[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7388-7390]
[FR Doc No: 2019-03828]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0280]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Financial Disclosure
by Clinical Investigators

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
3, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0396.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Financial Disclosure by Clinical Investigators

OMB Control Number 0910-0396--Extension

    Respondents to this collection are sponsors of marketing
applications that contain clinical data from studies covered by the
regulations. These sponsors represent pharmaceutical, biologic, and
medical device firms. Respondents are also clinical investigators who
provide financial information to the sponsors of marketing
applications.
    Table 1 of this document shows information that is the basis of the
estimated number of respondents in tables 2 through 4.

 Table 1--Estimated Number of Applications, Clinical Trials, and Investigators Subject to the Regulation by Type
                                               of Application \1\
----------------------------------------------------------------------------------------------------------------
                                   Total number      Number of
        Application type                of         applications      Number of trials            Number of
                                   applications      affected                                  investigators
----------------------------------------------------------------------------------------------------------------
Drugs:

    New drug application (NDA),               35              26  3 to 10...............  3 to 100.
     new molecular entity (NME).
    NDA nonNME:
        NDA efficacy supplement.             173              86  1 to 3................  10 to 30.
        Abbreviated new drug               1,152             250  1.1...................  2.
         application (ANDA).
        ANDA supplement.........           6,774             383  1.....................  2.
Biologics:
    Biologics license                         22              19  3 to 10...............  3 to 100.
     application (BLA).
    BLA efficacy supplement.....              16              14  1 to 3................  10 to 30.
Medical Devices:
    Premarket approval (PMA)....              48              48  1 to 3................  10 to 20.
    PMA supplement..............              23              23  1 to 3................  3 to 10.
    Reclassification devices....               3               1  1.....................  3 to 10.
    510(k)......................           4,000             200  1.....................  3 to 10.
----------------------------------------------------------------------------------------------------------------
\1\ Source: Agency estimates.

    In the Federal Register of September 27, 2018 (83 FR 48819), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment, however, it was
not responsive to the four collection of information topics solicited
and therefore this comment will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

Reporting Burden

    Under Sec.  54.4(a) (21 CFR 54.4(a)), applicants submitting an
application that relies on clinical studies must submit a complete list
of clinical investigators who participated in a covered clinical study,
and must either certify to the absence of certain financial
arrangements with clinical investigators (Form FDA 3454) or, under
Sec.  54.4(a)(3), disclose to FDA the nature of those arrangements and
the steps taken by the applicant or sponsor to minimize the potential
for bias (Form FDA 3455).
    FDA estimates that almost all applicants submit a certification
statement under Sec.  54.4(a)(1) and (a)(2). Preparation of the
statement using Form FDA 3454 should require no more than 1 hour per
study. The number of respondents is based on the estimated number of
affected applications.
    When certification is not possible and disclosure is made using
Form FDA 3455, the applicant must describe, under Sec.  54.4(a)(3), the
financial arrangements or interests and the steps that were taken to
minimize the potential for bias in the affected study. As the applicant
would be fully aware of those arrangements and the steps taken to
address them, describing them will be straightforward. The Agency
estimates that it will take about 5 hours to prepare this narrative.
Based on our experience with this collection, FDA estimates that
approximately 10 percent of the respondents with affected applications
will submit disclosure statements.

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and              1,050               1           1,050               1           1,050
 (a)(2)--Form FDA 3454..........
Disclosure--54.4(a)(3)--Form FDA             105               1             105               5             525
 3455...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,575
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Recordkeeping Burden

    Under Sec.  54.6, the sponsors of covered studies must maintain
complete records of compensation agreements with any compensation paid
to nonemployee clinical investigators, including information showing
any financial interests held by the clinical investigator, for 2 years
after the date of approval of the applications. Sponsors of covered
studies maintain many records regarding clinical investigators,
including protocol agreements and investigator resumes or curriculum
vitae. FDA estimates that an average of 15 minutes will be required for
each recordkeeper to add this record to the clinical investigator's
file.

                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                           21 CFR section                               Number of       records per      Total annual         per        Total hours \2\
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6................................................           1,050                1            1,050             0.25              263
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

Third-Party Disclosure Burden

    Under Sec.  54.4(b), clinical investigators supply to the sponsor
of a covered study financial information sufficient to allow the
sponsor to submit complete and accurate certification or disclosure
statements. Clinical investigators are accustomed to supplying such
information when applying for research grants. Also, most people know
the financial holdings of their immediate family and records of such
interests are generally accessible because they are needed for
preparing tax records. For these reasons, FDA estimates that the time
required for this task may range from 5 to 15 minutes; we used the
mean, 10 minutes, for the average burden per disclosure. The number of
respondents is the sum of the number of affected applications
multiplied by the mean of the estimated number of investigators for
each application type (rounded) (see table 1 of this document).

                                               Table 4--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of     disclosures per    Total annual    Average burden  Total hours \2\
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical Investigators....................................           7,894                1            7,894             0.17            1,342
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Our estimated burden for the information collection reflects an
overall increase of 222 hours and a corresponding increase of 893
responses/records. We attribute this adjustment to an increase in the
number of affected applications and the number of investigators. No
program changes were made.

    Dated: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03828 Filed 3-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76174-76177]
[FR Doc No: 2020-25274]

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DEPARTMENT OF TRANSPORTATION

Notice of Funding Opportunity for Letters of Interest for the
RRIF Express Pilot Program Under the Railroad Rehabilitation &
Improvement Financing Program

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Notice of funding opportunity.

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SUMMARY: This Notice of Funding Opportunity (NOFO) for the RRIF Express
Pilot Program expands eligibility criteria and extends the deadline for
submission of Letters of Interest. The eligibility criteria in section
IV. are revised to: Increase the total project size limit to $150
million, broaden project scope consistent with the RRIF statute, and
expand the proportion of refinancing allowed to 75%. Prospective RRIF
borrowers who have been accepted into the RRIF Express program may
amend their Letters of Interest to reflect the changed criteria.
Prospective RRIF borrowers who received advice from DOT on issues to
address in revising and resubmitting Letters of Interest may also take
advantage of the expanded criteria while also following the advice
provided. All projects that were previously eligible for RRIF Express
financing remain eligible under this NOFO.

DATES: Letters of Interest from prospective RRIF borrowers for the RRIF
Express Program will be accepted on rolling basis until available
funding is expended or this notice is superseded by another notice.
    Prospective RRIF borrowers that have previously submitted a Letter
of Interest but that also seek acceptance into the RRIF Express Program
should resubmit a Letter of Interest following the instructions below.
Prospective RRIF borrowers who previously submitted Letters of Interest
under a previous RRIF Express Notice of Funding Opportunity (published
on December 13, 2019, March 16, 2020, or June 19, 2020), and whose
Letters of Interest have not been returned as ineligible, do not have
to re-apply, and may amend their Letter of Interest to take advantage
of the revised eligibility criteria. Prospective RRIF borrowers whose
Letter of Interest for RRIF Express was returned by the Bureau with
advice on issues to address in resubmitting a Letter of Interest may
also take advantage of the revised eligibility criteria while also
following the advice provided.
    Irrespective of the above, the Bureau continues to accept Letters
of Interest on a rolling basis from any prospective RRIF borrower
interested in receiving RRIF credit assistance only (i.e., without
participation in the RRIF Express Program).

ADDRESSES: Applicants to the RRIF Express Program must use the latest
version of the Letter of Interest form available on the Build America
Bureau website: https://www.transportation.gov/content/build-america-bureau (including applicants who have previously submitted Letters of
Interest and who are now seeking participation in the RRIF Express
Program). Letters of Interest must be submitted to the Build America
Bureau via email at<EMAIL_ADDRESS>using the following subject
line: ``Letter of Interest for RRIF Express Program.'' Submitters
should receive a confirmation email, but are advised to request a
return receipt to confirm transmission. Only Letters of Interest
received via email at the above email address with the subject line
listed above shall be deemed properly filed.

FOR FURTHER INFORMATION CONTACT: For further information regarding this
notice please contact William Resch via email at<EMAIL_ADDRESS>or via telephone at<PHONE_NUMBER>. A TDD is available at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The original NOFO with modifications
follows.
    The RRIF Express Program is administered by the DOT's National
Surface Transportation and Innovative Finance Bureau (the ``Build
America Bureau'' or ``Bureau''). The overall RRIF program finances
development of railroad infrastructure, and is authorized to have up to
$35 billion in outstanding principal amounts from direct loans and loan
guarantees at any one time.
    The 2018 Consolidated Appropriations Act \1\ appropriated $25
million in budget authority to the DOT to cover the cost to the Federal
Government (``the Government'') of RRIF credit assistance (Credit Risk
Premium (``CRP'') Assistance or ``CRP Assistance''). Additionally, the
2016 Consolidated Appropriations Act \2\ and the 2018 Consolidated
Appropriations Act \3\ provided $1.96 million and $350,000,
respectively (of which approximately $1 million remains available), to
the DOT to fund certain expenses incurred by prospective RRIF borrowers
in preparation of their

applications for RRIF credit assistance (this approximately $1 million
assistance, collectively, ``Cost Assistance''). Using existing
authorities and these new budget authorities, the DOT has established
the RRIF Express Program.
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    \1\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
    \2\ Public Law 114-113, div. L, tit. I, Sec.  152, 129 Stat.
2242, 2856.
    \3\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
---------------------------------------------------------------------------

    Subject to the availability of funds, applicants accepted into the
RRIF Express Program may benefit from two types of financial
assistance: (a) Cost Assistance up to $100,000 per application to pay
for a portion of the Bureau's advisor expenses borne by applicants; and
(b) for those applicants that ultimately receive RRIF credit
assistance, CRP Assistance up to 10% of the final RRIF loan amount, not
to exceed $5 million, to offset the CRP paid by the borrower. Any costs
beyond $100,000 and any CRP beyond the lower of 10% and $5 million
would be paid by the prospective RRIF borrower. These funds will be
made available to benefit applicants accepted into the RRIF Express
Program on a first come, first served basis until each source of
funding is expended or this notice is superseded by a new Notice of
Funding Opportunity. Letters of Interest will be accepted in the order
received and will be allocated cost assistance based on the date of
acceptance into the pilot program. CRP assistance will be allocated in
the order of financial close. For more information about potential
financial assistance for RRIF Express applicants, see Supplementary
Information: Section II. Funding of CRP and Cost Assistance.
    This notice solicits Letters of Interest from prospective RRIF
borrowers seeking acceptance into the RRIF Express Program, establishes
eligibility criteria and describes the process that prospective
borrowers must follow when submitting Letters of Interest.
    RRIF Express pilot program information, including any additional
resources, terms, conditions and requirements when they become
available, can be found on the Build America Bureau website at: https://www.transportation.gov/buildamerica/rrif-express. For further
information about the overall RRIF program in general, including
details about the types of credit assistance available, eligibility
requirements and the creditworthiness review process, please refer to
the Build America Bureau Credit Programs Guide (``Programs Guide),''
available on the Build America Bureau website: https://www.transportation.gov/buildamerica/programs-services/tifia/program-guide.

Table of Contents

I. Background
II. Funding of CRP Assistance and Cost Assistance
III. Eligibility Requirements for RRIF Credit Assistance
IV. Eligibility Criteria for the RRIF Express Program
V. Letter of Interest Process and Review and Next Steps

I. Background

    The Transportation Equity Act for the 21st Century,\4\ established
the RRIF program, authorizing the DOT to provide credit assistance in
the form of direct loans and loan guarantees to public and private
applicants for eligible railroad projects. The RRIF program is a DOT
program and final approval of credit assistance is reserved for the
Secretary of the DOT. The 2005 Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users; \5\ the Rail Safety
Improvement Act of 2008; \6\ and the 2015 Fixing America's Surface
Transportation Act \7\ (the ``FAST Act'') each made a number of changes
to the RRIF program. In addition, the FAST Act authorized the creation
of the Bureau to consolidate administration of certain DOT credit and
grant programs, including the RRIF program.
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    \4\ Public Law 105-178, 7203, 112 Stat. 107, 471.
    \5\ Public Law 109-59, 9003, 119 Stat. 1144, 1921.
    \6\ Public Law 110-432, 701(e), 122 Stat. 4848, 4906.
    \7\ Public Law 114-94, Subtitle F, 129 Stat. 1312, 1693.
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II. Funding of CRP Assistance and Cost Assistance

    Through the RRIF program, the DOT is authorized to have, at any one
time, up to $35 billion in unpaid principal amounts of obligations
under direct loans and loan guarantees to finance development of
railroad infrastructure.

CRP Assistance

    Prior to the 2018 Consolidated Appropriations Act, the RRIF program
did not have an appropriation of budget authority to pay the cost to
the Government of providing RRIF credit assistance. As a result, the
RRIF borrower or a third party was required to bear this cost through
the payment of a CRP. The 2018 Consolidated Appropriations Act \8\
provided $25 million to the DOT to cover the cost to the Government of
RRIF credit assistance. The DOT will use this funding to pay or offset
the CRP (up to 10% of the RRIF loan amount, not to exceed $5 million)
payable by participants in the RRIF Express Program, until this funding
is expended or this notice is superseded by a new Notice of Funding
Opportunity.
---------------------------------------------------------------------------

    \8\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
---------------------------------------------------------------------------

Cost Assistance

    As described in the Programs Guide, RRIF borrowers are required to
pay (or reimburse the DOT) for costs incurred by the Bureau in
connection with the review of Letters of Interest and applications for
RRIF credit assistance. The 2016 Consolidated Appropriations Act \9\
and the 2018 Consolidated Appropriations Act \10\ collectively provided
$2.31 million to the DOT to be used to fund expenses incurred by
prospective RRIF borrowers in preparation to apply for RRIF credit
assistance. A portion of these funds have already been allocated for
prior RRIF projects. The DOT is reserving approximately $1 million of
remaining funds from these appropriations to offset the cost of DOT
advisors (up to $100,000 per application) that would be payable by
participants in the RRIF Express Program, until this funding is
expended or this notice is superseded by a new Notice of Funding
Opportunity.
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    \9\ Public Law 114-113, div. L, tit. I, Sec.  152, 129 Stat.
2242, 2856.
    \10\ Public Law 115-141, div. L, tit. I, H.R. 1625 at 646 (as
enrolled Mar. 23, 2018).
---------------------------------------------------------------------------

III. Eligibility Requirements for RRIF Credit Assistance

    The RRIF statute and implementing rules set forth eligibility
requirements for applicants and projects. These requirements as well as
other applicable federal requirements are described in detail in the
Programs Guide and apply to all applicants and projects, including
those seeking acceptance into the RRIF Express Program. In addition,
for prospective borrowers seeking RRIF Express Program benefits, the
requirements set forth in section IV (Eligibility Criteria for the RRIF
Express Program) of this notice also apply.

IV. Eligibility Criteria for the RRIF Express Program

    The DOT has identified the following strategic objectives for the
RRIF Express Program: Encouraging increased utilization of RRIF credit
assistance by Class II and Class III railroads; reducing transaction
costs for Class II and Class III railroads; and streamlining the
underwriting process for Class II and Class III railroads. These
priorities are reflected in the eligibility criteria below. Generally,
projects most suitable for the RRIF Express Program are rail line
modernization projects where the borrower has a well-documented
financial history and easily identified revenue stream(s) for loan
repayment.

    To differentiate among Letters of Interest received for projects
under this notice of funding opportunity, the DOT will consider whether
the project satisfies the following eligibility criteria as
demonstrated by the Letter of Interest:
    (i) Applicant: The applicant must be a Class II railroad, a Class
III railroad, a commuter railroad or a joint venture with a Class II,
III, or commuter railroad.
    (ii) Project Size: The project must have eligible project costs of
$150 million or less with no minimum amount.
    (iii) Project Scope: The project scope, as described in Section B4
of the Letter of Interest, must be limited to the support of railroad
activities that are otherwise eligible for RRIF financing and as
outlined below:
    (a) Acquire, improve, or rehabilitate intermodal or rail equipment
or facilities, including track, components of track, bridges, yards,
buildings, and shops, and costs related to these activities, including
pre-construction costs. Note that this category of eligible activities
includes the installation of positive train control systems;
    (b) Develop or establish new intermodal or railroad facilities;
    (c) Reimburse planning and design expenses relating to activities
listed above;
    (d) Refinancing of non-federal debt (incurred at least three years
prior to November 27, 2020) and for the purpose of one or more of the
activities listed in 45 U.S.C. 822(b)(1)(A) or (C). Refinancing is
limited to up to 75% of the final RRIF loan amount. Letters of Interest
including refinancing must demonstrate with specificity in Section D5
how the refinancing would improve the creditworthiness of the applicant
and document how such improvement would facilitate the activities
referenced in items (a) and (b) above and would increase the
applicant's ability to repay a RRIF loan and the overall financial
health of the applicant.
    (iv) Applicant Financial History and Projections: Attachment D-1 of
the Letter of Interest must include audited financial statements (by a
qualified third party, e.g., a certified public accountant) for the two
(2) most recent consecutive years preceding the year of application and
that have no significant unresolved findings (e.g., fiscal years 2018
and 2019). Interim unaudited financial statements may be submitted with
a letter pledging to provide these audited statements within 60 days of
submitting of the LOI and supporting materials. Failure to provide the
audited financial statements within 60 days will disqualify the LOI.
Applicants choosing this option must still provide unaudited financial
statements for the previous five years and prospective financial
projections (pro-forma) for the term of the loan.
    (v) Collateral: If collateral will be pledged for the RRIF loan,
Section D9 of the Letter of Interest must be supported with an
independent appraisal of the collateral that must have been completed
within the past 12 months preceding submission of an LOI. Section D9 of
the Letter of Interest must demonstrate that the collateral will be
unencumbered at time of closing, including a description of any lien
release process that would occur prior to closing on the RRIF loan to
render currently pledged collateral unencumbered.
    (vi) Environmental Documentation: Section B6 and Attachment B-6 of
the Letter of Interest must demonstrate that either NEPA review is
complete or the project is likely to qualify for a Categorical
Exclusion (CE) or Finding of No Significant Impact (FONSI) under NEPA.
If a NEPA review has not been completed, Attachment B-6 must include a
Federal Railroad Administration (FRA) CE worksheet with its Letter of
Interest. Where appropriate, the CE worksheet must include substantive
analysis of potential impacts to environmental resources and indicate
the sources of the information or data used to reach conclusions. For
some project types, the CE worksheet will satisfy NEPA review and
documentation requirements; however, for other project types, the CE
worksheet will inform FRA with sufficient details about the project
scope and potential environmental impacts to determine if an
Environmental Assessment (EA) is required. The Applicant would be
responsible for providing sufficient information and funding for the
preparation of an EA, which would also extend the duration of project
development activities. FRA may require the use of a third-party
contractor consistent with 23 CFR 771.109 (e) for the preparation of an
EA. In the event that an EA is necessary, eligible projects must
receive a FONSI to qualify for RRIF Express.
    To help address compliance with Section 106 of the National
Historic Preservation Act, supporting documentation must be submitted
for projects involving reconstruction or replacement of existing
railroad bridges, tunnels, culverts, stations, or depots that assesses
the eligibility of these architectural properties for listing in the
National Register of Historic Places. Supporting documentation must
also be provided for projects involving ground-disturbing site
preparation and construction activities in areas that have not been
previously disturbed (such as by prior land development, agricultural
activities, or the placement of fill), that assesses the archaeological
sensitivity of the project area.
    (vii) Domestic Preference: Section B4(a) of the Letter of Interest
must demonstrate that the steel, iron, and manufactured goods used in
the project will be produced in the United States in accordance with
the Federal Railroad Administration RRIF Buy America policy, which
follows 49 U.S.C. 24405(a). Projects that require a waiver are not
eligible for the RRIF Express Program, however, prospective borrowers
can seek a loan from the overall RRIF program for projects that require
a waiver.
    (viii) Project Readiness: Section B4(c) of the Letter of Interest
must demonstrate the prospective borrower's ability to commence the
contracting process for construction of the project (e.g., issuance of
a final RFP) by not later than 90 days after the date on which a RRIF
credit instrument is obligated for the project.

V. Letter of Interest Process and Review and Next Steps

A. Submission of Letters of Interest

    All prospective borrowers seeking acceptance into the RRIF Express
Program should submit a Letter of Interest following the instructions
described in this notice of funding opportunity. The Letter of Interest
should be annotated with ``RRIF EXPRESS'' immediately following the
Applicant Name in the Summary Information section on page one of the
Letter of Interest. The Letter of Interest must, among other things:
    (i) Describe the project and its components, location, and purpose
in Section B, and include as Attachment B-2 the project budget
organized according to construction elements from preliminary
engineering estimates, and including costs as appropriate for property,
vehicles, professional services, allocated and unallocated contingency,
and finance charges;
    (ii) Outline the proposed financial plan in Section C, and include
the financial model, that addresses such aspects as model assumptions,
annual cash flows, balance sheets, income statements and repayment
schedules for the duration of the loan, as well as coverage ratios and
debt metrics. The model should allow reviewers the flexibility to
evaluate scenarios in the native spreadsheet (Microsoft Excel, or

equivalent) format and be included in the application as Attachment C-
1;
    (iii) Provide information regarding satisfaction of other statutory
eligibility requirements of the RRIF credit program; and
    (iv) Provide information regarding satisfaction of the RRIF Express
Program eligibility criteria (as described in Section IV above).
    Prospective RRIF Express borrowers should describe in Letter of
Interest Section D8 if the project will (1) decrease transportation
costs and improve access, especially for rural communities or
communities in Opportunity Zones,\11\ through reliable and timely
access to employment centers and job opportunities; (2) improve long-
term efficiency, reliability or costs in the movement of workers or
goods; (3) increase the economic productivity of land, capital, or
labor, including assets in Opportunity Zones; (4) result in long-term
job creation and other economic opportunities; or (5) help the United
States compete in a global economy by facilitating efficient and
reliable freight movement. Projects that bridge gaps in service in
rural areas, and projects that attract private economic development,
all support local or regional economic competitiveness.
---------------------------------------------------------------------------

    \11\ See https://www.cdfifund.gov/Pages/Opportunity-Zones.aspx
for more information on Opportunity Zones.
---------------------------------------------------------------------------

    Letters of Interest must be submitted using the latest form on the
Build America Bureau website: https://www.transportation.gov/content/build-america-bureau. Other RRIF Express pilot program information
including any additional terms, conditions, and requirements can be
found on the Build America Bureau website at: https://www.transportation.gov/buildamerica/rrif-express. The Bureau may
contact a prospective borrower for clarification of specific
information included in the Letter of Interest. The Bureau will review
all Letters of Interest properly filed and received in the submission
time window provided herein.

B. Review and Evaluation

    Each Letter of Interest that is properly filed and received will be
evaluated for completeness and eligibility for the RRIF Express Program
using the criteria in this notice. This initial step of the review
process will include (1) an evaluation as to whether the proposed
project and applicant satisfy RRIF statutory eligibility requirements,
and (2) an evaluation as to whether the proposed project and applicant
satisfy the RRIF Express Program eligibility criteria. In addition, the
Bureau will conduct a high-level feasibility assessment of the proposed
project and the applicant's plan of finance before a Letter of Interest
is accepted into the RRIF Express Program and before a Letter of
Interest enters the creditworthiness process. With respect to the
project, factors that will be considered include, but are not limited
to, (1) the completion of the project being financed is not necessary
to repay the proposed RRIF loan; (2) the project budget is in year of
expenditure and includes contingencies to account for potential project
risks; and (3) the maturity of the proposed RRIF loan does not extend
beyond the project's anticipated useful life. With respect to the
applicant's plan of finance, factors that will be considered include,
but are not limited to, (1) a maximum loan size that, when added to the
proposed borrower's existing outstanding and undrawn available debt,
does not substantially exceed an earnings before interest, taxes,
depreciation, and amortization multiple that would be market
appropriate in a similar circumstance, for the most recent trailing
twelve month period and for any period of the applicant's forecast; and
(2) consistent levels of revenue and operating profitability
demonstrated by the proposed borrower over the most recent fiscal year.
    The Letters of Interest determined to be eligible for the RRIF
Express Program will then be advanced to the Bureau's creditworthiness
review process, which is an in-depth creditworthiness review of the
project sponsor and the revenue stream proposed to repay the RRIF
credit assistance as described in the Programs Guide. The Secretary
reserves the right to limit the number of applications from a single
entity or subordinates of a single parent or holding company.
Prospective RRIF borrowers whose RRIF Express Program Letters of
Interest are determined to be ineligible, but whose projects are
otherwise statutorily eligible for standard RRIF credit assistance,
have the option to be considered under the overall RRIF program.

    Issued in Washington, DC, on October 22, 2020.
Elaine L. Chao,
Secretary of Transportation.
[FR Doc. 2020-25274 Filed 11-25-20; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33489-33491]
[DOCID:fr13jy09-136]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60256; File No. SR-NYSEArca-2009-56]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Add Two New
Order Types to NYSE Arca Equities Rule 7.31

July 7, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on June 23, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 add two new order types to NYSE Arca
Equities Rule 7.31. A copy of this filing is available on the
Exchange's Web site at http://www.nyse.com, at the Exchange's principal
office and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to add two new order types to NYSE Arca
Equities Rule 7.31. The new order types will allow NYSE Arca Users \3\
to participate at the primary listing exchange during the first 15
minutes and last 15 minutes of the trading day. For the remainder of
the trading session the orders will remain in the NYSE Arca Book
(``Arca Book''). The two new order types behave like a combination of
currently existing order types and are discussed more thoroughly below.
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    \3\ See NYSE Arca Rule 1.1(yy) for the definition of ``User.''
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Primary Until 9:45 Order
    The Exchange proposes to add a new order type called the Primary
Until 9:45 Order. The Primary Until 9:45 Order will permit NYSE Arca
Users to submit an order that will be routed directly to the primary
listing market until 9:45 a.m. (Eastern Time).\4\ If the order is not
executed on the primary market by 9:45 a.m. (Eastern Time), the order
will be cancelled from the primary market and a new order will be
entered on the Arca Book for execution during the remainder of the
Exchange's Core Trading Session.\5\ The Primary Until 9:45 Order may be
marked with a Time in Force of Day, Good Till Cancelled (``GTC''), or
Good Till Date (``GTD''). Orders that return to NYSE Arca after routing
to the primary market will retain their original order attributes.
Orders that return to the Arca Book at 9:45 will

be treated as a new order and receive a new time priority.
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    \4\ The PO+ order was recently approved as Rule 7.31(x)(3). See
Securities and Exchange Act Release No. 58681 (September 29, 2008);
73 FR 58285 (October 6, 2008) (order approving SR-NYSEArca-2008-90).
    \5\ See NYSE Arca Rule 7.34(a)(2) for the definition of ``Core
Trading Session.''
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    Currently, NYSE Arca Users can only accomplish this proposed
functionality through the submission of two separate order types.
First, the User would direct an order to the primary market without
first sweeping the NYSE Arca Book by submitting a Primary Only (PO) or
Primary Only Plus (PO+) Order.\6\ \7\ Then at 9:45 the User
would cancel the PO or PO+ Order and submit an order to the Exchange.
The Primary Until 9:45 Order will operate in a manner similar to a
combination of a PO+ Order and an order that is executable on the
Exchange. The Primary Until 9:45 Order simplifies this functionality
into one new order type.
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    \6\ A PO Order will only participate in the primary market
opening or re-opening. A PO+ Order will participate at any time
other than the primary market opening or re-opening.
    \7\ PO+ Orders are routed to the primary market via the
Exchange's outbound routing facility, Archipelago Securities, LLC
(``Arca Securities''), a registered broker dealer. Arca Securities
is an affiliated member of the NYSE, NYSE Arca, and NYSE Amex, LLC.
As a result, each of these three exchanges have established certain
mechanisms designed to address potential conflicts of interest
regarding affiliated members generally, and Arca Securities in
particular. See Securities and Exchange Act Release No. 58680
(September 29, 2008), 73 FR 58283 (October 6, 2008) (order approving
SR-NYSE-2008-76); see also, Securities Exchange Act Release No.
58681 (September 29, 2008), 73 FR 58285 (October 6, 2008) (order
approving NYSEArca-2008-90); see also, Securities Exchange Act
Release No. 58705 (October 1, 2008), 73 FR 58995 (October 8, 2008)
(order approving SR-AMEX-2008-62).
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Primary After 3:45 Order
    Similarly, the Exchange proposes to add a new order type called the
Primary After 3:45 Order. The Primary After 3:45 Order will permit
Exchange Users to submit an order that will remain on the Arca Book
until 3:45 p.m. (Eastern Time). If the order is not executed by 3:45
p.m. (Eastern Time) the order will be cancelled from the Arca Book and
entered for execution on the primary market for the remainder of the
trading session. The Primary After 3:45 Order may only be marked with a
Time in Force of Day, and may not be marked as GTC or GTD. Orders that
route to the primary market at 3:45 will retain their original order
attributes.
    Currently, NYSE Arca Users can only accomplish this proposed
functionality through the submission of two separate order types. First
a User would submit an order for execution on the Exchange. Then, at
3:45 the User would cancel the order resting in the Arca Book and
submit a PO or PO+ Order for execution on the primary market. The
Primary After 3:45 Order type will operate in a manner similar to a
combination of two existing order types, but simplifies this compound
functionality into one new order type.
    The proposed order types provide Users the ability to participate
on the primary listing market during the two most active periods of the
trading day, the fifteen minutes following the open and prior to the
close. For the remainder of the trading day, the two new order types
offer Users access to the Exchange's liquidity.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \8\ of the
Securities Exchange Act of 1934 (the ``Exchange Act''), in general, and
furthers the objectives of Section 6(b)(5) \9\ in particular in that it
is designed to prevent fraudulent and manipulative acts and practices,
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. The Exchange believes that the proposed rule changes
are designed to accomplish these ends by providing Users the ability to
participate on the primary listing market during the most active
periods of the trading day.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

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

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

    Because the foregoing proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) by its terms, does not become operative for 30 days from the
date on which it was filed, or such shorter time as the Commission may
designate, if consistent with the protection of investors and the
public interest, it has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\12\
However, Rule 19b-4(f)(6)(iii) \13\ 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 to allow market
participants on NYSE Arca increased flexibility to participate on the
primary listing exchange during the 15 minutes following the open and
prior to the close. In addition, the waiver of the operative delay
would allow the proposal to become operative on the date of approval of
SR-NYSE-2009-58. The Commission believes such waiver is consistent with
the protection of investors and the public interest.\14\ Accordingly,
the Commission designates the proposed rule change operative on July 7,
2009.\15\
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    \12\ 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 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 complied with this requirement.
    \13\ Id.
    \14\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. See 15
U.S.C. 78c(f).
    \15\ Securities Exchange Act Release No. 60255 (July 7, 2009)
(SR-NYSE-2009-58).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File

Number SR-NYSEArca-2009-56 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2009-56. This
file number should be included on the subject line if e-mail 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 Web site (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 inspection
and copying in the Commission's Public Reference Room on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSEArca-2009-56 and should be submitted on or before
August 3, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
 [FR Doc. E9-16579 Filed 7-10-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71170-71171]
[FR Doc No: 2016-24923]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0443]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions of five
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were effective on May 19, 2016. The exemptions
will expire on May 19, 2018. Comments must be received on or before
November 14, 2016.

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

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0443 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    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 acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for two years 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 two-year period.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person:

    Has no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--

MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5.]
    The five individuals listed in this notice have requested renewal
of their exemptions from the Epilepsy and Seizure Disorders prohibition
in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable two-
year period.

II. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application. In accordance with 49 U.S.C. 31136(e) and 31315, each of
the five applicants has satisfied the conditions for obtaining an
exemption from the Epilepsy and Seizure Disorder requirements and were
published in the Federal Register (79 FR 74170). In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License information System (CDLIS) and the Motor Carrier Management
Information System (MCMIS) are searched for crash and violation data.
For non-CDL holders, the Agency reviews the driving records from the
State Driver's Licensing Agency (SDLA). These factors provide an
adequate basis for predicting each driver's ability to continue to
safely operate a CMV in interstate commerce.
    The five drivers in this notice remain in good standing with the
Agency, have maintained their medical monitoring and have not exhibited
any medical issues that would compromise their ability to safely
operate a CMV during the previous two-year exemption period. FMCSA has
concluded that renewing the exemptions for each of these applicants is
likely to achieve a level of safety equal to that existing without the
exemption. Therefore, FMCSA has decided to renew each exemption for a
two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each
driver has received a renewed exemption.
    As of May 19, 2016, the following five individuals have satisfied
the renewal conditions for obtaining an exemption from the Epilepsy and
Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from driving CMVs
in interstate commerce (79 FR 74170):

Thomas Bynum (NC)
Ronald Hartl (WI)
Craig Hoisington (NH)
Michael Miller (WI)
Peter Thompson (FL)

    These drivers were included in FMCSA-2013-0443. The exemptions were
effective on May 19, 2016, and will expire on May 19, 2018.

IV. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the two-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each
driver must provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy of his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the exemption when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official. The exemption will be rescinded 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(e) and
31315.

V. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the 5 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the Epilepsy
and Seizure Disorders requirement in 49 CFR 391.41 (b)(8). In
accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be
valid for two years unless revoked earlier by FMCSA.

    Issued on: October 7, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-24923 Filed 10-13-16; 8:45 am]
 BILLING CODE 4910-EX-P


Comment Info: =================

General Comment:75 days is not long enough for us to comment on the proposed deeming regulations. I request the said period to be extended to 180 days so that the majority will have time to understand and comment.


[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Notices]
[Pages 66401-66402]
[FR Doc No: 2019-26204]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-484-000]

Little Bear Solar 5, 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 Little Bear
Solar 5, 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 December 17, 2019.
    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 website 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: November 27, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-26204 Filed 12-3-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 106 (Friday, June 1, 2012)]
[Rules and Regulations]
[Pages 32398-32400]
[FR Doc No: 2012-13301]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0236; FRL-9670-8]

Revisions to the California State Implementation Plan, South
Coast Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve a revision to the
South Coast Air Quality Management District (SCAQMD) portion of the
California State Implementation Plan (SIP). This revision concerns
particulate matter (PM) emissions from cement manufacturing facilities.
We are approving a local rule that regulates this emission source under
the Clean Air Act as amended in 1990 (CAA or the Act).

DATES: This rule is effective on July 31, 2012 without further notice,
unless EPA receives adverse comments by July 2, 2012. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2012-0236, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact

you for clarification, EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed at www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps), and some may not be publicly
available in either location (e.g., CBI). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX,
(415) 947-4125<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule revision?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rule
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule we are approving with the dates that it was
adopted by the local air agency and submitted by the California.

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
           Local agency                 Rule No.           Rule title            Adopted           Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD...........................               1156  Further Reductions             03/06/09           04/29/09
                                                       of Particulate
                                                       Emissions from
                                                       Cement
                                                       Manufacturing
                                                       Facilities.
----------------------------------------------------------------------------------------------------------------

    On July 20, 2009, EPA determined that the submittal for SCAQMD Rule
1156 met the completeness criteria in 40 CFR Part 51 Appendix V, which
must be met before formal EPA review.

B. Are there other versions of this rule?

    EPA approved an earlier version of Rule 1156 into the SIP on March
10, 2008 (72 FR 12639). SCAQMD adopted a revision to the SIP-approved
version on March 6, 2009 and CARB submitted it to us on April 29, 2009.

C. What is the purpose of the submitted rule revision?

    PM contributes to effects that are harmful to human health and the
environment, including premature mortality, aggravation of respiratory
and cardiovascular disease, decreased lung function, visibility
impairment, and damage to vegetation and ecosystems. Section 110(a) of
the CAA requires States to submit regulations that control PM
emissions. Revised Rule 1156 would require total enclosure of clinker
storage and handling conducted within 1000 feet from, and inside, a
facility's property line. Rule 1156 would allow the use of
alternatives, such as a three-sided barrier covered with a roof and
wind fence for active barn-type storage, tarp and barrier/wind fence
for other active piles, and tarp for inactive piles. EPA's technical
support document (TSD) has more information about this rule.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act) and must not relax existing requirements (see sections 110(l) and
193). In addition, SIP rules must implement Reasonably Available
Control Measures (RACM), including Reasonably Available Control
Technology (RACT), in moderate PM nonattainment areas, and Best
Available Control Measures (BACM), including Best Available Control
Technology (BACT), in serious PM nonattainment areas (see CAA sections
189(a)(1) and 189(b)(1)). The SCAQMD regulates a PM nonattainment area
classified as serious (see 40 CFR part 81), so Rule 1156 must implement
BACM/BACT.
    Guidance and policy documents that we use to evaluate
enforceability and BACM/BACT requirements consistently include the
following:
    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations; Clarification to Appendix D of November 24, 1987 Federal
Register Notice,'' (Blue Book), notice of availability published in the
May 25, 1988 Federal Register.
    2. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    3. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,'' 57
FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    4. ``State Implementation Plans for Serious PM-10 Nonattainment
Areas, and Attainment Date Waivers for PM-10 Nonattainment Areas
Generally; Addendum to the General Preamble for the Implementation of
Title I of the Clean Air Act Amendments of 1990,'' 59 FR 41998 (August
16, 1994).
    5. ``PM-10 Guideline Document,'' EPA 452/R-93-008, April 1993.
    6. ``Fugitive Dust Background Document and Technical Information
Document for Best Available Control Measures,'' EPA 450/2-92-004,
September 1992.
    7. Standards of Performance for Portland Cement Plants (40 CRF Ch.1
(7-1-09 Edition), Subpart F Sec.  60.60).

B. Does the rule meet the evaluation criteria?

    We believe this rule is consistent with the relevant policy and
guidance regarding enforceability, BACM, and SIP relaxations. The TSD
has more information on our evaluation.

C. EPA Recommendations To Further Improve the Rule

    The TSD describes additional rule revisions that we recommend for
the next time the local agency modifies the rule.

D. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted rule because we believe it fulfills all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this

Federal Register, we are simultaneously proposing approval of the same
submitted rule. If we receive adverse comments by July 2, 2012, we will
publish a timely withdrawal in the Federal Register to notify the
public that the direct final approval will not take effect and we will
address the comments in a subsequent final action based on the
proposal. If we do not receive timely adverse comments, the direct
final approval will be effective without further notice on July 31,
2012. This will incorporate the rule into the federally enforceable
SIP.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 31, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirement.

    Dated: April 24, 2012.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(362)(i)(B)(2) to
read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (362) * * *
    (i) * * *
    (B) * * *
    (2) Rule 1156, ``Further Reductions of Particulate Emissions from
Cement Manufacturing Facilities,'' amended on March 6, 2009.
* * * * *

[FR Doc. 2012-13301 Filed 5-31-12; 8:45 am]
BILLING CODE 6560-50-P