[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Notices]
[Pages 8791-8792]
[FR Doc No: 2021-02649]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0049; FRL-10019-71]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients (December 2020)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 March 11, 2021.

ADDRESSES: Submit your comments, identified by 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), main telephone number: (703)
305-7090, 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).

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 https://www.epa.gov/dockets/commenting-epa-dockets.

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. For actions being evaluated under EPA's public
participation process for registration actions, there will be an
additional opportunity for public comment on the proposed decisions.
Please see EPA's public participation website for additional
information on this process (http://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions).

A. New Active Ingredients

    1. File Symbol: 89186-E. Docket ID number: EPA-HQ-OPP-2020-0252.
Applicant: ConidioTec LLC, 2440 Earlystown Rd., Ste. 600, Centre Hall,
PA 16828 (c/o Lewis & Harrison, 2461 South Clark St., Ste. 710,
Arlington, VA 22202). Product name: Aprehend RTU. Active ingredient:
Insecticide--Beauveria bassiana Strain l93-825 at 2%. Proposed use: To
control and prevent bed bug infestations in indoor environments.
Contact: BPPD.
    2. File Symbol: 95213-E. Docket ID number: EPA-HQ-OPP-2020-0576.
Applicant: Indigo Ag, Inc., 500 Rutherford Ave., Ste. 201, Boston, MA
02129. Product name: Kosakonia cowanii strain SYM00028 MUP. Active
ingredient: Fungicide--Kosakonia cowanii strain SYM00028 at 6.80%.
Proposed use: Manufacturing use. Contact: BPPD.
    3. File Symbol: 95213-G. Docket ID number: EPA-HQ-OPP-2020-0576.
Applicant: Indigo Ag, Inc., 500 Rutherford Ave., Ste. 201, Boston, MA
02129. Product name: Indigo 229 FP. Active ingredient: Fungicide--
Kosakonia cowanii strain SYM00028 at 3.00%. Proposed use: Seed
treatment. Contact: BPPD.
    4. File Symbol: 95213-R. Docket ID number: EPA-HQ-OPP-2020-0576.
Applicant: Indigo Ag, Inc., 500 Rutherford Ave., Ste. 201, Boston, MA
02129. Product name: Kosakonia cowanii strain SYM00028 Technical.
Active ingredient: Fungicide--Kosakonia cowanii strain SYM00028 at
100%. Proposed use: Manufacturing use. Contact: BPPD.
    5. File Symbol: 95213-U. Docket ID number: EPA-HQ-OPP-2020-0576.
Applicant: Indigo Ag, Inc., 500 Rutherford Ave., Ste. 201, Boston, MA
02129. Product name: Indigo 229 WD. Active ingredient: Fungicide--
Kosakonia cowanii strain SYM00028 at 3.300%. Proposed use: Seed
treatment. Contact: BPPD.

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

    Dated: January 21, 2021.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2021-02649 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Page 2859]
[FR Doc No: 2016-00815]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-706-000]

RE Garland A LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
RE Garland A LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is February 1, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: January 12, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-00815 Filed 1-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31241-31243]
[FR Doc No: 2018-14277]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83535; File No. SR-BX-2018-024]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Relocate the
Exchange's Rules Pertaining to Co-Location and Direct Connectivity

June 28, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 13, 2018, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to relocate the Exchange's rules pertaining
to co-location and direct connectivity, which are presently at Rules
7034 and 7051, to Sections 1 and 2, respectively, under a new General 8
(``Connectivity'') heading within the Exchange's new rulebook shell,
entitled ``General Equity and Options Rules.'' The Exchange also
proposes to correct an error in Rule 7051(b).
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to relocate its rules governing co-location
and direct connectivity services, which presently comprise Rules 7034
and 7051, respectively. The Exchange proposes to establish, within its
new rulebook shell,\3\ a new General 8 heading, entitled
``Connectivity,'' to renumber Rule 7034 as Section 1 thereunder, and to
renumber Rule 7051 as Section 2 thereunder. The Exchange furthermore
proposes to amend Rules 7011, 7025, 7030, and Options Rules Chapter XV
to update cross references therein to Rules 7034 and 7051, as
applicable. The Exchange also proposes to update internal cross-
references in the renumbered Rules.
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    \3\ Recently, the Exchange added a shell structure to its
Rulebook with the purpose of improving efficiency and readability
and to align its rules closer to those of its five sister exchanges:
The Nasdaq Stock Market, LLC; Nasdaq PHLX LLC; Nasdaq ISE, LLC;
Nasdaq GEMX, LLC; and Nasdaq MRX, LLC (together with BX, the
``Affiliated Exchanges''). See Securities Exchange Act Release No.
82174 (November 29, 2017), 82 FR 57492 (December 5, 2017) (SR-BX-
2017-054).
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    The Exchange considers it appropriate to relocate these Rules to
better organize its Rulebook. The other Affiliated Exchanges intend to
propose similar reorganizations of their co-location and direct
connectivity rules so that these rules will be harmonized among all of
the Affiliated Exchanges.
    The relocation of the co-location and direct connectivity rules is
part of the Exchange's continued effort to promote efficiency and
conformity of its processes with those of its Affiliated Exchanges. The
Exchange believes that moving the co-location and direct connectivity
rules to their new location will facilitate the use of the Rulebook by
Members of the Exchange who are members of other Affiliated Exchanges.
    In addition to the above, the Exchange proposes to correct an error
in Rule 7051(b), entitled ``Direct Circuit Connection to Third Party
Services.'' The Exchange recently amended Rule 7051 in an attempt to
harmonize it with the corresponding rules of the other Affiliated
Exchanges.\4\ However, the Exchange recently discovered one remaining
unintended discrepancy that it now proposes to remedy. The other
Affiliated Exchanges waive installation and ongoing monthly fees for
10Gb Ultra and 1 GB Ultra direct circuit

connections to third party services for the first two connections per
client to UTP SIP feeds only (UQDF and UTDF).\5\ The Exchange's Rule
does not presently provide for such waivers; it now proposes to amend
the Rule so that it does so. With this amendment, Rule 7051(b) will be
substantially the same as the corresponding rules of the other
Affiliated Exchanges.
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    \4\ See Securities Exchange Act Release No. 34-82628 (Feb. 5,
2018). 83 FR 5818 (Feb. 9, 2018) (SR-BX-2018-006).
    \5\ See Nasdaq Rule 7051(b), Phlx Pricing Schedule Section
XI(b), Nasdaq ISE Schedule of Fees Section VI.G, Nasdaq GEMX
Schedule of Fees Section IV.D [sic], Nasdaq MRX Schedule of Fees
Section VI.C.
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by improving the way its Rulebook is organized, providing ease of
reference in locating co-location and direct connectivity rules, and
harmonizing the Exchange's Rules with those of the other Affiliated
Exchanges. As previously stated, the proposed Rule relocation is non-
substantive.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that it is in the interests of investors
and the public to remedy unintended errors in the Exchange's rules.
Investors and the public have clear interests in the Exchange
maintaining an accurate rulebook and schedule of fees.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on intermarket or intra-market competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
The proposed changes to relocate the Exchange's rules do not impose a
burden on competition because, as previously stated, they (i) are of a
non-substantive nature, (ii) are intended to harmonize the Exchange's
rules with those of its Affiliated Exchanges, and (iii) are intended to
organize the Rulebook in a way that it will ease the Members'
navigation and reading of the rules across the Affiliated Exchanges.
Likewise, the Exchange's proposal to amend Rule 7051(b) will not burden
competition because it merely corrects an unintended error and renders
the Exchange's fees identical to those that the other Affiliated
Exchanges charge.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-
4(f)(6) thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \10\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \11\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become operative upon filing. The
proposed rule change merely relocates the Exchange's co-location and
direct connectivity rules, updates rule cross-references, and corrects
unintended errors from a previous proposed rule change.\12\
Accordingly, the Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest and hereby waives the operative delay and designates
the proposed rule change operative upon filing.\13\
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    \10\ 17 CFR 240.19b-4(f)(6).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ See supra notes 4-5 and accompanying text.
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BX-2018-024 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2018-024. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish

to make available publicly. All submissions should refer to File Number
SR-BX-2018-024, and should be submitted on or before July 24, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-14277 Filed 7-2-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16003-16007]
[FR Doc No: 2014-06367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0627]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Food and Drug Administration Approval
To Market a New Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requirements governing
applications for FDA approval to market a new drug.

DATES: Submit either written or electronic comments on the collection
of information by May 23, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration,1350 Piccard Dr., PI50-400B, Rockville, MD
20850<EMAIL_ADDRESS>
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, including
each proposed extension of an existing 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 listed below.
    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.

Application for FDA Approval To Market a New Drug--(OMB Control Number
0910-0001)--Extension

    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially
marketed in the United States, imported, or exported from the United
States, unless an approval of an application filed with FDA under
section 505(b) or 505(j) of the act is effective with respect to such
drug. Under the FD&C Act, it is the sponsor's responsibility to provide
the information needed by FDA to make a scientific and technical
determination whether the product is safe and effective for use.
    This approval request is for all information collection
requirements imposed on applicants by the regulations under part 314
(21 CFR part 314) who apply for approval of a new drug application
(NDA) or abbreviated new drug application (ANDA) in order to market or
to continue to market a drug.
    Section 314.50(a) requires that an application form (Form FDA 356h)
be submitted that includes introductory information about the drug as
well as a checklist of enclosures.
    Section 314.50(b) requires that an index be submitted with the
archival copy of the application and that it reference certain sections
of the application.
    Section 314.50(c) requires that a summary of the application be
submitted that presents a good general synopsis of all the technical
sections and other information in the application.
    Section 314.50(d) requires that the NDA contain the following
technical sections about the new drug: Chemistry, manufacturing, and
controls; nonclinical pharmacology and toxicology; human
pharmacokinetics and bioavailability; microbiology; clinical data;
statistical; and pediatric use sections.
    Section 314.50(e) requires the applicant to submit samples of the
drug if requested by FDA. In addition, the archival copy of the
application must include copies of the label and all labeling for the
drug.
    Section 314.50(f) requires that case report forms and tabulations
be submitted with the archival copy.
    Section 314.50(h) requires that patent information, as described
under Sec.  314.53, be submitted with the application. (The burden
hours for Sec.  314.50(h) are already approved by OMB under OMB control
number 0910-0513 and are not included in the burden estimates in Table
1 of this document.)
    Section 314.50(i) requires that patent certification information be
submitted in section 505(b)(2) applications for patents claiming the
drug, drug product, or method of use.
    Section 314.50(j) requires that applicants that request a period of
marketing exclusivity submit certain information with the application.
    Section 314.50(k) requires that the application contain a financial
certification or disclosure statement or both.
    Section 314.50(l) requires that an archival, review, and field copy
of the application be submitted, including the content of labeling and
all labeling and labels.
    Section 314.52 requires that any notice of certification of
invalidity or non-infringement of a patent to each patent owner and the
NDA holder be sent by a section 505(b)(2) applicant that relies on a
listed drug. A 505(b)(2) applicant is required to amend its application
at the time notice is provided to include a statement certifying that
the required notice has been provided. A 505(b)(2) applicant also is
required to amend its application to document receipt of the required
notice.
    Section 314.54 sets forth the content requirements for applications
filed under section 505(b)(2) of the FD&C Act. (The information
collection burden estimate for 505(b)(2) applications is included in
table 1 of this document under the estimates for Sec.  314.50 (a), (b),
(c), (d), (e), (f), (g), (i), (j), (k) and (l)).
    Section 314.60 sets forth reporting requirements for sponsors who
amend an unapproved application.
    Section 314.65 states that the sponsor must notify FDA when
withdrawing an unapproved application.
    Sections 314.70 and 314.71 require that supplements be submitted to
FDA for certain changes to an approved application.
    Section 314.72 requires sponsors to report to FDA any transfer of
ownership of an application.
    Section 314.80(c)(1) and (c)(2) sets forth requirements for
expedited adverse drug experience postmarketing reports and followup
reports, as well as for periodic adverse drug experience postmarketing
reports (Form FDA 3500A). (The burden hours for Sec.  314.80(c)(1) and
(c)(2) are already approved by OMB under OMB control numbers 0910-0230
and 0910-0291 and are not included in the burden estimates in table 1
of this document.)
    Section 314.80(i) establishes recordkeeping requirements for
reports of postmarketing adverse drug experiences. (The burden hours
for Sec.  314.80(i) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the burden
estimates in table 1 of this document.)
    Section 314.81(b)(1) requires that field alert reports be submitted
to FDA (Form FDA 3331).
    Section 314.81(b)(2) requires that annual reports be submitted to
FDA (Form FDA 2252).
    Section 314.81(b)(3)(i) requires that drug advertisements and
promotional labeling be submitted to FDA (Form FDA 2253).
    Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. (The burden
hours for Sec.  314.81(b)(3)(iii) are already approved by OMB under OMB
control number 0910-0045 and are not included in the burden estimates
in table 1 of this document.)
    Section 314.90 sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.50 through 314.81.
(The information collection burden estimate for NDA waiver requests is
included in table 1 of this document under the estimates for each
section that is in subpart B of part 314.)
    Section 314.93 sets forth requirements for submitting a suitability
petition in accordance with Sec.  10.20 (21 CFR 10.20) and Sec.  10.30.
(The burden hours for Sec.  314.93 are already approved by OMB under
0910-0183 and are not included in the burden estimates in table 1 of
this document.)
    Section 314.94(a) and (d) requires that an ANDA contain the
following information: Application form; table of contents; basis for
ANDA submission; conditions of use; active ingredients; route of
administration, dosage form, and strength; bioequivalence; labeling;
chemistry, manufacturing, and controls; samples; patent certification.
    Section 314.95 requires that any notice of certification of
invalidity or non-infringement of a patent to each patent owner and the
NDA holder be sent by ANDA applicants.

    Section 314.96 sets forth requirements for amendments to an
unapproved ANDA.
    Section 314.97 sets forth requirements for submitting supplements
to an approved ANDA for certain changes to the application.
    Section 314.98(a) sets forth postmarketing adverse drug experience
reporting and recordkeeping requirements for ANDAs. (The burden hours
for Sec.  314.98(a) are already approved by OMB under OMB control
numbers 0910-0230 and 0910-0291 and are not included in the burden
estimates in table 1 of this document.)
    Section 314.98(c) requires other postmarketing reports for ANDAs:
Field alert reports (Form FDA 3331), annual reports (Form FDA 2252),
and advertisements and promotional labeling (Form FDA 2253). (The
information collection burden estimate for field alert reports is
included in table 1 of this document under Sec.  314.81(b)(1); the
estimate for annual reports is included under Sec.  314.81(b)(2); the
estimate for advertisements and promotional labeling is included under
Sec.  314.81(b)(3)(i).)
    Section 314.99(a) requires that sponsors comply with certain
reporting requirements for withdrawing an unapproved ANDA and for a
change in ownership of an ANDA.
    Section 314.99(b) sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.92 through 314.99.
(The information collection burden estimate for ANDA waiver requests is
included in table 1 of this document under the estimates for each
section that is in subpart C of part 314.)
    Section 314.101(a) states that if FDA refuses to file an
application, the applicant may request an informal conference with FDA
and request that the application be filed over protest.
    Section 314.107(c) requires notice to FDA by the first applicant to
submit a substantially complete ANDA containing a certification that a
relevant patent is invalid, unenforceable, or will not be infringed of
the date of first commercial marketing. (The information collection
burden estimate for Sec.  314.107(c) is included in table 1 of this
document under the estimates for Sec.  314.50(a), (b), (c), (d), (e),
(f), (g), (i), (j), (k) and (l)).
    Section 314.107(e) requires that an applicant submit a copy of the
entry of the order or judgment to FDA within 10 working days of a final
judgment. (The information collection burden estimate for Sec.
314.107(e) applications is included in table 1 of this document under
the estimates for Sec.  314.50(a), (b), (c), (d), (e), (f), (g), (i),
(j), (k) and (l)).
    Section 314.107(f) requires that ANDA or section 505(b)(2)
applicants notify FDA immediately of the filing of any legal action
filed within 45 days of receipt of the notice of certification. A
patent owner may also notify FDA of the filing of any legal action for
patent infringement. If the patent owner or approved application holder
who is an exclusive patent licensee waives its opportunity to file a
legal action for patent infringement within the 45-day period, the
patent owner or approved application holder must submit to FDA a waiver
in the specified format. (The information collection burden estimate
for Sec.  314.107(f) is included in table 1 of this document under the
estimates for Sec.  314.50 (a), (b), (c), (d), (e), (f), (g), (i), (j),
(k) and (l)).
    Section 314.110(b)(3) states that, after receipt of an FDA complete
response letter, an applicant may request an opportunity for a hearing
on the question of whether there are grounds for denying approval of
the application. (The burden hours for Sec.  314.110(b)(3) are included
under parts 10 through 16 (21 CFR parts 10 and 16) hearing regulations,
in accordance with Sec.  314.201, and are not included in the burden
estimates in table 1 of this document.)
    Section 314.122(a) requires that an ANDA or a suitability petition
that relies on a listed drug that has been voluntarily withdrawn from
sale must be accompanied by a petition seeking a determination whether
the drug was withdrawn for safety or effectiveness reasons. (The burden
hours for Sec.  314.122(a) are already approved by OMB under OMB
control number 0910-0183 and are not included in the burden estimates
in table 1 of this document.)
    Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. (The burden hours for Sec.
314.122(d) are already approved by OMB under OMB control number 0910-
0183 and are not included in the burden estimates in table 1 of this
document.)
    Section 314.126(c) sets forth requirements for a petition to waive
criteria for adequate and well-controlled studies. (The burden hours
for Sec.  314.126(c) are already approved by OMB under 0910-0183 and
are not included in the burden estimates in table 1 of this document.)
    Section 314.151(a) and (b) set forth requirements for the
withdrawal of approval of an ANDA and the applicant's opportunity for a
hearing and submission of comments. (The burden hours for Sec.
314.151(a) and (b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.151(c) sets forth the requirements for withdrawal of
approval of an ANDA and the applicant's opportunity to submit written
objections and participate in a limited oral hearing. (The burden hours
for Sec.  314.151(c) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.153(b) sets forth the requirements for suspension of an
ANDA when the listed drug is voluntarily withdrawn for safety and
effectiveness reasons, and the applicant's opportunity to present
comments and participate in a limited oral hearing. (The burden hours
for Sec.  314.152(b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.161(b) and (e) sets forth the requirements for
submitting a petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
(The burden hours for Sec.  314.161(b) and (e) are already approved by
OMB under OMB control number 0910-0183 and are not included in the
burden estimates in table 1 of this document.)
    Section 314.200(c), (d), and (e) requires that applicants or others
subject to a notice of opportunity for a hearing who wish to
participate in a hearing file a written notice of participation and
request for a hearing as well as the studies, data, and so forth,
relied on. Other interested persons may also submit comments on the
notice. This section also sets forth the content and format
requirements for the applicants' submission in response to notice of
opportunity for hearing. (The burden hours for Sec.  314.200(c), (d),
and (e) are included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, and are not included in the burden
estimates in table 1 of this document.)
    Section 314.200(f) states that participants in a hearing may make a
motion to the presiding officer for the inclusion of certain issues in
the hearing. (The burden hours for Sec.  314.200(f) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, and are not included in the burden estimates in table 1 of
this document.)

    Section 314.200(g) states that a person who responds to a proposed
order from FDA denying a request for a hearing provide sufficient data,
information, and analysis to demonstrate that there is a genuine and
substantial issue of fact which justifies a hearing. (The burden hours
for Sec.  314.200(g) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, and are not included in
the burden estimates in table 1 of this document.)
    Section 314.420 states that an applicant may submit to FDA a drug
master file in support of an application, in accordance with certain
content and format requirements.
    Section 314.430 states that data and information in an application
are disclosable under certain conditions, unless the applicant shows
that extraordinary circumstances exist. (The burden hours for Sec.
314.430 are included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, and are not included in the burden
estimates in table 1 of this document.)
    Section 314.530(c) and (e) states that if FDA withdraws approval of
a drug approved under the accelerated approval procedures, the
applicant has the opportunity to request a hearing and submit data and
information. (The burden hours for Sec.  314.530(c) and (e) are
included under parts 10 through 16 hearing regulations, in accordance
with Sec.  314.201, and are not included in the burden estimates in
table 1 of this document.)
    Section 314.530(f) requires that an applicant first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. (The burden hours for Sec.  314.530(f)
are already approved by OMB under 0910-0194 and are not included in the
burden estimates in table 1 of this document.)
    Section 314.550 requires an applicant with a new drug product being
considered for accelerated approval to submit copies of all promotional
materials to the FDA during the preapproval and post-approval periods.
    Section 314.610(b)(1) requires that applicants include a plan or
approach to postmarketing study commitments in applications for
approval of new drugs when human efficacy studies are not ethical or
feasible, and provide status reports of postmarketing study
commitments. (The information collection burden estimate for Sec.
314.610(b)(1) is included in table 1 of this document under the
estimates for Sec. Sec.  314.50 (a), (b), (c), (d), (e), (f), (k) and
(l) and 314.81(b)(2)).
    Section 314.610(b)(3) requires that applicants propose labeling to
be provided to patient recipients in applications for approval of new
drugs when human efficacy studies are not ethical or feasible. (The
information collection burden estimate for Sec.  314.610(b)(3) is
included in table 1 of this document under the estimates for Sec.
314.50(e)).
    Section 314.630 requires that applicants provide postmarketing
safety reporting for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. (The burden hours for
Sec.  314.630 are already approved by OMB under OMB control numbers
0910-0230 and 0910-0291 and are not included in the burden estimates in
table 1 of this document.)
    Section 314.640 requires that applicants provide promotional
materials for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. (The information
collection burden estimate for Sec.  314.640 is included in table 1 of
this document under the estimates for Sec.  314.81(b)(3)(i)).
    Respondents to this collection of information are all persons who
submit an application or abbreviated application or an amendment or
supplement to FDA under part 314 to obtain approval of a new drug, and
any person who owns an approved application or abbreviated application.

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 21 CFR Section; [FDA Form No.]      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
314.50 (a), (b), (c), (d), (e),              106            1.42             151        1,921         290,071
 (f), (g), (i), (j), (k) and (l)
 [356h].........................
314.52..........................               7            3                 21           16             336
314.95..........................             209            3                627           16          10,032
314.60..........................             277            8.73           2,419           80         193,520
314.65..........................              18            1.16              21            2              42
314.70 and 314.71...............             374            7.63           2,854          150         428,100
314.72..........................              66            2.20             145            2             290
314.81(b)(1) [3331].............             260           16.31           4,241            8          33,928
314.81(b)(2) [2252].............             930           11.28          10,495           40         419,800
314.81(b)(3)(i) [2253]..........             520           87.43          45,461            2          90,922
314.94(a) and (d)...............             251            4.73           1,186          480         569,280
314.96..........................             434           24.60          10,675           80         854,000
314.97..........................             306           18.34           5,611           80         448,880
314.99(a).......................             219            3.01             659            2           1,318
314.101(a)......................               1            1                  1             .50             .50
314.420.........................             524            1.98           1,038           61          63,318
314.550.........................              20            7                140          120          16,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............    3,420,637.50
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06367 Filed 3-21-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28099-28101]
[FR Doc No: 2022-10012]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2022-0044]

Agency Information Collection Activities; Notice and Request for
Comment; Field Study of Heavy Vehicle Crash Avoidance Systems

ACTION: Notice and request for public comment on an extension of a
currently approved information collection.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
invites public comments about our intention to request approval from
the Office of Management and Budget (OMB) for an extension of a
currently approved information collection. Before a federal agency may
collect certain information from the public, it must receive approval
from OMB. Under procedures established by the Paperwork Reduction Act
of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatements of previously approved collections. This
document describes a collection of information for which NHTSA intends
to seek OMB extension approval, titled ``Heavy Vehicle Crash Avoidance
Systems'' and identified by OMB Control Number 2127-0741, which is
currently approved through August 31, 2022. This project has been
delayed due to COVID-19 shutdowns and precautions. The extension is
necessary to continue the current data collection to completion. This
extension request updates the burden hours to reflect the numbers of
respondents that are needed to complete the study, updates to time
estimates for responses, and mean hourly rates. Additionally, this
notice provides clarification on the burden hours and the costs to the
public.

DATES: Comments must be submitted on or before July 11, 2022.

ADDRESSES: You may submit comments using any of the following methods:
     Electronic submissions: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, West Building, Room W12-140,
Washington, DC 20590.
     Hand Delivery: 1200 New Jersey Avenue SE, West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. Telephone (202) 366-
9322.
    Instructions: Each submission must include the Agency name and
Docket number identified at the beginning of this document. Note that
all comments received will be posted without change to http://www.regulation.gov, including any personal information provided. Please
see the Privacy heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://www.dot.gov/privacy.html.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, or the street
address listed above. Follow the online instructions for accessing the
dockets via the internet.

FOR FURTHER INFORMATION CONTACT: Jenny Zhang, Office of Vehicle Safety
Research, National Highway Traffic Safety Administration, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC
20590, Telephone:<PHONE_NUMBER>; email address [email protected].
Please identify the relevant collection of

information by referring to its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. OMB has promulgated regulations describing what must be
included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following: (a)
Whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information will have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (c) how to enhance the quality, utility, and clarity of the
information to be collected; (d) how to minimize the burden of the
collection of information on those who are to respond, including 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. In
compliance with these requirements, NHTSA asks for public comments on
the extension of the following collection of information for which the
agency is seeking approval from OMB.
    Title: Field Study of Heavy Vehicle Crash Avoidance Systems.
    Type of Request: Extension of a currently approved information
collection.
    OMB Control Number: 2127-0741.
    Form Number: None.
    Type of Review Requested: Regular.
    Requested Expiration Date of Approval: Three years from date of
approval.
    Summary of the Collection of Information: The National Highway
Traffic Safety Administration (NHTSA) is gathering information
regarding drivers' naturalistic driving experiences and opinions about
crash avoidance systems (CAS) consisting of Lane Departure Warning,
Forward Collision Warning, Impact Alert, and Automatic Emergency
Braking for heavy vehicles.
    CAS technology has been advancing rapidly since the conclusion of
the previous study, with products for heavy commercial vehicles
becoming commercially available. These systems present opportunities
for improving driver awareness and behavior, improving drivers'
responses to potential collisions, and mitigating or preventing
collisions when drivers do not respond. The newest generation of CAS
technology includes several new features, such as multiple sensors,
improvements to radar algorithms, and new features such as full braking
in response to static objects or pedestrians. However, it is unknown if
this newest generation of products has been able to reduce the
prevalence of false or nuisance alerts observed in the previous study,
if there are any issues with new types of alerts that have been added
since previous studies, or whether driver have negative perceptions of
the technology due to these issues. As these technologies become more
popular with fleets, it is important to understand their real-world
performance and any unintended consequences that may arise from them.
    Data collection began in August 2021 after COVID delays and a
shortage of chips necessary for use in the data acquisition system
necessary for the naturalistic driving portion of the study. As of
December 31, 2021, one respondent has completed the study, three are in
the field study portion, and one has completed the informed consent
document and pre-field study surveys but still needs to go through the
installation portion of stage one and stages two to three of the study.
Information in this extension requests refers to the respondents and
burden associated with completing the study.
    Description of the Need for the Information and Proposed Use of the
Information: The collection of information consists of: An informed
consent for participation, a demographic questionnaire, an initial CAS
technology questionnaire, and a post-study CAS technology
questionnaire.
    The information to be collected will be used as follows:
     Informed Consent is collected from respondents who agree
to participate in the study; the informed consent has been approved by
an Institutional Review Board.
     Demographic questionnaire is used to obtain demographic
information so that potential analysis may account for participants
from various groups (e.g., age, self-identified gender, driving
experience, and experience with CAS technology).
     Initial CAS technology questionnaire is used to get
information about drivers' beliefs and attitudes towards the CAS
technology installed on the commercial vehicle they use for their job
prior to data collection. This questionnaire assesses perceived
usability of the systems in terms of acceptance and satisfaction, as
well as willingness to have this technology in their vehicle.
     Final CAS technology questionnaire is used to get
information about drivers' beliefs and attitudes towards the CAS
technology installed on the commercial vehicle they use for their job
at the end of data collection. These questionnaires will also be used
to assess perceived distraction potential of the systems in terms of
acceptance and satisfaction, as well as willingness to have this
technology in their vehicle. Each driver will complete a post-study
questionnaire once, after the completion of his or her data collection.
The post-study survey will gauge how drivers' attitudes and preferences
may have changed over the course of participation.
     Each participating driver will have a data acquisition
system (DAS) installed in their vehicle for approximately three months
while they perform their normal work duties. This system will collect
video of the driver and forward roadway, telemetry and vehicle network
data related to driving, and activations of the vehicle's CAS.
    Respondents: Respondents for this study are drawn from a
convenience sample from trucking fleets across the United States.
Drivers are recruited from fleets that have signed agreements with the
research team and have trucks that are outfitted with CAS technologies.
Recruitment will attempt to balance the number of vehicles using
particular brands of CAS technology but will be subject to fleet
availability and scheduling constraints. Requirements of drivers
involved in the study do not extend beyond employment requirements for
each fleet.
    Estimated Number of Respondents: 170 remaining respondents for
initial phases of the study; anticipating some drop-out, the end-goal
number of remaining respondents is 149.
    Estimated Number of Responses: 170 for the consent form (one per
respondent); 170 for the Demographic Questionnaire (one per
respondent); 170 for the Initial CAS Questionnaire (one per
respondent); 149 for the Final CAS Questionnaire (one per respondent)
that completes the study.
    Estimated Total Annual Burden: 123.6 hours total.
    Estimated Frequency: The Informed Consent Form, Demographic
Questionnaire, and Initial CAS Technology Questionnaire are completed
once at the start of participation and data collection. The

Final CAS Technology Questionnaire is completed once at the completion
of participation, approximately three months later.

                                               Table 1--Burden Calculations and Estimated Opportunity Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Estimated
                   Instrument                       Number of       time for        Total  estimated  burden hours       Hourly wage    Estimated total
                                                   respondents     completion                  [dagger]                                 opportunity cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage One:
    Informed Consent Form......................             170              20  57 hours............................          $23.42          $1,334.94
    Demographic Questionnaire..................             170               5  15 hours............................           23.42             351.30
    Initial CAS Technology Questionnaire.......             170              25  71 hours............................           23.42           1,662.82
Stage Two:
    Naturalistic Driving Study.................             171             N/A  N/A.................................             N/A                N/A
Stage Three:
    Final CAS Technology Questionnaire.........             149              25  63 hours............................           23.42           1,475.46
                                                --------------------------------------------------------------------------------------------------------
    Total Burden Remaining.....................  ..............  ..............  206 hours...........................  ..............           4,824.52
--------------------------------------------------------------------------------------------------------------------------------------------------------
Months Remaining...............................  ..............  ..............  20..................................  ..............  .................
Annual Burden Remaining........................  ..............  ..............  123.6 hours.........................  ..............           2,894.71
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The above table reflects the annual burden hours to be 123.6 to
complete data collection. While the table reflects opportunity costs,
this is not a burden incurred by the public for this information
collection. The annual burden cost to respondents is zero.
    The previous notice estimated total burden hours for this study to
be 193.5 total. The total number of burden hours to complete data
collection is now 206 based on updates to the time for the Informed
Consent and the Demographic Questionnaire. Opportunity costs have been
updated to reflect current average hourly wages; however, this is not a
burden to respondents for the information collection.
    Due to COVID-19 shutdowns and precautions, data collection efforts
were suspended. NHTSA anticipates additional time beyond the August 31,
2022, expiration date of the currently approved collection to complete
this effort. The federal government began this study at $2,581,075 in
contract expenses and has added expenses due to the time delays and
resulting changes in technology. The total cost expected at this time
is $2,954,970 with an annualized cost to the federal government over
the expected study time-to-completion of $402,950.
    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 the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department 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.
    Authority: The Paperwork Reduction Act of 1995, 44. U.S.C. Chapter
35, as amended; 5 CFR part 1320; and 49 CFR 1.95.

    Issued in Washington DC.
Cem Hatipoglu,
Associate Administrator for Vehicle Safety Research.
[FR Doc. 2022-10012 Filed 5-9-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Page 31965]
[FR Doc No: 2017-14480]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No.: 14568-003]

CB Energy Park, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14568-003.
    c. Date Filed: May 31, 2017.
    d. Submitted By: CB Energy Park, LLC.
    e. Name of Project: Coffin Butte Pumped Storage Project.
    f. Location: Near Two Dot in Wheatland and Meagher Counties,
Montana. No federal lands are occupied by the project works or located
within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Carl Borgquist, CB Energy Park,
LLC, 209 South Wilson Avenue, P.O. Box 309, Bozeman, MT 59771, phone:
(406) 585-3006.
    i. FERC Contact: Ryan Hansen at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. CB Energy Park, LLC filed its request to use the Traditional
Licensing Process on May 31, 2017. CB Energy Park, LLC provided public
notice of its request on June 9, 2017. In a letter dated July 5, 2017,
the Director of the Division of Hydropower Licensing approved CB Energy
Park, LLC's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR part
402. We are also initiating consultation with the Montana State
Historic Preservation Officer, as required by section 106, National
Historic Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating CB Energy Park, LLC as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. CB Energy Park, LLC filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

     Dated: July 5, 2017.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-14480 Filed 7-10-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Page 45247]
[FR Doc No: 2011-19076]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR 11-18-000]

Tesoro Refining and Marketing Company v. SFPP, L.P.; Notice of
Complaint

    Take notice that on July 20, 2011, pursuant to Rule 206 of the
Rules of Practice and Procedure of the Federal Energy Regulatory
Commission (Commission), 18 CFR 385.206; the Procedural Rules
Applicable to Oil Pipeline Proceedings, 18 CFR 343.2; sections 1(4),
1(5), 8, 9, 13, 15, and 16 of the Interstate Commerce Act, 49 U.S.C.
App. 1(4), 1(5), 8, 9, 13, 15, and 16 (1988); and section 1803 of the
Energy Policy Act of 1992.
    Tesoro Refining and Marketing Company (Complainant) filed a formal
complaint against SFPP L.P. (SFPP or Respondent) alleging that SFPP has
substantially over-recovered its cost of service for 2010. The
Complainant states that the Respondent's rates contained in Tariff Nos.
194.0.0, 195.0.0, 196.2.0, 197.0.0, 198.2.0, 199.0.0, and 200.0.0 are
unjust and unreasonable and request that the Commission prescribe new
rates for the shipment of refined petroleum products on its interstate
pipeline. The Complainant seeks repayment, reparations and damages plus
interest from the Respondent from July 1, 2010 through the date of the
Commission's resolution of this issue.
    The Complainant certifies that copies of the complaint were served
on the contacts for SFPP as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of 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 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 9, 2011.

    Dated: July 20, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-19076 Filed 7-27-11; 8:45 am]
BILLING CODE 6717-01-P