[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Proposed Rules]
[Pages 60926-60928]
[FR Doc No: 2020-19238]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 162

[Docket No. USCG-2020-0521]
RIN 1625-AA11

Connecting Waters From Lake Huron to Lake Erie; Traffic Rules

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to amend the navigation
regulations between the Great Lakes. Specifically, this proposed
amendment would allow a vessel to overtake another vessel that has
slowed its speed to await berth availability or to make the turn for
Rouge River and the overtaking vessel has so advised the Canadian Coast
Guard Marine communications and Traffic Services Centre located in
Sarnia, Ontario. Currently, the regulation only permits vessels to
overtake vessels engaged in towing between the west end of Belle Isle
and Peche Island Light. We invite your comments on this proposed
rulemaking.

DATES: Comments and related materials must reach the Coast Guard on or
before October 29, 2020.

ADDRESSES: You may submit comments identified by docket number USCG-
2020-0521 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Tracy Girard, Sector Detroit, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The purpose of this rulemaking is to update the navigation rule in
Sec.  162.134(a)(4) to improve traffic efficiency on the river while
maintaining safety. The Canadian Coast

Guard has modified their traffic rules to reflect this change and the
Lake Carriers Association has endorsed this change. This proposed rule
would provide consistency on the river, and would apprise the public in
a timely manner through permanent publication in Title 33 of the Code
of Federal Regulations.

III. Discussion of Proposed Rule

    This proposed modification to the rule will allow a vessel to
overtake another vessel that has slowed its speed to await berth
availability or to make the turn for Rouge River and the overtaking
vessel has so advised the Canadian Coast Guard Marine Communications
and Traffic Services Centre located in Sarnia, Ontario. This will
improve traffic efficiency on the river while maintaining safety.
Currently 33 CFR 162.134(a)(4) states, ``Between the west end of Belle
Isle and Peche Island Light, vessels may only overtake vessels engaged
in towing.'' We propose to replace 33 CFR 162.134(a)(4) with ``Between
the west end of Belle Isle and Peche Island Light, vessels may overtake
vessels if the vessel to be overtaken is engaged in towing or has
slowed its speed to await berth availability or to make the turn for
Rouge River, and the overtaking vessel has so advised the Canadian
Coast Guard Marine Communications and Traffic Services Centre located
in Sarnia, Ontario.''

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated areas may be small entities, for the reasons stated in
section IV.A above this proposed rule would not have a significant
economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves navigation
rules. Normally such actions are categorically excluded from further
review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your

message can be received without jeopardizing the safety or security of
people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects 33 CFR Part 162

    Navigation (water), Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 162 as follows:

PART 162--INLAND WATERWAYS NAVIGATION REGULATIONS

0
1. The authority citation for part 162 continues to read as follows:

    Authority:  33 U.S.C. 1231; Department of Homeland Security
Delegation No. 0170.1.

0
2. In Sec.  162.134, revise paragraph (a)(4) to read as follows:

Sec.  162.134   Connecting waters from Lake Huron to Lake Erie; traffic
rules.

    (a) * * *
    (4) Between the west end of Belle Isle and Peche Island Light,
vessels may overtake vessels if the vessel to be overtaken is engaged
in towing or has slowed its speed to await berth availability or to
make the turn for Rouge River, and the overtaking vessel has so advised
the Canadian Coast Guard Marine Communications and Traffic Services
Centre located in Sarnia, Ontario.
* * * * *

    Dated: August 26, 2020.
Brad. W. Kelly,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2020-19238 Filed 9-28-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Notices]
[Page 16091]
[DOCID:fr26mr08-140]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on December 6, 2007, vol. 72, no. 234, page
68950. The respondents supply information to the FAA Civil Aviation
Registry's Aircraft Registration Branch in order to obtain an
authorization code for access to the International Registry.

DATES: Please submit comments by April 25, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: FAA Entry Point Filing Form--International Registry.
    Type of Request: Revision of a currently approved collection.
    OMB Control Number: 2120-0697.
    Forms(s): 8050-135.
    Affected Public: An estimated 12,750 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 30 minutes per
response.
    Estimated Annual Burden Hours: An estimated 6,375 hours annually.
    Abstract: The respondents supply information through the AC Form
8050-135 to the FAA Civil Aviation Registry's Aircraft Registration
Branch in order to obtain an authorization code for access to the
International Registry.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to Nathan Lesser, Desk Officer, Department of Transportation/
FAA, and sent via electronic mail to<EMAIL_ADDRESS>or
faxed to<PHONE_NUMBER>.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on March 18, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
 [FR Doc. E8-5930 Filed 3-25-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56315-56317]
[FR Doc No: 2017-25693]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82152; File No. SR-NASDAQ-2017-122]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 4702

November 22, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 9, 2017, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
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

    The Exchange proposes to amend Rule 4702(b)(5) to provide that
Midpoint Peg Post-Only Orders may not participate in the Nasdaq Closing
Cross, and to make other technical changes with respect to Order Types
flagged for the Nasdaq Closing Cross pursuant to Rule 4702(b)(12).
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend Rule 4702(b)(5)
to provide that Midpoint Peg Post-Only Orders (``MPPOs'') may not
participate in the Nasdaq Closing Cross, and to make other technical
changes with respect to Order Types flagged for the Nasdaq Closing
Cross pursuant to Rule 4702(b)(12).
    An ``MPPO'' is defined in Rule 4702(b)(5) as an Order Type with a
Non-Display Order Attribute that is priced at the midpoint between the
national best bid and offer, and that will execute upon entry only in
circumstances where economically beneficial to the party entering the
Order. Today, MPPOs are available during Market Hours only, and MPPOs
remaining on the Nasdaq Book at 4:00 p.m. ET are cancelled by the
System. Due to how the Exchange currently processes these cancel
messages, however, Rule 4702(b)(5)(C) also provides that an MPPO may
participate in the Nasdaq Closing Cross if the Nasdaq Closing Cross
occurs prior to the cancellation message being fully processed. The
Exchange believes that it would be beneficial to members and investors
to completely prevent MPPOs from executing in the Nasdaq Closing Cross
rather than having their participation determined by whether the cancel
message is processed prior to the Nasdaq Closing Cross. The Exchange
therefore proposes to eliminate language indicating that MPPOs may
participate in the Nasdaq Closing Cross if the Nasdaq Closing Cross for
the security occurs prior to the cancellation message being fully
processed, and instead provide that MPPOs may not participate in the
Nasdaq Closing Cross. In connection with this change, the Exchange also
proposes to remove language indicating that the trading system
``attempts to'' cancel MPPOs prior to the commencement of the Nasdaq
Closing Cross as the ``attempts to'' language is no longer necessary
with the elimination of the race condition described above. With this
change members will have more certainty with respect to MPPO handling
for the Nasdaq Closing Cross since no MPPOs will be allowed to
participate, which is consistent with how the Exchange believes members
want these order treated. In addition, since the Exchange is explicitly
addressing MPPO availability for the Nasdaq Closing Cross in this rule,
the Exchange also proposes to add language indicating that MPPOs may
not participate in the Nasdaq Opening Cross. MPPOs are excluded from
the Nasdaq Opening Cross today as they can only be entered during
Market Hours and are cancelled at the end of the trading day.
Furthermore, Rule 4703(l) provides that Order Types except Supplemental
Orders participate in the Nasdaq Opening Cross and/or the Nasdaq
Closing Cross if the Order has a Time-in-Force that would cause the
Order to be in effect at the time of the Nasdaq Opening Cross and/or
Nasdaq Closing Cross. Since MPPOs will not be permitted to participate
in the Nasdaq Opening Cross or Nasdaq Closing Cross under any
circumstances, the Exchange proposes to amend Rule 4703(l) to state

that MPPOs do not participate in these crosses.
    Furthermore, Rule 4702(b)(12) contains language explaining which
Order Types are not available to be flagged for the Nasdaq Closing
Cross, including orders entered with a time-in-force of IOC, or orders
entered with a time-in-force that continues after the time of the
Nasdaq Closing Cross, i.e., Closing Cross/Extended Hours Orders. MPPOs
cannot be flagged for the Nasdaq Closing Cross today as closing cross
participation is not permitted for this Order Type, with the one
exception being remedied above. The same is also true of Supplemental
Orders. A ``Supplemental Order'' is an Order Type with a Non-Display
Order Attribute that is held on the Nasdaq Book in order to provide
liquidity at the NBBO through a special execution process described in
Rule 4757(a)(1)(D). Pursuant to Rule 4702(b)(6)(B), Supplemental Orders
are not permitted to participate in the Nasdaq Closing Cross. In
connection with the other changes described above, the Exchange
therefore proposes to amend Rule 4702(b)(12) to state that MPPOs and
Supplemental Orders may not be flagged to solely participate in the
Nasdaq Closing Cross. Rule 4702(b)(12) already contains language
indicating that these order types are not permitted to be entered as
Closing Cross/Extended Hours Orders. The Exchange believes that adding
this additional detail to the rule will make the operation of the
Exchange more transparent to members and other market participants.
Implementation
    The Exchange proposes to introduce the MPPO changes described in
this proposed rule change in Q4 2017 or Q1 2018. The Exchange will
announce the implementation date of this functionality in an Equity
Trader Alert issued to members prior to the launch date.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\3\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\4\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
As indicated in the Exchange's current rules, MPPOs are designed for
Market Hours trading and are therefore cancelled at 4:00 p.m. ET each
day when the Exchange begins processing the Nasdaq Closing Cross
pursuant to Rule 4754. Nevertheless, MPPOs may trade in the Nasdaq
Closing Cross in the race condition described above where the
cancellation of the MPPO is not processed by the trading system prior
to the Nasdaq Closing Cross. The Exchange believes that it is
consistent with the protection of investors and the public interest to
eliminate this race condition and ensure that no MPPOs participate in
the Nasdaq Closing Cross. This change will perfect the mechanism of a
free and open market by eliminating the possibility that MPPOs can
inadvertently make it into the Nasdaq Closing Cross due to the sequence
of messages received by the trading system. The Exchange believes that
members prefer not to have their MPPOs executed in the Nasdaq Closing
Cross, and therefore cancels these orders immediately prior to the
closing auction today. The proposed changes would further enhance MPPO
handling by ensuring that no MPPOs are permitted to trade in the Nasdaq
Closing Cross. Furthermore, the proposed rule change would increase
transparency surrounding the operation of the Exchange, and, in
particular, the availability of MPPOs and Supplemental orders to be
flagged for the Nasdaq Closing Cross. The Exchange believes that the
proposed changes will benefit members and other market participants by
specifying with additional clarity that these Order Types cannot be
flagged for participation in the Nasdaq Closing Cross, as closing cross
participation is not available for either MPPOs or Supplemental Orders.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Currently, MPPOs can
participate in the Nasdaq Closing Cross if the cancel message is not
fully processed prior to the closing auction. The Exchange is now
enhancing MPPO handling to prevent all MPPOs from participating in the
Nasdaq Closing Cross. The Exchange does not believe this change will
have any significant impact on competition as no members will have
their MPPOs participate in the Nasdaq Closing Cross, which is how the
Exchange believes members want these orders treated. Furthermore, the
other proposed change with respect to handling of MPPOs and
Supplemental Orders that are flagged for the Nasdaq Closing Cross is a
non-substantive clarifying change and will therefore have no impact on
competition.

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

    No written comments were either solicited or received.

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

    Because the 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) of the Act \5\ and Rule 19b-
4(f)(6) thereunder.\6\
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 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 the text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (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-NASDAQ-2017-122 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-NASDAQ-2017-122. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. 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-NASDAQ-2017-122 and should
be submitted on or before December 19, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-25693 Filed 11-27-17; 8:45 am]
 BILLING CODE 8011-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Monday, October 19, 2020 12:47 PM
To:
Knight, Jeffrey A<EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
Re: COETF Comments on EPA - DLL

The rationale was that is was a conservative measure.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Knight, Jeffrey A<EMAIL_ADDRESS>Sent: Monday, October 19, 2020 12:36 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: RE: COETF Comments on EPA - DLL

Got it, thanks again for following up.  We will also take a look at older RTR rules as well.  Again, we are trying to understand the rationale for why EPA would use 100% of the detection limit when it is a DLL situation vs 50% of the detection limit when it is a BDL.  The 50% approach has been EPA's long-standing practice for BDLs, and the rationale is sound for the BDL part of a DLL as well because it uses the middle value of the range of possible values between zero and the detection limit.  Thanks, - Jeff

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Monday, October 19, 2020 12:25 PM
To: Knight, Jeffrey A<EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: Re: COETF Comments on EPA - DLL

Mr Knight - So far, the consensus is that this is policy, as a conservative measure, and is in all our RTR rules to date. I don't have any time to look into the old rules right now (other than Integrated Steel) but maybe some time before we propose the rule. I will also check with the risk analyst for this project later this week to see if its been written down anywhere outside of the Federal Register (FR) and Code of Federal Regulations (CFR). The risk analyst (Ted Palma) was out of office last week. Our SPPD division RTR coordinator however already stated it was policy and in the FR and CFR.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Friday, October 16, 2020 12:13 PM
To:
Knight, Jeffrey A<EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
Re: COETF Comments on EPA - new RTI designation letter attached

Mr. Knight-- I will check into getting an "official"  document. I'm sure there is something. It's also in all the published FR notices to date that had this issue, so even if we do not have a "policy" memo, it's as firm as the "policy" to not treat COE as COE after a control device, which was written in the FR notice and support documents but not in any official memo. Also, the procedure was used in my recent rule (published 7/13/20) on the Integrated Iron and Steel RTR (subpart FFFFF). See the "Data memo" in the docket.

I will ask the measurement group today but it might be until Monday before I get a response because many people have Friday off if they work on a compressed schedule.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Knight, Jeffrey A<EMAIL_ADDRESS>Sent: Friday, October 16, 2020 8:42 AM
To: Jones, DonnaLee<EMAIL_ADDRESS>Allen Dittenhoefer<EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: RE: COETF Comments on EPA - new RTI designation letter attached

Dr. Jones, thank you for the quick responses.  On the DLL issue, you reference a measurement technology group policy.  Is this a written policy or just a practice?  If it's a written policy, we'd like to get a copy so we can understand better why EPA would use differing approaches for DLL vs. BDL situations.  Many thanks, - Jeff

Jeffrey A. Knight | Partner
Pillsbury Winthrop Shaw Pittman LLP
1200 Seventeenth Street NW | Washington, DC 20036-3006

t +1.202.663.9152 | m +1.703.887.6683

<EMAIL_ADDRESS>| website bio


[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Page 15001]
[FR Doc No: 2015-06502]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9020-1]

Environmental Impact Statements; Notice of Availability

AGENCY: Office of Federal Activities, General Information (202) 564-
7146 or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 03/09/2015 Through 03/13/2015
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20150063, Draft EIS, NOAA, HI, Hawaiian Islands Humpback Whale
National Marine Sanctuary Draft Management Plan, Comment Period Ends:
06/19/2015, Contact: Edward Lindelof<PHONE_NUMBER>.
EIS No. 20150064, Final EIS, USACE, FL, Port Everglades Harbor
Navigation, Review Period Ends: 04/20/2015, Contact: Terri Jordan-
Sellers,<PHONE_NUMBER>.
EIS No. 20150065, Final EIS, FERC, 00, Multi-Project for Hydropower
Licenses-Susquehanna River Hydroelectric Projects, Review Period Ends:
04/20/2015, Contact: Emily Carter<PHONE_NUMBER>.
EIS No. 20150066, Draft Supplement, VA, CA, San Francisco Veterans
Affairs Medical Center (SFVAMC) Long Range Development Plan, Comment
Period Ends: 05/18/2015, Contact: Robin Flanagan<PHONE_NUMBER>.
EIS No. 20150067, Draft EIS, BIA, IN, Pokagon Band of Potawatomi
Indians Fee-to-Trust Transfer for Tribal Village and Casino City of
South Bend, Comment Period Ends: 05/04/2015, Contact: Scott Doig 612-
725-4514.
EIS No. 20150068, Draft Supplement, USFS, OR, Wallowa-Whitman National
Forest Invasive Plants Treatment Project, Comment Period Ends: 05/04/
2015, Contact: Gene Yates<PHONE_NUMBER>.
EIS No. 20150069, Final EIS, USN, PA, Disposal and Reuse of the Former
Naval Air Station Joint Reserve Base (NAS JRB) Willow Grove, Review
Period Ends: 04/20/2015, Contact: James Anderson<PHONE_NUMBER>.
EIS No. 20150070, Revised Final EIS, USFS, ID, Lower Orogrande Project,
Review Period Ends: 04/20/2015, Contact: George Harbaugh<PHONE_NUMBER>.
EIS No. 20150071, Draft EIS, USACE, CA, American River Common Features,
Comment Period Ends: 05/04/2015, Contact: Anne Baker<PHONE_NUMBER>.
EIS No. 20150072, Revised Draft EIS, USACE, LA, Southwest Coastal
Louisiana, Comment Period Ends: 05/04/2015, Contact: Dr. William P.
Klein, Jr.<PHONE_NUMBER>.
EIS No. 20150073, Draft EIS, FTA, VA, Virginia Beach Transit Extension,
Comment Period Ends: 05/04/2015, Contact: Ryan Long<PHONE_NUMBER>.
EIS No. 20150074, Final EIS, USFS, OR, Lower Imnaha Rangeland Analysis,
Review Period Ends: 04/20/2015, Contact: Kris Stein<PHONE_NUMBER>.

     Dated: March 17, 2015.
Dawn Roberts,
Management Analyst, Office of Federal Activities.
[FR Doc. 2015-06502 Filed 3-19-15; 8:45 am]
 BILLING CODE 6560-50-P


Appendix I Pg. 1 of 15 Appendix I Daily Surface Water Volume Simulated Under Standard and Scenario Specific Water Body Conditions Appendix I Pg. 2 of 15 Appendix I Pg. 3 of 15 Appendix I Pg. 4 of 15 Appendix I Pg. 5 of 15 Appendix I Pg. 6 of 15 Appendix I Pg. 7 of 15 Appendix I Pg. 8 of 15 Appendix I Pg. 9 of 15 Appendix I Pg. 10 of 15 Appendix I Pg. 11 of 15 Appendix I Pg. 12 of 15 Appendix I Pg. 13 of 15 Appendix I Pg. 14 of 15 Appendix I Pg. 15 of 15


[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42826-42827]
[FR Doc No: 2015-17712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1992-N-0199]

David J. Brancato: Grant of Special Termination; Final Order
Terminating Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) granting
special termination of the debarment of David J. Brancato. FDA bases
this order on a finding that Dr. Brancato provided substantial
assistance in the investigations or prosecutions of offenses relating
to a matter under FDA's jurisdiction, and that special termination of
Dr. Brancato's debarment serves the interest of justice and does not
threaten the integrity of the drug approval process.

DATES: This order is effective July 20, 2015.

ADDRESSES: Comments should reference Docket No. FDA-1992-N-0199 and be
sent to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144),
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a Federal Register notice dated January
6, 1994 (59 FR 00751), David J. Brancato, a former review chemist with
FDA's Division of Generic Drugs was permanently debarred from providing
services in any capacity to a person with an approved or pending drug
product application under section 306(a) of the FD&C Act (21 U.S.C.
335a(a)). The debarment was based on FDA's finding that Dr. Brancato
was convicted of a felony under Federal law for conduct relating to the
development, or approval of any drug product, or otherwise relating to
the regulation of a drug product. On May 26, 1998, Dr. Brancato applied
for special termination of debarment, under section 306(d)(4) of the
FD&C Act, as amended by the Generic Drug Enforcement Act. On April 15,
2015, the Agency requested additional information. On April 20, 2015,
Dr. Brancato provided the requested information.
    Under section 306(d)(4)(C) and (d)(4)(D) of the FD&C Act, FDA may
limit the period of debarment of a permanently debarred individual if
the Agency finds that: (1) The debarred individual has provided
substantial assistance in the investigation or prosecution of offenses
described in section 306(a) or (b) of the FD&C Act or relating to a
matter under FDA's jurisdiction; (2) termination of the debarment
serves the interest of justice; and (3) termination of the debarment
does not threaten the integrity of the drug approval process.
    Special termination of debarment is discretionary with FDA. FDA
generally considers a determination by the Department of Justice
concerning the substantial assistance of a debarred individual
conclusive in most cases. Dr. Brancato cooperated with the United
States Attorney's Office in the investigation of several individuals,
as substantiated by letters submitted to the Agency by Thomas Holland,
a Special Agent in the Office of the Inspector General, U.S. Department
of Health and Human Services, and the U.S. Attorney's Office for the
District of Columbia. His cooperation contributed to the successful
prosecution of these individuals, and in one instance continued over a
period of 7 years. Accordingly, FDA finds that Dr. Brancato provided
substantial assistance as required by section 306(d)(4)(C) of the FD&C
Act.
    The additional requisite showings, i.e., that termination of
debarment serves the interest of justice and poses no threat to the
integrity of the drug approval process, are difficult standards to
satisfy. In determining whether these have been met, the Agency weighs
the significance of all favorable and unfavorable factors in light of
the remedial, public health-related purposes underlying debarment.
Termination of debarment will not be granted unless, weighing all
favorable and unfavorable information, there is a high level of
assurance that the conduct that formed the basis for debarment has not
recurred and will not recur, and that the individual will not otherwise
pose a threat to the integrity of the drug approval process.
    The evidence presented to FDA in support of termination shows that
Dr. Brancato was convicted for a first offense; that he has no prior or
subsequent convictions for conduct described under the FD&C Act and has
committed no other wrongful acts affecting the drug approval process;
and that his character and scientific accomplishments are highly
regarded by his professional peers. The evidence

presented supports the conclusion that the conduct upon which Dr.
Brancato's debarment was based is unlikely to recur. For these reasons,
the Agency finds that termination of Dr. Brancato's debarment serves
the interest of justice and will not pose a threat to the integrity of
the drug approval process.
    Under section 306(d)(4)(D) of the FD&C Act, the period of debarment
of an individual who qualifies for special termination may be limited
to less than permanent but to no less than 1 year. Dr. Brancato's
period of debarment, which commenced on January 6, 1994, has lasted
more than 1 year. Accordingly, the Director of the Office of
Enforcement and Import Operations, under section 306(d)(4) of the FD&C
Act and under authority delegated to the Director (Staff Manual Guide
1410.35), finds that David J. Brancato's application for special
termination of debarment should be granted, and that the period of
debarment should terminate immediately, thereby allowing him to provide
services in any capacity to a person with an approved or pending drug
product application. The Director of Enforcement and Import Operations
further finds that because the Agency is granting Dr. Brancato's
application, an informal hearing under section 306(d)(4)(C) of the FD&C
Act is unnecessary.
    As a result of the foregoing findings, Dr. David J. Brancato's
debarment is terminated effective (see DATES) (21 U.S.C. 335a(d)(4)(C)
and (d)(4)(D)).

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17712 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89949-89950]
[FR Doc No: 2016-29814]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2836]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Donor Risk Assessment
Questionnaire for the Food and Drug Administration/National Heart,
Lung, and Blood Institute-Sponsored Transfusion-Transmissible
Infections Monitoring System--Risk Factor Elicitation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
12, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--New and
title ``Donor Risk Assessment Questionnaire for the Food and Drug
Administration/National Heart, Lung, and Blood Institute-sponsored
Transfusion-Transmissible Infections Monitoring System--Risk Factor
Elicitation.'' Also include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
    Donor Risk Assessment Questionnaire for FDA/National Heart, Lung,
and Blood Institute (NHLBI)-sponsored Transfusion-Transmissible
Infections Monitoring System (TTIMS)--Risk Factor Elicitation OMB
Control Number--New
    FDA intends to interview blood donors to collect risk factor
information associated with testing positive for a Transfusion-
Transmissible Infection (TTI). This collection of information is part
of a larger initiative called TTIMS, which is a collaborative project
funded by FDA, the NHLBI of the National Institutes of Health (NIH),
and the Department of Health and Human Services (HHS) Office of the
Assistant Secretary of Health with input from other Agencies in HHS,
including the Centers for Disease Control and Prevention (CDC). FDA
will use these scientific data collected through such interview-based
risk factor elicitation of blood donors to monitor and help ensure the
safety of the U.S. blood supply.
    Previous assessments of risk factor profiles among blood donors
found to be positive for human immunodeficiency virus (HIV) were funded
by CDC for approximately 10 years after implementation of HIV serologic
screening of blood donors in the mid-1980s; whereas studies of
Hepatitis C virus (HCV) seropositive donors, funded by NIH, were
conducted in the early 1990s. Information on current risk factors in
blood donors as assessed using analytical study designs was next
evaluated by the Transfusion-Transmitted Retrovirus and Hepatitis Virus
Rates and Risk Factors Study conducted by the NHLBI Retrovirus
Epidemiology Donor Study-II (REDS-II) approved under OMB control number
0925-0630. Through a risk factor questionnaire, this study elicited
risk factors in blood donors who tested confirmed positive for one of
four transfusion-transmissible infections: HIV, HCV, Hepatitis B virus
(HBV), and Human T-cell Lymphotropic virus. The study also elicited
risk factors from donors who did not have any infections (controls) and
compared their responses to those of the donors with confirmed
infection (cases). Results from the REDS-II study were published in
2015.
    FDA issued a document entitled ``Revised Recommendations for
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products, Guidance for Industry'' dated December 2015 (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf)
that changed the blood donor criterion for men who have sex with men
(MSM) from an indefinite (permanent) deferral to a 12-month deferral
since last MSM contact. The impact of this change in the deferral
criteria requires a national monitoring effort as part of TTIMS to
assess if the relative proportions of risk factors for infection in
blood donors have changed following the adoption of the 12-month donor
deferral for MSM. TTIMS will use similar procedures as the ones used in
the REDS-II study to monitor and evaluate risk factors among HIV-
positive donors and recently HCV or HBV infected donors as well as
controls.
    This study will help identify the specific risk factors for TTI and
their prevalence in blood donors, and help inform FDA on the proportion
of incident (new) infections among all HIV positive blood donors.
Donations with incident infections have the greatest potential
transmission risk because they could be missed during routine blood
screening. The study will help FDA evaluate the effectiveness of
screening strategies in reducing the risk of HIV transmission from at-
risk donors and to evaluate if there are unexpected consequences
associated with the recent change in donor deferral policy such as an
increase in HIV incidence among donors. These data also will inform FDA
regarding future blood donor deferral policy options to reduce the risk
of HIV transmission, including the feasibility of moving from the
existing time-based deferrals related to risk behaviors to alternate
deferral options, such as the use of individual risk assessments, and
to inform the design of potential studies to evaluate the feasibility
and effectiveness of such alternative deferral options.
    TTIMS will include a comprehensive interview based epidemiological
study of risk factor information for viral infection-positive blood
donors at the American Red Cross (ARC), Blood Systems, Inc. (BSI), New
York Blood Center (NYBC), and OneBlood that will identify the current
predominant risk factors and reasons for virus-positive donations. The
TTIMS program establishes a new, ongoing donor hemovigilance capacity
that currently does not exist in the United States. Using procedures
developed by the REDS-II study, TTIMS will establish this capacity in
greater than 50 percent of all blood donations collected in the
country.
    As part of the TTIMS project, a comprehensive hemovigilance
database will be created that integrates the risk

factor information collected through donor interviews of blood donor
with the resulting data from disease marker testing and blood
components collected by participating organizations into a research
database. Following successful initiation of the risk factor
interviews, the TTIMS network is poised to be expanded to include
additional blood centers and/or re-focused on other safety threats as
warranted. In this way, the TTIMS program will maintain standardized,
statistically and scientifically robust processes for applying
hemovigilance information across blood collection organizations.
    The specific objectives are to:
     Determine current behavioral risk factors associated with
all HIV infections, incident HBV, and incident HCV infections in blood
donors (including parenteral and sexual risks) across the participating
blood collection organizations using a case-control study design.
     Determine infectious disease marker prevalence and
incidence for HIV, HBV, and HCV overall and by demographic
characteristics of donors in the majority of blood donations collected
in the country. This will be accomplished by forming epidemiological
databases consisting of harmonized operational data from ARC, BSI,
NYBC, and OneBlood.
     Analyze integrated risk factor and infectious marker
testing data concurrently because when taken together these may suggest
that blood centers are not achieving the same degree of success in
educational efforts to prevent donation by donors with risk behaviors
across all demographic groups.
    The respondents will be persons who donated blood in the United
States and these participants will be defined as cases and controls.
The estimated number of respondents is based on an overall expected
participation in the risk factor survey. We estimate a case to control
ratio of 1:2 (200 to 400) with a 50 percent case enrollment.
    In the Federal Register of September 30, 2016 (81 FR 67358), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received a few comments from the public.
FDA concurs with one comment that providing more information to the
blood center and FDA may aid in prevention of transmission of
infectious disease and is critical to the safety of the blood supply.
Four comments received were not responsive to the comment request on
the four specified aspects of the collection of information. None of
the responses specifically commented on any of the proposed questions,
nor did they request that FDA make any other changes to the Donor Risk
Assessment Questionnaire. Furthermore, the responses did not provide
any data or explanation that would support a change regarding the
information collection requirements.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Questionnaire/survey          Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cases and controls \2\........             600               1             600  0.75 (45                     450
                                                                                minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Cases consist of virus-positive donations, and controls represent uninfected donors.

    Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29814 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 14, 2008 (Volume 73, Number 199)]
[Notices]
[Page 60740-60742]
[DOCID:fr14oc08-99]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58744; File No. SR-ISE-2008-76]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

October 7, 2008.
    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 October 3, 2008, the International Securities Exchange, LLC (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested parties.
---------------------------------------------------------------------------

    \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 ISE is proposing to amend its Schedule of Fees to establish
fees for transactions in options on 5 Premium Products.\3\ The text of
the proposed rule change is available at the Exchange.
---------------------------------------------------------------------------

    \3\ Premium Products is defined in the Schedule of Fees as the
products enumerated therein.
---------------------------------------------------------------------------

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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 Exchange is proposing to amend its Schedule of Fees to
establish fees for transactions in options on the iShares Dow Jones
U.S. Oil Equipment & Services Index Fund (``IEZ''),\4\ the
Vanguard[supreg] Information Technology ETF (``VGT''),\5\ the
Vanguard[supreg] Mid-Cap ETF (``VO''),\6\ the SPDR[supreg] S&P Biotech
ETF

 (``XBI''),\7\ and the SPDR[supreg] S&P Oil & Gas Equipment & Services
ETF (``XES'').\8\ The Exchange represents that IEZ, VGT, VO, XBI and
XES are eligible for options trading because they constitute
``Exchange-Traded Fund Shares,'' as defined by ISE Rule 502(h).
---------------------------------------------------------------------------

    \4\ iShares[supreg] is a registered trademark of Barclays Global
Investors, N.A. (``BGI''), a wholly owned subsidiary of Barclays
Bank PLC. ``Dow Jones'' and ``Dow Jones U.S. Oil Equipment &
Services Index'' are trademarks and service marks of Dow Jones &
Company, Inc. (``Dow Jones'') and have been licensed for use for
certain purposes by BGI. All other trademarks and service marks are
the property of their respective owners. The iShares Dow Jones U.S.
Oil Equipment & Services Index Fund (``IEZ'') is not sponsored,
endorsed, or promoted by Dow Jones. BGI and Dow Jones have not
licensed or authorized ISE to (i) engage in the creation, listing,
provision of a market for trading, marketing, and promotion of
options on IEZ or (ii) to use and refer to any of their trademarks
or service marks in connection with the listing, provision of a
market for trading, marketing, and promotion of options on IEZ or
with making disclosures concerning options on IEZ under any
applicable federal or state laws, rules or regulations. BGI and Dow
Jones do not sponsor, endorse, or promote such activity by ISE, and
are not affiliated in any manner with ISE.
    \5\ Vanguard, Vanguard ETFs and Vanguard ETF are trademarks of
The Vanguard Group, Inc. (``Vanguard''). All other marks are the
exclusive property of their respective owners. The Vanguard[supreg]
Information Technology ETF (``VGT'') tracks the Morgan Stanley
Capital International[supreg] (MSCI[supreg]) U.S. Investable Market
Information Technology Index. MSCI does not sponsor, endorse, or
promote VGT and makes no representation regarding the advisability
of investing in VGT. Vanguard and MSCI have not licensed or
authorized ISE to (i) engage in the creation, listing, provision of
a market for trading, marketing, and promotion of options on VGT or
(ii) to use and refer to any of their trademarks or service marks in
connection with the listing, provision of a market for trading,
marketing, and promotion of options on VGT or with making
disclosures concerning options on VGT under any applicable federal
or state laws, rules or regulations. Vanguard and MSCI do not
sponsor, endorse, or promote such activity by ISE, and are not
affiliated in any manner with ISE.
    \6\ Vanguard, Vanguard ETFs and Vanguard ETF are trademarks of
The Vanguard Group, Inc. (``Vanguard''). All other marks are the
exclusive property of their respective owners. The Vanguard[supreg]
Mid-Cap ETF (``VO'') tracks the Morgan Stanley Capital
International[supreg] (MSCI[supreg]) U.S. Mid Cap 450 Index. MSCI
does not sponsor, endorse, or promote VO and makes no representation
regarding the advisability of investing in VO. Vanguard and MSCI
have not licensed or authorized ISE to (i) engage in the creation,
listing, provision of a market for trading, marketing, and promotion
of options on VO or (ii) to use and refer to any of their trademarks
or service marks in connection with the listing, provision of a
market for trading, marketing, and promotion of options on VO or
with making disclosures concerning options on VO under any
applicable federal or state laws, rules or regulations. Vanguard and
MSCI do not sponsor, endorse, or promote such activity by ISE, and
are not affiliated in any manner with ISE.
    \7\ ``Standard & Poor's[supreg],'' ``S&P[supreg],'' ``S&P
500[supreg],'' ``Standard & Poor's 500[supreg],'' ``Standard &
Poor's Depositary Receipts[supreg],'' ``SPDR[supreg],'' and ``the
S&P[supreg] Biotechnology Select Industry Index'' are trademarks of
The McGraw-Hill Companies, Inc. (``McGraw-Hill''), and have been
licensed for use by State Street Bank and Trust (``State Street'')
in connection with the listing and trading of SPDR[supreg] S&P
Biotech ETF (``XBI''). State Street and Standard & Poor's (``S&P''),
a division of McGraw-Hill, do not sponsor, endorse or promote XBI
and make no representation regarding the advisability of investing
in XME. State Street, McGraw-Hill and S&P have not licensed or
authorized ISE to (i) engage in the creation, listing, provision of
a market for trading, marketing, and promotion of options on XBI or
(ii) to use and refer to any of their trademarks or service marks in
connection with the listing, provision of a market for trading,
marketing, and promotion of options on XBI or with making
disclosures concerning options on XBI under any applicable federal
or state laws, rules or regulations. State Street, McGraw-Hill and
S&P do not sponsor, endorse, or promote such activity by ISE and are
not affiliated in any manner with ISE.
    \8\ ``Standard & Poor's[supreg],'' ``S&P[supreg],'' ``S&P
500[supreg],'' ``Standard & Poor's 500[supreg],'' ``Standard &
Poor's Depositary Receipts[supreg],'' ``SPDR[supreg],'' and ``the
S&P[supreg] Oil & Gas Equipment & Services Select Industry Index''
are trademarks of The McGraw-Hill Companies, Inc. (``McGraw-Hill''),
and have been licensed for use by State Street Bank and Trust
(``State Street'') in connection with the listing and trading of
SPDR[supreg] S&P Oil & Gas Equipment & Services ETF (``XES''). State
Street and Standard & Poor's (``S&P''), a division of McGraw-Hill,
do not sponsor, endorse or promote XES make no representation
regarding the advisability of investing in XES. State Street,
McGraw-Hill and S&P have not licensed or authorized ISE to (i)
engage in the creation, listing, provision of a market for trading,
marketing, and promotion of options on XES or (ii) to use and refer
to any of their trademarks or service marks in connection with the
listing, provision of a market for trading, marketing, and promotion
of options on XES or with making disclosures concerning options on
XES under any applicable federal or state laws, rules or
regulations. State Street, McGraw-Hill and S&P do not sponsor,
endorse, or promote such activity by ISE and are not affiliated in
any manner with ISE.
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    All of the applicable fees covered by this filing are identical to
fees charged by the Exchange for all other Premium Products.
Specifically, the Exchange is proposing to adopt an execution fee for
all transactions in options on IEZ, VGT, VO, XBI and XES.\9\ The amount
of the execution fee for products covered by this filing shall be $0.18
per contract for all Public Customer Orders \10\ and Firm Proprietary
orders.\11\ The amount of the execution fee for all ISE Market Maker
transactions shall be equal to the execution fee currently charged by
the Exchange for ISE Market Maker transactions in equity options.\12\
Finally, the amount of the execution fee for all non-ISE Market Maker
transactions shall be $0.45 per contract.\13\ Further, since options on
IEZ, VGT, VO, XBI and XES are multiply-listed, the Exchange's Payment
for Order Flow fee shall apply to all these products. The Exchange
believes the proposed rule change will further the Exchange's goal of
introducing new products to the marketplace that are competitively
priced.
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    \9\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2009, these fees
will also be charged to Linkage Principal Orders (``Linkage P
Orders'') and Linkage Principal Acting as Agent Orders (``Linkage P/
A Orders''). The amount of the execution fee charged by the Exchange
for Linkage P Orders and Linkage P/A Orders is $0.24 per contract
side and $0.15 per contract side, respectively. See Securities
Exchange Act Release No. 58143 (July 11, 2008), 73 FR 41388 (July
18, 2008) (SR-ISE-2008-52).
    \10\ Public Customer Order is defined in Exchange Rule
100(a)(39) as an order for the account of a Public Customer. Public
Customer is defined in Exchange Rule 100(a)(38) as a person or
entity that is not a broker or dealer in securities.
    \11\ The execution fee for firm proprietary orders is $0.20 per
contract, effective October 1, 2008. See Securities Exchange Act
Release No. 34-58671 [sic] (September 29, 2008), 73 FR 57722
(October 3, 2008) (SR-ISE-2008-71).
    \12\ The Exchange applies a sliding scale, between $0.01 and
$0.18 per contract side, based on the number of contracts an ISE
market maker trades in a month.
    \13\ The amount of the execution fee for non-ISE Market Maker
transactions executed in the Exchange's Facilitation and
Solicitation Mechanisms is $0.19 per contract.
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    Further, as a matter of housekeeping, the Exchange proposes to
remove IXX from the list of Premium Products on its Schedule of
fees.\14\ The Exchange also proposes to remove IXX and IXK \15\ from
the Payment for Order Flow fee line item on its Schedule of Fees.
Additionally, the Exchange recently adopted a sliding scale-based fee
credit applicable to the Exchange's Electronic Access Members (SR-ISE-
2008-71). The Exchange proposes to make a clarifying change to the rule
text applicable to the sliding scale. Specifically, the Exchange
proposes to add the word ``Thereafter,'' at the beginning of the last
bullet under the Firm Proprietary fee line item to clarify, as it was
stated in the purpose section of that filing, that the credit available
to member firms under this bullet applies once member firms have
achieved the criteria under the first three bullets.
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    \14\ This Premium Product was recently delisted and no longer
trades on the Exchange. Thus, the Exchange proposes to remove it
from its fee schedule. ISE filed SR-ISE-2008-75 on September 25,
2008 to, in part, delete IXX from its Schedule of Fees. However, in
that filing the Exchange inadvertently failed to mark IXX as deleted
text on its Schedule of Fees. ISE subsequently withdrew SR-ISE-2008-
75 and is submitting the instant filing with the corrected rule text
to replace that filing. The other fees covered by that filing, which
took effect on September 25, remain unchanged.
    \15\ The Exchange had previously filed to remove IXK from its
Schedule of Fees when this product ceased trading on the Exchange.
See Securities Exchange Act Release No. 57831 (May 16, 2008), 73 FR
30176 (May 23, 2008) (SR-ISE-2008-39). The Exchange inadvertently
failed to remove IXK from the Payment for Order Flow fee line item
in that filing and thus, proposes to do so with the instant filing.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6(b) of the Act,\16\ in general, and
furthers the objectives of Section 6(b)(4),\17\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges among its members and other persons using
its facilities.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \18\ and subparagraph (f)(2) of Rule 19b-4 \19\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(2).
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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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2008-76 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-ISE-2008-76. 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 inspection and
copying 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 the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISE-2008-76 and should be
submitted on or before November 4, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-24237 Filed 10-10-08; 8:45 am]

BILLING CODE 8011-01-P