[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Notices]
[Pages 46146-46147]
[FR Doc No: 2020-16657]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2020-0023; OMB No. 1660-0005]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; FEMA Inspection and Claims Form

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: 30-Day notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before August 31, 2020.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address<EMAIL_ADDRESS>or
Daniel Claire, Program Analyst, Federal Insurance & Mitigation
Administration,<PHONE_NUMBER><EMAIL_ADDRESS>or Brian
Thompson, Supervisory Program Specialist, FEMA Recovery Directorate,
540-686-3602<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on May 14, 2020, at 85 FR
28968 with a 60 day public comment period. No comments were received.
The purpose of this notice is to notify the public that FEMA will
submit the information collection abstracted below to the Office of
Management and Budget for review and clearance.

Collection of Information

    Title: FEMA Inspection and Claims Forms, formerly National Flood
Insurance Program Claim Forms.
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0005.
    Form Titles and Numbers: FEMA Form 086-0-6; Personal Property
(Contents) Worksheet, FEMA Form 086-0-7; Building Property Worksheet,
FEMA Form 086-0-9; Proof of Loss--Building & Contents (Policyholder-
Prepared), FEMA Form 086-0-10; Proof of Loss--Increased Cost of
Compliance (ICC), FEMA Form 086-0-11; First Notice of Loss, FEMA Form
086-0-17; Manufactured (Mobile) Home/Travel Trailer Worksheet, FEMA
Form 086-0-22; Proof of Loss--Building & Contents (Adjuster-Prepared),
FEMA Form 086-0-23; Advance Payment Request--Building & Contents, FEMA
Form 086-0-24; Advance Payment Request--Increased Cost of Compliance
(ICC), FEMA Form 086-0-25; Claim Appeal, FEMA Form 009-0-143; Onsite
Housing Inspections, FEMA Form 009-0-144; Remote Voice Telephony
Housing Inspections, FEMA Form 009-0-145; Remote Video Telephony
Housing Inspections.
    Abstract: The claims forms used for the National Flood Insurance
Program are used by policyholders to collect the information needed to
investigate, document, evaluate, and settle claims against National
Flood Insurance Program policies for flood damage to their insured
property or qualification for benefits under Increased Cost of
Compliance coverage. The housing inspection instruments are used to
collect and store damage assessment information in Automated
Construction Estimator software to assist in the determination of
Individuals and Households Program assistance for applicants with
disaster caused damage to their primary residence.
    Affected Public: Individuals, households, businesses, or other for-
profit.
    Estimated Number of Respondents: 312,026.
    Estimated Number of Responses: 312,026.
    Estimated Total Annual Burden Hours: 314,149.
    Estimated Total Annual Respondent Cost: $11,796,263.

    Estimated Respondents' Operation and Maintenance Costs: $0.00.
    Estimated Respondents' Capital and Start-Up Costs: $0.00.
    Estimated Total Annual Cost to the Federal Government:
$103,715,613.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Maile Arthur,
Acting Records Management Branch Chief, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2020-16657 Filed 7-30-20; 8:45 am]
BILLING CODE 9110-52-P


[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13340-13341]
[FR Doc No: 2018-06256]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: FAA Entry
Point Filing Form--International Registry

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The information collected is required from aircraft
operators who wish to obtain a unique authorization code for
transmitting information to the International Registry in Dublin,
Ireland. An estimated 30 minutes is required to complete the only form
in the collection, AC Form 8050-135.

DATES: Written comments should be submitted by May 29, 2018.

ADDRESSES: Send comments to the FAA at the following address: Barbara
Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Barbara Hall by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0697.
    Title: FAA Entry Point Filing Form--International Registry.
    Form Numbers: AC Form 8050-135.
    Type of Review: Renewal of existing collection.
    Background: This information collection supports Department of
Transportation strategic goals regarding safety and security. The
information collected is necessary to obtain an authorization code for
transmission of information to the International Registry.
    The Convention on International Interest in Mobile Equipment, as
modified by the Protocol to the Convention on International Interests
in Mobile Equipment on Matters Specific to Aircraft Equipment (herein
after the Cape Town Treaty or Treaty), provides for the creation and
sustainment of the International Registry. The International Registry
is an electronic registry system that works in tandem with the current
system operated by the FAA Civil Aviation Registry (Registry) for the
United States. Congress has designated the Registry as the exclusive
United States Entry Point for transmissions to the International
Registry. To transmit certain types of interests or prospective
interests to the International Registry, interested parties must file a
completed FAA Entry Point Filing Form--International Registry, AC Form
8050-135, with the Registry. Upon receipt of the completed form, the
Registry, upon verifying the accuracy of the submitted data, issues the
unique authorization code.
    Respondents: Aircraft owners desiring authorization for filing with
the International Registry. The submission of the information in
question is not an FAA requirement for aircraft registration. Its sole
purpose is to create authorization for filing with the International
Registry.
    Frequency: As desired by the aircraft owner.
    Estimated Average Burden per Response: 30 minutes.
    Estimated Total Annual Burden: Based on FY '17 approximately 15,000
filings, the estimated annual burden is 7,500 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Fort Worth, TX on March 20, 2018.
Barbara L. Hall,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2018-06256 Filed 3-27-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Rules and Regulations]
[Page 38115]
[FR Doc No: 2019-16634]

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

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

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

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

Federal Register / Vol. 84, No. 151 / Tuesday, August 6, 2019 / Rules
and Regulations

FEDERAL RESERVE SYSTEM

12 CFR Part 248

[Docket No. R-1643]
RIN 7100-AF33

FEDERAL DEPOSIT INSURANCE CORPORATION

12 CFR Part 351

RIN 3064-AE88

COMMODITY FUTURES TRADING COMMISSION

17 CFR Part 75

RIN 3038-AE72

SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 255

[Release No. BHCA-6; File No. S7-30-18]
RIN 3235-AM43

Revisions to Prohibitions and Restrictions on Proprietary Trading
and Certain Interests in, and Relationships With, Hedge Funds and
Private Equity Funds

AGENCY: Board of Governors of the Federal Reserve System (Board);
Federal Deposit Insurance Corporation (FDIC); Securities and Exchange
Commission (SEC); and Commodity Futures Trading Commission (CFTC),
collectively, the Agencies.

ACTION: Final rule; correction.

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SUMMARY: The Agencies published a final rule in the Federal Register on
July 22, 2019, that adopted final rules to amend regulations
implementing Section 13 of the Bank Holding Company Act (the Volcker
Rule) in a manner consistent with the statutory amendments made
pursuant to certain sections of the Economic Growth, Regulatory Relief,
and Consumer Protection Act. This document corrects errors in
amendatory instructions in the rule.

DATES: Effective August 6, 2019.

FOR FURTHER INFORMATION CONTACT:
    Board: Flora Ahn, Special Counsel,<PHONE_NUMBER>, Gregory
Frischmann, Senior Counsel,<PHONE_NUMBER>, Kirin Walsh, Attorney,
(202) 452-3058, or Sarah Podrygula, Attorney,<PHONE_NUMBER>, Legal
Division, Board of Governors of the Federal Reserve System, 20th and C
Streets NW, Washington, DC 20551.
    FDIC: Michael B. Phillips, Counsel<EMAIL_ADDRESS>Benjamin J.
Klein, Counsel<EMAIL_ADDRESS>or Annmarie H. Boyd, Counsel,
<EMAIL_ADDRESS>Legal Division, Federal Deposit Insurance Corporation,
550 17th Street NW, Washington, DC 20429.
    SEC: Andrew R. Bernstein, Senior Special Counsel, Sam Litz,
Attorney-Adviser, Aaron Washington, Special Counsel, Office of
Derivatives Policy and Trading Practices, Division of Trading and
Markets, U.S. Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549.
    CFTC: Cantrell Dumas, Special Counsel,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Mark Fajfar, Assistant General Counsel, (202) 418-
6636<EMAIL_ADDRESS>Office of the General Counsel; Commodity
Futures Trading Commission, Three Lafayette Centre, 1155 21st Street
NW, Washington, DC 20581.

SUPPLEMENTARY INFORMATION: This document corrects errors in amendatory
instructions in a final rule published on July 22, 2019, affecting 12
CFR 248.11, 12 CFR 351.11, 17 CFR 75.11, and 17 CFR 255.11 of the
Agencies' regulations.

Correction

0
In final rule FR Doc. 2019-15019 published in the Federal Register on
July 22, 2019 (84 FR 35008), beginning on page 35020, make the
following corrections:
0
1. On page 35020, in the third column, correct amendatory instruction
11 to read as follows:

``11. Revise paragraph (a)(6) to read as follows:''

0
2. On page 35021, in the second column, correct amendatory instruction
16 to read as follows:

``16. Revise paragraph (a)(6) to read as follows:''

0
3. On page 35022, in the first column, correct amendatory instruction
21 to read as follows:

``21. Revise paragraph (a)(6) to read as follows:''

0
4. On page 35022, in the second column, correct amendatory instruction
26 to read as follows:

``26. Revise paragraph (a)(6) to read as follows:''

    Board of Governors of the Federal Reserve System, July 26, 2019.
Ann E. Misback,
Secretary of the Board.

Federal Deposit Insurance Corporation.

    Dated at Washington, DC, on July 23, 2019.
Valerie J. Best,
Assistant Executive Secretary.
    Issued in Washington, DC, on July 23, 2019, by the Commission.
Christopher Kirkpatrick,
Secretary of the Commission.

    By the Securities and Exchange Commission

    Dated: July 23, 2019.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 2019-16634 Filed 8-5-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79992-79993]
[FR Doc No: 2015-32184]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0119]

Public Hearings on Planned Upgrades to the New Car Assessment
Program

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

ACTION: Notice of public hearings.

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SUMMARY: NHTSA is announcing two public hearings to invite public
comment on the planned upgrade to the New Car Assessment Program (NCAP)
recently announced in a Request for Comments (RFC) Notice.

DATES: NHTSA will hold a public hearing at the Patrick McNamara Federal
Building in Detroit, Michigan on January 14, 2016, that will begin at
9:00 a.m. The second hearing will be held at U.S. DOT Headquarters in
Washington, DC on January 29, 2016, and will begin at 9:00 a.m. We will
make every effort to accommodate all who wish to speak. Priority will
be given to those who register in advance. Each hearing will continue
until 1:00 p.m. or until everyone has had an opportunity to speak.
Note, however, that the Patrick McNamara Federal Building closes at
5:30 p.m. If you would like to present oral testimony related to the
RFC notice at one of the public hearings, please contact the person
identified under FOR FURTHER INFORMATION CONTACT at least 10 days
before the hearing.

ADDRESSES: The January 14, 2016 public hearing will be held at the
Patrick McNamara Federal Building, Room 1180, 477 Michigan Avenue,
Detroit, MI 48226-2523. The January 29, 2016 public hearing will be
held at the U.S. DOT Headquarters Building, Oklahoma City Room, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: If you would like to present oral
testimony at either of these public hearings, please contact Milton
Cooper by the date specified under DATES at telephone number: (202)
366-3223; or email address<EMAIL_ADDRESS>(preferred method of
contact). Please provide the following information: Name, affiliation,
telephone number, email address, and any reasonable accommodations you
may need.

SUPPLEMENTARY INFORMATION: The purpose of the public hearings is to
provide the public with an opportunity to present oral comments
regarding the planned upgrade to NHTSA's New Car Assessment Program.
NCAP provides comparative information on the safety of new vehicles to
assist consumers with vehicle purchasing decisions and to encourage
motor vehicle manufacturers to make vehicle safety improvements. To
keep pace with advancements in occupant protection and the introduction
of advanced technologies, NHTSA has periodically updated the program.
On December 16, 2015, NHTSA published in the Federal Register a notice
that describes and seeks comments on NHTSA's plan to advance the
capabilities and safety outcomes of NCAP.\1\
---------------------------------------------------------------------------

    \1\ 80 FR 78522; December 16, 2015.
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    The RFC notice announces the beginning of a process NHTSA believes
will provide the agency with significantly enhanced tools and
techniques for better evaluating the safety of vehicles, generating
star ratings, and stimulating the development of even safer vehicles
for American consumers. The agency believes the revised rating system
will result in even lower numbers of deaths and injuries resulting from
motor vehicle crashes. These tools and techniques include:

     A new frontal oblique test to address a crash type that
continues to result in deaths and serious injuries despite the use of
seat belts, air bags, and the crashworthy structures of late-model
vehicles;
     Use of the THOR 50th percentile male anthropomorphic test
device (ATD) (i.e., crash test dummy) in the frontal oblique and full
frontal tests because of its advanced instrumentation and more human-
like (i.e., biofidelic) response to the forces experienced in these
crashes;
     Use of the WorldSID 50th percentile male ATD in both side
pole and side moveable deformable barrier tests because of its advanced
instrumentation and enhanced biofidelic properties;
     Pedestrian crashworthiness testing to measure the extent
to which vehicles are designed to minimize injuries and fatalities when
they strike pedestrians;
     An update of the rollover static stability factor risk
curve using crash data from only newer electronic stability control
equipped vehicles;
     The addition of a crash avoidance rating based on whether
a vehicle offers any of the multiple technologies that will be added to
NCAP and whether the technologies meet NHTSA performance measures;
    [cir] These technologies would include forward collision warning,
lane departure warning, blind spot detection, lower beam headlighting
technologies, semi-automatic headlamp beam switching, amber rear turn
signal lamps, rear automatic braking and pedestrian automatic emergency
braking. (A decision concerning the addition of crash imminent braking
and dynamic brake support to the technologies recommended by NCAP is
the subject of a separate proceeding recently published.\2\)
---------------------------------------------------------------------------

    \2\ See www.regulations.gov, Docket No. NHTSA-2015-0006-0024.
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     A new approach to determining a vehicle's overall 5-star
rating that will, for the first time, incorporate advanced crash
avoidance technology features, along with ratings for crashworthiness
and pedestrian protection.
    You can learn more about the planned upgrade by reviewing the RFC
notice and the supplementary documents located at http://www.safercar.gov/5Stars or in the docket.
    Should it be necessary for the agency to cancel either public
hearing due to inclement weather or any other emergencies, a decision
to cancel will be made as soon as possible and emailed to those
individuals who have registered to provide oral comments. If you do not
have access to email, you may call the contacts listed in this
announcement and leave your telephone number and/or email address. You
will be contacted only if the public hearing is postponed or canceled.
    Public Hearing Procedures. Because the hearings will be located in
Federal facilities, security screening will be required. Attendees will
need to show photo identification and be screened for security
purposes. Please plan your arrival so as to allow sufficient time to
complete the screening. Please note that the Patrick McNamara Federal
Building does not open until 8:00 a.m.
    NHTSA will conduct the hearings informally. Thus, technical rules
of evidence will not apply. Panel members may ask clarifying questions
during the oral presentations, but will not respond to the
presentations at that time. You may make arrangements to obtain copies
of the transcripts directly with the court reporter. Written statements
and supporting information submitted during the comment period on the
RFC notice will be considered with the same weight as oral comments and
supporting information presented at the public hearings. The RFC notice
provides that written comments should be submitted no later than
February 16, 2016.

Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2015-32184 Filed 12-22-15; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Pages 9533-9534]
[FR Doc No: 2019-04816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1328]

Severely Debilitating or Life-Threatening Hematologic Disorders:
Nonclinical Development of Pharmaceuticals; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Severely
Debilitating or Life-Threatening Hematologic Disorders: Nonclinical
Development of Pharmaceuticals.'' This guidance outlines nonclinical
studies recommended for the development of pharmaceuticals used to
treat patients with severely debilitating or life-threatening
hematologic disorders (SDLTHDs) and addresses comments received to the
docket. This guidance is intended to streamline the development of
pharmaceuticals used to treat patients with SDLTHDs, other than cancer,
while protecting patients' safety and avoiding unnecessary use of
animals, in accordance with the 3R (reduce, refine, replace)
principles. This guidance applies to pharmaceuticals used both to treat
the active disease and to prevent the recurrence of a life-threatening
or debilitating event.

DATES: The announcement of the guidance is published in the Federal
Register on March 15, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1328 for ``Severely Debilitating or Life-Threatening
Hematologic Disorders: Nonclinical Development of Pharmaceuticals.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: John Leighton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2204, Silver Spring, MD 20993-0002, 301-
796-7550; or Haleh Saber, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2117,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Severely Debilitating or Life-Threatening Hematologic
Disorders: Nonclinical Development of Pharmaceuticals.'' The purpose of
this guidance is to assist sponsors in the design of nonclinical
studies for the development of pharmaceuticals used to treat patients
with SDLTHDs. This guidance is intended to streamline the development
of pharmaceuticals used to treat patients with SDLTHDs, other than
cancer, while protecting patients' safety and avoiding unnecessary use
of animals, in accordance with the 3R principles. This guidance applies
to pharmaceuticals used both to treat the active disease and to prevent
the recurrence of a life-threatening or debilitating event.
    SDLTHDs include conditions in which life expectancy is short or
quality of life is greatly diminished despite available therapies. FDA
has defined life-threatening and severely debilitating diseases in
regulations (21 CFR 312.81). A streamlined approach to drug development
is necessary to allow patients with SDLTHDs earlier and continued
access to new and potentially effective therapies. The draft guidance
for industry entitled ``Rare Diseases: Common Issues in Drug
Development'' (available at<EMAIL_ADDRESS>does not
specifically facilitate the nonclinical development of pharmaceuticals
for treatment of SDLTHDs. Because SDLTHDs are not all rare diseases,
they can fall outside the scope of the draft guidance for rare
diseases. The present document provides consistent guidance for all
nononcology SDLTHDs, independent of disease incidence or prevalence.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Severely Debilitating or Life-Threatening
Hematologic Disorders: Nonclinical Development of Pharmaceuticals.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information submitted under 21 CFR part 312
has been approved under OMB control number 0910-0014. The collection of
information submitted under 21 CFR part 314 has been approved under OMB
control number 0910-0001.

III. Electronic Access

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

    Dated: March 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04816 Filed 3-14-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Page 1473]
[FR Doc No: 2011-369]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting Notice

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, January
13, 2011 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
January 13, 2011 will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters; and other matters relating to enforcement
proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: January 6, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-369 Filed 1-6-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38379-38381]
[FR Doc No: 2012-15629]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0105]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt seven individuals from
the vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). The exemptions will enable these individuals to operate
commercial motor vehicles (CMVs) in interstate commerce without meeting
the prescribed vision requirement in one eye. The Agency has concluded
that granting these exemptions will provide a level of safety that is
equivalent to or greater than the level of safety

maintained without the exemptions for these CMV drivers.

DATES: The exemptions are effective June 27, 2012. The exemptions
expire on June 27, 2014.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, 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.
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgement that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On May 11, 2012, FMCSA published a notice of receipt of exemption
applications from certain individuals, and requested comments from the
public (77 FR 27852). That notice listed seven applicants' case
histories. The seven individuals applied for exemptions from the vision
requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in
interstate commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the seven applications on their merits
and made a determination to grant exemptions to each of them.

Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing requirement
red, green, and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their vision
limitation and demonstrated their ability to drive safely. The seven
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including enucleation of the eye, amblyopia, congenital eye
disease and retinal detachment. In most cases, their eye conditions
were not recently developed. Six of the applicants were either born
with their vision impairments or have had them since childhood. The
individual that sustained a vision condition as an adult has had it for
a period of 10 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these seven drivers have
been authorized to drive a CMV in intrastate commerce, even though
their vision disqualified them from driving in interstate commerce.
They have driven CMVs with their limited vision for careers ranging
from 10 to 43 years. In the past 3 years, none of the drivers were
involved in crashes, and none of the drivers were convicted of moving
violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the May 11, 2012
notice (77 FR 27852).

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    We believe we can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345,

March 26, 1996). The fact that experienced monocular drivers
demonstrated safe driving records in the waiver program supports a
conclusion that other monocular drivers, meeting the same qualifying
conditions as those required by the waiver program, are also likely to
have adapted to their vision deficiency and will continue to operate
safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the seven applicants, none of the drivers were involved in crashes and
none of the drivers were convicted of moving violations in a CMV. All
the applicants achieved a record of safety while driving with their
vision impairment, demonstrating the likelihood that they have adapted
their driving skills to accommodate their condition. As the applicants'
ample driving histories with their vision deficiencies are good
predictors of future performance, FMCSA concludes their ability to
drive safely can be projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the seven applicants listed in the notice of May
11, 2012 (77 FR 27852).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the seven individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

Discussion of Comments

    FMCSA received no comments in this proceeding.

Conclusion

    Based upon its evaluation of the seven exemption applications,
FMCSA exempts Charles S. Amyx, Jr. (LA), Giovanni B. Cerino, Jr. (FL),
Randall L. Mathis (AL), Shane N. Maul (IN), Michael E. McAfee (KY),
Dennis D. Pimley (CA) and James E. Sikkink (IL) from the vision
requirement in 49 CFR 391.41(b)(10), subject to the requirements cited
above (49 CFR 391.64(b)).
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (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 before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: June 20, 2012.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2012-15629 Filed 6-26-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Notices]
[Pages 44068-44069]
[FR Doc No: 2014-17776]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 6e-2 and Form N-6EI-1.
    SEC File No. 270-177, OMB Control No. 3235-0177.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 6e-2 (17 CFR 270.6e-2) under the Investment Company Act of
1940 (``Act'') (15 U.S.C. 80a) is an exemptive rule that provides
separate accounts formed by life insurance companies to fund certain
variable life insurance products, exemptions from certain provisions of
the Act, subject to conditions set forth in the rule. The rule sets
forth several information collection requirements.
    Rule 6e-2 provides a separate account with an exemption from the
registration

provisions of section 8(a) of the Act if the account files with the
Commission Form N-6EI-1, a notification of claim of exemption.
    The rule also exempts a separate account from a number of other
sections of the Act, provided that the separate account makes certain
disclosure in its registration statements (in the case of those
separate accounts that elect to register), reports to contractholders,
proxy solicitations, and submissions to state regulatory authorities,
as prescribed by the rule.
    Paragraph (b)(9) of Rule 6e-2 provides an exemption from the
requirements of section 17(f) of the Act and imposes a reporting burden
and certain other conditions. Section 17(f) requires that every
registered management company meet various custody requirements for its
securities and similar investments. The exemption provided in paragraph
(b)(9) applies only to management accounts that offer life insurance
contracts.
    Since 2008, there have been no filings under paragraph (b)(9) of
Rule 6e-2 by management accounts. Therefore, since 2008, there has been
no cost or burden to the industry regarding the information collection
requirements of paragraph (b)(9) of Rule 6e-2. In addition, there have
been no filings of Form N-6EI-1 by separate accounts since 2008.
Therefore, there has been no cost or burden to the industry since that
time. The Commission requests authorization to maintain an inventory of
one burden hour for administrative purposes.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    Please direct your written comments to Thomas Bayer, Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: July 23, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-17776 Filed 7-28-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Rules and Regulations]
[Pages 32327-32329]
[FR Doc No: 2011-13902]

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

Federal Motor Carrier Safety Administration

49 CFR Parts 383 and 390

Regulatory Guidance on the Designation of Steerable Rear Axle
Operators (Tillermen) as Drivers of Commercial Motor Vehicles

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

ACTION: Notice of Regulatory Guidance.

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SUMMARY: FMCSA issues regulatory guidance concerning the applicability
of the term ``driver'' to ``tillerman,'' a person who controls the
steerable rear axle on a commercial motor vehicle. The term ``driver''
is used in FMCSA's commercial

driver's license requirements and in the Agency's general safety rules.
This notice provides Federal and State enforcement personnel, and the
motor carrier industry, with uniform guidance as to when certain
Federal rules concerning driver licensing and qualifications are
applicable to tillermen.

DATES: Effective Date: This regulatory guidance is effective June 6,
2011.

FOR FURTHER INFORMATION CONTACT: Thomas L. Yager, Chief, Driver and
Carrier Operations Division, Office of Bus and Truck Standards and
Operations, Federal Motor Carrier Safety Administration, 1200 New
Jersey Ave., SE., Washington, DC 20590. E-mail<EMAIL_ADDRESS>Phone
(202) 366-4325.

SUPPLEMENTARY INFORMATION:

Legal Basis

    The Motor Carrier Act of 1935 provides that ``The Secretary of
Transportation may prescribe requirements for (1) qualifications and
maximum hours of service of employees of, and safety of operation and
equipment of, a motor carrier; and (2) qualifications and maximum hours
of service of employees of, and standards of equipment of, a motor
private carrier, when needed to promote safety of operation'' [49
U.S.C. 31502(b)].
    The Motor Carrier Safety Act of 1984 (MCSA) confers on the
Secretary the authority to regulate drivers, motor carriers, and
vehicle equipment. It requires the Secretary to prescribe safety
standards for commercial motor vehicles (CMVs). At a minimum, the
regulations must ensure that (1) CMVs are maintained, equipped, loaded,
and operated safely; (2) the responsibilities imposed on operators of
CMVs do not impair their ability to operate the vehicles safely; (3)
the physical condition of operators of CMVs is adequate to enable them
to operate the vehicles safely; and (4) the operation of CMVs does not
have a deleterious effect on the physical condition of the operator [49
U.S.C. 31136(a)]. The Act also grants the Secretary broad power to
``prescribe recordkeeping and reporting requirements'' and to ``perform
other acts the Secretary considers appropriate'' [49 U.S.C. 31133(a)(8)
and (10)].
    The Commercial Motor Vehicle Safety Act of 1986 (CMVSA) requires
the Secretary to prescribe regulations on minimum licensing and testing
standards for persons seeking a commercial driver's license (CDL) to
operate a CMV. For purposes of the CMVSA, the term CMV means (among
other things) a vehicle with a weight or weight rating of at least
26,001 pounds, compared to a minimum weight threshold of 10,001 pounds
for purposes of the MCSA [49 U.S.C. chapter 313].
    The Administrator of FMCSA has been delegated the authority to
carry out the functions vested in the Secretary by the Motor Carrier
Act of 1935 [49 CFR 1.73(l)], the MCSA [Sec.  1.73(g)], and the CMVSA
[Sec.  1.73(e)(1)]. The provisions affected by this Notice of
Regulatory Guidance are based on these three statutes.

Background

    This document revises current regulatory guidance on the
applicability of the definition of a ``driver'' in 49 CFR 390.5, to
``tillerman,'' a person exercising control over the movement of a
steerable rear axle on a CMV. Section 390.5 states that ``Driver means
any person who operates any [CMV].'' Today's guidance also pertains to
CDL requirements for ``* * * every person who operates a commercial
motor vehicle (CMV) * * *'' (Sec.  383.3(a)).
    Current Regulatory Guidance Question 14 to Sec.  390.5 (62 FR
16370, 16407, April 4, 1997) reads as follows:

    ``Question 14: Is the tillerman who controls the steerable rear
axle of a vehicle so equipped a driver subject to the FMCSRs while
operating in interstate commerce?
    Guidance: Yes. Although the tillerman does not control the
vehicle's speed or braking, the rear-axle steering he/she performs is
essential to prevent the trailer from off tracking into other lanes or
vehicles or off the highway entirely. Because this function is critical
to the safe operation of vehicles with steerable rear axles, the
tillerman is a driver.''

Reason for This Notice

    The FMCSA has received inquiries from various entities, including
the Professional Escort Vehicle Operators Association and the
Specialized Carriers and Riggers Association, asking about other
circumstances under which a person exercising control over a CMV's
steerable rear axle would be considered a driver of the CMV under Sec.
383.3 and thus subject to the CDL requirements, or a driver under Sec.
390.5 and therefore subject to many provisions of the FMCSRs, such as
driver qualifications and hours of service.
    In these new scenarios, the tillerman does not sit on the CMV, but
walks alongside it to use a wired or wireless remote control to steer
the rear axle; sometimes the tillerman may be in an escort car. These
CMVs are typically specialized oversize vehicles on which the rear axle
is steered only when ``released'' and when the CMV is moving at very
slow speeds.\1\ Under these circumstances, we do not believe that the
persons operating the steerable rear axle should be classified as
``tillermen,'' as the term is used in Question 14. CDL knowledge and
skills testing would have little relevance to the remote-control
operation of a steerable rear axle on an oversized CMV. Therefore,
FMCSA believes it is necessary to update Question 14 for Sec.  390.5 to
differentiate among persons who might be considered to be
``tillermen,'' consistent with the explanation above.
---------------------------------------------------------------------------

    \1\ Steerable rear axles may have a ``locked'' or ``unlocked''
status, used for highway speeds and low speeds, respectively. The
status can be changed by operation of the trailer controls when the
CMV is not moving. In the ``locked'' position, the axle may be
completely fixed, or have a limited self-steering capability,
depending on the manufacturer's design. In the self-steering mode,
the axle automatically steers itself within a range determined by
the manufacturer to prevent tire scrubbing in turns. Typically, the
unlocked mode is used for over-length CMVs that cannot turn at many
roadway intersections without steering the rear axle under close
guidance of a remote operator.
---------------------------------------------------------------------------

    FMCSA considers the tillerman's physical location in, on, or around
a CMV to be the most relevant factor in determining whether the person
is a driver. A tillerman physically located on a vehicle is likely to
be responsible for steering the rear axles of the CMV at highway
speeds, and should be held responsible for safe operation of the
vehicle, just like the driver in the cab. Anyone controlling a
steerable rear axle from outside the CMV would be doing so under the
direction of the person in the cab, and should not be considered a
driver. Although certain training may be needed for such remote
operators, that would vary according to the equipment involved.
    For the reasons explained above, FMCSA issues Regulatory Guidance
Question 34 to Sec.  383.3 and revises Question 14 of the Regulatory
Guidance to Sec.  390.5 of the FMCSRs.

PART 383--COMMERCIAL DRIVERS LICENSE STANDARDS; REQUIREMENTS AND
PENALTIES

Section 383.3, ``Applicability.''

    ``Question 34: Would a tillerman, a person exercising control over
the steerable rear axle(s) on a commercial motor vehicle (CMV), be
considered a driver or ``* * * person who operates a [CMV] * * *''
(Sec.  383.3), and thus subject to applicable commercial driver's
license regulations?
    Guidance:
    A person physically located on the rear of the CMV who controls a
steerable rear axle while the CMV is moving at

highway speeds would be considered a ``* * * person who operates a
commercial motor vehicle * * *'' (Sec.  383.3), and would therefore be
subject to the applicable commercial driver's license regulations in 49
CFR part 383.
    A person walking beside a CMV or riding in an escort car while
controlling a steerable rear axle at slow speeds would not be
considered a ``* * * person who operates a [CMV] * * *'' (Sec.  383.3),
and therefore would not be subject to applicable commercial driver's
license regulations.''

PART 390--FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL

Section 390.5, ``Definitions.''

    ``Question 14: Would a tillerman, a person exercising control over
the steerable rear axle(s) on a commercial motor vehicle (CMV), be
considered a driver as defined in Sec.  390.5, and thus subject to 49
CFR Parts 390 to 399?
    Guidance:
    A person physically located on the rear of the CMV who controls a
steerable rear axle while the CMV is moving at highway speeds would be
considered a driver as defined in Sec.  390.5 and therefore would be
subject to the regulations in 49 CFR parts 390-399.
    A person walking beside a CMV or riding in an escort car while
controlling a steerable rear axle at slow speeds would not be
considered a driver as defined in Sec.  390.5 and would therefore not
be subject to 49 CFR Parts 390 to 399.''

    Issued on: May 25, 2011.
Anne S. Ferro,
Administrator.
[FR Doc. 2011-13902 Filed 6-3-11; 8:45 am]
BILLING CODE P


[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Notices]
[Pages 9776-9777]
[FR Doc No: 2019-04973]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2019-0039; FRL-9989-78]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before April 17, 2019.

ADDRESSES: Submit your comments, identified by the Docket
Identification (ID) Number and the File Symbol of interest as shown in
the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), main telephone number:<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>The mailing address for each contact person is:
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing
address, include the contact person's name, division, and mail code.
The division to contact is listed at the end of each pesticide petition
summary.

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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications.

III. New Active Ingredients

    1. EPA Registration Number: 7969-UNA. Docket ID number: EPA-HQ-OPP-
2018-0002. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, North Carolina 27709-3528. Active ingredients:
Mefentrifluconazole, Pyraclostrobin, and Fluxapyroxad. Product type:
Fungicide. Proposed uses: Beans and peas, citrus, corn seed, field
corn, popcorn, and sweet corn, peanut, potato, rapeseed (canola), small
grains, sorghum and millet, soybean, and sugar beet. Contact: RD.
    2. EPA Registration Number: 7969-UNE. Docket ID number: EPA-HQ-OPP-
2018-0002. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, North Carolina 27709-3528. Active ingredient:
Mefentrifluconazole. Product type: Fungicide. Proposed uses: Cereals,
citrus, grape, legumes, peanuts, pome fruits, potato, rapeseed
(canola), stone fruits, sugar beet, and tree nuts; seed treatment use
on buckwheat, corn seed, field corn, popcorn, and sweet corn, millet,
oats, rye, sorghum, soybean, triticale, and wheat seeds; turfgrass use
sites including golf courses, institutional, commercial, and municipal
lawns, parks, cemeteries, and sod farms, nonturfgrass areas (including
landscape beds, stands of trees) within recreational turfgrass areas;
ornamental use sites (including containers, greenhouses, lathhouses,
and shadehouses, outdoor nurseries, including container, bench, flat,
plug, bed-grown or field-grown ornamentals), forest and conifer
nurseries, and plantations, retail nurseries, and ornamentals found in
interiorscapes, golf courses, recreational landscapes, and residential
and commercial landscapes. Contact: RD.
    3. EPA Registration Number: 7969-UNI. Docket ID number: EPA-HQ-OPP-
2018-0002. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, North Carolina 27709-3528. Active ingredient:
Mefentrifluconazole. Product type: Fungicide. Proposed uses: Beans and

peas, citrus, corn seed, field corn, popcorn, and sweet corn, peanut,
potato, rapeseed (canola), small grains, sorghum and millet, soybean,
and sugar beet. Contact: RD.
    4. EPA Registration Number: 7969-UNL. Docket ID number: EPA-HQ-OPP-
2018-0002. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, North Carolina 27709-3528. Active ingredient:
Mefentrifluconazole. Product type: Fungicide. Proposed uses: Seed
treatment on crops: Barley, buckwheat, field corn, popcorn, and sweet
corn, millet, oats, rye, sorghum, soybean, triticale, and wheat.
Contact: RD.
    5. EPA Registration Number: 7969-UNO. Docket ID number: EPA-HQ-OPP-
2018-0002. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, North Carolina 27709-3528. Active ingredient:
Mefentrifluconazole and Pyraclostrobin. Product type: Fungicide.
Proposed uses: Beans and peas, citrus, corn seed, field corn, popcorn,
and sweet corn, peanut, potato, rapeseed (canola), small grains,
sorghum and millet, soybean, and sugar beet. Contact: RD.
    6. EPA Registration Number: 7969-URR. Docket ID number: EPA-HQ-OPP-
2018-0002. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, North Carolina 27709-3528. Active ingredient:
Mefentrifluconazole. Product type: Fungicide. Proposed uses: Beans and
peas, citrus, corn seed, field corn, popcorn, and sweet corn, peanut,
potato, rapeseed (canola), small grains, sorghum and millet, soybean,
and sugar beet. Contact: RD.
    7. EPA Registration Number: 59639-EGE. Docket ID number: EPA-HQ-
OPP-2018-0038. Applicant: Valent U.S.A. LLC, 1600 Riviera Avenue, Suite
200, Walnut Creek, CA 94596. Product name: V-10417 FS Fungicide. Active
ingredient: Fungicide--Ethaboxam at 7.07%, metalaxyl 1.89%, Inpyrfluxam
at 4.71%. Proposed use: Seed treatment use on legume vegetable crop
group 6, except cowpea and field pea. Contact: RD.
    8. EPA Registration Number: 59639-EGG. Docket ID number: EPA-HQ-
OPP-2018-0038. Applicant: Valent U.S.A. LLC, 1600 Riviera Avenue, Suite
200, Walnut Creek, CA 94596. Product name: S-2399 Technical Fungicide.
Active ingredient: Fungicide--Inpyrfluxam at 97.4%. Proposed uses:
Apple, corn (field, pop and sweet), peanut, rice, soybean and sugar
beet. Seed treatment uses on legume vegetable crop group 6, cereal
grain crop group 15, rapeseed crop subgroup 20A and sugar beet.
Contact: RD.
    9. EPA Registration Number: 59639-EGN. Docket ID number: EPA-HQ-
OPP-2018-0038. Applicant: Valent U.S.A. LLC, 1600 Riviera Avenue, Suite
200, Walnut Creek, CA 94596. Product name: S-2399 2.84 SC Fungicide.
Active ingredient: Fungicide--Inpyrfluxam at 31.25%. Proposed uses:
Apple, corn (field, pop and sweet), peanut, rice, soybean and sugar
beet. Contact: RD.
    10. EPA Registration Number: 59639-EGR. Docket ID number: EPA-HQ-
OPP-2018-0038. Applicant: Valent U.S.A. LLC, 1600 Riviera Avenue, Suite
200, Walnut Creek, CA 94596. Product name: S-2399 3.2 FS Fungicide.
Active ingredient: Fungicide--Inpyrfluxam at 34.05%. Proposed uses:
Seed treatment uses on cereal grains crop group 15, legume vegetables
crop group 6, rapeseed crop subgroup 20A, and sugar beet. Contact: RD.

    Authority: 7 U.S.C. 136 et seq.

    Dated: February 27, 2019.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2019-04973 Filed 3-15-19; 8:45 am]
BILLING CODE 6560-50-P