[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34697-34700]
[FR Doc No: 2020-12161]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88980; File No. SR-NYSEARCA-2020-49]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE
Arca Options Fees and Charges and the NYSE Arca Equities Fees and
Charges Related to Co-location Services

June 1, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on May 18, 2020, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Arca Options Fees and
Charges and the NYSE Arca Equities Fees and Charges (together, the
``Fee Schedules'') related to co-location services with respect to
connectivity to the ICE Data Global Index and to waive any change fees
that a User would otherwise incur as a result of the proposed change.
The proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend the Fee Schedules related to co-
location \4\ services offered by the Exchange with respect to
connectivity to the ICE Data Global Index (``GIF'') and to waive any
change fees that a User would otherwise incur as a result of the
proposed change.
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    \4\ The Exchange initially filed rule changes relating to its
co-location services with the Securities and Exchange Commission
(``Commission'') in 2010. See Securities Exchange Act Release No.
63275 (November 8, 2010), 75 FR 70048 (November 16, 2010) (SR-
NYSEArca-2010-100). The Exchange is an indirect subsidiary of
Intercontinental Exchange, Inc. (``ICE''). Through its ICE Data
Services (``IDS'') business, ICE operates a data center in Mahwah,
New Jersey (the ``data center''), from which the Exchange provides
co-location services to Users.
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Proposed Change
    The Exchange offers Users \5\ connectivity to data feeds from third
party markets and other content service providers (``Third Party Data
Feeds'').\6\ The list of Third Party Data Feeds is set forth in the Fee
Schedules, and includes connectivity to the GIF for a monthly
connectivity fee of $100.\7\
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    \5\ For purposes of the Exchange's co-location services, a
``User'' means any market participant that requests to receive co-
location services directly from the Exchange. See Securities
Exchange Act Release No. 76010 (September 29, 2015), 80 FR 60197
(October 5, 2015) (SR-NYSEArca-2015-82). As specified in the Fee
Schedules, a User that incurs co-location fees for a particular co-
location service pursuant thereto would not be subject to co-
location fees for the same co-location service charged by the
Exchange's affiliates the New York Stock Exchange LLC, NYSE American
LLC, NYSE Chicago, Inc., and NYSE National, Inc. (collectively, the
``Affiliate SROs''). Each Affiliate SRO has submitted substantially
the same proposed rule change to propose the changes described
herein. See SR-NYSE-2020-46, SR-NYSEAmer-2020-40, SR-NYSECHX-2020-
17, and SR-NYSENAT-2020-19.
    \6\ See Securities Exchange Act Release No. 80310 (March 24,
2017), 82 FR 15763 (March 30, 2017) (SR-NYSEArca-2016-89) (notice of
filing of Partial Amendment No. 4 and order granting accelerated
approval of a proposed rule change, as modified by Amendment Nos. 1
through 4, to amend the co-location services offered by the Exchange
to add certain access and connectivity fees).
    \7\ The Exchange has an indirect interest in the GIF because ICE
is the Exchange's ultimate parent. See id., at 15771, and Securities
Exchange Act Release No. 79673 (December 22, 2016), 81 FR 96107
(December 29, 2016) (SR-NYSEArca-2016-89) (notice of filing of
Amendments Nos. 2 and 3 to proposed rule change to amend the co-
location services offered by the Exchange to add certain access and
connectivity fees).
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    ICE, which publishes the GIF, announced to its customers that
connect to the GIF that it will no longer offer the GIF as a stand-
alone product. Accordingly, the Exchange proposes to cease offering
connectivity to the GIF once it is no longer available. The Exchange
has been informed by ICE that cessation is currently expected to occur
before the end of 2020. The Exchange will announce the operative date
through a customer notice.
    Users are subject to a change fee if they request a change to one
or more existing co-location services.\8\ The Exchange proposes to
waive any change fees that a User would otherwise incur as a result of
the proposed change.
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    \8\ See Securities Exchange Act Release Nos. 67667 (August 15,
2012), 77 FR 50743 (August 22, 2012) (SR-NYSEArca-2012-63) (order
approving a proposed rule change amending the NYSE Arca Options Fee
Schedule to provide for additional co-location services and
establish related fees), and 67669 (August 15, 2012), 77 FR 50746
(August 22, 2012) (SR-NYSEArca-2012-62) (order approving a proposed
rule change amending the NYSE Arca Equites Schedule of Fees and
Charges for Exchange Services to provide for additional co-location
services and establish related fees).
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    In order to implement the proposed change, the Exchange proposes to
make

the following changes to the section entitled ``Connectivity to Third
Party Data Feeds'':
     In the first paragraph and in the table of Third Party
Data Feeds, add an asterisk after ``ICE Data Global Index.''
     Following the table of Third Party Data Feeds, add the
following text:
    * ICE will cease to offer the GIF as a stand-alone product, which
the Exchange has been informed by ICE is currently expected to occur
before the end of 2020. The Exchange will announce the operative date
through a customer notice. Any change fees that a User would otherwise
incur as a result of the proposed change will be waived.
    The GIF includes the values of various indices and exchange traded
product data.\9\ Based on information published by ICE Data Services,
all the data in the GIF was already available on the ICE Data Services
Consolidated Feed (``Consolidated Feed'').\10\ The Exchange offers
connectivity to the Consolidated Feed, and does not propose to change
the price for such connectivity. In addition, the Exchange's
connectivity to the GIF and the Consolidated Feed should have
approximately the same latency.
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    \9\ The Exchange understands that some of the indices may
include Exchange or Affiliate SRO data as underlying components, but
the GIF does not include those underlying components or other
information directly from the Exchange and Affiliate SROs.
    \10\ See ``Consolidated Data Feed Coverage List--Indices and
Indicators'' at https://www.theice.com/market-data/connectivity-and-feeds/consolidated-feed/coverage-list.
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Application and Impact of the Proposed Change
    The proposed change would not apply differently to distinct types
or sizes of market participants. Rather, it would apply to all Users
equally. As is currently the case, the purchase of any colocation
service is completely voluntary and the Fee Schedules are applied
uniformly to all Users.
    Currently, there are seven Users that have connectivity to the GIF,
and so would be affected by the change. If any of them wish to continue
having connectivity to the information in the GIF, they could connect
to the Consolidated Feed, which none of them do presently. The monthly
cost for connectivity to the Consolidated Feed depends on the size of
the bandwidth utilized. If a User opts to connect to the Consolidated
Feed to connect to the information in the GIF, the monthly connectivity
cost charged by the Exchange would be $200.
    ICE has informed the Exchange that currently there are various
third parties that offer Users connectivity to the Consolidated Feed.
To use such third party connectivity to the Consolidated Feed, a User
may utilize the IDS network, a third party telecommunication network, a
cross connect, or a combination thereof to access the Consolidated Feed
through a connection to an access center outside the data center (which
could be an IDS access center, a third-party access center, or both),
another User, or a third party vendor.
Competitive Environment
    The Exchange operates in a highly competitive market in which
exchanges and other vendors (e.g., Hosting Users) offer co-location
services as a means to facilitate the trading and other market
activities of those market participants who believe that co-location
enhances the efficiency of their operations. The Commission has
repeatedly expressed its preference for competition over regulatory
intervention in determining prices, products, and services in the
securities markets. Specifically, in Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \11\
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    \11\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
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    The proposed change is not otherwise intended to address any other
issues relating to co-location services and/or related fees, and the
Exchange is not aware of any problems that Users would have in
complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\12\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\13\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers. In addition, it is designed to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
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 because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposed Rule Change Is Reasonable and Equitable
    The Exchange believes that the proposed rule change is reasonable
and equitable for the following reasons.
    The Exchange believes that it is reasonable and an equitable
allocation of its fees and credits to add a note to its Fee Schedules
stating that ICE will cease to offer the GIF as a stand-alone product,
as the Exchange will no longer be able to offer the service once that
occurs.
    If a User wishes connectivity to the information in the GIF, the
Users could connect to the Consolidated Feed through IDS or from a
third party provider. A User may utilize the IDS network, a third party
telecommunication network, a cross connect, or a combination thereof to
access the Consolidated Feed, through a connection to an access center
outside the data center (which could be an IDS access center, a third-
party access center, or both), another User, or a third party vendor.
    The Exchange believes that it is reasonable and equitable that it
waive any change fees that a User would otherwise incur as a result of
the proposed change, as Users would have no choice but to terminate
connectivity to the GIF. The fee waiver would help to alleviate any
burden related to the change.
The Proposed Rule Change Would Protect Investors and the Public
Interest
    The Exchange believes that the proposed rule change would perfect
the mechanisms of a free and open market and a national market system
and, in general, protect investors and the public interest for the
following reasons.
    It would be against the protection of investors and the public
interest if the Exchange were to continue to offer something that it
cannot provide because the relevant feed has been discontinued. Adding
the proposed note to its Fee Schedules would reduce any potential
ambiguity and provide clarification concerning the availability and the
costs of connectivity to Third Party Data Feeds available to Users,
because it would highlight that the GIF will become obsolete, provide a
timeline for the change, and state that any change fees that a User
would otherwise incur as a result of the proposed change would be
waived.

The Proposed Change Is Not Unfairly Discriminatory
    The Exchange believes that the proposed change is not unfairly
discriminatory for the following reasons.
    The proposed change would not apply differently to distinct types
or sizes of market participants. Rather, it would apply to all Users
equally. As a consequence of ICE's ceasing to offer the GIF as a stand-
alone product, the Exchange will not be able to provide any Users with
connectivity to the GIF.
    If a User wishes connectivity to the information in the GIF, the
Users could connect to the Consolidated Feed through the Exchange. If
any of the seven Users that have connectivity to the GIF opt to connect
to the Consolidated Feed, the monthly connectivity cost charged by the
Exchange would be $200.
    ICE has informed the Exchange that currently there are various
third parties that offer Users connectivity to the Consolidated Feed.
To use such third party connectivity to the Consolidated Feed, a User
may utilize the IDS network, a third party telecommunication network, a
cross connect, or a combination thereof to access the Consolidated
Feed, through a connection to an access center outside the data center
(which could be an IDS access center, a third-party access center, or
both), another User, or a third party vendor.
    For the reasons above, the proposed changes do not unfairly
discriminate between or among market participants that are otherwise
capable of satisfying any applicable co-location fees, requirements,
terms and conditions established from time to time by the Exchange.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\14\ the Exchange
believes that the proposed rule change will not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
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    \14\ 15 U.S.C. 78f(b)(8).
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Intramarket Competition
    The Exchange does not believe that the proposed change would place
any burden on intramarket competition that is not necessary or
appropriate. The proposed change would not apply differently to
distinct types or sizes of market participants. Rather, it would apply
to all Users equally: As a consequence of ICE's ceasing to offer the
GIF as a stand-alone product, the Exchange will not be able to provide
any Users with connectivity to the GIF. The Exchange proposes to waive
any change fees that a User would otherwise incur as a result of the
proposed change.
    Adding the proposed note to the Fee Schedules would reduce any
potential ambiguity and provide clarification concerning the
availability and the costs of connectivity to Third Party Data Feeds
available to Users, because it would highlight that the GIF will become
obsolete, provide a timeline for the change, and state that any change
fees that a User would otherwise incur as a result of the proposed
change would be waived.
    If a User wishes connectivity to the information in the GIF, the
Users could connect to the Consolidated Feed through the Exchange. If
any of the seven Users that have connectivity to the GIF opt to connect
to the Consolidated Feed, the monthly connectivity cost charged by the
Exchange would be $200.
    ICE has informed the Exchange that currently there are various
third parties that offer Users connectivity to the Consolidated Feed.
To use such third party connectivity to the Consolidated Feed, a User
may utilize the IDS network, a third party telecommunication network, a
cross connect, or a combination thereof to access the Consolidated
Feed, through a connection to an access center outside the data center
(which could be an IDS access center, a third-party access center, or
both), another User, or a third party vendor.
    Use of any co-location service is completely voluntary, and each
market participant is able to determine whether to use co-location
services based on the requirements of its business operations.
Intermarket Competition
    The Exchange does not believe that the proposed fee would impose
any burden on intermarket competition that is not necessary or
appropriate.
    The Exchange operates in a highly competitive market in which
exchanges and other vendors (i.e., Hosting Users) offer co-location
services as a means to facilitate the trading and other market
activities of those market participants who believe that co-location
enhances the efficiency of their operations. Accordingly, fees charged
for co-location services are constrained by the active competition for
the order flow of, and other business from, such market participants.
    The Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. Specifically, in
Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \15\
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    \15\ See 70 FR 37496, supra note 11.
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    The Exchange believes that the proposed change is necessary and
appropriate. Adding the proposed note to the Fee Schedules would reduce
any potential ambiguity and provide clarification concerning the
availability and the costs of connectivity to Third Party Data Feeds
available to Users, because it would highlight that the GIF will become
obsolete and provide a timeline for the change.
    For the reasons described above, the Exchange believes that the
proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \16\ and Rule 19b-4(f)(6) thereunder.\17\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \16\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \17\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \18\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant

to Rule 19b-4(f)(6)(iii),\19\ the Commission may designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has requested that the Commission
waive the 30-day operative delay so that the proposal may become
operative immediately upon filing. The Exchange believes that such
waiver would be consistent with the protection of investors and the
public interest because it would allow the Exchange to waive the change
fee sooner. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest because it would permit the Exchange, without undue delay, to
cease offering the GIF when it becomes unavailable, provide notice to
customers and waive the change fee. Accordingly, the Commission waives
the 30-day operative delay and designates the proposed rule change
operative upon filing.\20\
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    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii).
    \20\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \21\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \21\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEARCA-2020-49 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-NYSEARCA-2020-49. 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-NYSEARCA-2020-49 and should be submitted
on or before June 26, 2020.
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    \22\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-12161 Filed 6-4-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81776-81778]
[FR Doc No: 2016-27840]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3535]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Special Protocol Assessment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection in
the guidance for industry on special protocol assessment.

DATES: Submit either electronic or written comments on the collection
of information by January 17, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-3535 for ``Agency Information Collection Activities:
Proposed Collection; Comment Request; Guidance for Industry on Special
Protocol Assessment.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
St., 10A-12M, North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed

collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques, when appropriate,
and other forms of information technology.

Guidance for Industry on Special Protocol Assessment--OMB Control
Number 0910-0470--Extension

    The ``Guidance for Industry on Special Protocol Assessment''
describes Agency procedures to evaluate issues related to the adequacy
(e.g., design, conduct, analysis) of certain proposed studies. The
guidance describes procedures for sponsors to request special protocol
assessment and for the Agency to act on such requests. The guidance
provides information on how the Agency interprets and applies
provisions of the Food and Drug Administration Modernization Act of
1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA)
goals for special protocol assessment associated with the development
and review of PDUFA products. The guidance describes the following two
collections of information: (1) The submission of a notice of intent to
request special protocol assessment of a carcinogenicity protocol and
(2) the submission of a request for special protocol assessment.

I. Notification for a Carcinogenicity Protocol

    As described in the guidance, a sponsor interested in Agency
assessment of a carcinogenicity protocol should notify the appropriate
division in FDA's Center for Drug Evaluation and Research (CDER) or the
Center for Biologics Evaluation and Research (CBER) of an intent to
request special protocol assessment at least 30 days prior to
submitting the request. With such notification, the sponsor should
submit relevant background information so that the Agency may review
reference material related to carcinogenicity protocol design prior to
receiving the carcinogenicity protocol.

II. Request for Special Protocol Assessment

    The guidance asks that a request for special protocol assessment be
submitted as an amendment to the investigational new drug application
(IND) for the underlying product and that it be submitted to the Agency
in triplicate with Form FDA 1571 attached. The guidance also suggests
that the sponsor submit the cover letter to a request for special
protocol assessment via fax to the appropriate division in CDER or
CBER. Agency regulations (21 CFR 312.23(d)) state that information
provided to the Agency as part of an IND is to be submitted in
triplicate and with the appropriate cover form, Form FDA 1571. An IND
is submitted to FDA under existing regulations in part 312 (21 CFR part
312), which specifies the information that manufacturers must submit so
that FDA may properly evaluate the safety and effectiveness of
investigational drugs and biological products. The information
collection requirements resulting from the preparation and submission
of an IND under part 312 have been estimated by FDA and the reporting
and recordkeeping burden has been approved by OMB under OMB control
number 0910-0014.
    FDA suggests that the cover letter to the request for special
protocol assessment be submitted via fax to the appropriate division in
CDER or CBER to enable Agency staff to prepare for the arrival of the
protocol for assessment. The Agency recommends that a request for
special protocol assessment be submitted as an amendment to an IND for
two reasons: (1) To ensure that each request is kept in the
administrative file with the entire IND and (2) to ensure that
pertinent information about the request is entered into the appropriate
tracking databases. Use of the information in the Agency's tracking
databases enables the appropriate Agency official to monitor progress
on the evaluation of the protocol and to ensure that appropriate steps
will be taken in a timely manner.
    The guidance recommends that the following information should be
submitted to the appropriate Center with each request for special
protocol assessment so that the Center may quickly and efficiently
respond to the request:
     Questions to the Agency concerning specific issues
regarding the protocol; and
     All data, assumptions, and information needed to permit an
adequate evaluation of the protocol, including: (1) The role of the
study in the overall development of the drug; (2) information
supporting the proposed trial, including power calculations, the choice
of study endpoints, and other critical design features; (3) regulatory
outcomes that could be supported by the results of the study; (4) final
labeling that could be supported by the results of the study; and (5)
for a stability protocol, product characterization and relevant
manufacturing data.
    Description of Respondents: A sponsor, applicant, or manufacturer
of a drug or biologic product regulated by the Agency under the Federal
Food, Drug, and Cosmetic Act or section 351 of the Public Health
Service Act (42 U.S.C. 262) who requests special protocol assessment.
    Burden Estimate: Table 1 of this document provides an estimate of
the annual reporting burden for notifications for a carcinogenicity
protocol and requests for a special protocol assessment.
    Notification for a Carcinogenicity Protocol: Based on the number of
notifications for carcinogenicity protocols and the number of
carcinogenicity protocols currently submitted to CDER and CBER, CDER
estimates that it will receive approximately 52 notifications of an
intent to request special protocol assessment of a carcinogenicity
protocol per year from approximately 28 sponsors. CBER estimates that
it will receive approximately one notification of an intent to request
special protocol assessment of a carcinogenicity protocol per year from
approximately one sponsor. The hours per response, which is the
estimated number of hours that a sponsor would spend preparing the
notification and background information to be submitted in accordance
with the guidance, is estimated to be approximately 8 hours.
    Requests for Special Protocol Assessment: Based on the number of
requests for special protocol assessment currently submitted to CDER
and CBER, CDER estimates that it will receive approximately 211
requests for special protocol assessment per year from approximately
112 sponsors. CBER estimates that it will receive approximately nine
requests from approximately seven sponsors. The hours per response is
the estimated number of hours that a respondent would spend preparing
the information to be submitted with a request for special protocol
assessment, including the time it takes to gather and copy questions to
be posed to the Agency regarding the protocol and data, assumptions,
and information needed to permit an adequate evaluation of the
protocol. Based on the Agency's experience with these submissions, FDA
estimates approximately 15 hours on average would be needed per
response.
    FDA estimates the burden of this collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity              29             1.8              53               8             424
 Protocols......................
Requests for Special Protocol                119             1.8             220              15           3,300
 Assessment.....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,724
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27840 Filed 11-17-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Rules and Regulations]
[Page 38926]
[FR Doc No: 2021-15651]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0573]

Safety Zone; Spirit Lake Dredging

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the USX Superfund Site Safety
Zones: St. Louis River, and this notice of enforcement serves as a
reminder to mariners this is still an enforced safety zone under Coast
Guard regulations. Our regulation for safety zones within the Ninth
Coast Guard District identifies this area is a regulated area within
Spirit Lake Duluth, MN.

DATES: The regulations in 33 CFR 165.905(a)(1) and (2) will be enforced
from August 2, 2021, through November 30, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LTJG Joseph R. McGinnis, MSU
Duluth Waterways Management, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the USX
Superfund Site Safety Zones: St. Louis River, and this notice of
enforcement serves as a reminder to mariners this is still an enforced
safety zone under 33 CFR 165.905(a)(1) and (2) for the USX Superfund
Site Safety Zone: St. Louis River at Safety Zone #1 (North Spirit
Lake): North Boundary 46[deg]41'33'' W, South Boundary 46[deg]41'18''
W, East Boundary 92[deg]11'53'' W, West Boundary 92[deg]12'11'' W, and
Safety Zone #2 (South Spirit Lake): North Boundary 46[deg]40'45'' N,
South Boundary 46[deg]40'33'' N, East Boundary 92[deg]11'40'' W, West
Boundary 92[deg]12'05'' W. Transit of vessels through the waters
covered by these zones is prohibited. Swimming (including water skiing
or other recreational use of the water which involves a substantial
risk of immersion in the water) or taking of fish (including all forms
of aquatic animals) from the waters covered by these safety zones is
prohibited at all times. Our regulation for safety zones within the
Ninth Coast Guard District identifies this area is a regulated area
within Spirit Lake Duluth, MN. In addition to this notice of
enforcement in the Federal Register, the Coast Guard plans to provide
notification of this enforcement period via the Local Notice to
Mariners and marine information broadcasts.

    Dated: July 19, 2021.
Frances M. Smith,
CDR, U.S. Coast Guard, Captain of the Port MSU Duluth.
[FR Doc. 2021-15651 Filed 7-22-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18322-18323]
[DOCID:fr11ap06-91]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepting for Filing and Soliciting Motions
to Intervene, Protests and Comments

April 5, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12633-000.
    c. Date filed: December 21, 2005.
    d. Applicant: SV Hydro LLC.
    e. Name of Project: Saylorville Hydroelectric Project.
    f. Location: On the Des Moines River, Polk County, Iowa, utilizing
Federal lands administrated by the U.S. Army Corps of Engineers. The
existing dam is owned by the U.S. Army Corps of Engineers.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)--825(r).
    h. Applicant Contact: Mr. Douglas A. Spaulding, Spaulding
Consultants, LLC, 1433 Utica Avenue South, Suite 162, Minneapolis, MN
55416,<PHONE_NUMBER>.
    i. FERC Contact: Etta Foster,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Please include the project
number (P-12633-000) on any comments, protests, or motions filed.
    k. Description of Project: The proposed project would consist of
the existing U.S. Army Corps of Engineers' Saylorville Dam and would
consist of: (1) Thirty-six 280-kW submersible bulb-type turbine
generator units mounted on three independent movable racks for a total
installed capacity of 10 MW; (2) a raceway consisting of six 4,160-volt
buried cables and a 100 pair direct buried control cable; (3) a 30-
foot-square generator control building, (4) a switchyard; (5) a
proposed 7,000-foot-long,13.8-kV transmission line; and (6) appurtenant
facilities.
    The project would have an estimated annual generation of
approximately 50 gigawatt-hours. The applicant plans to sell the
generated energy.
    l. Location of Application: A copy of the application is available
for inspection and reproduction at the Commission in the Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
h. above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.

    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letter the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``MOTION TO INTERVENE'',
``NOTICE OF INTENT'', or ``COMPETING APPLICATION'', as applicable, and
the Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. A copy of any motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5306 Filed 4-10-06; 8:45 am]

BILLING CODE 6717-01-P