[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96011-96013]
[FR Doc No: 2016-31513]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4318]

Compounding and Repackaging of Radiopharmaceuticals by State-
Licensed Nuclear Pharmacies and Federal Facilities; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Compounding and Repackaging of Radiopharmaceuticals by State-Licensed
Nuclear Pharmacies and Federal Facilities.'' This guidance sets forth
FDA's policy regarding compounding and repackaging of
radiopharmaceuticals for human use by State-licensed nuclear pharmacies
and Federal facilities that are not registered as outsourcing
facilities. Because such radiopharmaceuticals are not eligible for
exemptions from provisions of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) related to the production of drugs, FDA is issuing this
guidance to describe the conditions under which it does not intend to
take action for violations of certain provisions of the FD&C Act when a
State-licensed nuclear pharmacy or Federal facility compounds or
repackages radiopharmaceuticals.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 27, 2017. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by February 27, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-D-4318 for ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal
Facilities.'' Received

comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://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 https://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 https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Edisa Gozun, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    Under current law, radiopharmaceuticals that are compounded by
entities that are not registered with FDA as outsourcing facilities,
and radiopharmaceuticals that are repackaged, are subject to all
applicable provisions of the FD&C Act related to the production of
drugs. Because Congress explicitly excluded radiopharmaceuticals from
section 503A of the FD&C Act (21 U.S.C. 353a) (see section
503A(d)(2)),\1\ compounded radiopharmaceuticals are not eligible for
the exemptions under section 503A from section 505 of the FD&C Act (21
U.S.C. 355) (concerning new drug approval requirements), section
502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (concerning labeling
with adequate directions for use), and section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)B)) (concerning current good manufacturing
practice (CGMP) requirements). In addition, Congress did not exempt
repackaged radiopharmaceuticals from any provisions of the FD&C Act.
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    \1\ Section 503A of the FD&C Act describes the conditions that
must be met for drug products compounded by a licensed pharmacist in
a State-licensed pharmacy or Federal facility, or by a licensed
physician, to qualify for exemptions from sections 505, 502(f)(1),
and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act
states that ``this section shall not apply to . . .
radiopharmaceuticals.''
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    Because State-licensed nuclear pharmacies and Federal facilities
sometimes compound or repackage radiopharmaceuticals for patients, but
radiopharmaceuticals are not eligible for the exemptions in section
503A of the FD&C Act, FDA is issuing this guidance to describe the
conditions under which the Agency does not intend to take action for
violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act
when a State-licensed nuclear pharmacy or a Federal facility that is
not an outsourcing facility compounds or repackages
radiopharmaceuticals for human use.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a separate draft guidance document concerning
compounding and repackaging of radiopharmaceuticals by outsourcing
facilities entitled ``Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing Facilities.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Compounding
and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear
Pharmacies and Federal Facilities.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    One of the conditions of the draft guidance is that the compounded
radiopharmaceutical is not essentially a copy of an approved
radiopharmaceutical. If a compounder intends to rely on a determination
from a prescriber that there is a change between the compounded
radiopharmaceutical and the

comparable approved radiopharmaceutical that produces for an identified
individual patient a clinical difference, the determination is
documented on the prescription or order in writing by either (1) the
prescribing practitioner, or (2) the compounder, reflecting a
conversation with the prescribing practitioner. The compounder
maintains records of the prescription or order documenting this
determination.
    We estimate that annually a total of approximately 10 compounders
(``No. of Respondents'' in table 1, line 1) will consult a prescriber
to determine whether he or she has made a determination that the
compounded radiopharmaceutical has a change that produces a clinical
difference for an identified individual patient as compared to the
comparable approved radiopharmaceutical. We estimate that compounders
will document this determination on approximately 250 prescriptions or
orders for compounded radiopharmaceuticals ``Total Annual Disclosures''
in table 1, line 1). We estimate that the consultation between the
compounder and the prescriber and noting this determination on each
prescription or order that does not already document this determination
will take approximately 3 minutes per prescription or order.
    A compounder also maintains records of prescriptions or orders
noting the determination that a prescriber has determined that the
compounded radiopharmaceutical has a change that produces a clinical
difference for an identified individual patient. We estimate that the
compounder will take approximately 2.1 hours to maintain the records of
250 prescriptions or orders documenting the prescriber's determination
of clinical difference (``Total Hours'' in table 2). We estimate that
maintaining such records will take approximately 30 seconds per
prescription or order.
    FDA estimates the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                     Number of
               Type of reporting                    Number of     disclosures per    Total annual      Average burden per disclosure       Total hours
                                                   respondents       respondent      disclosures
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Consultation between the compounder and                      10               25              250   3 minutes..........................            12.5
 prescriber or health care facility, and the
 notation on the prescription or order
 documenting the prescriber's determination of
 clinical difference.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                     Number of
               Type of reporting                    Number of       records per      Total annual     Average burden per recordkeeping     Total hours
                                                  recordkeepers     recordkeeper       records
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Maintenance of records of prescriptions or                   10               25              250   30 seconds.........................             2.1
 orders documenting the prescriber's
 determination of clinical difference.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

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

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31513 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P


From: 	Chris Sarsony, HDR|e2M

To: 	Amy Hambrick, U.S. Environmental Protection Agency

Re:  	August 6, 2009 Meeting Between the U.S. EPA and the Pennsylvania
Department of Environmental Protection, Penn Future, and Earth Justice
regarding the Halogenated Solvent Cleaning Reconsideration

Date: 	August 12, 2009

On August 6, 2009, a teleconference meeting was held between the U.S.
Environmental Protection Agency (EPA) and representatives from the
Pennsylvania Department of Environmental Protection (PA DEP), Penn
Future, and Earth Justice to discuss PA DEP’s comments on the October
20, 2008, Proposed Notice of Reconsideration and Request for Public
Comment for Halogenated Solvent Cleaning (73 FR 62384).  The meeting
participants are listed below.

Name	Organization

Tim Benner	EPA/ORD

Francine Carlini	PA DEP

Ron Davis	PA DEP

Susmita Dubey	EPA/OGC

Robin Dunkins	EPA/OAQPS

John Guth	PA DEP

Amy Hambrick	EPA/OAQPS

Ann Johnson	EPA/OPEI

Elaine Manning	EPA/OAQPS

Charley McPhedran	Penn Future

Dennis Pagano	EPA/OAQPS

Jim Pew	Earth Justice

Krish Ramamurthy	PA DEP

Bo Reiley	PA DEP

Chris Sarsony	HDR|e2M Inc.

Kim Teal	EPA/OAQPS

Meeting Agenda (see attachment for detailed agenda):

1.	Introductions and Meeting Purpose

2.	Issues for Discussion

3.	PA DEP Questions/Concerns

4.	Open Discussion

Meeting Summary:

 Introduction and Meeting Purpose

Ms. Hambrick of the U.S. EPA began the meeting with introductions and by
stating the following purpose for the meeting: “To discuss new
information that the PA-DEP and other commenters provided on the
Halogenated Solvent Proposed Rule regarding technologies used by certain
narrow tube solvent cleaning machines located at facilities within
Pennsylvania.”

Ms. Hambrick indicated a meeting summary would be developed for the
meeting and this summary would be made available to the public in the
docket.

Issues for Discussion

Clarification of PA-DEP position on the proposed reconsideration options
for narrow tube manufacturers, including achievability of proposed
limits as well as PA-DEP recommended limit.

PA DEP stated that in their public comment they were basically
commenting on the three regulatory options that were proposed by EPA in
the October 20, 2008 proposal.  Of the three Options presented, PA DEP
prefers Options 2 and 3, which would both require a 60,000 kg Methylene
Chloride Equivalents (MC EQ) limit for tube manufacturers.  PA DEP does
not support Option 1, which would not require any additional control for
narrow tube manufacturers beyond what is required in the original
NESHAP.

PA DEP stated that they recognize some tube manufacturing facilities,
such as Accellent, may have difficulty in achieving a 60,000 kg MC EQ
limit.  Therefore, they proposed in their comments that EPA add a
provision that would require tube manufacturing facilities that exceed
the 60,000 kg MC EQ limit to achieve an 80 percent overall control
efficiency and conduct a site-specific risk assessment.

PA DEP clarified that the 80 percent control number was based on Option
3 for web cleaning machines and was not based on any new analysis
specific to tube manufacturing facilities.

PA DEP stated that when it asked tube manufacturing facilities to
achieve voluntary halogenated solvent emission reductions, not all
facilities chose the same approach.  Some facilities, such as Superior
Tube and Tube Methods, chose to switch from TCE to n-Propyl Bromide
(nPB).  Other facilities, such as Accellent (new carbon adsorption
system) and Salem Tube (new vacuum-to-vacuum machine), chose to install
new equipment.

Compliance time frame.

EPA asked PA-DEP if and how quickly the narrow tube industry technology
was changing and improving such that companies like Accellent could have
additional controls available to them if given more time.  PA-DEP
responded that they were unsure of how quickly the technology was
changing and for a facility like Accellent they have retrofitted
controls to existing machines.

Technical differences between facilities manufacturing the smallest
tubes, those used in medical devices, and larger tubes.

The majority of the tubing made by Accellent is for medical devices
(intra-body use), and therefore, is subject to high standards of
cleanliness.  The products they manufacture are subject to strict FDA
and client specifications for quality.  Therefore, any change they make
in the manufacturing process must go through the FDA approval process,
which can take years.  Accellent determined through their own bench
scale tests that nPB would not achieve to necessary level of cleanliness
for their products.

A noted difference between Accellent and Superior Tube is that Accellent
produces end products, whereas Superior Tube produces tubing that
typically undergoes additional manufacturing at their client’s
facility.

EPA asked PA-DEP if it might make sense to subcategorize narrow tubing
manufactured for medical uses.  PA-DEP responded that it may make sense
to subcategorize medical tubing, but did not know what basis should be
used to define this subcategory.

Information on Salem Tube’s (Greenville, PA) new vacuum cleaning
system.

PA-DEP indicated that Salem Tube installed a new vacuum-to-vacuum
cleaning machine in late 2007 or early 2008.  The new cleaning machine,
which can clean tubes up to 45 feet in length, dramatically decreased
their TCE emissions.  For example, Salem Tube’s total emissions for
June 2009 were 0.5 lbs, whereas in 2002 their emissions were over 5 tons
per month.

EPA asked PA-DEP if vacuum-to-vacuum technology could be used at
Accellent’s facility to reduce their emissions.  PA-DEP indicated that
Accellent cleans tubing that is narrower (some narrower than a human
hair) and longer (coils of up to 3,000 feet of tubing).  Accellent has
determined that it is not technically feasible to use vacuum-to-vacuum
technology.  Additionally, it is not economically feasible for Accellent
to use vacuum-to-vacuum technology.  Based on Accellent’s analysis
they would have to install multiple vacuum-to-vacuum machines to meet
their production rates.  Furthermore, Accellent would have to construct
a new building to accommodate the extra equipment and the end loading
design of large vacuum-to-vacuum machines.

PA-DEP stated that they will send EPA a spreadsheet summarizing solvent
cleaning equipment cost data that they have collected from Superior
Tube, Accellent, and Salem Tube.

Recent data capture and control efficiency data from Accellent.

In 2007 and 2008, Accellent installed carbon adsorption systems (CAS) on
their two halogenated solvent cleaning machines.  Accellent has tried to
optimize both systems as much as possible by improving their capture
efficiency.  Currently, the CAS on Unit One is achieving an overall
control efficiency of  approximately 75% and the CAS on Unit Two is
achieving an overall control efficiency of approximately 35%.  The
overall control efficiency takes into account both the capture
efficiency and the control efficiency of the CAS.  The percent
efficiencies were determined based on a material balance calculation.
Accellent continues to look for ways to optimize the performance of both
units, and may even evaluate changes to the roof of their building to
improve the capture efficiency for the CAS on Unit Two.

Information on production levels, e.g., in permits.

PA DEP indicated that there are no specific production limits in the
tube manufacturer permits; however, there are limits to the amount of
TCE they can emit.  In a sense, these TCE emission limits could be
viewed as restricting production.  Accellent has voluntarily accepted a
reduction in their TCE emissions from 94 tons/year to 45 tons/year.

PA-DEP air monitoring program.

PA DEP has air monitors in Collegeville, PA in the vicinity and downwind
of the Accellent and Superior Tube facilities.  The most recent ambient
air data for TCE is much lower than previous levels and is more
consistent with levels in other areas of the state.  PA DEP has seen a
strong cause and effect relationship between the voluntary TCE
reductions at Accellent and Superior Tube and the ambient levels of TCE
in Collegeville, PA.

Title V permits for Summerville Tube (Scottdale, PA) and Accellent
(Collegeville, PA).

PA DEP agreed to send EPA copies of the most current Title V permits for
Salem Tube, Tube Methods, Summerill Tube, and Accellent.

EPA indicated that very little is known about Summerill Tube (Scottdale,
PA) and asked PA DEP what they know about this facility.  PA DEP
indicated that Summerill Tube makes an intermediate tubing product, not
a finished product.  Summerill Tube does not make any medical tubing.
The Summerill facility is older, had housekeeping issues, and may be
shut down.  PA-DEP will send EPA a copy of Summerill Tube’s permit,
which was modified recently.

Closing Statements

EPA indicted that if additional options for the narrow tub industry
(i.e., options not proposed in the October 20, 2008 proposal) are
considered, then a supplemental proposal will have to be published.  The
publication of a supplemental proposal will delay the publication of the
final rule.

AttachmentsAgenda

EPA Halogenated Solvent Reconsideration Proposal Workgroup

Meeting with the State of Pennsylvania Department of Environmental
Protection

August 6, 2009

9:00 am to 10:00 am

Conference Line:<PHONE_NUMBER>/ Room: E141B

Introductions & Meeting Purpose

Introduce meeting participants

To discuss new information that the PA-DEP and other commenters provided
on the Halogenated Solvent Proposed Rule regarding technologies used by
certain narrow tube solvent cleaning machines located at facilities
within Pennsylvania.

Issues for Discussion.

Clarification of PA-DEP position on the proposed reconsideration options
for narrow tube, including achievability of proposed limits as well as
PA-DEP recommended limit

Compliance time frame.

Technical differences between facilities manufacturing the smallest
tubes, those used in medical devices and larger tubes.

Information on Salem Tube’s (Greenville, PA) new vacuum cleaning
system.

Recent data capture and control efficiency data.

Information on production levels, e.g., in permits.

PA-DEP air monitoring program.

Title V permits for Summerville Tube (Scottdale, PA) and Accellent
(Collegeville, PA).

PA-DEP any questions/concerns to communicate with EPA?

Please share by noon Wednesday August 5, 2009.  PA-DEP did not add any
items.

Open discussion for any additional questions or discussion points

Meeting adjourned.  Thank you!

  PAGE   \* MERGEFORMAT  1


[Federal Register Volume 80, Number 199 (Thursday, October 15, 2015)]
[Notices]
[Pages 62161-62163]
[FR Doc No: 2015-26248]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0055]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 45 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). They are unable to meet the vision requirement in one eye for
various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in one eye. The Agency has
concluded that granting these exemptions will provide a level of safety
that is equivalent to or greater than the level of safety maintained
without the exemptions for these CMV drivers.

DATES: The exemptions were granted August 25, 2015. The exemptions
expire on August 25, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m., Monday through Friday, except
Federal holidays. If you have questions on viewing or submitting
material to the docket, contact Docket Services, telephone (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On July 24, 2015, FMCSA published a notice of receipt of exemption
applications from certain individuals, and requested comments from the
public (80 FR 44188). That notice listed 45 applicants' case histories.
The 45 individuals applied for exemptions from the vision requirement
in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate
commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 45 applications on their merits
and made a determination to grant exemptions to each of them.

III. Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their vision
limitation and demonstrated their ability to drive safely. The 45
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, aphakia, central retinal scar,
chorioretinal scar complete loss of vision due to traumatic injury,
corneal scarring, large optic nerve coloboma, macular degeneration,
macular edema retinal scarring, no light perception, ocular
hypertension ocular nerve damage, optic nerve atrophy, ocular
sarcoidosis, prosthetic eye due to traumatic injury, refractive
amblyopia, retinal damage, retinal disease, retinal vein occlusion, and
traumatic glaucoma. In most cases, their eye conditions were not
recently developed. Thirty of the applicants were either born with
their vision impairments or have had them since childhood.
    The 15 individuals that sustained their vision conditions as adults
have had it for a range of 4 to 38 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 45 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision in careers ranging for 2 to 50
years. In the past three years, two drivers were involved in crashes,
and two drivers were convicted of moving violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the July 24, 2015
notice (80 FR 44188).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates

and Neyman, University of California Publications in Statistics, April
1952). Other studies demonstrated theories of predicting crash
proneness from crash history coupled with other factors. These
factors--such as age, sex, geographic location, mileage driven and
conviction history--are used every day by insurance companies and motor
vehicle bureaus to predict the probability of an individual
experiencing future crashes (See Weber, Donald C., ``Accident Rate
Potential: An Application of Multiple Regression Analysis of a Poisson
Process,'' Journal of American Statistical Association, June 1971). A
1964 California Driver Record Study prepared by the California
Department of Motor Vehicles concluded that the best overall crash
predictor for both concurrent and nonconcurrent events is the number of
single convictions. This study used 3 consecutive years of data,
comparing the experiences of drivers in the first 2 years with their
experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 45 applicants, two drivers were involved in crashes, and two
drivers were convicted of moving violations in a CMV. All the
applicants achieved a record of safety while driving with their vision
impairment, demonstrating the likelihood that they have adapted their
driving skills to accommodate their condition. As the applicants' ample
driving histories with their vision deficiencies are good predictors of
future performance, FMCSA concludes their ability to drive safely can
be projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 45 applicants listed in the notice of July
24, 2015 (80 FR 44188).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 45 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

V. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based upon its evaluation of the 45 exemption applications, FMCSA
exempts the following drivers from the vision requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)):

Charles R. Airey (MD)
Harold D. Albrecht (IL)
Joseph W. Bahr, Jr. (NJ)
Jerry A. Bordelon (LA)
Stephen C. Brueggeman (KY)
Dale E. Bunke (ID)
James E. Byrne (MO)
Larry O. Cheek (CA)
Louise D. Curtis (FL)
Marvin P. Cusey (MN)
Bradford W. Davis (KS)
Roy H. Degner (IA)
Chris DeJong (NM)
Jonathan G. Estabrook (MA)
Robert J. Falanga (FL)
Elhadji M. Faye (CA)
Donald A. Hall (NC)
Willard D. Hall (CA)
Refugio Haro (IL)
Kevin L. Harrison (TN)
Timothy N. Hollenbeck (OR)
Elmer G. Isenhart, Jr. (OH)
Abdullah T. Khalil (VA)
Don J. Labrum (UT)
Scott E. Landegent (SD)
Steven D. Leonard (MD)
Bruce A. Lloyd (MA)
Duane S. Lozinski (IA)
Rob A. Matthews, Jr. (SC)
Keith W. McNabb (ID)
Ronald W. Neujahr (KS)
Frank L. Novich Jr. (MO)
Russell Nutter (OH)
Lonnie D. Prejean (TX)
Robert C. Reid (KY)
Thomas E. Riley (NJ)
Danilo A. Rivera (MD)
Steven L. Roberts (AR)
John B. Stiltner (KY)
James M. Stroupe (VA)
Steven W. Stull (IL)
Dale R. Sweigart (PA)
Rick R. Warner (MI)
Theodore White (PA)
Larry L. Yow (NC)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: October 7, 2015.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-26248 Filed 10-14-15; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62808-62810]
[FR Doc No: 2011-25907]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-3180-N2]

 Food and Drug Administration

[Docket No. FDA-2010-N-0308]

Pilot Program for Parallel Review of Medical Products

AGENCY: Food and Drug Administration, Centers for Medicare and Medicaid
Services, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid Services (CMS) (the Agencies) are soliciting
nominations from sponsors of innovative device technologies to
participate in a pilot program for concurrent review of certain FDA
premarket review submissions and CMS national coverage determinations.
The Agencies announced the intention to initiate a pilot program in the
Federal Register of September 17, 2010. The Agencies are now providing
notice of the procedures for voluntary participation in the pilot
program, as well as the guiding principles the Agencies intend to
follow.

DATES: Effective Date: November 10, 2011.

FOR FURTHER INFORMATION CONTACT:
    For device sponsors interested in requesting voluntary parallel
review:

Markham C. Luke, Center for Devices and Radiological Health, Food and
Drug Administration,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
    For General questions about parallel review:

Peter Beckerman, Office of Policy, Food and Drug Administration, 301-
796-4830, e-mail<EMAIL_ADDRESS>or
Tamara Syrek Jensen, Centers for Medicare and Medicaid Services, 410-
786-3529, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

A. Parallel Review Proposal

    As discussed in the September 17, 2010, Federal Register notice (75
FR 57045), parallel review is intended to reduce the time between FDA
marketing approval and CMS national coverage determinations, thereby
improving the quality of patient health care by facilitating earlier
access to innovative medical products for Medicare beneficiaries. In
the notice of September 17, 2010, we solicited comments on parallel
review of submissions to FDA and CMS for regulated medical products. We
also stated our intention to initiate a pilot program for parallel
review of devices. The Agencies received 36 comments before the comment
period closed on December 16, 2010. The public comments can be found
at: http://www.regulations.gov, identified by docket number FDA-2010-N-
0308. Major themes of the comments included, among others: Parallel
review should be sponsor/requester initiated, voluntary, and include an
option to opt out of a national coverage determination (NCD); agencies
should clarify the confidentiality standards for data sharing between
the Agencies; and agencies should establish clear and concise
guidelines on the procedures and a timeline for parallel review. These
comments have informed the parallel review pilot program for medical
devices we are announcing in this notice. We also intend to seek input
and feedback from candidate sponsor/requesters who participate in the
pilot. Current information describing the FDA-CMS Parallel Review Pilot
Program for Medical Devices can be found at the following Web site:
http://www.parallel-review.fda.gov.

B. Expected Benefits of Parallel Review

    The expected benefits of an FDA-CMS parallel review program were
discussed in the September 17, 2010, notice. The anticipated benefits
include facilitating development of innovative new products and
increased efficiency in the Agencies' review processes.
    It has come to our attention that innovators have generally focused
solely on obtaining FDA approval, only to later realize that Medicare
payment may not automatically be forthcoming.
    As stated in the notice of September 17, 2010, parallel review will
serve the

public interest by providing the possibility of reducing the time
between FDA marketing approval or clearance decisions and Medicare
NCDs. The efficiencies gained by parallel review are expected to
benefit all interested parties. Patients are expected to gain quicker
access to innovative medical technologies if they are covered. The
sponsor/requester gains timely insight to the information needs of CMS
with respect to pursuing a positive NCD as well as a potentially
shortened time to payment due to a streamlined multi-review process.
The Agencies gain enhanced channels of communication. Specifically with
regard to CMS, its early involvement will streamline the decision
making process. It will also focus attention on health outcomes of
importance to Medicare, and provide early awareness of any remaining
evidence gaps. If there are evidence gaps, CMS may address them by
implementing coverage with evidence development (CED) or other policy
vehicles. For example, if FDA approval or clearance is conditioned on a
post-approval study, CMS could decide to cover the device within the
parameters of the post-approval study under CED.

II. Parallel Review Pilot Program for Medical Devices

    The Agencies have developed a pilot program that reflects our
review of the comments received on the September 17, 2010, notice and
our interest in creating a streamlined process with minimal additional
burden to interested sponsor/requesters. This document outlines the:
(1) Guiding principles underlying the pilot program; (2) appropriate
candidates for the pilot program; (3) procedures FDA and CMS intend to
follow in conducting parallel product reviews; and (4) general roles
and responsibilities of the sponsor/requester, FDA, and CMS.

A. Guiding Principles

    In response to comments received, the Agencies have identified
basic principles underlying the parallel review pilot program described
in this document. The following principles are intended to create a
common understanding among the sponsor/requester, FDA, and CMS about
the goals and parameters of the parallel review pilot program:
    1. Participation in parallel review will not affect the review
standard for device approval by FDA or for a coverage determination by
CMS.
    2. The Agencies will adhere to all statutory and regulatory
requirements as stipulated in the memorandum of understanding between
FDA and CMS, available at http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm217585.htm.
    3. A sponsor/requester may withdraw from, and FDA and CMS may
terminate, parallel review up until the time of CMS's public posting of
an NCD tracking sheet.
    4. The Agencies will not publicly disclose participation of a
sponsor/requester in parallel review prior to CMS's posting of an NCD
tracking sheet, unless the sponsor/requester consents or has already
made this information public or disclosure is required by law. If a
sponsor/requester does not wish the information that would be revealed
by the posting of the NCD tracking sheet to become public, it must
withdraw from parallel review prior to this point.
    5. Due to Agency resource issues the pilot program expects to
accept no more than three to five candidates per year.

B. Appropriate Candidates

    During its pilot phase, the Agencies believe parallel review should
focus on truly innovative technologies that are most likely to benefit
from the efficiencies of parallel review. Accordingly, appropriate
candidates for the parallel review pilot are medical devices which each
use the following:
    1. New technologies for which the sponsor/requester has had
sufficient pre-investigational device exemption (IDE) interaction with
FDA or approved IDE application.
    2. New technologies for which an original or supplemental
application for premarket approval (PMA) or petition for de novo review
would be required.
    3. New technologies that fall within the scope of a Part A or Part
B Medicare benefit category and are not subject to an NCD.
    The agencies encourage any interested sponsors who believe their
devices are appropriate candidates and would like to explore the use of
the pilot program to contact FDA by e-mail at<EMAIL_ADDRESS>
before initiating the procedures referenced under section II.C of this
document entitled ``C. Procedures.''

C. Procedures

    For sponsor/requesters of devices that have already had contact
with FDA through the pre-IDE or IDE process, much of the information
necessary to assess the suitability of a candidate technology should
already be in FDA's possession. The Agencies have developed the
following procedures to ensure adequate information to assess a
candidate's suitability for parallel review without creating a
burdensome new application process:
    1. Nomination. The sponsor/requester of an innovative therapeutic
or diagnostic device may nominate its device for participation in
parallel review by following the instructions posted on the http://www.parallel-review.fda.gov web page. FDA intends to acknowledge
receipt of nominations by e-mail. The following information will assist
FDA in processing and responding to nominations:
     Name of the sponsor/requester and relevant contact
information;
     Pre-IDE/IDE/PMA/De Novo reference number;
     Name of the product;
     Succinct description of the technology and disease or
condition the device is intended to diagnose or treat;
     Stage of development of the technology (that is, in
preclinical testing, in clinical trials, currently undergoing premarket
review by FDA);
     Brief statement explaining why the device is an
appropriate candidate for the pilot program as described under the
section II.B of this document entitled: ``B. Appropriate Candidates.''
    2. FDA/CMS Consideration. The Agencies intend to meet to consider a
nomination within 30 days of receiving a complete nomination containing
the information described previously. The Agencies may contact the
sponsor/requester to request supplemental information.
    3. Sponsor/requester Notification. Upon completion of the
consideration meeting, the Agencies will notify the sponsor/requester
whether the product is an appropriate candidate for the parallel review
pilot program.
    4. Acceptance Meeting. If deemed an appropriate candidate, the
Agencies will meet with the product sponsor/requester, either in person
or by phone.
    5. FDA Review. Parallel review candidates will be reviewed
according the normal FDA review process. Participation in parallel
review will not affect user fees, review timeframes or procedures, or
the FDA standard of approval, which is reasonable assurance of safety
and effectiveness.
    6. CMS NCD Review and Timing. CMS will begin its informal review
process sometime after submission of the PMA or de novo petition. For
PMAs, this will typically begin after the PMA-specific Panel meeting of
the FDA Medical Devices Advisory Committee.

D. Roles and Responsibilities

    The Agencies have outlined the general roles and responsibilities
of each participant in the parallel review process to ensure clarity
and shared

understandings. These roles and responsibilities are as follows:
    1. Sponsor/requester. The sponsor/requester initiates consideration
for parallel review by submitting a complete nomination as outlined
previously under ``1. Nomination,'' of section II.C of this document
entitled ``Procedures.''. Once a nomination has been submitted, the
sponsor/requester should comply with all requirements necessary for FDA
review of a PMA or de novo petition and CMS issuance of an NCD
including the submission of a formal request for an NCD. The Agencies
request that a sponsor/requester who wishes to withdraw from the
parallel review process notify the FDA and CMS in writing before CMS'
formal opening of an NCD by the posting of the NCD tracking sheet.
    2. The FDA. FDA will provide a secure and confidential nomination
and review process as outlined previously in section II.C of this
document. FDA will initiate review of nominations for parallel review
by retrieving applications from the secure mailbox, and coordinating
with CMS, on the planning and implementation of the parallel review
process. FDA will review PMAs and de novo petitions for products that
have been selected by the Agencies for parallel review according to the
usual timeframes, procedures, and review standards for PMA approval and
de novo classification.
    3. The CMS. In addition to the coverage review, CMS's parallel
review roles include participating in the nomination process as well as
coordinating with FDA regarding the planning and implementation of the
parallel review process. During the parallel review, CMS is responsible
for maintaining open communication channels with FDA and the sponsor/
requester and for fulfilling its statutory obligations concerning the
NCD process.

E. Duration of the Pilot

    The Agencies intend to accept requests for participation in the
pilot program for parallel review for 2 years. The Agencies may
terminate the pilot program before the close of the 2-year period, or
may extend the pilot program beyond 2 years. The decisions will be
announced in the Federal Register.

F. Evaluation

    The Agencies intend to use their experience with the pilot program
to develop a parallel review program not only for devices but also for
drugs and biological products. The Agencies anticipate their experience
with the parallel review program for devices and feedback from
participants in the program will inform guidance for a broader program
applicable to all medical products. The Agencies may also determine
that they should extend or modify the parallel review pilot program to
continue their evaluation.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program) (Catalog of Federal Domestic Assistance Program
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)

    Dated: September 21, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: September 21, 2011.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2011-25907 Filed 10-6-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Rules and Regulations]
[Pages 23353-23355]
[FR Doc No: 2023-07614]

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

40 CFR Part 52

[EPA-R03-OAR-2023-0179; FRL-10883-02-R3]

West Virginia; Finding of Failure To Submit State Implementation
Plan Revision in Response to the 2015 Findings of Substantial
Inadequacy and SIP Calls To Amend Provisions Applying to Excess
Emissions During Periods of Startup, Shutdown, and Malfunction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final action.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to find that the West Virginia Department of Environmental
Protection (WVDEP) failed to timely submit a state implementation plan
(SIP) revision required by the Clean Air Act (CAA) to address the
deficiencies identified in EPA's 2015 findings of substantial
inadequacy and ``SIP calls'' for provisions applying to excess
emissions during periods of startup, shutdown, and malfunction (SSM).
EPA is issuing this finding of failure to submit (FFS) without prior
public notice and opportunity for comment. This action triggers certain
CAA deadlines for EPA to impose sanctions if a state does not submit a
complete SIP revision addressing the outstanding requirements and to
promulgate a Federal Implementation Plan (FIP) if EPA does not approve
the state's submission as a SIP revision. In a separate but related
action, published elsewhere in this issue of the Federal Register, EPA
is also issuing a final disapproval of a SIP revision submitted by West
Virginia which allowed sources who could not meet emission limits
during startup and shutdown events to apply for alternative emission
limits (AELs) (see Docket ID No. EPA-R03-OAR-2022-0956).

DATES: This action is effective on May 17, 2023.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2023-0179. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (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 through
www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Serena Nichols, Planning and
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1600 John F. Kennedy
Boulevard, Philadelphia, Pennsylvania 19103. The telephone number is
(215) 814-2053. Ms. Nichols can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

A. Notice and Comment Under the Administrative Procedure Act (APA)

    Section 553(b)(3)(B) of the APA, 5 U.S.C. 553(b)(3)(B), provides
that, when an agency for good cause finds that notice and public
procedures are impracticable, unnecessary, or contrary to the public
interest, the agency may issue a rule without providing notice and an
opportunity for public comment. EPA has determined that there is good
cause for making this final agency action without prior proposal and
opportunity for comment because no significant EPA judgment is involved
in making findings of failure to submit SIPs, or elements of SIPs,
required by the CAA, where states have made no submissions to meet the
requirement. As is discussed in further detail later, pursuant to CAA
section 110(k)(1)(B), EPA ``shall determine'' no later than six months
after the date by which a state is required to submit a SIP whether a
state has made a submission that meets the minimum completeness
criteria established pursuant to CAA section 110(k)(1)(A). EPA
exercises no significant judgment in making a determination that a
state failed to make a submission and subsequently issuing a finding of
failure to submit. Thus, notice and public procedures are unnecessary
to take this action. EPA finds that this constitutes good cause under 5
U.S.C. 553(b)(3)(B).

I. Background

    On June 12, 2015, EPA finalized an action (2015 SSM SIP Action),
which clarified, restated, and updated EPA's national policy regarding
SSM provisions in SIPs (2015 Policy).\1\ The 2015 Policy explained
EPA's interpretation of certain CAA requirements, affirming that SSM
exemption provisions (e.g., automatic exemptions, discretionary
exemptions, and overly broad enforcement discretion provisions) and
affirmative defense SIP provisions are generally viewed as inconsistent
with CAA requirements. At the same time, pursuant to CAA section
110(k)(5), EPA issued findings of substantial inadequacy for SIP
provisions applying to excess emissions during SSM periods for 36
states that were applicable in 45 statewide and local jurisdictions
(air agencies).\2\ As part of the 2015 SSM SIP Action, EPA also issued
a ``SIP call'' (2015 SIP Call) to each of those 45 air agencies. The
2015 SIP Call required air agencies to adopt and submit revisions to
EPA to correct identified SSM-related deficiencies in their SIPs by
November 22, 2016. The 2015 SSM SIP Action also responded to a petition
for rulemaking alleging specific deficiencies related to SSM provisions
in existing SIPs. On July 27, 2015, the 2015 SSM SIP Action was
challenged in the United States Court of Appeals for the District of
Columbia Circuit.\3\
---------------------------------------------------------------------------

    \1\ State Implementation Plans: Response to Petition for
Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to
SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend
Provisions Applying to Excess Emissions During Periods of Startup,
Shutdown and Malfunction, 80 FR 33840 (June 12, 2015).
    \2\ For convenience, the EPA refers to ``air agencies'' in this
action collectively when meaning to refer in general to states, the
District of Columbia, and local air permitting authorities that are
currently administering, or may in the future administer, EPA-
approved implementation plans.
    \3\ Environ. Comm. Fl. Elec. Power v. EPA, et al., No. 15-1239
(D.C. Cir.) (and consolidated cases).
---------------------------------------------------------------------------

    In 2017, EPA requested that the pending litigation on the final
2015 SSM SIP Action be held in abeyance to allow the new administration
time to review the action. In 2020, Regions 4, 6, and 7 took final
actions that were inconsistent with the 2015 Policy and EPA withdrew
the corresponding SIP calls previously issued to Texas, North Carolina,
and Iowa. These state-specific actions are the subject of pending
litigation.\4\ Moreover, in alignment with the SIP call withdrawals for
Texas, North Carolina, and Iowa, EPA issued a Memorandum in October
2020 (2020 Memorandum), which established a new national policy that
permitted the

inclusion of certain provisions governing SSM periods in SIPs,
including those related to exemptions and affirmative defenses.
Importantly, the 2020 Memorandum was not a regulatory action and did
not alter or withdraw the 2015 SIP Call for any of the 45 air agencies
identified in the 2015 SSM SIP Action. The 2020 Memorandum did,
however, indicate EPA's intent at the time to review the remaining SIP
calls that were issued in the 2015 SSM SIP Action to determine whether
EPA should maintain, modify, or withdraw particular SIP calls through
future agency actions.
---------------------------------------------------------------------------

    \4\ Sierra Club, et al. v. EPA, et al., No. 20-1115 (D.C. Cir.
Apr. 7, 2020); Sierra Club, et al. v. EPA, et al., No. 20-1229 (D.C.
Cir. June 29, 2020); Sierra Club, et al. v. EPA, et al., No. 21-1022
(D.C. Cir. January 2021).
---------------------------------------------------------------------------

    On September 30, 2021, EPA issued a Memorandum (2021 Memorandum)
that announced a withdrawal of the 2020 Memorandum and EPA's intent to
return to the 2015 Policy and implement it fully. As previously
articulated in the 2015 Policy, the 2021 Memorandum states that SSM
exemption provisions and affirmative defense provisions included in
SIPs will generally be viewed as inconsistent with CAA requirements.
    As part of the reinstatement of the 2015 Policy, EPA intends to
implement the pending SIP calls, which remain in place from the 2015
SSM SIP Action. Pursuant to CAA section 110(k)(1)(B), EPA must
determine no later than six months after the date by which a state is
required to submit a SIP whether a state has made a submission that
meets the minimum completeness criteria established pursuant to CAA
section 110(k)(1)(A). These criteria are set forth at 40 CFR part 51,
appendix V. EPA refers to the determination that a state has not
submitted a SIP submission that meets the minimum completeness
criteria, or has not submitted a SIP at all, as a ``finding of failure
to submit.''
    For the 2015 SIP Call, as previously discussed, SIP submissions
were due by November 22, 2016. EPA's determinations of whether air
agencies made submittals were therefore due on May 22, 2017. West
Virginia submitted a SIP revision to EPA on June 13, 2017, which became
complete by operation of law on December 13, 2017. The June 13, 2017
SIP revision asked EPA to approve into the SIP new West Virginia
regulations allowing sources that could not meet their emission limits
during periods of startup or shutdown to apply for AELs during these
periods of startup and/or shutdown. These new West Virginia regulations
also prohibited sources which were subject to Federal new source
performance standards (NSPS) or national emission standards for
hazardous air pollutants (NESHAPS) from applying for AELs if the
applicable NSPS or NESHAP had emission limits or provisions covering
startup or shutdown. In a separate rulemaking action, EPA is taking
final action to disapprove West Virginia's June 13, 2017 SIP revision
published elsewhere in the ``Rules'' section of this issue of the
Federal Register (see Docket ID No. EPA-R03-OAR-2022-0956).
    EPA originally assumed that WVDEP's June 13, 2017 submittal was
intended as a response to the 2015 SIP Call. However, WVDEP submitted
comments in response to EPA's December 22, 2022 notice of proposed
rulemaking (NPRM) \5\ indicating that the 2017 SIP submittal was not
intended to address the provisions identified in EPA's 2015 SSM SIP
Action and that West Virginia would submit future SIP revisions to
address the provisions identified in the 2015 SSM SIP Action.\6\
However, West Virginia has not submitted those future SIP revisions
addressing the 2015 SSM SIP Action. This clarification means that WVDEP
has not submitted the required SIP revisions responding to the 2015 SIP
call. Accordingly, EPA is now issuing a finding of failure to submit
(FFS).
---------------------------------------------------------------------------

    \5\ 87 FR 78617.
    \6\ See West Virginia's comments in response to the NPRM,
located in the docket for the NPRM. Docket ID EPA-R03-OAR-2022-0956.
---------------------------------------------------------------------------

II. Finding of Failure To Submit

    In the 2015 SSM SIP Action, EPA issued a final determination that
14 provisions in the West Virginia SIP were substantially inadequate to
meet CAA requirements.\7\ Specifically, the 2015 SSM SIP Action issued
a SIP call for the following sections of the West Virginia SIP: W. Va.
Code R. 45-2-9.1, W. Va. Code R. 45-7-10.3, W. Va. Code R. 45-40-100.8,
W. Va. Code R. 45-2-10.1, W. Va. Code R. 45-3-7.1, W. Va. Code R. 45-5-
13.1, W. Va. Code R. 45-6-8.2, W. Va. Code R. 45-7-9.1, W. Va. Code R.
45-10-9.1, W. Va. Code R. 45-21-9.3, W. Va. Code R. 45-3-3.2, W. Va.
Code R. 45-7-10.4, W. Va. Code R. 45-2-10.2, and W. Va. Code R. 45-2-
9.4.\8\ The rationale underlying EPA's determination that these
provisions were substantially inadequate to meet CAA requirements, and
therefore to issue a SIP call to West Virginia to remedy the
provisions, is detailed in the 2015 SSM SIP Action and the relevant
proposals prior to the SIP call and will not be repeated here.
---------------------------------------------------------------------------

    \7\ 80 FR 33840, at 33961, June 12, 2015.
    \8\ Id.
---------------------------------------------------------------------------

    West Virginia's June 13, 2017, SIP submittal did not remove any of
these provisions from the West Virginia SIP, and West Virginia did not
submit any other SIP revisions subsequent to the June 13, 2017 SIP
submittal removing or otherwise addressing any of these West Virginia
SIP provisions identified above and in the 2015 SSM SIP Action. As
noted above, these revisions were due by May 22, 2017. Therefore, EPA
is issuing a finding that West Virginia has failed to submit revisions
to the substantially inadequate SIP provisions identified in EPA's 2015
SSM SIP action.

III. Consequences of Findings of Failure To Submit

    If EPA finds that a state has failed to make the required SIP
submittal or that a submitted SIP is incomplete, then CAA section
179(a) establishes specific consequences, after a period of time,
including the imposition of mandatory sanctions under CAA section
179(b) for the affected areas or states. The two applicable sanctions
enumerated in CAA section 179(b) are: (1) the 2-to-1 emission offset
requirement for all new and modified major sources subject to the
nonattainment New Source Review (NSR) program, and (2) restrictions on
highway funding. Additionally, a finding that a state has failed to
submit a complete SIP triggers an obligation under CAA section 110(c)
for EPA to promulgate a FIP no later than two years after issuance of
the finding of failure to submit if the affected state has not
submitted, and EPA has not approved, the required SIP submittal.
    With respect to mandatory sanctions, if EPA has not affirmatively
determined that a state has made the required complete SIP submittal
within 18 months \9\ of the effective date of this final action, then,
pursuant to CAA section 179(a) and (b) and 40 CFR 52.31, the offset
sanction identified in CAA section 179(b)(2) will apply in the affected
nonattainment area or state. If EPA has not affirmatively determined
that the state has made the required complete SIP submittal within six
months after the offset sanction is imposed, then the highway funding
sanction will apply in the affected nonattainment area(s), in
accordance with CAA section 179(b)(1) and 40 CFR 52.31.\10\ The
sanctions will not take effect if, within 18 months after the effective
date of these findings, EPA affirmatively determines that the state has
made a complete SIP submittal addressing the deficiency for which the
finding was made. Additionally, if the state makes the required SIP
submittal and EPA takes final action to approve the submittal within
two years of the

effective date of these findings, EPA is not required to promulgate a
FIP.
---------------------------------------------------------------------------

    \9\ CAA 110(k)(5).
    \10\ Such highway sanctions would only apply in nonattainment
areas. If a state jurisdictional area does not contain any
nonattainment areas, then the highway sanctions would not apply in
that state.
---------------------------------------------------------------------------

IV. Final Action

    Based on a review of SIP submittals received and deemed complete as
of the date of signature of this action, the EPA finds that WVDEP has
failed to submit a SIP revision by November 22, 2016, addressing the
deficiencies identified in the 2015 SSM SIP Call.

V. Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Executive Order
13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the PRA. This final action does not establish any new
information collection requirement apart from what is already required
by law. This action relates to the requirement in the CAA for states to
submit SIPs in response to findings of substantial inadequacy under
section 110(k)(5).

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. The action
is a finding that the named air agencies have not made the necessary
SIP submission in response to findings of substantial inadequacy under
section 110(k)(5) of the CAA.

D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments, or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It 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 the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This action finds that several air agencies have
failed to submit SIP revisions in response to findings of substantial
inadequacy under section 110(k)(5) of the CAA. No tribe is subject to
the requirement to submit an implementation plan under the findings of
inadequacy relevant to this action. Thus, Executive Order 13175 does
not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern health or safety risks that the EPA has
reason to believe may disproportionately affect children, per the
definition of ``covered regulatory action'' in section 2-202 of the
Executive order. This action is not subject to Executive Order 13045
because it is a finding that several air agencies failed to submit SIP
revisions in response to findings of substantial inadequacy under
section 110(k)(5) of the CAA and does not directly or
disproportionately affect children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This final action does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    EPA did not perform an EJ analysis and did not consider EJ in this
action. Consideration of EJ is not required as part of this action, and
there is no information in the record inconsistent with the stated goal
of E.O. 12898 of achieving environmental justice for people of color,
low-income populations, and Indigenous peoples.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 16, 2023. Filing a petition for
reconsideration by the Administrator of this final action does not
affect the finality of this action for the purposes of judicial review
nor does it extend the time within which a petition for judicial review
may be filed, and shall not postpone the effectiveness of such action.
This action may not be challenged later in proceedings to enforce its
requirements (see CAA section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Administrative practice and procedures,
Air pollution control, Approval and promulgation of implementation
plans, Incorporation by reference, Intergovernmental relations,
Reporting and recordkeeping requirements.

Adam Ortiz,
Regional Administrator, Region III.
[FR Doc. 2023-07614 Filed 4-14-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 27, 2008 (Volume 73, Number 60)]
[Notices]
[Page 16400-16401]
[DOCID:fr27mr08-89]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57541; File No. SR-Amex-2008-25]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Restore Amex's Revenue Sharing Program for ETF Quoting Participants

March 20, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 18, 2008, the American Stock Exchange LLC (``Exchange'' or
``Amex'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to restore a previously-adopted revenue
sharing program for ETF quoting participants on the Exchange.

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

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

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

1. Purpose
    The Exchange proposes to restore a revenue sharing program
(``RSP'') for ETF quoting participants on the Exchange. The RSP was
first implemented by the Exchange for ETF specialists and registered
traders on July 1, 2007, and was to be in effect through December 31,
2007 unless otherwise extended.\3\ The RSP was inadvertently allowed to
lapse without the Exchange filing to extend it, so the purpose of the
proposed rule change is to restore the RSP on a prospective basis,
effective immediately, on the same terms that previously governed the
RSP (described below). The Exchange will be submitting a separate
filing to request retroactive approval of the RSP for the period
January 1, 2008 through March 17, 2008.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 55983 (June 29,
2007), 72 FR 37059 (July 6, 2007) (SR-Amex-2007-68).
---------------------------------------------------------------------------

    RSP payments will be made from the Exchange's general revenues and
will not be limited to a particular revenue source. In order to
continue to provide ETF quoting participants (ETF specialists,
registered traders, and, most recently, Designated Amex Remote Traders
(DARTs) \4\) with a source of payments to provide incentives to quote

aggressively in Amex-traded shares, the Exchange proposes to distribute
revenue to quoting participants as outlined below. The program will be
in effect through the end of September 2008.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 57540 (March 20,
2008) (SR-Amex-2008-23) (adding DARTs to the RSP as of March 17,
2008).
---------------------------------------------------------------------------

    The RSP will work as follows:
     ETF specialists will receive an aggregate RSP payment
(calculated monthly) of $0.0024 per share (or 24 cents per 100 shares)
whenever the specialist either buys or sells its specialty ETF on the
Exchange and is a provider of liquidity in that transaction (e.g., the
specialist's quote is traded against or the specialist offsets an order
imbalance as part of an opening or closing transaction). The RSP
payment is comprised of $0.0004 per share (or 4 cents per 100 shares)
for all shares executed on the Exchange in their specialty ETF
(irrespective of whether the specialist is the provider of liquidity),
plus another $0.0020 (or 20 cents per 100 shares) if the specialist is
the provider of liquidity in the transaction. If the specialist is not
the liquidity provider, then the RSP payment is limited to $0.0004 per
share executed on the Exchange in its specialty ETF.
     Registered traders in ETFs will receive an RSP payment of
$0.0010 per share (or 10 cents per 100 shares) whenever the registered
trader either buys or sells an ETF on the Exchange and is a provider of
liquidity in that transaction.
     DARTs, as described in the Exchange's recent proposed rule
change adding DARTs to the RSP,\5\ will receive an RSP payment of
$0.0015 per share (or 15 cents per 100 shares) whenever the DART either
buys or sells an ETF on the Exchange and is a provider of liquidity in
that transaction.
---------------------------------------------------------------------------

    \5\ See id.
---------------------------------------------------------------------------

    No ETF quoting participant will receive an RSP payment when another
ETF quoting participant is the contra-party to the transaction.
Further, RSP payments will be made on transactions in securities
trading at less than $1.00 only in amounts proportionate to the amount
on which the Exchange collects revenue. Finally, as customer
transaction charges are capped at $100 per transaction, meaning that
the transaction charge of $0.0023 per share is assessed only on the
first 43,478 shares executed, an ETF quoting participant would receive
an RSP payment based only on the first 43,478 shares executed.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \6\ in general and furthers the objectives
of Section 6(b)(4) of the Act \7\ in particular in that it is intended
to assure the equitable allocation of reasonable dues, fees, and other
charges among its members and issuers and other persons using its
facilities. Specifically, the Exchange is restoring a revenue sharing
program to maintain incentives for an increase in order flow.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed rule change does not impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

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

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

    Because the foregoing proposed rule change establishes or changes a
due, fee, or other charge imposed by the Exchange, it has become
effective upon filing pursuant to Section 19(b)(3)(A) of the Act \8\
and Rule 19b-4(f)(2) thereunder.\9\ At any time within 60 days of the
filing of the proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml ); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-Amex-2008-25 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2008-25. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Amex. All comments received will
be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Amex-2008-25 and should be submitted on
or before April 17, 2008.
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-6251 Filed 3-26-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28317]
[DOCID:fr16my06-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL06-69-000]

ALLETE, Inc.; Complainant v. Midwest Independent Transmission
System Operator, Inc.; Respondent; Notice of Complaint

May 9, 2006.
    Take notice that on May 8, 2006, pursuant to sections 206 and 306
of the Federal Power Act, ALLETE, Inc. (d/b/a Minnesota Power) filed a
complaint against Midwest Independent Transmission System Operator,
Inc. (Midwest ISO) alleging that Midwest ISO has erred in assessing
excessive congestion charges against Minnesota Power.
    The Complainant states that copies of the complaint were served on
the contacts for the Midwest ISO as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions or protests must be filed on or before the
comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 29, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7374 Filed 5-15-06; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on September 15, 2005

   SUPPLEMENTAL NOTICE OF ACTION TAKEN -- DOCKET OST-2005-21422

________________________________________________________________________
_____________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of MN AIRLINES, LLC dba SUN COUNTRY AIRLINES (SUN COUNTRY)
filed 6/3/05 for:

XX  Exemption for two years under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between (1) the terminal point Dallas/Ft. Worth, Texas, and the terminal
point Puerto Vallarta, Mexico; (2) the terminal point Dallas/Ft. Worth,
Texas, and the terminal point San Jose del Cabo, Mexico; and (3) the
terminal point Dallas/Ft. Worth, Texas, and the terminal point Cozumel,
Mexico.  Sun Country proposes to operate this service on a year-round
basis, beginning May 1, 2006.

Background

By Notice of Action Taken issued August 1, 2005, in the instant docket,
the Department granted Sun Country exemption authority to serve the
Dallas/Ft .Worth-San Jose del Cabo market, but dismissed its request to
serve the Dallas/Ft .Worth-Puerto Vallarta and Dallas/Ft. Worth-Cozumel
markets.

On August 9, 2005, Sun Country filed a petition objecting to the
dismissal.  Sun Country stated that although Champion had held the
authority for more than a year, Sun Country was informed that Champion
had not yet flown a scheduled flight.  Sun Country requested that the
Department declare the authority previously granted to Champion to be
dormant, and issue the appropriate authorization to Sun Country.

On September 1, 2005, Champion advised the Department that it has no
current plans to serve the Dallas/Ft .Worth-Puerto Vallarta and
Dallas/Ft. Worth-Cozumel markets.

Applicant rep: John S. Fredericksen<PHONE_NUMBER>   DOT Analyst: Thuy
H. Cooper<PHONE_NUMBER>

D I S P O S I T I O N

We have decided to grant Sun Country’s petition and to award Sun
Country authority to serve the Dallas/Ft. Worth-Cozumel and Dallas/Ft.
Worth-Puerto Vallarta markets.  The designation opportunities are now
available for these markets, and Sun Country’s request for the
authority stands unopposed.

XX  Granted (subject to conditions, see below)

The above action was effective when taken: September 15, 2005 through
August 1, 2007.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX Holder’s certificates of public convenience and necessity

   	XX Standard exemption conditions (attached)

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Regarding the issue of the start-up deadline, we have
determined that, in the circumstances presented, including Sun
Country’s proposed   May 1, 2006, start-up date and the fact that no
party opposed the request, we will require Sun Country to institute the
proposed service no later than May 1, 2006.

________________________________________________________________________
___________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the exemption services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  05/2004

 The basis for the dismissal was that, under the U.S.-Mexico aviation
agreement, a total of two U.S.-carriers could be designated to provide
direct-carrier (own-aircraft) services in the city-pair markets at
issue.  At the time we acted upon the application, American Airlines,
Inc. and Grand Holdings, Inc. dba Champion Air (Champion), already held
authority to serve the Dallas/Ft. Worth-Cozumel and Dallas/Ft.
Worth-Puerto Vallarta markets; hence, authority to serve those markets
was not available.

 Answers to Sun Country’s petition would have been due on August 18.
On August 23, we granted Champion’s motion to extend the answer date
to September 1.

 By Notice of Action Taken dated June 1, 2004, in Docket OST-2004-17408,
the Department granted Champion exemption authority to serve the
Dallas/Ft. Worth-Cozumel, Dallas/Ft .Worth-Puerto Vallarta, and St.
Louis-Puerto Vallarta markets.  We will withdraw Champion’s
designation to serve all three markets as it has advised the Department
that it has no current plans to use the scheduled authority.

 The exemption authority granted is for a period co-extensive with the
exemption granted previously to Sun Country in the instant docket
(through August 1, 2007).