[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40127-40128]
[FR Doc No: 2019-17339]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2018-0072; Notice 2]

Michelin North America, Inc., Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: Michelin North America, Inc. (MNA) has determined that certain
Michelin XZL brand tires do not fully comply with Federal Motor Vehicle
Safety Standard (FMVSS) No. 119, New Pneumatic Tires for Motor Vehicles
with a GVWR of more than 4,536 kilograms (10,000 lbs.) and Motorcycles.
MNA filed a noncompliance report dated May 21, 2018, and subsequently
petitioned NHTSA on June 15, 2018, for a decision that the subject
noncompliance is inconsequential as it relates to motor vehicle safety.

FOR FURTHER INFORMATION CONTACT: Abraham Diaz, Office of Vehicle Safety
Compliance, NHTSA, telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Overview

    MNA has determined that certain Michelin brand tires do not fully
comply with paragraph S6.4 of Federal Motor Vehicle Safety Standard
(FMVSS) No. 119, New Pneumatic Tires for Motor Vehicles with a GVWR of
more than 4,536 kilograms (10,000 lbs.) and Motorcycles (49 CFR
571.119). MNA filed a noncompliance report dated May 21, 2018, pursuant
to 49 CFR part 573, Defects and Noncompliance Responsibility and
Reports. MNA subsequently petitioned NHTSA on June 18, 2018, for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential as
it relates to motor vehicle safety pursuant to 49 U.S.C. 20118(d) and
30120(h) and 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    Notice of receipt of MNA's petition was published with a 30-day
public comment period, on December 6, 2018, in the Federal Register (83
FR 62951). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) website at https://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2018-0072.''

II. Tires Involved

    Approximately 752 Michelin XZL size 16.00R20 tires manufactured
between January 19, 2018, and April 9, 2018, are potentially involved.

III. Noncompliance

    MNA explains that the noncompliance was due to a mold error which
left the subject tires with fewer than the required number of treadwear
indicators specified in paragraph S6.4 of FMVSS No. 119. Specifically,
the tires were manufactured with 4 rows of treadwear indicators instead
of the required minimum of 6 treadwear indicators.

IV. Rule Requirements

    Paragraph S6.4 of FMVSS No. 119, includes the requirements relevant
to this petition:
     Each tire shall have at least six treadwear indicators
spaced approximately equally around the circumference of the tire that
enable a person inspecting the tire to determine visually whether the
tire has worn to a tread depth of 1.6 mm (one-sixteenth of an inch).
Tires with a rim diameter code of 12 or smaller shall have at least
three such treadwear indicators. Motorcycle tires shall have at least
three such indicators which permit visual determination that the tire
has worn to a tread depth of 0.8 mm (one-thirty-second of an inch).

V. Summary of Petition

    MNA described the subject noncompliance and stated its belief that
the noncompliance is inconsequential as it relates to motor vehicle
safety.
    In support of its petition, MNA submitted the following arguments:
    1. Functionality: Truck tires normally have 6 treadwear indicators
spaced equally around the circumference of the tire. The function of
these indicators is to enable a person inspecting the tire to determine
visually whether the tire has worn to a tread depth of 1.6 mm (1/16
in). In the case where tires have 6 treadwear indicators spaced equally
around the tire, the indicators would appear at 60 degree intervals
around the circumference of the tread. In the case of the subject
tires, the 4 treadwear indicators are equally spaced; thus, appearing
at 90 degree intervals around the circumference of the tread area of
the tire. When normally loaded, approximately 10 percent of the tread
band is in contact with the road surface. In most truck applications,
the remaining 90 percent of the tread band is accessible for
inspection. In the event that a vehicle is parked with one of the
treadwear indicators positioned in the ground contact patch area, three
other treadwear indicators would be accessible around the circumference
of the tire.
    In addition, MNA tires have a molded ``Bib'' symbol on the tread
shoulder to indicate the location of the treadwear indicator. These
molded symbols aid the person inspecting the tire to visually locate
the treadwear indicator and determine if the tire has worn to the
extent that the tread depth is 1.6 mm (1/16 in) or less.
    2. NHTSA's Prior Decisions: NHTSA has previously granted Petitions
for Determination of Inconsequential Noncompliance in similar cases
related to 49 CFR 571.119 S6.4 treadwear indicators.
    On August 19, 2014, NHTSA issued a Grant of Petition to Cooper Tire
and Rubber Company with the following comments:
    ``NHTSA Analysis: The purpose for tire treadwear indicators is to
serve as a means for a person to visually inspect a tire's tread depth
and readily determine if a tire has worn to the extent that tread depth
is 1.6 mm (one-sixteenth of an inch) or less.
    Cooper stated that while the subject tires were molded with only
five treadwear indicators that it believes that those indicators still
provide ample coverage over the surface of the tire. NHTSA agrees with
Cooper that in this case the subject noncompliance will have no
significant effect on the safety of the vehicles on which the subject
tires are mounted. The subject tires have five indicators; 4 indicators
spaced at 60 degrees and one indicator spaced at 120 degrees. NHTSA
believes that in this

case, the absence of a single indicator does not significantly affect a
person's ability to visually inspect a tire and readily recognize when
a significant portion of the tire's tread is worn to the point that a
tire should be replaced.''
    In the Cooper decision, it is relevant to note:
    (a) While the Cooper Mickey Thompson Baja MTZ tires had only one
missing treadwear indicator, the maximum circumferential space between
the two most distant treadwear indicators was 120 degrees. NHTSA
determined that this confirmation of treadwear indicators does not
significantly affect a person's ability to inspect a tire. In MNA's
case, the maximum circumferential space between the two most distant
treadwear indicators is less, at 90 degrees.
    (b) The Cooper petition cites a Grant of Petition issued to Motor
Bikes Imports, Inc. in 1987 which included a 49 CFR 571.119 S6.4
noncompliance related to motor bike tires with only l treadwear
indicator. NHTSA's decision stated a ``relatively small number of tires
which remain in use nevertheless bear one treadwear indicator''
concluding the existence of only a single treadwear indicator combined
with the relatively low volume of tires in the market were
inconsequential as they relate to motor vehicle safety.
    3. Product Performance & Monitoring: MNA has no indication through
our customer care network, fleet contacts or field engineers, of any
issues related to monitoring and measuring of treadwear on the l6.00R20
XZL tires. The lack of two treadwear indicators on the tire was
detected in the manufacturing process. We have no customer complaints
or warranty claims related to the reduced number of treadwear
indicators. The reduced number of treadwear indicators has no impact on
product performance. Product performance and customer satisfaction of
the subject tires is equivalent to tires produced with 6 treadwear
indicators. The tires comply with all safety standards and tire marking
requirements of 49 CFR 571.119.
    MNA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.

VI. NHTSA's Analysis

    NHTSA has evaluated the merits of MNA's inconsequential
noncompliance petition and has determined that this particular
noncompliance is inconsequential to motor vehicle safety. The agency
believes that the purpose of the treadwear indicators is to serve as a
means for a person to visually inspect and determine if a tire has worn
to the extent of the tread depth, which is 1.6 mm (one-sixteenth of an
inch) or less.
    After review of the petition, NHTSA agrees with the petition that
this noncompliance will have no significant impact on the safety of the
vehicles on which the subject tires are mounted. The subject tires have
four indicators spaced at 90 degrees around the circumference of the
tread pattern of the tire. The absence of two indicators does not
significantly affect the end user's ability to visually inspect a tire
and recognize when the tire's tread has been worn to the point that it
needs to be replaced.

VII. NHTSA's Decision

    In consideration of the foregoing, NHTSA has decided that MNA has
met its burden of persuasion that the FMVSS No. 119 noncompliance is
inconsequential to motor vehicle safety. Accordingly, MNA's petition is
hereby granted and MNA is exempted from the obligation of providing
notification of, and a remedy for, that noncompliance under 49 U.S.C.
30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allows NHTSA to exempt
manufacturers only from the duties found in sections 30118 and 30120,
respectively, to notify owners, purchasers, and dealers of a defect or
noncompliance and to remedy the defect or noncompliance. Therefore,
this decision only applies to the subject tires that MNA no longer
controlled at the time it determined that the noncompliance existed.
However, the granting of this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after MNA
notified them that the subject noncompliance existed.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8).

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2019-17339 Filed 8-12-19; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26934-26936]
[FR Doc No: 2017-12067]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0493]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Utilization of Adequate Provision Among Low to Non-
Internet Users

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on research entitled ``Utilization of Adequate
Provision among Low to Non-Internet Users.''

DATES: Submit either electronic or written comments on the collection
of information by August 11, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-0493 for ``Utilization of Adequate Provision among Low to
Non-Internet Users.'' 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: 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For copies of the questionnaire:
Office of Prescription Drug Promotion Research Team,
<EMAIL_ADDRESS>For questions on the PRA: JonnaLynn Capezzuto,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques,

when appropriate, and other forms of information technology.

Utilization of Adequate Provision Among Low to Non-Internet Users; OMB
Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    Prescription drug advertising regulations require that broadcast
advertisements containing product claims present the product's major
side effects and contraindications in either audio or audio and visual
parts of the advertisement (21 CFR 202.1(e)(1)); this is often called
the major statement. The regulations also require that broadcast
advertisements contain a brief summary of all necessary information
related to side effects and contraindications or that ``adequate
provision'' be made for dissemination of the approved package labeling
in connection with the broadcast (21 CFR 202.1(e)(1)). The requirement
for adequate provision is generally fulfilled when a firm gives
consumers the option of obtaining FDA-required labeling or other
information via a toll-free telephone number, through print
advertisements or product brochures, through information disseminated
at health care provider offices or pharmacies, and through the Internet
(Ref. 1). The purpose of including all four elements is to ensure that
most of a potentially diverse audience can access the information.
    Internet accessibility is increasing, but many members of sensitive
demographic groups (e.g., older adults, low socioeconomic status
individuals) nonetheless report that the Internet is inaccessible to
them either as a resource or due to limited knowledge, and so a Web
site alone may not adequately serve all potential audiences (Refs. 2
and 3). Similarly, some consumers may prefer to consult sources other
than a health care provider to conduct initial research, for privacy
reasons or otherwise (Refs. 1, 4, and 5). In light of these
considerations, the 1-800 number and print ad may provide special value
to consumers who are low to non-Internet users and/or those who value
privacy when conducting initial research on a medication, though not
necessarily unique value relative to one another. As such, a primary
purpose of this research is to examine the value of including both the
1-800 number and print ad as part of adequate provision in direct-to-
consumer (DTC) prescription drug broadcast ads. Secondarily, we will
also investigate the ability and willingness of low to non-Internet
users to make use of Internet resources if other options were
unavailable. These questions will be assessed using a survey
methodology administered via telephone.
    In addition, building on concurrent FDA research regarding drug
risk information,\1\ we will assess risk perceptions as influenced by
opening statements that could be used to introduce risks in DTC
prescription drug broadcast ads. Opening statements may be used to
frame risk information that follows. As such, consumers may interpret
the likelihood, magnitude, and duration of risks differently depending
on how those risks are introduced (Refs. 6-9). The intended outcome of
this component of the research is to evaluate the influence of these
opening statements within a sample of low to non-Internet users. This
research question will be addressed using a 1 x 3 between-subjects
experimental design embedded in the previously mentioned survey. This
particular component of the research will serve as an exploratory test
intended to inform FDA's future research efforts.
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    \1\ https://www.federalregister.gov/documents/2015/01/13/2015-00269/agency-information-collection-activities-submission-for-office-of-management-and-budget-review.
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    Sampling Frame. Given that older adults (i.e., those aged 65 and
older) are among the largest consumers of prescription drugs (Ref. 10)
and that approximately 41 percent of older adults do not use the
Internet (Ref. 2), investigating use of adequate provision in this
population is especially important. Also of concern, 34 percent of
those with less than a high school education do not use the Internet,
23 percent of individuals with household incomes lower than $30,000 per
year do not use the Internet, and 22 percent of individuals living in
rural areas do not use the Internet (Ref. 2). These estimates capture
non-Internet users, and so consideration of low-Internet users warrants
additional concern. Consistent with these citations, the present
research will utilize a nationally representative sample of low to non-
Internet users from these and other relevant demographic groups.
    Data collection will utilize a random digit dialing (RDD) sample
that has been pre-identified as being a non-Internet household, or
having at least one non-Internet using member. This sample solution is
ideal because it relies on a dual-frame (landline and cell phone)
probability-sample, yet has the advantage of prior knowledge of those
who are likely to be low to non-Internet users (re-screening will
verify this). The Social Science Research Solutions (SSRS) Omnibus,
within which this survey will be embedded, utilizes a sample designed
to represent the entire adult U.S. population, including Hawaii and
Alaska, and including bilingual (Spanish-speaking) respondents. As
reflected in the overall population of low to non-Internet users, we
intend to collect a small sample of Spanish-speaking individuals, which
comprise a subsample of the regular landline and cell phone RDD
sampling frames. We may also screen for past and present prescription
drug use in order to ensure a motivated sample.
    Survey Protocol. This survey will be conducted by telephone on
landline and cell phones, with an expected 50 to 60 percent of
interviews conducted on cell phones. Interviewing for the pretest and
main study will be conducted via SSRS's computer-assisted telephone
interviewing (CATI) system. We expect to achieve a roughly 40 percent
survey completion rate from the pre-identified respondents to be
sampled in this study, given an 8-week field period and a maximum of 10
attempts to reach respondents. The original SSRS Omnibus from which
this sample is derived receives an approximately 8 to 12 percent
response rate. These are not uncommon response rates for high-quality
surveys and have been found to yield accurate estimates (Refs. 11 and
12).
    As communicated earlier, the primary focus of interview questions
concern the ability and willingness of low to non-Internet users to
utilize the various components of adequate provision, particularly the
1-800 number and print ad components. In addition to these questions,
experimental manipulations will be embedded in the survey as an
exploratory test to assess the impact of opening statements that could
be used to introduce risks in DTC prescription drug broadcast ads,
which is a related concept. To form the experimental manipulations,
participants will be presented with a statement of major risks and side
effects (``the major statement'') drawn from a real prescription drug
product, but modified to include only serious and actionable risks.
Preceding this description of major risks will be one of three opening
statements: (1) ``[Drug] can cause severe, life threatening reactions.
These include

. . .''; (2) ``[Drug] can cause serious reactions. These include . .
.''; or (3) ``[Drug] can cause reactions. These include . . .'' All
risk statements will conclude with the following language: ``This is
not a full list of risks and side effects. Talk to your doctor and read
the patient labeling for more information.'' Participants will be
randomly assigned to experimental condition, and all manipulations will
be pre-recorded to allow for consistent administration. Following
exposure to these manipulations, participants will respond to several
questions designed to assess risk perceptions.
    Before the main study, we will execute a pretest with a sample of
25 participants from the same sampling frame as outlined in this
document. The pretest questionnaire will take approximately 15 minutes
to complete. The goal of the pretest will be to assess the
questionnaire's format and the general protocol to ensure that the main
study is ready for execution. To test the protocol among the target
groups, we will seek to recruit a mix of participants based on
demographic and other characteristics of interest. We do not plan to
use incentives for the pretest or main study portions of this survey.
However, upon request, cell phone respondents may be offered $5 to
cover the cost of their cell phone minutes.
    Questionnaire development is an iterative process and so the main
study questionnaire will include any changes from pretesting, as well
as other outcomes, such as OMB and public comments, or cognitive
interviewing. Like pretesting, the main study questionnaire should take
approximately 15 minutes to complete. Based on a power analyses, the
main study sample will include approximately 1,996 participants. This
sample size will allow us to draw statistical comparisons between the
various demographic groups in the sample.
    Measurement and Planned Analyses. Consistent with the larger
purpose of the study, survey questions will examine access, technical
ability, and willingness to use adequate provision options; preference
for and experience using adequate provision options; privacy concerns;
and potentially other secondary questions of interest. In addition, to
assess the impact of the experimental manipulations, survey questions
will assess perceived risk likelihood, perceived risk magnitude, and
perceived risk duration. Demographic information will also be
collected. To examine differences between experimental conditions, we
will conduct inferential statistical tests such as analysis of
variance. A copy of the draft questionnaire is available upon request.
    FDA estimates the burden of this collection of information as
follows:

                                                         Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                    Activity                        Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener...............................              63               1              63  0.05 (3 minutes).......................            3.15
Pretest Survey.................................              25               1              25  0.25 (15 minutes)......................            6.25
Main Study Screener............................           4,990               1           4,990  0.05 (3 minutes).......................           249.5
Main Study Survey..............................           1,996               1           1,996  0.25 (15 minutes)......................             499
                                                --------------------------------------------------------------------------------------------------------
    Total Hours................................  ..............  ..............  ..............  .......................................           757.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

1. U.S. Department of Health and Human Services, Food and Drug
Administration (1999). ``Guidance for Industry: Consumer-Directed
Broadcast Advertisements.'' Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125039.htm.
2. Anderson, M. and A. Perrin (2016). ``13% of Americans Don't Use
the Internet: Who Are They?'' Pew Research Center. Available at
http://www.pewresearch.org/fact-tank/2016/09/07/some-americans-dont-use-the-internet-who-are-they/.
3. U.S. Department of Commerce, U.S. Census Bureau (2013).
``Computer and Internet Use in the United States: Population
Characteristics.'' Available at https://www.census.gov/prod/2013pubs/p20-569.pdf.
4. Fox, S. and L. Rainie (2002). ``Vital Decisions: How Internet
Users Decide What Information to Trust When They or Their Loved Ones
Are Sick. Pew Internet & American Life Project.'' Available at
http://www.pewinternet.org/2002/05/22/main-report-the-search-for-online-medical-help/.
5. DeLorme, D. E., J. Huh, and L. N. Reid (2011). ``Source Selection
in Prescription Drug Information Seeking and Influencing Factors:
Applying the Comprehensive Model of Information Seeking in an
American Context.'' Journal of Health Communication, 16: pp. 766-
787.
6. O'Donoghue, A. C., H. W. Sullivan, K. J. Aikin, et al. (2014).
``Important Safety Information or Important Risk Information? A
Question of Framing in Prescription Drug Advertisements.''
Therapeutic Innovation and Regulatory Science, 48: pp. 305-307. doi:
10.1177/2168479013510306
7. Kahneman, D. (2011). Thinking, Fast and Slow. New York, NY:
Farrar, Straus, and Giroux.
8. Rothman, A. J. and P. Salovey (1997). ``Shaping Perceptions To
Motivate Healthy Behavior: The Role of Message Framing.''
Psychological Bulletin, 121: pp. 3-19.
9. Armstrong, K., J. S. Schwartz, G. Fitzgerald, et al. (2002).
``Effect of Framing as Gain Versus Loss on Understanding and
Hypothetical Treatment Choices: Survival and Mortality Curves.''
Medical Decision Making, 22: pp. 76-83.
10. National Center for Health Statistics. ``Health, United States,
2015: With Special Feature on Racial and Ethnic Health
Disparities.'' Hyattsville, MD. 2016.
11. Brick, J. M. and D. Williams (2013). ``Explaining Rising
Nonresponse Rates in Cross-Sectional Surveys.'' The Annals of the
American Academy of Political and Social Science, 645: pp. 36-59.
12. Groves, R. M. (2006). ``Nonresponse Rates and Nonresponse Bias
in Household Surveys.'' Public Opinion Quarterly, 70: pp. 646-675.

    Dated: June 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12067 Filed 6-9-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Page 45353]
[FR Doc No: 2017-20827]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Eighty Sixth RTCA SC-147 Plenary Session

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Eighty Sixth RTCA SC-147 Plenary Session.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Eighty Sixth RTCA SC-147 Plenary Session. This is a
subcommittee to RTCA.

DATES: December 7, 2017.

ADDRESSES: The meeting will be held at: Johns Hopkins Applied Physics
Laboratory at 11100 Johns Hopkins Rd, Laurel, MD 20723.

FOR FURTHER INFORMATION CONTACT: Al Secen at<EMAIL_ADDRESS>or 202-
330-0647, or The RTCA Secretariat, 1150 18th Street NW., Suite 910,
Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at (202)
833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Eighty Sixth RTCA SC-147 Plenary
Session. The agenda will include the following:

December 7, 2017

1. Opening Plenary Session--Co-Chairs
    a. Chairmen's Opening Remarks/Introductions
    b. RTCA Federal Advisory Act and Proprietary Material Policies
Review
    c. Approval of Minutes From 85th Meeting of SC-147
    d. Approval of Minutes From September 2017 Joint Working Group
Meeting
    e. Approval of Agenda
    f. Future Meeting Scheduling
2. Report From WG-75
3. SESAR Updates
4. Working Group Report
    a. Report From Coordination Subgroup
    b. Report From Threat Resolution Working Group
    c. Report From Surveillance Working Group
    d. Report From ACAS Xu Subgroup
5. CAS Interoperability MASPS: Status, Schedule, and SC-147 TORS
6. Status Of Mitigations for Transponder Failures
7. ACAS Xa/Xo MOPS Status & Approval to conduct Final Review and
Comment (FRAC) Process
8. Other Business
9. New Business

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC on September 25, 2017.
Mohannad Dawoud,
Management and Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-20827 Filed 9-27-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Rules and Regulations]
[Pages 47634-47637]
[FR Doc No: 2022-16645]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0325; FRL-9983-01-OCSPP]

IN-11693: Oxirane, 2-Methyl-, Polymer With Oxirane, di-(9Z)-9-
Octadecenoate; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate (CAS Reg. No. 67167-17-3) average
number molecular weight (in amu), 2500 when used as an inert ingredient
in a pesticide chemical formulation. Ethox Chemicals, LLC, submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate on food or feed commodities.

DATES: This regulation is effective August 4, 2022. Objections and
requests for hearings must be received on or before October 3, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0325, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room 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 and OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0325 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 3, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2022-0325, by one of the following methods.
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of May 20, 2022 (87 FR 30855) (FRL-9410-
13), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11693)
filed by Ethox Chemicals, LLC (1801 Perimeter Road, Greenville, SC
29605). The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate (CAS Reg. No. 67167-17-3). That notice included a summary
of the petition prepared by the petitioner and solicited comments on
the petitioner's request. The Agency did not receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the

relationship of this information to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. In the case of certain chemical substances that are defined
as polymers, the Agency has established a set of criteria to identify
categories of polymers expected to present minimal or no risk. The
definition of a polymer is given in 40 CFR 723.250(b) and the exclusion
criteria for identifying these low-risk polymers are described in 40
CFR 723.250(d). Oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate conforms to the definition of a polymer given in 40 CFR
723.250(b) and meets the following criteria that are used to identify
low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
Although hydrolysis is expected in the environment to yield oleic acid
and ethylene oxide/propylene oxide (E.O./PO) copolymer, the E.O./PO
copolymer portion is not anticipated to further biodegrade.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40
CFR 723.250(d)(6). Additionally, the polymer also meets as required the
following exemption criteria: specified in 40 CFR 723.250(e):
    The number average molecular weight is greater than 1,000 and less
than 10,000 Daltons. The polymer contains less than 10% oligomeric
material below MW 500 and less than 25% oligomeric material below MW
1,000 and the polymer does not contain any reactive functional groups
as specified in 40 CFR 723.250.
    Thus, oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate meets the criteria for a polymer to be considered low
risk under 40 CFR 723.250. Based on its conformance to the criteria in
this unit, no mammalian toxicity is anticipated from dietary,
inhalation, or dermal exposure to oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate could be present in all raw and
processed agricultural commodities and drinking water, and that non-
occupational non-dietary exposure was possible. The number average MW
of oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate is
2,500 daltons. Generally, a polymer of this size would be poorly
absorbed through the intact gastrointestinal tract or through intact
human skin. Since oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate conforms to the criteria that identify a low-risk
polymer, there are no concerns for risks associated with any potential
exposure scenarios that are reasonably foreseeable. The Agency has
determined that a tolerance is not necessary to protect the public
health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found oxirane, 2-methyl-, polymer with oxirane, di-
(9Z)-9-octadecenoate to share a common mechanism of toxicity with any
other substances, and oxirane, 2-methyl-, polymer with oxirane, di-
(9Z)-9-octadecenoate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate does not have a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at https://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9-octadecenoate, EPA has not used a
safety factor analysis to assess the risk. For the same reasons the
additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate.

VIII. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of oxirane, 2-
methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate from the
requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety

Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 27, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, add in alphabetical order the polymer ``Oxirane,
2-methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate'' to table 1
to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

                           Table 1 to 180.960
------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-          67167-17-3
 octadecenoate, minimum number average molecular weight
 (in amu), 2500.........................................

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2022-16645 Filed 8-3-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30624-30625]
[FR Doc No: 2014-12279]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0034]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ADCETRIS--Biologics License Application 125399

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 ADCETRIS based on biologics license
application (BLA) 125399 and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human biological product, ADCETRIS.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 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 Patents and
Trademarks 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 ADCETRIS
(brentuximab vedotin). ADCETRIS as approved under BLA 125399 is
indicated for treatment of patients with systemic anaplastic large cell
lymphoma (sALCL) after failure of at least one prior multi-agent
chemotherapy regimen. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
ADCETRIS (U.S. Patent Nos. 7,829,531 and 7,090,843) from Seattle
Genetics, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated February 4, 2013, FDA advised the Patent
and Trademark Office that this human biological product had undergone a
regulatory review period and that the approval of ADCETRIS under BLA
125388 and BLA 125399 represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
ADCETRIS is 1,851 days. Of this time, 1,678 days occurred during the
testing phase of the regulatory review period, while 173 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: July 27,
2006. FDA has verified the applicant's claim that the date the
investigational new drug application (IND) became effective was on July
27, 2006. This is the same IND and the same date FDA determined was the
beginning of the regulatory review period for ADCETRIS approved under
BLA 125388. The regulatory review period for ADCETRIS approved under
BLA 125388 is publishing in this issue of the Federal Register.
    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): February 28, 2011. FDA has verified the
applicant's claim that the BLA for ADCETRIS (BLA 125399) was initially
submitted on February 28, 2011.
    3. The date the application was approved: August 19, 2011. FDA has
verified the applicant's claim that BLA 125399 was approved on August
19, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 229 days of
patent term extension for U.S. Patent No. 7,829,531.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 28, 2014. 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 November 24, 2014. To meet its burden, the petition must
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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12279 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Page 75351]
[FR Doc No: 2023-24176]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98811; File No. SR-CboeEDGX-2023-057]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Withdrawal of Proposed Rule Change To Amend Its Fee Schedule Related
to Physical Port Fees

October 27, 2023.
    On September 1, 2023, Cboe EDGX Exchange, Inc. (``Exchange'') filed
with the Securities and Exchange Commission (``Commission''), pursuant
to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend certain connectivity and port fees.
---------------------------------------------------------------------------

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

    The proposed rule change was immediately effective upon filing with
the Commission pursuant to Section 19(b)(3)(A) of the Act.\3\ The
proposed rule change was published for comment in the Federal Register
on September 20, 2023.\4\ On September 29, 2023, pursuant to Section
19(b)(3)(C) of the Act,\5\ the Commission: (1) temporarily suspended
the proposed rule change; and (2) instituted proceedings under Section
19(b)(2)(B) of the Act \6\ to determine whether to approve or
disapprove the proposed rule change.\7\ On October 25, 2023, the
Exchange withdrew the proposed rule change (SR-CboeEDGX-2023-057).
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release No. 98396 (September 14,
2023), 88 FR 64960.
    \5\ 15 U.S.C. 78s(b)(3)(C).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 98653, 88 FR 68774
(October 4, 2023).
    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-24176 Filed 11-1-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Proposed Rules]
[Pages 79654-79655]
[FR Doc No: 2013-31125]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R01-RCRA-2013-0554; FRL-9904-46-Region 1]

Vermont: Proposed Authorization of State Hazardous Waste
Management Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to grant final authorization to the State of
Vermont for changes to its hazardous waste program. In the ``Rules and
Regulations'' section of this Federal Register we are authorizing the
changes to the Vermont hazardous waste program under the Resource
Conservation and Recovery Act (RCRA) as a direct final rule without
prior proposed rule. EPA has determined that these changes satisfy all
requirements needed to qualify for final authorization. If we receive
no adverse comment, we will not take further action on this proposed
rule.

DATES: Written comments must be received by January 30, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
RCRA-2013-0554, by mail to Sharon Leitch, RCRA Waste Management and UST
Section, Office of Site Remediation and Restoration (OSRR07-1), US EPA
Region 1, 5 Post Office Square, Suite 100, Boston, MA 02109-3912.

Comments may also be submitted electronically or thorough hand
delivery/courier by following the detailed instructions in the
ADDRESSES section of the direct final rule located in the rules section
of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Sharon Leitch, RCRA Waste Management
and UST Section, Office of Site Remediation and Restoration (OSRR07-1),
US EPA Region 1, 5 Post Office Square, Suite 100, Boston, MA 02109-
3912; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of
this Federal Register, EPA is authorizing these changes by a direct
final rule. EPA did not make a proposal prior to the direct final rule
because we believe this action is not controversial and do not expect
adverse comments that oppose it. We have explained the reasons for this
authorization in the preamble to the direct final rule. Unless we
receive written adverse comments which oppose this authorization during
the comment period, the direct final rule will become effective on the
date it establishes, and we will not take further action on this
proposal. If we get comments that oppose this action, we will withdraw
the direct final rule and it will not take immediate effect. We will
then respond to public comments in a later final rule based on this
proposal. You may not have another opportunity for comment. If you want
to comment on this action, you should do so at this time.

    Dated: November 5, 2013.
H. Curtis Spalding,
Regional Administrator, EPA Region 1.
[FR Doc. 2013-31125 Filed 12-30-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Page 49220]
[FR Doc No: 2015-20200]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-539-000]

Columbia Gulf Transmission, LLC; Notice of Application

    Take notice that on July 29, 2015, Columbia Gulf Transmission, LLC
(Columbia Gulf), 5151 San Felipe, Suite 2500, Houston, Texas 77056,
filed an application under section 7(c) of the Natural Gas Act and Part
157 of the Commission's regulations requesting authorization to
construct, own and operate 51,800 horsepower at two greenfield
compressor stations in Carter, Menifee and Montgomery Counties,
Kentucky, to enable up to 621,000 Dekatherms per day (Rayne XPress
Project) of firm transportation on its system, all as more fully
described in the application.
    The filing may also be viewed on the web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC at<EMAIL_ADDRESS>or toll
free at<PHONE_NUMBER>, or TTY,<PHONE_NUMBER>.
    Any questions regarding the proposed project should be directed to
William A. Sala, Jr., Senior Counsel, Columbia Gulf Transmission, LLC,
5151 San Felipe, Suite 2500, Houston, Texas 77056; telephone: 713-386-
3743.
    On June 22, 2015 in Docket No. CP15-514-000, the Commission issued
a Notice of Application (June 22 Notice) for Columbia Gulf's affiliate,
Columbia Gas Transmission, LLC's (Columbia Gas) Leach XPress Project.
The June 22 Notice stated that the Rayne Express Project may have some
connection to Columbia Gas' Leach Xpress Project, and further, that
``Until the details of the Rayne Xpress project are filed and more
fully understood, the Commission cannot begin preparation of the
Environmental Impact Statement (EIS) to comply with the NEPA of 1969.''
Columbia Gulf's Rayne XPress application filing confirms the connection
between the Leach XPress and Rayne XPress Projects and thus, we can
begin our analysis.
    Within 90 days after the date of this Notice of Application for the
Rayne Xpress project, the Commission staff will issue a Notice of
Schedule for Environmental Review that will indicate the anticipated
date for the Commission's staff issuance of the final EIS analyzing
both the Leach XPress and Rayne XPress proposals. The issuance of a
Notice of Schedule for Environmental Review will also serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's final EIS.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: September 1, 2015.

     Dated: August 11, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-20200 Filed 8-14-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Rules and Regulations]
[Pages 35966-35967]
[FR Doc No: 2011-15116]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0070; Airspace Docket No. 10-ASO-43]

Amendment of Class E Airspace; Cocoa, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E Airspace at Cocoa, FL, as the
Merritt Island Non-Directional Beacon (NDB) has been decommissioned and
new Standard Instrument Approach Procedures have been developed at
Merritt Island Airport. This action enhances the safety and airspace
management of Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, August 25, 2011. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of

Federal Regulations, part 51, subject to the annual revision of FAA,
Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On April 15, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace at Merritt
Island Airport, Cocoa, FL (75 FR 21266) Docket No. FAA-2011-0070.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and
effective September 15, 2010, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace extending upward from 700 feet above
the surface to accommodate new standard instrument approach procedures
developed at Merritt Island Airport, Cocoa, FL. Airspace
reconfiguration is necessary due to the decommissioning of the Merritt
Island NDB and cancellation of the NDB approach, and for continued
safety and management of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Merritt Island Airport, Cocoa, FL.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASO FL E5 Cocoa, FL [Amended]

Merritt Island Airport, FL
    (Lat. 28[deg]20'30'' N., long. 80[deg]41'08'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of the Merritt Island Airport and within
2.5 miles each side of the 303[deg] bearing from the Merritt Island
Airport, extending from the 6.3-mile radius to 7 miles northwest of
the airport; excluding that airspace within the Titusville, FL, and
Melbourne, FL, Class E airspace areas.

    Issued in College Park, Georgia, on June 2, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-15116 Filed 6-20-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Rules and Regulations]
[Page 45344]
[FR Doc No: 2014-18372]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0670]

Drawbridge Operation Regulation; Lake Washington Ship Canal,
Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Montlake Bridge across the Lake
Washington Ship Canal, mile 5.2, in Seattle, WA. The deviation is
necessary to accommodate vehicular traffic attending football games at
Husky Stadium at the University of Washington, Seattle, Washington.
This deviation allows the bridge to remain in the closed position two
hours before and two hours after each game. Please note that the game
times for five of the seven games scheduled for Husky Stadium have not
yet been determined due to NCAA television scheduling.

DATES: This deviation is effective from 10 a.m. on September 6, 2014
through November 22, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0670] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Steven M. Fischer, Bridge
Specialist, Thirteenth District, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Washington State Department of
Transportation, on behalf of the University of Washington Police
Department, has requested that the Montlake Bridge bascule span remain
closed and need not open to vessel traffic to facilitate timely
movement of pre-game and post-game football traffic. The Montlake
Bridge crosses the Lake Washington Ship Canal at mile 5.2 and while in
the closed position provides 30 feet of vertical clearance throughout
the navigation channel and 46 feet of vertical clearance throughout the
center 60-feet of the bridge. These vertical clearance measurements are
made in reference to the Mean Water Level of Lake Washington. Vessels
which do not require a bridge opening may continue to transit beneath
the bridges during this closure period. Under normal conditions this
bridge opens on signal, subject to the list of exceptions provided in
33 CFR 117.1051(e).
    This deviation period will cover the dates September 6, 2014 to
November 22, 2014 as follows. From 10 a.m. to Noon, and from 3 p.m. to
5 p.m. on September 6, 2014; from 11 a.m. to 1 p.m. and from 4 p.m. to
6 p.m. on September 13, 2014. The times for the closures on September
20, 2014, September 27, 2014, October 25, 2014, November 8, 2014, and
November 22, 2014 will be determined and announced in the Coast Guard's
Local Notice to Mariners and Broadcast Notice to Mariners as they
become available. Due to NCAA television scheduling, the times for the
games are not currently available.
    The deviation allows the bascule span of the Montlake Bridge to
remain in the closed position and need not open for maritime traffic
from 10 a.m. to Noon, and 3 p.m. to 5 p.m. on September 6, 2014, and
from 11 a.m. to 1 p.m., and 4 p.m. to 6 p.m. on September 13, 2014, for
times to be determined on September 20, 2014, September 27, 2014,
October 25, 2014, November 8, 2014, and November 22, 2014. The bridge
shall operate in accordance to 33 CFR Sec.  117.1051(e) at all other
times. Waterway usage on the Lake Washington Ship Canal ranges from
commercial tug and barge to small pleasure craft.
    Vessels able to pass through the bridge in the closed positions may
do so at any time. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterways through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridges must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: July 24, 2014.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2014-18372 Filed 8-4-14; 8:45 am]
BILLING CODE 9110-04-P