[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41979-41985]
[FR Doc No: 2013-16686]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0355; FMCSA-2011-0389, FMCSA-2012-0050, FMCSA-
2012-0094, FMCSA 2012-0294]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to grant requests from 24
individuals for exemptions from the regulatory requirement that
interstate commercial motor vehicle (CMV) drivers have ``no established
medical history or clinical diagnosis of epilepsy or any other
condition which is likely to cause loss of consciousness or any loss of
ability to control a CMV.'' The regulation and the associated advisory
criteria published in the Code of Federal Regulations as the
``Instructions for Performing and Recording Physical Examinations''
have resulted in numerous drivers being prohibited from operating CMVs
in interstate commerce based on the fact that they have had one or more
seizures and are taking anti-seizure medication, rather than an
individual analysis of their circumstances by a qualified medical
examiner. The Agency concluded that granting exemptions for these CMV
drivers will provide a level of safety that is equivalent to or greater
than the level of safety maintained without the exemptions. FMCSA
grants exemptions that will allow these 24 individuals to operate CMVs
in interstate commerce for a 2-year period. The exemptions preempt
State laws and regulations and may be renewed.

DATES: The exemptions are effective July 12, 2013. The exemptions
expire on July 13, 2015.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Division Chief,
Physical Qualifications, Office of Medical Programs,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

A. 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., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's complete Privacy Act Statement in the
Federal Register (73 FR 3316, January 17, 2008). This statement is also
available at http://Docketinfo.dot.gov.

B. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the safety regulations 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.
    FMCSA grants 24 individuals an exemption from the regulatory
requirement in Sec.  391.41(b)(8) allowing individuals who take anti-
seizure medication to operate CMVs in interstate commerce for a 2-year
period. The Agency's decision on these exemption applications is based
on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s); the
length of time elapsed since the individual's last seizure; and each
individual's treatment regimen. In addition, the Agency reviewed the
applicant's driving record found in the CDLIS,\1\ for CDL holders, and
interstate and intrastate inspections recorded in MCMIS.\2\ The Agency
acknowledges the potential consequences of a driver experiencing a
seizure while operating a CMV. However, the Agency believes the drivers
covered by the exemptions have demonstrated that they are unlikely to
have a seizure and their medical condition does not pose a risk to
public safety.
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    \1\ Commercial Driver License Information System (CDLIS) is an
information system that allows the exchange of commercial driver
licensing information among all the States. CDLIS includes the
databases of fifty-one licensing jurisdictions and the CDLIS Central
Site, all connected by a telecommunications network.
    \2\ Motor Carrier Management Information System (MCMIS) is an
information system that captures data from field offices through
SAFETYNET, CAPRI, and other sources. It is a source for FMCSA
inspection, crash, compliance review, safety audit, and registration
data.
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    In reaching the decision to grant these exemption requests, the
Agency considered both current medical literature and information and
the 2007 recommendations of the Agency's Medical Expert Panel (MEP).
The Agency previously gathered evidence for potential changes to the
regulation by conducting a comprehensive review of scientific
literature that was compiled into the ``Evidence Report on Seizure
Disorders and Commercial Vehicle Driving'' (Evidence Report) [CD-ROM HD
TL230.3 .E95 2007]. The Agency then convened a panel of medical experts
in the field of neurology (MEP) on May 14-15, 2007, to review 49 CFR
391.41(b)(8) and the advisory criteria regarding individuals who have
experienced a seizure, and the 2007 Evidence Report. The Evidence
Report and the MEP recommendations are published on-line at http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm, under
Seizure Disorders, and are in the docket for this notice.

MEP Criteria for Evaluation

    On October 15, 2007, the MEP issued the following recommended
criteria for evaluating whether an individual with epilepsy or a
seizure disorder should be allowed to operate a CMV.\3\ The MEP
recommendations are included in an appendix at the end of this notice
and in each of the previously published dockets.
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    \3\ Engel, J., Fisher, R.S., Krauss, G.L., Krumholz, A., and
Quigg, M.S., ``Expert Panel Recommendations: Seizure Disorders and
Commercial Motor Vehicle Driver Safety,'' FMCSA, October 15, 2007.

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    Epilepsy diagnosis. If there is an epilepsy diagnosis, the
applicant should be seizure-free for 8 years, on or off medication. If
the individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with an epilepsy diagnosis should be
performed every year.
    Single unprovoked seizure. If there is a single unprovoked seizure
(i.e., there is no known trigger for the seizure), the individual
should be seizure-free for 4 years, on or off medication. If the
individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with a single unprovoked seizure should be
performed every 2 years.
    Single provoked seizure. If there is a single provoked seizure
(i.e., there is a known reason for the seizure), the Agency should
consider specific criteria that fall into the following two categories:
Low-risk factors for recurrence and moderate-to-high risk factors for
recurrence.
     Examples of low-risk factors for recurrence include
seizures that were caused by a medication; by non-penetrating head
injury with loss of consciousness less than or equal to 30 minutes; by
a brief loss of consciousness not likely to recur while driving; by
metabolic derangement not likely to recur; and by alcohol or illicit
drug withdrawal.
     Examples of moderate-to-high-risk factors for recurrence
include seizures caused by non-penetrating head injury with loss of
consciousness or amnesia greater than 30 minutes, or penetrating head
injury; intracerebral hemorrhage associated with a stroke or trauma;
infections; intracranial hemorrhage; post-operative complications from
brain surgery with significant brain hemorrhage; brain tumor; or
stroke.
    The MEP report indicates individuals with moderate to high-risk
conditions should not be certified. Drivers with a history of a single
provoked seizure with low risk factors for recurrence should be
recertified every year.

Medical Review Board Recommendations and Agency Decision

    FMCSA presented the MEP's findings and the Evidence Report to the
Medical Review Board (MRB) for consideration. The MRB reviewed and
considered the 2007 ``Seizure Disorders and Commercial Driver Safety''
evidence report and the 2007 MEP recommendations. The MRB recommended
maintaining the current advisory criteria, which provide that ``drivers
with a history of epilepsy/seizures off anti-seizure medication and
seizure-free for 10 years may be qualified to drive a CMV in interstate
commerce. Interstate drivers with a history of a single unprovoked
seizure may be qualified to drive a CMV in interstate commerce if
seizure-free and off anti-seizure medication for a 5 year period or
more'' [Advisory criteria to 49 CFR 391.43(f)].
    The Agency acknowledges the MRB's position on the issue but
believes relevant current medical evidence supports a less conservative
approach. The medical advisory criteria for epilepsy and other seizure
or loss of consciousness episodes was based on the 1988 ``Conference on
Neurological Disorders and Commercial Drivers'' (NITS Accession No.
PB89-158950/AS). A copy of the report can be found in the docket
referenced in this notice.
    The MRB's recommendation treats all drivers who have experienced a
seizure the same, regardless of individual medical conditions and
circumstances. In addition, the recommendation to continue prohibiting
drivers who are taking anti-seizure medication from operating a CMV in
interstate commerce does not consider a driver's actual seizure history
and time since the last seizure. The Agency has decided to use the 2007
MEP recommendations as the basis for evaluating applications for an
exemption from the seizure regulation on an individual, case-by-case
basis.

C. Exemptions

    Following individualized assessments of the exemption applications,
including a review of detailed follow-up information requested from
each applicant, FMCSA is granting exemptions from 49 CFR 391.41(b)(8)
to 24 individuals. Under current FMCSA regulations, all of the 24
drivers receiving exemptions from 49 CFR 391.41(b)(8) would have been
considered physically qualified to drive a CMV in interstate commerce
except that they presently take or have recently stopped taking anti-
seizure medication. All but one of the 24 drivers receiving an
exemption currently take anti-seizure medication. For these 24 drivers,
the primary obstacle to medical qualification was the FMCSA Advisory
Criteria for Medical Examiners, based on the 1988 ``Conference on
Neurological Disorders and Commercial Drivers,'' stating that a driver
should be off anti-seizure medication in order to drive in interstate
commerce. In fact, the Advisory Criterion has little if anything to do
with the actual risk of a seizure and more to do with assumptions about
individuals who are taking anti-seizure medication.
    In addition to evaluating the medical status of each applicant,
FMCSA evaluated the crash and violation data for the 24 drivers, some
of whom currently drive a CMV in intrastate commerce. The Commercial
Driver's License Information System (CDLIS) and the FMCSA Motor Carrier
Management Information System (MCMIS) were searched for crash and
violation data on the 24 applicants. The crash and violation history on
each individual driver is listed in his or her biographical profile.
    These exemptions are contingent on the driver maintaining a stable
treatment regimen and remaining seizure-free during the 2-year
exemption period. The exempted drivers must submit annual reports from
their treating physicians attesting to the stability of treatment and
that the driver has remained seizure-free. The driver must undergo an
annual medical examination by a medical examiner, as defined by 49 CFR
390.5, following the FCMSA's regulations for the physical
qualifications for CMV drivers.
    FMCSA published a notice of receipt of application and requested
public comment during a 30 day public comment period in a Federal
Register notice for each of the applicants. A short summary of the
applicants' qualifications follows. A discussion of the comments
received follows in section D. Comments. For those applicants who were
denied an exemption, a notice will be published at a later date.

Docket FMCSA-2008-0355

    On December 10, 2008, FMCSA published a notice of receipt of
exemption applications and requested public comment on 15 individuals
(Docket number FMCSA-2008-0355). The comment period ended on January
10, 2009. Seven commenters responded to the Federal Register notice. A
discussion of the comments is presented later in this document. FMCSA
has determined that one of these applicants should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
    Prince Austin Jr. Mr. Austin is a 55- year-old intrastate driver in
Ohio. Mr. Austin should be granted an exemption because he meets the
MEP criteria of being seizure-free 8 years in May 2013. He was
diagnosed with epilepsy in 1974. He has remained on anti-seizure
medication with the dose and frequency

remaining the same for the last eight years. His personal physician
states that he and Mr. Austin's treating neurologist are supportive of
the exemption. Mr. Austin has no recent entries in CDLIS or MCMIS.

Docket FMCSA-2011-0389

    On April 5, 2011, FMCSA published a notice of receipt of exemption
applications and requested public comment on 8 individuals (Docket
number FMCSA-2011-0094). The comment period ended on May 5, 2011. Seven
commenters responded to the Federal Register notice. A discussion of
the comments is presented later in this document. FMCSA has determined
that one of these applicants should be granted an exemption. The Agency
will issue a decision on the other drivers at a later date.
    Frank Cekovic. Mr. Cekovic is 45-year-old intrastate CMV driver in
the state of Pennsylvania. Mr. Cekovic should be granted an exemption
because he meets the MEP criteria of having no diagnosis of epilepsy
and being seizure-free four years as of April 2013. He was diagnosed
with a seizure disorder in January 2009 and placed on the anti-seizure
medication Keppra at that time. His treating physician states that he
is compliant with his medication regimen and that his risk of a
recurrent seizure is very low. The CMV that he operates is a ``bucket
truck'' for a power and light company, and Mr. Cekovic states that the
maximum distance he drives between job sites is no more than 20 miles
per day. He has 2 minor speeding entries on CDLIS, one each in 2009 and
2010, and no entries in MCMIS.

Docket FMCSA-2011-0389

    On January 5, 2012, FMCSA published a notice of receipt of
exemption applications and requested public comment on 15 individuals
(Docket number FMCSA-2011-0389). The comment period ended on February
5, 2012. Seven commenters responded to the Federal Register notice. A
discussion of the comments is presented later in this document. FMCSA
has determined that four of the applicants should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
    Joseph D'Angelo. Mr. D'Angelo is a 56-year-old CMV driver in New
York. Mr. D'Angelo should be granted an exemption because he meets the
MEP criteria by having no seizures for the last 43 years, and being on
a stable medication regimen for over 10 years. He experienced a single
seizure at age 14 in 1970. Mr. D'Angelo believes that he would achieve
a level of safety that is equivalent to the level of safety obtained by
complying with the regulation because he has remained seizure-free for
43 years. He has no entries in CDLIS or MCMIS.
    Ricki Gutermann. Mr. Gutermann is a 46-year-old intrastate CMV
driver in Wisconsin. Mr. Gutermann should be granted an exemption
because he meets the MEP criteria by having no seizures for the last 15
years, and being on a stable medication regimen for 15 years. He
previously held a CDL and drove a truck for Mobil Oil. He was involved
in a non-job related motor vehicle accident and sustained a traumatic
head injury. He was prescribed anti-seizure medication and had two
seizures in 1998 while physicians were adjusting his medication. His
last seizure was July 1998. His physician states he is taking the same
medication, with dose and frequency remaining the same for 15 years and
states he beleves it is appropriate to allow Mr. Gutermann to be
recertified to drive commercial vehicles. Mr. Gutermann has no entries
in CDLIS or MCMIS.
    David Kietzman. Mr. Kietzman is a 50-year-old intrastate CMV driver
in Wisconsin. Mr. Kietzman should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, having been
seizure-free for over four years and on a stable medication regimen for
over four years. In December 2007 he underwent surgery for a right
parietal vascular formation. His physician states this brain
abnormality was the cause of his seizures. He has remained on the same
anti-seizure medication since December 2007, with the dose and
frequency remaining the same since October 2008. His last seizure was
October 2008. His physician states he is neurologically normal. His
current employer states he has been an intrastate semi-tractor trailer
driver for them since 1991 and has proven to be a safe, competent and
conscientious driver. Mr. Kietzman has no entries in CDLIS or MCMIS.
    Joseph Kogut. Mr. Kogut is a 54-year-old intrastate CMV driver in
North Carolina. Mr. Kogut should be granted an exemption because he
meets the MEP criteria by having no seizures for the last 30 years and
being on a stable medication regimen for 30 years. In 1982 he was
involved in a motor vehicle accident and sustained a head injury.
Following the accident, he had a single seizure. He has been seizure-
free for over 30 years. He takes the same anti-seizure medication with
the dose and frequency remaining the same for 30 years. His physician
states he believes Mr. Kogut should be allowed to drive CMV's. Mr.
Kogut has one entry from CDLIS for failure to obey a traffic signal in
1999.

Docket FMCSA-2012-0050.

    On February 29, 2012, FMCSA published a notice of receipt of
exemption applications and requested public comments on five
individuals (Docket number FMCSA-2012-0050). The comment period ended
on March 30, 2012. No comments were received. Of the five applicants,
FMCSA determined that the following three individuals should be granted
an exemption. The Agency will issue a decision on the other drivers at
a later date.
    Todd Brock. Mr. Brock is a 54-year-old driver in Colorado. Mr.
Brock should be granted an exemption because he meets the MEP criteria
by having no seizures for the last 10 years, and being on a stable
medication regimen, with dose and frequency remaining the same for 4
years. He previously drove delivery trucks. He was diagnosed with a
seizure disorder in 2003. He takes the same anti-seizure medication
with dose and frequency remaining the same for 4 years. He will return
to driving package trucks in interstate commerce. Mr. Brock has no
entries in CDLIS or MCMIS.
    Diana Mugford. Ms. Mugford is a 44-year-old intrastate CMV driver
in Vermont. Ms. Mugford should be granted an exemption because she
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 8 years, and being on a stable medication regimen for
longer than 2 years. She was diagnosed with complex partial seizures
and takes anti-seizure medication. She has remained seizure-free for 9
years, having her last seizure in 2004. She takes the same anti-seizure
medication with the dose and frequency remaining the same for 9 years.
Her physician endorses her receiving the exemption. She has two CDLIS
entries, one for a CMV accident with property damage in 2011 and a
speeding violation in 2004. Ms. Mugford has no entries in MCMIS.
    James Wiggins. Mr. Wiggins is a 57-year-old intrastate CMV driver
in Florida. Mr. Wiggins should be granted an exemption because he meets
the MEP criteria by having no diagnosis of epilepsy, no seizures for
the last 4 years, and being on a stable medication regimen for longer
than 2 years. He had a single seizure in March 2008 and was diagnosed
with a brain tumor. He had the brain tumor removed in April 2008 and
has remained seizure-free for over 4 years. He takes anti-seizure
medication with the dose and frequency remaining the same for 4 years.
Mr.

Wiggins has no entries in CDLIS or MCMIS.

Docket  FMCSA-2012-0094

    On January 15, 2013, FMCSA published a notice of receipt of
exemption applications and requested public comment on 14 individuals
(Docket number FMCSA-2012-0094). The comment period ended on February
15, 2013. FMCSA received 16 comments. A discussion of the comments is
presented later in this document. Of the 14 applicants, FMCSA
determined that the following seven individuals should be granted an
exemption. The Agency will issue a decision on the other drivers at a
later date.
    Salvatore Gerard Adamita. Mr. Adamita is a 46-year-old intrastate
CMV driver in Florida. Mr. Adamita should be granted an exemption
because he meets the MEP criteria by having a diagnosis of epilepsy, no
seizures for the last 8 years, and being on a stable medication regimen
for longer than 2 years. He has a history of epilepsy and has had two
seizures in his lifetime; the last seizure was in 1992. He has remained
seizure free for 20 years. He takes anti-seizure medication with the
dosage and frequency remaining the same for 20 years. He would like to
drive straight trucks or single tractor trailer trucks. His physician
states he is supportive of Mr. Adamita receiving an exemption and Mr.
Adamita states he feels he would operate a vehicle at the same safety
level as someone who did not require an exemption. Mr. Adamita has no
entries in CDLIS or MCMIS.
    John W. Boerth. Mr. Boerth is a 61-year-old intrastate CMV driver
in Wisconsin. Mr. Boerth should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and being on a stable medication regimen for
longer than 2 years. He had brain surgery in 2002 and has since had 2
seizures, one in 2002 and the last seizure was June 2003. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 10 years. He would like to drive vehicles from one-half
ton vans to 18,000 pound straight trucks in interstate commerce. Mr.
Boerth has no entries in CDLIS or MCMIS.
    Michael C. Breitbach. Mr. Breitbach is a 57-year-old intrastate CMV
driver in Iowa. Mr. Breitbach should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and being on a stable medication regimen for
longer than 2 years. He has a history of two nocturnal seizures in his
lifetime; the last seizure was in 2002. He has remained seizure free
for 11 years. He takes anti-seizure medication with the dosage and
frequency remaining the same for 5 years. He would like to drive
tractor trailer trucks. His physician states he is supportive of Mr.
Breitbach receiving an exemption. Mr. Breitbach has one CDLIS entry
with a non-injury crash in 2011 and no entries in MCMIS.
    Timothy Grant Edwards. Mr. Edwards is a 25-year-old intrastate CMV
driver in Tennessee. Mr. Edwards should be granted an exemption because
he meets the MEP criteria by having no diagnosis of epilepsy, no
seizures for the last 4 years, and being on a stable medication regimen
for longer than 2 years. He has a diagnosis of complex partial
seizures. His last seizure was in 1992. He has remained seizure free
for 20 years. He takes anti-seizure medication with the dosage and
frequency remaining the same for 10 years. He would like to drive a
service truck for his employer that weighs more than 10,000 pounds, but
less than 26,000 pounds, in interstate commerce. Mr. Edwards has no
entries in CDLIS or MCMIS.
    James Gorniak. Mr. Gorniak is a 49-year-old intrastate CMV driver
in Wisconsin. Mr. Gorniak should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and has been off of anti-seizure medication for
over 5 years. Mr. Gorniak had a single seizure in January 2007. It was
discovered he had a brain tumor which was then removed. He was given
anti-seizure medication for a short time after the surgery, but has
been off the medication for 6 years and has remained seizure free since
2007. His physician states he is supportive of him receiving the
exemption. He would like to return to driving tractor trailers in
interstate commerce. Mr. Gorniak has no entries in CDLIS or MCMIS.
    Brian Hanson. Mr. Hanson is a 54-year-old intrastate driver in
Oregon. Mr. Hanson should be granted an exemption because he meets the
MEP criteria by having a diagnosis of epilepsy, no seizures for the
last 8 years, and being on a stable medication regimen for longer than
2 years. Mr. Hanson has a diagnosis of epilepsy and his last seizure
was in April 2004. He has been off of anti-seizure medication for 7
years. He has remained seizure free for 9 years. He would like to
attend truck driving school and drive tractor trailers with his wife,
as she is a long-haul driver. His physician found him fit has no
concerns regarding his driving a CMV. Mr. Hanson has no entries in
CDLIS or MCMIS.
    Robert J. Mooney. Mr. Mooney is a 51-year-old intrastate CMV driver
in Ohio. Mr. Mooney should be granted an exemption because he meets the
MEP criteria by having no diagnosis of epilepsy, no seizures for the
last 4 years, and being on a stable medication regimen for longer than
2 years. He has a diagnosis of seizure disorder and his last seizure
was in 1981. He has remained seizure free for over 30 years. He takes
anti-seizure medication with the dosage and frequency remaining the
same for over 20 years. He would like to drive 18-passenger buses in
interstate commerce. He has entries in CDLIS for 2009 and 2010 for non-
injury (property damage) motor vehicle crashes and a 2009 improper turn
violation. Mr. Mooney has no entries in MCMIS.

Docket  FMCSA-2012-0294

    On January 15, 2013, FMCSA published a notice of receipt of
exemption applications and requested comments from the public on nine
individuals (Docket number FMCSA-2012-0294). The comment period ended
on February 15, 2013. FMCSA received eight comments, including three
duplicate comments. A discussion of the comments is presented later in
this document. Of the nine applicants, FMCSA determined that the
following seven individuals should be granted an exemption. The Agency
will issue a decision on the other drivers at a later date.
    Patrick Andreasen. Mr. Andreasen is a 55-year-old Class C driver in
Pennsylvania. Mr. Andreasen should be granted an exemption because he
meets the MEP criteria by having a diagnosis of epilepsy, no seizures
for the last 8 years, and being on a stable medication regimen for
longer than 2 years. He has a diagnosis of epilepsy and his last
seizure was in 1982. He has remained seizure free for 30 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for 20 years. He would like to drive a 15-passenger bus. His
physician states he is strongly supportive of Mr. Andreasen receiving
an exemption and Mr. Andreasen states he feels he would operate a
vehicle at the same safety level as someone who did not require an
exemption. Mr. Andreasen has no entries in CDLIS or MCMIS.
    Samuel D. Beverly Jr. Mr. Beverly is a 47-year-old driver in
Virginia. Mr. Beverly should be granted an exemption because he meets
the MEP criteria by having no diagnosis of epilepsy, no seizures for
the last 4 years, and being on a stable medication regimen for longer
than 2 years. He has a history of seizures and his last seizure was in

1995. He takes anti-seizure medication with the dosage and frequency
remaining the same for over 17 years. He would like to drive a dump
truck. Mr. Beverly's physician states he is highly supportive of Mr.
Beverly receiving an exemption. Mr. Beverly has one entry in CDLIS for
speeding in 2010 and no entries in MCMIS.
    Craig Bugella. Mr. Bugella is a 46-year-old intrastate CMV driver
in Wisconsin. Mr. Bugella should be granted an exemption because he
meets the MEP criteria by having no diagnosis of epilepsy, no seizures
for the last 4 years, and being on a stable medication regimen for
longer than 2 years. He has a history of complex partial and
generalized seizures. He has remained seizure free for 11 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for 11 years. He would like to drive bucket trucks and Derrick
diggers. His physician states he is extremely confident Mr. Bugella can
operate CMVs in interstate commerce. Mr. Bugella has no entries in
CDLIS or MCMIS.
    Eric Hilmer. Mr. Hilmer is a 37-year-old driver in Wisconsin. Mr.
Hilmer should be granted an exemption because he meets the MEP criteria
by having no diagnosis of epilepsy, no seizures for the last 4 years,
and being on a stable medication regimen for longer than 2 years. He
has a history of generalized seizure disorder as a child. His last
seizure in October 2007, following a closed head injury and at that
time, he was not taking anti-seizure medication prior to that event,
his last seizure had been at age 17. He takes anti-seizure medication
with the dosage and frequency remaining the same for 6 years. He would
like to drive CMVs. His physician is supportive of Mr. Hilmer being
granted an exemption. Mr. Hilmer has no entries in CDLIS or MCMIS.
    Tye Dale Moore. Mr. Moore is a 47-year-old driver in Indiana. Mr.
Moore should be granted an exemption because he meets the MEP criteria
by having no diagnosis of epilepsy, no seizures for the last 4 years,
and being on a stable medication regimen for longer than 2 years. He
has a diagnosis of seizure disorder and has remained seizure free for
more than 28 years; his last seizure was May 1984. He takes anti-
seizure medication with the dosage and frequency remaining the same for
18 years. He would like to drive tractor trailers in interstate
commerce. His physician states he is supportive of Mr. Moore receiving
an exemption. Mr. Moore has no entries in CDLIS or MCMIS.
    Robert Spencer. Mr. Spencer is a 30-year-old driver in Florida. Mr.
Spencer should be granted an exemption because he meets the MEP
criteria by having no diagnosis of epilepsy and being on a stable
medication regimen for longer than 2 years. He will be seizure-free for
4 years in April 2013. He has a diagnosis of seizure disorder and his
last seizure was in April 2009. He takes anti-seizure medication with
the dosage and frequency remaining the same for 4 years. He would like
to drive a delivery van under 26,000 pounds. His physician is
supportive of Mr. Spencer being granted an exemption. Mr. Spencer has
no entries in CDLIS or MCMIS.
    Brian J. Wiggins. Mr. Wiggins is a 52-year-old driver in Idaho. Mr.
Wiggins should be granted an exemption because he meets the MEP
criteria by not having a diagnosis of epilepsy, no seizures for the
last 4 years, and being on a stable medication regimen for longer than
2 years. He has a diagnosis of seizure disorder and his last seizure
was in 1996. This seizure was the result of his physician taking him
off of his anti-seizure medication. He has remained seizure free for 16
years. He takes anti-seizure medication with the dosage and frequency
remaining the same for 16 years. He is a diesel mechanic and will be
driving Class 6, 7, and 8 trucks for diagnosis and repair purposes. His
physician is supportive of Mr. Wiggins being granted an exemption. Mr.
Wiggins has no entries in CDLIS or MCMIS.
    Timothy M. Zahratka. Mr. Zahratka is a 38-year-old driver in
Minnesota. He suffered a penetrating head injury in 1993 and developed
a seizure disorder following the injury. He was taking anti-seizure
medications with good control until his treating physician changed his
medication to a generic in 2008. His last seizure was in August 2008
and his medication was changed. He has remained seizure-free for over 4
years. He takes anti-seizure medication with the dosage and frequency
remaining the same for over 4 years. He would like to drive a single
axle dump truck. His physician states he is supportive of Mr. Zarhatka
being granted an exemption. Mr. Zahratka has no entries in CDLIS or
MCMIS.

D. Comments

    In response to the five notices, FMCSA received 35 comments,
including several duplicate comments. Comments that relate specifically
to applicants other than the ones covered in this notice will be
addressed in a subsequent notice of denial of application.

Medical Expert Panel's Criteria is Too Liberal

    Natalie Hartenbaum, MD, states that she believes the MEP's criteria
for granting exemptions from the epilepsy standard is too liberal and
that not all of the applicants in the notice would meet those criteria.
She further states that the MEP's criteria is based on faulty
assumptions and an inadequate understanding of the commercial driver
medical certification process. She notes that the MEP addressing the
seizure topic lacked an Occupational Physician. It is her expressed
belief that the Panel's assessment did not take into consideration the
commercial drivers who have long periods of time behind the wheel and
that some anti-seizure medications have a high risk of cognitive
impairment with prolonged use. Dr. Hartenbaum notes that the treating
physician is most often not the provider conducting the medical
certification exam and is not legally obligated in more than 7 states
to report a driver they feel would be a safety risk. She urges FMCSA to
again review current literature and ensure it is reassessed, addressing
the Medical Review Board's comments.
    FMCSA Response: FMCSA acknowledges Dr. Hartenbaum's concerns. Dr.
Hartenbaum is correct in stating that not all of the applicants in the
notice will meet the criteria. FMCSA is required to publish all
applicants in the Federal Register for 30-day public comment,
regardless of whether they meet the criteria. Each applicant is
considered on a case-by-case basis. The Agency believes that evaluating
each individual's medical history on a case-by-case basis and
investigating the past driving/violation record ensures an acceptable
level of safety for a driver who has not experienced a seizure for an
extended period of time. FMCSA will only consider granting an exemption
to those applicants who meet the criteria indicated above in this
notice on a case-by-case basis.
    The Agency conducted a comprehensive literature review and convened
a panel of medical experts in epilepsy and neurology to address key
questions and make recommendations concerning new guidelines for CMV
drivers. FMCSA is conducting individualized case assessments of persons
seeking an exemption from Sec.  391.41(b)(8). The Agency seeks to
assess safety risks, medical history, and compliance to determine
whether there is likelihood the individual will experience a seizure
while operating a CMV in interstate commerce on or off medication. The
goal is to ensure a

minimal safety risk to the driver and the traveling public.

Concerns From the Previous Medical Review Board Members

    The comments are authored by five previous MRB members who
constituted the MRB at the time the subject of seizures was addressed
by FMCSA. The group notes several concerns. They state that the Seizure
Evidence Report did not include a summary of the basic incidence and
prevalence rates of seizures and epilepsy and failed to include what
they felt were relevant studies. They also state that the report used
graphs that omitted available data points to extrapolate risks over
time. These former MRB members note that while they felt most of the
evidence reports they examined during their tenure were excellent, the
report on seizures had notable weaknesses.
    In further comment, the group notes that they had previously
requested that FMCSA include an occupational physician and/or
physicians with occupational medicine expertise. They note that the
seizure MEP did not have an expert in occupational medicine, relied
almost exclusively on the Evidence Report and included two members they
felt held bias in favor of loosening the limitations on those with
seizures. They alleged several errors in the Evidence Report.
    The former MRB members recommend, after reviewing the Evidence
Report and hearing the MEP's recommendations, maintaining the previous
criteria. The group states that FMCSA has represented that the MRB
recommended treating all drivers the same, and they strongly state that
this is not what the MRB concluded. They conclude their comments with
recognizing the work of the MEP, but note the extrapolation of risk
after a seizure to zero was scientifically unsound. The MRB calculated
that the 2% risk, recommended by the MEP, translated to a 40-fold
increased risk of crash, which was not tolerable.
    FMCSA Response: The Agency acknowledges the five former MRB
members' comments. The MRB members advocated the continued use of the
Agency's advisory criteria recommending the 10-year seizure-free/off
medication period for driving a CMV which were established by a panel
of neurologists in 1988. In 2007, the MEP updated the information
regarding treatment of seizure disorders and the likelihood of seizure
recurrence for a variety of seizure disorders and situations. FMCSA
believes that this current research and information supersede the
information presented by the panel of neurologists in the 1988
``Conference on Neurological Disorders and Commercial Drivers.''
    Also, the drivers covered by the exemptions have been free of
seizures for a period of 4 to more than 20 years. The Agency believes
that a driver who has not experienced a seizure for such extended
periods should not be precluded from driving a CMV in interstate
commerce solely because he remains on anti-seizure medication.
Generally, the Agency does not preclude drivers with medical conditions
other than seizure disorders from operating a CMV in interstate
commerce solely because they are taking medication. In addition, all
drivers must be stable on the medication for 2 years, which is a long
enough period of time for the driver and his treating physician to note
any adverse reactions to the medication such as excessive drowsiness.
As mentioned in the background section, only those drivers meeting the
MEP criteria are being granted an exemption.
    In response to the former MRB members' comment regarding medical
evidence, FMCSA reviews each individual applicant, assesses the driving
record and the individual's medical condition, and determines on a
case-by-case basis the driver's risk to public safety. FMCSA is not
granting drivers with recent seizure events an exemption based on the
MEP recommendations. The Agency has made the decision to use the more
current 2007 MEP recommendations to grant exemptions on a case-by-case
basis rather than to judge all drivers by the criteria established in
the 1988 ``Conference on Neurological Disorders and Commercial
Drivers'' report. The Agency evaluated each individual's medical
condition, comparing it to the 2007 MEP. In addition, to ensure the
safest roads possible, the Agency researched each individual's driving
record. Further, we believe that each driver has shown evidence of
compliance with his or her treatment regimen. Thus, we believe that the
individuals listed above have a level of safety equivalent to those
drivers who do not suffer from a seizure disorder. FMCSA's MRB is a
Federal Advisory Committee, whose role is to provide scientific and
medical advice to FMCSA on ongoing medical issues, including the
identification of appropriate physical qualifications of CMV drivers,
medical standards, and educational curriculum for training medical
examiners who certify that drivers meet the physical qualification
standards and functional tests for drivers with disabilities. The MRB
reviews all current FMCSA medical standards and makes recommendations
to FMCSA for new science-based standards and guidelines to ensure that
drivers operating CMVs in interstate commerce, as defined in 49 CFR
390.5, are physically capable. Thus, the MRB makes recommendations, but
the Agency is the deciding body, determining what advice and which of
the MRB's recommendations to adopt. 49 U.S.C. 31149(a)(1) and (c)(1).
The Agency does not believe it was the Congress's intent that the MRB
serve as a medical certification review board for each individual
seeking an exemption.

No Exemptions for Seizures

    The American College for Occupational and Environmental Medicine
(ACOEM) commented that it has special interest sections of physicians
working in the transportation industry and familiar with the job
requirements of commercial drivers. These comments are from its
perspective. ACOEM expresses concern that if a driver were to have a
seizure while operating a CMV, fatalities and injuries would likely
result. ACOEM states further that the anti-seizure medications can have
worrisome side effects and that other departments of transportation
continue to disqualify drivers with a history of seizures.
    The ACOEM physicians state that, in their opinion, the MEP
recommendations are too liberal, that the recommendations were made
without considering fully all the available literature, and that the
MEP failed to incorporate the risk of medications. They note that
seizures may occur after years of seizure-free periods and there are no
tests to guarantee that an individual will not have a seizure in the
future. They oppose granting any exemption for seizures or epilepsy.
    FMCSA Response: FMCSA acknowledges the concerns of the ACOEM. FMCSA
believes, however, that the current research and information supersede
the information presented by the panel of neurologists in the 1988
``Conference on Neurological Disorders and Commercial Drivers.'' The
Agency believes that a driver who has not experienced a seizure in
years should not be precluded from driving a CMV in interstate commerce
solely because he remains on anti-seizure medication. FMCSA does not
preclude drivers with medical conditions other than seizure disorders
from operating a CMV in interstate commerce solely because they are
taking medication. The findings of the 2007 comprehensive literature
review and the

MEP recommendations provide current information that the Agency
considered in making the determination that an exemption would likely
achieve a level of safety that is equivalent to or greater than the
level achieved without the exemption.

Public Support for Applicants and the Exemptions

    Duane Napper comments (FMCSA-2011-0389) that he has known David
Kietzman for more than 20 years, that Mr. Kietzman takes his job very
seriously and that he is careful at all times. He also states he
believes Mr. Kietzman should be allowed to drive trucks. Ms. Tana
Shallenbanger (FMCSA-2011-0389) comments that Mr. Kietzman is
motivated, hauls for their company and that his ``safety practices are
stellar.'' Bart James Gardner and Duane Jon Hegland (FMCSA-2012-0094)
both commented that they have worked with James Gorniak for over 15
years and see no reason he should not be able to drive a CMV. David J.
Sander (FMCSA-2012-0094) also commented that he has worked with James
Gorniak for over 20 years and he was an excellent driver and worker.
Anonymous (FMCSA-2012-0094) stated that he is a close friend of James
Gorniak and gives an account of Mr. Gorniak's hospital visit. He states
he is supportive of Mr. Gorniak receiving the exemption. Dr. Stephen
Tenniswood, DC (FMCSA-2012-0094) states that Mr. Gorniak has been his
patient for 15 years and he can accurately attest to his functionality.
He states he sees no reason not to allow him to drive a CMV again.
    Shannon Hilmer (FMCSA-2012-0294) comments that she believes that
``as long as their seizures are under control, they should be able to
live out their dream.'' Sharon Bugella (FMCSA-2012-0294) says of her
husband Craig Bugella, that he has been a lineman for 20 years. She
states that he has not had a seizure in over 11 years and that by
receiving the exemption he will be able to receive full lineman wages
and benefits.

E. Basis for Exemption

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) 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, the
Agency's 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.

Conclusion

    The Agency is granting exemptions from the epilepsy standard, 49
CFR 391.41(b)(8), to 24 individuals based on a thorough evaluation of
each driver's qualifications, safety experience, and medical condition.
Safety analysis of information relating to these 24 applicants meets
the burden of showing that granting the exemptions would achieve a
level of safety that is equivalent to or greater than the level that
would be achieved without the exemption. By granting the exemptions,
the interstate CMV industry will gain 24 highly trained and experienced
drivers. In accordance with 49 U.S.C. 31315, each exemption will be
valid for 2 years with annual recertification required unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (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 prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136 and 31315.
    FMCSA exempts the following 24 drivers for a period of 2 years with
annual medical certification required: Prince Austin Jr. (OH); Frank
Cekovic (PA); Joseph D'Angelo (NY); Ricki Gutermann (WI); David R.
Kietzman (WI); Joseph Kogut (NC); Todd Brock (CO); Diana Mugford (VT);
James Wiggins (FL); Salvatore Gerard Adamita (FL); John Boerth (WI);
Michael Breitbach (IA); Timothy Grant Edwards (TN); James Gorniak (WI);
Brian Hanson (OR); Robert J. Mooney (OH); Patrick Andreasen (PA);
Samuel D. Beverly (VA); Craig Bugella (WI); Eric Hilmer (WI); Tye Dale
Moore (IN); Robert Spencer (FL); Brian J. Wiggins, (IN), and Timothy M.
Zahratka (MN) from the prohibition of CMV operations by persons with a
clinical diagnosis of epilepsy or seizures. If the exemption is still
in effect 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: July 2, 2013.
Anne S. Ferro,
Administrator.
[FR Doc. 2013-16686 Filed 7-11-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Rules and Regulations]
[Pages 65519-65520]
[FR Doc No: 2022-22189]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 87, No. 209 / Monday, October 31, 2022 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-1153; Airspace Docket No. 19-AAL-76]
RIN 2120-AA66

Amendment of United States Area Navigation (RNAV) Route T-278;
Sisters Island, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends United States Area Navigation (RNAV) route
T-278 in the vicinity of Sisters Island, AK, in support of a large and
comprehensive T-route modernization project for the state of Alaska.

DATES: Effective date 0901 UTC, December 29, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it expands the availability of RNAV in Alaska and improves
the efficient flow of air traffic within the National Airspace System
by lessening the dependency on ground based navigation.

History

    The FAA published a notice of proposed rulemaking (NPRM) for Docket
No. FAA-2021-1153 in the Federal Register (86 FR 74002; December 29,
2021), amending RNAV route T-278 in the vicinity of Sisters Island, AK,
in support of a large and comprehensive T-route modernization project
for the state of Alaska. Interested parties were invited to participate
in this rulemaking effort by submitting comments on the proposal. No
comments were received.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11G, dated August 19, 2022, and effective
September 15, 2022, which is incorporated by reference in 14 CFR 71.1.
The RNAV route listed in this document will be published subsequently
in FAA Order JO 7400.11.

Differences From the NPRM

    In the NPRM, the HAPIT, AK, Fix was incorrectly listed as a
waypoint (WP) in the T-278 route description in the proposed amendment
to part 71; however, it was correctly listed as a Fix in the
``Background'' and ``The Proposal'' sections in the preamble. This
action corrects the error and lists all HAPIT, AK, route point
references as a Fix.
    Additionally, the CSPER, AK, Fix was incorrectly listed as a WP in
the ``Background'' section of the preamble and in the T-278 route
description in the proposed amendment to part 71. This action corrects
that error and lists the CSPER, AK, route point as a Fix in the T-278
route description.
    Lastly, the RADKY, AK, Fix was incorrectly listed as a WP in the
``Background'' and ``The Proposal'' sections of the preamble; however,
it was correctly listed in the T-278 route description in the proposed
amendment to part 71 as a Fix. This action corrects those errors and
lists all RADKY, AK, route point references as a Fix.
    These corrections are editorial only and do not change the
alignment of T-278.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by amending RNAV route T-278 in
the vicinity of Sisters Island, AK, in support of a large and
comprehensive T-route modernization project for the state of Alaska.
The route amendment is described below.
    T-278: T-278 extends between the HAPIT, AK, Fix and the Sisters
Island, AK (SSR), VHF Omnidirectional Radar/Tactical Air Navigational
(VORTAC) navigational aid. The route is amended by adding two new route
points and extending the route eastward from the Sisters Island VORTAC
to the RADKY, AK, Fix. The resulting T-route will extend between the
HAPIT, AK, Fix and the RADKY, AK, Fix.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034;

February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
will not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this airspace action of amending RNAV
route T-278 in the vicinity of Sisters Island, AK, qualifies for
categorical exclusion under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points), and paragraph 5-6.5i, which categorically excludes from
further environmental review the establishment of new or revised air
traffic control procedures conducted at 3,000 feet or more above ground
level (AGL); procedures conducted below 3,000 feet AGL that do not
cause traffic to be routinely routed over noise sensitive areas;
modifications to currently approved procedures conducted below 3,000
feet AGL that do not significantly increase noise over noise sensitive
areas; and increases in minimum altitudes and landing minima. As such,
this action is not expected to result in any potentially significant
environmental impacts. In accordance with FAA Order 1050.1F, paragraph
5-2 regarding Extraordinary Circumstances, the FAA has reviewed this
action for factors and circumstances in which a normally categorically
excluded action may have a significant environmental impact requiring
further analysis. Accordingly, the FAA has determined that no
extraordinary circumstances exist that warrant preparation of an
environmental assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-278 HAPIT, AK to RADKY, AK [Amended]

HAPIT, AK                                       FIX                            (Lat. 58[deg]11'57.57'' N, long. 137[deg]31'12.45'' W)
CSPER, AK                                       FIX                            (Lat. 58[deg]11'44.47'' N, long. 136[deg]38'37.44'' W)
BIKUW, AK                                       WP                             (Lat. 58[deg]16'59.40'' N, long. 135[deg]48'31.20'' W)
Sisters Island, AK (SSR)                        VORTAC                         (Lat. 58[deg]10'39.58'' N, long. 135[deg]15'31.91'' W)
RADKY, AK                                       FIX                            (Lat. 58[deg]08'00.39'' N, long. 134[deg]29'55.53'' W)

* * * * *

    Issued in Washington, DC, on October 5, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-22189 Filed 10-28-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 28, 2009 (Volume 74, Number 143)]
[Notices]
[Page 37231-37232]
[DOCID:fr28jy09-47]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0379]

Guidance for Industry: Nucleic Acid Testing To Reduce the
Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Nucleic
Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19
Transmission by Plasma-Derived Products,'' dated July 2009. The
guidance document provides to manufacturers of plasma-derived products
recommendations for performing parvovirus B19 NAT as an in-process test
for Source Plasma and recovered plasma to identify and help to prevent
the use of plasma units containing high levels of parvovirus B19. The
guidance also recommends how to report to FDA implementation of
parvovirus B19 NAT. The guidance announced in this notice finalizes the
draft guidance of the same title, dated July 2008.

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the
Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived
Products,'' dated July 2009. Parvovirus B19 is a small, non-enveloped
single stranded DNA virus. Virus clearance studies, using non-human
parvoviruses as models for parvovirus B19, have indicated that this
virus is highly resistant to all commonly used inactivation methods,
including heat and solvent/detergent (S/D) treatment, and is also
difficult to remove by filtration because of its small size. More
recent studies have demonstrated that human parvovirus B19 may be more
readily cleared than certain model animal parvoviruses. The parvovirus
B19 can be transmitted by blood components and certain plasma
derivatives and may cause morbidity to susceptible recipients such as
pregnant women, persons with underlying hemolytic disorders, and immune
compromised individuals. The disease transmission from transfusion of
blood components is rare. However, extremely high levels of parvovirus
B19 in plasma of acutely infected but asymptomatic donors may present a
greater risk in plasma derivatives due to pooling of large numbers of
units of these products in the manufacturing process.
    The guidance provides recommendations for performing parvovirus B19
NAT as an in-process test for Source Plasma and recovered plasma used
in the further manufacturing of plasma-derived products to identify and
help to prevent the use of plasma units containing high levels of
parvovirus B19. The guidance also recommends how to report to FDA
implementation of parvovirus B19 NAT.
    In the Federal Register of July 30, 2008 (73 FR 44272), FDA
announced the availability of the draft guidance of the same title,
dated July 2008. FDA received a few comments on the draft guidance and
those comments were considered as the guidance was finalized. In
addition to minor editorial changes made to improve clarity, changes to
the draft guidance include the addition of 4 references to reflect
recent studies that show B19 may be less resistant to inactivation than
animal-derived parvoviruses that have been used as models; and removal
of the recommendation on the acceptable limit for B19 DNA titer in
individual plasma units. The guidance announced in this notice
finalizes the draft guidance dated July 2008.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 601.12(a)(2) and 601.12(c)(5),
have been approved under OMB No. 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://

www.fda.gov/cber/guidelines.htm or http://www.regulations.gov.

    Dated: July 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17965 Filed 7-27-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48826-48827]
[FR Doc No: 2017-22736]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's Web site.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by December 19, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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 Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/

fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidances 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 documents.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002,
301-796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's Web
site and announced periodically in the Federal Register. The public is
encouraged to submit comments on those recommendations within 60 days
of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on July 14, 2017 (82 FR 32556). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's Web site.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Azelastine hydrochloride.
Azithromycin.
Barium sulfate.
Betamethasone dipropionate.
Budesonide.
Canagliflozin; Metformin hydrochloride.
Dantrolene sodium.
Dapsone.
Deflazacort (multiple Reference Listed Drugs).
Docosanol.
Empagliflozin; Metformin hydrochloride.
Epinephrine.
Erythromycin.
Everolimus.
Fluorometholone.
Hydrocortisone acetate.
Ivermectin.
Levorphanol tartrate.
Lisdexamfetamine dimesylate.
Mometasone furoate.
Nitisinone.
Olaparib.
Osimertinib mesylate.
Permethrin.
Pirfenidone.
Telotristat etiprate.
Terbutaline sulfate.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------

-------------------------------------------------------------------------
Brimonidine tartrate (multiple Reference Listed Drugs).
Bromfenac sodium.
Ciprofloxacin hydrochloride.
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate.
Dapsone.
Diclofenac sodium.
Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide
 fumarate.
Emtricitabine; Tenofovir alafenamide fumarate.
Esomeprazole magnesium.
Lisdexamfetamine dimesylate.
Mesalamine.
Mycophenolate mofetil.
Ofloxacin.
Olopatadine hydrochloride (multiple Reference Listed Drugs).
Ropinirole hydrochloride.
Sucralfate.
Tadalafil.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. Electronic Access

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

    Dated: October 16, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22736 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Rules and Regulations]
[Pages 60240-60241]
[FR Doc No: 2016-21123]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2016-4135; Special Conditions No. 25-636-SC]

Special Conditions: Bombardier Aerospace Inc. Model BD-700-2A12
and BD-700-2A13 Airplanes; Sidestick Controllers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Bombardier
Aerospace Inc. (Bombardier) Model BD-700-2A12 and BD-700-2A13
airplanes. These airplanes will have a novel or unusual feature when
compared to the state of technology envisioned in the airworthiness
standards for transport-category airplanes. This design feature is a
sidestick controller, designed to be operated with only one hand, in
lieu of the conventional wheel or stick controls. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.

DATES: This action is effective on Bombardier on September 1, 2016. We
must receive your comments by October 17, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-4135
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Todd Martin, FAA, Airframe and Cabin
Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive on or before the closing
date for comments. We may change these special conditions based on the
comments we receive.

Background

    On May 30, 2012, Bombardier applied for an amendment to type
certificate no. T00003NY to include the new Model BD-700-2A12 and BD-
700-2A13 airplanes. These airplanes are derivatives of the Model BD-700
series of airplanes currently approved under type certificate no.
T00003NY, and are marketed as the Bombardier Global 7000 (Model BD-700-
2A12) and Global 8000 (Model BD-700-2A13). These airplanes are ultra-
long-range, executive-interior business jets.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-
700-2A13 airplanes meet the applicable provisions

of the regulations listed in type certificate no. T00003NY, or the
applicable regulations in effect on the date of application for the
change, except for earlier amendments as agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the BD-700-2A12 and BD-700-2A13
airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same type certificate be modified to incorporate the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply
with the fuel-vent and exhaust-emission requirements of 14 CFR part 34,
and the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 airplanes
will have a novel or unusual design feature associated with sidestick
controllers designed to be operated with only one hand.

Discussion

    The Bombardier Aerospace Model BD-700-2A12 and BD-700-2A13
airplanes are equipped with sidestick controllers instead of the
conventional wheel or control stick. This controller is designed to be
operated using only one hand. The requirements of Sec.  25.397(c),
which define limit pilot forces and torques for conventional wheel or
stick controls, are not adequate for sidestick controllers because
pilot forces are applied to sidestick controllers with only the wrist,
not arms. Special conditions are necessary to specify the appropriate
loading conditions for sidestick controllers.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    As discussed above, these special conditions are applicable to the
Model BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at
a later date for a change to the type certificate to include another
model incorporating the same novel or unusual design feature, these
special conditions would apply to the other model as well.

Conclusion

    This action affects only certain novel or unusual design features
on two model series of airplanes. It is not a rule of general
applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, the FAA has determined
that prior public notice and comment are unnecessary, and good cause
exists for adopting these special conditions upon publication in the
Federal Register. The FAA is requesting comments to allow interested
persons to submit views that may not have been submitted in response to
the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

0
The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Bombardier Model BD-700-2A12 and BD-
700-2A13 airplanes.
    In lieu of the pilot forces specified in Sec.  25.397(c), for
airplanes equipped with sidestick controls designed for force
application by one wrist and not arms, the limit pilot forces are as
follows:
    1. For all components between and including the handle and its
control stops.

------------------------------------------------------------------------
                   Pitch                                Roll
------------------------------------------------------------------------
Nose up: 200 pounds force (lbf)...........  Nose left: 100 lbf.
Nose down: 200 lbf........................  Nose right: 100 lbf.
------------------------------------------------------------------------

    2. For all other components of the sidestick control assembly,
excluding the internal components of the electrical sensor assemblies,
to avoid damage as a result of an in-flight jam.

------------------------------------------------------------------------
                   Pitch                                Roll
------------------------------------------------------------------------
Nose up: 125 lbf..........................  Nose left: 50 lbf.
Nose down: 125 lbf........................  Nose right: 50 lbf.
------------------------------------------------------------------------

    Issued in Renton, Washington, on August 23, 2016.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-21123 Filed 8-31-16; 8:45 am]
 BILLING CODE 4910-13-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2007-0451; FRL-         ]

Approval and Promulgation of Air Quality Implementation Plans; Delaware;

Control of VOC Emissions from Crude Oil Lightering Operations

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Delaware.  This SIP revision pertains to the
control of volatile organic compound (VOC) emissions from crude oil
lightering operations.  EPA is approving this SIP revision in accordance
with the Clean Air Act.

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2007-0451.  All documents in the docket are listed
in the www.regulations.gov website.  Although listed in the electronic
docket, some information is not publicly available, i.e., 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 either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies of the State
submittal are available at the Delaware Department of Natural Resources
& Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover,
Delaware 19903.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On July 3, 2007 (72 FR 36402), EPA published a notice of proposed
rulemaking (NPR) for the State of Delaware.  The NPR proposed approval
of Delaware’s regulation for crude oil lightering operations
(Regulation No. 1124, Section 46).  The formal SIP revision was
submitted by the Delaware Department of Natural Resources and
Environmental Control (DNREC) on May 2, 2007.  Requirements of
Delaware’s regulation and the rationale for EPA's proposed action are
explained in the NPR and will not be restated here.  No public comments
were received on the NPR.

II.  Final Action

EPA is approving Regulation No. 1124, Section 46 – Crude Oil
Lightering Operations, as a revision to the Delaware SIP.  This SIP
revision was submitted on May 2, 2007.

III.  Statutory and Executive Order Reviews

A.  General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action
is not a "significant regulatory action" and therefore is not subject to
review by the Office of Management and Budget.  For this reason, this
action is also not subject to Executive Order 13211, "Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use" (66 FR 28355, May 22, 2001).  This action merely approves state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).  Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(Public Law 104-4).  This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).  This action also
does not have Federalism implications because it does 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, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).  This
action merely approves a state rule implementing a Federal requirement,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act.  This rule also is
not subject to Executive Order 13045 (Protection of Children from
Environmental Health Risks and Safety Risks( (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for the State to
use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  This rule is not a
(major rule( as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.  This action, approving Delaware’s regulation for
crude oil lightering operations, may not be challenged later in
proceedings to enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

Environmental protection, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

August 30, 2007						/s/

_________________
___________________________

Dated:                            				Donald S. Welsh,
              								Regional Administrator,

                                  					Region III.

40 CFR part 52 is amended as follows:

PART 52 - [AMENDED]

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

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

Subpart I ( Delaware

2.  In ( 52.420, the table in paragraph (c) is amended by revising the
title for Regulation No. 24 – Control of Volatile Organic Compound
Emissions and adding Section 46 to read as follows:

( 52.420  		Identification of plan.

*		*		*		*		*

(c)  *   *   *

EPA-APPROVED REGULATIONS IN THE DELAWARE SIP

State citation

Title/subject

State effective date

EPA approval date

Additional explanation

          *            *               *              *              *
              *             *

Regulation No. 1124 - Control of Volatile Organic Compound Emissions
(Formerly Regulation No. 24)

          *            *               *              *              *
              *             *

Section 46	Crude Oil Lightering Operations	05/11/07	[Insert Federal
Register publication date]

[Insert page number where the document begins

          *             *               *                *
 *               *           *

*	*	*	*	*

 PAGE  5