Summary:
--------------------------------------------------------------------------------
On March 29, 2018, members from U.S. EPA's Office of Pesticide Programs met with oxamyl registrants representing Corteva Agriscience; Orion ATO, LLC; Argite, LLC; and Rotam Limited as part of the oxamyl registration review to discuss address risks of concern identified in the human health and ecological draft risk assessment and potential risk mitigation options for the development of the Proposed Interim Decision. The registrants provided some preliminary feedback and generally agreed to increasing the required droplet size for oxamyl applications. The registrants requested additional time -- up to April 20, 2018-- to review other potential mitigation options presented to them prior to the meeting.
Agenda:
 Introductions
 Mark Baldwin (U.S. EPA), Chemical Review Manager for Oxamyl
 U.S. EPA Oxamyl Workgroup Members
 Oxamyl Registrants

 Discussion of Oxamyl Draft Risk Assessments and Potential Risk Mitigation Options
 Mark Baldwin (U.S. EPA)
 Oxamyl Registrants

 Summary of Discussion and Next Steps
 Mark Baldwin (U.S. EPA)
 Oxamyl Registrants

For attendees list see, Oxamyl Registrant Meeting Attendance Sheet March 29 2018


[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89946-89947]
[FR Doc No: 2016-29838]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0625]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NUCALA 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 biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 13, 2017. 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 June 12,
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-0625 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NUCALA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any

information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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,<PHONE_NUMBER>.

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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of the 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 biological 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 biologic product NUCALA
(mepolizumab). NUCALA is indicated for add-on maintenance treatment of
patients with severe asthma aged 12 years and older, and with an
eosinophilic phenotype. Subsequent to this approval, the USPTO received
a patent term restoration application for NUCALA (U.S. Patent No.
5,693,323) from GlaxoSmithKline LLC, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated May 10, 2016, FDA advised the USPTO that
this human biological product had undergone a regulatory review period
and that the approval of NUCALA 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
NUCALA is 6,862 days. Of this time, 6,496 days occurred during the
testing phase of the regulatory review period, while 366 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 (21 U.S.C. 355(i)) became effective: January 22,
1997. The applicant claims January 21, 1997, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was January 22, 1997,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): November 4, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NUCALA (BLA 125526) was initially submitted on November 4, 2014.
    3. The date the application was approved: November 4, 2015. FDA has
verified the applicant's claim that BLA 125526 was approved on November
4, 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 application for patent extension,
this applicant seeks 5 years 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 ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (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 Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29838 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P


From: Johnson, Steffan
Sent: Friday, August 16, 2013 1:44 PM
To<EMAIL_ADDRESS>Cc: Fairchild, Susan; Angus Crane<EMAIL_ADDRESS>Subject: RE: Rock Wool Method 316 Testing

Randy,

Thank you very much for your prompt attention and response.  I appreciate the level of detail your letter provides and given that no further information is available regarding what the lab actually measured (or just what was submitted to them), I agree with your findings.
Thank you, also, for providing the revised emissions calculations from your 2012 testing.
Should any other questions arise regarding the 2012 test results we will, again, contact you through Rockwool and NAIMA.

Sincerely,

Steffan Johnson
Environmental Scientist
OAQPS SPPD Measurement Policy Group

109 TW Alexander Drive
Mail Drop D243-05
Research Triangle Park, NC  27711
919-541-4791
<EMAIL_ADDRESS>

From<EMAIL_ADDRESS><EMAIL_ADDRESS>Sent: Friday, August 16, 2013 1:23 PM
To: Johnson, Steffan
Cc: Fairchild, Susan; Angus Crane<EMAIL_ADDRESS>Subject: Rock Wool Method 316 Testing

Mr. Johnson,

Attached is a letter summarizing the issues with the Method 316 testing conducted at the Rock Wool Manufacturing facility in Leeds, Alabama.  If you have any questions or need any additional information, please call me.

Sincerely,

Randal J. Tysar
Senior Environmental Engineer
BT Environmental Consulting, Inc. (BTEC)
4949 Fernlee Avenue
Royal Oak, Michigan 48073

DIRECT:<PHONE_NUMBER>
FAX:<PHONE_NUMBER>
CELL:<PHONE_NUMBER>


[Federal Register: February 22, 2007 (Volume 72, Number 35)]
[Notices]
[Page 7973-7974]
[DOCID:fr22fe07-39]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0041; FRL-8279-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; RadNet (Previously Known as
ERAMS) (Renewal); EPA ICR No. 0877.09, OMB Control No. 2060-0015

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before March 26,
2007.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2003-0041, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket

Center, Environmental Protection Agency, Air and Radiation Docket and
Information Center, 6102T, 1200 Pennsylvania Ave., NW., Washington, DC
20460, and (2) OMB by mail to: Office of Information and Regulatory
Affairs, Office of Management and Budget (OMB), Attention: Desk Officer
for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Charles M. Petko, Office of Radiation
and Indoor Air (ORIA), National Air and Radiation Environmental
Laboratory (NAREL), 540 South Morris Avenue, Montgomery, Alabama 36115-
2601. Tel:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 14, 2006 (71 FR 54278), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2003-0041, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air and Radiation

Docket and Information Center in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/
DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket and Information Center is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, CBI, or other information whose public disclosure is
restricted by statute. For further information about the electronic
docket, go to http://www.regulations.gov.

    Title: RadNet (Renewal).
    ICR Numbers: EPA ICR No. 0877.09, OMB Control No. 2060-0015.
    ICR Status: This ICR is scheduled to expire on February 28, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: RadNet is a national network of stations collecting
sampling media that include air, precipitation, drinking water, and
milk. Samples are sent to EPA National Air and Radiation Environmental
Laboratory (NAREL) in Montgomery, Alabama, where they are analyzed for
radioactivity. RadNet provides emergency response/homeland security and
ambient monitoring information on levels of environmental radiation
across the nation. All stations, usually operated by state and local
personnel, participate in RadNet voluntarily. Station operators
complete information forms that accompany the samples. The forms
request descriptive information pertaining to sample location, e.g.,
sample type, sample location, length of sampling period, and volume
represented.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 0.7
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing

and providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements which have
subsequently changed; train personnel to be able to respond to a
collection of information; search data sources; complete and review the
collection of information; and transmit or otherwise disclose the
information.
    Respondents/Affected Entities: All fifty states, primarily the
State Public Health Departments (NAICS Code 92312), send samples along
with one page sample collection forms to NAREL.
    Estimated Number of Respondents: 275.
    Frequency of Response: Frequency varies according to medium being
sampled: milk, quarterly; drinking water, quarterly; rain
(precipitation), as events occur; and air, twice weekly.
    Estimated Total Annual Hour Burden: 9,333.
    Estimated Total Annual Cost: $451,206.
    Changes in the Estimates: There is an increase of 3,606 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is due to the fact that the RadNet
air monitoring network is being upgraded and expanded. By the end of
the period of this ICR, the air network will have expanded from the 64
conventional stations reported in the previous ICR to 120
technologically updated stations, all of which will provide data in
near real-time.

    Dated: February 15, 2007.
Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. E7-3002 Filed 2-21-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 221 (Monday, November 17, 2014)]
[Notices]
[Pages 68499-68500]
[FR Doc No: 2014-27078]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-136]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary

is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before December 8, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0906 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility 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.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility 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: Nia Daniels,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 10, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0906.
    Petitioner: Viking Unmanned Aerial Systems, Inc.
    Section of 14 CFR Affected: part 21; 45.23(b); 61.113(a) and (b);
91.7(a); 91.9(b)(2); 91.103; 91.109; 91.119; 91.121; 91.151(a);
91.203(a) and (b); 91.405(a); 91.407(a)(1); 91.409(a)(2); and 91.417(a)
and (b).
    Description of Relief Sought: Viking Unmanned Aerial Systems, Inc.
is requesting an exemption to allow commercial operation for its
tethered aerial platform to conduct aerial photography and 3D mapping
for the agriculture industry, tower and pipeline inspection, real
estate photography, and movie and news video gathering.

[FR Doc. 2014-27078 Filed 11-14-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 89009-89010]
[FR Doc No: 2023-28397]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0040]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of denials.

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

SUMMARY: FMCSA announces its decision to deny applications from 26
individuals who requested an exemption from the Federal Motor Carrier
Safety Regulations (FMCSRs) prohibiting persons with a clinical
diagnosis of epilepsy or any other condition that is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV) from operating CMVs in interstate commerce.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, Department of Transportation, 1200
New Jersey Avenue SE, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing material in the docket, contact Dockets Operations,
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Comments

    To view comments go to www.regulations.gov. Insert the docket

number (FMCSA-2023-0040) in the keyword box, and click ``Search.''
Next, choose the only notice listed, and click ``Browse Comments.'' If
you do not have access to the internet, you may view the docket online
by visiting Dockets Operations on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To
be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    FMCSA received applications from 26 individuals who requested an
exemption from the FMCSRs prohibiting persons with a clinical diagnosis
of epilepsy or any other condition that is likely to cause a loss of
consciousness or any loss of ability to operate a CMV from operating
CMVs in interstate commerce.
    FMCSA has evaluated the eligibility of these applicants and
concluded that granting these exemptions would not provide a level of
safety that would be equivalent to, or greater than, the level of
safety that would be obtained by complying with Sec.  391.41(b)(8).

III. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-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 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification. The Agency's decision regarding these
exemption applications is based on the eligibility criteria, the terms
and conditions for Federal exemptions, and an individualized assessment
of each applicant's medical information provided by the applicant.

IV. Conclusion

    The Agency has determined that these applicants do not satisfy the
eligibility criteria or meet the terms and conditions of the Federal
exemption and granting these exemptions would not provide a level of
safety that would be equivalent to, or greater than, the level of
safety that would be obtained by complying with Sec.  391.41(b)(8).
Therefore, the 26 applicants in this notice have been denied exemptions
from the physical qualification standards in Sec.  391.41(b)(8).
    Each applicant has, prior to this notice, received a letter of
final disposition regarding his/her exemption request. Those decision
letters fully outlined the basis for the denial and constitute final
action by the Agency. This notice summarizes the Agency's recent
denials as required under 49 U.S.C. 31315(b)(4) by periodically
publishing names and reasons for denial.
    The following 26 applicants do not meet the minimum time
requirement for being seizure-free, either on or off of anti-seizure
medication:

Daniel Ashley (MD)
Joseph Bodle (CA)
Milverton Burton (FL)
Joe Celedonia (MD)
Cannon Fowler (AL)
Brian Hagen (MN)
Tomrone Harris (PA)
Andre Hartig (ME)
Dylan Hill (KS)
Jacob Johnstone (WI)
Regan Keller (NH)
Richard Kelley (IL)
Jeramie Kozlowski (PA)
Adam Martin (IN)
Dawn McGann (WA)
Jaysen Meidell (IL)
Douglas Pelton (OH)
Kevin Pustelak (PA)
Nicholas Quairoli (FL)
Jesus Reyna (IL)
Jennifer Roberts (NM)
Quac'era Schaffer (NC)
Paritpal Singh (CA)
Kristina Walters (IN)
Trevor Ward (CO)
Penny Witteman (OH)

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-28397 Filed 12-22-23; 8:45 am]
BILLING CODE 4910-EX-P