[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Notices]
[Page 30011]
[FR Doc No: 2020-10699]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0320; FMCSA-2017-0254]

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 renew exemptions for four
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) 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 exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on March 22, 2020. The exemptions
expire on March 22, 2022.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2015-0320 or http://www.regulations.gov/docket?D=FMCSA-2017-0254 and choose the document to review. If you do not have access
to the internet, you may view the docket online by visiting Docket
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, 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 Docket Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On April 6, 2020, FMCSA published a notice announcing its decision
to renew exemptions for four individuals from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in
interstate commerce and requested comments from the public (85 FR
19215). The public comment period ended on May 6, 2020, and no comments
were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
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    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the four renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in Sec.  391.41(b)(8).
    As of March 22, 2020, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (85 FR
19215):

Daniel Halstead (NV)
Matthew Heinen (MN)
Derick Pendergrass (NC)
Paul Vitous (WA)

    The drivers were included in docket number FMCSA-2015-0320 and
FMCSA-2017-0254. Their exemptions are applicable as of March 22, 2020,
and will expire on March 22, 2022.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date 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(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-10699 Filed 5-18-20; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19850-19853]
[FR Doc No: 2018-09441]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83134; File No. SR-NYSE-2018-17]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Rule 13

April 30, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b--4 thereunder,\3\ notice is hereby
given that on April 20, 2018, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the preamble to Rule 13 to provide
that the definition of ``retail'' in subsection (f)(2) be applicable to
trading of UTP

Securities on Pillar trading platform. The proposed rule change is
available on the Exchange's website at www.nyse.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    On April 9, 2018, the Exchange introduced trading of UTP Securities
on the Exchange on the Pillar trading platform.\4\ As described in the
UTP Trading Rules Filing, for each current Exchange rule that is not
applicable for trading on the Pillar trading platform, the Exchange
added a preamble to such rule providing that ``this rule is not
applicable to trading UTP Securities on the Pillar trading platform.''
Exchange rules governing equities trading that do not have this
preamble currently govern Exchange operations on Pillar.\5\
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    \4\ See Securities Exchange Act Release No.82945 (March 26,
2018), 83 FR 13553, 13555 (March 29, 2018) (SR-NYSE-2017-36) (the
``UTP Trading Rules Filing''). The term ``UTP Security'' means a
security that is listed on a national securities exchange other than
the Exchange and that trades on the Exchange pursuant to unlisted
trading privileges. See Rule 1.1(ii).
    \5\ See UTP Trading Rules Filing, 83 FR at 13554, n.17.
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    The Exchange proposes to amend the preamble to Rule 13 to provide
that the definition of ``retail'' modifier in subsection (f)(2) would
be applicable to the trading of UTP Securities on the Pillar trading
platform.
    Under Rule 13(f)(2)(A), an order designated with a ``retail''
modifier is an agency order or a riskless principal order that meets
the criteria of FINRA Rule 5320.03 that originates from a natural
person and is submitted to the Exchange by a member organization,
provided that no change is made to the terms of the order with respect
to price or side of market and the order does not originate from a
trading algorithm or any other computerized methodology. An order with
a ``retail'' modifier is separate and distinct from a ``Retail Order''
under Rule 107C. Under subsection (C), to submit a ``retail'' order, a
member organization must also submit an attestation, in a form
prescribed by the Exchange, that substantially all orders submitted as
``retail'' will qualify as such. Finally, a member organization must
have written policies and procedures reasonably designed to assure that
it will only designate orders as ``retail'' if all requirements of
paragraph (f)(4)(A) are met.\6\ The Exchange would determine if and
when a member organization is disqualified from submitting ``retail''
orders and, when disqualification determinations are made, the Exchange
would provide a written disqualification notice to the member
organization.\7\ A disqualified member organization may (1) appeal such
disqualification, and/or (B) resubmit the attestation described in Rule
13(f)(4)(C) 90 days after the date of the disqualification notice from
the Exchange.\8\
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    \6\ Rule 13(f)(2)(D) provides that such written policies and
procedures must require the member organization to (i) exercise due
diligence before entering a ``retail'' order to assure that entry as
a ``retail'' order is in compliance with the requirements of Rule
13(f)(4)(A), and (ii) monitor whether orders entered as ``retail''
orders meet the applicable requirements. If a member organization
represents ``retail'' orders from another broker-dealer customer,
the member organization's supervisory procedures must be reasonably
designed to assure that the orders it receives from such broker-
dealer customer that it designates as ``retail'' orders meet the
definition of a ``retail'' order in Rule 13(f)(4)(A). Further, the
member organization must (i) obtain an annual written
representation, in a form acceptable to the Exchange, from each
broker-dealer customer that sends it orders to be designated as
``retail'' orders that entry of such orders as ``retail'' orders
will be in compliance with the requirements of Rule 13(f)(4)(A); and
(ii) monitor whether its broker-dealer customer's ``retail'' order
flow meets the applicable requirements.
    \7\ See Rule 13(f)(4)(E).
    \8\ If a member organization disputes the Exchange's decision to
disqualify it from submitting ``retail'' orders, the member
organization may request, within five business days after notice of
the decision is issued by the Exchange, that the ``retail'' order
``Hearing Panel'' review the decision to determine if it was
correct. The Hearing Panel would consist of the NYSE's Chief
Regulatory Officer (``CRO''), or a designee of the CRO, and two
officers of the Exchange designated by the Chief Executive Officer
of ICE Group. The Hearing Panel would review the facts and render a
decision within the time frame prescribed by the Exchange. The
Hearing Panel may overturn or modify an action taken by the Exchange
under this Rule. A determination by the Hearing Panel shall
constitute final action by the Exchange. See Rule 13(f)(4)(F).
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    The proposed applicability of the definition of ``retail'' modifier
to the trading of UTP Securities on the Pillar trading platform would
enable the Exchange to propose transaction pricing related to retail
orders in UTP Securities that add liquidity to the Exchange, as is
currently the case for orders designated as ``retail'' in Tape A
securities.\9\ As is also the case with orders designated as ``retail''
in Tape A securities, member organizations not wishing to be eligible
for the proposed pricing would be free to not designate orders in UTP
Securities as ``retail.'' The Exchange believes providing member
organizations with the ability to submit orders designated as
``retail'' in UTP Securities would incentivize the submission of
additional retail order flow to a public market, to the benefit of the
marketplace and all market participants.
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    \9\ See page 5 of the current Price List, available at https://www.nyse.com/publicdocs/nyse/markets/nyse/NYSE_Price_List.pdf.
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    To effect this change, the Exchange proposes to amend the preamble
to Rule 13 by adding the clause ``With the exception of the definition
of a ``retail'' modifier in Rule 13(f)(2)'' immediately before the
phrase ``This Rule is not applicable to trading UTP Securities on the
Pillar trading platform.''
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\10\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\11\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and protect investors and the public interest and
because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change is consistent
with these principles because it would increase competition among
execution venues by enabling the Exchange to file a separate proposed
rule change to establish fees and credits relating to orders in UTP
Securities designated as ``retail,'' thereby encouraging the submission
of retail order flow in UTP Securities to a public market. The Exchange
believes that promoting submission of orders designated as ``retail''
in UTP Securities would attract additional retail order flow to a
public market and that such a process would contribute to perfecting
the mechanisms of a free and open market and a national market system.
The Exchange further

believes that promoting such orders in UTP Securities would not permit
unfair discrimination between customers, issuers, brokers, or dealers
because, as is currently the case for orders designated as ``retail''
in Tape A securities, promoting orders designated as ``retail'' in UTP
Securities would promote a competitive process around retail executions
and would result in greater transparency and competitiveness
surrounding executions of retail flow.\12\
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    \12\ See Securities Exchange Act Release No.72253 (May 27,
2014), 79 FR 31353, 31355 (June 2, 2014) (SR-NYSE-2014-26) (Notice).
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    The Exchange believes that the proposed change is designed to
prevent fraudulent and manipulative acts and practices and to promote
just and equitable principles of trade because it would contribute to
increasing the proportion of retail flow in UTP Securities that are
executed on a registered national securities exchange and would protect
investors and the public interest by contributing to investors'
confidence in the fairness of their transactions and because it would
benefit all investors by deepening the Exchange's liquidity pool,
supporting the quality of price discovery, promoting market
transparency and improving investor protection.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Instead, the Exchange
believes that the proposed change would increase competition among
execution venues and encourage additional liquidity in UTP Securities.
In this regard, the Exchange believes that the transparency and
competitiveness of attracting additional executions on an exchange
market would encourage competition. The proposal would also promote
competition on the Exchange because the ability to designate an order
as ``retail'' would be available to all member organizations that
submit qualifying orders and satisfy the other related requirements.

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

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

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \13\ and Rule 19b-4(f)(6) thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \15\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \16\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. According to
the Exchange, waiver of the operative delay would allow the Exchange to
implement, without undue delay, a process that is already in place for
Tape A securities that would incentivize the submission of retail order
flow in UTP securities to a public market to the benefit of the
marketplace and all market participants. The Commission believes that
the proposal raises no new or novel issues and that waiver of the
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the operative
delay and designates the proposal operative upon filing.\17\
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    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSE-2018-17 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2018-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2018-17 and should be submitted on
or before May 25, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-09441 Filed 5-3-18; 8:45 am]
 BILLING CODE 8011-01-P


EPA Questions Asked in Consultation for the 6 (a) (2) ICR:

Name __Jason Castroman__________, Company____Sysco Corporation____

Date___2/18/2014_____________, e-mail address
<EMAIL_ADDRESS>
(1)	Publicly Available Data

Is the data that the Agency seeks available from any public source, or
already collected by another office at EPA or by another agency?

Some of them are reported to other agencies and some of them are not.
For example, an incident report and detailed information would be sent
to the FDA or USDA if a pesticide were to contaminate or cause injury to
human or animal food (the agency would be determined by the specific
food).  Another example would be if there is a complaint of an employee
stating that there are unsafe work conditions, or that there are no MSDS
sheets available for their bleach cleaner.  This COULD be reported to
OSHA.  “Could” is emphasized since this is the source of our
complaints and a number of them do not contact a regulatory action given
that they failed to follow directions on the label, took the product
home, mixed the product with another product, or drank the product.  So
ultimately for uniformity I would say that I do not have a problem in
reporting them to the EPA, I would probably include a note stating the
other agency’s involvement.

If yes, where can you find the data?  (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are
available, but that they don’t meet our data needs very well?)

(2)	 Frequency of Collection

Can the Agency collect the information less frequently and still produce
the same outcome?

I think that minor events can be collected yearly and major events
quarterly.  Possibly rate a class of pesticides as high risk or new
registrants required monthly?

(3)	Clarity of Instructions

The ICR is intended to require that respondents provide certain data so
that the Agency can utilize them.

This is clear.

Based on the instructions (regulations, PR Notices, etc.), is it clear
what you are required to do and how to submit such data?  If not, what
suggestions do you have to clarify the instructions?

Maybe it is the way I printed the regulations, but then I expected to
see the submission instructions on page 49372 rather than 49390.

Do you understand that you are required to maintain records?

Not really.  Since the last clause of the last sentence states,
“therefore has eliminated this requirement entirely.”  In addition,
having a beginning sentence that is vague generalizations, “most
types.”  Simply state the requirement if there is one.  A short,
separate note can be added to the bottom of this section explaining how
the record keeping requirements were reached – “series of three”,
etc.; however, in my opinion, it will probably just cause confusion and
would be better placed in guidance material than a Final Rule.

Considering that there is no required submission format, is it difficult
to submit information in ways that are clear, logical and easy to
complete?

No – We have a third party provided and we have developed a form.

Regarding the Voluntary Incident Reporting Forms, do you use them?  Are
they clear, logical, and easy to complete?

Yes and Yes.

(4) Electronic Reporting and Record keeping

The Government Paperwork Elimination Act requires agencies make
available to the public electronic reporting alternatives to paper-based
submissions by 2003, unless there is a strong reason for not doing so.
The U.S. E.P.A. Office of Pesticide Programs has a program for
electronic study submissions, and is currently developing plans for
systems to support electronic incident reporting.  The Agency is also
concerned to protect FIFRA CBI as well as personal information.

What do you think about electronic alternatives to paper-based records
and data submissions?  Current electronic reporting alternatives include
the use of web forms/XML based submissions via the Agency’s Internet
site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc.
Would you be interested in pursuing electronic reporting?  Are you
keeping your records electronically?  If yes, in what format?

Would you be more inclined to submit CBI on diskette, CD, or DVD, or via
web rather than on paper?

This electronic conversion NEEDS to happen!  Submitting it by web via an
excel or csv attachment would be our preference.

What benefits would electronic submission bring you in terms of burden
reduction or greater efficiency in compiling the information?

Time savings and Cost savings.

I no longer have to:

Find the Report

Open the Report

Print the Report.

Find the Cover Letter

Open the Cover Letter

Change Aspects of Template Cover Letter, such as Month, Year, Number of
incidents

Print out a cover Letter

Verify Report for accuracy

Sign the Cover Letter

Send the Report and Cover Letter First Class letters with priority
tracking.

Instead, I only have to:

Find the report

Open the Report

Review Report for Accurancy

Upload Report

Burden and Costs – NA – Third party and different depart handles
costs.

Are the labor rates accurate?

Sysco only has one item and one individual is responsible for reporting;
however, Sysco pays a third party, PROSAR, that prepares a majority of
the of the reporting for our review.  Sysco pays them Quarterly and
Annually.  This fee ends up being as if the Manager was performing the
entire process.

The Agency assumes there is no capital cost associated with this
activity.  Is that correct?

Yes, unless you consider the annual fee for PROSAR as a capital cost.

Bearing in mind that the burden and cost estimates include only burden
hours and costs associated with the paperwork involved with this ICR,
e.g., the ICR does not include estimated burden hours and costs for
conducting studies, are the estimated burden hours and labor rates
accurate?  If you provide burden and cost estimates that are
substantially different from EPA’s, please provide an explanation of
how you arrived at your estimates.

For our company, only one person is responsible for reviewing the report
and submitting the information and handing the compliant when they do
arrive.  As a result, I would combine the Clerical and the Clerical
together, but then the totals are fairly accurate.

Are there other costs that should be accounted for that may have been
missed?

No

 PAGE

 PAGE   1


[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Notices]
[Pages 55738-55739]
[FR Doc No: 2020-19889]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2020-0077]

Pipeline Safety: Request for Special Permit; Tennessee Gas
Pipeline Company, L.L.C.

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
Transportation (DOT).

ACTION: Notice.

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SUMMARY: PHMSA is publishing this notice to solicit public comments on
a request for special permit received from the Tennessee Gas Pipeline
Company, L.L.C. (TGP). The special permit request is seeking relief
from compliance with certain requirements in the Federal pipeline
safety regulations. At the conclusion of the 30-day comment period,
PHMSA will review the comments received from this notice as part of its
evaluation to grant or deny the special permit request.

DATES: Submit any comments regarding this special permit request by
October 9, 2020.

ADDRESSES: Comments should reference the docket number for this
specific special permit request and may be submitted in the following
ways:
     E-Gov website: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: 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: Docket Management System: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two (2) copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.
    Note: There is a privacy statement published on http://www.Regulations.gov. Comments, including any personal information
provided, are posted without changes or edits to http://www.Regulations.gov.
    Confidential Business Information: 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 notice 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 notice, it is important that you clearly designate
the submitted comments as CBI. Pursuant to 49 Code of Federal
Regulations (CFR) Sec.  190.343, you may ask PHMSA to give confidential
treatment to information you give to the agency by taking the following
steps: (1) Mark each page of the original document submission
containing CBI as ``Confidential''; (2) send PHMSA, along with the
original document, a second copy of the original document with the CBI
deleted; and (3) explain why the information you are submitting is CBI.
Unless you are notified otherwise, PHMSA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this notice. Submissions containing CBI should
be sent to Kay McIver, DOT, PHMSA-PHP-80, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001. Any commentary PHMSA receives that is not
specifically designated as CBI will be placed in the public docket for
this matter.

FOR FURTHER INFORMATION CONTACT:
    General: Ms. Kay McIver by telephone at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>    Technical: Mr. Steve Nanney by telephone at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: PHMSA received a special permit request from
TGP seeking a waiver from the requirements of 49 CFR 192.611(a) and
(d): Change in class location: Confirmation or revision of maximum
allowable operating pressure, and Sec.  192.619(a): Maximum allowable
operating pressure: Steel or plastic pipelines. This special permit is
being requested in lieu of pipe replacement or pressure reduction for
one (1) special permit segment of 1.02 miles on the TGP pipeline
system. The proposed special permit segment is located in Ouachita
Parish, Louisiana. The TGP pipeline class location in the special

permit segment has changed from a Class 1 to a Class 3 location. The
TGP pipeline special permit segment is a 24-inch diameter pipeline with
an existing maximum allowable operating pressure of 632 pounds per
square inch gauge (psig). The installation of the special permit
segment occurred in 1944.
    The special permit request, proposed special permit with
conditions, and Draft Environmental Assessment (DEA) for the TGP
pipeline are available for review and public comment in Docket No.
PHMSA-2020-0077. We invite interested persons to review and submit
comments on the special permit request and DEA in the docket. Please
include any comments on potential safety and environmental impacts that
may result if the special permit is granted. Comments may include
relevant data.
    Before issuing a decision on the special permit request, PHMSA will
evaluate all comments received on or before the comment closing date.
Comments received after the closing date will be evaluated, if it is
possible to do so without incurring additional expense or delay. PHMSA
will consider each relevant comment it receives in making its decision
to grant or deny this special permit request.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2020-19889 Filed 9-8-20; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83547-83548]
[FR Doc No: 2023-26260]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0676]

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

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 ZEGALOGUE 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 (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
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 May 28, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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 No.
FDA-2022-E-0676 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZEGALOGUE.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

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 or biologic 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, ZEGALOGUE
(dasiglucagon), which is indicated for the treatment of severe
hypoglycemia in pediatric and adult patients with diabetes aged 6 years
and older. Subsequent to this approval, the USPTO received a patent
term restoration application for ZEGALOGUE (U.S. Patent No. 10,442,847)
from Zealand Pharma A/S, and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated September 28, 2022, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ZEGALOGUE 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
ZEGALOGUE is 1,734 days. Of this time, 1,373 days occurred during the
testing phase of the regulatory review period, while 361 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 24, 2016. The applicant claims February 22, 2017, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 24, 2016,
which was the first date after receipt of the first IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 27,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for ZEGALOGUE (NDA 214231) was initially submitted on
March 27, 2020.
    3. The date the application was approved: March 22, 2021. FDA has
verified the applicant's claim that NDA 214231 was approved on March
22, 2021.
    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 47 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: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26260 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P