[Federal Register Volume 84, Number 175 (Tuesday, September 10, 2019)]
[Notices]
[Pages 47521-47525]
[FR Doc No: 2019-19492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3968]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; APINACA; AB-FUBINACA;
5F-AMB; 5F-MDMB-PICA; 4-F-MDMB-BINACA; 4-CMC; N-ethylhexedrone; alpha-
PHP; DOC; Crotonyl Fentanyl; Valeryl Fentanyl; Flualprazolam; Etizolam;
and 8 Additional Preparations Listed in Schedule III of the 1961 Single
Convention on Narcotic Drugs; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
interested persons to submit comments concerning abuse potential,
actual

abuse, medical usefulness, trafficking, and impact of scheduling
changes on availability for medical use of 21 drug substances. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drugs. This notice requesting comments
is required by the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by October 4, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before (October 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 4, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3968 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; APINACA
(AKB-48); AB-FUBINACA; 5F-AMB (5F-AMB-PINACA, 5F-MMB-PINACA); 5F-MDMB-
PICA (5F-MDMB-2201); 4-F-MDMB-BINACA (4F-ADB); 4-CMC (4-
chloromethcathinone; clefedrone); N-ethylhexedrone (NEH, hexen, ethyl-
hex); alpha-PHP (PV-7, [alpha]-pyrrolidinohexanophenone); DOC (2,5-
dimethoxy-4-chloroamfetamine); Crotonyl Fentanyl; Valeryl Fentanyl;
Flualprazolam; Etizolam; Preparations listed in Schedule III of the
1961 Single Convention on Narcotic Drugs as follows:
Acetyldihydrocodeine, Codeine; Dihydrocodeine; Ethylmorphine;
Nicocodine; Nicodicodine; Norcodeine; Pholcodine: Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Article 2 of the Psychotropic
Convention provides that if a party to the convention or WHO has
information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary-General of the United Nations (the U.N. Secretary-General)
and provide the U.N. Secretary-General with information in support of
its opinion.
    Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides
that when WHO notifies the United States under Article 2 of the
Psychotropic Convention that it has information that may justify adding
a drug or other substances to one of the schedules of the Psychotropic
Convention, transferring a drug or substance from one schedule to
another, or deleting it from the schedules, the Secretary of State must
transmit the notice to the Secretary of Health and Human Services
(Secretary of HHS). The Secretary of HHS must then publish the notice
in the Federal Register and provide opportunity for interested persons
to submit comments that will be considered by HHS in its

preparation of the scientific and medical evaluations of the drug or
substance.

II. WHO Notification

    The Secretary of HHS received the following notice from WHO (non-
relevant text removed):

Ref.: C.L.30.2019

    The World Health Organization (WHO) presents its compliments to
Member States and Associate Members and in reference to C.L.14.2019
has the pleasure of informing that the 42nd Expert Committee on Drug
Dependence (ECDD) will meet in Geneva from 21 to 25 October 2019.
The Expert Committee on Drug Dependence meetings are of a closed
nature, however a public information session on 21 October will be
open to Member States.
    Further information, including a full agenda of the meeting,
will be available on the ECDD website: https://www.who.int/medicines/access/controlled-substances/ecdd/ecdd/en/.
    The 42nd ECDD will convene to review psychoactive substances
(attached) regarding their potential to cause dependence, abuse and
harm to health, and their potential therapeutic applications. WHO
will make recommendations to the UN Secretary-General on the need
for and level of international control of these substances.
    Member States are invited to collaborate in this process through
designated national focal points, as in the past and in line with
the publication ``Guidance on the WHO review of psychoactive
substances for international control'' (EB126/2010/REC1, Annex 6,
Para 21).\1\
    For this purpose, a questionnaire was designed to gather country
information on the legitimate use, harmful use, status of national
control and potential impact of international control for each
substance under evaluation.
    National focal points designated by Member States following
C.L.14.2019 will be approached to complete the questionnaire on
substances under review at the 42nd ECDD meeting. Focal points will
be given further instructions and direct access to online
questionnaires. The questionnaires will be analysed by the
Secretariat and prepared as a report that will be shared with the
Committee for review.
    Focal points are also encouraged to provide any additional
relevant information (unpublished or published) on substances to be
reviewed at the 42nd ECDD to<EMAIL_ADDRESS>by 20
September 2019.
    The World Health Organization takes this opportunity to renew to
Member States and Associate Members the assurance of its highest
consideration.
    GENEVA, 29 July 2019

\1\http://apps.who.int/gb/ebwha/pdf_files/EB126-REC1/B126_REC1-en.pdf#page=95.

42nd Expert Committee on Drug Dependence (ECDD) 21 to 25 October 2019,
WHO headquarters, Geneva, Switzerland Substances Under Review

                             Critical Review
------------------------------------------------------------------------

------------------------------------------------------------------------
Synthetic cannabinoids.................  1. APINACA (AKB-48).
                                         2. AB-FUBINACA.
                                         3. 5F-AMB (5F-AMB-PINACA, 5F-
                                          MMB-PINACA).
                                         4. 5F-MDMB-PICA (5F-MDMB-2201).
                                         5. 4-F-MDMB-BINACA (4F-ADB).
Synthetic stimulants...................  6. 4-CMC (4-
                                          chloromethcathinone;
                                          clefedrone).
                                         7. N-ethylhexedrone (NEH,
                                          Hexen, Ethyl-Hex).
                                         8. Alpha-PHP (PV-7, [alpha]-
                                          pyrrolidinohexanophenone).
                                         9. DOC (2,5-Dimethoxy-4-
                                          chloroamfetamine).
Fentanyl Analogues.....................  10. Crotonyl fentanyl.
                                         11. Valeryl fentanyl.
Benzodiazepines........................  12. Flualprazolam.
                                         13. Etizolam.
------------------------------------------------------------------------

                               Pre-Review
------------------------------------------------------------------------

------------------------------------------------------------------------
Preparations listed in Schedule III of   Preparations of:
 the 1961 Single Convention on Narcotic  [cir] Acetyldihydrocodeine.
 Drugs.                                  [cir] Codeine.
                                         [cir] Dihydrocodeine.
                                         [cir] Ethylmorphine.
                                         [cir] Nicocodine.
                                         [cir] Nicodicodine.
                                         [cir] Norcodeine.
                                         [cir] Pholcodine.
                                         when compounded with one or
                                          more other ingredients and
                                          containing not more than 100
                                          milligrams of the drug per
                                          dosage unit and with a
                                          concentration of not more than
                                          2.5 percent in undivided
                                          preparation.
------------------------------------------------------------------------

    FDA has verified the website addresses contained in the WHO notice,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time. Access to view the WHO
questionnaire can be found at https://www.who.int/medicines/access/controlled-substances/ecdd_41_meeting/en/.

III. Substances Under WHO Review

    APINACA (AKB-48) (chemical name: N-(1-adamantyl)-1-pentyl-1H-
indazole-3-carboxamide) is a synthetic cannabinoid with a high affinity
for the CB1 receptor. This substance functionally (biologically) mimics
the effects of delta-9-tetrahydrocannabinol (THC), a Schedule I
substance, and the main psychoactive constituent in the cannabis
(marijuana) plant. Synthetic cannabinoids have been marketed under the
guise of ``herbal incense,'' and promoted by drug traffickers as legal
alternatives to marijuana. Chronic abuse of synthetic cannabinoids has
been linked to adverse health effects including signs of addiction and
withdrawal, as well as numerous reports of emergency room admissions
resulting from their abuse. There are no commercial or approved medical
uses for APINACA. On May 16, 2013, APINACA was temporarily controlled
as a Schedule I substance under the CSA. On May 11, 2016, APINACA was
permanently placed in Schedule I under the CSA.
    AB-FUBINACA (chemical name: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
(4-fluorobenzyl)-1H-indazole-3-carboxamide) is a synthetic cannabinoid

that is a potent full agonist at CB1 receptors. This substance
functionally (biologically) mimics the effects of the structurally
unrelated THC, a Schedule I substance, and the main psychoactive
chemical constituent in marijuana. Synthetic cannabinoids have been
marketed under the guise of ``herbal incense,'' and promoted by drug
traffickers as legal alternatives to marijuana. AB-FUBINACA use has
been associated with serious adverse events including death in the
United States. There are no commercial or approved medical uses for AB-
FUBINACA. On February 10, 2014, AB-FUBINACA was temporarily controlled
as a Schedule I substance under the CSA. On September 6, 2016, AB-
FUBINACA was permanently placed as a Schedule I controlled substance
under the CSA.
    5F-AMB (5F-AMB-PINACA, 5F-MMB-PINACA) (chemical name: Methyl 2-(1-
(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) is a
synthetic cannabinoid that is a potent full agonist at CB1 receptors.
This substance functionally (biologically) mimics the effects of THC, a
Schedule I substance, and the main psychoactive constituent in
marijuana. Synthetic cannabinoids have been marketed under the guise of
``herbal incense,'' and promoted by drug traffickers as legal
alternatives to marijuana. The use of synthetic cannabinoids,
including, 5F-AMB has been associated with nausea and vomiting,
shortness of breath or depressed breathing, hypertension, tachycardia,
chest pain, muscle twitching, acute renal failure, anxiety, agitation,
psychosis, suicidal ideation, and/or cognitive impairment. There are no
commercial or approved medical uses for 5F-AMB. On April 10, 2017, 5F-
AMB was temporarily controlled as a Schedule I substance under the CSA.
This temporary rule was extended effective April 10, 2019. On April 8,
2019, a Drug Enforcement Administration Notice of Proposed Rulemaking
proposed permanently placing 5F-AMB into Schedule I of the CSA.
    5F-MDMB-PICA (5F-MDMB-2201) (chemical name: Methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) is a
synthetic cannabinoid that has been sold online and used to mimic the
biological effects of THC, the main psychoactive constituent in
marijuana. Research and clinical reports have demonstrated that
synthetic cannabinoids are applied onto plant material so that the
material may be smoked as users attempt to obtain a euphoric and
psychoactive ``high.'' Synthetic cannabinoids have been marketed under
the guise of ``herbal incense,'' and promoted by drug traffickers as
legal alternatives to marijuana. 5F-MDMB-PICA has been associated with
law enforcement seizures and overdoses requiring emergency medical
intervention. On April 16, 2019, 5F-MDMB-PICA was temporarily
controlled as a Schedule I substance under the CSA.
    4F-MDMB-BINACA (4F-ADB) (chemical name: Methyl 2-(1-(4-
fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) is a
synthetic cannabinoid that is a potent full agonist at CB1 receptors.
This substance functionally (biologically) mimics the effects of THC, a
Schedule I substance, and the main psychoactive constituent in
marijuana. 4F-MDMB-BINACA has been encountered in numerous synthetic
cannabinoid products that are smoked for their psychoactive effects.
Multiple law enforcement encounters of 4F-MDMB-BINACA have been
reported involving overdose deaths, illicit use, and seizures of drug
evidence between December 2018 and February 2019. There are no
commercial or approved medical uses for 4F-MDMB-BINACA. 4F-MDMB-BINACA
is a positional isomer of 5F-AMB (chemical name: Methyl 2-(1-(5-
fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate), as defined
by 21 CFR 1300.01, and has been a Schedule I controlled substance under
the CSA since April 10, 2017.
    4-CMC (4-chloromethcathinone; clefedrone, clephedrone) (chemical
name: 1-(4-chlorophenyl)-2-(methylamino)propan-1-one) is a synthetic
cathinone. 4-CMC produces central nervous system stimulant effects and
is abused for its psychoactive properties. 4-CMC abuse has been
associated with adverse health effects. 4-CMC has no currently accepted
medical use in treatment in the United States. 4-CMC is not controlled
under the CSA, but it is considered a Schedule I controlled substance
by a number of states in the United States.
    N-Ethylhexedrone (chemical name: 2-(ethylamino)-1-phenylhexan-1-
one; NEH, hexen, Ethyl-Hex) and alpha-PHP (chemical name: 1-phenyl-2-
(pyrrolidin-1-yl)hexan-1-one; PV-7, [alpha]-pyrrolidinohexanophenone)
are synthetic cathinones. N-Ethylhexedrone and alpha-PHP produce
central nervous system stimulant effects and are abused for their
psychoactive properties. N-Ethylhexedrone and alpha-PHP have been
associated with adverse health effects leading to emergency department
admissions, and deaths. N-Ethylhexedrone and alpha-PHP have no
currently accepted medical use in treatment in the United States. On
July 18, 2019, N-Ethylhexedrone and alpha-PHP were temporarily
controlled as a Schedule I substance under the CSA.
    DOC (chemical names: 2,5-Dimethoxy-4-chloroamfetamine; 2,5-
dimethoxy-4-chloroamphetamine; 1-(4-chloro-2,5-dimethoxyphenyl)propan-
2-amine) is a hallucinogenic substance with psychedelic effects. Law
enforcement has encountered DOC in tablet, capsule, powder, liquid, and
blotter paper forms. Its use has been associated with at least one
death. DOC has no currently accepted medical use in treatment in the
United States. DOC is not controlled under the CSA but is a Schedule I
controlled substance in the state of Florida.
    Crotonyl fentanyl (chemical name: N-(1-phenethylpiperidin-4-yl)-N-
phenylbut-2-enamide) and valeryl fentanyl (chemical name: N-(1-
phenethylpiperidin-4-yl)-N-phenylpentanamide) are synthetic opioids
that have a pharmacological profile similar to other Schedule I and II
controlled opioid substances such as cyclopropyl fentanyl, fentanyl,
and other related mu-opioid receptor agonist substances. They are
clandestinely produced and associated with adverse events typically
associated with opioid use such as respiratory depression, anxiety,
constipation, tiredness, hallucinations, and withdrawal. Crotonyl
fentanyl and valeryl fentanyl have been encountered by law enforcement
and/or reported in the scientific literature by public health officials
as being illicitly distributed and abused. Crotonyl fentanyl and
valeryl fentanyl have no commercial or currently accepted medical uses
in the United States. On February 1, 2018, valeryl fentanyl was
temporarily placed into Schedule I of the CSA. The chemical structure
of crotonyl fentanyl defines it as a fentanyl-related substance, as
defined in 21 CFR 1308.11(h)(30); therefore, crotonyl fentanyl was
temporarily controlled as a Schedule I controlled substance under the
CSA as of February 6, 2018.
    Flualprazolam and etizolam belong to a class of substances known as
benzodiazepines. Benzodiazepines produce central nervous system
depression and are commonly used to treat insomnia, anxiety, and
seizure disorders. Etizolam is currently prescribed in some countries;
however, neither drug substance is approved for medical use in the
United States. Currently, flualprazolam and etizolam are not controlled
under the CSA, but are controlled in a number of States.

    Acetyldihydrocodeine is an opiate derivative of low to moderate
potency used as a cough suppressant and analgesic in various other
countries. Acetyldihydrocodeine is not approved for medical use in the
United States and is controlled under Schedule I of the CSA.
    Codeine is an opioid drug closely related to morphine. Codeine can
cause opioid tolerance, dependence, addiction, poisoning, and
respiratory depression in high doses. It is an active ingredient in
several approved narcotic analgesic and antitussive medicines in the
United States. Codeine is approved for marketing in the United States
and available as a single-ingredient product, or in combination with
one or more nonnarcotic ingredients in recognized therapeutic amounts.
Codeine is controlled in Schedule II of the CSA. Some codeine
combination products are controlled in Schedule III and some in
Schedule V, depending on the concentration or amount of codeine present
in the approved product.
    Dihydrocodeine is a semisynthetic narcotic related to codeine.
Dihydrocodeine is an active ingredient in prescription-only oral tablet
combination products approved for marketing in the United States for
the treatment of moderate to moderately severe pain. Dihydrocodeine is
controlled in Schedule II of the CSA. Some dihydrocodeine-containing
combination products are controlled in Schedule III and some in
Schedule V, depending on the concentration or amount of dihydrocodeine
present in the approved product.
    Ethylmorphine is a derivative of morphine with analgesic and
antitussive effects. It is not approved for medical use in the United
States but is approved for use in various other countries around the
world. Ethylmorphine is controlled in Schedule II of the CSA. Some
ethylmorphine containing combination products are controlled in
Schedule III and some in Schedule V, depending on the concentration or
amount of ethylmorphine present in the approved product.
    Nicocodine (nicocodeine) and nicodicodine (nicodicodeine) are
esters of codeine and dihydrocodeine, respectively. They are opioids
with analgesic and cough suppressant effects. They are not approved for
medical use in the United States. Nicocodeine is controlled in Schedule
I of the CSA. As an ester of dihydrocodeine, nicodicodeine is
controlled in Schedule II of the CSA.
    Pholcodine is an opiate with cough suppressant effects but little
to no analgesic effects. It is an active ingredient in cough lozenges
in some countries but is not an ingredient in any products approved for
medical use in the United States. Pholcodine is controlled in Schedule
I of the CSA.

IV. Opportunity To Submit Domestic Information

    As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of
HHS, invites interested persons to submit comments regarding the 21
drug substances. Any comments received will be considered by HHS when
it prepares a scientific and medical evaluation for drug substances
that is responsive to the WHO Questionnaire for these drug substances.
HHS will forward such evaluation of these drug substances to WHO, for
WHO's consideration in deciding whether to recommend international
control/decontrol of any of these drug substances. Such control could
limit, among other things, the manufacture and distribution (import/
export) of these drug substances and could impose certain recordkeeping
requirements on them.
    Although FDA is, through this notice, requesting comments from
interested persons, which will be considered by HHS when it prepares an
evaluation of these drug substances, HHS will not now make any
recommendations to WHO regarding whether any of these drugs should be
subjected to international controls. Instead, HHS will defer such
consideration until WHO has made official recommendations to the
Commission on Narcotic Drugs, which are expected to be made in late
2019. Any HHS position regarding international control of these drug
substances will be preceded by another Federal Register notice
soliciting public comments, as required by paragraph (d)(2)(B) of the
CSA.

    Dated: September 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19492 Filed 9-9-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2983-2985]
[FR Doc No: 2015-00834]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74049; File No. SR-FINRA-2015-001]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Extend the Expiration Date of FINRA Rule 0180
(Application of Rules to Security-Based Swaps)

January 14, 2015.
    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 January 7, 2015, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to extend the expiration date of FINRA Rule 0180
(Application of Rules to Security-Based Swaps) to February 11, 2016.
FINRA Rule 0180 temporarily limits, with certain exceptions, the
application of FINRA rules with respect to security-based swaps.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
    On July 1, 2011, the SEC issued an Order granting temporary
exemptive relief (the ``Temporary Exemptions'') from compliance with
certain provisions of the Exchange Act in connection with the revision,
pursuant to Title VII of the Dodd-Frank Wall Street Reform and Consumer
Protection Act (the ``Dodd-Frank Act''),\4\ of the Exchange Act
definition of ``security'' to encompass security-based swaps.\5\
Consistent with the Commission's action, on July 8, 2011, FINRA filed
for immediate effectiveness FINRA Rule 0180,\6\ which, with certain
exceptions, is intended to temporarily limit the

application of FINRA rules \7\ with respect to security-based swaps,
thereby helping to avoid undue market disruptions resulting from the
change to the definition of ``security'' under the Act.\8\
---------------------------------------------------------------------------

    \4\ Public Law 111-203, 124 Stat. 1376 (2010).
    \5\ See Securities Exchange Act Release No. 64795 (July 1,
2011), 76 FR 39927 (July 7, 2011) (Order Granting Temporary
Exemptions Under the Securities Exchange Act of 1934 in Connection
With the Pending Revision of the Definition of ``Security'' To
Encompass Security-Based Swaps, and Request for Comment) (the
``Exemptive Release''). The term ``security-based swap'' is defined
in Section 761 of the Dodd-Frank Act. See also Securities Exchange
Act Release No. 67453 (July 18, 2012), 77 FR 48207 (August 13, 2012)
(Further Definition of ``Swap,'' ``Security-Based Swap,'' and
``Security-Based Swap Agreement''; Mixed Swaps; Security-Based Swap
Agreement Recordkeeping).
    \6\ See Securities Exchange Act Release No. 64884 (July 14,
2011), 76 FR 42755 (July 19, 2011) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change; File No. SR-FINRA-2011-033)
(``FINRA Rule 0180 Notice of Filing''). See also Securities Exchange
Act Release No. 71287 (January 10, 2014), 79 FR 2924 (January 16,
2014) (Notice of Filing and Immediate Effectiveness of Proposed Rule
Change; File No. SR-FINRA-2014-001) (extending the expiration date
of FINRA Rule 0180 to February 11, 2015).
    \7\ The current FINRA rulebook consists of: (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from NYSE (``Incorporated
NYSE Rules''). While the NASD Rules generally apply to all FINRA
members, the Incorporated NYSE Rules apply only to those members of
FINRA that are also members of the NYSE. The FINRA Rules apply to
all FINRA members, unless such rules have a more limited application
by their terms. For more information about the rulebook
consolidation process, see Information Notice, March 12, 2008
(Rulebook Consolidation Process).
    \8\ In its Exemptive Release, the Commission noted that the
relief is targeted and does not include, for instance, relief from
the Act's antifraud and anti-manipulation provisions. FINRA has
noted that FINRA Rule 0180 is similarly targeted. For instance,
paragraph (a) of FINRA Rule 0180 provides that FINRA rules shall not
apply to members' activities and positions with respect to security-
based swaps, except for FINRA Rules 2010 (Standards of Commercial
Honor and Principles of Trade), 2020 (Use of Manipulative, Deceptive
or Other Fraudulent Devices), 3310 (Anti-Money Laundering Compliance
Program) and 4240 (Margin Requirements for Credit Default Swaps).
See also paragraphs (b) and (c) of FINRA Rule 0180 (addressing the
applicability of additional rules) and FINRA Rule 0180 Notice of
Filing.
---------------------------------------------------------------------------

    The Commission, noting the need to avoid a potential unnecessary
disruption to the security-based swap market in the absence of an
extension of the Temporary Exemptions, and the need for additional time
to consider the potential impact of the revision of the Exchange Act
definition of ``security'' in light of ongoing Commission rulemaking
efforts under Title VII of the Dodd-Frank Act, issued an Order which
extended and refined the applicable expiration dates for the previously
granted Temporary Exemptions.\9\ The Commission previously noted that
extending the Temporary Exemptions would facilitate a coordinated
consideration of these issues with the relief provided pursuant to
FINRA Rule 0180.\10\ In establishing Rule 0180, and in extending the
rule's expiration date, FINRA noted its intent, pending the
implementation of any SEC rules and guidance that would provide greater
regulatory clarity in relation to security-based swap activities, to
align the expiration date of FINRA Rule 0180 with the termination of
relevant provisions of the Temporary Exemptions.\11\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 71485 (February 5,
2014), 79 FR 7731 (February 10, 2014) (Order Extending Temporary
Exemptions Under the Securities Exchange Act of 1934 in Connection
With the Revision of the Definition of ``Security'' to Encompass
Security-Based Swaps, and Request for Comment) (``Temporary
Exemptions Extension Release'') stating that, for those expiring
Temporary Exemptions ``that are not directly linked to pending
security-based swap rulemakings, the Commission is extending the
expiration date until the earlier of such time as the Commission
issues an order or rule determining whether any continuing exemptive
relief is appropriate for security-based swap activities with
respect to any of these Exchange Act provisions or until three years
following the effective date of this Order.'' The Temporary
Exemptions Extension Release further stated that for each expiring
Temporary Exemption ``that is related to pending security-based swap
rulemakings, the Commission is extending the expiration date until
the compliance date for the related security-based swap-specific
rulemaking.'' See also Securities Exchange Act Release No. 71482
(February 5, 2014), 79 FR 7570 (February 10, 2014) (Extension of
Exemptions for Security-Based Swaps) (extending the expiration dates
in interim final rules that provide exemptions under the Securities
Act of 1933 (the ``Securities Act''), the Exchange Act, and the
Trust Indenture Act of 1939 for those security-based swaps that
prior to July 16, 2011 were security-based swap agreements and are
defined as ``securities'' under the Securities Act and the Exchange
Act as of July 16, 2011 due solely to the provisions of Title VII of
the Dodd-Frank Act).
    \10\ See Securities Exchange Act Release No. 68864 (February 7,
2013), 78 FR 10218 (February 13, 2013) (Order Extending Temporary
Exemptions Under the Securities Exchange Act of 1934 in Connection
With the Revision of the Definition of ``Security'' to Encompass
Security-Based Swaps, and Request for Comment).
    \11\ See note 6 supra.
---------------------------------------------------------------------------

    The Commission's rulemaking and development of guidance in relation
to security-based swap activities is ongoing. As such, FINRA believes
it is appropriate and in the public interest, in light of the
Commission's goals as set forth in the Exemptive Release and the
Temporary Exemptions Extension Release, to extend FINRA Rule 0180 for a
limited period, to February 11, 2016, so as to avoid undue market
disruptions resulting from the change to the definition of ``security''
under the Act. As noted in the FINRA Rule 0180 Notice of Filing, FINRA
will amend the expiration date of Rule 0180 in subsequent filings as
necessary such that the expiration date will be coterminous with the
termination of relevant provisions of the Temporary Exemptions.
    FINRA has filed the proposed rule change for immediate
effectiveness. FINRA is proposing that the implementation date of the
proposed rule change will be February 11, 2015.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\12\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change would
further the purposes of the Act because, consistent with the goals set
forth by the Commission in the Exemptive Release and in the Temporary
Exemptions Extension Release, the proposed rule change will help to
avoid undue market disruption that could result if FINRA Rule 0180
expires before the implementation of any SEC rules and guidance that
would provide greater regulatory clarity in relation to security-based
swap activities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. FINRA believes that the
proposed rule change would prevent undue market disruption that would
otherwise result if security-based swaps were, by virtue of the
expansion of the Act's definition of ``security'' to encompass
security-based swaps, subject to the application of all FINRA rules
before the implementation of any SEC rules and guidance that would
provide greater regulatory clarity in relation to security-based swap
activities. FINRA believes that, by extending the expiration of FINRA
Rule 0180, the proposed rule change will serve to promote regulatory
clarity and consistency, thereby reducing burdens on the marketplace
and facilitating investor protection.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of

investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission shall institute
proceedings to determine whether the proposed rule should be approved
or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2015-001 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2015[dash]001.
This file number should be included on the subject line if email is
used. To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street NE., Washington, DC 20549, on official business days between the
hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2015-001
and should be submitted on or before February 11, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-00834 Filed 1-20-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Rules and Regulations]
[Pages 48323-48326]
[FR Doc No: 2013-18878]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0058; FRL-9841-8]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Update of the Motor Vehicle Emissions Budgets for the
Lancaster 1997 8-Hour Ozone Maintenance Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action to approve revisions to the
Commonwealth of Pennsylvania's (Pennsylvania) State Implementation Plan
(SIP). The revisions consist of an update to the SIP-approved Motor
Vehicle Emissions Budgets (MVEBs) for nitrogen oxides (NOX)
and volatile organic compounds (VOCs), and an updated point source
inventory for NOX and VOCs for the 1997 8-Hour Ozone
National Ambient Air Quality Standard (NAAQS) SIP for Lancaster County
(hereafter referred to as the ``Lancaster Maintenance Area''). EPA's
approval of the updated MVEBs makes them available for transportation
conformity purposes. EPA is approving these revisions to the MVEBs and
point source inventory in accordance with the requirements of the Clean
Air Act (CAA).

DATES: This rule is effective on October 7, 2013 without further
notice, unless EPA receives adverse written comment by September 9,
2013. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2013-0058 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2013-0058, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2013-0058. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI 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 in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Asrah Khadr,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On November 19, 2012, Pennsylvania submitted formal revisions to
its SIP. One SIP revision consists of updated MVEBs for NOX
and VOCs for the 1997 8-Hour Ozone NAAQS. The other SIP revision
updates the point source inventory for NOX and VOCs.
    On July 18, 1997 (62 FR 38856), EPA established the 1997 8-Hour
Ozone NAAQS. On April 30, 2004 (69 FR 23857), Lancaster County was
designated as nonattainment for the 1997 8-Hour Ozone NAAQS. On
September 20, 2006, the Pennsylvania Department of Environmental
Protection (DEP) submitted a SIP revision which consisted of a
maintenance plan, a 2002 base year inventory and MVEBs for
transportation conformity purposes. On November 8, 2006, Pennsylvania
DEP supplemented their September 20, 2006 submittal. On July 6, 2007
(72 FR 36889), EPA approved the SIP revision as well as the
redesignation request made by Pennsylvania DEP and Lancaster County was
redesignated as a maintenance area.
    The currently SIP-approved MVEBs for the Lancaster Area were
developed using the Highway Mobile Source Emission Factor Model
(MOBILE6.2). On March 2, 2010 (75 FR 9411), EPA published a notice of
availability for the Motor Vehicle Emissions Simulator (MOVES2010)
model for use in developing MVEBs for SIPs and for conducting
transportation conformity analyses. EPA commenced a two year grace
period after which time the MOVES2010 model would have to be used for
transportation conformity purposes. The two year grace period was
scheduled to end on March 2, 2012. On February 27, 2012 (77 FR 11394),
EPA published a final rule extending the grace period for one more year
to March 2, 2013 to ensure adequate time for affected parties to have
the capacity to use the MOVES model to develop or update the applicable
MVEBs in SIPs and to conduct conformity analyses. On September 8, 2010,
EPA released MOVES2010a, which is a minor update to MOVES2010 and which
is used by Pennsylvania in this SIP revision.

II. Summary of SIP Revision

    This MVEBs SIP revision updates the MVEBs for NOX and
VOCs for the years 2009 (interim year) and 2018 (maintenance year) that
were produced using the MOVES2010a model. The point source inventory
SIP revision updates the point source inventory for NOX and
VOCs. A comparison between the previous point source inventory and the
updated point source inventory is

provided in Table 1. The previously approved MVEBs were produced using
the Mobile Source Emission Factor Model (MOBILE6.2). A summary of the
updated MOVES-based MVEBs and previously approved MOBILE6.2-based MVEBs
for the years 2009 and 2018 is provided in Table 2. Even though there
is an emissions increase in the MOVES-based MVEBs, the increase is not
due to an increase in emissions from mobile sources. The increase is
due to the fact that the MOVES model provides more accurate emissions
estimates than MOBILE6.2, rather than growth that had not been
anticipated in the maintenance plan. Also, part of the update of the
MVEBs is the addition of a two tons per day (tpd) safety margin for
both NOX and VOCs. The MVEBs that will be utilized for
transportation conformity purposes and include the safety margins are
presented in Table 3. These safety margins were added because emissions
in the interim (2009) and maintenance (2018) years are significantly
less than the attainment year emissions, which is the year that the
Lancaster Maintenance Area attained the standard. A detailed summary of
EPA's review and rationale for proposing to approve this SIP revision
may be found in the Technical Support Documents (TSDs) prepared in
support of this proposed approval and are available on line at http://www.regulations.gov, Docket number EPA-R03-OAR-2013-0058.

                  Table 1--Summary of Point Source Inventory for the Lancaster Maintenance Area
----------------------------------------------------------------------------------------------------------------
                                                              Current                         Updated
                      Year                       ---------------------------------------------------------------
                                                       2009            2018            2009            2018
----------------------------------------------------------------------------------------------------------------
VOCs (tpd)......................................             8.7              11             5.5             7.7
NOX (tpd).......................................             4.1             4.6             3.2             3.6
----------------------------------------------------------------------------------------------------------------

                 Table 2--Summary of Motor Vehicle Emissions for the Lancaster Maintenance Area
----------------------------------------------------------------------------------------------------------------
                      Model                                  MOBILE6.2                      MOVES2010a
----------------------------------------------------------------------------------------------------------------
                      Year                             2009            2018            2009            2018
----------------------------------------------------------------------------------------------------------------
VOCs (tpd)......................................           14.33            7.77           14.29            8.14
NOX (tpd).......................................           22.32            8.99           33.18           18.57
----------------------------------------------------------------------------------------------------------------

        Table 3--Updated MVEBs for the Lancaster Maintenance Area
------------------------------------------------------------------------
                         Year                             2009     2018
------------------------------------------------------------------------
VOCs (tpd)............................................    35.18    14.29
NOX (tpd).............................................    20.57    10.14
------------------------------------------------------------------------

III. Final Action

    EPA is approving Pennsylvania's SIP revision from November 19, 2012
to update the SIP-approved MVEBs for the Lancaster County Maintenance
Area to reflect the use of the MOVES model. EPA is also approving the
update to the SIP-approved point source inventory. This SIP revision
allows the Lancaster County Maintenance Area to continue to be in
attainment of the 1997 8-Hour Ozone NAAQS. The updated MVEBs meet the
adequacy requirements set forth in 40 CFR 93.118(e)(4)(i)-(vi), and
have been correctly calculated to reflect the use of the MOVES model.
Upon final approval, these updated MVEBs will be both adequate and SIP-
approved for purposes of transportation conformity. EPA is publishing
this rule without prior proposal because EPA views this as a
noncontroversial amendment and anticipates no adverse comment. However,
in the ``Proposed Rules'' section of today's Federal Register, EPA is
publishing a separate document that will serve as the proposal to
approve the SIP revision if adverse comments are filed. This rule will
be effective on October 7, 2013 without further notice unless EPA
receives adverse comment by September 9, 2013. If EPA receives adverse
comment, EPA will publish a timely withdrawal in the Federal Register
informing the public that the rule will not take effect. EPA will
address all public comments in a subsequent final rule based on the
proposed rule. EPA will not institute a second comment period on this
action. Any parties interested in commenting must do so at this time.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 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. Accordingly, 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 Order
12866 (58 FR 51735, October 4, 1993);
     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).

    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    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 October 7, 2013. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking action.
    This action pertaining to the update of the SIP-approved MVEBs and
point source inventory for the Lancaster Maintenance Area 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, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: July 18, 2013.
W.C. Early,
Acting Regional Administrator, Region III.

    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 NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by
revising the entry for the 8-Hour Ozone Maintenance Plan and 2002 Base
Year Emissions Inventory. The revised text reads as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory SIP         Applicable        State submittal                           Additional
            revision                geographic area          date          EPA approval date      explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-Hour Ozone Maintenance Plan     Lancaster Area        9/20/06, 11/8/06  7/6/07, 72 FR       ..................
 and 2002 Base Year Emissions      (Lancaster                              36889.
 Inventory.                        County).
                                                                11/29/12  8/8/13 [Insert      Revised 2009 and
                                                                           page number where   2018 Motor
                                                                           the document        Vehicle Emission
                                                                           begins].            Budgets. Revised
                                                                                2009 and 2018
                                                                                point source
                                                                                inventory. See
                                                                                sections 52.2043
                                                                                and 52.2052.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.2043 is added to read as follows:

Sec.  52.2043  Control strategy for maintenance plans: ozone.

    As of August 8, 2013, EPA approves the following revised 2009 and
2018 point source inventory for nitrogen oxides (NOX) and
volatile organic compounds (VOCs) for the Lancaster 1997 8-Hour Ozone
Maintenance Area submitted by the Secretary of the Pennsylvania
Department of Environmental Protection:

----------------------------------------------------------------------------------------------------------------
                                                                                Tons per day    Tons per day
                   Applicable geographic area                          Year             NOX            VOCs
----------------------------------------------------------------------------------------------------------------
Lancaster 1997 8-Hour Ozone Maintenance Area....................            2009             3.2             5.5
Lancaster 1997 8-Hour Ozone Maintenance Area....................            2018             3.6             7.7
----------------------------------------------------------------------------------------------------------------

0
4. Section 52.2052 is added to read as follows:

Sec.  52.2052  Motor vehicle emissions budgets for Pennsylvania ozone
areas.

    As of August 8, 2013, EPA approves the following revised 2009 and
2018 Motor Vehicle Emissions Budgets (MVEBs) for nitrogen oxides
(NOX) and volatile organic compounds (VOCs) for the
Lancaster 1997 8-Hour Ozone

Maintenance Area submitted by the Secretary of the Pennsylvania
Department of Environmental Protection:

----------------------------------------------------------------------------------------------------------------
                                                                                Tons per day    Tons per day
                   Applicable geographic area                          Year             NOX            VOCs
----------------------------------------------------------------------------------------------------------------
Lancaster 1997 8-Hour Ozone Maintenance Area....................            2009           20.57           35.18
Lancaster 1997 8-Hour Ozone Maintenance Area....................            2018           10.14           14.29
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-18878 Filed 8-7-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Rules and Regulations]
[Pages 45179-45180]
[FR Doc No: 2011-18946]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0362; Airspace Docket No. 11-ANM-7]

Modification of Class E Airspace; Glasgow, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace at Wokal Field/Glasgow
International Airport, Glasgow, MT. Controlled airspace is necessary to
accommodate aircraft using Area Navigation (RNAV) Global Positioning
System (GPS) standard instrument approach procedures at the airport.
This improves the safety and management of Instrument Flight Rules
(IFR) operations at the airport. This action also updates the airport
name.

DATES: Effective date, 0901 UTC, October 20, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual

revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On May 25, 2011, the FAA published in the Federal Register a notice
of proposed rulemaking to amend Class E controlled airspace at Glasgow,
MT (76 FR 30300). Interested parties were invited to participate in
this rulemaking effort by submitting written comments on the proposal
to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.9U dated August 18, 2010, and
effective September 15, 2010, which is incorporated by reference in 14
CFR part 71.1. The Class E airspace designations listed in this
document will be published subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by modifying Class E surface airspace, and Class E airspace
extending upward from 700 feet above the surface, at Wokal Field/
Glasgow International Airport, Glasgow, MT. Controlled airspace is
necessary to accommodate IFR aircraft executing RNAV (GPS) standard
instrument approach procedures at the airport. This action is necessary
for the safety and management of IFR operations. This action also
updates the airport name from Glasgow International Airport to Wokal
Field/Glasgow International Airport.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it creates
additional controlled airspace at Wokal Field/Glasgow International
Airport, Glasgow, MT.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR part 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010 is amended as follows:

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ANM MT E2 Glasgow, MT [Amended]

Wokal Field/Glasgow International Airport, MT
    (Lat. 48[deg]12'45'' N., long. 106[deg]36'53'' W.)
Glasgow VOR/DME
    (Lat. 48[deg]12'55'' N., long. 106[deg]37'32'' W.)
Milk River NDB
    (Lat. 48[deg]12'28'' N., long. 106[deg]37'34'' W.)

    Within a 4.2-mile radius of the Wokal Field/Glasgow
International Airport, and within 2.7 miles each side of the Glasgow
VOR/DME 327[deg] radial extending from the 4.2-mile radius to 7.4
miles northwest of the VOR/DME, and within 2.7 miles each side of
the Glasgow VOR/DME 127[deg] radial extending from the 4.2-mile
radius to 7.4 miles southeast of the VOR/DME, and within 2.7 miles
each side of the Milk River NDB 106[deg] bearing extending from the
4.2-mile radius to 7.4 miles east of the NDB.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM MT E5 Glasgow, MT [Modified]

Wokal Field/Glasgow International Airport, MT
    (Lat. 48[deg]12'45'' N., long. 106[deg]36'53'' W.)

    That airspace extending upward from 700 feet above the surface
within a 9.6-mile radius of Wokal Field/Glasgow International
Airport; that airspace extending upward from 1,200 feet above the
surface starting at lat. 48[deg]40'00'' N., long. 106[deg]00'02''
W.; to lat. 48[deg]32'00'' N., long. 105[deg]50'02'' W.; to lat.
48[deg]03'00'' N., long. 105[deg]50'02'' W.; to lat. 48[deg]03'00''
N., long. 106[deg]00'02'' W.; to lat. 47[deg]49'00'' N., long.
106[deg]22'32'' W.; to lat. 48[deg]15'00'' N., long. 107[deg]07'02''
W.; to lat. 48[deg]40'00'' N., long. 107[deg]07'02'' W., thence to
point of beginning.

    Issued in Seattle, Washington, on July 19, 2011.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2011-18946 Filed 7-27-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Pages 33276-33277]
[FR Doc No: 2019-14842]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0256]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0065

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0065,
Offshore Supply Vessels; without change. Our ICR describes the
information we seek to collect from the public. Review and comments by
OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before August
12, 2019.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2019-0256] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    (3) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, attention Desk Officer for the Coast
Guard.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast Guard is also requesting comments
on the extent to which this request for information could be modified
to reduce the burden on respondents. These comments will help OIRA
determine whether to approve the ICR referred to in this notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2019-0256], and must be received by August 12,
2019.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0065.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (84 FR 19094, May 3, 2019)
required by 44 U.S.C. 3506(c)(2). That notice elicited no comments.
Accordingly, no changes have been made to the Collections.

Information Collection Request

    Title: Offshore Supply Vessels--Title 46 CFR subchapter L.
    OMB Control Number: 1625-0065.
    Summary: Title 46 U.S.C. 3305 and 3306 authorizes the Coast Guard
to prescribe safety regulations. Title 46 CFR Subchapter L promulgates
marine safety regulations for offshore supply vessels (OSV).
    Need: The OSV posting/marking requirements are needed to provide
instructions to those onboard of actions to be taken in the event of an
emergency. The reporting instructions to those on board of actions to
be taken in the event of an emergency. The reporting/recordkeeping
requirements verify compliance with regulations without Coast Guard
presence to witness routine matters, including OSV's based overseas as
an alternative to Coast Guard inspection.
    Forms: None.
    Respondents: Owners and operators of vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from 2,368
hours to 1,230 hours a year, due to a decrease in the estimated annual
number of respondents.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: July 9, 2019.
James D. Roppel,
Chief, Office of Information Management, U.S. Coast Guard.
[FR Doc. 2019-14842 Filed 7-11-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54457-54458]
[FR Doc No: 2021-21386]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-N-2231; FDA-2011-N-0362; FDA-2018-N-0073; FDA-
2018-N-0074; FDA-2010-N-0155; FDA-2011-N-0781; FDA-2021-N-0525; FDA-
2014-N-0987; FDA-2020-N-1657; FDA-2017-N-6931; FDA-2020-N-2217; FDA-
2012-N-0369; FDA-2017-N-6730; FDA-2020-N-1207; FDA-2012-N-0115; FDA-
2021-N-0363; FDA-2009-N-0025; FDA-2012-N-0547; FDA-2014-N-2347; FDA-
2018-N-1129; FDA-2021-N-0387; FDA-2020-N-1261; and FDA-2020-N-1644]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of information collections that have been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Blood Establishment Registration and           0910-0052       7/31/2024
 Product Listing for Manufacturers of
 Blood and Blood Products and Licensed
 Devices................................
Current Good Manufacturing Practice:           0910-0139       7/31/2024
 Manufacturing, Processing, Packing, and
 Holding of Drugs; GMP for Finished
 Pharmaceuticals (Including Gases and
 Active Pharmaceutical Ingredients).....
Irradiation in the Production,                 0910-0186       7/31/2024
 Processing, and Handling of Food.......
State Enforcement Notifications.........       0910-0275       7/31/2024
Veterinary Feed Directive...............       0910-0363       7/31/2024
Record Retention Requirements for the          0910-0428       7/31/2024
 Soy Protein/Coronary Heart Disease
 Health Claim...........................
Prescription Drug Marketing:                   0910-0435       7/31/2024
 Administrative Procedures, Policies,
 and Requirements.......................
Generic Clearance for the Collection of        0910-0796       7/31/2024
 Qualitative Data on Tobacco Products
 and Communications.....................
Survey of Drug Product Manufacturing,          0910-0899       7/31/2024
 Processing, and Packing Facilities.....
Current Good Manufacturing Practices for       0910-0116       8/31/2024
 Blood and Related Regulations for Blood
 Components; and Requirements for Donor
 Testing, Donor Notification and
 ``Lookback''...........................
New Animal Drugs for Investigational Use       0910-0117       8/31/2024
Regulations Under the Federal Import           0910-0212       8/31/2024
 Milk Act...............................
Medical Device Reporting................       0910-0437       8/31/2024
New Plant Varieties Intended for Food          0910-0583       8/31/2024
 Use....................................
Guidance for Industry and FDA Staff;           0910-0594       8/31/2024
 Class II Special Controls: Automated
 Blood Cell Separator Device Operating
 by Centrifugal or Filtration Separation
 Principle..............................
Prescription Drug Advertisements........       0910-0686       8/31/2024
Animal Food Labeling; Declaration of           0910-0721       8/31/2024
 Certifiable Color Additives............
Survey on the Occurrence of Foodborne          0910-0744       8/31/2024
 Illness Risk Factors in Selected Retail
 and Food Service Facility Types........
Food and Cosmetic Export Certificates...       0910-0793       8/31/2024
National Agriculture and Food Defense          0910-0855       8/31/2024
 Strategy Survey........................
Medical Product Communications That are        0910-0856       8/31/2024
 Consistent With the Food and Drug
 Administration Required Labeling--
 Questions and Answers..................
Drug and Device Manufacturer                   0910-0857       8/31/2024
 Communications with Payors, Formulary
 Committees, and Similar Entities
 Questions and Answers..................
Study of Disclosures to Health Care            0910-0900       8/31/2024
 Providers Regarding Data That Do Not
 Support Unapproved Use of an Approved
 Prescription Drug......................
Medical Conference Attendees'                  0910-0901       8/31/2024
 Observations About Prescription Drug
 Promotion..............................
------------------------------------------------------------------------

    Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21386 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Notices]
[Page 65875]
[FR Doc No: 2012-26789]

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

[EPA-HQ-RCRA-2012-0757, FRL-9748-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Part B Permit Application, Permit Modifications, and
Special Permits

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Part B Permit Application,
Permit Modifications, and Special Permits'' (EPA ICR No. 1573.13, OMB
Control No. 2050-0009) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act (44
U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a proposed extension of the ICR, which is
currently approved through February 28, 2013. An Agency may not conduct
or sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before January 4, 2013.

ADDRESSES: Submit your comments, referencing by Docket ID No. EPA-HQ-
RCRA-2012-0757, online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Toshia King, Office of Resource
Conservation and Recovery, mailcode 5303P, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Section 3005 of Subtitle C of RCRA requires treatment,
storage or disposal facilities (TSDFs) to obtain a permit. To obtain
the permit, the TSDFs must submit an application describing the
facility's operation. There are two parts to the RCRA permit
application--Part A and Part B. Part A defines the processes to be used
for treatment, storage, and disposal of hazardous wastes; the design
capacity of such processes; and the specific hazardous wastes to be
handled at the facility. Part B requires detailed site specific
information such as geologic, hydrologic, and engineering data. In the
event that permit modifications are proposed by the applicant or EPA,
modifications must conform to the requirements under Sections 3004 and
3005.
    Form Numbers: None.
    Respondents/affected entities: Business or other for-profit; as
well as State, Local, or Tribal governments.
    Respondent's obligation to respond: Mandatory (RCRA 3005).
    Estimated number of respondents: 97.
    Frequency of response: On occasion.
    Total estimated burden: 33,260 Burden is defined at 5 CFR
1320.03(b).
    Total estimated cost: $7,956,839, which includes $2,254,188
annualized labor costs and $5,702,651 annualized capital or O&M costs.
    Changes in Estimates: The burden hours are likely to stay
substantially the same.

    Dated: October 23, 2012.
Suzanne Rudzinski,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2012-26789 Filed 10-30-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Notices]
[Pages 4376-4377]
[FR Doc No: 2014-01347]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2009-0203]

Pipeline Safety: Meeting of the Technical Pipeline Advisory
Committee and the Liquid Pipeline Advisory Committee

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

ACTION: Notice of advisory committee meeting.

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

SUMMARY: This notice announces a public meeting of the Gas Pipeline
Advisory Committee (GPAC), also known as the Technical Pipeline Safety
Standards Committee, and the Liquid Pipeline Advisory Committee (LPAC),
also known as the Technical Hazardous Liquid Pipeline Safety Standards
Committee.

DATES: The committees will meet in joint sessions on Tuesday, February,
25, 2014, from 1 p.m. to 5 p.m. and on Wednesday, February 26, 2014,
from 9 a.m. to 5 p.m., EST.
    The meetings will not be web cast; however, presentations will be
available on the meeting Web site and posted on the E-Gov Web site:
http://www.regulations.gov under docket number PHMSA-2009-0203 within
30 days following the meeting.

ADDRESSES: The meeting location, agenda, and any additional information
will be published on the PHMSA Web site (http://www.phmsa.dot.gov/public) under ``Latest News'' on the homepage. In the interim, please
register on the following pipeline advisory committee page: https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=94. An email announcing
the meeting location will be forwarded to all who have preregistered
with PHMSA as soon as the meeting location is determined.
    Any additional information will be published on the PHMSA Web site
(http://www.phmsa.dot.gov/public) under ``Latest News'' on the
homepage.
    Comments on the meeting may be submitted to the docket in the
following ways:
    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except on Federal holidays.
    Instructions: Identify the docket number PHMSA-2009-0203 at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. You should know that anyone is able to
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). Therefore, you may want to review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000, (65 FR 19476) or view the Privacy Notice at http://www.regulations.gov before submitting any such comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on PHMSA-2009-0203.'' The Docket Clerk
will date-stamp the postcard prior to returning it to you via the U.S.
mail. Please note that due to delays in the delivery of U.S. mail to
Federal offices in Washington, DC, we recommend that persons consider
an alternative method (Internet, fax, or professional delivery service)
of submitting comments to the docket and ensuring their timely receipt
at DOT.

Privacy Act Statement

    Anyone may search the electronic form of comments received in
response to any of our dockets by the name of the individual who
submitted the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). DOT's complete Privacy
Act Statement was published in the Federal Register on April 11, 2000
(65 FR 19476).

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities, or to seek special assistance at the meeting, please
contact Cheryl Whetsel at<PHONE_NUMBER> by February 10, 2014.

FOR FURTHER INFORMATION CONTACT: For information about the meeting,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details

    The committees will meet to discuss whether or not to support the
exclusion of section 4.2 of ASTM D2513-09a, ``Standard Specification
for Polyethylene (PE) Gas Pressure Pipe, Tubing, and Fittings,'' for PE
materials. Section 4.2 addresses the use of rework materials. Other
topics to be discussed will include performance metrics for pipeline
operations, safety management systems in other industries, and agency,
State, and stakeholder priorities.

    Members of the public may attend and make a statement during the
advisory committee meeting. If you intend to make a statement, please
notify PHMSA in advance by forwarding an email to
<EMAIL_ADDRESS>by February 10, 2014.

II. Committee Background

    The GPAC and LPAC are statutorily mandated advisory committees that
advise PHMSA on proposed safety standards, risk assessments, and safety
policies for natural gas pipelines and for hazardous liquid pipelines.
Both committees were established under the Federal Advisory Committee
Act (Pub. L. 92-463, 5 U.S.C. App. 1) and the pipeline safety law (49
U.S.C. Chap. 601). Each committee consists of 15 members--with
membership evenly divided among the Federal and State government, the
regulated industry, and the public. The committees advise PHMSA on the
technical feasibility, practicability, and cost-effectiveness of each
proposed pipeline safety standard.

III. Agenda

    The Agenda will be published on the PHMSA Web site.

    Authority: 49 U.S.C. 60102, 60115; 60118.

    Issued in Washington, DC, on January 17, 2014.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2014-01347 Filed 1-24-14; 8:45 am]
BILLING CODE 4910-60-P