[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24076-24078]
[FR Doc No: 2011-10447]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64341; File No. SR-FINRA-2011-017]

 Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend
FINRA Rule 5131 (New Issue Allocations and Distributions)

April 26, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 18, 2011, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared substantially by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 5131 (New Issue Allocations
and Distributions) to simplify the spinning provision and to delay the
implementation date of paragraphs (b) and (d)(4).
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    On November 29, 2010, FINRA issued Regulatory Notice 10-60
announcing

Commission approval of SR-NASD-2003-140 \3\ and designating the
effective date of new Rule 5131 (the ``Rule'') as May 27, 2011.\4\
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    \3\ See Securities Exchange Act Release No. 63010 (September 29,
2010), 75 FR 61541 (October 5, 2010) (Order Approving File No. SR-
NASD-2003-140).
    \4\ See Regulatory Notice 10-60 (November 2010) (Approval of New
Issue Rule).
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A. Spinning

    Paragraph (b) of the Rule (Spinning), implements a recommendation
from the IPO Advisory Committee Report \5\ to prohibit spinning--i.e.,
an underwriter's allocation of IPO shares to directors or executives of
investment banking clients in exchange for receipt of investment
banking business. The primary means by which the Rule prohibits
spinning is through a series of prophylactic prohibitions on the
allocation of new issues. Specifically, the Rule prohibits allocations
of a new issue to any account in which an executive officer or director
of a public company or a covered non-public company, or a person
materially supported by such executive officer or director, has a
beneficial interest: (A) If the company is currently an investment
banking services client of the member or the member has received
compensation from the company for investment banking services in the
past 12 months; (B) if the person responsible for making the allocation
decision knows or has reason to know that the member intends to
provide, or expects to be retained by the company for, investment
banking services within the next 3 months; or (C) on the express or
implied condition that such executive officer or director, on behalf of
the company, will retain the member for the performance of future
investment banking services.
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    \5\ NYSE/NASD IPO Advisory Committee Report and Recommendations
(May 2003). http://www.finra.org/web/groups/industry/@ip/<EMAIL_ADDRESS>---------------------------------------------------------------------------

    Paragraph (b)(1) requires that members establish, maintain and
enforce policies and procedures reasonably designed to ensure that
investment banking personnel have no involvement or influence, directly
or indirectly, in the new issue allocation decisions of the member.
However, because the term ``investment banking personnel'' is not
defined in the Rule, members have raised concern that, if the term is
read co-extensively with the definition of ``investment banking
services,'' certain necessary functions traditionally performed by
syndicate personnel would be prohibited. In light of this unintended
consequence, FINRA is proposing to delete paragraph (b)(1). FINRA
believes that benefits of the anti-spinning provisions can be attained
without this particular provision inasmuch as firms currently are
required to have written policies and procedures with respect to the
spinning prohibitions in paragraph (b)(2) pursuant to NASD Rule 3010.
    In addition, upon further discussions with member firms regarding
the steps necessary to prepare for compliance with the spinning
provisions,\6\ FINRA proposes to delay the implementation date of
paragraph (b), as amended, until September 26, 2011.
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    \6\ For example, members have requested additional time to: (1)
Create additional forms, account documents and other measures of
obtaining information from clients necessary to assess eligibility
for new issue allocations under the new Rule; (2) build systems and
surveillance infrastructure to ensure appropriate blocks of
allocations; and (3) develop appropriate compliance policies and
procedures and training materials on the new policies and
procedures.
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B. Market Orders

    Paragraph (d)(4) of the Rule (Market Orders) prohibits members from
accepting any market order for the purchase of shares of a new issue in
the secondary market prior to the commencement of trading of such
shares in the secondary market. Members have requested additional time
to develop a process for reliably identifying new issues and to modify
their order handling systems to prevent the acceptance of market orders
in new issue shares in contravention of the Rule. FINRA believes the
Rule must carefully balance the investor protection concerns with needs
of issuers in capital formation and market participants in price
discovery. Accordingly, FINRA proposes to delay the implementation date
of paragraph (d)(4) until September 26, 2011.
    The effective date of the proposed rule change will be the date of
Commission approval. However, FINRA also is proposing to delay the
implementation date of paragraphs (b) and (d)(4) until September 26,
2011.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Exchange Act,\7\ which requires,
among other things, that FINRA rules must be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, and, in general, to protect investors
and the public interest. FINRA believes the proposed rule change
simplifies member obligations with respect to Rule 5131, thereby aiding
member compliance efforts and helping to maintain investor confidence
in the capital markets.
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    \7\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.
    The Commission is considering granting accelerated approval of the
proposed rule change at the end of a 15-day comment period.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-017 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-017. This
file number should be included on the

subject line if e-mail 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 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 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of FINRA. 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 Number
SR-FINRA-2011-017 and should be submitted on or before May 16, 2011.
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    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-10447 Filed 4-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 11, 2007 (Volume 72, Number 69)]
[Notices]
[Page 18223]
[DOCID:fr11ap07-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP99-301-154]

ANR Pipeline Company; Notice of Negotiated Rate Filing

April 5, 2007.
    Take notice that on April 2, 2007, ANR Pipeline Company (ANR)
tendered for filing and approval a negotiated rate agreement between
ANR and Tenaska Gas Storage, L.L.C. (Tenaska). The service agreement is
being filed as a negotiated rate because the parties have agreed to a
fixed rate for the term of the contract.
    ANR requests that the Commission accept and approve the subject
filing to be effective April 1, 2007.
    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 and 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. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6812 Filed 4-10-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38372-38378]
[FR Doc No: 2020-13829]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1138, FDA-
2020-D-1139, FDA-2020-D-1140]

Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); 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 FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidance documents have been implemented without prior comment, but
they remain subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidances is published in the Federal
Register on June 26, 2020. The guidance documents have been implemented
without prior comment, but they remain 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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of these guidances to the
addresses noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance documents.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, HFZ-450, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Phil
Chao, Center for Food Safety and Applied Nutrition (CFSAN), CPK1 Rm.
1C001, HFS-024, Food and Drug Administration, College Park, MD 20740,
240-402-2112; Diane Heinz, Center for Veterinary Medicine (CVM), Food
and Drug Administration, MPN2 RME435 HFV-6, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247d) (PHS Act), determined that a PHE exists and has existed since
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J.
Trump declared that the COVID-19 outbreak in the United States
constitutes a national emergency, beginning March 1, 2020.\2\
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    \1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020. These PHE Determinations are available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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    In the Federal Register of March 25, 2020 (the March 25, 2020,
notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available
FDA guidance documents related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec.
10.115(g)(2))). The guidances are available at FDA's web page entitled
``COVID-19-Related Guidance Documents for Industry, FDA Staff, and
Other Stakeholders'' (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled
``Search for FDA Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidance
documents FDA issued during the relevant period, as included in table
1. This notice announces COVID-19-

related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidance documents:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
             Docket No.                       Center              Title of guidance       request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1138.....................  CDRH..................  Notifying CDRH of         CDRH-
                                                               Permanent                 [email protected]
                                                               Discontinuance or         Please include the
                                                               Interruption in           document number 20032
                                                               Manufacturing of a        and complete title of
                                                               Device Under Section      the guidance in the
                                                               506J of the FD&C Act      request.
                                                               During the COVID-19
                                                               Public Health Emergency
                                                               (May 6, 2020).
FDA-2020-D-1138.....................  CDRH..................  Supplements for Approved  CDRH-
                                                               Premarket Approval        [email protected]
                                                               (PMA) or Humanitarian     Please include the
                                                               Device Exemption (HDE)    document number 20028
                                                               Submissions During the    and complete title of
                                                               Coronavirus Disease       the guidance in the
                                                               2019 (COVID-19) Public    request.
                                                               Health Emergency (May
                                                               21, 2020).
FDA-2020-D-1138.....................  CDRH..................  Enforcement Policy for    CDRH-
                                                               Face Masks and            [email protected]
                                                               Respirators During the    Please include the
                                                               Coronavirus Disease       document number 20018
                                                               (COVID-19) Public         and complete title of
                                                               Health Emergency (April   the guidance in the
                                                               2020) (Updated May 26,    request.
                                                               2020).
FDA-2020-D-1138.....................  CDRH..................  Recommendations for       CDRH-
                                                               Sponsors Requesting       [email protected]
                                                               EUAs for                  Please include the
                                                               Decontamination and       document number 20033
                                                               Bioburden Reduction       and complete title of
                                                               Systems for Face Masks    the guidance in the
                                                               and Respirators During    request.
                                                               the Coronavirus Disease
                                                               (COVID-19) Public
                                                               Health Emergency (May
                                                               26, 2020).
FDA-2020-D-1136.....................  CDER..................  Exemption and Exclusion<EMAIL_ADDRESS>                                                               of Certain Requirements   Please include the
                                                               of the Drug Supply        docket number FDA-2020-
                                                               Chain Security Act        D-1136 and complete
                                                               During the COVID-19       title of the guidance
                                                               Public Health Emergency   in the request.
                                                               (April 30, 2020).
FDA-2020-D-1136.....................  CDER..................  COVID-19 Public Health<EMAIL_ADDRESS>                                                               Emergency: General        Please include the
                                                               Considerations for Pre-   docket number FDA-2020-
                                                               IND Meeting               D-1136 and complete
                                                               Requirements for COVID-   title of the guidance
                                                               19 Related Drugs and      in the request.
                                                               Biological Products
                                                               (May 11, 2020).
FDA-2020-D-1136.....................  CDER..................  Temporary Policy<EMAIL_ADDRESS>                                                               Regarding Non-Standard    Please include the
                                                               PPE Practices for         docket number FDA-2020-
                                                               Sterile Compounding by    D-1136 and complete
                                                               Pharmacy Compounders      title of the guidance
                                                               not Registered as         in the request.
                                                               Outsourcing Facilities
                                                               During the COVID-19
                                                               Public Health Emergency
                                                               (April 10, 2020)
                                                               (Updated May 14, 2020).
FDA-2020-D-1136.....................  CDER..................  Temporary Policy for<EMAIL_ADDRESS>                                                               Compounding of Certain    Please include the
                                                               Drugs for Hospitalized    docket number FDA-2020-
                                                               Patients by Outsourcing   D-1136 and complete
                                                               Facilities During the     title of the guidance
                                                               COVID-19 Public Health    in the request.
                                                               Emergency (April 2020)
                                                               (Updated May 21, 2020).
FDA-2020-D-1136.....................  CDER..................  Temporary Policy for<EMAIL_ADDRESS>                                                               Compounding of Certain    Please include the
                                                               Drugs for Hospitalized    docket number FDA-2020-
                                                               Patients by Pharmacy      D-1136 and complete
                                                               Compounders not           title of the guidance
                                                               Registered as             in the request.
                                                               Outsourcing Facilities
                                                               During the COVID-19
                                                               Public Health Emergency
                                                               (April 2020) (Updated
                                                               May 21, 2020).
FDA-2020-D-1136.....................  CDER..................  Effects of the COVID-19<EMAIL_ADDRESS>                                                               Public Health Emergency   Please include the
                                                               on Formal Meetings and    docket number FDA-2020-
                                                               User Fee Applications--   D-1136 and complete
                                                               Questions and Answers     title of the guidance
                                                               (May 26, 2020).           in the request.
FDA-2020-D-1106.....................  CDER..................  FDA Guidance on Conduct   clinicaltrialconduct-
                                                               of Clinical Trials of     [email protected]
                                                               Medical Products during   Please include the
                                                               COVID-19 Public Health    docket number FDA-2020-
                                                               Emergency (March 2020)    D-1106 and complete
                                                               (Updated May 14 and       title of the guidance
                                                               June 3, 2020).            in the request.
FDA-2020-D-1139.....................  CFSAN.................  Returning Refrigerated    Retail Food Protection
                                                               Transport Vehicles and    Staff, Office of Food
                                                               Refrigerated Storage      Safety, Center for Food
                                                               Units to Food Uses        Safety and Applied
                                                               After Using Them to       Nutrition, Food and
                                                               Preserve Human Remains    Drug Administration,
                                                               During the COVID-19       5001 Campus Dr.,
                                                               Pandemic (May 12, 2020).  College Park, MD 20740.
FDA-2020-D-1139.....................  CFSAN.................  Temporary Policy          Office of Nutrition and
                                                               Regarding Certain Food    Food Labeling, Food
                                                               Labeling Requirements     Labeling and Standards
                                                               During the COVID-19       Staff, Center for Food
                                                               Public Health             Safety and Applied
                                                               Emergency: Minor          Nutrition, Food and
                                                               Formulation Changes and   Drug Administration,
                                                               Vending Machines (May     5001 Campus Dr.,
                                                               22, 2020).                College Park, MD 20740.
FDA-2020-D-1140.....................  CVM...................  GFI# 271 Reporting and<EMAIL_ADDRESS>                                                               Mitigating Animal Drug    Please include the
                                                               Shortages during the      docket number FDA-2020-
                                                               COVID-19 Public Health    N-1140 and complete
                                                               Emergency (May 7, 2020).  title of the guidance
                                                                                in the request.
----------------------------------------------------------------------------------------------------------------

    Although these guidance documents have been implemented immediately
without prior comment, FDA will consider all comments received and
revise the guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are 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. Paperwork Reduction Act of 1995

A. CDRH Guidances

    The guidances listed in the table below refer to previously
approved 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 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:

                                     Table 2--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                         Another guidance title
          COVID-19 guidance title              CFR cite referenced in    referenced in COVID-19     OMB control
                                                 COVID-19 guidance              guidance              No(s).
----------------------------------------------------------------------------------------------------------------
Supplements for Approved Premarket Approval  21 CFR part 814, subparts                                 0910-0231
 (PMA) or Humanitarian Device Exemption       A through E.                                             0910-0332
 (HDE) Submissions During the Coronavirus    21 CFR part 814, subpart                                  0910-0073
 Disease 2019 (COVID-19) Public Health        H.
 Emergency.                                  21 CFR part 820..........
                                             21 CFR parts 800, 801,     ........................       0910-0485
                                              and 809.
Recommendations for Sponsors Requesting      21 CFR part 803..........  ........................       0910-0437
 EUAs for Decontamination and Bioburden                                 Emergency Use                  0910-0595
 Reduction Systems for Face Masks and                                    Authorization of
 Respirators During the Coronavirus Disease                              Medical Products and
 2019 (COVID-19) Public Health Emergency.                                Related Authorities.
Enforcement Policy for Face Masks and        21 CFR parts 800, 801,     ........................       0910-0485
 Respirators During the Coronavirus Disease   and 809.                  ........................  ..............
 (COVID-19) Public Health Emergency.         21 CFR part 803..........  ........................       0910-0437
                                             21 CFR part 806..........  ........................       0910-0359
                                             21 CFR part 807, subpart   ........................       0910-0120
                                              E.
                                             21 CFR part 807, subparts  ........................       0910-0625
                                              A through D.
                                             21 CFR part 820..........  ........................       0910-0073
                                             21 CFR part 830 and        ........................       0910-0720
                                              801.20.
                                                                        Emergency Use                  0910-0595
                                                                         Authorization of
                                                                         Medical Products and
                                                                         Related Authorities.
----------------------------------------------------------------------------------------------------------------

    The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by the Department of Health and Human Services (HHS) on March
19, 2020, under section 319(f) of the PHS Act. Information concerning
the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 3--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance
   COVID-19 guidance     CFR cite referenced   referenced in COVID-  OMB control   New collection covered by PHE
         title           in COVID-19 guidance       19 guidance         No(s).              PRA waiver
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of       21 CFR part 807,                               0910-0625
 Permanent               subparts A through D. ....................  ...........
 Discontinuance or                             Emergency Use           0910-0595
 Interruption in                                Authorization of
 Manufacturing of a                             Medical Products
 Device Under Section                           and Related
 506J of the FD&C Act                           Authorities;
 During the COVID-19                            Guidance for
 Public Health                                  Industry and Other
 Emergency.                                     Stakeholders.
                                                                                Notifications to FDA about
                                                                                changes in the production of
                                                                                certain medical device
                                                                                products that will help the
                                                                                Agency prevent or mitigate
                                                                                shortages of such devices
                                                                                during the COVID-19 PHE.
                                                                                Updates to FDA every 2 weeks
                                                                                after initial notification on
                                                                                the shortage situation,
                                                                                including the expected
                                                                                timeline for recovery.
                                                                                Voluntary submission of other
                                                                                information that enables FDA
                                                                                to work more effectively with
                                                                                manufacturers and other
                                                                                entities to prevent or limit
                                                                                any negative impact on
                                                                                patients or healthcare
                                                                                providers during the COVID-19
                                                                                PHE.
----------------------------------------------------------------------------------------------------------------

B. CDER Guidances

    The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidances have been
approved by OMB as listed in the following table:

                                     Table 4--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                       Another guidance title
        COVID-19 guidance title           CFR cite referenced in       referenced in COVID-19       OMB control
                                            COVID-19 guidance                 guidance                No(s).
----------------------------------------------------------------------------------------------------------------
Effects of the COVID-19 Public Health   Sec.   10.115(g)(2)......  Planning for the Effects of         0910-0001
 Emergency on Formal Meetings and User                              High Absenteeism to Ensure         0910-0014
 Fee Applications..                                                 Availability of Medically          0910-0429
                                                                    Necessary Drug Products.           0910-0693
                                                                   Formal Meetings Between the         0910-0718
                                                                    FDA and Sponsors or                0910-0719
                                                                    Applicants of PDUFA Products.      0910-0727
                                                                   Formal Meetings Between the
                                                                    FDA and Sponsors or
                                                                    Applicants of BsUFA Products.
Exemption and Exclusion of Certain      .........................  Drug Supply Chain Security          0910-0777
 Requirements of the Drug Supply Chain                              Act Implementation:                0910-0800
 Security Act During the COVID-19                                   Identification of Suspect          0910-0806
 Public Health Emergency..                                          Product and Notification.          0910-0827
                                                                   Verification Systems Under          0910-0859
                                                                    the Drug Supply Chain
                                                                    Security Act for Certain
                                                                    Prescription Drugs.
                                                                   Definitions of Suspect
                                                                    Product and Illegitimate
                                                                    Product for Verification
                                                                    Obligations Under the Drug
                                                                    Supply Chain Security Act.
General Considerations for Pre-IND      21 CFR part 312..........  COVID-19: Developing Drugs          0910-0001
 Meeting Requirements for COVID-19                                  and Biological Products for        0910-0014
 Related Drugs and Biological                                       Treatment or Prevention.           0910-0338
 Products..                                                        Formal Meetings Between the         0910-0429
                                                                    FDA and Sponsors or                0910-0595
                                                                    Applicants of PDUFA Products.      0910-0719
                                                                   Emergency Use Authorization
                                                                    of Medical Products and
                                                                    Related Authorities.
                                                                   Preclinical Assessment of           0910-0814
                                                                    Investigational Cellular and
                                                                    Gene Therapy Products.
                                                                   Guidance for Clinical Trial
                                                                    Sponsors: Establishment and
                                                                    Operation of Clinical Trial
                                                                    Data Monitoring Committees.
                                                                   Use of Liquids and/or Soft
                                                                    Foods as Vehicles for Drug
                                                                    Administration: General
                                                                    Considerations for Selection
                                                                    and In Vitro Methods for
                                                                    Product Quality Assessments.
                                                                   Demonstrating Substantial
                                                                    Evidence of Effectiveness
                                                                    for Human Drug and
                                                                    Biological Products.
----------------------------------------------------------------------------------------------------------------

    The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidances have been
approved by OMB as listed in the below table. These guidances also
contain new collections of information not approved under a current
collection. These new collections of information have been granted a
PHE waiver from the PRA by HHS on March 19, 2020, under section 319(f)
of the PHS Act. Information concerning the PHE PRA waiver can be found
on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                    Table 5-- CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance                              New collection
   COVID-19 guidance     CFR cite referenced   referenced in COVID-   OMB control No(s).     covered by PHE PRA
         title          in COVID-19 guidance       19 guidance                                     waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy for    21 CFR 314.81, 21     Current Good           0910-0777, 0910-      To provide
 Compounding of          CFR 600.82.           Manufacturing          0338, 0910-0001,      suitability and
 Certain Drugs for                             Practice--Guidance     0910-0139.            proof of sterility
 Hospitalized Patients                         for Human Drug                               for the container
 by Outsourcing                                Compounding                                  closure systems
 Facilities During the                         Outsourcing                                  used.
 COVID-19 Public                               Facilities Under
 Health Emergency.                             Section 503B of the
                                               FD&C Act.
Temporary Policy for    ....................  Compounded Drug        0910-0001, 0910-      For reporting of
 Compounding of                                Products That are      0139, 0910-0338.      adverse events by
 Certain Drugs for                             Essentially Copies                           pharmacy compounders
 Hospitalized Patients                         of a Commercially                            to the MedWatch
 by Pharmacy                                   Available Drug                               system and
 Compounders not                               Product under                                maintaining records
 Registered as                                 Section 503A of the                          of drugs suppliers
 Outsourcing                                   Federal Food, Drug,                          and patients who
 Facilities During the                         and Cosmetic Act.                            receive the
 COVID-19 Public                              Temporary Policy for                          compounded products.
 Health Emergency.                             Compounding of
                                               Certain Drugs for
                                               Hospitalized
                                               Patients by
                                               Outsourcing
                                               Facilities During
                                               the COVID-19 Public
                                               Health Emergency.
                                              Prescription
                                               Requirement Under
                                               Section 503A of the
                                               Federal Food, Drug,
                                               and Cosmetic Act.

                                              Temporary Policy
                                               Regarding Non-
                                               Standard PPE
                                               Practices for
                                               Sterile Compounding
                                               by Pharmacy
                                               Compounders not
                                               Registered as
                                               Outsourcing
                                               Facilities during
                                               the COVID-19 Public
                                               Health Emergency.
Temporary Policy        21 CFR parts 210 and  Enforcement Policy     0910-0139...........  Recordkeeping of
 Regarding Non-          211.                  for Face Masks and                           compounding
 Standard PPE                                  Respirators During                           performed without
 Practices for Sterile                         the Coronavirus                              standard PPE;
 Compounding by                                Disease (COVID-19)                           recordkeeping of any
 Pharmacy Compounders                          Public Health                                change of
 not Registered as                             Emergency (Revised).                         sterilization/
 Outsourcing                                  Enforcement Policy                            aseptic processing
 Facilities During the                         for Gowns, Other                             methods;
 COVID-19 Public                               Apparel, and Gloves                          documentation of
 Health Emergency.                             During the                                   mitigation
                                               Coronavirus Disease                          strategies for
                                               (COVID-19) Public                            sterile compounding
                                               Health Emergency.                            without standard
                                                                                PPE.
                                              Electronic Drug
                                               Product Reporting
                                               for Human Drug
                                               Compounding
                                               Outsourcing
                                               Facilities Under
                                               Section 503B of the
                                               Federal Food, Drug,
                                               and Cosmetic Act.
Guidance on Conduct of  21 CFR part 11, 21    Formal Meetings        0910-0001, 0910-      Submission by
 Clinical Trials of      CFR part 50, 21 CFR   Between the FDA and    0014, 0910-0130,      investigators of
 Medical Products        part 56, 21 CFR       Sponsors or            0910-0303, 0910-      informed consent
 during COVID-19         part 312, 21 CFR      Applicants of PDUFA    0338, 0910-0119,      forms to third
 Public Health           part 314, 21 CFR      Products.              0910-0581, 0910-      parties.
 Emergency.              part 601, 21 CFR     Formal Meetings         0733, 0910-0078.
                         part 812.             Between the FDA and
                                               Sponsors or
                                               Applicants of BsUFA
                                               Products.
                                              Pediatric Study
                                               Plans: Content of
                                               and Process for
                                               Submitting Initial
                                               Pediatric Study
                                               Plans and Amended
                                               Pediatric Study
                                               Plans.
                                              Draft Guidance for
                                               Industry on
                                               Demonstrating
                                               Substantial Evidence
                                               of Effectiveness for
                                               Human Drug and
                                               Biological Products.
                                              Enhancing the
                                               Diversity of
                                               Clinical Trial
                                               Populations--Eligibi
                                               lity Criteria,
                                               Enrollment
                                               Practices, and Trial
                                               Design.
                                              Pregnant Women:
                                               Scientific and
                                               Ethical
                                               Considerations for
                                               Inclusion in
                                               Clinical Trials.
                                              Part 11, Electronic
                                               Records; Electronic
                                               Signatures Scope and
                                               Application.
                                              Use of Electronic
                                               Records and
                                               Electronic
                                               Signatures in
                                               Clinical
                                               Investigations under
                                               21 CFR Part 11--
                                               Questions and
                                               Answers.
                                              Safety Reporting
                                               Requirements for
                                               INDs and BA/BE
                                               Studies.
                                              Adverse Event
                                               Reporting to IRBs--
                                               Improving Human
                                               Subject Protection.
                                              Use of Electronic
                                               Informed Consent In
                                               Clinical
                                               Investigations.
                                              E6(R2) Good Clinical
                                               Practice: Integrated
                                               Addendum to ICH
                                               E6(R1).
                                              Providing Regulatory
                                               Submissions in
                                               Electronic Format--
                                               Certain Human
                                               Pharmaceutical
                                               Product Applications
                                               and Related
                                               Submissions Using
                                               the eCTD
                                               Specifications.
                                              Best Practices for
                                               Communication
                                               Between IND Sponsors
                                               and FDA During Drug
                                               Development.

                                              Requests for Feedback
                                               and Meetings for
                                               Medical Device
                                               Submissions: The Q-
                                               Submission Program.
----------------------------------------------------------------------------------------------------------------

C. CFSAN Guidance

    The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by the HHS on March 19, 2020, under section 319(f) of the PHS
Act. Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 6--CFSAN Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance                              New collection
   COVID-19 guidance     CFR cite referenced   referenced in COVID-   OMB control No(s).     covered by PHE PRA
         title           in COVID-19 guidance       19 guidance                                    waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy        21 CFR part 101;       ....................  0910-0381, 0910-      Recommend that
 Regarding Certain       section 403(w) of                            0782, 0910-0792.      manufacturers post
 Mandatory Food          the FD&C Act.                                                      ingredient omissions
 Labeling Requirements                                                                      or substitutions not
 During the COVID-19                                                                        reflected on the
 Public Health                                                                              product label.
 Emergency: Minor
 Formulation Changes
 and Vending Machines.
----------------------------------------------------------------------------------------------------------------

    The guidance entitled ``Returning Refrigerated Transport Vehicles
and Refrigerated Storage Units to Food Uses After Using Them to
Preserve Human Remains During the COVID-19 Pandemic'' contains no
collection of information. Therefore, clearance by OMB under the PRA is
not required.

D. CVM Guidance

    This guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as indicated in the table. This guidance also contains
a new collection of information not approved under a current
collection. This new collection of information has been granted a PHE
waiver from the PRA by HHS on March 19, 2020, under section 319(f) of
the PHS Act. Information concerning the PHE PRA waiver can be found on
the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                      Table 7--CVM Guidance and Collection
----------------------------------------------------------------------------------------------------------------
                                                 Another guidance                              New collection
   COVID-19 guidance     CFR cite referenced   referenced in COVID-   OMB control No(s).     covered by PHE PRA
         title           in COVID-19 guidance       19 guidance                                    waiver
----------------------------------------------------------------------------------------------------------------
GFI# 271, Reporting     21 CFR 514.1(a)).....  ....................  0910-0032, 0910-0669  Reporting and
 and Mitigating Animal                                                                      mitigating animal
 Drug Shortages during                                                                      drug shortages.
 the COVID-19 Public
 Health Emergency.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     The FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     the FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13829 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 15, 2010 (Volume 75, Number 178)]
[Notices]
[Page 56127-56128]
[DOCID:fr15se10-102]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2010-0032]

Federal Radiological Preparedness Coordinating Committee

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Federal Radiological Preparedness Coordinating Committee
is holding a public meeting on September 28, 2010 in Arlington, VA.

DATES: The meeting will take place on September 28, 2010. The session
is open to the public and will take place from 9 a.m. to 11 a.m. Send
written statements and requests to make oral statements to the person
listed in the FOR FURTHER INFORMATION CONTACT section by close of
business September 25, 2010.

ADDRESSES: The meeting will be held at the Marriott Crystal Gateway
located at 1700 Jefferson Davis Highway, Arlington, VA 22202, in the
Alexandria Room.

FOR FURTHER INFORMATION CONTACT: Timothy Greten, FRPCC Executive
Secretary, DHS/FEMA, 1800 South Bell Street--CC847, Mail Stop 3025,

Arlington, VA 20598-3025; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The role and functions of the Federal
Radiological Preparedness Coordinating Committee (FRPCC) are described
in 44 CFR 351.10(a) and 351.11(a). The FRPCC is holding a public
meeting on September 28, 2010, from 9 a.m. to 11 a.m., at the Marriott
Crystal Gateway located at 1700 Jefferson Davis Highway, Arlington, VA
22202, in the Alexandria Room. Please note that the meeting may close
early. This meeting is open to the public. Public meeting participants
must pre-register to be admitted to the meeting. To pre-register,
please provide your name and telephone number by close of business on
September 25, 2010, to the individual listed in the FOR FURTHER
INFORMATION CONTACT section.
    The tentative agenda for the FRPCC meeting includes: (1)
Introductions, (2) reports from FRPCC Subcommittees, (3) status of
finalization of Radiological Emergency Preparedness (REP) Program
Manual and NUREG-0654 Supplement 4, and (4) REP Program Manual and
Supplement 4 Implementation ``Impact Papers.'' The FRPCC Chair shall
conduct the meeting in a way that will facilitate the orderly conduct
of business. Reasonable provisions will be made, if time permits, for
oral statements from the public of not more than five minutes in
length. Any member of the public who wishes to make an oral statement
at the meeting should send a written request for time by close of
business on September 25, 2010, to the individual listed in the FOR
FURTHER INFORMATION CONTACT section. Any member of the public who
wishes to file a written statement with the FRPCC should provide the
statement by close of business on September 25, 2010, to the individual
listed in the FOR FURTHER INFORMATION CONTACT section. For further
information and to review any supporting documents please go to http://
www.regulations.gov, Docket ID FEMA-2010-0032.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, please
write or call the individual listed in the FOR FURTHER INFORMATION
CONTACT section as soon as possible.

    Authority: 44 CFR 351.10(a) and 351.11(a).

Timothy W. Manning,
Deputy Administrator, Protection and National Preparedness, Federal
Emergency Management Agency.
[FR Doc. 2010-22984 Filed 9-14-10; 8:45 am]
BILLING CODE 9110-21-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Notices]
[Pages 15245-15247]
[FR Doc No: 2019-07369]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85567; File No. SR-MIAX-2019-19]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 530, Limit Up-Limit Down,
and Exchange Rule 521, Nullification and Adjustment of Options
Transactions Including Obvious Errors

April 9, 2019.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on April 5, 2019, Miami International Securities
Exchange, LLC (``MIAX Options'' or the ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is filing a proposal to amend (i) Exchange Rule 530,
Limit Up-Limit Down, and (ii) Exchange Rule 521, Nullification and
Adjustment of Options Transactions Including Obvious Errors,
Interpretations and Policies .01, to extend the pilot to the close of
business on October 18, 2019, for certain options market rules that are
linked to the equity market Plan to Address Extraordinary Market
Volatility.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/ at MIAX Options'
principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to extend the pilot to
the close of business on October 18, 2019, for certain options market
rules that are linked to the equity market Plan to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
the ``Plan''). This change is being proposed in connection with a
proposed amendment to the Limit Up-Limit Down Plan that would allow the
Plan to continue to operate on a permanent basis (``Amendment 18'').
    In an attempt to address extraordinary market volatility in NMS
Stock, and, in particular, events like the severe volatility on May 6,
2010, U.S. national securities exchanges and the Financial Industry
Regulatory Authority, Inc. (collectively, ``Participants'') drafted the
Plan pursuant to Rule 608 of Regulation NMS and under the Act.\3\ On
May 31, 2012, the Commission approved the Plan, as amended, on a one-
year pilot basis.\4\ Though the Plan was primarily designed for equity
markets, the Exchange believed it would, indirectly, potentially impact
the options markets as well. Thus, the Exchange has previously amended
and adopted Rule 530, and Rule 521, Interpretation and Policy .01 to
ensure the option markets were not harmed as a result of the Plan's
implementation and has implemented such rules on a pilot basis that has
coincided with the pilot period for the Plan (the ``Options
Pilots'').\5\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011) (File No. 4-631).
    \4\ See Securities and Exchange Act Release No. 67091 (May 31,
2012) 77 FR 33498 (June 6, 2012).
    \5\ See Securities Exchange Act Release Nos. 69342 (April 8,
2013), 78 FR 22017 (April 12, 2013) (SR-MIAX-2013-12) and 74918 (May
8, 2015), 80 FR 27781 (May 14, 2015) (SR-MIAX-2015-35).
---------------------------------------------------------------------------

    The Commission recently published an Amendment 18, which would
allow the Plan to operate on a permanent, rather than pilot, basis.\6\
In connection with this change, the Exchange proposes to amend the
Options Pilots to expire at the close of business on October 18, 2019--
i.e., six months after the expiration of the current pilot period for
the Plan. Specifically, the Exchange proposes to amend Exchange Rule
530 and Rule 521, Interpretation and Policy .01 to untie the Options
Pilot's effectiveness from that of the Plan and to extend the Options
Pilot's effectiveness to the close of business on October 18, 2019. The
Exchange understands that the other national securities exchanges will
also file similar proposals to extend their respective pilot programs,
the substance of which are identical to the proposal.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release Nos. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (Amendment No. 18 Proposing
Release).
---------------------------------------------------------------------------

    The Exchange does not propose any additional changes to Exchange
Rules 530 or Rule 521, Interpretation and Policy .01. The Exchange
believes the benefits to market participants from the Options Pilots
should continue on a limited six month pilot basis after Commission
approves the Plan to operate on a permanent basis. Assuming the Plan is
approved by the Commission to operate on a permanent, rather than
pilot, basis the Exchange intends to assess whether additional changes
should also be made to the Options Pilots. Extending the Options Pilots
for an additional six months should provide the Exchange and other
national securities exchanges additional time to consider further
amendments to their rules in light of proposed Amendment 18.

2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \8\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest and not to
permit unfair discrimination between customers, issuers, brokers, or
dealers. The Exchange believes that the proposed rule change promotes
just and equitable principles of trade in that it promotes transparency
and uniformity across markets concerning rules for options markets
adopted to coincide with the Plan. The Exchange believes that extending
the Options Pilots for an additional six months would help assure that
the rules subject to such Pilots are either similarly made permanent,
amended or removed, following additional discussion and analysis by the
Exchange and other national securities exchanges. The proposed rule
change would also help assure that such rules are not immediately
eliminated, thus furthering fair and orderly markets, the protection of
investors and the public interest. Based on the foregoing, the Exchange
believes the Options Pilots should continue to be in effect on a pilot
basis while the Exchange and the other national securities exchanges
consider and develop a permanent proposal for such rules.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 proposal would ensure
the continued, uninterrupted operation of the Options Pilots while the
Exchange and other national securities exchanges consider further
amendments to these rules in light of proposed Amendment 18. The
Exchange understands that the other national securities exchanges will
also file similar proposals to extend their respective pilot programs,
the substance of which are identical to this proposal. Thus, the
proposed rule change will help to ensure consistency across market
centers without implicating any competitive issues.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing 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)(iii) of the Act \9\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and 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.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \12\ 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 proposed
rule change may become effective and operative immediately upon filing.
The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the current Options Pilots to continue uninterrupted,
without any changes, while the Exchange and the other national
securities exchanges consider and develop a permanent proposal for
Options Pilots. For this reason, the Commission hereby waives the 30-
day operative delay and designates the proposed rule change as
operative upon filing.\13\
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    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-MIAX-2019-19 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 Number SR-MIAX-2019-19. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit

personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MIAX-2019-19 and should be
submitted on or before May 6, 2019.

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

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

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-07369 Filed 4-12-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: July 24, 2009 (Volume 74, Number 141)]
[Notices]
[Page 36720]
[DOCID:fr24jy09-83]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0650]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; General Administrative Procedures:
Citizen Petitions; Petition for Reconsideration or Stay of Action;
Advisory Opinions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``General Administrative Procedures:
Citizen Petitions; Petition for Reconsideration or Stay of Action;
Advisory Opinions'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 10, 2009
(74 FR 10255), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. 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. OMB has now approved the
information collection and has assigned OMB control number 0910-0183.
The approval expires on May 31, 2012. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 16, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17621 Filed 7-23-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10645-10646]
[FR Doc No: 2016-04430]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-B-1558]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before May 31, 2016.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1558, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
For communities with multiple ongoing Preliminary studies, the studies
can be identified by the unique project number and Preliminary FIRM
date listed in the tables. Additionally, the current effective FIRM and
FIS report for each community are accessible online through the FEMA
Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: January 22, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

                     I. Non-Watershed-Based Studies
------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Washington County, Indiana and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
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           Project: 15-05-2057S Preliminary Date: June 1, 2012
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City of Salem..........................  Salem City Hall, Department of
                                          Building and Safety, Suite
                                          104, 201 East Market Street,
                                          Salem, IN 47167.
Town of Little York....................  Washington County Building
                                          Department, 600 Anson Street,
                                          Salem, IN 47167.
Town of New Pekin......................  Pekin Town Hall, 75 South Mill
                                          Street, Pekin, IN 47165.
Unincorporated Areas of Washington       Washington County Building
 County.                                  Department, 600 Anson Street,
                                          Salem, IN 47167.
------------------------------------------------------------------------
            Whatcom County, Washington and Incorporated Areas
------------------------------------------------------------------------
      Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
        Project: 13-10-0343S Preliminary Date: September 30, 2015
------------------------------------------------------------------------
City of Bellingham.....................  City Hall, 210 Lottie Street,
                                          Bellingham, WA 98225.
City of Blaine.........................  City Hall, 435 Martin Street,
                                          Suite 3000, Blaine, WA 98230.
City of Ferndale.......................  Planning and Public Works
                                          Department, 2095 Main Street,
                                          Ferndale, WA 98248.
City of Lynden.........................  City Hall, 300 4th Street,
                                          Lynden, WA 98264.
City of Nooksack.......................  City Hall, 103 West Madison
                                          Street, Nooksack, WA 98276.
Lummi Indian Reservation...............  Lummi Nation Natural Resources
                                          Department, 2665 Kwina Road,
                                          Bellingham, WA 98226.
Unincorporated Areas of Whatcom County.  Public Works/River and Flood
                                          Division, 322 North Commercial
                                          Street, Suite 120, Bellingham,
                                          WA 98225.
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[FR Doc. 2016-04430 Filed 2-29-16; 8:45 am]
 BILLING CODE 9110-12-P