[Federal Register Volume 78, Number 61 (Friday, March 29, 2013)]
[Rules and Regulations]
[Pages 19103-19105]
[FR Doc No: 2013-07283]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0166]
RIN 1625-AA00

Safety Zone; Spanish Navy School Ship San Sebastian El Cano
Escort; Bahia de San Juan; San Juan, PR

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
on the waters of Bahia de San Juan during the transit of the Spanish
Navy School Ship San Sebastian El Cano, a public vessel, and during
their 21 gun salute in accordance with the military tradition of vessel
proving that it is unarmed upon entrance into a foreign country. The
safety zone is necessary to protect the public from the hazards
associated with the 21 gun salute near the Bar Channel entrance, and to
protect the high ranking officials on board the Spanish Navy School
Ship San Sebastian El Cano. The inbound escort is scheduled to take
place on Saturday, April 6, 2013, and will entail an escort of the
Spanish Navy School Ship San Sebastian El Cano and 21 gun salute. The
outbound escort is scheduled to take place on Wednesday, April 10,
2013. The safety zone is necessary to ensure the safety of high ranking
officials, commercial traffic, spectators, and the general public on
the navigable waters of the United States during the transit and
salute. Persons and vessels are prohibited from entering, transiting
through, anchoring in, or remaining within the safety zone unless
authorized by the Captain of the Port San Juan or a designated
representative.

DATES: This rule is effective from 8 a.m. on April 6, 2013, until 10
a.m. on April 10, 2013. This rule will be enforced from 8 a.m. until
9:30 a.m. on April 6, 2013, and from 8 a.m. until 10 a.m. on April 10,
2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0166]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Warrant Officer Anthony Cassisa, Sector San Juan
Prevention Department, U.S. Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. The Coast Guard
did not receive the request for an escort and safety zone nor a
confirmed itinerary, from the Office of Puerto Rican Secretary of State
with sufficient time to publish an NPRM and to receive public comments
prior to the event. Any delay in the effective date of this rule would
be impracticable because immediate action is needed to minimize
potential danger to high ranking officials and the general public.
    Under 5 U.S.C. 553(d)(3), for the same reasons as above, the Coast
Guard finds that good cause exists for making this rule effective less
than 30 days after publication in the Federal Register.

B. Basis and Purpose

    On April 6, 2013, the Spanish Navy School Ship San Sebastian El
Cano, a public vessel will be transiting in with high ranking officials
to honor and return the remains of Captain Ramon Power y Giralt, a
famous and respected Puerto Rican Navy Captain. The escort will be held
on the waters of Bahia de San Juan, San Juan, Puerto Rico of the
Spanish Navy School Ship San Sebastian El Cano, and will include a 21
gun salute near the Bar Channel entrance.
    The purpose of the rule is to protect high ranking officials on
board the Spanish Navy School Ship San Sebastian El Cano and the public
from the hazards associated with the 21 gun salute over navigable
waters of the United States.
    The legal basis for the rule is the U. S. Coast Guard's authority
to establish regulated navigation areas and other limited access areas:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195;
33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.

C. Discussion of the Final Rule

    The safety zone encompasses certain waters of Bahia de San Juan,
San Juan, Puerto Rico. The safety zone will be enforced from 8 a.m. to
9:30 a.m. on April 6, 2013, and from 8 a.m. to 10 a.m. on April 10,
2013.

    Persons and vessels are prohibited from entering, transiting
through, anchoring in, or remaining within the safety zone unless
authorized by the Captain of the Port San Juan or a designated
representative. Persons and vessels may request authorization to enter,
transit through, anchor in, or remain within the safety zone by
contacting the Captain of the Port San Juan by telephone at (787) 289-
2041, or a designated representative via VHF radio on channel 16. If
authorization to enter, transit through, anchor in, or remain within
the safety zone is granted by the Captain of the Port San Juan or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port San Juan or a designated representative. The U. S. Coast Guard
will provide notice of the safety zone by Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic impact of this rule is not significant for the
following reasons: (1) The special local regulation will be enforced
for only one and a half hours on the first day, and two hours four days
later; (2) although persons and vessels will not be able to enter,
transit through, anchor in, or remain within the safety zone without
authorization from the Captain of the Port San Juan or a designated
representative, they may operate in the surrounding area during the
enforcement period; (3) persons and vessels may still enter, transit
through, anchor in, or remain within the safety zone during the
enforcement period if authorized by the Captain of the Port San Juan or
a designated representative; and (4) the Coast Guard will provide
advance notification of the special local regulation to the local
maritime community by Local Notice to Mariners and Broadcast Notice to
Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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 rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule may affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to enter,
transit through, anchor in, or remain within that portion of Bahia de
San Juan encompassed within the safety zone from 8 a.m. until 9:30 a.m.
on April 6, 2013, and from 8 a.m. until 10 a.m. on April 10, 2013. For
the reasons discussed in the Regulatory Planning and Review section
above, this rule will not have a significant economic impact on a
substantial number of small entities.

3. Assistance for Small Entities

    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 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,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    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 rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INTFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
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 rule involves a safety zone that will be enforced for
a maximum of three and a half hours. This rule is categorically
excluded, under, paragraph 34(g) of Figure 2-1 of the Commandant
Instruction. An environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination are available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T07-0166 to read as follows:

Sec.  165.T07-0166  Safety Zone, Spanish Navy School Ship San Sebastian
El Cano escort, Bahia de San Juan; San Juan, PR.

    (a) Regulated Areas. The following regulated area is established as
a safety zone. All coordinates are North American Datum 1983.
    (1) Regulated Area. All waters within a 200 yard radius of the
vessel Spanish Navy School Ship San Sebastian El Cano while the vessel
is transiting within 1.5 nautical miles from the entrance of Bar
Channel on approach or departure from San Juan Harbor. Persons and
vessels are prohibited from entering, transiting through, anchoring in,
or remaining within the safety zone unless authorized by the Captain of
the Port San Juan.
    (b) Definition. The term ``designated representative'' means U.S.
Coast Guard Patrol Commanders, including U.S. Coast Guard coxswains,
petty officers, and other officers operating U.S. Coast Guard vessels,
and Federal, state, and local officers designated by or assisting the
Captain of the Port San Juan in the enforcement of the regulated areas.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
safety zone, unless authorized by the Captain of the Port San Juan.
    (2) Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the regulated area by contacting
the Captain of the Port San Juan by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. If authorization
is granted by the Captain of the Port San Juan or a designated
representative, all persons and vessels receiving such authorization
must comply with the instructions of the Captain of the Port San Juan
or a designated representative.
    (3) The U. S. Coast Guard will provide notice of the safety zone by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Enforcement Date. This rule will be enforced from 8 a.m. until
9:30 a.m. on April 6, 2013 and from 8 a.m. until 10:00 a.m. on April
10, 2013.

    Dated: March 19, 2013.
D. W. Pearson,
Captain, U.S. Coast Guard, Captain of the Port San Juan.
[FR Doc. 2013-07283 Filed 3-28-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 79 (Wednesday, April 26, 2017)]
[Notices]
[Pages 19300-19304]
[FR Doc No: 2017-08388]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80494; File No. SR-NYSEMKT-2017-21]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change To Adopt Rule 994NY,
Broadcast Order Liquidity Delivery Mechanism

April 20, 2017.
    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 April 11, 2017, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') 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 adopt Rule 994NY, Broadcast Order
Liquidity Delivery (``BOLD'') Mechanism. The proposed rule change is
available on the Exchange's Web site 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 purpose of the filing is to adopt a rule that governs the
operation of the Exchange's new BOLD Mechanism. As proposed, BOLD
Mechanism is a feature within the Exchange's trading system that would
provide automated order handling for eligible orders in designated
classes. Regarding BOLD Mechanism eligibility, the Exchange will
designate eligible order size, eligible order type, eligible capacity
code (e.g., Customer \4\ orders, non-Market Maker non-Customer orders,
and Market Maker \5\ orders), and classes in which the BOLD Mechanism
will be available. Orders must be specifically marked to be eligible
for the BOLD Mechanism. After trading with eligible interest on the
Exchange, the BOLD Mechanism will automatically process an eligible
incoming order that is marketable against quotations disseminated by
other exchanges that are participants in the Options Order Protection
and Locked/Crossed Market Plan (the ``Linkage Plan'').
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    \4\ The term ``Customer'' means an individual or organization
that is not a Broker/Dealer; when not capitalized, ``customer''
refers to any individual or organization whose order is being
represented, including a Broker/Dealer. See Rule 900.2NY(18).
    \5\ Market Makers are included in the definition of ATP Holders.
See Rule 900.2NY(5) (defining ATP Holder as ``a natural person, sole
proprietorship, partnership, corporation, limited liability company
or other organization, in good standing, that has been issued an
ATP,'' and requires that ``[a]n ATP Holder must be a registered
broker or dealer pursuant to Section 15 of the Securities Exchange
Act of 1934.'' See also Rule 900.2NY(38) (providing that a Market
Maker is ``an ATP Holder that acts as a Market Maker pursuant to
Rule 920NY'').
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    With respect to order handling, orders that are received by the
BOLD Mechanism pursuant to paragraph (a) of

the proposed rule will be electronically exposed at the National Best
Bid or Offer (``NBBO'') upon receipt. The exposure will be for a period
of time determined by the Exchange on a class-by-class basis, which
period of time will not exceed one second. All ATP Holders will be
permitted to trade against interest exposed during the exposure period.
    Regarding the allocation of exposed orders, any interest priced at
the prevailing NBBO or better will be executed pursuant to Rule 964NY
(Display, Priority and Order Allocation).\6\ If during the exposure
period the Exchange receives an order (or quote) on the opposite side
of the market from the exposed order that could trade against the
exposed order at the prevailing NBBO price or better, then the exposed
order will trade with such order at the prevailing NBBO price or
better. The exposure period will not terminate if the exposed order has
not been completely executed following such trade. Interest that is not
immediately executable based on the prevailing NBBO may become
executable during the exposure period based on changes to the NBBO. In
the event of a change to the NBBO during the exposure period, the
Exchange will evaluate the disseminated best bid/offer, and to the
extent possible, execute any remaining portion of the exposed order at
the best price(s) of resting interest on the Exchange. Following the
exposure period, the Exchange will route the remaining portion of the
exposed order to other exchanges, unless otherwise instructed by the
ATP Holder. Any portion of a routed order that returns unfilled will
trade against the Exchange's best bid/offer unless another exchange is
quoting at a better price in which case new orders will be generated
and routed to trade against such better prices. All executions on the
Exchange pursuant to this paragraph will comply with Rule 991NY (Order
Protection).
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    \6\ NYSE Amex provides customer priority and size pro-rata
allocation. Pursuant to Rule 964NY, customers at a given price are
executed first in priority. Non-customers are executed on a pro-rata
basis pursuant to the size pro rata algorithm set forth in Rule
964NY(b)(3).
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    Regarding the early termination of the exposure period, the
exposure period will terminate if the entire exposed order trades at
the NBBO or better. In addition, the exposure period will terminate
prior to its expiration and the exposed order will be processed in
accordance with paragraph (c) of the proposed rule if, during the
exposure period, the NBBO updates such that the exposed order is no
longer marketable against the prevailing NBBO.
    The purpose of the proposed rule change is to provide all ATP
holders with the opportunity to improve their prices and ``step up'' to
meet the NBBO in order to interact with orders sent to the Exchange.
This would allow the market participant sending an order to NYSE Amex
to increase its chances of receiving an execution at NYSE Amex (the
market participant's chosen venue) instead of having the order routed
to another exchange. This ``step up'' process allows market
participants to take into account factors beyond just disseminated
prices, such as execution costs, system reliability, and quality of
service, when determining the exchange to which to route an order. A
market participant that prefers NYSE Amex due to some combination of
these other factors will know that, even if NYSE Amex is not displaying
a price that is the NBBO, the market participant may still receive an
execution at NYSE Amex because another ATP Holder may ``step up'' to
match the NBBO. Further, the BOLD Mechanism and the ``step up'' process
enable ATP Holders to add liquidity that is available to interact with
orders sent to the Exchange. Indeed, when an ATP Holder on NYSE Amex
``steps up'' to match the NBBO that is displayed on another exchange,
more contracts may be executed at this NBBO price on NYSE Amex than are
available at that same price on another exchange.
    The Exchange's proposed BOLD Mechanism and the ``step up'' process
are not novel concepts. As proposed, the BOLD Mechanism is similar to
the Step Up Mechanism (``SUM'') offered on Bats EDGX Exchange, Inc.
(``EDGX''), which provides the same manner of ``step up'' process.\7\
Similar to SUM, the proposed BOLD Mechanism would be entirely
electronic.
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    \7\ See Securities Exchange Act Release No. 78339 (July 15,
2016), 81 FR 47461 (July 21, 2016) (SR-BatsEDGX-2016-29) (``SUM
Approval''). The SUM Approval was based on the Commission's prior
approval of the Chicago Board Options Exchange, Inc.'s (``CBOE'')
Hybrid Agency Liaison (``HAL''). See Securities Exchange Act Release
No. 60551 (August 20, 2009), 74 FR 43196 (August 26, 2009) (SR-CBOE-
2009-040) (``Approval of CBOE's HAL'').
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    Another similarity between the proposed BOLD Mechanism and SUM is
the determination by the Exchange to permit all ATP Holders to trade
against interest exposed during the exposure period.\8\ The proposed
BOLD Mechanism, however, is different from CBOE's HAL in that on CBOE,
only Market Makers with an appointment in the relevant option class and
Trading Permit Holders acting as agent for orders resting at the top of
CBOE's book in the relevant option series opposite the order submitted
to HAL may submit responses to the exposure message during the exposure
period (unless CBOE determines, on a class-by-class basis, to allow all
Trading Permit Holders to submit responses to the exposure message).
Therefore, on CBOE, an order will not be exposed if the CBOE quotation
contains resting orders and does not contain sufficient CBOE Market
Maker quotation interest to satisfy the entire order. The Exchange does
not propose this limitation because the proposed BOLD Mechanism is not
dependent only on Market Maker interest in any way, but rather, seeks
to expose the order for execution to all participants on NYSE Amex. In
this respect, the proposed BOLD Mechanism is similar to EDGX's SUM,
which also is not dependent just on Market Maker interest and exposes
orders to all participants on that exchange. Also, Interpretation and
Policy .01 to CBOE Rule 6.14A (the CBOE rule regarding HAL), which
prohibits the redistribution of exposure messages to market
participants not eligible to respond to such messages (except in
classes in which CBOE allows all Trading Permit Holders to respond to
such messages) also would not apply to the proposed BOLD Mechanism, as
all ATP Holders would be permitted to trade against the interest
exposed during the exposure period.
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    \8\ The Exchange is adopting the term ``interest'' rather than
``response'' (as known on EDGX) to distinguish that the BOLD
Mechanism is not an auction functionality that requires ATP Holders
to ``respond'' to an auction message. Rather, ATP Holders would be
permitted to trade against the ``interest'' that is exposed during
the exposure period in accordance with the execution priority set
forth in Rule 964NY(b)(3).
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    With regards to early termination of the exposure period, while the
Exchange proposes different criteria for early termination of an
exposure period than those reasons set forth in the corresponding CBOE
rule regarding HAL, the proposed rule is, in most cases, similar to the
SUM rule. Similar to SUM, an exposure period will terminate early if an
order is executed in full. CBOE also terminates an exposure period in
slightly different circumstances than the Exchange has proposed,
including when a same side order is received by CBOE, if CBOE Market
Maker interest decrements to an amount equal to the size of the exposed
order and if the underlying security enters a limit up limit down
state. Similar to EDGX, the Exchange does not believe early termination
is necessary for the BOLD Mechanism under any of these reasons, and has
proposed to

terminate the exposure period early in a scenario not covered by HAL
but that is available by SUM. Specifically, the Exchange would
terminate an exposure period early when the exposed order is no longer
marketable against the NBBO. The Exchange notes that SUM also
terminates the exposure period early if a resting order on EDGX is
locked or crossed by another options exchange. The Exchange does not
believe early termination is necessary for the BOLD Mechanism because
the BOLD Mechanism is not an auction. Accordingly, the Exchange
believes that permitting the exposure period to continue would allow
other orders to arrive and trade with any order exposed via the BOLD
Mechanism (including any from the locking Exchange). Although the early
termination section of the proposed rule represents the greatest
departure from the HAL rule, the proposed BOLD Mechanism rule is nearly
identical to the SUM rule, and the Exchange does not believe that any
of the differences raise new policy issues generally with respect to a
step up process.
    With respect to the early termination scenarios not adopted by the
Exchange, the Exchange believes that the fact that an ATP Holder will
have the ability to cancel its order after the BOLD Mechanism process
is initiated coupled with the fact that the Exchange will only execute
an order that has been exposed via the BOLD Mechanism process to the
extent the order is marketable against the NBBO mitigate any potential
concern regarding such differences.\9\ Further, regarding the
termination scenarios specified by the Exchange, the Exchange believes
that these are reasonable reasons to terminate the BOLD Mechanism
process. Specifically, if an order is no longer marketable, then it
cannot be executed through the BOLD Mechanism process so no longer
benefits from being exposed. Generally speaking, the Exchange's
proposed rule is similar to the SUM rule in terms of its structure and
wording. The Exchange's proposed rule differs slightly from the SUM
rule in that the proposed BOLD Mechanism is not an auction and
therefore, when an ATP Holder ``steps up'' to trade against an exposed
order, the proposed rule does not refer to that as a ``response'' by
the ATP Holder. The proposed rule also differs from the SUM rule in
that orders received pursuant to paragraph (a) of the proposed rule
would only be processed by the BOLD Mechanism once because, having
exposed the order and attracted insufficient (or no) liquidity, the
order (or balance thereof) would not be exposed again. The Exchange
does not believe the terminology used or different wording represents
any substantive difference between the proposed BOLD Mechanism and the
functionality offered through SUM and HAL. Any such differences are
intended to highlight the exact operation of the proposed BOLD
Mechanism process.
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    \9\ As a general matter, ATP Holders can cancel their orders on
the Exchange unless expressly prohibited. For example, Rule
971.1NY(c) provides, in part, that ``[o]nce commenced, the CUBE
Order (as well as the Contra Order) may not be cancelled or
modified.'' No such restriction exists for orders processed by the
BOLD Mechanism.
---------------------------------------------------------------------------

    Despite the differences highlighted above, the proposed BOLD
Mechanism would otherwise operate in similar manner to SUM and HAL, the
latter of which was previously approved by the Commission and formed
the basis for the former to be made immediately effective upon its
filing with the Commission. The Commission has always been clear that
honoring better prices on other markets can be accomplished by matching
those better prices.\10\ The proposed BOLD Mechanism would allow
participants on NYSE Amex to do just that. If an ATP Holder wants to
ensure that an order does not go through the proposed BOLD Mechanism,
then that participant can submit an order that would not be exposed to
the BOLD Mechanism.\11\
---------------------------------------------------------------------------

    \10\ For example, in adopting the Order Protection Rule (Rule
611) under Regulation NMS in 2005, the Commission stated: ``The
Order Protection Rule generally requires that trading centers match
the best quoted prices, cancel orders without an execution, or route
orders to the trading centers quoting the best prices.'' See
Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR
37495 (June 29, 2005), at 37525 (S7-10-04).
    \11\ An ATP Holder will be able to opt-in to the BOLD Mechanism
by including a specific field in their orders submitted to the
Exchange. Details regarding the ability to opt-in will be set forth
in the Exchange's order entry specifications, which are made
publicly available to all ATP Holders. The ability to opt-in to the
BOLD Mechanism is different from the SUM process. SUM has adopted an
`opt-out' approach where members of EDGX are able to opt-out by
including a specific field in orders submitted to that exchange.
---------------------------------------------------------------------------

    In addition to Rule 994NY proposed above, the Exchange proposes to
adopt Commentary .01 to proposed Rule 994NY, which states that all
determinations by the Exchange pursuant to proposed Rule 994NY (i.e.,
eligible order size, order type, increment, participant ID, BOLD
Mechanism timer and classes) will be announced in a Trader Update and
maintained in specifications made publicly available via the Exchange's
Web site. As noted above, the Exchange also proposes to adopt
Commentary .02 to proposed Rule 994NY to make clear that orders that
are received paragraph (a) of the proposed rule would only be processed
by the BOLD Mechanism once.
    The Exchange also proposes to amend certain other Exchange rules
that would be impacted by the proposed BOLD Mechanism. First, the
Exchange proposes to adopt paragraph (F) under Rule 971.1NY(c)(4) to
reflect that the Exchange's Customer Best Execution Auction (``CUBE
Auction'') will conclude early if the BOLD Mechanism, i.e., orders that
are eligible for exposure under proposed Rule 994NY, receives an
unrelated order in the same series during the CUBE Auction's Response
Time Interval. When the CUBE Auction concludes, the CUBE Order would
execute pursuant to current Rule 971.1NY(c)(5). The Exchange believes
that early conclusion of a CUBE Auction in this circumstance would
allow the Exchange to appropriately handle unrelated orders exposed via
the BOLD Mechanism, while at the same time allowing the CUBE Order to
execute against the Contra Order and any RFR Responses that may have
been entered up to that point.
    Next, the Exchange proposes to adopt Commentary .04 to Rule
971.1NY, which states that a CUBE Order will be rejected if the CUBE
Order is in the same series as an order exposed pursuant to the
proposed BOLD Mechanism. Finally, the Exchange proposes to adopt
Commentary .04 to Rule 985NY, which states that a Qualified Contingent
Cross (``QCC'') Order will be rejected if the QCC Order is in the same
series as an order exposed pursuant to the proposed BOLD Mechanism. The
Exchange believes the rejection of a CUBE Order and/or a QCC Order in
these circumstances would allow the full exposure period for the order
submitted pursuant to the BOLD Mechanism, which should maximize the
opportunity for the exposed order to be executed on the Exchange.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Securities Exchange Act of 1934 (the ``Act'') and
the rules and regulations thereunder that are applicable to a national
securities exchange, and, in particular, with the requirements of
Section 6(b) of the Act.\12\ In particular, the proposal is consistent
with Section 6(b)(5) of the Act \13\ because it is designed to adopt
the BOLD Mechanism, which is designed to offer market participants
greater flexibility with respect to orders entered

into the NYSE Amex book, thereby promoting just and equitable
principles of trade, fostering cooperation and coordination with
persons engaged in facilitating transactions in securities, removing
impediments to, and perfecting the mechanisms of, a free and open
market and a national market system.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange's proposal to adopt the BOLD Mechanism would provide
ATP Holders on NYSE Amex with the opportunity to improve their prices
to match the NBBO in order to interact with orders sent to the
Exchange. This will allow the market participant sending an order to
NYSE Amex to increase its chances of receiving an execution on NYSE
Amex (the market participant's chosen venue) instead of having the
order be routed to another exchange. This ``step up'' process allows
market participants to take into account factors beyond just
disseminated prices, such as execution costs, system reliability, and
quality of service, when determining the exchange to which to route an
order. A market participant that prefers NYSE Amex due to some
combination of these other factors will know that, even if NYSE Amex is
not displaying a price that is the NBBO, the market participant may
still receive an execution at NYSE Amex because another ATP Holder may
``step up'' to match the NBBO. Therefore, the fact that the BOLD
Mechanism allows a market participant who elects to send an order to
NYSE Amex to have a greater likelihood of achieving execution at their
chosen venue removes an impediment to and perfects the mechanism for a
free and open national market system. Further, the BOLD Mechanism and
the ``step up'' process enables ATP Holders to add liquidity that is
available to interact with orders sent to the Exchange. Indeed, when an
ATP Holder ``steps up'' to match the NBBO that is displayed on another
exchange, more contracts maybe executed at this NBBO price on NYSE Amex
than are available at that same price on the other exchange. This
increased liquidity benefits all market participants on NYSE Amex,
thereby perfecting the mechanism for a free and open national market
system and protecting investors and the public interest.
    The Exchange's proposed BOLD Mechanism is similar to EDGX's SUM,
which provides the same manner of ``step up'' process. To the extent
there are differences between the proposed BOLD Mechanism and SUM, as
described elsewhere in the proposal, the Exchange does not believe such
differences raise any new or significant policy concerns. Further,
despite the differences, the proposed BOLD Mechanism would otherwise
operate in a similar manner to the SUM process. As such, the Exchange
merely desires to adopt functionality that is similar to one that
already exists on EDGX, and on CBOE.\14\ Permitting the Exchange to
operate on an even playing field relative to other exchanges that have
similar functionality removes impediments to and perfects the mechanism
for a free and open market and a national market system.
---------------------------------------------------------------------------

    \14\ See supra, note 7.
---------------------------------------------------------------------------

    The Commission has always been clear that honoring better prices on
other markets can be accomplished by matching those other prices.\15\
The proposed BOLD Mechanism would allow participants on NYSE Amex to do
just that.
---------------------------------------------------------------------------

    \15\ See supra, note 10.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change to
adopt the BOLD Mechanism will impose any burden on competition not
necessary or appropriate in furtherance of the purposes of the Act. The
Exchange's proposed BOLD Mechanism is open to all market participants.
The ``step up'' feature of the proposed BOLD Mechanism allows for
execution at the NBBO for price improvement. When such price
improvement is achieved via this ``stepping up'' to meet (or beat) the
best quoted price at another exchange, market participants are able to
receive the best quoted price while still achieving execution on NYSE
Amex, the exchange to which they elected to send their orders. As noted
above, the proposed BOLD Mechanism is similar to processes offered on
other options exchanges that compete with NYSE Amex, and therefore the
proposal is pro-competitive.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \16\ and Rule 19b-4(f)(6)
thereunder.\17\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \18\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \19\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
stated that waiver of the operative delay will allow the Exchange to
provide functionality on NYSE Amex that is similar to functionality
provided by other options exchanges, including but not limited to
EDGX.\20\ In addition, the Exchange stated that waiver of the operative
delay will allow it to more effectively compete with other options
exchanges. For these reasons, the Commission believes the waiver of the
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the operative
delay and designates the proposal operative upon filing.\21\
---------------------------------------------------------------------------

    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii).
    \20\ See supra, note 7.
    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing,

including whether the proposed rule change is consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2017-21 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-NYSEMKT-2017-21. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2017-21, and should
be submitted on or before May 17, 2017.
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-08388 Filed 4-25-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10972-10974]
[FR Doc No: 2021-03630]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0197]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Shortages Data Collections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on information collections associated with Shortages
Data Collections and with notifications to FDA of an interruption or
permanent discontinuance in manufacturing of certain medical devices as
required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by April 26, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 26, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 26, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-N-0197 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Shortages Data Collection.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the

``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 revision 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.

Shortages Data Collections

OMB Control Number 0910-0491--Revision

    Under section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)), the
Commissioner of Food and Drugs is authorized to implement general
powers (including conducting research) to carry out effectively the
mission of FDA.
    After the events of September 11, 2001, and as part of broader
counterterrorism and emergency preparedness activities, FDA's Center
for Devices and Radiological Health (CDRH) began developing operational
plans and interventions that would enable CDRH to anticipate and
respond to medical device shortages that might arise in the context of
federally declared disasters/emergencies or regulatory actions. In
particular, CDRH identified the need to acquire and maintain detailed
data on domestic inventory, manufacturing capabilities, distribution
plans, and raw material constraints for medical devices that would be
in high demand and/or would be vulnerable to shortages in specific
disaster/emergency situations or following specific regulatory actions.
Such data could support prospective risk assessment, help inform risk
mitigation strategies, support real-time decision making by the
Department of Health and Human Services (HHS) during actual emergencies
or emergency preparedness exercises, and mitigate or prevent harm to
the public health.
    This voluntary data collection process consists of outreach to
firms who have been identified as producing or distributing medical
devices that may be considered essential to the response effort. In
this initial outreach, the intent and goals of the data collection
effort will be described, and the specific data request made. Data will
be collected, using least burdensome methods, in a structured manner to
answer specific questions. After the initial outreach, we will request
updates to the information on a quarterly basis to keep the data
current and accurate. Additional followup correspondence may
occasionally be needed to verify/validate data, confirm receipt of
followup correspondence(s), and/or request additional details to
further inform FDA's public health response. These data, collected
under section 1003(d)(2) of the FD&C Act, are currently approved under
OMB control number 0910-0491. We have made minor changes to this
``Shortages data collection'' at this time (see first row of table 1 of
this document) to reflect additional learnings from recent experience.
    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
was enacted on March 27, 2020. Section 3121 of the CARES Act amended
the FD&C Act by adding section 506J (21 U.S.C. 356j). Section 506J of
the FD&C Act provides FDA with new authorities intended to help prevent
or mitigate medical device shortages by requiring medical device
manufacturers to inform FDA about changes in device manufacturing that
could potentially lead to a device shortage. Apprised with that
information, section 506J authorizes FDA to take several actions that
may help to mitigate or avoid supply disruptions.
    Section 506J of the FD&C Act requires manufacturers of certain
devices,\1\ to notify FDA ``of a permanent discontinuance in the
manufacture of the device'' or an interruption in ``the manufacture of
the device that is likely to lead to a meaningful disruption in supply
of that device in the United States'' during or in advance of a
declared public health emergency (PHE), and the reason for such
discontinuance or interruption.\2\ Section 506J requires FDA to take
action based on that information, including (1) publicly posting a list
of devices it determines to be in shortage, (2) publicly posting the
reasons for the shortage, and (3) issuing letters to manufacturers that
fail to comply with the notification requirements of section 506J.
---------------------------------------------------------------------------

    \1\ Under section 506J of the FD&C Act, manufacturers of the
following devices must notify FDA of an interruption or permanent
discontinuance in manufacturing:
     Devices that are critical to public health during a
public health emergency, including those that are life-supporting,
life-sustaining, or intended for use in emergency medical care or
during surgery; or
     Devices for which FDA determines information on
potential meaningful supply disruptions is needed during a public
health emergency.
    See section 506J(a)(1) and (2) of the FD&C Act.
    \2\ See section 506J(a) of the FD&C Act.
---------------------------------------------------------------------------

    Section 3087 of the 21st Century Cures Act, signed into law in
December 2016, added subsection (f) to section 319 of the Public Health
Service Act. This new subsection gives the HHS Secretary the authority
to waive PRA requirements with respect to voluntary collections of
information during a PHE, as declared by the Secretary, or when a
disease or disorder is significantly likely to become a PHE. In 2020
FDA published the immediately in effect guidance document entitled
``Notifying CDRH of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act During the
COVID-19 Public Health Emergency (Revised)--Guidance for Industry and
Food and Drug Administration Staff'' (see 86 FR 106, January 4, 2021)
\3\ to implement section 506J of the FD&C Act, as it relates to device
shortages and potential device shortages occurring during the COVID-19
pandemic, for the duration of the COVID-19 PHE. The guidance includes

additional voluntary items that manufacturers could provide the
---------------------------------------------------------------------------

    \3\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc.
---------------------------------------------------------------------------

Agency, including additional information about device manufacturing and
supply, and updates to initial notifications. While PRA requirements
for the voluntary information collections recommended in the guidance
are waived \4\ during the COVID-19 pandemic PHE using this new
authority, mandatory collections such as those under section 506J of
the FD&C Act may not be part of the waiver. FDA requested emergency
clearance under 44 U.S.C. 3507(j) and 5 CFR 1320.13 to immediately
approve revision of OMB control number 0910-0491 to add the information
collection required by section 506J of the FD&C Act, as amended. The
emergency clearance approval expires on May 31, 2021; therefore, CDRH
is requesting a revision of OMB control number 0910-0491 to add the
information collection required by 506J of the FD&C Act.
---------------------------------------------------------------------------

    \4\ See https://aspe.hhs.gov/system/files/pdf/258866/FDA-PHE-PRA-Waiver-Notice_COVID-19_03.19.20.pdf.
---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

I. Shortages Data Collection Currently Approved Under OMB Control
Number 0910-0491

    FDA bases these estimates on past experiences with direct contact
with the medical device manufacturers and distributors, and anticipated
changes in the medical device manufacturing and distributions patterns
for the specific devices that may be monitored. FDA estimates that
there may be up to 500 manufacturers and distributors for which there
may be targeted outreach because their devices may be essential to the
response effort. This targeted outreach will be conducted quarterly to
either obtain primary data or to verify/validate updated data (although
additional outreach may be undertaken as needed).
    From the manufacturer and distributor's point of view, the data
being requested represent common data elements that they monitor and
track as part of routine business operations and therefore are readily
available. It is anticipated that for most manufacturers and
distributors, the estimated time to fulfill CDRH's data request will
not exceed 30 minutes per request, or 2 hours per year.

II. Information Collection Under Section 506J of the FD&C Act and
Related Voluntary Collections

    Based on current registration and listing data (approved under OMB
control number 0910-0625), we estimate the number of respondents that
will submit a notification under section 506J of the FD&C Act to be
approximately 20 percent of currently registered manufacturers. Data
from our Registration & Listing system indicates that there are
approximately 42,000 unique FDA Establishment Identification registered
manufacturers. Therefore, we estimate 8,400 respondents per year. We
believe that the burden as well as the provision of required
information under section 506J of the FD&C Act--as well as additional
voluntary information related to the determination (including
additional issues that may impact the availability of the device, such
as information about critical suppliers, potential mitigations,
production capacity and market share, and notification updates)--is
minimal and such information is readily available to manufacturers of
the applicable devices. Therefore, we estimate the burden of this
information collection to be 15 minutes or less per determination and
notification.

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shortages data collection....................             500               4           2,000  0.5 (30 minutes).........................           1,000
Information collection under section 506J of            8,400               1           8,400  0.25 (15 minutes)........................           2,100
 the FD&C Act.
Additional voluntary collections related to             8,400               1           8,400  0.25 (15 minutes)........................           2,100
 section 506J of the FD&C Act.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............          18,800  .........................................           5,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection reflects a revision to add the
information collection required by section 506J of the FD&C Act (as
amended by section 3121 of the CARES Act) and additional voluntary
collections related to section 506J of the FD&C Act to OMB control
number 0910-0491.
    Upon review of OMB control number 0910-0491, we note that there is
a data-entry error in the RISC/ORIA Combined Information System (ROCIS)
for a previous information collection approval on February 3, 2020.
Currently, ROCIS lists the total burden hours for that approval as 390
hours; the correct total burden hour estimate is 520 hours. This error
has carried through to the current total hour burden listed in ROCIS as
2,481 hours for the approval on November 24, 2020; the correct total
burden hour estimate should be 2,611 hours. We will correct this error
upon submission of this information collection request to OMB.
    Additionally, we have updated the number of respondents in each
information collection to reflect our current data and estimations.
    These revisions and adjustments reflect an overall increase of
2,589 hours to the (corrected) estimated total burden.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03630 Filed 2-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 8, 2006 (Volume 71, Number 236)]
[Notices]
[Page 71155]
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 30, 2006.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC07-26-000.
    Applicants: Evergreen Wind Power, LLC.
    Description: Evergreen Wind Power, LLC submits an application for
authorization of transaction under Section 203 of the Federal Power
Act.
    Filed Date: 11/22/2006.
    Accession Number: 20061130-0121.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 13, 2006.

    Docket Numbers: EC07-27-000.
    Applicants: Cinergy Capital & Trading, Inc.; Caledonia Power I,
LLC; Wood Group Power Solutions, Inc.
    Description: Cinergy Capital & Trading, Inc et al. submit an
application for authorization for disposition of jurisdictional assets
pursuant to section 203 of the FPA.
    Filed Date: 11/24/2006.
    Accession Number: 20061130-0126.
    Comment Date: 5 p.m. Eastern Time on Friday, December 15, 2006.

    Docket Numbers: EC07-28-000.
    Applicants: Cleco Midstream Resources LLC; Attala Transmission LLC;
Perryville Energy Holdings LLC; Perryville Energy Partners, L.L.C.;
Cleco Corporation.
    Description: Cleco Midstream Resources LLC, Attala Transmission
LLC, Perryville Energy Holding LLC et al. submits an application for
authorization for internal corporate reorganization.
    Filed Date: 11/27/2006.
    Accession Number: 20061130-0083.
    Comment Date: 5 p.m. Eastern Time on Monday, December 18, 2006.

    Docket Numbers: EC07-29-000.
    Applicants: PPM Energy, Inc.; PPM Wind Energy LLC; Aeolus Wind
Power III LLC; Big Horn Wind Project LLC; Twin Buttes Wind LLC;
Atlantic Renewable Projects II, LLC; Flat Rock Windpower II LLC.
    Description: PPM Energy, Inc, PPM Wind Energy, LLC et al. submit a
joint application for authorization to dispose of jurisdictional
facilities, pursuant to section 203 of the FPA.
    Filed Date: 11/27/2006.
    Accession Number: 20061130-0123.
    Comment Date: 5 p.m. Eastern Time on Monday, December 18, 2006.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG07-16-000.
    Applicants: Telocaset Wind Power Partners, LLC.
    Description: Telocaset Wind Power Partners, LLC submits a notice of
Self-Certification of Exempt Wholesale Generator Status located in
Union County, Oregon.
    Filed Date: 11/28/2006.
    Accession Number: 20061128-5012.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 19, 2006.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER07-249-000.
    Applicants: Red Shield Environmental, L.L.C.
    Description: Red Shield Environmental LLC submits a request for
expedited consideration and temporary waiver of Definition of
Settlement Only Resource Under Market Rule I et al.
    Filed Date: 11/27/2006.
    Accession Number: 20061130-0084.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 7, 2006.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR Sec.  385.211 and
Sec.  385.214) on or before 5 p.m. Eastern time on the specified
comment date. It is not necessary to separately intervene again in a
subdocket related to a compliance filing if you have previously
intervened in the same docket. Protests will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Anyone filing
a motion to intervene or protest must serve a copy of that document on
the Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-20828 Filed 12-7-06; 8:45 am]

BILLING CODE 6717-01-P


316B RULE TELEPHONE LOG Name of Caller: John Sunda, SAIC Date: September 9, 2002 Company Name: Cinergy Street Address:

City/ State/ ZIP:

Person Contacted: Jim Stirietz Title: Sr Env Scientist Telephone #: 513 287 2269 Called to ask about construction of the passive screen retrofit at the WH Zimmer Plant in Ohio.

Plant started operation in 1989. Confirmed that plant was originally constructed as a nuclear plant but converted to coal before completion. Noted that the cooling system was recirculating cooling towers and that if there was a problem with the screens they are set up to use treated wastewater as an alternative source if needed. He said that sometimes the screens get clogged with leaves ( in fall) and that divers are needed to clean the screens. He said the original intake consisted of traveling screens but it was located in an area subject to sediment deposition and was plagued by sediment in and around the intake. He said that the original intake screen portion was abandoned and only the intake pump well & pumps were retained. The screens uses an air backwash system. The intake is covered by 5 ft of water and includes dolphins for protection. Construction occurred before the plant start up so there was no attempt to minimize downtime associated with intake retrofit construction.

He said to call Ron Frey ( difficult to find in office) at 513 467 5270 for more detailed information