid or offer
(the ``Order Exposure Rule'').
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    \6\ Exchange Rule 16.1(a)(59) defines ``System'' as ``the
automated trading system used by BZX Options for the trading of
options contracts.''
    \7\ An Options Member is defined as ``a firm, or organization
that is registered with the Exchange pursuant to Chapter XVII of
these Rules for purposes of participating in options trading on BZX
Options as an `Options Order Entry Firm' or `Options Market
Maker.''' See Exchange Rule 16.1(a)(38).
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    Although the Order Exposure Rule still applies on BZX Options and
the Exchange is not proposing any changes to such rule in connection
with this proposal, Options Members have other means to comply with the
Rule, including programming their own systems to comply, and very
rarely use orders with a time-in-force of WAIT. Further, such orders
are not offered by EDGX Options. Accordingly, the Exchange proposes to
stop offering WAIT orders on BZX Options and to eliminate reference to
such orders from Rule 21.1 (Definitions). In connection with this
change, the Exchange proposes to remove reference to WAIT orders from
the Exchange's rule regarding the opening procedures on the Exchange,
Rule 21.7 (Market Opening Procedures).
    Second, the Exchange proposes to modify the ``Aggressive'' Re-Route
instruction contained in Exchange Rule 21.9 (Order Routing) to align
the operation of such functionality with that offered by EDGX Options.
Under the current Aggressive Re-Route instruction on BZX Options, set
forth in Rule 21.9(a)(3)(A), to the extent the unfilled balance of a
routable order has been posted to the BZX Options Book pursuant to
paragraph (a)(2), should the order subsequently be locked or crossed by
another accessible options exchange, the System shall route the order
to the locking or crossing options exchange if the User \8\ has
selected the Aggressive Re-Route instruction. In contrast, on EDGX
Options, the Aggressive Re-Route instruction routes an order posted to
EDGX Options only if such order is subsequently crossed by another
accessible options exchange. The Exchange proposes to modify the
Aggressive Re-Route instruction to mirror the behavior offered on EDGX
Options such that an order posted to BZX Options that has been flagged
with the Aggressive Re-Route instruction will only be routed away to
the extent such order is subsequently crossed by another accessible
options exchange.
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    \8\ A User is defined as ``any Options Member or Sponsored
Participant who is authorized to obtain access to the System
pursuant to Rule 11.3 (Access).'' See Exchange Rule 16.1(a)(63).
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    Although the Exchange intentionally offers certain features that
differ from those offered by EDGX Options and will continue to do so,
the Exchange believes that offering similar functionality on both EDGX
Options and BZX Options to the extent practicable will reduce potential
confusion for Users.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \9\ in general, and furthers the objectives of Section
6(b)(5) of the Act \10\ 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.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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    Consistent rules and functionality between the Exchange and EDGX
will reduce complexity and help avoid potential confusion by the Users
of the Exchange that are also participants on EDGX. The Exchange again
notes that WAIT orders are very rarely used by Users of BZX Options and
that such orders are not offered by EDGX Options. Like WAIT orders, the
Aggressive Re-Route instruction is very rarely used. The Exchange also
notes that the proposed changes to the Aggressive Re-Route instruction
are based on EDGX rules and will result in consistent functionality
between BZX Options and EDGX Options.
    Also, with respect to the current implementation of Aggressive and
Super Aggressive functionality, the Exchange notes that this
implementation is due to a change previously made to the functionality
that was primarily made by the Exchange in order to keep functionality
consistent on BZX Options with the Exchange's equity securities
platform (``BZX Equities'').\11\ Although as implemented on BZX
Equities both Aggressive and Super Aggressive Re-Route functionality
re-routes if an order is locked or crossed, there are other differences
between the two features make the Super Aggressive option more
aggressive. These differences, however, are not applicable to BZX
Options and therefore Aggressive and Super Aggressive are redundant
options. The proposed change will again make the Aggressive feature
less aggressive than Super Aggressive, such that an order marked for
Aggressive Re-Route will re-route an order only such order is crossed.
A User who wishes to achieve the current Aggressive functionality to
have the Exchange re-route an order if it is locked or crossed can
instead select the Super Aggressive instruction.
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    \11\ See Securities Exchange Act Release No. 76623 (December 11,
2015), 80 FR 78800 (December 17, 2015) (SR-BATS-2015-112) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Rules 11.13(b)(4)(A) and 21.9(a)(3)(A), Amending Aggressive Re-Route
Instruction).
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    The Exchange believes the proposed amendment will reduce complexity
and increase the understanding of the Exchange's operations for all
Users of the Exchange. As such, the proposed rule change would foster
cooperation and coordination with persons engaged in facilitating
transactions in securities and would remove impediments to and perfect
the mechanism of a free and open market and a national market system.
The proposed rule changes do not propose to implement new or unique
functionality that has not been previously filed with the Commission or
is not available on EDGX Options already.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange notes that the
proposal will further promote consistency between the Exchange and
EDGX, thereby reducing complexity and avoiding potential confusion by
Users of the Exchange that are also participants on EDGX. The Exchange
does not believe that either of the proposed changes will have any
direct impact on competition.

Thus, the Exchange does not believe that the proposal creates any
significant impact on competition.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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 \12\ and Rule 19b-4(f)(6) thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 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.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \14\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \15\ 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
the proposal may become operative immediately upon filing. The Exchange
states that waiver of the 30-day operative delay would allow the
Exchange to immediately provide functionality that is consistent with
functionality provided by EDGX, thereby reducing complexity and
avoiding potential confusion. The Commission believes the waiver of the
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the operative
delay and designates the proposal operative upon filing.\16\
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ 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).
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    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 change 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_ADDRESS>Please include
File No. SR-BatsBZX-2016-59 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-BatsBZX-2016-59. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BatsBZX-2016-59, and should be
submitted on or before October 25, 2016.

    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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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-23904 Filed 10-3-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Rules and Regulations]
[Page 31608]
[FR Doc No: 2023-10606]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. FDA-2000-P-0126 (formerly Docket No. 2000P-0658)]

International Dairy Foods Association: Response to the Objections
and Requests for a Public Hearing on the Final Rule To Revoke the
Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard
for Yogurt; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; response to objections and denial of public
hearing requests; removal of administrative stay; final amendment;
correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a
final order that appeared in the Federal Register on April 14, 2023.
The document responded to objections and requests for a public hearing
on the final rule to revoke the standards for lowfat yogurt and nonfat
yogurt and amend the standard for yogurt. The final order published
with an inadvertent error. This document corrects that error.

DATES: Effective May 18, 2023.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>, or Holli Kubicki,
Center for Food Safety and Applied Nutrition, Office of Regulations and
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of April 14, 2023 (88 FR 22907), in FR Doc.
2023-07723, the following correction is made:
    On page 22908, in the first column, under DATES, the compliance
date is corrected to read: ``January 1, 2024''.

    Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10606 Filed 5-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13169-13170]
[FR Doc No: 2020-04630]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0987]

Policy for Diagnostics Testing in Laboratories Certified To
Perform High Complexity Testing Under the Clinical Laboratory
Improvement Amendments Prior to Emergency Use Authorization for
Coronavirus Disease-2019 During the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Policy for Diagnostics
Testing in Laboratories Certified to Perform High Complexity Testing
under CLIA prior to Emergency Use Authorization for Coronavirus
Disease-2019 during the Public Health Emergency.'' On February 4, 2020,
the Secretary of Health and Human Services (HHS) determined that there
is a public health emergency and that circumstances exist justifying
the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid
detection of Coronavirus Disease-2019 (COVID-19) cases in the United
States requires wide availability of diagnostic testing to control the
emergence of this rapidly spreading, severe illness. This guidance
describes a policy regarding laboratories using tests they develop and
validate before FDA has issued an Emergency Use Authorization (EUA) for
their test in order to achieve more rapid testing capacity in the
United States. The guidance document is immediately in effect, but it
remains subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on March 6, 2020. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0987 for ``Policy for Diagnostics Testing in Laboratories
Certified to Perform High Complexity Testing under CLIA prior to
Emergency Use Authorization for Coronavirus Disease-2019 during the
Public Health Emergency.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) 21 CFR 10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Policy for Diagnostics Testing in Laboratories Certified to Perform
High Complexity Testing under CLIA prior to Emergency Use Authorization
for Coronavirus Disease-2019 during the Public Health Emergency'' to
the Office of Policy, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Brittany Goldberg, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire

Ave., Bldg. 66, Rm. 3108, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Policy
for Diagnostics Testing in Laboratories Certified to Perform High
Complexity Testing under CLIA prior to Emergency Use Authorization for
Coronavirus Disease-2019 during the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories and Food and
Drug Administration Staff.'' On February 4, 2020, the Secretary of HHS
determined that there is a public health emergency and that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostics for detection and/or diagnosis of the novel
coronavirus (2019-nCoV).\1\ Rapid detection of COVID-19 cases in the
United States requires wide availability of diagnostic testing to
control the emergence of this rapidly spreading, severe illness. This
guidance describes a policy regarding laboratories using tests they
develop and validate before FDA has issued an EUA for their test in
order to achieve more rapid testing capacity in the United States.
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    \1\ https://www.fda.gov/media/135010/download.
---------------------------------------------------------------------------

    In light of this public health emergency, FDA has determined that
prior public participation for this guidance is not feasible or
appropriate and is issuing this guidance without prior public comment
(see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec.  10.115(g)(2)). Although this
guidance is immediately in effect, FDA will consider all comments
received and revise the guidance document as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). The guidance represents the
current thinking of FDA on ``Policy for Diagnostics Testing in
Laboratories Certified to Perform High Complexity Testing under CLIA
prior to Emergency Use Authorization for Coronavirus Disease-2019
during the Public Health Emergency.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Policy for
Diagnostics Testing in Laboratories Certified to Perform High
Complexity Testing under CLIA prior to Emergency Use Authorization for
Coronavirus Disease-2019 during the Public Health Emergency;
Immediately in Effect Guidance for Clinical Laboratories and Food and
Drug Administration Staff'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 20010 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. 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 collection of information for
``Emergency Use Authorization of Medical Products and Related
Authorities Guidance for Industry and Other Stakeholders'' has been
approved under OMB control number 0910-0595.

    Dated: March 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04630 Filed 3-5-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 171 (Friday, September 2, 2011)]
[Notices]
[Page 54814]
[FR Doc No: 2011-22574]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 30b2-1, SEC File No. 270-213, OMB Control No. 3235-0220.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit the existing collection of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Rule 30b2-1 (17 CFR 270.30b2-1) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) (the ``Investment Company Act'')
requires a registered investment company (``fund'') to (1) File a
report with the Commission on Form N-CSR (17 CFR 249.331 and 274.128)
not later than 10 days after the transmission of any report required to
be transmitted to shareholders under rule 30e-1 under the Investment
Company Act, and (2) file with the Commission a copy of every periodic
or interim report or similar communication containing financial
statements that is transmitted by or on behalf of such fund to any
class of such fund's security holders and that is not required to be
filed with the Commission under (1), not later than 10 days after the
transmission to security holders. The purpose of the collection of
information required by rule 30b2-1 is to meet the disclosure
requirements of the Investment Company Act and certification
requirements of the Sarbanes-Oxley Act of 2002 (Pub. L. 107-204, 116
Stat. 745 (2002)), and to provide investors with information necessary
to evaluate an interest in the fund.
    The Commission estimates that there are 2,520 funds, with a total
of 9,250 portfolios, that are governed by the rule. For purposes of
this analysis, the burden associated with the requirements of rule
30b2-1 has been included in the collection of information requirements
of rule 30e-1 and Form N-CSR, rather than the rule. The Commission has,
however, requested a one hour burden for administrative purposes.
    The collection of information under rule 30b2-1 is mandatory. The
information provided under rule 30b2-1 is not kept confidential. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas A. Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
e-mail to<EMAIL_ADDRESS>
    Dated: August 29, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-22574 Filed 9-1-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Page 5101]
[FR Doc No: 2015-01746]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP15-285-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Penalty Revenue Crediting Report of Columbia Gas
Transmission, LLC under RP15-285.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5202.
    Comments Due: 5 p.m. ET 1/26/15.

    Docket Numbers: RP15-286-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Penalty Revenue Crediting Report of Columbia Gulf
Transmission, LLC under RP15-286.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5203.
    Comments Due: 5 p.m. ET 1/26/15.

    Docket Numbers: RP15-287-000.
    Applicants: Crossroads Pipeline Company.
    Description: Penalty Revenue Crediting Report of Crossroads
Pipeline Company under RP15-287.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5205.
    Comments Due: 5 p.m. ET 1/26/15.

    Docket Numbers: RP15-288-000.
    Applicants: Central Kentucky Transmission Company.
    Description: Penalty Revenue Crediting Report of Central Kentucky
Transmission Company under RP15-288.
    Filed Date: 12/29/14.
    Accession Number: 20141229-5208.
    Comments Due: 5 p.m. ET 1/26/15.

    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 date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP15-176-001.
    Applicants: Discovery Gas Transmission LLC.
    Description: Compliance filing per 154.203: Second Compliance
Filing To Remove Costs From Rates to be effective 2/1/2015.
    Filed Date: 1/21/15.
    Accession Number: 20150121-5131.
    Comments Due: 5 p.m. ET 2/2/15.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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: January 22, 2015.
Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2015-01746 Filed 1-29-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 70078-70079]
[FR Doc No: 2015-28714]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2015-0221]

60-Day Notice of Request for Renewal of a Previously Approved
Collection

AGENCY: Office of the Secretary (OST), Department of Transportation
(Department) or (DOT).

ACTION: Notice and requests for comments.

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

SUMMARY: The OSDBU invites public comments about our intention to
request the Office of Management and Budget's (OMB) approval to renew
an information collection. The collection involves the following form
with an expiration date of 2/29/2016, and is presently in use.

DATES: Please submit comments by January 12, 2016.

ADDRESSES: You may submit comments [identified by Docket No. DOT-OST-
2015-0221] through one of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax:<PHONE_NUMBER>.
     Mail or Hand Delivery: U.S. Department of Transportation,
Dockets Management Facility, 1200 New Jersey Avenue SE., West Building,
Room W12-140, Washington, DC 20590.
     Agency Web site: http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Michelle Harris,<PHONE_NUMBER> ext.
62253, Office of Small and Disadvantaged Business Utilization, Office
ofthe Secretary, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Room W56-444, Washington, DC 20590. Office hours are from
9:00 a.m. to 5:00p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:
    Title: SBTRC Regional Field Offices Intake Form (DOT F 4500).
    OMB Control Number: 2105-0554.
    Background: In accordance with Public Law 95-507, an amendment to
the Small Business Act and the Small Business Investment Act of 1953,
OSDBU is responsible for the implementation and execution of DOT
activities on behalf of small businesses, in accordance with Section 8,
15 and 31 of the Small Business Act (SBA), as amended. The Office of
Small and Disadvantaged Business Utilization also administers the
provisions of Title 49, of the United States Cole, Section 332, the
Minority Resource Center (MRC) which includes the duties of advocacy,
outreach, and financial services on behalf of small and disadvantaged
businesses and those certified under CFR 49 parts 23 and or 26 as
Disadvantaged Business Enterprises (DBE).
    SBTRC's Regional Field Offices will collect information on small
businesses, which includes Disadvantaged Business Enterprise (DBE),
Women-Owned Small Business (WOB), Small Disadvantaged Business (SDB),
8(a), Service Disabled Veteran Owned Business (SDVOB), Veteran Owned
Small Business (VOSB), HubZone, and types of services they seek from
the Regional Field Offices. Services and responsibilities of the Field
Offices include business analysis, general management & technical
assistance and training, business counseling, outreach services/

conference participation, short-term loan and bond assistance. The
cumulative data collected will be analyzed by the OSDBU to determine
the effectiveness of services provided, including counseling, outreach,
and financial services. Such data will also be analyzed by the OSDBU to
determine agency effectiveness in assisting small businesses to enhance
their opportunities to participate in government contracts and
subcontracts.
    We are required to publish this notice in the Federal Register by
the Paperwork Reduction Act of 1995, Public Law 104-13.
    Title: Small Business Transportation Resource Center Regional Field
Office Intake Form (DOT F 4500).
    Form Numbers: DOT F 4500.
    Type of Review: Renewal of an information collection.
    The Regional Field Offices Intake Form, (DOT F 4500) is used to
enroll small business clients into the program in order to create a
viable database of firms that can participate in government contracts
and subcontracts, especially those projects that are transportation
related. Each area on the fillable pdf form must be filled in
electronically by the Field Offices and submitted every quarter to
OSDBU. The Offices will retain a copy of each Intake Form for their
records. The completion of the form is used as a tool for making
decisions about the needs of the business, such as; referral to
technical assistance agencies for help, identifying the type of
profession or trade of the business, the type of certification that the
business holds, length of time in business, and location of the firm.
This data can assist the Field Offices in developing a business plan or
adjusting their business plan to increase its ability to market its
goods and services to buyers and potential users of their services.
    Respondents: SBTRC Regional Field Offices.
    Estimated Number of Respondents: 100.
    Frequency: The information will be collected quarterly.
    Estimated Number of Responses: 100.
    Estimated Total Annual Burden on Respondents: 600 hours per year.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) 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; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information collection;
and (d) ways to minimize the burden of the collection of information on
respondents, by the use of electronic means, including the use of
automated collection techniques or other forms of information
technology. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on November 5, 2015.
Michelle Harris,
Manager, Regional Assistance Division, Office of Small and
Disadvantaged, Business Utilization.
[FR Doc. 2015-28714 Filed 11-10-15; 8:45 am]
 BILLING CODE 4910-9X-P