[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31431-31433]
[FR Doc No: 2018-14362]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83553; File No. SR-NYSEAMER-2018-34]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Modify
the NYSE American Options Fee Schedule

June 28, 2018.
    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 June 27, 2018, NYSE American LLC (the ``Exchange'' or
``NYSE American'') filed with the Securities and Exchange Commission
(the ``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 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 modify the NYSE American Options Fee
Schedule (``Fee Schedule''). The Exchange proposes to implement the fee
change effective June 27, 2018. The proposed rule change is available
on the Exchange's website at www.nyse.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to modify the Fee Schedule, effective
June 27, 2018, to introduce fees for the newly listed options on the
NYSE FANG+ Index (``NYSE FANG+''), which will trade under the symbol
FAANG. Section 1 of the Fee Schedule sets forth the rates for options
transactions, both manual and electronic.\4\ The Exchange proposes to
introduce fees related to transactions in NYSE FANG+ in new note 8 to
Section I, Options Transaction Fees and Credits. As proposed, the
Exchange would charge $0.35 per contract, per side for non-Customer
NYSE FANG+ transactions, whether executed manually or electronically.
However, the Exchange would not charge a fee for any NYSE FANG+ options
transactions (i) on behalf of Customers or (ii) by Market Makers with
an appointment in NYSE FANG+.\5\ Further, the Exchange would not impose
any Marketing Charges on NYSE FANG+ option transactions or any Rights
Fees upon allocation in options on NYSE FANG+.\6\ Market Makers that do
not have an appointment in NYSE FANG+ will be subject to the same fee
of $0.35 per contract, per side for non-Customer NYSE FANG+
transactions. However, volume in NYSE FANG+ would be included in the
calculations to qualify for any volume-based incentives currently being
offered on the Exchange (e.g., such monthly volume would be counted
towards the Market Maker Sliding Scale program, per Section I.C., and
the American Customer Engagement (``ACE'') Program, per Section I.E. of
the Fee Schedule, and the Firm Monthly Fee Cap, per Section I.J.).\7\
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    \4\ See e.g., Fee Schedule, I.A. (Rates for Standard Options
transactions), available here, https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf.
    \5\ The term Market Maker, as used herein, includes NYSE
American Options Market Makers, Specialists, e-Specialists and
Directed Order Market Makers.
    \6\ See Fee Schedule, Sections I.A., note 3 (for description of
the collection, and distribution of, Marketing Fees); and Section
III.C. (for description of the e-Specialist, DOMM and Specialist
Monthly Rights Fees). See also proposed Fee Schedule, note 8 to
Section I, Options Transaction Fees and Credits (providing, in part,
that ``Marketing Charges will not be applied to FAANG
transactions'').
    \7\ See proposed Fee Schedule, note 8 to Section I, Options
Transaction Fees and Credits (providing, in part, that ``[a]ny
volume in FAANG will be included in the calculations to qualify for
any volume-based incentives currently being offered on the
Exchange'').
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    The Exchange believes the proposed fees for NYSE FANG+ would
further the Exchange's goal of introducing new products to the
marketplace by encouraging trading in this index, in particular by
encouraging Market Makers to make a market in these products, which
would in turn, benefit market participants.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act, in general, and furthers the objectives
of Sections 6(b)(4) and (5) of the Act, in particular, because it
provides for the equitable allocation of reasonable dues, fees, and
other charges among its members, issuers and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers or dealers.
    The Exchange believes the proposal to implement fees for options on
NYSE FANG+ is reasonable, equitable and not unfairly discriminatory for
the following reasons. The Exchange believes the proposed fees, which
apply equally to electronic and manual (open outcry) transactions on
behalf of non-Customers, on the one hand, and Customers, on the other
hand, to be reasonable and equitable because the proposed
differentiation among market participants for NYSE FANG+ fees is
consistent with the manner in which the Exchange distinguishes among
market participants for fee purposes in other contexts.\8\ The Exchange
believes that not imposing fees for NYSE FANG+ transactions on behalf
of Customers is likewise reasonable, equitable and not unfairly
discriminatory because Customer order flow enhances liquidity on the
Exchange for the benefit of all market participants. Specifically,
Customer liquidity benefits all market participants by providing more
trading opportunities, which attracts Market Makers. An increase in the
activity of Market Makers in turn facilitates tighter spreads, which
may cause an additional corresponding increase in order flow from other
market participants.
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    \8\ See id. (providing that non-Customers (i.e., NYSE American
Options Market Makers, Firms and Broker Dealers and Professional
Customers) are charged a total $0.25 per contract for manual
executions, while Customers are charged $0.00 per contract for
manual executions).
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    The Exchange believes that applying the same fee on all non-
Customer NYSE FANG+ option transactions, other than those by Market
Makers with an appointment in NYSE FANG+, is non-discriminatory because
it applies to all similarly situated participants on an equal basis
that opt to trade the product. Moreover, the decision to transact in
NYSE FANG+ (or, for Market Makers, to seek an appointment) is
voluntary. The Exchange believes that allowing Market Makers with an
appointment in NYSE FANG+ to transact in the product free of charge
(and without incurring Marketing Fees) is not unfairly discriminatory
because Market Makers have heightened obligations that are not
applicable to other non-Customer market participants.\9\ It is also
non-discriminatory because all Market Makers may apply for an
appointment in NYSE FANG+ options. Further, encouraging Market Makers
to seek an appointment in, and thus provide continuous quotes in, NYSE
FANG+ would add liquidity to the market and provide market
participants--both Customer and non-Customer alike--increased
opportunities to trade options on NYSE FANG+. The Exchange believes
that exempting transactions in NYSE FANG+ from the monthly Rights Fees
would likewise encourage trading in NYSE FANG+ options, which increase
in the availability of such options would benefit all market
participants.
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    \9\ See, e.g., Rules 920NY, 925.1NY(b) and 927NY (setting forth
heightened quoting obligations).
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    Further, the proposal to include any volume in NYSE FANG+ in the
calculations to qualify for any volume-based incentives offered on the
Exchange would further the Exchange's

goal of introducing new products to the marketplace by encouraging
trading in these products. To the extent that the proposed change
incentivizes any market participants to direct their order flow to the
Exchange, all market participants would benefit from increased
liquidity and trading opportunities on the Exchange. Finally, the
Exchange notes that offering market participants incentives to trade in
certain newly offered products is not new or novel.\10\
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    \10\ See, e.g., Securities Exchange Act Release No. 77293 (March
4, 2016), 81 FR 12762 (March 4, 2016) (SR-NYSEMKT-2016-34)
(addressing the treatment of Binary Return Derivatives--or ByRDs--
and exempting such transactions from all Exchange fees to encourage
trading in the product).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act, the Exchange does
not believe that the proposed rule change would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes the proposed transaction
fees for NYSE FANG+ would not place an unfair burden on competition as
it would apply to all similarly situated non-Customer/non-Market Maker
participants. The Exchange also believes the proposed pricing for NYSE
FANG+ is procompetitive as it would further the Exchange's goal of
introducing new products to the marketplace and encouraging Market
Makers to make a market in these products, which would in turn, benefit
market participants. Market participants that do not wish to trade in
or seek an appointment in NYSE FANG+ are not obliged to do so.
    The Exchange does not believe that the proposed change will impair
the ability of any market participants or competing order execution
venues to maintain their competitive standing in the financial markets.
Further, the fees would be applied to all similarly situated
participants (i.e., non-Customers), and, as such, the proposed change
would not impose a disparate burden on competition either among or
between classes of market participants.

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

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \11\ of the Act and subparagraph (f)(2) of Rule
19b-4 \12\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \13\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \13\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File No. SR-NYSEAMER-2018-34 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-NYSEAMER-2018-34. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File No. SR-NYSEAMER-2018-34, and should be submitted
on or before July 26, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-14362 Filed 7-3-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Pages 64150-64151]
[FR Doc No: 2020-22402]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1867]

Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of
13 New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 13 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.

DATES: Approval is withdrawn as of November 9, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 003290..................  Neo-Calglucon         Novartis
                               (calcium              Pharmaceuticals
                               glubionate) Syrup.    Corp., 1 Health
                                                     Plaza, East
                                                     Hanover, NJ 07936.
NDA 009816..................  Cortef Acetate        Upjohn, a Pfizer
                               S.E.E. Drops          Division, 235 East
                               (hydrocortisone       42nd St., New York,
                               acetate) Ophthalmic   NY 10017.
                               Solution.
NDA 009817..................  Cortef Acetate        Do.
                               (hydrocortisone
                               acetate) Ophthalmic
                               Ointment, 1.5%.
NDA 010645..................  Optef Drops           Do.
                               (hydrocortisone
                               probutate)
                               Ophthalmic
                               Solution, 0.2%.
NDA 010155..................  Mytelase (ambenonium  Sanofi-Aventis U.S.
                               chloride) Tablets,    LLC, 55 Corporate
                               10 milligrams (mg).   Dr., Bridgewater,
                                                     NJ 08807.
NDA 016659..................  Norinyl 1 + 50        Actavis Laboratories
                               (norethindrone and    Ut, Inc. (an
                               mestranol) Tablets,   indirect, wholly
                               1 mg/0.05 mg.         owned subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 41
                                                     Moores Rd., Frazer,
                                                     PA 19355.
NDA 016807..................  Thyrolar (liotrix     Allergan Sales, LLC,
                               [tetraiodothyronine   5 Giralda Farms,
                               levothyroxine         Madison, NJ 07940.
                               sodium (T4) and
                               triiodothyronine
                               liothyronine sodium
                               (T3)]) Tablets,
                               0.0125 mg/0.0031
                               mg, 0.025 mg/0.0063
                               mg, 0.05 mg/0.0125
                               mg, 0.1 mg/0.025
                               mg, 0.15 mg/0.0375
                               mg, and 0.25 mg/
                               0.0625 mg.
NDA 017919..................  Ortho Novum 1/35      Janssen
                               (ethinyl estradiol    Pharmaceuticals,
                               and norethindrone)    Inc., 1125 Trenton-
                               Tablets, 0.035 mg/1   Harbourton Rd.,
                               mg.                   Titusville, NJ
                                                     08560.
NDA 018768..................  VePesid (etoposide)   Corden Pharma Latina
                               Injection, 20 mg/mL.  S.p.A., c/o
                                                     Clinipace Inc.,
                                                     1434 Spruce St.,
                                                     Suite 100, Boulder,
                                                     CO 80302.
NDA 019972..................  Ocupress (carteolol   Novartis
                               hydrochloride)        Pharmaceuticals
                               Ophthalmic            Corp.
                               Solution, 1%.
NDA 021590..................  FazaClo (clozapine)   Jazz Pharmaceuticals
                               Orally                Ireland Ltd., c/o
                               Disintegrating        Jazz
                               Tablets, 12.5 mg,     Pharmaceuticals,
                               25 mg, 100 mg, 150    Inc., 3170 Porter
                               mg, and 200 mg.       Dr., Palo Alto, CA
                                                     94304.
NDA 021664..................  Bromday/Xibrom        Bausch & Lomb Inc.,
                               (bromfenac)           400 Somerset
                               Ophthalmic            Corporate Blvd.,
                               Solution,             Bridgewater, NJ
                               Equivalent to 0.09%.  08807.
NDA 022018..................  Lamivudine and        Pharmacare Ltd., c/o
                               Zidovudine Tablets,   Lachman Consultants
                               150 mg lamivudine     Services, Inc.,
                               and 300 mg            1600 Stewart Ave.,
                               zidovudine.           Suite 604,
                                                     Westbury, NY 11590.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 9, 2020. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on November 9, 2020 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22402 Filed 10-8-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 111 (Thursday, June 9, 2011)]
[Rules and Regulations]
[Pages 33639-33641]
[FR Doc No: 2011-14327]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0222]
RIN 1625-AA00

Safety Zone; New York Water Taxi 10th Anniversary Fireworks,
Upper New York Bay, Red Hook, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary Final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
Captain of the Port (COTP) Zone New York on the navigable waters of the
Upper New York Bay in the vicinity of Red Hook, New York for a
fireworks display. This temporary safety zone is necessary to ensure
the safety of vessels and spectators from hazards associated with
fireworks displays. Persons and vessels are prohibited from entering
into, transiting through, mooring, or anchoring within the temporary
safety zone unless authorized by the COTP New York or the designated
on-scene representative.

DATES: This rule is effective from 8:30 p.m. until 10 p.m. on June 21,
2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0222 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0222 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 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
temporary rule, call or e-mail LTJG Eunice James, Coast Guard Sector
New York Waterways Management Division;<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary 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 the Coast Guard did not receive
information regarding the dates and scope of the event in time to
publish a NPRM followed by a final rule before the effective date. The
sponsor was not aware of the requirements for submitting an application
for a marine event 135 days in advance, resulting in a late
notification. The sponsor is now aware of this requirement for all
future events. Nevertheless, the sponsor is unable to reschedule this
event due to other activities being held in conjunction with the
fireworks display. The safety zone is necessary to provide for the
safety of event participants, spectator craft, and other vessels
operating near the event area. For the safety concerns noted, it is in
the public interest to have these regulations in effect during the
event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The rule must become effective on
the date specified above in order to provide for the safety of the
public including spectators and vessels operating in the area near the
fireworks display.

Background and Purpose

    The fireworks event was planned by a private party to celebrate the
10th Anniversary of New York Water Taxi. The fireworks will commence at
9 p.m. on June 21, 2011 and will last approximately 10 minutes. This
event poses significant risk to participants, spectators and the
maritime public because of hazardous conditions associated with a
fireworks display. This temporary safety zone is necessary to ensure
the safety of these participants, spectators and vessels.

Discussion of Rule

    This rule establishes a temporary safety zone on the waters of the
Upper New York Bay. The temporary safety zone will encompass all waters
of the Upper New York Bay in the vicinity of Red Hook, Brooklyn, NY,
within a 180 yards radius around position 40[deg]40'52'' N,
074[deg]01'39'' W (NAD 83) approximately 400 yards south of Governors
Island. All persons and vessels shall comply with the instructions of
the COTP New York or the designated representative. Entry into,
transiting, or anchoring within the temporary safety zone is prohibited
unless authorized by the COTP New York or the designated on-scene
representative. The COTP New York or the designated representative may
be reached on VFH Channel 16.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, as supplemented by Executive Order 13563,
Regulatory Planning and Review, and does not require an assessment of
potential costs and benefits under section 6(a)(3) of that Order. The
Office of Management and Budget has not reviewed it under that Order.
    The Coast Guard's implementation of this temporary safety zone will
be of short duration and designed to minimize the impact to vessel
traffic on navigable waters. This safety zone will only be enforced for
90 minutes. Furthermore, vessels may be authorized to transit the zone
with permission of the COTP New York or the designated on-scene
representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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 will affect the following entities, some of which may be
small entities: the owners and operators of vessels intending to
transit or anchor in a portion of the Upper New York Bay in the
vicinity of Governors Island and Red Hook, NY. The fireworks will
commence at 9 p.m. on June 21, 2011 and will last approximately 10
minutes.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons: Vessel
traffic can safely transit around the zone. Before the effective
period, we will issue maritime advisories widely available to users of
the waterway. This rule will be in effect for only 90 minutes.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 or more in any
one year. Though this rule will not result in such expenditure, we do
discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

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

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.

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.

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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,

Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

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 concluded
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 is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a temporary
safety zone on a portion of the Upper New York Bay during the launching
of fireworks. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

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. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0222 to read as follows:

Sec.  165.T01-0222  Safety Zone; New York Water Taxi 10th Anniversary
Fireworks, Upper New York Bay, Red Hook, NY.

    (a) Location. The following area is a temporary safety zone: A 180
yard radius around position 40[deg]40'52'' N, 074[deg]01'39'' W in the
vicinity of Governors Island and Red Hook, NY on the Upper NY Bay.
    (b) Enforcement period. This section will be enforced from 8:30
p.m. until 10 p.m. on June 21, 2011.
    (c) Definitions. ``Designated on-scene representative'' means any
commissioned, warrant, and petty officer of the Coast Guard on board
Coast Guard, Coast Guard Auxiliary, and local, state, and Federal law
enforcement vessels who have been authorized to act on behalf of the
COTP New York.
    (d) Regulations.
    (1) Entry into, transit through, mooring or anchoring within this
safety zone is prohibited unless authorized by the COTP New York or the
designated on-scene representative.
    (2) Persons desiring to operate within the safety zone established
in this section may contact the COTP New York at telephone number 718-
354-4398 or via on-scene patrol personnel on VHF channel 16 to seek
permission to do so. If permission is granted, all persons and vessels
must still comply with the instructions of the COTP New York or the
designated on-scene representative.

    Dated: May 23, 2011.
L.L. Fagan,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2011-14327 Filed 6-8-11; 8:45 am]
BILLING CODE 9110-04-P


[Slide]
Then, for the last slide I thought I would just
give you the summary of the number of donations that we
have tested and some of the frequency rates.  We have

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
looked at 11 million, 600-something thousand HBVs for a
total of 1136 serologically negative.  We have looked at 18
million HCVs for a total of 1653 serologically negative,
and we have looked at 14 million HIVs and found 101
donations that were serologically negative.  And, those are
the frequencies for the serologically negative in those
three large studies.  So, 1 in 10,000, 1 in 11,000 and 1 in
142,000 for HIV.  That is all.
DR. YUWEN:  Any short questions or comments?
Yes?
DR. ALLAIN:  You mentioned you have 85 HCV
positive and you said there were window periods.  Did they
also convert?  How many of them seroconverted?
DR. CONRAD:  We attempted to follow-up on all
patients in the clinical trial, some of the patients that
were donors.  But of all the people who came into the
clinical trial that made up those 82, all of them
seroconverted.  So, all the patients whom we were able to
follow through time seroconverted.
DR. YUWEN:  Our next speaker is Dr. Lorraine
Peddada, representing Alpha Therapeutic Corporation.
Alpha Therapeutic Corporation
[Slide]
DR. PEDDADA:  Today I am just going to have a
brief overview of what we did with the HIV and HCV

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
screening program, and give an update on our progress with
HBV PCR.
[Slide]
We heard the history of PCR already today several
times, but we actually started in 1997, working with NGI as
the principal investigator for the HIV and HCV INDs.  In
1999 we filed an IND for HBV, and in September of 2001 we
received the first license to test source plasma using PCR.
[Slide]
We have already gone over our three-dimensional
pooling scheme.
[Slide]
This is the sensitivity of PCR screening source
plasma at our pool size, which is 512 donations per pool,
and it is about 2000 copies/ml for HIV and HBV and 10,000
copies/ml for HCV.
[Slide]
During our clinical trial we submitted data on
the enrolled subjects for HIV and HCV, and we did a
retrospective analysis of samples that we had in inventory
from positive donors.  With those panels we were able to
calculate a window period reduction of four days for HIV
and 57 days for HCV.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
The HBV clinical study was initiated in August of
2000, and our basis for enrolling would be that the donor
is PCR positive with minipool testing or hepatitis B
surface antigen positive, but not both.  We had 26 PCR
positive eligible donors and we enrolled five.  We had nine
HBV surface antigen positive donors and we were able to
enroll four.  Our plan was to follow the donors six months
or to seroconversion.  We were monitoring the donors weekly
with PCR surface antigen testing, and later we added anti-
core, anti-HBE and E antigen because the donors presented a
very complex pattern.
[Slide]
With the HBV trial we have only enrolled nine
subjects.  So, what we did was to look in our inventory for
panels of donors that would qualify.  We found 65 HBsAg
positive donors and we analyzed the look-back donations
from all of the donors.  From 65 donors we were able to
look at 512 donations, and we screened each one undiluted
by PCR, using the NGI UltraQual test, and 315 were positive
undiluted.  Then we prepared simulated master pools of 512
and tested again.  We were able to detect 142 of the
donations, which gives us a sensitivity of 45 percent.
[Slide]
This is just to give you an idea of how we
calculate window period.  What we are trying to do is

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
determine the amount of time it takes for a donor to go
from being HBV DNA positive to surface antigen positive.
[Slide]
Because we have the panel of donors, the 65
donors, all of the samples and the bleed dates, we were
able to make these calculations.  So, with a pool size of
512 we were able to analyze samples from 43 donors and we
achieved a reduction of 15 days in the window period.
Because we were not sure how the master pool of 512 we
would work, we also analyzed primary pools of 64 and we
were able to reduce the window period by 23 days.  And, the
total window period as measured by NAT in undiluted samples
was 36 days in our hands.
[Slide]
This is just to illustrate that in the plasma
industry we do have a 60-day inventory hold and by closing
the window by 15 days we are pushing back our inventory
hold 15 days.  Then you add onto that the 60-day inventory
hold.
[Slide]
This is a summary of our screening to date.  We
have been screening HIV and HCV for four years -- four
years for HIV and HCV.  One year, actually, we did not
screen using PCR.  So, that is three years for HIV.  The
total donations tested is six million for HIV and the total

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
number of positive donations was 472 and this includes all
positives, not PCR only.  This gives us a frequency of 8
donations per 100,000.
For HCV we screened ten million donations and had
more than 3000 positives, for a frequency of 32 donations
per 100,000.  Since we have just started HBV, we have
screened 2.5 million donations, with a frequency of 11
donations per 100,000.
[Slide]
What I did next was to look at all of the PCR
positive donations out of the six million screened, and
look at PCR only to see how many we would pick up just with
PCR.  We picked up 84 out of six million, which gives a 50
percent increase over what we would have gotten with
antigen alone.
I also looked at PCR plus antibody.  We were able
to detect 33, and we are calling these true positives
because we got confirmation that the donor was actually
positive.
Over here, what I have labeled as false positives
would be the donations that were p24 antigen positive only.
I am very pleased to hear that we may be able to reenter
these donors that were deferred.  They may be reentered
into our program.  We detected 837 antibody positive

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
donations, and we really don't know if they are true
positives or not.
[Slide]
In conclusion, I just want to say that with
minipool testing we have been able to detect donations that
were positive and not positive by antigen and antibody, and
we have reduced the window period donations of our
manufacturing pools and, hopefully, eliminated many high
titer units.  Any questions?
Dr. YUWEN:  Any questions or comments?  Keep it
short, please.
DR. GALLARDA:  What was your test of record for
surface antigen?
DR. PEDDADA:  What was what?
DR. GALLARDA:  What was your test of record for
the surface antigen EIA?
DR. PEDDADA:  Genetic Systems.
DR. YUWEN:  I would like to remind anybody from
the audience to please identify themselves when they ask
questions.  Thank you, Lorraine.  Our next speaker is Dr.
Donald Baker, from Baxter.
Baxter
[Slide]
DR. BAKER:  This may seem like deja vu to you
because you are going to see two Baxter presentations, but

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
this is the Baxter on this side of the Atlantic as opposed
to the Baxter on the other side of the  Atlantic, which is
going to be the next one.
[Slide]
I am going to be looking at this from the
perspective of a manufacturer.  I am not going to talk
about PCR test details because I am, frankly, not competent
to speak about that.
In the integration of the PCR, we integrated in
two places in the manufacturing process, one is the donor
screening and the second is the production pool.  Now, from
a manufacturer's perspective, which is not necessarily
shared by regulatory agencies, our objective is to get a
low defined level of viral burden in the manufacturing
pool.  That is not considered primarily a donor screening
test.
[Slide]
In the resolution of the results, the information
flow is, of course, critical and this is something that we
won't get into in this presentation but I just wanted to
illustrate the complexity of the flow of the results.  We
use NGI as our NAT testing lab and you can see between the
centers, many of these which are contract centers to us,
there is a tremendously complicated flow of information.
[Slide]

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
I am going to present our integrate summary
which, for HCV and HIV, will be from 1998 to June of 2001.
It will include both the qualified, that is donors who have
donated at least twice successfully, as well as the
applicant donors.  In the first half of this year applicant
donors represented about 11 percent of the PCR positives,
just to give you some sense of their contribution.  So, for
HCV in a little over 5.2 million donations we found 894
positive and that represented 313 donors.  Obviously,
because of the short time between donations, an individual
donor might contribute two or three positive donations
before they are deferred.
[Slide]
For HIV, again we started HIV and HCV testing
simultaneously, we turned up 14 positive donors.  During
that time period and still to date we are continuing to do
p24 testing.  Had we not done p24 testing in those five
million donations, we would have had approximately another
30 individuals who were only p24 positive who would have
come into the PCR testing.  So, that gives you some sense
of the number of individuals that the p24 test is excluding
for us at present.
[Slide]
For HBV, there are times when it is better to be
lucky than good.  Initially, when we were looking at HBV we

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
considered that it might be possible or more economical not
to do HBV testing and just throw out positive pools.  I am
very glad that we did not take that approach because, as it
turned out, our HBV positivity in PCR was much higher than
we had initially anticipated and it would have been very
uneconomical not to do HBV testing.
[Slide]
Finally, here are our PCR positives with time.  I
wouldn't read a lot of meaning into the apparent increase
with time with some.  A lot depends on how fast your PCR
turnaround is, and our PCR turnaround has become more rapid
and, consequently, since we exclude our EIA positive
results, we have had less chance with EIA testing to
exclude individuals so we have had more individuals enter
the system, which is why the PCR positivity has seemed to
increase in some circumstances.  It also is predicated on
changes in collections practices and addition of new
centers and the increasing number of donations.
[Slide]
Finally, the system works.  It is robust and
reproducible.  We have never had a positive manufacturing
pool, touch wood.  It is timely.  We have been able to, of
course, complete all the testing and donation resolution
within our 60-day inventory hold.  And, it has had a
minimal impact, at least in terms of deferred plasma.  We

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
have approximately 1000 donations or so that have been
discarded in this period of time.  Thank you.
DR. YUWEN:  Thank you.  Are there any questions
for Donald?  Michael?
DR. BUSCH:  Mike Busch.  It was interesting to
hear that you do test your applicant donors and you sort of
separate your yield in applicant versus registered.  On a
per donation basis, what is the rate of NAT only in the
applicant versus the registered donors?  This would give
you a sense of the relevant incidence in these first-time
applicant donors versus your regular repeat donors.
DR. BAKER:  You know, Mike, I know where you are
coming from but I don't think I can address the question
because, don't forget, we do our EIA and antigen screening
first so they all get kicked out.  So, of the PCR
positives, for the first half of this year there was only
about 11 percent that were applicants.  But I don't know
what the EIA positivity among the applicants is.
DR. BUSCH:  What percentage of all accepted
donations are from applicant versus regular registered?  Do
you have a sense of that?
DR. BAKER:  We don't accept applicant donations.
Right?  So, they have to donate twice before we accept
them.  I can't give you the answer you want.  We don't
collect our data that way.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
DR. BUSCH:  Thank you, Donald.
DR. YUWEN:  Our next speaker is Dr. Gerald
Zerlauth, representing BaxterHylandImmuno.
BaxterHylandImmuno
DR. ZERLAUTH:  Thank you.
[Slide]
This is the other part of Baxter's activities,
comprising actually both sides of the world.  We are
collecting plasma in the United States, pooling it in the
United States and sending it over to Europe.  So, this HIQ
PCR IND approach is a truly global activity.
[Slide]
As I said, we are collecting our plasma in the
U.S. in community bioresources plasma centers, 23 centers
which bring about one million liters of plasma per year.
These donations and serology samples are sent to Hoover,
Alabama for serology testing, while the PCR vials are going
to the pooling lab in Round Lake, north of Chicago.  These
samples are pooled upon the arrival of the serology data.
So, we are only pooling serology non-reactive sample into
pools of 512, according to the scheme already seen in pools
of 512 individual donations.
[Slide]
These the PCR pools, the master pools are then
sent to Vienna in a daily approach by airplane and are

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
tested in Vienna with a test system which we call HIQ PCR.
Most of you know it.  It is the same for HIV, HCV and HBV
RT or PCR, depending on the virus.  It is a laser-induced
fluorescence detection system based on size-dependant
separation on polyacrilomide gels.  We have an internal
standard which we termed the internal quality marker.  The
tests are validated as qualitative tests, and these tests,
of course, are tested against all available genotype panels
and are validated according to the guidelines that have
been cited several times this morning, in Europe and, of
course, against the FDA guideline and, of course, against
all the panels that have been released by the FDA.
[Slide]
So, overall, the sensitivities are now in IU and
not calculated but tested against WHO standards,
calibrated, as given here, HBV, 11 IU/ml; HCV, 24; and HIV-
1, 65.  Just to complete, we also include parvo B19 which
has 34 IU/ml, which is a quantitative assay; and HAV, with
157 what we call Baxter units because we are lacking an
international standard at the moment.  Just to avoid genome
or other equivalence we have Baxter units which will be
replaced as soon as we have a WHO international standard.
[Slide]
The results, as we are a newcomer in this IND
business, we only started in April and we have done 540,000

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
donations so far in about 1000 pools, and we have seen 13
positive pools for HCV, one for HBV and none for HIV.  In
terms of donations, we have 13 donations but these 13
donations were from three individual donors that we could
identify in this process and, obviously, one donor a non-
HIV.  So, I think we have to carry on until we get the
necessary number to calculate the numbers as we have seen
them previously.  Of course, we are going to use depository
samples to increase the number of positive pools and show
that the system works.
[Slide]
So, this is actually what I have to show at the
moment, and I hope next time I have more conclusive
results. Thank you for your attention.
DR. KLEINMAN:  Steve Klienman.  Just a very quick
question, is this a triplex assay or three individual PCR
assays?
DR. ZERLAUTH:  These are three individual PCR
assays and extraction as well for two.
DR. BUSCH:  Mike Busch.  A clarification, so the
plasma that you are testing is a separate collection
system, separate centers from Baxter U.S. is collecting?
DR. ZERLAUTH:  It is a Baxter owned group of
plasma centers.  We just used those because we have those
in our European files and we can use that plasma in Europe

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
as well.  So, we get the million liters for testing and
most of it for use in Europe.
DR.
BUSCH:  It is completely separate collection
from what Don Baker was talking about?
DR. ZERLAUTH:  Don Baker's is contained in this
to some degree.
DR. YUWEN:  Our next speaker is Barbara Masecar,
representing Bayer.
Bayer
MS. MASECAR:  Thank you for the opportunity to
present this afternoon.
[Slide]
I would like to briefly give you a summary of the
NAT donor screening at Bayer Corporation.
[Slide]
This is a recap of where we are right now.  All
of our donations are currently screened for the big three,
HCV, HIV and HBV and we are also doing in-process testing
for parvovirus B19 by NAT.  Currently, HCV, HIV and parvo
testing is Bayer's Raleigh test laboratory in North
Carolina and that is on a 96-sample minipool format.  The
HBV testing is performed at NGI on master pools, if you
will, of 480 samples that are prepared at the Raleigh test
lab and then sent to NGI, in Los Angeles.

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
Today I will be giving you summaries of the HCV,
HIV and HBV, and my colleague, Todd Gierman, will be
presenting the parvovirus data later on today.
[Slide]
As far as HCV goes, we began testing in September
of 1997 and we have been using the Roche AmpliScreen
microwell plate method.  We began enrolling follow-up study
donors that were found to be NAT positive and antibody
negative in 1997, and we continued that enrollment until
January of this year.  During that time frame we screened
6.5 million samples representing 385,000 donors
approximately.
[Slide]
During that time we discovered and identified 383
NAT positive, antibody negative donors.  I want to
underscore here that this was as judged by the Abbott EIA
version 2.0 test.  Of these  283, 289 were qualified; 94
were applicant.  We were able to enroll 152 into the
follow-up studies, which is 24 weeks in our program.  We
found that compared to EIA 2.0 the reduction in the window
period was 66 days.
[Slide]
We provided 71 of the sample panels from follow-
up to Leslie Tobler, Blood Centers of the Pacific, for
further study, and she, among other things, retested these

sgg
MILLER REPORTING COMPANY, INC.
735 8th Street, S.E.
Washington, D.C. 20003-2802
(202) 546-6666
panels with the Chiron version 3.0 EIA test.  What she
found was that in 42 of the 71 panels seroconversion did
not occur simultaneously with the version 2.0 and 3.0.  As
you might expect, in those cases where there were
discordant results seroconversion with the 3.0 preceded
seroconversion by 2.0 by a median of 17 days.
[Slide]
In 55 of the 71 panels that Dr. Tobler tested the
index donation showed concordant negative results with both
the version 2.0 and 3.0.  So, the index donation being the
first NAT positive donation was, indeed, negative with both
versions of the EIA test in 77 percent of these panels.
However, in 16 of these panels, or 22 percent, the index
donation was actually positive with version 3.0.
Interestingly, two of the 16 we followed for about six
months, and with version 2.0 there was never a
seroconversion.  One of these was RIBA positive, one was
RIBA indeterminate, but in our program we don't test RIBA
unless the EIA is positive.  So, we didn't have an
indication prior to this work that the RIBA was positive.


[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Proposed Rules]
[Page 16981]
[FR Doc No: 2017-06878]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2016-0575; FRL-9960-56-Region 4]

Air Plan Approval; Tennessee: Reasonable Measures Required

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Tennessee, through the Tennessee Department of Environment and
Conservation (TDEC), on March 25, 1999. The SIP submittal includes a
change to the TDEC regulation ``Reasonable Measures Required.'' EPA is
proposing to approve this SIP revision because it is consistent with
the Clean Air Act and federal regulations governing SIPs.

DATES: Written comments must be received on or before May 8, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2016-0575 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: D. Brad Akers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mr. Akers can be reached via telephone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period on this document.
Any parties interested in commenting on this document should do so at
this time.

    Dated: March 15, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
[FR Doc. 2017-06878 Filed 4-6-17; 8:45 am]
BILLING CODE 6560-50-P