[Federal Register: November 2, 2007 (Volume 72, Number 212)]
[Rules and Regulations]
[Page 62108-62110]
[DOCID:fr02no07-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2005-22490; Airspace Docket No. 05-AEA-018]

Amendment of Class E Airspace; Pottsville, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule, request for comments.

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SUMMARY: This action amends Class E Airspace at Pottsville, PA to
provide adequate airspace for a new Area Navigation (RNAV) Global
Positioning System (GPS) Special Instrument Approach Procedure (IAP)
that has been developed to serve the Pottsville Hospital (91PN),
Pottsville, PA.

DATES: Effective 0901 UTC, December 20, 2007. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.
Comments for inclusion in the Rules Docket must be received on or
before November 30, 2007.

ADDRESSES: Send comments on this rule to: Docket Management Facility,
U.S. Department of Transportation, 1200 New Jersey, SE., West Building
Ground Floor, Room W12-140, Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2005-22490; Airspace Docket No. 05-AEA-018, at the beginning of
your comments. You may also submit comments through the Internet at
http://www.regulations.gov. You may review the public docket containing

the rule, any comments received, and any final disposition in person in
the Dockets Office (see ADDRESSES section for address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined during normal
business hours at the office of the Eastern Service Center, Federal
Aviation Administration, Room 210, 1701 Columbia Avenue, College Park,
Georgia 30337.

FOR FURTHER INFORMATION CONTACT: Daryl Daniels, Airspace Specialist,
System Support Group, Eastern Service Center, Federal Aviation
Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404)
305-5581.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Unless a written adverse or negative comment or a written notice of
intent to submit an adverse or negative comment is received within the
comment period, the regulation will become effective on the date
specified above. After the close of the comment period, the FAA will
publish a document in the Federal Register indicating that no adverse
or negative comments were received and confirming the effective date.
If the FAA receives, within the comment period, an adverse or negative
comment, or written notice of intent to submit such a comment, a
document withdrawing the direct final rule will be published in the
Federal Register, and a notice of proposed rulemaking may be published
with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. Communications should identify both
docket numbers and be submitted in triplicate to the address specified
under the caption ADDRESSES. All communications received on or before
the closing data for comments will be considered, and this rule may be
amended or withdrawn in light of comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's ideas and suggestions is extremely helpful in
evaluating the effectiveness of this action and determining whether
additional rulemaking action would be needed. All comments submitted
will be available, both before and after the closing date for comments,
in the Rules Docket for examination by interested persons. Those
wishing the FAA to acknowledge receipt of their comments submitted in
response to this rule must submit a self-addressed stamped postcard on
which the following statement is made: ``Comments to Docket No. FAA-
2005-22490; Airspace Docket No. 05-AEA-018.'' The postcard will be date
stamped and returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace at Pottsville, PA establishing the
controlled airspace required to support the new RNAV (GPS) Copter 095
Point in Space (PinS) approach developed for Pottsville Hospital.
Controlled airspace extending upward from 700 feet Above Ground Level
(AGL) is required to encompass the IAP and for Instrument Flight Rule
(IFR) operations, therefore, the FAA is amending Title 14, Code of
Federal Regulations (14 CFR) part 71 to establish additional class E5
Airspace at Pottsville, PA. The current E5 airspace at Pottsville does
not provide adequate airspace for this new approach. This action
provides the required controlled airspace. Designations for Class E
airspace areas extending upward from 700 feet or more above the surface
of the Earth are published in FAA Order 7400.9R, signed August 15, 2007
effective September 15, 2007, which is incorporated by reference in 14
CFR 71.1. The Class E designations listed in this document will be
published subsequently in the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (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 that 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 United States Code. Subtitle I, Section 106
describes 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 the authority
as it established controlled airspace near the Pottsville Hospital,
Pottsville, PA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
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 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 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, effective September 15, 2007, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Pottsville, PA [AMENDED]

Schuylkill County (Joe Zerbey) Airport
    (Lat. 40[deg]42'23'' N., long. 76[deg]22'24'' W.)

Pottsville Hospital [ADDED]
Point In Space Coordinates
    (Lat. 40[deg]41'45'' N., long. 76[deg]12'34'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Schuylkill County (Joe Zerbey) Airport;
and that airspace within a 6-mile radius of the point in space (lat.
40[deg]41'45'' N., long. 76[deg]12'34'' W.) serving Pottsville
Hospital.
* * * * *

    Issued in College Park, Georgia, on October 15, 2007.
Mark D. Ward,
Manager, System Support Group, Eastern Service Center
[FR Doc. 07-5420 Filed 11-1-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64162-64164]
[FR Doc No: 2016-22472]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2633]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; 4-Methylethcathinone
and Eleven Other Substances; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 12 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, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2633 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; 3,4-
dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700);
Butyrfentanyl (Butyrylfentanyl); 4-Methylethcathinone (4-MEC); 3-
Methylmethcathinone (3-methyl-N-methylcathinone; 3-MMC); Ethylone (3,4-
methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC); Pentedrone ([alpha]-
Methylaminovalerophenone); Ethylphenidate (EPH); Methiopropamine (MPA);
MDMB-CHMICA; 5F-APINACA (5F-AKB48); JWH-073; XLR-11 (5-Fluoro UR-144,
5F-UR-144); Request for Comments.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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.
    Section 201 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.28.2015
    The World Health Organization (WHO) presents its compliments to
Member States and Associate Members and has the pleasure of
informing that the Thirty-eighth Expert Committee on Drug Dependence
(ECDD) will meet in Geneva from 14 to 18 November 2016 to review a
number of substances with potential for dependence, abuse and harm
to health, and will make recommendations to the U.N. Secretary-
General, on the need for and level of international control of these
substances.
    At its 126th session in January 2010, the Executive Board
approved the publication ``Guidance on the WHO review of
psychoactive substances for international control'' (EB126/2010/
REC1, Annex 6) which requires the Secretariat to request relevant
information from Ministers of Health in Member States to prepare a
report for submission to the ECDD. For this purpose, a questionnaire
was designed to gather information on the legitimate use, harmful
use, status of national control and potential impact of
international control for each substance under evaluation. Member
States are invited to collaborate, as in the past, in this process
by providing pertinent information as requested in the questionnaire
and concerning substances under review.
    It would be appreciated if a person from the Ministry of Health
could be designated as the focal point responsible for coordinating
and answering the questionnaire. The designated focal point, and
only this person, should access and complete the questionnaires:
    1. U-47700;
    2. Butyrfentanyl (Butyrylfentanyl);
    3. 4-Methylethcathinone (4-MEC);
    4. 3-Methylmethcathinone (3-methyl-N-methylcathinone; 3-MMC);
    5. Ethylone (3,4-methylenedioxy-N-ethylcathinone; bk-MDEA;
MDEC);
    6. Pentedrone ([alpha]-Methylaminovalerophenone);
    7. Ethylphenidate (EPH);
    8. Methiopropamine (MPA);
    9. MDMB-CHMICA;
    10. 5F-APINACA (5F-AKB48);
    11. JWH-073;
    12. XLR-11 (5-Fluoro UR-144, 5F-UR-144).
    For ease of reference a PDF version of the questionnaire in
English, French and Spanish may be downloaded from the link http://www.who.int/medicines/access/controlled-substances/ecdd/en/. Please
note that these versions are for reference only and all
questionnaires must be answered through the online system. Further
clarification regarding the questionnaire may be obtained from the
Secretariat by emailing<EMAIL_ADDRESS>    Replies to the questionnaire must reach the Secretariat by 20
September 2016 in order to facilitate analyses and preparation of
the report before the planned meeting. Where there is a competent
National Authority under the International Drug Control Treaties, it
is kindly requested that the questionnaire be completed in
collaboration with such body.
    The summary information from the questionnaire will be published
online as part of the report on the Web site for the 38th ECDD
linked to the Department of Essential Medicines and Health Products
(EMP).
    The World Health Organization takes this opportunity to renew to
Member States and Associate Members the assurance of its highest
consideration.

GENEVA, 8 August 2016

    HHS received an extension from WHO that replies to the
questionnaire must reach the Secretariat by October 11, 2016. FDA has
verified the Web site addresses contained in the WHO notice, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.

III. Substances Under WHO Review

    U-47700 is a synthetic opioid drug developed in the 1970s. U-47700
is structurally related to the opioid AH-7921. U-47700 is selective for
the [micro]-opioid receptor. U-47700 has never been studied on humans,
but would be expected to produce effects similar to those of other
potent opioid agonists, including strong analgesia, sedation, euphoria,
constipation, itching, and respiratory depression which could be
harmful or fatal. Overdoses and overdose fatalities have been directly
attributed to U-47700 misuse. There have been reports of U-47700 being
encountered in counterfeit pills. On September 7, 2016, the Drug
Enforcement Administration issued a notice of intent to temporarily
schedule U-47700 into schedule I pursuant to the temporary scheduling
provisions of the Controlled Substances Act.
    Butyrfentanyl (butyrylfentanyl) is a synthetic opioid and analog of
fentanyl. Fentanyl is controlled in Schedule II of the CSA, and an
active ingredient in drug products approved for medical use and
marketed in the United States. Butyrylfentanyl has a pharmacological
profile similar to that of fentanyl and other [micro]-opioid receptor
agonists. Risks associated with abuse of butyrylfentanyl include
development of substance use disorder, overdose, and death similar to
that of other [micro]-opioid agonists. The U.S. Drug Enforcement
Administration (DEA) is aware of at least 40 confirmed fatalities
associated with butyrylfentanyl. It has no approved medical use in the
United States. On May 12, 2016, butyrylfentanyl was temporarily placed
into Schedule I of the CSA for 2 years upon finding that it posed an
imminent hazard to the public safety. The Attorney General, though, may
extend this temporary scheduling for up to 1 year.
    4-Methylethcathinone (4-MEC), 3-Methylmethcathinone (3-methyl-N-
methylcathinone; 3-MMC): 3-methyl-methcathinone (3-MMC), pentedrone,
and ethylone (3,4-methylenedioxy-N-ethylcathinone; bk-MDEA; MDEC) are
synthetic cathinones that are structurally and pharmacologically
similar to amphetamine, 3-4 methylenedioxymethamphetamine (MDMA),
cathinone, and other related substances. These substances are central
nervous system stimulants with psychoactive properties similar to
Schedule I and II amphetamine type substances. Public health risks
associated with the use of synthetic cathinones suggest that these
substances are associated with cardiac, psychiatric, and neurological
symptoms that may lead to emergency department admissions, violent
behaviors causing harm to self or others, or death. 4-MEC, 3-MMC,
pentedrone, and ethylone have no known medical use in the United
States. On March 7, 2014, the DEA published a final order in the
Federal Register amending 21 CFR 1308.11(h) to temporarily place 4-MEC
and pentedrone into Schedule I of the CSA pursuant to the temporary
scheduling provisions of 21 U.S.C. 811(h). On March 4, 2016, the
temporary Schedule I status of 4-MEC and pentedrone was extended for 1
year, or until permanent scheduling is completed. Permanent scheduling
for 4-MEC and pentedrone was initiated on March 4, 2016, upon
publication of the notice of proposed rulemaking. As a positional
isomer of 4-methylmethcathinone, 3-MMC is considered a Schedule I
substance under the CSA. In the United States,

ethylone has been sold as the street drug ``Molly'' and encountered as
a replacement for methylone. As a positional isomer of the controlled
drug butylone, ethylone is considered a Schedule I controlled substance
under the CSA.
    Ethylphenidate (EPH) is structurally related to methylphenidate.
Methylphenidate is controlled in Schedule IV of the CSA, and an active
ingredient in drug products approved for medical use and marketed in
the United States. Ethylphenidate is not approved for medical use in
the United States. Ethylphenidate is structurally related to
methylphenidate are being marketed as novel psychoactive substances
with psychoactive effects similar to methylphenidate, therefore posing
similar health risks to the users. Ethylphenidate is a controlled
substance in several European countries, and is not a controlled
substance in the United States under the CSA.
    Methiopropamine (MPA) is a structural analogue of the Schedule II
controlled substance methamphetamine. Pharmacologically, it functions
as a norepinephrine-dopamine reuptake inhibitor and, secondarily, as a
serotonin reuptake inhibitor. MPA is a thiophene based analog of
methamphetamine. It has stimulant properties as an inhibitor of
dopamine, norepinephrine transporters in the central nervous system.
MPA was critically reviewed by the WHO at its 36th meeting of the
Expert Committee on Drug Dependence in June 2014. It is not approved
for medical use or controlled in the United States under the CSA, but
is a controlled substance in the United Kingdom.
    MDMB-CHMICA is an indole-based synthetic cannabinoid that is a
potent full agonist at CB1 receptors and mimics functionally
(biologically) the effects of the structurally unrelated delta-9-
tetrahydrocannabinol (THC), a Schedule I substance, and the main active
ingredient of marijuana. Synthetic cannabinoids are marketed under the
guise of ``herbal incense,'' and promoted by drug traffickers as legal
alternatives to marijuana. MDMB-CHMICA use is associated with serious
adverse events including death in several European countries. There are
no commercial or approved medical uses for MDMB-CHMICA. MDMB-CHMICA is
not controlled under the CSA, but may be treated as a ``controlled
substance analogue'' under the CSA pursuant to 21 U.S.C 802(32)(A) and
813, and is a controlled substance in the State of Louisiana.
    5F-APINACA (5F-AKB48) is a synthetic cannabinoid belonging to a
chemical structural class with an indazole core. In vitro studies show
that it binds to the cannabinoid CB1 receptors and displays agonist
properties in functional assays, suggesting that it would share in vivo
effects with delta-9-THC and various synthetic cannabinoids. There are
no commercial or medical uses for 5F-APINACA. Synthetic cannabinoids
are marketed under the guise of ``herbal incense,'' and promoted by
drug traffickers as legal alternatives to marijuana. SF-APINACA is not
a controlled substance under the CSA, but may be treated as a
``controlled substance analogue'' under the CSA pursuant to 21 U.S.C.
802(32)(A) and 813.
    JWH-073 is an indole-based synthetic cannabinoid agonist without
the classical cannabinoid chemical structure. Pharmacology studies have
been conducted on this substance. Behavioral pharmacology studies show
that JWH-073 has delta-9-THC-like activity in animals. Synthetic
cannabinoids are marketed under the guise of ``herbal incense,'' and
promoted by drug traffickers as legal alternatives to marijuana. On
March 1, 2011, JWH-073 was temporarily controlled in Schedule I and on
July 9, 2012, JWH-073 was permanently controlled as a Schedule I
substance under the CSA.
    XLR-11 (5-Fluoro-UR-144, 5F-UR-144) is an indole-based synthetic
cannabinoid and acts as an agonist at cannabinoid CB1 receptors. Animal
studies indicate that it mimics functionally (biologically) the effects
of the structurally unrelated delta-9-THC, a Schedule I substance, and
the main active ingredient of marijuana and numerous other Schedule I
synthetic cannabinoids. Synthetic cannabinoids are marketed under the
guise of ``herbal incense,'' and promoted by drug traffickers as legal
alternatives to marijuana. On May 16, 2013, XLR-11 was temporarily
placed under Schedule I and on May 11, 2016, XLR11 was permanently
controlled as a Schedule I substance under the CSA.

IV. Opportunity To Submit Domestic Information

    As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of
the Department of Health and Human Services (HHS), invites interested
persons to submit comments regarding the 12 named drugs. Any comments
received will be considered by HHS when it prepares a scientific and
medical evaluation of these drugs. HHS will forward a scientific and
medical evaluation of these drugs to WHO, through the Secretary of
State, for WHO's consideration in deciding whether to recommend
international control/decontrol of any of these drugs. Such control
could limit, among other things, the manufacture and distribution
(import/export) of these drugs 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 drugs, 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 early 2017. Any HHS
position regarding international control of these drugs will be
preceded by another Federal Register notice soliciting public comments,
as required by section 201(d)(2)(B) of the CSA.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22472 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. Environmental Protection Agency, OAQPS 2. OMB control number b. G None a 2060  0336 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Information Collection Request for Part 71 Federal Operating Permit Regulations 8. Agency form number( s) ( If applicable) EPA ICR Number 1713.04 9. Keywords Clean Air Act, Environmental Protection 10. Abstract The part 71 program is a Federal operating permits program that will be implemented for sources located in Indian Country, Outer Continental Shelf sources, and also in those areas without acceptable part 70 programs. Title V of the Clean Air Act imposes on States the duty to develop, administer and enforce operating permit programs which comply with title V and requires EPA to stand ready to issue Federal operating permits when States fail to perform this duty. Section 502( b) of the Act requires EPA to promulgate regulations setting forth provisions under which States will develop operating permit programs and submit them to EPA for approval. Pursuant to this section, EPA promulgated 40 CFR part 70 on July 21, 1992 ( 57 FR 32250) which specifies the minimum elements of State operating permit programs. Pursuant to regulations promulgated by EPA on February 19, 1999 ( 64 FR 8247) EPA has authority to establish part 71 programs within Indian Country and EPA began administering the program in Indian country on March 22, 1999.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 95 b. Total annual responses 3,179 1. Percentage of these responses collected electronically _ 10 _ % c. Total hours requested 15,323 d. Current OMB inventory 677,719 e. Difference ( 662,396) f. Explanation of difference 1. Program Change 2. Adjustment ________ ( 662,396) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs N/ A b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 19,813 e. Difference ( 19,813) f. Explanation of difference 1. Program change 2. Adjustment ( 19,813)

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. X Annually 7. Q Biannually 8. X Other ( describe) One Time 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Scott Voorhees Phone: ( 919) 541 5348 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Rules and Regulations]
[Pages 69558-69562]
[FR Doc No: 2012-28100]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1188; Directorate Identifier 2012-SW-049-AD;
Amendment 39-17254; AD 2012-10-53]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland GmbH Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter Deutschland GmbH (ECD) Model EC135 P1, EC135 P2, EC135 P2+,
EC135 T1, EC135 T2, and EC135 T2+ helicopters. This is the Federal
Register publication of an Emergency AD (EAD) that was previously sent
to all known owners and operators of these helicopters. That EAD
superseded an earlier related EAD. This AD requires, before further
flight and at specified intervals, checking and inspecting the upper
and lower main rotor hub (MRH) shaft flanges for a crack, and
inspecting the lower hub-shaft flange bolt attachment areas for a
crack. This AD is prompted by three reported incidents of cracking on
the lower hub-shaft flanges of EC135 model helicopters. These actions
are intended to detect a crack on the hub-shaft flange, which if not
corrected could result in failure of the MRH and subsequent loss of
control of the helicopter.

DATES: This AD becomes effective December 5, 2012 to all persons except
those persons to whom it was made immediately effective by Emergency AD
No. 2012-10-53, issued on May 18, 2012, which contained the
requirements of this AD.
    We must receive comments on this AD by January 22, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the economic evaluation, any
comments received, and other information. The street address for the
Docket Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.
    For service information identified in this AD, contact American
Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, Texas
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    On May 15, 2012, we issued Emergency AD 2012-10-51 for the ECD
Model EC135 series helicopters to detect a crack on the MRH shaft
flange. Emergency AD 2012-10-51 required a pilot check of the lower MRH
shaft flange for a crack or deformed blade attachment bolt safety pins
before the first flight of each day, inspecting the upper and lower MRH
shaft flanges for a crack within 5 hours time-in-service (TIS), and
replacing the MRH shaft if there is a crack.
    After we issued Emergency AD 2012-10-51, the European Aviation
Safety

Agency (EASA), which is the Technical Agent for the Member States of
the European Union, issued EASA AD No. 2012-0085-E, dated May 17, 2012
(2012-0085-E), which superseded EASA AD No. 2012-0041R1, dated March
15, 2012 (2012-0041R1), to correct an unsafe condition for the ECD
Model EC 135 series helicopters. EASA advises that since issuing 2012-
0041R1, further cracks have been detected on two other helicopters
during the pre-flight checks. These are the same two cracks that
prompted our Emergency AD. However, EASA also states that
identification of deformed safety pins may not be sufficient to detect
a crack on the MRH shaft flange. ECD is investigating the cause of the
cracks and has developed new inspection procedures with further
corrective actions. Therefore, we issued superseding Emergency AD 2012-
10-53 on May 18, 2012, to detect a crack on the MRH shaft flange, which
if not corrected could result in failure of the MRH and subsequent loss
of control of the helicopter.
    When we issued superseding Emergency AD 2012-10-53, we included
additional part-numbered MRH shafts that should have been included in
EAD 2012-10-51, changed the daily checks to recurring checks at
intervals not to exceed 6 hours TIS, added a 10 hour-TIS recurring
inspection on MRH shafts with 400 or more hours TIS, and removed the
check of the blade attachment bolt safety pins for deformation.
    This is the Federal Register publication of Emergency AD 2012-10-53
as Amendment 39-17254; AD 2012-10-53. There are no differences in the
regulatory language or requirements between this AD and that Emergency
AD as it was previously sent to all known owners and operators of these
helicopters.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Germany and are approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs.

Related Service Information

    Eurocopter has issued Emergency Alert Service Bulletin EC135-62A-
029, Revision 2, dated May 17, 2012 (EC135-62A-029), which describes
procedures for conducting a repetitive check of the visible area of the
upper and lower MRH shaft flanges and a repetitive inspection of the
area of the blade bolts lower MRH shaft flange.

AD Requirements

    This AD supersedes Emergency AD 2012-10-51 and requires the
following:
     Before further flight, and thereafter at intervals not to
exceed 6 hours TIS, checking the lower MRH shaft flange and the visible
area of the upper MRH shaft flange for a crack. An owner/operator
(pilot) may perform this required visual check and must enter
compliance with the applicable paragraph of this AD into the helicopter
maintenance records in accordance with 14 CFR 43.9(a)(1)-(4) and
91.417(a)(2)(v). A pilot may perform this check because it involves
only looking at the visible area of the MRH shaft flanges and can be
performed equally well by a pilot or a mechanic. This check is an
exception to our standard maintenance regulations.
     For an MRH shaft with 400 or more hours TIS, within 10
hours TIS, and thereafter at intervals not to exceed 10 hours TIS,
removing the rotor-hub cap; inspecting the upper and lower hub-shaft
flanges for a crack; removing the blade attachment bolt safety pins,
nut, and washer; and inspecting the lower hub-shaft flange bolt
attachment areas for a crack.
     If there is a crack, replacing the MRH shaft.

Differences Between This AD and the EASA AD

    The EASA AD identifies ECD Alert Service Bulletin EC135-62A-029,
Revision 1, dated May 16, 2012. This AD references Revision 2. The EASA
AD requires you to report the findings and sending any cracked MRH to
ECD, and this AD does not. The EASA AD requires the initial check
within 3 days, while this AD requires the check before further flight.

Interim Action

    We consider this AD to be an interim action. Eurocopter is
currently developing a modification that will address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, we might consider additional rulemaking.

Costs of Compliance

    We estimate that this AD will affect 244 helicopters of U.S.
Registry. We estimate inspecting the MRH shaft flanges will require 2.5
hours at an average labor rate of $85 per work-hour, for a total cost
per helicopter of $212 and a total cost to U.S. operators of $51,850
per inspection cycle. Replacing an MRH shaft will require about 8 hours
at an average labor rate of $85 per work-hour, and required parts will
cost $55,715, for a total cost per helicopter of $56,395.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because the required corrective
actions must be accomplished before further flight.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed, I certify that this AD:

    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2012-10-53 Eurocopter Deutschland GMBH (ECD): Amendment 39-17254;
Docket No. FAA-2012-1188; Directorate Identifier 2012-SW-049-AD.

(a) Applicability

    This AD applies to Model EC135 P1, EC135 P2, EC135 P2+, EC135
T1, EC135 T2, and EC135 T2+ helicopters, with a main rotor hub (MRH)
shaft, part number (P/N) L623M1006101, L623M1206101, L623M1006102,
L623M1206102, L623M1006103, or L623M1206103 installed, certificated
in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in the MRH shaft
flange, which could result in failure of the MRH shaft and
subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective December 5, 2012 to all persons except
those persons to whom it was made immediately effective by Emergency
AD No. 2012-10-53, issued on May 18, 2012, which contained the
requirements of this AD.

(d) Other Affected ADs

    This AD supersedes Emergency AD No. 2012-10-51, dated May 15,
2012.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time.

(f) Required Actions

    (1) Before further flight, and thereafter at intervals not to
exceed 6 hours time-in-service (TIS), check the MRH shaft lower
flange and the visible area of the MRH shaft upper flange for a
crack. Figures 1 and 2 to Paragraph (f)(1) of this AD are examples
of cracks that have been discovered in the MRH shaft lower flange.
The actions required by this paragraph may be performed by the
owner/operator (pilot) holding at least a private pilot certificate,
and must be entered into the aircraft records showing compliance
with this AD in accordance with 14 CFR 43.9 (a)(1)-(4) and 14 CFR
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439.
[GRAPHIC] [TIFF OMITTED] TR20NO12.000

    (2) For MRH shafts with 400 or more hours TIS, within 10 hours
TIS, and thereafter at intervals not to exceed 10 hours TIS:
    (i) Remove rotor-hub cap.
    (ii) Clean the upper and lower MRH shaft flange as depicted in
Figure 3 to Paragraph (f)(2)(ii) of this AD and visually inspect for
a crack.

[GRAPHIC] [TIFF OMITTED] TR20NO12.001

    (iii) Remove the safety pins and nut from each blade bolt and
the washers from the lower MRH shaft flange.
    (iv) Clean the blade bolt attachment area.
    (v) Using a 10X or higher power magnification, inspect all lower
MRH shaft flange blade bolt attachment areas for a crack as shown in
Figure 4 to Paragraph (f)(2)(v) of this AD.
[GRAPHIC] [TIFF OMITTED] TR20NO12.002

    (3) If there is a crack in the upper or lower MRH shaft flange,
before further flight, replace the MRH shaft. Replacing the MRH
shaft with an MRH shaft having a part number listed in the
applicability of this AD does not constitute terminating action for
the requirements of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Gary Roach, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    (1) Eurocopter Emergency Alert Service Bulletin EC135-62A-029,
Revision 2, dated May 17, 2012, which is not incorporated by
reference, contains additional information about the subject of this
AD. For service information identified in this AD, contact American
Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, Texas
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (972) 641-
3775; or at http://www.eurocopter.com/techpub. You may review this
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency AD No. 2012-0085-E, dated May 17, 2012.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 6220, Main Rotor
Head.

    Issued in Fort Worth, Texas, on October 30, 2012.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2012-28100 Filed 11-19-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Page 49327]
[FR Doc No: 2019-20286]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3415-EM; Docket ID FEMA-2019-0001]

California; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of California (FEMA-3415-EM), dated July 8, 2019, and related
determinations.

DATES: This amendment was issued August 28, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective July 12, 2019.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-20286 Filed 9-18-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Notices]
[Page 15616]
[FR Doc No: 2014-06126]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[OMB Control No. 3235-0675, SEC File No. 270-620]

Submission for OMB Review; Comment Request

Extension: Form ABS-15G

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Form ABS-15G (17 CFR 249.1300) is used for reports of information
required under Rule 15Ga-1 (17 CFR 240.15Ga-1) of the Exchange Act of
1934 (``Exchange Act''). Exchange Act Rule 15Ga-1 requires asset-backed
securitizers to provide disclosure regarding fulfilled an unfulfilled
repurchase requests with respect to asset-backed securities. The
purpose of the information collected on Form ABS-15G is to implement
the disclosure requirements of Section 943 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act to provide information
regarding the use of representations and warranties in the asset-backed
securities markets. We estimate that approximately 810 securitizers
will file Form ABS-15G annually at estimated 311.223 burden hours per
response. In addition, we estimate that 75% of the 311.223 hours per
response (233.417 hours) is carried internally by the securitizers for
a total annual reporting burden of 189,068 hours (233.417 hours per
response x 810 responses).
    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 control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov .
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100
F Street NE., Washington, DC 20549 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: March 14, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-06126 Filed 3-19-14; 8:45 am]
BILLING CODE 8011-01-P


Testimony

of

David Darling, Director Environmental Affairs

National Paint and Coating Association

on

National Emission Standards for Hazardous Air Pollutants: Areas Source
Standards for Paints and Allied Products Manufacturing

Public Hearing

Environmental Protection Agency – Research Triangle Park

July 16, 2009

Good morning, my name is David Darling and I am the Director of
Environmental Affairs at the National Paint & Coatings Association.  I
have several issues I would like to discuss today.

As mentioned earlier we are concerned that while the OSHA de minimis
threshold is helpful, a facility could be subject to the rule via one
MSDS. To minimize this possibility, especially for small businesses, we
request EPA include an applicability exemption for uses of small amounts
of the metal HAPs that may be found in raw materials at contaminant
levels. This is opposed to HAP metals that are intentionally used in
larger concentrations. EPA has recognized the difference between
contaminants and intentional use in the Chemical Manufacturing Area
source. We will provide suggestions for this exemption in our comments.

EPA correctly concluded that after the addition processes, pigments and
associated metal HAP are in solution and subsequent metal HAP emissions
are minimal. Further EPA recognized that metal particulate emissions
from pigments that are in the form of a paste or slurry are also
minimal. Since there are minimal particulate emissions from the use of
pigments and slurries, NPCA suggests that EPA exempt pastes and slurries
from the applicability of this rule.

NPCA suggests the following:

“Section 63.11599 Am I subject to this subpart?

a) You are subject to this subpart if you own or operate a facility that
performs paints and allied products manufacturing that is an area source
of hazardous air pollutant (HAP) emissions and processes, uses, or
generates materials containing one or more of the following HAP:
benzene, methylene chloride, and compounds of cadmium, chromium, lead
and nickel, unless pigments containing compounds of cadmium, chromium,
lead and nickel are in the form of a paste or slurry.”

NPCA has commented on several areas source rules that EPA should
recognize the difference between trivalent and hexavalent chromium.
While EPA has to date not been receptive to this, NPCA suggests that EPA
recognize that OSHA does not consider trivalent chromium a carcinogen so
we recommend that allow a 1% de minimis for trivalent chromium instead
of 0.1%.

We are concerned with several issues in the rule that will make
compliance very difficult.

EPA proposed that new and affected sources must capture particulate
emissions and route them to a particulate control device during the
addition of pigments and other solids and during the grinding and
milling of solids. NPCA agrees with EPA that after the addition
processes, the pigments and associated metal HAP are in solution, and
metal HAP emissions are minimal. Please note that grinding and milling
occurs after the addition process when the pigments are in solution, so
NPCA questions whether particulate controls are needed during the
grinding and milling stage. Further – many grinding and milling
equipment is fully enclosed so there is no way emissions could be
collected during these processes.  Bottom-line, since pigments and
solids are in solution when they are milled and ground, and that the
milling and grinding equipment is fully enclosed with no emission points
– particulate controls should only be required when pigments and
solids are added to the high speed dispersion tanks.

EPA correctly recognized the need for operators to open mixing vessel
covers/lids for quality control testing of the product and/or the
addition of pigments or other materials to meet final product
specifications. However operators need to open nearly every process or
storage tank at sometime for quality control testing, adding of
materials or removal of product from the vessel. Therefore, consistent
with the Miscellaneous Coatings Manufacturing MACT (MCM), NPCA requests
that EPA revise the regulation such that operators be allowed to open
any vessel, be it mixing, process, or storage for quality control
testing and sampling of the product, addition of materials, or removal
of product from the vessel.

EPA proposed that process tank covers or lids must maintain contact
along at least 90 percent of the vessel rim. This is a very rare
requirement in that very, very few operating permits have this
requirement, especially since this requirement is very difficult to
comply with. It is nearly impossible to confirm that a lid or cover
touches at least 90 percent of the vessel rim. A person would need to
know the exact perimeter of the tank, and somehow measure sections that
may not be touching the rim. Further, what is the definition of
“touching” is it metal to metal or some other measure?

NPCA believes that the covers/lids that EPA used to estimate costs for
this rule -  either a sheet of plywood (4 feet by 4 feet) or two sheets
of plywood (8 feet by 8 feet) would probably not meet this standard.
Plywood even new may be warped or may warp over time especially two
sheets of plywood that are somehow connected and unsupported a distance
of 8 feet – it is very unlikely that EPA’s plywood cover/lid would
touch at least 90 percent of the vessel rim. Given the fact that it is
nearly impossible to determine compliance with the “90 percent of the
vessel rim” requirement, that very few operating permits contain this
requirement and that EPA’s cover/lid would probably not meet the
requirement, NPCA suggests that this required be deleted.

Finally, we believe that many of the assumptions that EPA used in its
emission and cost estimates are arbitrary. For example we are concerned
that EPA used the very old AP-42 emission factors we believe the
calculated emissions are probably double actual emissions. We are also
concerned that the cost of process vessel covers and the thermal
oxidation estimates in the background documents are too low.
Bottom-line, the estimated 8.1 million in capital costs (too low) to
remove 0.13 tons per year of cadmium, chromium, lead and nickel is not
justified especially since as mentioned earlier the industry has reduced
emission of these HAP’s by greater than 90% since 1990. This rule is
not needed.


                       EPA and Franklin Fueling Meeting
                                April 25, 2013

Attendees
EPA  -  Linda Gerber, Paul Miller, Erin Knighton, Liz McDermott, Cho Yi Kwan, Andrea Barbery
Franklin Fueling  -  Jay Walsh, Brooke Randall

EPA and Franklin Fueling met to discuss a number of issues from the proposed revisions to the UST regulations.  The discussion included secondary containment, testing secondary containment, biofuels and standards.


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53925-53926]
[FR Doc No: 2011-22170]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4007-DR; Docket ID FEMA-2011-0001]

Wyoming; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Wyoming (FEMA-4007-DR), dated July 22, 2011,
and related determinations.

DATES: Effective Date: July 22, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 22, 2011, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Wyoming resulting from severe storms, flooding, and landslides
during the period of May 18 to July 8, 2011, is of sufficient
severity and

magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Wyoming.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Mark H. Armstrong, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Wyoming have been designated as
adversely affected by this major disaster:

Albany, Big Horn, Carbon, Crook, Fremont, Goshen, Johnson, Lincoln,
Platte, Sheridan, Sublette, Teton, Uinta, Washakie, and Weston
Counties and the Wind River Indian Reservation for Public
Assistance.
    All counties and Indian Tribes within the State of Wyoming are
eligible to apply for assistance under the Hazard Mitigation Grant
Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-22170 Filed 8-29-11; 8:45 am]
BILLING CODE 9111-23-P


Telephone log

Date:  Tuesday, March 09, 2010

Call from:  Matt Kevnick and Julie He, Toyota

734-995-0540

Call to:  Margaret Sheppard, EPA/SPD

Matt Kevnick and Julie He had three questions related to HFO-1234yf:

Would EPA like a meeting to ask questions about Toyota’s public
comment with information on hybrid vehicles?  Response:  Not necessary.
The information was clear enough.

Who should they talk to with a question related to the Significant New
Use Rule?  Response:  Karen Chu.

What is the timing of the final SNAP rule for HFO-1234yf?  Response:
Later this year—interagency review will be required.


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Page 68784]
[FR Doc No: 2023-21925]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-558, OMB Control No. 3235-0617]

Proposed Collection; Comment Request; Extension: Rule 433 Under
the Securities Act of 1933--Conditions to Permissible Post-Filing Free
Writing Prospectuses

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collections
of information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 433 (17 CFR 230.433) governs the use and filing of free
writing prospectuses under the Securities Act of 1933 (15 U.S.C. 77a et
seq.). The purpose of Rule 433 is to reduce the restrictions on
communications that a company can make to investors during a registered
offering of its securities, while maintaining a high level of investor
protection. A free writing prospectus meeting the conditions of Rule
433(d)(1) must be filed with the Commission and is publicly available.
We estimate that it takes approximately 9.79057 burden hours per
response to prepare a free writing prospectus and that the information
is filed by 20,179 responses. We estimate that 25% of the 9.79052
burden hours per response (2.44764 hours) is prepared by the company
for total annual reporting burden of 49,391 hours (2.4476 hours x
20,179 responses).
    Written comments are invited on: (a) whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication by December 4, 2023.
    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 control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: September 28, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-21925 Filed 10-3-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Proposed Rules]
[Page 30873-30875]
[DOCID:fr29my08-36]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No., EPA-R02-OAR-2008-0020; FRL-8572-5]

Approval and Promulgation of Implementation Plans; Variance
Determination for Particulate Matter from a Specific Source in the
State of New Jersey

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the State Implementation Plan (SIP) submitted by
the State of New Jersey. This SIP revision consists of a source-
specific reasonably available control technology (RACT) determination
for controlling particulate matter from the cooling tower operated by
the PSEG Nuclear LLC Hope Creek and Salem Generating Stations. This
action proposes an approval of the source-specific variance
determination that was made by New Jersey in accordance with the
provisions of its rule to help meet the national ambient air quality
standards (NAAQS) for particulate matter. The intended effect of this
proposed rule is to approve source-specific emissions limitations
required by the Clean Air Act.

DATES: Comments must be received on or before June 30, 2008.

ADDRESSES: Submit your comments, identified by Docket Number EPA-R02-
OAR-2008-0020, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Raymond Werner, Chief, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866.
     Hand Delivery: Raymond Werner, Chief, Air Programs Branch,
Environmental Protection Agency, Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866. Such deliveries are only accepted
during the Regional Office's normal hours of operation. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30 excluding Federal holidays.
    Instructions: Direct your comments to Docket No. EPA-R02-OAR-2008-
0020. 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 e-mail.
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 e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail 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 or any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region II Office, Air Programs Branch, 290 Broadway,
25th Floor, New York, New York 10007-1866. EPA requests, if at all
possible, that you contact the individual listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. You
may view the hard copy of the docket Monday through Friday, 8 a.m. to 4
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Paul Truchan, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10007-1866,<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. EPA's Proposed Action
    A. What Action Is EPA Proposing?
    B. Why Is EPA Proposing This Action?
    C. What Is EPA's Evaluation of New Jersey's SIP Revision?
II. New Jersey's SIP Revision
    A. What Are New Jersey's PM Requirements?
    B. When Was New Jersey's Variance Determination Proposed and
Adopted?
    C. When Was New Jersey's SIP Revision Submitted to EPA?
    D. What Are EPA's findings?
III. Conclusion
IV. Statutory and Executive Order Reviews

I. EPA's Proposed Action

A. What Action Is EPA Proposing?

    EPA is proposing to approve New Jersey's revision to the
particulate matter (PM) State Implementation Plan (SIP) submitted on
November 2, 2007. This SIP revision relates to New Jersey's PM variance
determination for the cooling tower at the PSEG Nuclear LLC Hope Creek
and Salem Generating Stations located in Lower Alloways Creek Township,
Salem County. As part of this variance evaluation, alternate emission
limitations are specified for total suspended particulates (TSP) and
PM-10 (particles with an aerodynamic diameter of 10 micrometers or
less). This evaluation and variance only involves the operation of the
cooling tower.

B. Why Is EPA Proposing This Action?

    EPA is proposing this action to:
     Give the public the opportunity to submit comments on
EPA's proposed

action, as discussed in the DATES and ADDRESSES sections; and
     Fulfill New Jersey's and EPA's requirements under the
Clean Air Act (Act); and
     Make New Jersey's variance determination federally-
enforceable.

C. What Is EPA's Evaluation of New Jersey's SIP Revision?

    EPA has determined that New Jersey's SIP revision for the PM
variance for the cooling tower at the PSEG Nuclear LLC Hope Creek and
Salem Generating Stations is consistent with New Jersey's PM rule and
EPA's guidance. EPA's basis for evaluating New Jersey's SIP revision is
whether it meets the SIP requirements described in section 110 of the
Act. EPA has determined that New Jersey's SIP revision will not
interfere with any applicable requirement concerning attainment or any
other applicable requirement of the Act.
    After reviewing New Jersey's SIP revision submittal, EPA found it
administratively and technically complete. EPA has determined that the
TSP and PM-10 emission limits were developed and adopted through a
source-specific SIP revision and incorporated into a revision of the
source's Title V Operating Permit. The permit contains specific
conditions relating to emissions limits, work practice standards,
testing, monitoring, and recordkeeping/reporting requirements. These
conditions are consistent with the PM requirements specified in
Subchapter 6, Control and Prohibition of Particulates from
Manufacturing Processes of Chapter 27, Title 7 of the New Jersey
Administrative Code and conform to EPA guidance. EPA proposes to
approve the conditions contained in the ``Facility Specific
Requirements'' which includes alternative emission limits for the
cooling tower. PSEG will comply with the following hourly emission
limits: for TSP less than or equal to 42 pounds per hour and for PM-10
(total) less than or equal to 42 pounds per hour. PSEG will comply with
the following annual emission limits: for TSP less than or equal to
65.9 tons per year and for PM-10 (total) less than or equal to 65.9
tons per year. In addition to the limits, New Jersey will include other
requirements, such as adequate monitoring, recordkeeping, and reporting
in the Title V Operating Permit.

II. New Jersey's SIP Revision

A. What Are New Jersey's PM Requirements?

    New Jersey's PM requirements are contained in Subchapter 6, Control
and Prohibition of Particulates from Manufacturing Processes of Chapter
27, Title 7, of the New Jersey Administrative Code. Section 6.5 of New
Jersey's rule establishes a variance procedure should a source not be
able to meet the prescribed emission limits for technology reasons. The
source must provide the reasons and justifications why the prescribed
emission limits cannot be technologically achieved. Any variance issued
by New Jersey is conditioned on the source complying with requirements
that New Jersey deems necessary. In order for EPA to recognize any
variance as Federally enforceable, New Jersey must submit the variance
as a revision to its SIP and EPA must approve it through notice and
rulemaking.

B. When Was New Jersey's Variance Determination Proposed and Adopted?

    New Jersey's variance was proposed on April 3, 2007, with the
public hearing held on May 1, 2007. The comment period ended May 3,
2007. New Jersey adopted the variance on August 7, 2007. No verbal
comments were received during the public hearing and only PSEG Fossil
LLC submitted written comments.

C. When Was New Jersey's SIP Revision Submitted to EPA?

    New Jersey's SIP revision was submitted to EPA on November 2, 2007.
EPA determined that the submittal was administratively and technically
complete on December 19, 2007.

D. What Are EPA's Findings?

    The variance request would allow the evaporation rate of the
cooling tower to be increased by approximately 20 percent. This would
increase the cooling tower particulate matter emissions from the
currently permitted value of 29.4 pounds per hour (lbs/hr) to a
projected 35.28 lbs/hr, based on the total dissolved solids (TDS) in
the cooling water. However, under worst-case conditions of the ambient
water salinity, hydrologic conditions, and the tidal hydrodynamics of
the Delaware Estuary, which is the water source of the circulating
cooling water, the maximum emissions that could be expected from the
cooling tower would be 42.0 lbs/hr. Worst-case conditions are projected
to occur once in 20 years and to address this occurrence, the new
allowable will be set at 42.0 lbs/hr. New Jersey now requires that PSEG
sample the circulating water at a minimum of every seven days and
analyze it for TDS, which will help ensure that the emission limits are
not exceeded.
    The cooling tower is currently limited to annual allowable
emissions of 129 tons per year (tpy). Based on calculations, the actual
annual emissions are only 54.7 tpy. Adjusting for the new cooling rate,
the annual emissions are projected to be 65.9 tpy. New Jersey has
limited the new annual emissions to 65.9 tpy, instead of the existing
limit of 129 tpy.
    As part of this variance request, a review was undertaken to
determine ``state-of-the-art'' controls for this type of cooling tower.
EPA's RACT/BACT/LAER Clearinghouse, the manufacturer of the existing
cooling tower, and internationally available information were consulted
on currently available controls and control efficiency for this type of
tower. The only currently available controls involve drift eliminators
which are already installed and any additions would not be technology
feasible due to space constraints. Further, the current drift rate for
the cooling tower is lower than the most stringent rate found in EPA's
database. There is also no alternative source of makeup water that
would result in a decrease in total dissolved solids (TDS), which are
contained in the water and are the source of the particulate matter
emissions.
    The result of air quality modeling analysis predicts that the
impact on TSP, PM-10 and PM-2.5 will be below their respective
significant impact levels and will not cause or contribute to a
violation of a NAAQS, or a prevention of significant deterioration
(PSD) Class II increment.
    The only comment received on the variance request was from PSEG and
involved issues raised at an earlier adjudicatory hearing and did not
involve the action being proposed on the cooling tower.
    Based on the above findings, EPA proposes to find that requirements
for approving a variance request pursuant to the Clean Air Act, EPA
guidance and requirements of New Jersey's Subchapter 6 have been
satisfied.

III. Conclusion

    EPA is proposing to approve the New Jersey SIP revision for an
alternative emission limit determination for the PSEG Nuclear LLC Hope
Creek and Salem Generating Stations. This SIP revision contains source-
specific particulate emission limitations for PSEG Nuclear LLC Hope
Creek and Salem Generating Stations. EPA will consider all comments
submitted prior to any final rulemaking action.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act 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 Clean Air Act.
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 Clean Air Act; 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

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

    Dated: May 19, 2008.
Alan J. Steinberg,
Regional Administrator, Region 2.
[FR Doc. E8-11979 Filed 5-28-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 31 (Thursday, February 14, 2019)]
[Rules and Regulations]
[Page 3985]
[FR Doc No: 2019-02202]

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

40 CFR Part 60

[EPA-R01-OAR-2018-0849; FRL-9989-00-Region 1]

Notice of Delegation of Authority; Connecticut; New Source
Performance Standards for Stationary Combustion Turbines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Delegation of authority.

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SUMMARY: On December 13, 2018, the Environmental Protection Agency
(EPA) sent the State of Connecticut a letter approving Connecticut's
request for delegation of the New Source Performance Standards for
Stationary Combustion Turbines. To inform regulated facilities and the
public of the EPA's approval of Connecticut's request for delegation of
authority to implement and enforce these standards, the EPA is making
available a copy of EPA's letter to Connecticut through this document.

DATES: On December 13, 2018, the EPA sent the State of Connecticut a
letter approving Connecticut's request for delegation of the New Source
Performance Standards for Stationary Combustion Turbines.

ADDRESSES: The EPA has established a docket for this action under
Docket Identification No. EPA-R01-OAR-2018-0849. All documents in the
docket are listed on the https://www.regulations.gov website. 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 at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
Region 1 Regional Office, Office of Ecosystem Protection, Air Permits,
Toxics, and Indoor Programs Unit, 5 Post Office Square--Suite 100,
Boston, MA. The EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.

FOR FURTHER INFORMATION CONTACT: Eric Wortman, Air Permits, Toxics, and
Indoor Programs Unit, Office of Ecosystem Protection, U.S.
Environmental Protection Agency, EPA Region 1, 5 Post Office Square
(OEP05-2), Boston, MA 02109-3912, telephone number<PHONE_NUMBER>, fax
number<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In a letter dated November 8, 2018, the
Connecticut Department of Energy and Environmental Protection (CT DEEP)
requested full delegation to implement and enforce the New Source
Performance Standards for Stationary Combustion Turbines at 40 CFR part
60, subpart KKKK (NSPS KKKK) for all affected sources in Connecticut.
On December 13, 2018, the EPA sent CT DEEP a letter approving the
request for delegation to implement and enforce NSPS KKKK as specified
by CT DEEP in its request to the EPA. The text of the EPA's December
13, 2018 letter to CT DEEP is reproduced below:

Robert Kaliszewski, Deputy Commissioner
Department of Energy and Environmental Protection
79 Elm Street
Hartford, CT 06106-5127

Dear Deputy Commissioner Kaliszewski:

    In your letter dated November 8, 2018, the Connecticut
Department of Energy and Environmental Protection (CT DEEP)
requested full delegation to implement and enforce the New Source
Performance Standards for Stationary Combustion Turbines at 40 CFR
part 60, subpart KKKK (NSPS KKKK) for all affected sources in
Connecticut.
    The EPA has reviewed the pertinent regulations of the State of
Connecticut and has determined they provide adequate authority and
procedures for implementation of NSPS KKKK. In light of these
authorities and related information in your letter dated November 8,
2018, the EPA approves your request for full delegation of authority
to implement and enforce the provisions of NSPS KKKK.
    This delegation of authority is subject to the following terms
and conditions:
     CT DEEP will assume primary responsibility for
enforcement of NSPS KKKK;
     CT DEEP will not grant a variance or waiver from
compliance with applicable emission standards of NSPS KKKK;
     CT DEEP will communicate with EPA Region 1 to keep each
office fully informed regarding the current compliance status of
subject sources in Connecticut and interpretation of applicable
regulations;
     CT DEEP will require all NSPS KKKK sources to adhere to
all the reporting, monitoring, and recordkeeping requirements
specified in NSPS KKKK;
     CT DEEP will notify the EPA of any variation from
emission test methods and continuous emission monitoring
requirements specified in NSPS KKKK. Written approval from the EPA
must be obtained by CT DEEP prior to the granting or the
implementation of such variations; and
     If the Regional Administrator determines that CT DEEP
is not adequately implementing or enforcing NSPS KKKK, the Regional
Administrator may revoke delegation of NSPS KKKK in whole or part.
    Because this delegation is effective immediately, there is no
need for CT DEEP to notify the EPA of its acceptance. Unless the EPA
receives written notice of objection from CT DEEP within ten days
from the date of this letter, CT DEEP will be deemed to have
accepted all of the terms as stated herein. The EPA will publish a
notice of delegation of authority in the Federal Register informing
the public of this action.
    The EPA appreciates CT DEEP's efforts to accept delegation to
implement and enforce the provisions of NSPS KKKK. If you have any
questions regarding this matter, please don't hesitate to contact
Eric Wortman at<PHONE_NUMBER>.

Sincerely,

Alexandra Dapolito Dunn,
Regional Administrator

    This document informs regulated facilities and the public of the
EPA's approval of Connecticut's request for delegation of authority to
implement and enforce NSPS KKKK. The delegation of authority was
effective on December 13, 2018.

List of Subjects in 40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and record keeping requirements.

    Authority: This action is issued under the authority of section
111 of the Clean Air Act, as amended, 42 U.S.C. 7412.

    Dated: February 7, 2019.
Deborah Szaro,
 Acting Regional Administrator, EPA Region 1.
[FR Doc. 2019-02202 Filed 2-13-19; 8:45 am]
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