[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Proposed Rules]
[Pages 31989-31992]
[FR Doc No: 2021-12603]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0501; Project Identifier MCAI-2021-00168-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2019-20-10, which applies to certain Airbus SAS Model A318 series
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and
-232 airplanes. AD 2019-20-10 requires repetitive rototest inspections
of the holes at the door stop fittings for any cracking, and corrective
actions if necessary. Since the FAA issued AD 2019-20-10, a
clarification of a certain compliance time for the rototest inspection
was added. This proposed AD would clarify a certain compliance time and
continue to require repetitive rototest inspections of the holes at the
door stop fittings for any cracking, and repair if necessary, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 2,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0501.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0501; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0501; Project Identifier
MCAI-2021-00168-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Sanjay Ralhan, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA issued AD 2019-20-10, Amendment 39-19763 (84 FR 61526,
November 13, 2019) (AD 2019-20-10), which applies to certain Airbus SAS
Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -
131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231,
-232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -
213, -231, and -232 airplanes. AD 2019-20-10 requires repetitive
rototest inspections of the holes at the door stop fittings for any
cracking, and corrective actions if necessary. The FAA issued AD 2019-
20-10 to address cracking of the web holes at the door stop fittings,
which could affect the structural integrity of the airplane.

Actions Since AD 2019-20-10 Was Issued

    Since the FAA issued AD 2019-20-10, a clarification of the initial
compliance time for the rototest inspection, related to the
incorporation of certain airworthiness limitations (ALI) tasks has been
added. Certain airworthiness limitations (ALI) tasks referenced in EASA
AD 2018-0289, dated December 21, 2018 (which corresponds to FAA AD
2019-20-10) were initially applicable only to the left- and right-hand
door stop fitting holes at position 1 or 7 at fuselage frame (FR)20,
and, at a later stage, were made applicable to the left- and right-hand
door stop fitting holes at position 1 or 7 at fuselage FR16. An
operator reported a possible misunderstanding of the compliance time in
EASA AD 2018-0289. Therefore, EASA determined that the compliance time
language related to accomplishment of those ALI tasks needed to be
clarified.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0289R1, dated February 10, 2021
(EASA AD 2018-0289R1) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for certain Airbus SAS Model A318 series airplanes; Model A319-111, -
112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211,
-212, -214, -215, -216, -231, -232, and -233 airplanes; and Model A321-
111, -112, -131, -211, -212, -213, -231, and -232 airplanes. EASA AD
2018-0289R1 supersedes EASA AD 2018-0289 (which corresponds to FAA AD
2019-20-10). Model A320-215 airplanes are not certificated by the FAA
and are not included on the U.S. type certificate data sheet; this AD
therefore does not include those airplanes in the applicability.
    This proposed AD was prompted by a report that cracks were detected
on FR16 and FR20 web holes and passenger door intercostal fitting holes
at the door stop fitting locations. The FAA is proposing this AD to
address cracking of the web holes at the door stop fittings, which
could affect the structural integrity of the airplane. See the MCAI for
additional background information.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2019-20-10, this proposed AD would retain all of the
requirements of AD 2019-20-10. Those requirements are referenced in
EASA AD 2018-0289R1, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2018-0289R1 describes procedures for repetitive rototest
inspections of the holes at the door stop fittings for any cracking and
repair if necessary. This material is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2018-0289R1 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2018-
0289R1 will be incorporated by reference in the FAA final rule. This
proposed AD would, therefore, require compliance with EASA AD 2018-
0289R1 in its entirety, through that incorporation, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. Using common terms that are the same as the heading of a
particular section in the EASA AD does not mean that operators need
comply only with that section. For example, where the AD requirement
refers to ``all required actions and compliance times,'' compliance
with this AD requirement is not limited to the section titled
``Required Action(s) and Compliance Time(s)'' in the EASA AD. Service
information specified in EASA AD 2018-0289R1 that is required for
compliance with EASA AD 2018-0289R1 will be available on the internet
at https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0501 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 1,528 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
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                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
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Retained actions from AD 2019-20-10     33 work-hours x $85 per               $0          $2,805      $3,447,345
 (1,229 airplanes).                      hour = $2,805.
Inspections...........................  33 work-hours x 85 per                 0           2,805       4,286,040
                                         hour = 2,805.
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    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need this on-condition action:

                 Estimated Costs of On-Condition Actions
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                                                             Cost per
               Labor cost                   Parts cost        product
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51 work-hours x $85 per hour = $4,335...            $350          $4,685
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Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2019-20-10, Amendment 39-19763
(84 FR 61526, November 13, 2019), and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2021-0501; Project Identifier MCAI-2021-
00168-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 2, 2021.

(b) Affected ADs

    This AD replaces AD 2019-20-10, Amendment 39-19763 (84 FR 61526,
November 13, 2019) (AD 2019-20-10).

(c) Applicability

    This AD applies to Airbus SAS airplanes specified in paragraphs
(c)(1) through (4) of this AD, certificated in any category, as
identified in European Union Aviation Safety Agency (EASA) AD 2018-
0289R1, dated February 10, 2021 (EASA AD 2018-0289R1).
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report that cracks were detected on
frame (FR)16 and FR20 web holes and passenger door intercostal
fitting holes at the door stop fitting locations, and a
determination that a certain compliance time needs to be clarified.
The FAA is issuing this AD to address cracking of the web holes at
the door stop fittings, which could affect the structural integrity
of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2018-0289R1.

(h) Exceptions to EASA AD 2018-0289R1

    (1) Where EASA AD 2018-0289R1 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2018-0289R1 does not
apply to this AD.
    (3) Where Table 1 of EASA AD 2018-0289R1 refers to a compliance
time ``after 31 May 2017,'' this AD requires using a compliance time
after May 31, 2018 (the effective date of task 531103-01-1 in ``ALS
Part 2 rev. 6'').
    (4) Where paragraphs (3) and (6) of EASA AD 2018-0289R1 refers
to actions that have been done ``in accordance with Airbus Repair
Design Approval Sheet (RDAS),'' this AD includes repair done ``in
accordance with a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.''

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (ii) AMOCs approved previously for AD 2019-20-10 are approved as
AMOCs for the corresponding provisions of EASA AD 2018-0289R1 that
are required by paragraph (g) of this AD, except for those airplanes
having a compliance time specified in ``Table 1:

Inspection Thresholds,'' Row B, of EASA AD 2018-0289R1.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2018-0289R1 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2018-0289R1, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0501.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on June 10, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-12603 Filed 6-15-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41985-41988]
[FR Doc No: 2013-16683]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0106]

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 nine
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 nine 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(b), 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 nine individuals an exemption from the regulatory
requirement in Sec.  391.41(b)(8), to allow these 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 each
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 granted here 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.
---------------------------------------------------------------------------

    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 at 49 CFR 391.41(b)(8) 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 (the 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 previously published dockets.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 9 individuals. Under current FMCSA regulations, all of the 9 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 drivers receiving an exemption
currently take anti-seizure medication. For these 9 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 Criteria have 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 nine 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 nine 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 the applicant who was
denied an exemption, a notice will be published at a later date.

Docket FMCSA-2013-0106

    On April 24, 2013, FMCSA published a notice of receipt of exemption
applications and requested public comment on 10 individuals (Docket
number FMCSA-2013-0106). The comment period ended on May 24, 2013. Two
commenters responded to the Federal Register notice. A discussion of
the comments is presented later in this document. FMCSA has determined
that nine of these applicants should be granted an exemption. The
Agency will issue a decision on the other driver at a later date.
Steven L. Gordon
    Mr. Gordon is a 57 year-old CMV driver in Montana. He has a history
of seizures as a result of a head injury in 1986 and his last seizure
was in 2005. He takes anti-seizure medication with the dosage and
frequency remaining the same for over 7 years. If granted the
exemption, he would like to drive a tractor trailer. His physician
states he is supportive of Mr. Gordon receiving an exemption to operate
a CMV. Mr. Gordon has no entries in CDLIS or MCMIS within the last 3
years.
Kevin A. Jandreau
    Mr. Jandreau is a 46 year-old Class A CMV driver in Maine. He has a
diagnosis of seizure disorder. He has remained seizure free for at
least 15 years. He takes anti-seizure medication with the dosage and
frequency remaining the same for 15 years. If granted the exemption, he
would like to drive a tractor trailer. Mr. Jandreau has no entries in
CDLIS or MCMIS within the last 3 years.
Jason C. Kirkham
    Mr. Kirkham is a 39 year-old CMV driver in Wisconsin. He has a
history of seizures and has remained seizure free for 17 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same for 17 years. If granted the exemption, he would like to drive
straight trucks, cranes, or heavy equipment. His physician states he is
supportive of Mr. Kirkham receiving an exemption. Mr. Kirkham has no
entries in CDLIS or MCMIS within the last 3 years.
William P. Lago
    Mr. Lago is a 26 year-old driver in Massachusetts. He has a
diagnosis of epilepsy and has remained seizure free for 8 years. He
takes anti-seizure medication with the dosage and frequency remaining
the same since June 2010. If granted the exemption, he would like to
drive a dump truck. Mr. Lago has no entries in CDLIS or MCMIS within
the last 3 years.
Michael K. Lail
    Mr. Lail is a 54 year-old CMV driver in North Carolina. He had a
single post-traumatic seizure 46 years ago and has remained seizure
free since that time. Mr. Lail has not taken anti-seizure medication
since July 2012. If granted the exemption, he would like to drive a
tractor trailer. His physician states he is supportive of Mr. Lail
receiving an exemption. Mr. Lail has one entry in CDLIS for an accident
in 2012, not involving a CMV, and no entries in MCMIS within the last 3
years.
Verbon T. Latta
    Mr. Latta is a 43 year-old driver in Alabama. He has had 2
seizures, both in May of 2007, 13 days apart while on a new medication
following back surgery. He has remained seizure free since that time.
He takes anti-seizure medication with the dosage and frequency
remaining the same for 6 years. If granted the exemption, he would like
to drive a tractor trailer. Mr. Latta has no entries in CDLIS or MCMIS
within the last 3 years.
Jeffrey P. Moore
    Mr. Moore is a 36 year-old driver in New York. He has a diagnosis
of seizure disorder, and his last seizure was in July of 1999. He has
remained seizure free since that time. He takes anti-seizure medication
with the dosage and frequency remaining the same for over 12 years. If
granted the exemption, he would like to drive a box truck or van. Mr.
Moore has no entries in CDLIS or MCMIS within the last 3 years.

Michael E. Righter
    Mr. Righter is a 38 year-old driver in Pennsylvania. Mr. Righter
has a diagnosis of seizure disorder, and his last seizure was in March
of 1987. He has remained seizure free since that time. He takes anti-
seizure medication with the dosage and frequency remaining the same for
over 20 years. If granted the exemption, he would like to drive a Class
B truck with air brakes. Mr. Righter has no entries in CDLIS or MCMIS
within the last 3 years.
Douglas S. Slagel
    Mr. Slagel is a 48 year-old CMV driver in Ohio. Mr. Slagel has a
diagnosis of seizure disorder, and his last seizure was in 1977. He has
remained seizure free since that time. He takes anti-seizure medication
with the dosage and frequency remaining the same for over 20 years. If
granted the exemption, he would like to drive a Class B truck with air
brakes. His physician is supportive of Mr. Slagel receiving his
exemption. Mr. Slagel has 2 entries in CDLIS for speeding, not
involving a CMV, and no entries in MCMIS within the last 3 years.

D. Comments

    In response to the notice, FMCSA received two comments. The one
comment specific to these applicants is addressed here. 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.

Public Support for Applicants and the Exemptions

    Jennifer Lail comments that her husband Michael Lail had a seizure
as a child when he ``collided with another kid on the the playground''
and has suffered no seizures since. She states that driving is his
passion and that he has been driving a truck for the same company since
1988.

E. Basis for Exemption

    Under 49 U.S.C. 31136(e) and 31315(b), 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 to driving
in intrastate commerce.

Conclusion

    The Agency is granting exemptions from the epilepsy standard, 49
CFR 391.41(b)(8), to nine individuals based on a thorough evaluation of
each driver's qualifications, safety experience, and medical condition.
Safety analysis of information relating to these nine 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 nine highly trained and
experienced drivers. In accordance with 49 U.S.C. 31315(b)(1), 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 9 drivers for a period of 2 years with
annual medical certification required: Steven Gordon (MT); Kevin
Jandreau (ME); Jason Kirkham (WI); William Lago (MA); Michael Lail
(NC); Verbon Latta (AL); Jeffrey Moore (NY); Michael Righter (PA); and
Douglas Slagel (OH) 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 3, 2013.
Anne S. Ferro,
Administrator.
[FR Doc. 2013-16683 Filed 7-11-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Page 31322]
[FR Doc No: 2017-14215]

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ENVIRONMENTAL PROTECTION AGENCY

[9964-51-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Georgia

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of Georgia's
request to revise its National Primary Drinking Water Regulations
Implementation EPA-authorized program to allow electronic reporting.

DATES: EPA's approval is effective August 7, 2017 for the State of
Georgia's National Primary Drinking Water Regulations Implementation
program, if no timely request for a public hearing is received and
accepted by the Agency.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On June 25, 2017, the Georgia Department of Natural Resources (GA
DNR) submitted an application titled ``Compliance Monitoring Data
Portal'' for revision to its EPA-approved drinking water program under
title 40 CFR to allow new electronic reporting. EPA reviewed GA DNR's
request to revise its EPA-authorized program and, based on this review,
EPA determined that the application met the standards for approval of
authorized program revision set out in 40 CFR part 3, subpart D. In
accordance with 40 CFR 3.1000(d), this notice of EPA's decision to
approve Georgia's request to revise its Part 142--National Primary
Drinking Water Regulations Implementation program to allow electronic
reporting under 40 CFR part 141 is being published in the Federal
Register.
    GA DNR was notified of EPA's determination to approve its
application with respect to the authorized program listed above.
    Also, in today's notice, EPA is informing interested persons that
they may request a public hearing on EPA's action to approve the State
of Georgia's request to revise its authorized public water system
program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f).
Requests for a hearing must be submitted to EPA within 30 days of
publication of today's Federal Register notice. Such requests should
include the following information:
    (1) The name, address and telephone number of the individual,
organization or other entity requesting a hearing;
    (2) A brief statement of the requesting person's interest in EPA's
determination, a brief explanation as to why EPA should hold a hearing,
and any other information that the requesting person wants EPA to
consider when determining whether to grant the request;
    (3) The signature of the individual making the request, or, if the
request is made on behalf of an organization or other entity, the
signature of a responsible official of the organization or other
entity.
    In the event a hearing is requested and granted, EPA will provide
notice of the hearing in the Federal Register not less than 15 days
prior to the scheduled hearing date. Frivolous or insubstantial
requests for hearing may be denied by EPA. Following such a public
hearing, EPA will review the record of the hearing and issue an order
either affirming today's determination or rescinding such
determination. If no timely request for a hearing is received and
granted, EPA's approval of the State of Georgia's request to revise its
part 142--National Primary Drinking Water Regulations Implementation
program to allow electronic reporting will become effective 30 days
after today's notice is published, pursuant to CROMERR section
3.1000(f)(4).

Matthew Leopard,
Director, Office of Information Management.
[FR Doc. 2017-14215 Filed 7-5-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 31, 2006 (Volume 71, Number 104)]
[Notices]
[Page 30907-30909]
[DOCID:fr31my06-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

May 22, 2006.
    Take notice that the Commission received the following electric
rate filings.

    Docket Numbers: ER98-4515-008.
    Applicants: Cadillac Renewable Energy LLC.
    Description: Cadillac Renewable Energy, LLC submits a notification
of a non-material change in status related to market rate authority in
compliance with the reporting requirements of order 652.
    Filed Date: May 4, 2006.
    Accession Number: 20060517-0026.

    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER01-316-020.
    Applicants: ISO New England Inc.
    Description: ISO New England, Inc submits its Index of Customers
for the first quarter of 2006 in response to the Commission's letter
order issued June 1, 2001.
    Filed Date: May 1, 2006.
    Accession Number: 20060517-0024.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER04-230-024; ER01-3155-016; ER01-1385-025; EL01-
45-024.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits its
Seventh Quarterly Report.
    Filed Date: May 9, 2006.
    Accession Number: 20060509-5024.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER05-515-002.
    Applicants: Atlantic City Electric Company.
    Description: Atlantic City Electric Company submits its 2006
Formula Rate Annual Update pursuant to Settlement Agreement issued
April 19, 2006.
    Filed Date: May 15, 2006.
    Accession Number: 20060515-5005.
    Comment Date: 5 p.m. Eastern Time on Monday, June 5, 2006.

    Docket Numbers: ER05-515-003.
    Applicants: Delmarva Power & Light Company.
    Description: Delmarva Power & Light Company submits its 2006
Formula Rate Annual Update pursuant to Settlement Agreement issued
April 19, 2006.
    Filed Date: May 15, 2006.
    Accession Number: 20060515-5007.
    Comment Date: 5 p.m. Eastern Time on Monday, June 5, 2006.

    Docket Numbers: ER05-515-004.
    Applicants: Baltimore Gas and Electric Company.
    Description: Baltimore Gas and Electric Company submits its 2006
Formula Rate Annual Update pursuant to Settlement Agreement issued
April 19, 2006.
    Filed Date: May 15, 2006.
    Accession Number: 20060515-5037.
    Comment Date: 5 p.m. Eastern Time on Monday, June 5, 2006.

    Docket Numbers: ER05-515-006.
    Applicants: Potomac Electric Power Company.
    Description: Potomac Electric Power Company submits its 2006
Formula Rate Annual Update pursuant to Settlement Agreement issued
April 19, 2006.
    Filed Date: May 15, 2006.
    Accession Number: 20060515-5009.
    Comment Date: 5 p.m. Eastern Time on Monday, June 5, 2006.

    Docket Numbers: ER05-636-004.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator Inc
submits its Large Generator Interconnection Agreement among itself,
Columbia Community Windpower LLC and American Transmission Company,
LLC.
    Filed Date: May 8, 2006.
    Accession Number: 20060517-0017.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER05-652-006; RT04-1-021; ER05-109-005; ER04-48-
021.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits its compliance
filing providing for a revision to its Open Access Transmission Tariff.
    Filed Date: May 8, 2006.
    Accession Number: 20060517-0016.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER05-1352-003; RT04-1-020; ER04-48-020.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits its compliance
filing revising its Bylaws to establish a process for providing waivers
of annual membership fees.
    Filed Date: May 5, 2006.
    Accession Number: 20060517-0018.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER06-477-001.
    Applicants: Aquila Networks, L&P, Aquila, Inc.
    Description: Aquila, Inc dba Aquila Networks, L&P submits a
redesignated Facilities Modifications and Construction Agreement for
Cooper South Flowgate Upgrades pursuant to FERC's March 7, 2006order.
    Filed Date: May 8, 2006.
    Accession Number: 20060517-0023.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 30, 2006.

    Docket Numbers: ER06-933-001.
    Applicants: ZZ Corporation.
    Description: ZZ Corporation submits its petition for acceptance of
initial tariff (FERC Electric Tariff, Original Volume 1), waivers and
blanket authority.
    Filed Date: May 10, 2006.
    Accession Number: 20060517-0029.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 31, 2006.

    Docket Numbers: ER06-989-000.
    Applicants: American Electric Power Service Corp.
    Description: American Electric Power Service Corp as agent for Ohio
Power Co and Columbus Southern Power Company submit their fourth
revision to the Interconnection & Local delivery Agreement with Buckeye
Power, Inc.
    Filed Date: May 10, 2006.
    Accession Number: 20060517-0030.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 31, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-8323 Filed 5-30-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Notices]
[Page 21995]
[FR Doc No: 2017-09508]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R06-OW-2017-0217; FRL-9961-96-Region 6]

Notice of Proposed NPDES General Permit; Proposed NPDES General
Permit for New and Existing Sources and New Dischargers in the Offshore
Subcategory of the Oil and Gas Extraction Category for the Western
Portion of the Outer Continental Shelf of the Gulf of Mexico
(GMG290000)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Water Division Director of Region 6 today proposes to
reissue the National Pollutant Discharge Elimination System (NPDES)
General Permit No. GMG290000 for existing and new sources and new
dischargers in the Offshore Subcategory of the Oil and Gas Extraction
Point Source Category, located in and discharging to the Outer
Continental Shelf offshore of Louisiana and Texas. The discharge of
produced water to that portion of the Outer Continental Shelf from
Offshore Subcategory facilities located in the territorial seas of
Louisiana and Texas is also authorized by this permit.
    This draft permit proposes to retain, with certain modifications,
the limitations and conditions of the existing 2012 issued permit (2012
permit). The 2012 permit limitations conform with the Oil and Gas
Offshore Subcategory Guidelines and contain additional requirements to
assess impacts from the discharge of produced water to the marine
environment, as required by section 403(c) of the Clean Water Act.

DATES: Comments must be received by July 10, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-
OW-2017-0217 to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. EPA
may publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e. on the web, cloud, or
other file sharing system). For additional submission methods, the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Ms. Evelyn Rosborough, Region 6, U.S.
Environmental Protection Agency, 1445 Ross Avenue, Dallas, Texas 75202-
2733.Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>    A complete draft permit and a fact sheet more fully explaining the
proposal may be obtained online from the Federal eRulemaking Portal by
accessing the Docket listed above or from Ms. Rosborough. In addition,
the Agency's current administrative record on the proposal is available
for examination at the Region's Dallas offices during normal working
hours after providing Ms. Rosborough 24 hours advance notice.

PUBLIC HEARING: Public meetings and hearings on the proposed permit
will be held during the comment period. EPA will publish public hearing
times and places in the following newspapers: Houston Chronicle and New
Orleans Advocate. The meetings will include a presentation on the
proposed permit followed by the opportunity for questions and answers.
The public hearings will be held in accordance with the requirements of
40 CFR 124.12. At the public hearing, any person may submit oral or
written statements and data concerning the proposed permit. Any person
who cannot attend one of the public hearings may still submit written
comments, which have the same weight as comments made at the public
hearing, through the end of the public comment period.
    Public meeting and hearing times and places could be found online
from the Federal eRulemaking Portal: http://www.regulations.gov with
Docket ID No. listed above.

SUPPLEMENTARY INFORMATION:
    Other statutory and regulatory requirements are discussed in the
fact sheet that include: Oil Spill Requirement; Ocean Discharge
Criteria Evaluation; Marine Protection, Research, and Sanctuaries Act;
National Environmental Policy Act; Magnuson-Stevens Fisheries
Conservation and Management Act; Endangered Species Act; State Water
Quality Standards and State Certification; Coastal Zone Management Act;
Paperwork Reduction Act; and Regulatory Flexibility Act.

    Dated: April 7, 2017.
David F. Garcia,
Deputy Director, Water Division.
[FR Doc. 2017-09508 Filed 5-10-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 192 (Tuesday, October 4, 2011)]
[Proposed Rules]
[Pages 61293-61294]
[FR Doc No: 2011-25500]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 98

[EPA-HQ-OAR-2011-0512; FRL-9474-8]
RIN 2060-AR09

Extension of Public Comment Period: Mandatory Reporting of
Greenhouse Gases: Technical Revisions to the Electronics Manufacturing
and the Petroleum and Natural Gas Systems Categories of the Greenhouse
Gas Reporting Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of public comment period.

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SUMMARY: On September 9, 2011, EPA published a proposed action,
Mandatory Reporting of Greenhouse Gases: Technical Revisions to the
Electronics Manufacturing and the Petroleum and Natural Gas Systems
Categories of the Greenhouse Gas Reporting Rule. In this action, EPA is
extending the comment period for that action until October 24, 2011.

DATES: Comments must be received on or before October 24, 2011.

ADDRESSES: You may submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2011-0512 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>Include Docket ID No. EPA-HQ-OAR-2011-0512 in the subject
line of the message.
     Fax:<PHONE_NUMBER>.
     Mail: Environmental Protection Agency, EPA Docket Center
(EPA/DC), Mail Code 28221T, Attention Docket ID No. EPA-HQ-OAR-2011-
0512, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
     Hand/Courier Delivery: EPA Docket Center, Public Reading
Room, EPA West Building, Room 3334, Attention Docket ID No. EPA-HQ-OAR-
2011-0512, 1301 Constitution Avenue, NW., Washington, DC 20004. Such
deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2011-0512, Mandatory Reporting of Greenhouse Gases: Petroleum and
Natural Gas Systems. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be confidential business information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available for viewing at the
EPA Docket Center. Publicly

available docket materials are available either electronically in
http://www.regulations.gov or in hard copy at the EPA Docket Center,
EPA/DC, EPA West Building, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. This Docket Facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Carole Cook, Climate Change Division,
Office of Atmospheric Programs (MC-6207J), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>For technical questions, please see the
Greenhouse Gas Reporting Program Web site http://www.epa.gov/climatechange/emissions/ghgrulemaking.html. To submit a question,
select Rule Help Center, followed by Contact Us. To obtain information
about the public hearing or to register to speak at the public hearing,
please go to http://www.epa.gov/climatechange/emissions/ghgrulemaking.html. Alternatively, you may contact Carole Cook at 202-
343-9263.

SUPPLEMENTARY INFORMATION:
    Worldwide Web (WWW). In addition to being available in the docket,
an electronic copy of today's notice will also be available through the
WWW. Following the Administrator's signature, a copy of this action
will be posted on EPA's greenhouse gas reporting rule Web site at
http://www.epa.gov/climatechange/emissions/ghgrulemaking.html.
    Additional information on submitting comments. To expedite review
of your comments by Agency staff, you are encouraged to send a separate
copy of your comments, in addition to the copy you submit to the
official docket, to Carole Cook, U.S. EPA, Office of Atmospheric
Programs, Climate Change Division, Mail Code 6207-J, Washington, DC
20460, telephone<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    Background on Today's Action. In this action, EPA is providing
notice that it is extending the public comment period on the action
published on September 9, 2011 (76 FR 56010), Mandatory Reporting of
Greenhouse Gases: Technical Revisions to the Electronics Manufacturing
and the Petroleum and Natural Gas Systems Categories of the Greenhouse
Gas Reporting Rule. The current deadline for submitting public comment
on that rule is October 11, 2011. EPA is extending that deadline to
October 24, 2011. This extension will provide the general public
additional time for public participation.

List of Subjects in 40 CFR Part 98

    Environmental protection, Administrative practice and procedure,
Greenhouse gases, Incorporation by reference, Suppliers, Reporting and
recordkeeping requirements.

    Dated: September 27, 2011.
Elizabeth Craig,
Acting Director, Office of Atmospheric Programs.
[FR Doc. 2011-25500 Filed 10-3-11; 8:45 am]
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[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6868-6869]
[FR Doc No: 2018-03127]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1301; FDA-2016-E-1302; and FDA-2016-E-1299]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ORKAMBI

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ORKAMBI and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 14, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2016-E-1301; FDA-2016-E-1302; and FDA-2016-E-1299 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ORKAMBI.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,

10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993,
301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ORKAMBI
(lumacaftor and ivacaftor). ORKAMBI is indicated for the treatment of
cystic fibrosis (CF) in patients age 12 years and older who are
homozygous for the F508del mutation in the CFTR gene. Subsequent to
this approval, the USPTO received patent term restoration applications
for ORKAMBI (U.S. Patent Nos. 8,653,103; 8,741,933; and 8,846,718) from
Vertex Pharmaceuticals Inc., and the USPTO requested FDA's assistance
in determining the patents' eligibility for patent term restoration. In
a letter dated July 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ORKAMBI represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ORKAMBI is 2,785 days. Of this time, 2,545 days occurred during the
testing phase of the regulatory review period, while 240 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: November 18, 2007. FDA has verified the applicant's claim
that November 18, 2007, is the date the investigational new drug
application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
5, 2014. FDA has verified the applicant's claim that the new drug
application (NDA) for ORKAMBI (NDA 206038) was initially submitted on
November 5, 2014.
    3. The date the application was approved: July 2, 2015. FDA has
verified the applicant's claim that NDA 206038 was approved on July 2,
2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 210 or 317 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03127 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68784-68785]
[FR Doc No: 2023-21928]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-114, OMB Control No. 3235-0102]

Proposed Collection; Comment Request; Extension: Tender Offer--
Regulation 14D and Regulation 14E, Schedule 14D-9

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

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Regulation 14D (17 CFR 240.14d-1--240.14d-11) and Regulation 14E
(17 CFR 240.14e-1--240.14e-8) and related Schedule 14D-9 (17 CFR
240.14d-101) require information important to security holders in
deciding how to respond to tender offers. Schedule 14D-9 takes
approximately 260.56 hours per

response to prepare and is filed by approximately 63 companies
annually. We estimate that 25% of the 260.56 hours per response (65.14
hours) is prepared by the company for an annual reporting burden of
4,104 hours (65.14 hours per response x 63 responses).
    Written comments are invited on: (a) whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication by December 4, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: September 28, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-21928 Filed 10-3-23; 8:45 am]
BILLING CODE 8011-01-P