[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Rules and Regulations]
[Pages 48077-48081]
[FR Doc No: 2019-19648]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Part 395

[Docket No. FMCSA-2004-19608]
RIN 2126-AC30

Hours of Service of Drivers--Restart Provisions

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

ACTION: Final rule.

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SUMMARY: FMCSA amends its hours-of-service (HOS) requirements
applicable to drivers of property-carrying commercial motor vehicles
(CMVs) to remove provisions requiring that a 34-hour restart include
two periods between 1 a.m. and 5 a.m. and limiting use of a restart to
once every 168

hours--provisions that were promulgated in December 2011. In a series
of Appropriations Acts, Congress suspended these provisions, pending
completion of a naturalistic study comparing the effects of the restart
provisions in effect under the 2011 rule versus provisions in effect
prior to the 2011 rule's compliance date. The 2017 naturalistic study
found no statistically significant benefits from the restart rule.
Pursuant to a 2017 Appropriations Act, the 2011 restart rules are
therefore void by operation of law. Although not in effect, the
provisions remain in the Code of Federal Regulations (CFR), which could
cause confusion for some stakeholders.

DATES: This final rule is effective September 12, 2019.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, Federal Motor
Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington,
DC 20590-0001, by telephone at<PHONE_NUMBER>, or email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This Final Rule is organized as follows:

I. Abbreviations and Acronyms
II. Legal Basis for the Rulemaking
III. Background
IV. International Impacts
V. Section-by-Section Analysis
VI. Regulatory Analyses
    A. Executive Order (E.O.) 12866 (Regulatory Planning and
Review), E.O. 13563 (Improving Regulation and Regulatory Review),
and DOT Regulatory Policies and Procedures
    B. E.O. 13771 (Reducing Regulation and Controlling Regulatory
Costs)
    C. Congressional Review Act
    D. Regulatory Flexibility Act
    E. Assistance for Small Entities
    F. Unfunded Mandates Reform Act of 1995
    G. Paperwork Reduction Act
    H. E.O. 13132 (Federalism)
    I. E.O. 12988 (Civil Justice Reform)
    J. E.O. 13045 (Protection of Children)
    K. E.O. 12630 (Taking of Private Property)
    L. Privacy
    M. E.O. 12372 (Intergovernmental Review)
    N. E.O. 13211 (Energy Supply, Distribution, or Use)
    O. E.O. 13783 (Promoting Energy Independence and Economic
Growth)
    P. E.O. 13175 (Indian Tribal Governments)
    Q. National Technology Transfer and Advancement Act (Technical
Standards)
    R. Environment (NEPA)
    S. Fixing America's Surface Transportation Act (FAST Act)

I. Abbreviations and Acronyms

APA Administrative Procedure Act
CFR Code of Federal Regulations
CMV Commercial motor vehicle
DOT Department of Transportation
E.O. Executive Order
FMCSA Federal Motor Carrier Safety Administration
FMCSRs Federal Motor Carrier Safety Regulations
FR Federal Register
HOS Hours of service
NEPA National Environmental Policy Act
OMB Office of Management and Budget
Sec.  Section
U.S.C. United States Code

II. Legal Basis for the Rulemaking

    This rulemaking is based on authority derived from the Motor
Carrier Act of 1935 (1935 Act) and the Motor Carrier Safety Act of 1984
(1984 Act), as well as a series of appropriations acts that ultimately
invalidated certain HOS provisions.
    The 1935 Act, as amended, provides that ``The Secretary of
Transportation may prescribe requirements for--(1) qualifications and
maximum hours of service of employees of, and safety of operation and
equipment of, a motor carrier; and (2) qualifications and maximum hours
of service of employees of, and standards of equipment of, a motor
private carrier, when needed to promote safety of operation'' (49
U.S.C. 31502(b)(1), (2)). The HOS regulations concern the ``maximum
hours of service of employees'' of both motor carriers and motor
private carriers, as authorized by the 1935 Act.
    The 1984 Act, as amended, provides broad concurrent authority to
regulate drivers, motor carriers, and vehicle equipment. It requires
the Secretary of Transportation to ``prescribe regulations on
commercial motor vehicle safety. The regulations shall prescribe
minimum safety standards for commercial motor vehicles.'' (49 U.S.C.
31136(a)). The 1984 Act also requires that: ``At a minimum, the
regulations shall ensure that--(1) commercial motor vehicles are
maintained, equipped, loaded, and operated safely; (2) the
responsibilities imposed on operators of commercial motor vehicles do
not impair their ability to operate the vehicles safely; (3) the
physical condition of operators of commercial motor vehicles is
adequate to enable them to operate the vehicles safely. . .; (4) the
operation of commercial motor vehicles does not have a deleterious
effect on the physical condition of the operators; and (5) an operator
of a commercial motor vehicle is not coerced by a motor carrier,
shipper, receiver, or transportation intermediary to operate a
commercial motor vehicle in violation of a regulation promulgated under
this section . . .'' (49 U.S.C. 31136(a)(1)-(5)).
    This final rule is a non-discretionary ministerial act to conform
certain sections of the Agency's HOS rules governing the restart of a
driver's 60- or 70-hour limit to a prior version of those limits
restored by operation of law, as discussed below. Thus, there is no
practical impact in any area identified under 49 U.S.C. 31136(a).
    In 2014, Congress suspended two provisions of the 2011 restart rule
(the requirement for 2 off-duty periods from 1:00 to 5:00 a.m. and the
limitation of the restart to once a week) and prohibited the use of
appropriated funds to enforce them unless and until a naturalistic
study required by the statute, and described in detail, found that the
2011 restart rule provided greater net operational, safety, health and
fatigue benefits than the pre-2011 restart rule. In the meantime, the
pre-2011 restart rule was restored to full effect (Consolidated and
Further Continuing Appropriations Act, 2015, Pub. L. 113-235, Div. K,
Title I, sec. 133, 128 Stat. 2130, 2711-2713 (Dec. 16, 2014)). The
statute required both the Secretary of Transportation (whose authority
in this area has been delegated to FMCSA) and the Inspector General
(IG) to review and report to Congress the results of the study.
Congress then extended the suspension and funding prohibition through
fiscal year 2016 (Consolidated Appropriations Act, 2016, Pub. L. 114-
113, Div. L, Title I, sec. 133, 129 Stat. 2242, 2850 (Dec. 18, 2015)).
This Act also expanded the factors that would need to be evaluated,
requiring FMCSA and the IG to determine whether the naturalistic study
showed that drivers operating under the 2011 restart rule achieved
``statistically significant improvement in all outcomes related to
safety, operator fatigue, driver health and longevity, and work
schedules, in comparison to commercial motor vehicle drivers who
operated under'' the pre-2011 restart rule. Id.
    This provision then was further amended to make clear that, if the
study did not demonstrate such statistically significant improvements,
``the 34-hour restart rule in operational effect on June 30, 2013
[i.e., the pre-2011 rule] shall be restored to full force and effect on
the date that the Secretary submits the final report to the Committees
on Appropriations of the House of Representatives and the Senate, and
funds appropriated or otherwise made available by this Act or any other
Act shall be available to implement, administer, or enforce the rule''
(Further Continuing and Security Assistance Appropriations Act, 2017,
Pub. L. 114-254, Div. A, sec. 180, 130 Stat. 1005, 1016-1017 (Dec. 10,
2016)).
    In January 2017, the final report required by the 2015
Appropriations Act was submitted for review to the IG, as required by
statute. After reviewing the IG's findings, FMCSA's Deputy

Administrator reported to the Senate and House Appropriations
Committees that drivers using the 2011 restart rule experienced safety
outcomes not significantly different from those using the pre-2011
restart rule.\1\ On March 2, 2017, the IG confirmed this conclusion to
Congress. Because the 2011 restart rule generated no statistically
significant improvements in safety, it became void by operation of law
and the pre-2011 restart rule was restored to full force and effect.
Today's rule adopts the pre-2011 version of 49 CFR 395.3(c), conforming
the language of the regulation to the statutory requirement.\2\
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    \1\ Commercial Motor Vehicle Driver Restart Study Report to
Congress; Pursuant to Section 133 of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235), March 2017,
See https://www.fmcsa.dot.gov/mission/policy/commercial-motor-vehicle-driver-restart-study-report-congress. A copy has been placed
in the docket.
    \2\ Because the study failed to establish a statistically
significant improvement in the initial factors required by Congress,
evaluation of the additional factors added by Congress became moot.
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    The Administrative Procedure Act (APA) specifically provides
exceptions to its notice and comment rulemaking procedures when an
agency finds there is good cause to dispense with them and incorporates
``the finding and a brief statement of reasons therefor in the rules
issued.'' (5 U.S.C. 553(b)(B)). Generally, good cause exists when an
agency determines that notice and public comment procedures are
impractical, unnecessary, or contrary to the public interest (id.).
Here, FMCSA finds that it is unnecessary to provide notice and public
comment procedures because, as explained above, this final rule is a
non-discretionary ministerial act to implement a statutory requirement.
Therefore, in accordance with the APA, good cause exists for not
providing notice and comment rulemaking procedures on this final rule.
    Additionally, the APA allows agencies to make rules effective
immediately with good cause (5 U.S.C. 553(d)(3)), instead of requiring
publication at least 30 days prior to the effective date. For the
reasons given above, FMCSA finds good cause to make this rule effective
immediately.

III. Background

    Among the provisions included as part of the 2011 HOS rule were
restrictions on the use of the 34-hour restart provision, limiting its
use to once every 168 hours and requiring that a restart include two
periods between the hours of 1 a.m. and 5 a.m. These restrictions
proved problematic for many drivers and carriers, adversely affecting
their operations and generating significant controversy. As noted
above, Congress suspended these restrictions, subject to a study of the
effectiveness of the new rule. Specifically, Congress required the
Secretary to initiate a ``naturalistic study of the operational,
safety, health and fatigue impacts of the restart provisions''; the law
addressed the methodology of the study in detail and made clear that
the 2011 HOS restart provisions would have no effect unless the study
showed that those provisions had a greater net benefit compared to the
pre-2011 HOS restart rule.\3\ Subsequent legislation made clear that
the study would need to show a statistically significant improvement in
multiple factors enumerated in the legislation. The effectiveness study
\4\ and the March 2017 report to Congress \5\ confirmed the finding
that no statistically significant benefits accrued from the 2011 HOS
restart rule. See discussion under II Legal Basis for this Rulemaking,
above.
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    \3\ Shortly after the initial suspension, FMCSA issued a notice
of the suspension of enforcement of these restrictions and announced
that the restart provisions in place on June 30, 2013 (the day
before the applicable compliance date under the 2011 rule), would
govern (79 FR 76241 (December 22, 2014)). Today's rule would align
the applicable provisions in 49 CFR 395.3 with the provisions in
effect at that time, consistent with the governing legislation.
After reviewing the IG's findings, FMCSA's Deputy Administrator
reported to the Senate and House Appropriations Committees that
drivers using the 2011 restart rule did not experience a ``greater
net benefit'' in safety outcomes compared to those using the pre-
2011 restart rule.
    \4\ Dinges, et al., Commercial Motor Vehicle (CMV) Driver
Restart Study: Final Report, FMCSA-RRR-15-011, Dec. 2015, See
https://www.fmcsa.dot.gov/safety/research-and-analysis/cmv-driver-restart-study-final-report. A copy has been placed in the docket.
    \5\ See footnote 1, above.
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    Thus, the limitation on use of the restart option to once every 168
hours and the requirement that a restart include the two periods from 1
a.m. to 5 a.m. are no longer in effect; however, the fact that they
still appear in the Code of Federal Regulations (CFR) causes confusion
for stakeholders. Today's rule makes technical amendments to Sec.
395.3, removing the two phrases in paragraph (c)(1) and (2) relating to
the 1 a.m. to 5 a.m. requirement and removing paragraph (d) relating to
the 168-hour limitation, consistent with the HOS rules concerning the
34-hour restart option currently in effect. Because the changes in this
rule are ministerial, they will have no adverse effect on safety.

IV. International Impacts

    The FMCSRs, and any exceptions to the FMCSRs, apply only within the
United States (and, in some cases, United States territories). Motor
carriers and drivers are subject to the laws and regulations of the
countries in which they operate, unless an international agreement
states otherwise. Drivers and carriers should be aware of the
regulatory differences among nations.

V. Section-by-Section Analysis

Section 395.3 Maximum Driving Time for Property-Carrying Vehicles

    This action removes from Sec.  395.3(c) both instances of the
phrase ``that includes two periods from 1 a.m. to 5 a.m.'' and restores
the rule text of paragraph (c) to the Oct. 1, 2011, text. The change is
ministerial and technical only and has no legal effect.
    In addition, paragraph (d) is removed completely. It currently
provides that ``a driver may not take an off-duty period allowed by
paragraph (c) of this section to restart the calculation of 60 hours in
7 consecutive days or 70 hours in 8 consecutive days until 168 or more
consecutive hours have passed since the beginning of the last such off-
duty period. When a driver takes more than one off-duty period of 34 or
more consecutive hours within a period of 168 consecutive hours, he or
she must indicate in the Remarks section of the record of duty status
which such off-duty period is being used to restart the calculation of
60 hours in 7 consecutive days or 70 hours in 8 consecutive days.'' The
change also is ministerial and technical only and has no legal effect.

VI. Regulatory Analyses

A. E.O. 12866 (Regulatory Planning and Review), E.O. 13563 (Improving
Regulation and Regulatory Review), and DOT Regulatory Policies and
Procedures

    FMCSA performed an analysis of the impacts of this final rule and
determined it is not a significant regulatory action under section 3(f)
of E.O. 12866 (58 FR 51735, October 4, 1993), Regulatory Planning and
Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011),
Improving Regulation and Regulatory Review. Accordingly, the Office of
Management and Budget (OMB) has not reviewed it under these Orders. It
is also not significant within the meaning of DOT regulatory policies
and procedures (DOT Order 2100.6 dated Dec. 20, 2018). This rule
conforms 49 CFR 395.3 to statutory requirements and current practice by
removing provisions that are not in effect, thus, not enforced, and
does not result in costs or benefits to any regulated entity.

B. E.O. 13771 (Reducing Regulation and Controlling Regulatory Costs)

    This rule has been designated as a deregulatory action under
Executive Order (E.O.) 13771 by the Office of Information and
Regulatory Affairs because it updates obsolete regulatory text.

C. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801, et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).

D. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612),
FMCSA is not required to complete a regulatory flexibility analysis
because, as discussed earlier in the Legal Basis for the Rulemaking
section, this action is not subject to notice and public comment under
section 553(b) of the APA.

E. Assistance for Small Entities

    In accordance with section 213(a) of the Small Business Regulatory
Enforcement Fairness Act, FMCSA wants to assist small entities in
understanding this rule so that they can better evaluate its effects on
themselves and participate in the rulemaking initiative. If the rule
will affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please consult the FMCSA point of contact,
Richard Clemente, listed in the For Further Information Contact section
of this rule.
    Small businesses may send comments on the actions of Federal
employees who enforce or otherwise determine compliance with Federal
regulations to the Small Business Administration's Small Business and
Agriculture Regulatory Enforcement Ombudsman and the Regional Small
Business Regulatory Fairness Boards. The Ombudsman evaluates these
actions annually and rates each agency's responsiveness to small
business. If you wish to comment on actions by employees of FMCSA, call
1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights
of small entities to regulatory enforcement fairness and an explicit
policy against retaliation for exercising these rights.

F. Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector, of $165 million (which is the
value equivalent of $100,000,000 in 1995, adjusted for inflation to
2018 levels) or more in any 1 year. Because this rule will not result
in such an expenditure, a written statement is not required.

G. Paperwork Reduction Act

    This rule does not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Nor does
this rule modify the existing approved collection of information (OMB
Control Number 2126-0001, HOS of Drivers Regulations, approved Jun. 13,
2016, through Jun. 30, 2019).

H. E.O. 13132 (Federalism)

    A rule has implications for federalism under section 1(a) of E.O.
13132 if it has ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' FMCSA determined that this rule does not have substantial
direct costs on or for States, nor does it limit the policymaking
discretion of States. Nothing in this rule preempts any State law or
regulation. Therefore, this rule does not have sufficient federalism
implications to warrant the preparation of a Federalism Impact
Statement.

I. E.O. 12988 (Civil Justice Reform)

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate
ambiguity, and reduce burden.

J. E.O. 13045 (Protection of Children)

    E.O. 13045, Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997), requires agencies
issuing ``economically significant'' rules, if the regulation also
concerns an environmental health or safety risk that an agency has
reason to believe may disproportionately affect children, to include an
evaluation of the regulation's environmental health and safety effects
on children. The Agency determined this rule is not economically
significant and does not anticipate that this regulatory action could
in any respect present an environmental or safety risk that could
disproportionately affect children.

K. E.O. 12630 (Taking of Private Property)

    FMCSA reviewed this rule in accordance with E.O. 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights, and has determined it does not effect a taking of
private property or otherwise have taking implications.

L. Privacy

    Section 522 of title I of division H of the Consolidated
Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447,
118 Stat. 2809, 3268, note following 5 U.S.C. 552a), requires the
Agency to conduct a Privacy Impact Assessment of a regulation that will
affect the privacy of individuals. The assessment considers impacts of
the rule on the privacy of information in an identifiable form and
related matters. The FMCSA Privacy Officer has evaluated the risks and
effects the rulemaking might have on collecting, storing, and sharing
personally identifiable information and has evaluated protections and
alternative information handling processes in developing the rule to
mitigate potential privacy risks. FMCSA determined that this rule does
not require the collection of individual personally identifiable
information.
    The DOT Privacy Office has determined that this rulemaking does not
create privacy risk.
    The E-Government Act of 2002, Public Law 107-347, sec. 208, 116
Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct
a Privacy Impact Assessment for new or substantially changed technology
that collects, maintains, or disseminates information in an
identifiable form. No new or substantially changed technology will
collect, maintain, or disseminate information because of this rule.

M. E.O. 12372 (Intergovernmental Review)

    The regulations implementing E.O. 12372 regarding intergovernmental
consultation on Federal programs and activities do not apply to this
rulemaking.

N. E.O. 13211 (Energy Supply, Distribution, or Use)

    FMCSA has analyzed this rule under E.O. 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use. The Agency has determined that it is not a ``significant energy
action'' under that order because it is not a ``significant regulatory
action'' likely to have a significant adverse effect on the supply,

distribution, or use of energy. Therefore, it does not require a
Statement of Energy Effects under E.O. 13211.

O. E.O. 13783 (Promoting Energy Independence and Economic Growth)

    E.O. 13783 directs executive departments and agencies to review
existing regulations that potentially burden the development or use of
domestically produced energy resources, and to appropriately suspend,
revise, or rescind those that unduly burden the development of domestic
energy resources. In accordance with E.O. 13783, DOT prepared and
submitted a report to the Director of OMB that provides specific
recommendations that, to the extent permitted by law, could alleviate
or eliminate aspects of agency action that burden domestic energy
production. This rule has not been identified by DOT under E.O. 13783
as potentially alleviating unnecessary burdens on domestic energy
production.

P. E.O. 13175 (Indian Tribal Governments)

    This rule does not have tribal implications under E.O. 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes.

Q. National Technology Transfer and Advancement Act (Technical
Standards)

    The National Technology Transfer and Advancement Act (note
following 15 U.S.C. 272) directs agencies to use voluntary consensus
standards in their regulatory activities unless the agency provides
Congress, through OMB, with an explanation of why using these standards
will be inconsistent with applicable law or otherwise impractical.
Voluntary consensus standards (e.g., specifications of materials,
performance, design, or operation; test methods; sampling procedures;
and related management systems practices) are standards that are
developed or adopted by voluntary consensus standards bodies. This rule
does not use technical standards. Therefore, FMCSA did not consider the
use of voluntary consensus standards.

R. Environment (NEPA)

    FMCSA analyzed this rule for the purpose of the National
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and
determined this action is categorically excluded from further analysis
and documentation in an environmental assessment or environmental
impact statement under FMCSA Order 5610.1 (69 FR 9680, Mar. 1, 2004),
Appendix 2, paragraph 6.b. This Categorical Exclusion addresses minor
corrections such as those found in this rulemaking; therefore,
preparation of an environmental assessment or environmental impact
statement is not necessary. The Categorical Exclusion determination is
available for inspection or copying in docket FMCSA-2004-19608.

S. Fixing America's Surface Transportation Act (FAST Act)

    Under 49 U.S.C. 31136(g), FMCSA is required to publish an advance
notice of proposed rulemaking, unless the Agency finds good cause that
an ANPRM is impracticable, unnecessary, or contrary to the public
interest, or conduct a negotiated rulemaking when it engages in certain
rulemakings. These requirements pertain to a proposed rulemaking likely
to result in a ``major rule.'' \6\ Because this rulemaking does not
involve issuance of a proposed rule, and today's final rule is not a
``major rule,'' these requirements are not applicable.
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    \6\ In enacting this provision, Congress did not define ``major
rule.'' See section 5202 of the FAST Act, Public Law 114-94, 129
Stat. 1312, 1534-1535 (December 4, 2015). However, Congress used the
term in enacting another statute addressing Agency rulemaking,
popularly referred to as the Congressional Review Act, which
includes a definition of the term ``major rule.'' See 5 U.S.C.
804(2). The Agency relies on this definition in evaluating the
application of 49 U.S.C. 31136(g).
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List of Subjects for 49 CFR Part 395

    Highway safety, Motor carriers, Reporting and recordkeeping
requirements.

    In consideration of the foregoing, FMCSA amends 49 CFR part 395 to
read as follows.

PART 395--HOURS OF SERVICE OF DRIVERS

0
1. The authority citation for part 395 continues to read as follows:

    Authority: 49 U.S.C. 504, 31133, 31136, 31137, 31502; sec. 113,
Pub. L. 103-311, 108 Stat. 1673, 1676; sec. 229, Pub. L. 106-159 (as
added and transferred by sec. 4115 and amended by secs. 4130-4132,
Pub. L. 109-59, 119 Stat. 1144, 1726, 1743, 1744); sec. 4133, Pub.
L. 109-59, 119 Stat. 1144, 1744; sec. 108, Pub. L. 110-432, 122
Stat. 4860-4866; sec. 32934, Pub. L. 112-141, 126 Stat. 405, 830;
sec. 5206(b), Pub. L. 114-94, 129 Stat. 1312, 1537; and 49 CFR 1.87.

0
2. In Sec.  395.3, revise paragraph (c) and remove paragraph (d) to
read as follows:

Sec.  395.3  Maximum driving time for property-carrying vehicles.

* * * * *
    (c)(1) Any period of 7 consecutive days may end with the beginning
of an off-duty period of 34 or more consecutive hours.
    (2) Any period of 8 consecutive days may end with the beginning of
an off-duty period of 34 or more consecutive hours.

    Issued under authority delegated in 49 CFR 1.87.

    Dated: September 5, 2019.
Raymond P. Martinez,
Administrator.
[FR Doc. 2019-19648 Filed 9-11-19; 8:45 am]
BILLING CODE 4910-EX-P


Page 1 of 2 February 9, 2005 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING MARCH 1 2, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0395 SCIENTIFIC ISSUES ASSOCIATED WITH THE HUMAN HEALTH ASSESSMENT OF THE CRY34AB1 PROTEIN Holiday Inn  National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 684 7200 PANEL MEMBERS FIFRA SAP Session Chair:

Stephen M. Roberts, Ph. D. Professor and Program Director Center for Environmental and Human Toxicology University of Florida, Box 110885 Building 471, Mowry Road Gainesville, FL 32611 0885 Designated Federal Official:

Paul Lewis, Ph. D. FIFRA Scientific Advisory Panel Office of Science Coordination and Policy U. S. Environmental Protection Agency 1200 Pennsylvania Ave, N. W. ( 7201M) EPA East Building Washington, D. C. 20460 Phone: 202 564 8450; Fax: 202 564 8382 Lewis. paul@ epa. gov FIFRA SAP Members:

Stuart Handwerger, M. D., Director, Division of Endocrinology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH 45229 Page 2 of 2 Steven Heeringa, Ph. D., Research Scientist & Director for Statistical Design, Institute for Social Research, University of Michigan, PO Box 1248, Ann Arbor, MI, 48106 1248 Kenneth Portier, Ph. D., Associate Professor, Statistics, Institute of Food and Agricultural Sciences, University of Florida, 522 McCarty Hall C, P. O. Box 110339, Gainesville, FL, 32611 0339 FQPA Science Review Board Members:

Tong Jen Fu, Ph. D., National Center for Food Safety and Technology, Food and Drug Administration, 6502 South Archer Road, Summit Argo, IL, 60501 Louis B. Hersh, Ph. D., George Schwert Professor and Chair, Department of Molecular and Cellular Biochemistry, College of Medicine, University of Kentucky, MS607, Lexington, KY, 40536 0298 Simon Hogan, Ph. D., Assistant Professor of Pediatrics, Research Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, ML 7028, Cincinnati, OH 45229 Dean Metcalfe, MD, Chief, Laboratory of Allergic Diseases, NIAID, NIH, DHHS, Building 10, Room 11C210, 10 Center Drive, MSC 1881, Bethesda, MD, 20892 1181 Shridhar K Sathe, Ph. D., D. K. Salunkhe Professor of Food Science, Distinguished Teaching Professor, Department of Nutrition, Food and Exercise Sciences, Florida State University, 402 Sandels Building, Tallahassee, FL, 32306 1493 Santiago Schnell, Ph. D. Assistant Professor, School of Informatics, Indiana University, Eigenmann Hall 9061900 East Tenth Street, Bloomington, IN, 47406 Abraham R Tzafriri, Ph. D. Postdoctoral Fellow, Harvard MIT Biomedical Engineering Center, Division of Health Science and Technology, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Room 16343, Cambridge, MA, 02139


 1Johnston, Carey A., " EPA Data Needs to Help EPA Assess section 316( b) Comments related to MODUs," Memorandum to Alan Spackman ( IADC) et al., March 21, 2001.

Page 1 of 4 Memorandum From: Carey A. Johnston USEPA/ OW/ OST ph: ( 202) 260 7186 johnston. carey@ epa. gov To: File Cc: Mr. James M. Magill U. S. Coast Guard Vessel and Facility Operating Standards Division Date: May 7, 2001 Re: Notes from April 4, 2001 Meeting with U. S. Coast Guard Background EPA received several comments on the August 10, 2000 new source cooling water intake proposal related to mobile offshore drilling units ( MODUs). EPA outlined the major issues raised by the offshore oil and gas industry and identified several data needs. 1 EPA contacted Jim Magill ( 202 267 1082; jmagill@ comdt. uscg. mil) U. S. Coast Guard, to assist with EPA's data collection. Mr. Magill is an Offshore Specialist in the Coast Guard's Vessel and Facility Operating Standards Division. On April 4, 2001, Peter Sherman ( EPA Contractor, TetraTech) and I met with Mr. Magill at his Coast Guard Headquarters office. The meeting lasted approximately 90 minutes. The following are the Mr. Magill's answers to my questions.

Summary Meeting Notes Q: What are typical cooling water intake ( CWI) rates, velocities, and durations?

Mr. Magill reviewed and agreed with the cooling water intake figures provided in comments to the proposed rule by Mr. Spackman ( International Association of Drilling Contractors). Mr. Magill noted that Mr. Spackman formerly worked for the U. S. Coast Guard and should have a sufficient background to estimate these CWI rates. Specifically, Mr. Spackman identified the following CWI rates for the following vessels: Page 2 of 4 S Drill Ships 16  20 MGD;

S Semi submersibles 2  15+ MGD;

S Jack ups 2  10+ MGD;

S Submersibles 2  10+ MGD w/ most < 2 MGD; and S Drill Barges < 2 MGD.

Mr. Magill also agreed with Mr. Spackman that the majority of offshore oil and gas drilling operations use drill ships, semi submersibles, and jack ups with submersibles and drill barges being used less frequently and in shallower waters. There are about 7 to 10 drillships in operation in the GOM with the remaining bulk of drilling being split 50/ 50 by semi submersibles and jack ups. Mr. Magill has less experience estimating through screen cooling water intake velocities but felt that Mr. Spackman's estimates of through screen cooling water intake velocities for each of the MODUs were reasonable.

Mr. Magill stated that exploratory drilling can take 1 to 3 months while development drilling can take 1 to 2 years to drill approximately 24 total wells for a particular location. Mr. Magill also stated that the life span of semi submersibles is approximately 20 years.

Q: What are the potential retro fit costs associated with reducing the intake velocities for various MODUs?

Mr. Magill stated that he did not have a good estimate of these costs but did have a general idea of the work requirements for these potential retrofits. Mr. Magill stated that retrofits for drill ships and semi submersibles that use seachests as the CWI structure would be in the millions of dollars ( 8 10) and require several weeks to months for drydocking operations. Complicating matters is that there are only a few deepwater drydock harbors capable of handling semi submersibles.

Costs for retro fitting jack ups would likely be much less complicated and expensive than sea chest retro fits. Mr. Magill assumed that operators could install a bell or cone intake device on the existing CWI structures to reduce CWI velocities.

Q: What is a typical design of a drill ship and semi submersible sea chest?

Mr. Magill stated that in previous years the Coast Guard's Marine Safety Center ( MSC) reviewed all MODU designs. Now that function has been delegated to the American Bureau of Shipping ( ABS) which offers a wide range of ship classification and industrial certification services. As a result of this delegation, Mr. Magill nor the MSC had any sea chest designs or schematics for EPA to review. In general there are three pipes for each sea chest ( these include CWIs and fire pumps). One of the three intake pipes is always set aside for use solely for emergency fire fighting operations. These pipes are usually back on the flush line of the sea chest. The sea chest is cavity in the hull or pontoon of the MODU and is exposed to the ocean with a screen often set along the flush line of the sea chest. There are generally two sea chests for each Page 3 of 4 drill ship or semi submersible ( port and starboard) for redundancy and ship stability considerations. In general, only one seachest is required at any given time for drilling operations.

Q: What is the typical depth below water of sea chests?

When semi submersibles are drilling their sea chests are 80 to 100 feet below the water surface and are less than 20 feet below water when the pontoons are raised for transit or screen cleaning operations. Drill ships have their sea chests on the bottom of their hulls and are typically 20 to 40 feet below water at all times.

Q: Must CWI velocities be higher than 2 5 ft/ s to reduce marine biofouling?

Mr. Magill stated that the answer depends on the environment in which you are drilling and gave several examples from his field experience. His experience in waters off of the Carribean nation of Belize show that there can be substantial biological growth on vessel structures in less than a year. Mr. Magill stated that current Coast Guard requirements are that operators must inspect sea chests twice in five years with at least one cleaning. These requirements are particularly important to ensure that the separate intake for the fire pump is clear. Mr. Magill estimated that the regular cleaning and inspection schedule should be enough to control marine biofouling in the GOM.

Q: What are the typical water requirements for various MODU operations?

Mr. Magill estimated that 80% of the intake water is for cooling water. Other water intakes are for fire pumps ( intermittent), hotel loads, industrial cleaning, desalinators. Mr. Magill stated that a typical drill ship or semi submersible will use three to four 1,500 HP engines to provide operating power and also use other engines for auxiliary back up power for fire fighting and emergency situations.

Q: Would CWI retrofits cause problems with hull design, load paths, and fatigue?

Mr. Magill stated that a re designed sea chest with a bell intake set back approximately four feet or a bell or funnel shaped cone on the end of a jack up CWI pipe would not cause the problems identified by Noble Drilling. However, Mr. Magill also stated that using the same pipe diameter ( e. g., 4 to 6 feet) from the CWI structure to the top of the jack up rig would however be a major undertaking and may cause additional concerns similar to the ones identified by Noble Drilling. Page 4 of 4 Attachment  Review of Draft Memorandum From: Magill, James < Jmagill@ comdt. uscg. mil> To: Carey Johnston/ DC/ USEPA/ US Cc: Prescott, Mark CDR < MPrescott@ comdt. uscg. mil> Date: 05/ 07/ 01 07: 26 AM Re: draft summary meeting notes Carey, Your draft notes on our meeting look good. I have only one small change: On page 3, Q: What is the typical depth below water of sea chests?

When semi submersibles are drilling their sea chests are 80 to 100 feet below the water surface and are less than 20 feet below water when the pontoons are raised for transit or screen cleaning operations. Drill ships have their sea chests on the bottom of their hulls and are typically 20 feet or more below the water at all times.

As you see I have changed the last sentence, as the draft of drill ships, depending on their size, is usually from 20 to 40 feet. If I can be of any further assistance please do not hesitate to call or email

Jim Magill Offshore Specialist, G MSO 2 Tel# ( 202) 267 1082 Fax# ( 202) 2674570 E mail: jmagill@ comdt. uscg. mil  Original Message From: Johnston. Carey@ epamail. epa. gov Sent: Monday, April 30, 2001 8: 35 AM To: Magill, James Subject: RE: draft summary meeting notes Dear Jim:

Sorry for the delay. Here is the file in *. doc format. Please let me know if you have any more problems reading the file. Thank you again for you assistance.

Sincerely, Carey ( See attached file: coastguard. doc)


[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5436-5437]
[FR Doc No: 2016-01803]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-59-000]

Cheniere Corpus Christi Pipeline, L.P.; Notice of Request Under
Blanket Authorization

    Take notice that on January 15, 2016, Cheniere Corpus Christi
Pipeline, L.P. (Cheniere Corpus Christi), 700 Milam Street, Suite 1900,
Houston, Texas 77002, filed in Docket No. CP16-59-000 a prior notice
request pursuant to sections 157.205, 157.208 and 157.210 of the
Commission's regulations under the Natural Gas Act (NGA) as amended,
requesting authorization to install two electric motor drive (EMD)
compressors and associated facilities at the previously authorized
Sinton Compressor Station site at San Patricio County, Texas (Sinton
Compressor Station EMD Project).
    Cheniere Corpus Christi was granted authorization in Docket No.
CP12-508-000 \1\ to construct its Corpus Christi Pipeline Project which
included two compressor stations. Cheniere Corpus Christi states that
the Taft Compressor Station is no longer needed and proposes to install
approximately 29,600 horsepower (HP) of additional compression via two
Solar EMD compressor units (14,800 HP each) at

the Sinton Compressor Station. Cheniere Corpus Christi states that, as
a result of the relocation of compression, neither the capacity nor the
maximum allowable operating pressure of the Corpus Christi Pipeline
will differ from what was authorized by the Commission in the
Certificate.
---------------------------------------------------------------------------

    \1\ 149 FERC ]61,283 (2014).
---------------------------------------------------------------------------

    Cheniere Corpus Christi estimates the cost of the Sinton Compressor
Station EMD Project to be approximately $30 million, all as more fully
set forth in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Patricia Outtrim, Cheniere Energy Inc., 700 Milam Street, Suite 1900,
Houston, Texas 77002, by telephone at<PHONE_NUMBER>, by facsimile at
(713) 375-6485, or by email at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and seven copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426.

    Dated: January 21, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-01803 Filed 2-1-16; 8:45 am]
 BILLING CODE 6717-01-P


MEMORANDUM

TO:		Public Record for the NPDES Electronic Reporting Rule  -  Phase 2 Extension
		EPA Docket Number EPA-HQ-OECA-2019-0408 (www.regulations.gov)

FROM:		Carey A. Johnston, P.E.
            USEPA/OECA/OC
            ph:<PHONE_NUMBER>
<EMAIL_ADDRESS>
DATE:		12 June 2020

--------------------------------------------------------------------------------
SUBJECT:	Notes from State Outreach Meeting with ACWA (12 May 2020) [DCN 0026]
--------------------------------------------------------------------------------

Overview
EPA convened this meeting with the Association of Clean Water Administrators (ACWA) to discuss their comments on the NPDES Electronic Reporting Rule - Phase 2 Extension proposed rule. This proposed rule was published on February 28, 2020 and the comment period closed on April 28, 2020. The ACWA comments are in the public docket for this rulemaking. The following people participated in this meeting:
 Carey Johnston, U.S. EPA
 Courtney Tuxbury, U.S. EPA
 Randy Hill, U.S. EPA
 Sean Rolland, ACWA

Review of State Comments
Mr. Johnston provided a quick review of the people that provided comments on the proposed rule. As shown in the following table, EPA received 9 public comments with all but one from state representatives. EPA provided ACWA will a summary of the comments it received on the proposed rule. Commenters were generally supportive of the proposed rule. State commenters also requested a five-year extension instead of the proposed three-year extension. EPA received no comments on the accompanying ICR.

                                      No.
Commenter
                                 Commenter Org
                                Date Submitted
                                     Pages
                                       1
Brian Weigel, Watershed Management Bureau Director
Adrian Stocks, Water Quality Bureau Director
                   Wisconsin Department of Natural Resources
                                   3/20/2020
                                       1
                                       2
Kayla Lyon, Director
                     Iowa Department of Natural Resources
                                   4/27/2020
                                       2
                                       3
Lynn Barlow, Community and Program Assistance Manager
                  Oregon Department of Environmental Quality
                                   4/27/2020
                                       2
                                       4
Patrick McDonnell, Secretary
              Pennsylvania Department of Environmental Protection
                                   4/28/2020
                                       1
                                       5
Toby Baker, Executive Director
                   Texas Commission on Environmental Quality
                                   4/28/2020
                                       3
                                       6
David E. Ramsey, ICIS Program Coordinator
                Arkansas Department of Energy & Environment
                                   4/28/2020
                                       1
                                       7
Melanie D. Davenport
                                ACWA President
                                   4/28/2020
                                       4
                                       8
Jeffery W. Kitchens, Chief, Water Division
                Alabama Department of Environmental Management
                                   4/28/2020
                                       1
                                       9
Anonymous public comment
                        Anonymous or Individual Person
                                   4/28/2020
                                       1

Discussion of the NNCR Publication Date
Mr. Johnston then focused the discussion on the NPDES Noncompliance Report (NNCR). In accordance with EPA regulations, the NNCR will be an EPA-issued report that summarizes noncompliance based on data it collects and data that is collected by states and shared with EPA. The NPDES eRule established data sharing requirements for states and shifted the responsibility of summarizing NPDES noncompliance from states to EPA. EPA promulgated these changes when it published the NPDES eRule. In the proposed Phase 2 extension rule, EPA proposed to postpone the regulatory deadline for publication of the initial version of the NNCR to the public by one year (from December 21, 2021 to December 21, 2022).
Mr. Johnston asked Mr. Rolland to elaborate on the following ACWA comment on the proposed rule:
   "EPA should remove the deadline for public release of the NNCR and not plan to publicly release this tool until most of the data quality issues have been resolved. If EPA plans to use the NNCR internally, before final Phase 2 implementation is completed for all states, EPA should also designate the NNCR as "beta" or "draft" and explain why this designation is appropriate."
Mr. Rolland noted that his members are concerned about potential errors in the data leading to EPA misidentify a facility as being in noncompliance. Mr. Rolland noted that there are a number of states with long-standing data sharing problems that lead to inaccuracies in how the EPA's national NPDES data system (ICIS-NPDES) identifies noncompliance [e.g., Discharge Monitoring Report (DMR) non-receipt violations].
Mr. Johnston responded by noting that DMR data quality and data sharing between EPA and the states has improved dramatically over the past few years (e.g., Oregon). He also acknowledged that some states continue to have difficulties in sharing NPDES permit and DMR data with ICIS-NPDES, which results in ICIS-NPDES misidentifying noncompliance. Mr. Johnston noted that EPA is providing states with financial support (e.g., Exchange Network grants) and in-kind support from EPA's ICIS help desk and specialized contractors to resolve these data sharing issues.
Mr. Rolland noted that EPA's support is appreciated but that data sharing problems should be resolved before the NNCR is publicly released. Mr. Johnston noted that EPA plans to make the draft (or "beta") version of the NNCR available to states for one year before the planned public release. He noted that this one-year review period should provide states with enough time to identify data errors and missing contextual information for the data on the NNCR. Mr. Rolland agreed that states need time to fix their data sharing issues and that some states have centralized information technology (IT) departments, which makes it harder for authorized NPDES programs to have their issued prioritized for resolution.
Mr. Johnston also noted that EPA and states have been holding active and ongoing bi-weekly discussions for the past two years on how to develop and implement the NNCR. The primary focus of those discussions to date have been on display of the Phase 1 data. Mr. Rolland noted his appreciation for the outreach EPA is conducting with states to scope out the requirements for the NNCR.
Finally, Mr. Johnston noted that EPA is proposing to push the NNCR publication deadline from December 21, 2021 to December 21, 2022. He noted that this extension should provide states with enough time so that they can resolve their facility, permit, and DMR data sharing problems.


[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51021-51022]
[FR Doc No: 2011-20889]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 14204-000, 14231-000]

Percheron Power, LLC, FFP Project 85, LLC; Notice of Competing
Preliminary Permit Applications Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Competing Applications

    On May 31, 2011, Percheron Power, LLC (Percheron Power), filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Scooteney Reservoir Inlet Water Power Project, to be located on the
Potholes East Canal, which is an inlet structure to the Scooteney
Reservoir, near Othello, Franklin County, Washington. Another permit
application for the Scooteney Water Power Project, located at the same
site,

was filed by FFP Project 85, LLC (FFP), on July 18, 2011. Both of the
proposed projects would utilize the existing Potholes East Canal, which
is owned by the U.S. Bureau of Reclamation. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed Percheron Power project would consist of the
following: (1) An approximately 500-foot-long intake structure
installed on the Potholes East Canal to divert flow from the canal to
the turbines, which would be 120 feet wide at the intersection with the
canal and would narrow to 60 feet wide before entering the powerhouse,
and would include a 120-foot-wide, 15-foot-high intake grate and a 60-
foot-wide, 15-foot-high trash rack; (2) a approximately 80-foot-long,
30-foot-wide powerhouse containing four low-head turbine/generator
units rated for approximately 350 kilowatts each (total capacity of
1,420 kilowatts) at an average head of 14 feet; (3) a 600-foot-long,
11-foot-high bypass weir, constructed in parallel to the west bank of
the existing Potholes East Canal, to function as a project spillway;
(4) a discharge canal returning flows from the powerhouse to the
Potholes East Canal; (5) a 20-foot-long, 40-foot-wide substation at the
powerhouse which will connect with the existing distribution line at
the project site; and (6) appurtenant facilities. The estimated annual
generation of the project would be 4.23 gigawatt-hours (GWh).
    The proposed FFP project would consist of the following: (1) An
approximately 40-foot-wide, 100-foot-long approach channel installed on
the Potholes East Canal to divert flow from the canal to the turbines;
(2) a approximately 125-foot-long, 40-foot-wide powerhouse containing
one Kaplan turbine/generator unit rated at 2,500-kW at a hydraulic head
of 13 feet; (3) a 120-foot-long, 50-foot-wide discharge canal returning
flows from the powerhouse to the Potholes East Canal; (4) a 40-foot-
long, 50-foot-wide substation at the powerhouse which will connect with
the existing distribution line at the project site; and (5) appurtenant
facilities. The estimated annual generation of the project would be 15
GWh.
    Applicant Contact (Percheron Power): Mr. Jerry Straalsund,
President, Percheron Power, LLC, 6855 W. Clearwater Ave., A101-260,
Kennewick, WA 99336; e-mail<EMAIL_ADDRESS>    Applicant Contact (FFP): Ms. Ramya Swaminathan, Free Flow Power
Corporation, 239 Causeway Street, Suite 300, Boston, MA 02114; phone:
(978) 283-2822.
    FERC Contact: Jennifer Harper,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about these projects, including copies of the
applications, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket numbers (P-14204-000 and P-14231-000) in the docket
number field to access the documents. For assistance, contact FERC
Online Support.

    Dated: August 10, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20889 Filed 8-16-11; 8:45 am]
BILLING CODE 6717-01-P


applicable Federal, State, or local law (including tribal law passed by
the official governing body of an American Indian or Alaska Native
tribe).
0
8. Revise Sec.  50.27 to read as follows:

Sec.  50.27   Documentation of informed consent.

    (a) Except as provided in Sec.  56.109(c) of this chapter, informed
consent shall be documented by the use of a written consent form
approved by the IRB and signed and dated (including in an electronic
format) by the subject or the subject's legally authorized
representative at the time of consent. A written copy shall be given to
the person signing the informed consent form.
    (b) Except as provided in Sec.  56.109(c) of this chapter, the
consent form may be either of the following:
    (1) A written informed consent form that meets the requirements of
this part. The investigator shall give either the subject or the
subject's legally authorized representative adequate opportunity to
read the informed consent form before it is signed; alternatively, this
form may be read to the subject or the subject's legally authorized
representative.
    (2) A short form written informed consent form stating that the
elements of informed consent required by Sec.  50.25 have been
presented orally to the subject or the subject's legally authorized
representative. The key information required by Sec.  50.20 must be
presented first to the subject or the subject's legally authorized

representative, before other information, if any, is provided. The IRB
shall approve a written summary of what is to be said to the subject or
the legally authorized representative. When this method is used, there
shall be a witness to the oral presentation. Only the short form itself
is to be signed by the subject or the subject's legally authorized
representative. However, the witness shall sign both the short form and
a copy of the summary, and the person actually obtaining consent shall
sign a copy of the summary. A copy of the summary shall be given to the
subject or the subject's legally authorized representative, in addition
to a copy of the short form.

PART 56--INSTITUTIONAL REVIEW BOARDS

0
9. The authority citation for part 56 continues to read as follows:

    Authority:  21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351,
352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371,
379e, 381; 42 U.S.C. 216, 241, 262.

0
10. In part 56, remove the words ``the act'' and add in their place
``the Federal Food, Drug, and Cosmetic Act''.
0
11. In Sec.  56.102, remove and reserve paragraph (a), revise
paragraphs (b)(17) and (l), and add paragraph (n).
    The revisions and addition read as follows:

Sec.  56.102   Definitions.

* * * * *
    (b) * * *
    (17) Data and information regarding an electronic product submitted
as part of the procedures for establishing, amending, or repealing a
standard for such products, described in section 534 of the Federal
Food, Drug, and Cosmetic Act.
* * * * *
    (l) Test article means any drug for human use, biological product
for human use, medical device for human use, human food additive, color
additive, electronic product, or any other article subject to
regulation under the Federal Food, Drug, and Cosmetic Act or under
section 351 of the Public Health Service Act (42 U.S.C. 262).
* * * * *
    (n) Written or in writing means writing on a tangible medium (e.g.,
paper) or in an electronic format.
0
12. In Sec.  56.103, revise paragraphs (a) and (c) to read as follows:

Sec.  56.103   Circumstances in which IRB review is required.

    (a) Except as provided in Sec. Sec.  56.104 and 56.105, any
clinical investigation that must meet the requirements for prior
submission (as required in parts 312 and 812 of this chapter) to the
Food and Drug Administration shall not be initiated unless that
investigation has been reviewed and approved by, and remains subject to
continuing review by, an IRB meeting the requirements of this part.
* * * * *
    (c) Compliance with these regulations will in no way render
inapplicable pertinent Federal, State, or local laws or regulations
(including tribal law passed by the official governing body of an
American Indian or Alaska Native tribe) that may otherwise be
applicable and that provide additional protections for human subjects.
0
13. Revise Sec.  56.107 to read as follows:

Sec.  56.107   IRB membership.

    (a) Each IRB shall have at least five members, with varying
backgrounds to promote complete and adequate review of research
activities commonly conducted by the institution. The IRB shall be
sufficiently qualified through the experience and expertise of its
members (professional competence), and the diversity of its members,
including race, gender, cultural backgrounds, and sensitivity to such
issues as community attitudes, to promote respect for its advice and
counsel in safeguarding the rights and welfare of human subjects. The
IRB shall be able to ascertain the acceptability of proposed research
in terms of institutional commitments (including policies and
resources) and regulations, applicable law, and standards of
professional conduct and practice. The IRB shall therefore include
persons knowledgeable in these areas. If an IRB regularly reviews
research that involves a category of subjects that is vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, consideration shall be given to
the inclusion of one or more individuals who are knowledgeable about
and experienced in working with these categories of subjects.
    (b) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose primary
concerns are in nonscientific areas.
    (c) Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
    (d) No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the IRB.
    (e) An IRB may, in its discretion, invite individuals with
competence in special areas to assist in the review of complex issues
that require expertise beyond or in addition to that available on the
IRB. These individuals may not vote with the IRB.
0
14. Revise Sec.  56.108 to read as follows:

Sec.  56.108   IRB functions and operations.

    (a) In order to fulfill the requirements of these regulations, each
IRB shall:
    (1) [Reserved]
    (2) Prepare and maintain a current list of the IRB members
identified by name; earned degrees; representative capacity;
indications of experience such as board certifications or licenses
sufficient to describe each member's chief anticipated contributions to
IRB deliberations; and any employment or other relationship between
each member and the institution, for example, full-time employee, part-
time employee, member of governing panel or board, stockholder, paid or
unpaid consultant;
    (3) Establish and follow written procedures for:
    (i) Conducting its initial and continuing review of research and
for reporting its findings and actions to the investigator and the
institution;
    (ii) Determining which projects require review more often than
annually and which projects need verification from sources other than
the investigator that no material changes have occurred since previous
IRB review;
    (iii) Ensuring prompt reporting to the IRB of proposed changes in a
research activity; and for ensuring that investigators will conduct the
research activity in accordance with the terms of the IRB approval
until any proposed changes have been reviewed and approved by the IRB,
except when necessary to eliminate apparent immediate hazards to the
subject.
    (4) Establish and follow written procedures for ensuring prompt
reporting to the IRB, appropriate institutional officials, and the Food
and Drug Administration of:
    (i) Any unanticipated problems involving risks to subjects or
others, or any serious or continuing noncompliance with these
regulations or the requirements or determinations of the IRB; and
    (ii) any suspension or termination of IRB approval.
    (b) Except when an expedited review procedure is used (as described
in Sec.  56.110), an IRB must review proposed research at convened
meetings at which

a majority of the members of the IRB are present, including at least
one member whose primary concerns are in nonscientific areas. In order
for the research to be approved, it shall receive the approval of a
majority of those members present at the meeting.
0
15. In Sec.  56.109:
0
a. Revise paragraph (b);
0
b. Add paragraph (c)(3);
0
c. Revise paragraphs (d) and (f);
0
d. Redesignate paragraphs (g) and (h) as paragraphs (i) and (j),
respectively;
0
e. Add new paragraphs (g) and (h); and
0
f. Revise newly redesignated paragraphs (i) and (j).
    The revisions and additions read as follows:

Sec.  56.109   IRB review of research.

* * * * *
    (b) An IRB shall require that information given to subjects or
legally authorized representatives, when appropriate, as part of
informed consent is in accordance with Sec.  50.25 of this chapter. The
IRB may require that information, in addition to that specifically
mentioned in Sec.  50.25 of this chapter, be given to the subjects when
in the IRB's judgment the information would meaningfully add to the
protection of the rights and welfare of subjects.
    (c) * * *
    (3) The IRB may waive documentation of informed consent if it finds
that the subjects or legally authorized representatives are members of
a distinct cultural group or community in which signing forms is not
the norm, that the research presents no more than minimal risk of harm
to subjects, and provided there is an appropriate alternative mechanism
for documenting that informed consent was obtained.
    (d) In cases where the documentation requirement is waived under
paragraph (c)(1) or (3) of this section, the IRB may require the
investigator to provide subjects or legally authorized representatives
with a written statement regarding the research.
* * * * *
    (f) An IRB shall conduct continuing review of research covered by
these regulations at intervals appropriate to the degree of risk, but
not less than once per year, except as described in paragraph (g) of
this section.
    (g) Unless an IRB determines otherwise, continuing review of
research is not required for research that has progressed to the point
that it involves only one or both of the following, which are part of
the IRB-approved study:
    (1) Data analysis, including analysis of identifiable private
information or identifiable biospecimens, or
    (2) Accessing followup clinical data from procedures that subjects
would undergo as part of clinical care.
    (h) An IRB shall have authority to observe or have a third party
observe the consent process and the research.
    (i) An IRB shall provide in writing to the sponsor of research
involving an exception to informed consent under Sec.  50.24 of this
chapter a copy of information that has been publicly disclosed under
Sec.  50.24(a)(7)(ii) and (iii) of this chapter. The IRB shall provide
this information to the sponsor promptly so that the sponsor is aware
that such disclosure has occurred. Upon receipt, the sponsor shall
provide copies of the information disclosed to FDA.
    (j) When some or all of the subjects in a study are children, an
IRB must determine that the research study is in compliance with part
50, subpart D of this chapter, at the time of its initial review of the
research.
0
16. In Sec.  56.110, revise paragraphs (b) and (c) to read as follows:

Sec.  56.110   Expedited review procedures for certain kinds of
research involving no more than minimal risk, and for minor changes in
approved research.

* * * * *
    (b)(1) An IRB may use the expedited review procedure to review
either or both of the following:
    (i) Some or all of the research appearing on the list described in
paragraph (a) of this section and found by the reviewer(s) to involve
no more than minimal risk;
    (ii) Minor changes in previously approved research during the
period for which approval is authorized.
    (2) Under an expedited review procedure, the review may be carried
out by the IRB chairperson or by one or more experienced reviewers
designated by the IRB chairperson from among the members of the IRB. In
reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove the
research. A research activity may be disapproved only after review in
accordance with the nonexpedited review procedure set forth in Sec.
56.108(b).
    (c) Each IRB that uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals that have
been approved under the procedure.
* * * * *
0
17. In Sec.  56.111, revise paragraphs (a)(1), (3), and (5) through (7)
and (b) to read as follows:

Sec.  56.111   Criteria for IRB approval of research.

    (a) * * *
    (1) Risks to subjects are minimized:
    (i) By using procedures that are consistent with sound research
design and that do not unnecessarily expose subjects to risk and
    (ii) Whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.
* * * * *
    (3) Selection of subjects is equitable. In making this assessment
the IRB should take into account the purposes of the research and the
setting in which the research will be conducted. The IRB should be
particularly cognizant of the special problems of research that
involves a category of subjects who are vulnerable to coercion or undue
influence, such as children, prisoners, individuals with impaired
decision-making capacity, or economically or educationally
disadvantaged persons.
* * * * *
    (5) Informed consent will be appropriately documented or
appropriately waived, in accordance with Sec.  50.27 of this chapter.
    (6) When appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of subjects.
    (7) When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these
subjects.
* * * * *
0
18. In Sec.  56.115, revise paragraphs (a)(3), (5), and (6) and (b) to
read as follows:

Sec.  56.115   IRB records.

    (a) * * *
    (3) Records of continuing review activities, including the
rationale for conducting continuing review of research that otherwise
would not require continuing review as described in Sec.  56.109(g).
* * * * *
    (5) A list of IRB members in the same detail as Sec.  56.108(a)(2).
    (6) Written procedures for the IRB as required by Sec.
56.108(a)(3) and (4).
* * * * *

    (b) The records required by this regulation shall be retained for
at least 3 years after completion of the research. The institution or
IRB may maintain the records in printed form or electronically. All
records shall be accessible for inspection and copying by authorized
representatives of the Food and Drug Administration at reasonable times
and in a reasonable manner.
* * * * *
0
19. In Sec.  56.121, revise the last sentence in paragraph (c) to read
as follows:

Sec.  56.121   Disqualification of an IRB or an institution.

* * * * *
    (c) * * * In addition, the Agency may elect to publish a notice of
its action.
* * * * *
0
20. Revise Sec.  56.122 to read as follows:

Sec.  56.122   Public disclosure of information regarding
disqualification.

    A determination that FDA has disqualified an IRB or an institution
and the administrative record regarding that determination are
disclosable to the public under part 20 of this chapter.

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
21. The authority citation for part 812 is revised to read as follows:

    Authority:  21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e,
381, 382; 42 U.S.C. 216, 241, 262.

0
22. In Sec.  812.150, revise paragraphs (a)(3) and (b)(5) to read as
follows:

Sec.  812.150   Reports.

    (a) * * *
    (3) Progress. An investigator shall submit progress reports on the
investigation to the sponsor, the monitor, and the reviewing IRB at
regular intervals, but in no event less often than yearly. Such
progress reports shall be submitted to the reviewing IRB to the extent
that continuing review is required by part 56 of this chapter.
* * * * *
    (b) * * *
    (5) Progress reports. At regular intervals, and at least yearly, a
sponsor shall submit progress reports to all reviewing IRBs. Such
progress reports shall be submitted to reviewing IRBs to the extent
that continuing review is required by part 56 of this chapter. In the
case of a significant risk device, a sponsor shall submit progress
reports to FDA at regular intervals, and at least yearly. A sponsor of
a treatment IDE shall submit semiannual progress reports to all
reviewing IRBs and FDA in accordance with Sec.  812.36(f) and annual
progress reports in accordance with this section.
* * * * *

    Dated: September 23, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-21088 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45282-45283]
[FR Doc No: 2017-20787]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2428-007]

Aquenergy Systems, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent License.
    b. Project No.: 2428-007.
    c. Date filed: December 30, 2015.
    d. Applicant: Aquenergy Systems, LLC (Aquenergy).
    e. Name of Project: Piedmont Hydroelectric Project.
    f. Location: The existing project is located on the Saluda River in
the Town of Piedmont, in Anderson and Greenville Counties, South
Carolina. The project does not affect federal land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Beth E. Harris, P.E., Regional Operations
Manager, Enel Green Power North America, Inc., 11 Anderson Street,
Piedmont, SC 29673; Telephone--(864) 846-0042; Email_
<EMAIL_ADDRESS>OR Kevin Webb, Hydro Licensing Manager, Enel Green
Power North America, Inc., One Tech Drive, Suite 220, Andover, MA
01810; Telephone--(978) 681-1900<EMAIL_ADDRESS>    i. FERC Contact: Navreet Deo,<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests and
requests for cooperating agency status: 60 days from the issuance date
of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene and protests and requests for cooperating agency
status using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-2428-007.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted, but is not ready for
environmental analysis at this time.
    l. The Piedmont Project consists of: (1) A 600-foot-long by 25-
foot-high stone masonry dam, consisting of (i) a 200-foot-long non-
overflow section, (ii) a 200-foot-long central overflow spillway topped
with 16-inch wooden flashboards, and (iii) a 200-foot-long non-overflow
spillway housing the inoperable J.P. Stevens Canal intake; (2) a 22-
acre impoundment at a normal pool elevation of 774 feet mean sea level;
(3) a 144-foot-long by 81-foot-wide intake canal consisting of eight
gates at the head of the canal controlling flow to the powerhouse; (4)
a 55-foot-long by 55-foot-wide brick masonry powerhouse protected by a
trashrack structure with 2-inch clear bar spacing, located 120 feet
downstream of the dam, containing one vertical Francis turbine
generating unit that totals 1,000 kilowatt (kW); (5) a 180-foot-long by
38-foot-wide tailrace; (6) a 263-foot-long, 600-volt transmission line
connecting the powerhouse to the non-project substation; and (7)
appurtenant facilities.
    Aquenergy operates the project in a run-of-river mode, with no
useable storage or flood control capacity. A continuous minimum flow of
15 cubic feet per second (cfs) or inflow, whichever is less, is
released into the bypassed area. The minimum flow is

achieved via a weir on the spillway crest. The project operates under
an estimated average head of 26 feet, including the 16-inch spillway
flashboards. The impoundment water surface elevation is maintained at
774 feet. River flows between 159 cfs and 535 cfs are used for power
generation, while flows in excess of 535 cfs are passed over the
flashboards and spillway. The total installed capacity of the project
is 1,000 kW from the single generating unit. The project generates
approximately 5,369 megawatt-hours annually, which are sold to a local
utility.
    Aquenergy proposes to continue to operate and maintain the Piedmont
Project as is required in the existing license, and to develop canoe
portage facilities. No changes to project operations are proposed.
Other than the development of canoe portage facilities, no new
construction or major project modifications are proposed.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room, or may be viewed on the
Commission's Web site at http://www.ferc.gov using the eLibrary link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, and .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    All filings must: (1) Bear in all capital letters the title PROTEST
or MOTION TO INTERVENE; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain
copies of the application directly from the applicant. A copy of any
protest or motion to intervene must be served upon each representative
of the applicant specified in the particular application.

    Dated: September 21, 2017.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-20787 Filed 9-27-17; 8:45 am]
 BILLING CODE 6717-01-P