[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Pages 39765-39766]
[FR Doc No: 2015-16882]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-1714-007.
    Applicants: LG&E Energy Marketing Inc.

    Description: Triennial Market Power Update for Central Region of
LG&E Energy Marketing Inc.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5467.
    Comments Due: 5 p.m. ET 8/31/15.

    Docket Numbers: ER10-3110-005; ER10-3144-006.
    Applicants: Union Power Partners, L.P., Entegra Power Services LLC.
    Description: Updated Market Power Analysis for Market-Based Rate
Authority for Central Region of Union Power Partners, L.P., et al.
    Filed Date: 6/30/15.
    Accession Number: 20150630-5468.
    Comments Due: 5 p.m. ET 8/31/15.

    Docket Numbers: ER13-1371-002.
    Applicants: GP Big Island, LLC.
    Description: Compliance filing: Compliance filing to 8202018 to be
effective 7/2/2015.
    Filed Date: 7/1/15.
    Accession Number: 20150701-5299.
    Comments Due: 5 p.m. ET 7/22/15.

    Docket Numbers: ER13-1653-002.
    Applicants: FirstEnergy Solutions Corp.
    Description: Compliance filing: Authorization for Affiliate Sales
to be effective 6/1/2015.
    Filed Date: 7/1/15.
    Accession Number: 20150701-5165.
    Comments Due: 5 p.m. ET 7/22/15.

    Docket Numbers: ER15-1440-001.
    Applicants: Midcontinent Independent System Operator, Inc., Cleco
Power LLC.
    Description: Compliance filing: 2015-07-01_Compliance Cleco-COA JPZ
Agreement Filing to be effective 12/1/2014.
    Filed Date: 7/1/15.
    Accession Number: 20150701-5200.
    Comments Due: 5 p.m. ET 7/22/15.

    Docket Numbers: ER15-1905-002.
    Applicants: AZ721 LLC.
    Description: Tariff Amendment: Second Amendment to Market Based
Rate Filing to be effective 8/11/2015.
    Filed Date: 7/1/15.
    Accession Number: 20150701-5227.
    Comments Due: 5 p.m. ET 7/22/15.

    Docket Numbers: ER15-2089-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Original Service Agreement
No. 4158, Queue Position #None to be effective 6/1/2015.
    Filed Date: 7/1/15.
    Accession Number: 20150701-5188.
    Comments Due: 5 p.m. ET 7/22/15.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 1, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-16882 Filed 7-9-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9889-9891]
[FR Doc No: 2020-03414]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88215; File No. SR-BX-2020-002]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Related to Order
Types and Times-in-Force Provisions

February 14, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 6, 2020, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes changes related to order types and times-in-
force provisions.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Options 3, Section 7, ``Types of
Orders and Quote Protocols'' to provide that the Exchange may determine
which order types and times-in-force provisions are available on a
class or system basis. This proposed change is based on the rules of
Cboe BZX Exchange, Inc. (``BZX Options''),\3\ Rule 21.1, Cboe EDGX
Exchange, Inc. (``EDGX Options'') Rule 21.1,\4\ Cboe Exchange, Inc.
(``Cboe'') Rule 5.6 \5\ and Cboe C2 Exchange, Inc. (``C2'') Rule
6.10(a).\6\ The Exchange proposes to also amend the title of the rule
from ``Types of Orders and Quote Protocols'' to ``Types of Orders and
Order and Quote Protocols'' to reflect the information in the rule.
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    \3\ BZX Options Rule 21.1(d), Definitions, provides ``The term
``Order Type'' shall mean the unique processing prescribed for
designated orders, subject to the restrictions set forth in
paragraph (l) below with respect to orders and bulk messages
submitted through bulk ports, that are eligible for entry into the
System. Unless otherwise specified in the Rules or the context
indicates otherwise, the Exchange determines which of the following
Order Types are available on a class or system basis.''
     BZX Options Rule 21.1(f), Definitions, provides ``The term
``Time in Force'' means the period of time that the System will hold
an order, subject to the restrictions set forth in paragraph (j)
below with respect to bulk messages submitted through bulk ports,
for potential execution. Unless otherwise specified in the Rules or
the context indicates otherwise, the Exchange determines which of
the following Times-in-Force are available on a class, system, or
trading session basis. Rule 21.20 sets forth the Times-in-Force the
Exchange may make available for complex orders.''
    \4\ EDGX Options Rule 21.1, Definitions, provides, ``The term
``Order Type'' shall mean the unique processing prescribed for
designated orders, subject to the restrictions set forth in
paragraph (j) below with respect to orders and bulk messages
submitted through bulk ports, that are eligible for entry into the
System. Unless otherwise specified in the Rules or the context
indicates otherwise, the Exchange determines which of the following
Order Types are available on a class, system, or trading session
basis. Rule 21.20 sets forth the Order Types the Exchange may make
available for complex orders.''
    \5\ Cboe Rule 5.6, Availability of Orders, provides, ``Unless
otherwise specified in the Rules or the context indicates otherwise,
the Exchange determines which of the following order types are
available on a class-by-class and system-by-system basis.''
    \6\ C2 Rule 6.10(a), Availability of Orders, provides,
``Availability. Unless otherwise specified in the Rules or the
context indicates otherwise, the Exchange determines which of the
following order types, Order Instructions, and Times-in-Force are
available on a class, system, or trading session basis. Rule 6.13
sets forth the order types, Order Instructions, and Times-in-Force
the Exchange may make available for complex orders.''
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    The Exchange proposes to add rule text at the beginning of Options
3, Section 7 which states, ``The Exchange may determine to make certain
order types and time-in-force, respectively, available on a class or
System basis.'' The purpose of this rule change is to provide the
Exchange with appropriate flexibility to address different trading
characteristics, market models, and the investor base of each class, as
well as to handle any System issues that may arise and require the
Exchange to temporarily not accept certain order types. This rule

is consistent with BZX Options Rule 21.1, EDGX Options Rules 21.1(d)
and 21.1(f), Cboe Rule 5.6 and C2 Rule 6.10(a), each of which provides
these exchanges with the same flexibility. The Exchange intends to file
rule changes to adopt this rule across all Nasdaq affiliated markets.
    This rule change will not permit the Exchange to discriminate among
market participants when determining which order types and times-in-
force provisions are available on a class or system basis. The
Exchange's proposal allows the Exchange to make certain order types and
time-in-force, respectively, available on a class or System basis
uniformly for all market participants. For example, if the Exchange
determined to make a certain order type unavailable, that order type
would not be available for any market participant.
    The Exchange would issue an Options Trader Alert to provide
notification to Participants that a change is being made to the
availability or unavailability of a certain order type or time-in-
force. The Exchange notes that in the event of System disruption, the
Exchange would notify Participants of the unavailability of any order
type and would also provide notification when that order type was
available once the disruption was resolved.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\8\ in particular, in that it
is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest. The proposed rule change would
provide the Exchange with the flexibility to determine the availability
of order types and times-in-force on a class and System basis. This
flexibility would remove impediments to and perfect the mechanism of a
free and open market and a national market system by allowing the
Exchange to address the specific characteristics of different classes
and different market conditions. The Exchange believes that this
proposal serves to protect investors by ensuring that the appropriate
order types and times-in-force are tailored to the different class
characteristics and by mitigating risks associated with changing market
conditions.\9\ The Exchange would issue a notification to Participants
to provide them notice that a change is being made to the availability
or unavailability of a certain order type or time-in-force before
implementing the change. In the event of a System issue, the Exchange
believes that it is consistent with the Act to temporarily not offer a
certain order type to ensure the proper executions of transactions
within the System thereby protecting investors and the public interest.
The Exchange anticipates that exercising its ability to temporarily not
offer order types would be infrequent.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ The Exchange may also determine to temporarily not offer an
order type or a time-in-force based on a System issue.
---------------------------------------------------------------------------

    Adding this provision on all Nasdaq affiliated markets will ensure
consistency between the Exchange rules and that of its affiliates and
would remove impediments to and perfect the mechanism of a free and
open market and promote just and equitable principles of trade, as well
as foster cooperation and coordination with persons engaged in
facilitating transactions in securities. The proposed rule change
provides the Exchange with the same flexibility currently permitted on
BZX Options, EDGX Options, Cboe and C2. The Exchange believes that this
consistency promotes market participants' understanding of the rules
across the multiple affiliated exchanges and promotes a fair and
orderly national options market system. The Exchange also notes that
the proposed change is reasonable and does not affect investor
protection because the proposed change does not present any novel or
unique issues, as it has previously been filed with the Commission.
    The Exchange's proposal is not unfairly discriminatory because the
Exchange will not discriminate among market participants when
determining which order types and times-in-force provisions are
available on a class or system basis. The Exchange's proposal allows
the Exchange to make certain order types and time-in-force,
respectively, available on a class or System basis uniformly for all
market participants. For example, if the Exchange determined to make a
certain order type unavailable, that order type would not be available
for any market participant.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe the proposed rule change will impose any burden on intra-market
competition, as the proposed rule change will apply in the same manner
to all order types and/or times-in-force, as the Exchange determines,
for all Participants. The Exchange does not believe the proposed rule
change will impose any burden on inter-market competition because the
proposed change provides the Exchange with substantially the same
flexibility as the rules of other exchanges.\10\ Therefore, the
Exchange believes that the proposed rule change will allow it to make
determinations regarding the availability of orders that will enable it
to remain competitive as markets and market conditions evolve.
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    \10\ See notes 4-6 above.
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    The Exchange's proposal does not impose an undue burden on
competition because the Exchange's proposal will uniformly make certain
order types and time-in-force, respectively, available on a class or
System basis for 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 either solicited or received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
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, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
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    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.

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    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\16\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become operative immediately. The Exchange notes that
waiver of the operative delay will allow BX to exercise immediately the
same flexibility to make certain order types available or unavailable
as its affiliated exchanges (i.e., BZX Options, EDGX Options, Cboe and
C2). The Exchange states that this consistent flexibility among the
affiliated exchanges would serve to protect investors and the public
interest by mitigating risks associated with changing market
conditions. Based on the foregoing, the Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest, and the Commission hereby waives the
30-day operative delay and designates the proposal operative upon
filing.\17\
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    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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 change 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-BX-2020-002 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-BX-2020-002. 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 offices of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2020-002, and should be submitted on
or before March 12, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2020-03414 Filed 2-19-20; 8:45 am]
 BILLING CODE 8011-01-P


Requests to receive prescribing         129,090              1           129,090           *0.25         516,360
 information by fax, email, or
 mail when requested (Sec.
 Sec.   201.100(c)(5) and
 201.100(g))...................
                                --------------------------------------------------------------------------------

    Total......................  ..............  ...............  ..............  ..............         574,301
----------------------------------------------------------------------------------------------------------------
\1\ Totals may not sum because frequency numbers are rounded.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (15 minutes).

                                 Table 2--Estimated One-Time Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                       Number of     Total one-       Average
   Type of reporting and 21 CFR       Number of      responses per      time        burden per      Total hours
             section                 respondents      respondent      responses      response
----------------------------------------------------------------------------------------------------------------
Review for accuracy and                      3,550           14.60        51,830            5            259,150
 completeness of posted
 prescribing information under
 Sec.   201.100(c)(4)............
Submission of circular of                    1,300               1         1,300            1.25           1,625
 information by blood
 establishments under Sec.
 201.100(c)(4)...................
                                  ------------------------------------------------------------------------------
    Total........................  ...............  ..............  ............  ..............         260,775
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated One-Time Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
   Type of disclosure and 21 CFR        Number of      Frequency per      Total       Hours per
              section                  respondents      disclosure     disclosures   disclosure     Total hours
----------------------------------------------------------------------------------------------------------------
Design, testing, and production of             3,550            49.3       175,015           160      28,002,400
 labels for existing products......
Production of new label statement              3,550            49.3       175,015            24       4,200,360
 on immediate container label or
 outside package (Web site and toll-
 free number) under Sec.  Sec.
 201.100(b)(8), 606.121(c)(8)(ii),
 610.60(a)(8), and 610.61(t).......
                                    ----------------------------------------------------------------------------
    Total..........................  ...............  ..............  ............  ............      32,202,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                 Table 4--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Number of        Number of                     Average
   Type of disclosure and 21 CFR section     disclosures per   responses per  Total annual   burden per    Total hours    Total capital, operating  and
                                                respondent      respondent     disclosures   disclosure                         maintenance costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Distribution of prescribing information by               993             130       129,090             1       129,090  $26,500 to $90,750.
 fax, email, or mail when requested (Sec.
 Sec.   201.100(c)(5) and 201.100(g)).
Design, testing and production of labels                 381            3.80         1,395           160       223,200
 for new prescription drug and biological
 products and blood and blood components.
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ...............  ..............  ............  ............       352,290
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Other Annualized Cost Burdens to Respondents: Operating and
Maintenance Costs of the Toll-Free Telephone Number and Responding to
Requests

    This proposed rule would require that manufacturers provide and
maintain a toll-free telephone number that users of prescribing
information can call if they want the prescribing information to be
faxed, emailed, or mailed to them. It was assumed that all
manufacturers would use existing telephone infrastructure, and they
would need to add options to the system so that someone could request
the prescribing information in other forms, particularly if Internet
access is not available. The costs would include labor costs to modify
the phone system and to respond to requests. We will adopt the estimate
for the annualized cost to have a functioning system and maintaining it
from the economic impact analysis. The recurring annual costs to
operate and maintain the toll-free telephone number and to send paper
prescribing information upon request would range from $26,500 to
$90,750 (Ref. 6). An average of this range will be used for this
estimation, resulting in $58,619 per manufacturer.
    Concerning the distribution of prescribing information by fax,
email, or mail when requested (Sec. Sec.  201.100(c)(5) and
201.100(g)), and based on data described in section IX.H of the
Analysis of Impacts, we estimate that each manufacturer, repacker,
relabeler, or contract manufacturer will receive approximately 130
requests annually to distribute prescribing information by fax, email,
or mail, and that each distribution of prescribing information

would take approximately 1 hour (table 4). In addition, we estimate
that each request to receive prescribing information by fax, email, or
mail will take approximately 15 minutes (table 1).
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507)(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. To ensure that
comments on the information collection are received by January 20,
2015, OMB recommends that written comments be faxed to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:
202-395-7285, or emailed to<EMAIL_ADDRESS>All comments
should be identified with the title ``Electronic Distribution of
Prescribing Information for Human Prescription Drugs, Including
Biological Products.''

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule, does not contain policies that have substantial
direct effects 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. Accordingly,
we have concluded that the proposed rule does not contain policies that
have federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

IX. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). This proposed rule would be an economically significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The proposed rule would have a significant economic
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA expects this
proposed rule to result in a 1-year expenditure that would meet or
exceed this amount.

Summary

    The proposed rule would generate costs to set up a system for the
electronic distribution of prescribing information for human
prescription drugs. While this system may support other or all
components of the product labeling in addition to the prescribing
information, this proposed rule covers the prescribing information
portion of product labeling.
    The proposed rule would generate costs for users of prescribing
information who would need additional hardware, training, Internet
access, and information access time. In addition, incremental costs
would be associated with some printing of the prescribing information.
Table 5 shows a summary of the ranges of annualized costs using
discount rates of 7 percent and 3 percent over 10 years. The proposed
rule would generate benefits in the form of production cost savings
because eliminating the production of most paper forms would reduce the
costs of providing prescribing information on human prescription drugs.
Table 5 shows the ranges of savings. The large ranges for both costs
and savings indicate the uncertainty associated with such a large
change in practices for such a large number of manufacturers and users.
If we use a 7 percent discount rate to annualize the costs and savings
over 10 years, the effects of the proposed rule could range from
annualized net savings of $5.0 million to annualized net savings of
$73.5 million. With a 3 percent discount rate to annualize cost
savings, the effects could range from an annualized net savings of
$10.0 million to annualized net savings of $82.2 million. These
quantified effects do not include the public health benefits associated
with users having access to the most up-to-date versions of the
prescribing information.
    The full assessment of the economic analysis is available in Docket
FDA-2007-N-0363 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 7).

                              Table 5--Summary of Annualized Costs and Cost Savings
                                                  [In millions]
----------------------------------------------------------------------------------------------------------------
                                                     Low  (7%)      High  (7%)       Low  (3%)      High  (3%)
----------------------------------------------------------------------------------------------------------------
Cost Savings....................................           $51.8          $163.7           $56.6          $170.8
Costs...........................................            46.8            89.2            46.6            88.6
                                                 ---------------------------------------------------------------
    Net Savings (Cost Savings-Costs)............             5.0            73.5            10.0            82.2
----------------------------------------------------------------------------------------------------------------

X. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XI. Proposed Effective Date

    We propose that any final rule based on this proposal become
effective 6 months after publication in the Federal Register.
Implementation of this rule

would require that manufacturers and applicants have up-to-date
electronic prescribing information posted on FDA's labeling repository
Web site, that manufacturers and applicants have verified the content
of that information, that the immediate container label and outer
container or package bear the required statement, and that paper
labeling no longer accompany the drug. The FDA labeling repository Web
site is currently available at labels.fda.gov and is populated with
prescribing information submitted to the Agency under current
regulatory requirements, such as requirements to submit labeling with
listing information or with annual reports. If the prescribing
information available in the repository is current, manufacturers and
applicants would not be required to resubmit labeling before beginning
the electronic distribution of labeling.
    Any human prescription drug that an applicant or manufacturer
introduces into interstate commerce after the effective date that does
not have accurate, complete, and updated electronic prescribing
information available on FDA's labeling repository Web site, as well as
the statement on the product's immediate container label and the outer
container or package explaining how to access the information, or that
continues to be accompanied by paper prescribing information would not
meet the criteria to be exempt from the requirement to provide
``adequate directions for use'' and would be misbranded under section
502(f)(1) of the FD&C Act. As explained further in section XII, we
understand that 6 months is not likely to be sufficient time for many
manufacturers and applicants to implement this rule with regard to some
or all of their marketed products. As a result, we are proposing to
exercise enforcement discretion for 2 years from publication of the
final rule. However, we anticipate that some will be able to comply
with the rule beginning on the effective date. We want to ensure that
those that are able to comply as soon as 6 months after publication can
take advantage of the benefits of electronic distribution of labeling
at that time and will no longer need to provide paper labeling with
their products (as long as all other requirements of the rule are met).
Because, technically, full implementation (elimination of paper
labeling that accompanies the product) cannot take place until the rule
is effective, a longer effective date could delay implementation by
those able to comply as soon as 6 months after the publication date. We
request comment on whether a 6 month effective date is sufficient given
the concerns raised in the GAO report about potential workflow
disruptions in pharmacies as a result of an online-only system for
prescribing information. Additionally, FDA requests comments on whether
a dual system, where the regulation would require distribution of both
paper and electronic versions of labeling until the compliance date, is
desirable and information about the potential benefits or consequences
of such a requirement.

XII. Proposed Compliance Date

    Given the time that may be needed for industry to make necessary
changes to the drugs' immediate container labels and outer containers
or packages to comply with this rule and to enable firms to exhaust
existing stock of drugs already packaged with paper prescribing
information, we propose a compliance date of 2 years after the final
rule is published. Thus, until the compliance date, we will exercise
enforcement discretion with regard to products subject to the
electronic labeling requirements, so long as those products continue to
be distributed with the current prescribing information in paper form.
However, a product distributed between the effective date and the
compliance date that bears the new required statement on the label and
outer container must have the current electronic prescribing
information in the labeling repository at labels.fda.gov and should not
be accompanied by the paper prescribing information.
    We note that registration and listing information for blood and
blood components is currently not electronically submitted to the
Agency. FDA is in the process of developing standards for the
electronic submission of labeling for blood and blood components. The
Agency will consider progress in developing such standards when setting
a compliance date in a final rule for blood and blood components and/or
on our own initiative grant an exemption for blood and blood components
for a period of time until electronic submission of the labeling for
blood and blood components is supported. Thus, the final regulation may
include staggered compliance dates, with a later compliance date for
blood and blood components and an earlier compliance date for all other
drug products.
    FDA is requesting comments on the proposed effective and compliance
dates, and whether they are appropriate. Specifically, we request
comment on whether a delayed compliance date would alleviate concerns
raised in the GAO report about potential workflow disruptions in
pharmacies as a result of an online-only system for prescribing
information and, if so, how much additional time would be needed to
change operations.

XIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site address in this reference section, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

1. ``Electronic Drug Labeling: No Consensus on the Advantages and
Disadvantages of Its Exclusive Use,'' GAO-13-592, Report by the
Government Accountability Office, July 8, 2013.
2. ``Analysis of the Feasibility of Safety Labeling Changes
Implementation Timeline,'' Final Report by Eastern Research Group,
Inc., June 22, 2012.
3. Ho, Y., Q. Chen, H. Nian, K.B. Johnson, ``An Assessment of
Pharmacists' Readiness for Paperless Labeling: A National Survey.''
Journal of the American Medical Informatics Association, 1-6, 2013.
4. Internal analysis of safety-related labeling changes approved by
FDA between 2003 and 2013.
5. Internal review of labeling changes for new molecular entities
for calendar years 2005 to 2007.
6. ``Electronic Distribution of Labeling Proposed Rule Final Report
Economic Impact Analysis,'' Report by Eastern Research Group, Inc.,
October 4, 2010.
7. Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for
Electronic Distribution of Prescribing Information for Human
Prescription Drugs, Including Biological Products; Proposed Rule,
available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 606

    Blood, Labeling, Laboratories, Reporting and recordkeeping
requirements.

21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public

Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, it is proposed that 21 CFR parts 201, 606, and 610
be amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Amend Sec.  201.100 as follows:
0
a. In paragraph (b)(7), remove the phrase ``on or within the package
from which it is to be dispensed'' and add in its place ``either on or
within the package from which it is to be dispensed, or accompanying
the package from which it is to be dispensed under paragraph (b)(8) of
this section'';
0
b. Add paragraph (b)(8);
0
c. In paragraph (c)(1) remove the phrase ``on or within the package
from which the drug is to be dispensed'' and add in its place ``on or
within or accompanying the package from which the drug is to be
dispensed under paragraph (b)(8) of this section'';
0
d. Add paragraphs (c)(3) through (5);
0
e. Revise the introductory text of paragraph (d);
0
f. In paragraph (d)(2), remove the phrase ``on or within the package
from which the drug is to be dispensed'' and add in its place ``on or
within or accompanying the package from which the drug is to be
dispensed under paragraph (b)(8) of this section'';
0
g. Add paragraphs (d)(4) and (g).
    The additions and revisions read as follows:

Sec.  201.100  Prescription drugs for human use.

* * * * *
    (b) * * *
    (8) The statement: ``To obtain the current prescribing information,
go to labels.fda.gov or call (insert the toll-free telephone number)
for a faxed, emailed, or mailed copy.'' This statement must be no
smaller than 6-point type. Provided, however, that in the case of a
container too small or otherwise unable to accommodate a label with
sufficient space to bear the statement, the statement shall be affixed
to the immediate container label by other means, such as a peel-back
label. Additionally, if the container is packaged within an outer
container from which it is removed for dispensing or use, the statement
shall also be included on the outer container or package.
    (c) * * *
    (3) Labeling containing prescribing information accompanying the
package from which the drug is to be dispensed under paragraphs (b)(8)
and (c)(4) of this section is distributed electronically and not in
paper form except for any FDA-approved patient labeling, any labeling
containing prescribing information that is distributed upon request by
FAX or mail, any labeling distributed under the exemption provisions of
paragraph (g) of this section that is on or within the package from
which the drug is to be dispensed, and any prescribing information
accompanying promotional labeling.
    (4) Labeling containing prescribing information must be submitted
to FDA in an electronic format that FDA can process, review, and
archive. FDA will periodically issue guidance on how to provide the
electronic submission (e.g., method of transmission, media, file
formats, preparation and organization of files). Upon initial approval
of a new drug or biological product, labeling containing prescribing
information must be submitted and posted before introducing the drug
into interstate commerce. For drugs already approved under section 505
of the Federal Food, Drug, and Cosmetic Act or biological products
licensed under section 351 of the Public Health Service Act, applicants
must submit labeling containing prescribing information within 2
business days of a change to the prescribing information. For
unapproved drugs, the person responsible for the content of labeling
must submit labeling containing prescribing information within 2
business days of a change to the prescribing information. Other
manufacturers, such as repackers or relabelers, must submit labeling
containing prescribing information within 2 business days of the
posting or new posting of an applicant's labeling. The entity
responsible for submitting the labeling for the drug must verify that
the correct version of the prescribing information appears on FDA's
labeling repository Web site labels.fda.gov. The entity responsible for
submitting the labeling must contact FDA's Structured Product Labeling
Coordinator by calling 1-888-463-6332 or emailing<EMAIL_ADDRESS>within 4 business days of its submission if the labeling is not posted
on FDA's labeling repository Web site or within 2 business days of its
posting if the labeling that is posted is incorrect. Products with
missing, inaccurate, false, misleading, or outdated labeling on the
FDA's labeling repository Web site are misbranded.
    (5) The applicant, manufacturer, or person responsible for the
content of labeling must provide a toll-free telephone number in the
label statement required in paragraph (b)(8) of this section.
    (i) The applicant, manufacturer, or person responsible for the
content of labeling must ensure that the telephone number is current,
fully functioning, and maintained for 24 hours a day, 7 days a week.
    (ii) The applicant, manufacturer, or person responsible for the
content of labeling must have a fully functioning and maintained system
to respond to requests to obtain an alternate form of the prescribing
information which the manufacturer receives through the toll-free
number. The applicant, manufacturer, or person responsible for the
content of labeling must take adequate steps to provide the requested
prescribing information promptly to the requestor.
    (d) Any labeling, as defined in section 201(m) of the Federal Food,
Drug, and Cosmetic Act, whether or not it is on or within a package
from which the drug is to be dispensed or accompanying a package from
which the drug is to be dispensed under paragraph (b)(8) of this
section, distributed by or on behalf of the manufacturer, packer, or
distributor of the drug, that furnishes or purports to furnish
information for use or which prescribes, recommends, or suggests a
dosage for the use of the drug (other than dose information required by
paragraph (b)(2) of this section and Sec.  201.105(b)(2)) contains:
* * * * *
    (4) In the case of prescribing information accompanying promotional
labeling, the information required, in paper form and in the format
specified, by Sec. Sec.  201.56, 201.57, and 201.80.
* * * * *
    (g) If FDA has granted an exemption of the drug from the
requirements for the electronic distribution of labeling, the
applicant, manufacturer, or person responsible for the content of
labeling of unapproved drugs, distributes the content of labeling in
paper form.
    (1) On FDA's initiative, or in response to a written request from
an applicant, manufacturer, or person responsible for the content of
labeling of unapproved drugs, the appropriate Center Director may
exempt a human prescription drug from the requirements for electronic
distribution of labeling set forth in this section. The exemption
request must document why compliance with the electronic distribution
of labeling requirements could adversely affect the safety,
effectiveness, purity, or potency of the drug; is not technologically
feasible; or is otherwise inappropriate;

and must explain why the concerns underlying the request could not
reasonably be addressed by other measures. If an exemption is granted,
the applicant, manufacturer, or person responsible for the content of
labeling of unapproved drugs must distribute the content of labeling in
paper form.
    (2) For products regulated by the Center for Drug Evaluation and
Research, requests for an exemption should be sent to the Office of New
Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, or
for drug products for which there is no reference listed drug, to the
Office of Generic Drugs, Center for Drug Evaluation and Research, Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. For
products regulated by the Center for Biologics Evaluation and Research,
requests for an exemption should be submitted to the attention of the
appropriate Review Division in the relevant Center for Biologics
Evaluation and Research Product Office using the following address:
Center for Biologics Evaluation and Research, Food and Drug
Administration, Document Control Center, 1401 Rockville Pike (HFM-99),
Rockville, MD 20852.
0
3. In Sec.  201.306, revise paragraph (a)(1)(ii) introductory text and
paragraph (b)(2) to read as follows:

Sec.  201.306  Potassium salt preparations intended for oral ingestion
by man.

    (a) * * *
    (1) * * *
    (ii) The labeling either on or within the package from which the
drug is to be dispensed or accompanying the package from which the drug
is to be dispensed under Sec.  201.100(b)(8) bears adequate information
for its use by practitioners in accord with the ``full disclosure''
labeling requirements of Sec.  201.100, including the following warning
statement: * * *
* * * * *
    (b) * * *
    (2) The labeling either on or within the package from which the
drug is to be dispensed or accompanying the package from which the drug
is to be dispensed under Sec.  201.100(b)(8) bears adequate information
for its use by practitioners in accord with the ``full disclosure''
labeling requirements of Sec.  201.100, including a recommendation that
patients be directed to dissolve any such tablets in an appropriate
amount of liquid and to dilute any such liquid preparations adequately
to assure against gastrointestinal injury associated with the oral
ingestion of concentrated potassium salt preparations.
0
4. In Sec.  201.310, revise the third sentence of paragraph (a) to read
as follows:

Sec.  201.310  Phenindione; labeling of drug preparations intended for
use by man.

    (a) * * * In view of the potentially serious effects found to be
associated with preparations of this drug intended for use by man, the
Commissioner of Food and Drugs will regard such preparations as
misbranded within the meaning of section 502(f)(1) and (2) of the
Federal Food, Drug, and Cosmetic Act, unless the label and labeling
either on or within the package from which the drug is to be dispensed
or accompanying the package from which the drug is to be dispensed
under Sec.  201.100(b)(8), and any other labeling furnishing or
purporting to furnish information for use of the drug, bear a
conspicuous warning statement to the following effect: * * *
* * * * *

PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS

0
5. The authority citation for 21 CFR part 606 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371,
374; 42 U.S.C. 216, 262, 263a, 264.

0
6. In Sec.  606.121 revise paragraph (c)(8)(ii) to read as follows:

Sec.  606.121  Container label.

* * * * *
    (c) * * *
    (8) * * *
    (ii) ``See circular of information for indications,
contraindications, cautions, and methods of infusion. To obtain the
current circular of information, go to labels.fda.gov, or call (insert
toll-free telephone number) for a faxed, emailed, or mailed copy.''
This statement must be no smaller than 6-point type.
* * * * *

Sec.  606.122  [Amended]

0
7. In Sec.  606.122 introductory text, remove the words ``must be
available for distribution'' and add in their place ``must be
distributed electronically.''

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
8. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

0
9. In Sec.  610.60, add paragraph (a)(8) to read as follows:

Sec.  610.60  Container label.

    (a) * * *
    (8) The container label for biological products must bear the
statement: ``To obtain the current prescribing information, go to
labels.fda.gov, or call (insert the toll-free telephone number) for a
faxed, emailed, or mailed copy.'' This statement must be no smaller
than 6-point type. If the container label is incapable of bearing the
statement due to inadequate space, the statement must be affixed to the
container by other means, such as a peel-back label.
* * * * *
0
10. In Sec.  610.61, revise paragraphs (k) and (n) and add paragraph
(t) to read as follows:

Sec.  610.61  Package label.

* * * * *
    (k) The route of administration recommended, or reference to such
directions in an enclosed circular or the electronic prescribing
information;
* * * * *
    (n) The inactive ingredients when a safety factor, or reference to
an enclosed circular or the electronic prescribing information;
* * * * *
    (t) The package label for products must bear the statement: ``To
obtain the current prescribing information, go to labels.fda.gov or
call (insert the toll-free telephone number) for a faxed, emailed, or
mailed copy.'' This statement must be no smaller than 6-point type.

    Dated: December 11, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29522 Filed 12-16-14; 11:15 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 3 (Thursday, January 5, 2012)]
[Rules and Regulations]
[Pages 429-431]
[FR Doc No: 2011-33853]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 173

[Docket No. PHMSA-2011-0315; Notice No. 11-13]

Clarification and Further Guidance on the Fireworks Approvals
Policy

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Clarification.

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

SUMMARY: This clarification provides further guidance on PHMSA's policy
that it will only accept fireworks approvals applications from
fireworks manufacturers or their designated agents and grant approvals
only to manufacturers of fireworks devices. This clarification and
additional guidance follows the issuance of Docket No. PHMSA-2010-0353;
Notice 10-9, published on June 29, 2011.

DATES: The policy clarification discussed in this document is effective
January 5, 2012.

FOR FURTHER INFORMATION CONTACT: Mr. Ryan Paquet, Director, Approvals
and Permits Division, Office of Hazardous Materials Safety, (202) 366-
4512, PHMSA, 1200 New Jersey Avenue SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION:

I. Introduction

    This document provides clarification and further guidance on
PHMSA's Office of Hazardous Materials Safety (OHMS), Clarification of
the Fireworks Approval Policy published on June 29, 2011 (76 FR 38053).
Specifically, this document provides clarification and additional
guidance on how we intend to implement our policy with respect to: (1)
EX classification approvals with expiration dates; (2) applications
from non-manufacturers that seek to add new item names to existing EX
classification approvals; and (3) applications from non-manufacturers
that were denied prior to June 29, 2011.
    In addition to addressing questions as to how we intend to
implement our earlier policy clarification, this document clarifies our
policy regarding the transfer of EX classification approvals.

II. Background

    The transportation of an explosive (fireworks device) requires an
EX classification approval issued by PHMSA, commonly referred to as an
EX number. The EX number is a unique

identifier that indicates the device has been classed and approved for
transportation in the U.S., and is specific to a particular device as
specified in 49 CFR 173.56(j) and the American Pyrotechnic Association
(APA) Standard 87-1.
    PHMSA understands that it is a common industry practice for
fireworks devices produced by one manufacturer to be marketed and sold
under different trade names. Further, in the past, each retailer,
importer or distributor, in addition to the manufacturer, applied for
and received an EX classification approval for the identical fireworks
device. This practice resulted in PHMSA processing multiple
applications and issuing multiple approvals for the same fireworks
device. This redundant and burdensome process did not promote the safe
transportation of explosives (fireworks devices); instead, it impeded
the conduct of business for both the fireworks industry and PHMSA.
    On June 29, 2011, we issued a clarification of our policy to issue
fireworks classification approvals only to fireworks manufacturers, and
accept fireworks classification applications only from fireworks
manufacturers or their U.S. designated agents. This policy
clarification was intended to restate the requirements of the Hazardous
Materials Regulations (HMR), enhance safety by ensuring accountability
of manufacturing, and reducing the number of duplicate applications and
EX classification approvals being issued for identical fireworks
devices.
    Since the policy clarification was issued, we have received
questions about how we intend to implement it with respect to: (1) EX
classification approvals with expiration dates; (2) applications from
non-manufacturers that seek to add new item names to existing EX
classification approvals; and (3) applications from non-manufacturers
that were denied prior to June 29, 2011.
    We have also received questions about our policy regarding the
transfer of EX classification approvals, which was not addressed in the
prior clarification notice.
    To address these questions regarding our fireworks approvals
policy, we are providing the following clarification and additional
guidance.

III. EX Classification Approvals With Expiration Dates

    After June 29, 2011, only a manufacturer that holds a valid EX
classification approval may reapply to have the EX number renewed.
Regardless of who originally applied for the approval, to renew the EX
classification approval, the manufacturer or its designated agent must
be the entity who submits an application for renewal and all supporting
documentation to<EMAIL_ADDRESS>The manufacturer must sign and
certify that the device for which the approval is requested conforms to
the APA Standard 87-1, and the descriptions and technical information
contained in the application are complete and accurate in accordance
with Sec.  173.56(j)(3).
    All EX approvals with expiration dates held by non-manufacturers
will expire as follows: Fireworks EX approvals expiring January 1, 2012
through December 31, 2012 will expire two years from the date indicated
in the approval. For example, a fireworks EX approval expiring on
January 1, 2012 will be extended until January 1, 2014. A revised EX
classification approval will be automatically sent to the approval
holder on record with the new expiration date. After December 31, 2014,
the manufacturer or its designated agent must submit the application
for renewal and all supporting documentation to<EMAIL_ADDRESS>The
manufacturer must sign and certify that the device for which the
approval is requested conforms to the APA Standard 87-1, and the
descriptions and technical information contained in the application are
complete and accurate in accordance with Sec.  173.56(j)(3).
    Fireworks EX classification approvals expiring January 1, 2013
through December 31, 2015 will expire on the date noted in the EX
approval and will not be extended. The manufacturer or its designated
agent must submit an application for renewal and all supporting
documentation to<EMAIL_ADDRESS>The manufacturer must sign and
certify that the device for which the approval is requested conforms to
the APA Standard 87-1, and the descriptions and technical information
contained in the application are complete and accurate in accordance
with Sec.  173.56(j)(3). For example, a fireworks EX Approval expiring
on March 22, 2014 will expire on March 22, 2014.
    All fireworks EX approvals with expiration dates will expire by the
end of 2015.

IV. Requests To Add Additional Item Names to Existing EX Classification
Approvals

    We often receive applications to add fireworks device item names to
an existing EX classification approval. Only a manufacturer or its
designated agent may submit a request after June 29, 2011 to add an
additional item name to an existing EX approval.
    If anyone other than the manufacturer or its designated agent holds
an existing EX classification approval and it is desired to add
additional items to that approval, then the manufacturer or its
designated agent must submit the EX classification approval as a new
application.

V. Firework Applications Denied Before June 29, 2011

    Firework applications resubmitted after June 29, 2011 by any
person, company or entity other than the manufacturer or its designated
agent that were previously denied will not be accepted unless those
applications are submitted by the manufacturer or its designated agent
as the applicant. The manufacturer must sign and certify that the
device for which the approval is requested conforms to the APA Standard
87-1, and the descriptions and technical information contained in the
application are complete and accurate in accordance with Sec.
173.56(j)(3).

VI. Non-Transferability of EX Approvals

    EX approvals are non-transferrable, and therefore, may not be sold
or transferred. Accordingly, EX approvals cannot be acquired in
connection with any sale of assets, sale of business, acquisition or
merger. PHMSA may find a company in violation of the HMR should a
manufacturer attempt to use an EX approval issued by PHMSA to another
company for manufacturing of the device. The manufacturer or its
designated agent must submit an application for a new approval. The
manufacturer must sign and certify that the device for which the
approval is requested conforms to the APA Standard 87-1, and the
descriptions and technical information contained in the application are
complete and accurate in accordance with Sec.  173.56(j)(3). If
approved, PHMSA will issue a new EX approval to the manufacturer
specified in the application.

Summary

    PHMSA's Office of Hazardous Materials Safety (OHMS), Approvals
Office will continue to issue approvals only to fireworks manufacturers
and accept applications only from manufacturers or their designated
agents. Consistent with this policy, we will only reissue EX
classification approvals with expiration dates that have been submitted
by the manufacturer or its designated agent. If the manufacturer was
not the original applicant, the manufacturer or its

designated agent must submit the application as a new application.
However, we will provide an extended expiration date of two years for
EX classification approvals that expire through December 31, 2012.
    Additionally, we will only accept applications that seek to add new
item names to existing EX classification approvals from the
manufacturer or its designated agent. If the manufacturer was not the
original applicant, the application must be submitted by the
manufacturer or its designated agent as a new application. Further,
applications from non-manufacturers that were denied prior to June 29,
2011 must be resubmitted by the manufacturer.
    Finally, EX approvals are non-transferable, and therefore may not
be sold or transferred.

    Issued in Washington, DC, on December 30, 2011.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2011-33853 Filed 1-4-12; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Rules and Regulations]
[Pages 31739-31741]
[FR Doc No: 2019-14136]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0760; FRL-9995-85-Region 4]

Air Plan Approval; North Carolina; Revision To Permit Term for
Non-Title V Air Quality Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision provided
by the State of North Carolina, through the North Carolina Department
of Environmental Quality, Division of Air Quality (DAQ), on January 12,
2018. The SIP revision makes changes to the State's combined
construction and operating permit program for non-Title V sources. EPA
is proposing to approve the revision to the North Carolina SIP because
it is consistent with the Clean Air Act (CAA or Act).

DATES: This rule is effective August 2, 2019.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R04-OAR-2018-0609. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air and Radiation Division (formerly the Air, Pesticides and Toxics
Management Division), U.S. Environmental Protection Agency, Region 4,
61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that if
at all possible, you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday 8:30 a.m.
to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Evan Adams of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9009. Mr. Adams can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    EPA is taking final action to approve changes to the North Carolina
SIP that were provided to EPA through a letter dated January 12,
2018.\1\ EPA is finalizing approval of the portions of this SIP
revision that make changes to 15 North Carolina Administrative Code
(NCAC) 02Q.0300--Construction and Operation Permits.\2\ These
regulations set forth the State's process for issuing combined
construction and operating permits. They do not apply to Title V
permits issued by DAQ. See 15A NCAC 02Q.0301(a). The January 12, 2018,
submittal requests minor typographical/administrative edits to 15 NCAC
02Q .0308. For example, the submittal fixes a grammar error in 15 NCAC
02Q .0308(b) by replacing the word ``which'' with the word ``that'' in
the first sentence. In addition, the submittal changes the permit term
(duration) for combined construction and operating permits from five
years, or less as determined reasonable by the Director, to eight
years. This permit term in Section .0308 of the rule affects only minor
sources because sources subject to Title V (i.e., major sources) are
subject to the separate operating permit term provisions of North
Carolina's Title V program.
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    \1\ EPA notes that the Agency received the SIP revision on
February 2, 2018.
    \2\ In the table of North Carolina regulations federally
approved into the SIP at 40 CFR 52.1770(c), 15A NCAC 02Q is referred
to as ``Subchapter 2Q Air Quality Permits.''
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    In a notice of proposed rulemaking (NPRM) published on March 28,
2019 (84 FR 11695), EPA proposed to approve the aforementioned changes
to 15 NCAC 02Q .0308 in the North Carolina SIP, which make
typographical/administrative edits to the rule. The NPRM provides
additional details regarding EPA's action. Comments on the NPRM were
due on or before April 29, 2019. EPA received no comments on the
proposed action and is now taking final action to approve the above-
referenced revision.

II. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference under Subchapter
2Q, Air Quality Permits of the North Carolina SIP, Section .0308,
entitled Final Action on Permit Applications, state effective January
1, 2015. EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 4
Office (please contact the person identified in the For Further
Information Contact section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the State implementation plan, have been incorporated by reference by
EPA into that plan, are fully federally enforceable under sections 110
and 113 of the CAA as of the effective date of the final rulemaking of
EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\3\
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    \3\ See 62 FR 27968 (May 22, 1997).
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III. Final Action

    EPA is taking final action to approve changes to the North Carolina
SIP that were provided to EPA through a letter dated January 12, 2018.
Specifically, EPA is approving 15 NCAC 02Q .0308 to modify the permit
term for non-title V combined construction and operating permits and
make other typographical/administrative edits. These rule changes are
consistent with the CAA and its implementing regulations, and will not
interfere with any applicable requirement concerning attainment and
reasonable further progress (as defined in section 7501 of the Act).
See 42 U.S.C. 7410(l).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory

action because SIP approvals are exempted under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 3, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 7, 2019.
Mary S. Walker,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42.U.S.C. 7401 et seq.

Subpart (II)--North Carolina

0
2. In Sec.  52.1770, the table in paragraph (c)(1) is amended under
Subchapter 2Q Air Quality Permits, Section .0300 Construction and
Operating Permits by revising the entry for ``Section .0308'' to read
as follows:

Sec.  52.1770   Identification of plan.

* * * * *
    (c) * * *

                                                       (1) EPA Approved North Carolina Regulations
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                                                                       State
          State citation                    Title/subject         effective date              EPA approval date                      Explanation
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                                                                      * * * * * * *
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                                                            Subchapter 2Q Air Quality Permits
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                                                                      * * * * * * *
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                                                    Section .0300 Construction and Operating Permits
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                                                                      * * * * * * *
Section .0308.....................  Final Action on Permit              1/1/2015  07/3/2019, [Insert citation of            ............................
                                     Applications.                                 publication]

                                                                      * * * * * * *
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* * * * *
[FR Doc. 2019-14136 Filed 7-2-19; 8:45 am]
 BILLING CODE 6560-50-P