[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Page 61209]
[FR Doc No: 2021-24264]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-288-000]

Dry Bridge Solar 3, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Dry Bridge Solar 3, 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 November 22, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: November 1, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-24264 Filed 11-4-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Proposed Rules]
[Pages 59596-59599]
[FR Doc No: 2011-24729]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket No. USCG-2011-0443]
RIN 1625-AA01

Anchorage Regulations; Newport, RI

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to change the shape and expand the
dimensions of anchorage ``D'' at Newport, Rhode Island, to better
accommodate increasing cruise ship visits to Newport and to improve
navigation safety.

DATES: Comments and related material, including requests for public
meetings, must be received by the Coast Guard on or before October 27,
2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0443 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. See the
``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Mr. Edward G. LeBlanc, Chief, Waterways Management Division,
Coast Guard Sector Southeastern New England, at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0443), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov), or by fax, mail or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2011-0443'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8[frac12] by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0443'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But, you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Basis and Purpose

    The legal basis for the proposed rule is: 33 U.S.C. 471, 1221
through 1236, 2030, 2035, 2071; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1, which collectively authorize
the Coast Guard to define anchorage grounds.
    This proposed rule would change the shape and expand the dimensions
of anchorage ``D'' at Newport, Rhode Island, to better accommodate
increasing cruise ship visits to Newport, and to improve navigation
safety.

Discussion of Proposed Rule

    This proposed rule is intended to change the shape and expand the
size of anchorage ``D'' west of Goat Island, Newport, RI, to safely
accommodate up to three cruise ships simultaneously. Currently, it is a
trapezoid-shaped anchorage of approximately 0.11 square nautical miles
that can safely accommodate only two cruise ships simultaneously. Over
the past several years cruise ship visits to Newport, RI, have been
more frequent. On occasion, there is a need to anchor up to three
cruise ships simultaneously in anchorage ``D''. For the convenience and
safety of passengers, an increase in the size of the anchorage is
necessary. The Coast Guard believes the depth of water, water-sheet
area, and density of vessel traffic in the vicinity of Newport west of
Goat Island are sufficient to accommodate this change.
    Consequently, the Coast Guard proposes to change the shape of
anchorage ``D'' from a trapezoid to a square, and expand its size from
approximately 0.11 to 0.24 square nautical miles. The proposed rule
also includes specific anchorage points when there are one, two, or
three vessels anchored in anchorage ``D''.
    This proposed rule will not change the current provision in 33 CFR
110.145(a)(4)(i) and (ii) that gives preference to the U.S. Navy from
May 1 to October 1 each year should it require the anchorage, and
allows temporary floats or buoys for marking of anchors or moorings.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    We expect the economic impact of this proposed would not be
significant because it only modifies the shape of a currently-existing
anchorage at Newport, RI. Although it also would increase the size of
the anchorage, the water-sheet area covered by the proposed anchorage
is still less than 0.25 square nautical miles.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule may affect the following
entities, some of which might be small entities: the owners or
operators of vessels that have a need to anchor in anchorage ``D'' at
Newport, RI.
    This proposed rule would not have a significant economic impact on
a substantial number of small entities for the following reasons. This
rule would only modify the shape of a currently-existing anchorage at
Newport, RI, and although it also would increase the size of the
anchorage, the water-sheet area covered by the proposed anchorage is
still less than 0.25 square nautical miles. It would not impose new
requirements that would affect vessels' schedules or their ability to
transit in the Newport, RI, area or Narragansett Bay, nor would it
require the purchase of any new equipment or the hiring of any
additional crew.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES above) explaining why you think it qualifies and how and
to what degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Mr. Edward G. LeBlanc, Chief,
Waterways Management Division, Coast Guard Sector Southeastern New
England, at<PHONE_NUMBER>, or<EMAIL_ADDRESS>The Coast Guard
will not retaliate against small entities that question or complain
about this proposed rule or any policy or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork

Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

    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 $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule does not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule will not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

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

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed rule is not an economically significant rule and
does not create an environmental risk to health or risk to safety that
may disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

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

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. This proposed
rule involves the modification of a currently-existing anchorage area
at Newport, RI. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 110 as follows:

PART 110--ANCHORAGE REGULATIONS

    1. The authority citation for part 110 continues to read as
follows:

    Authority: 33 U.S.C. 471; 1221 through 1236, 2030, 2035, 2071;
33 CFR 1.05-1; Department of Homeland Security Delegation No.
0170.1.

    2. Revise paragraphs (a)(4) and (d)(2) of Sec.  110.145 to read as
follows:

Sec.  110.145  Narragansett Bay, R.I.

    (a) * * *
    (4) Anchorage D. West of Goat Island, an area bounded by the
following coordinates:
    Northeast Corner: 41[deg]29.484' N, 071[deg]19.975' W;
    Northwest Corner: 41[deg]29.484' N, 071[deg]20.578' W;
    Southwest Corner: 41[deg]29.005' N, 071[deg]20.578' W;
    Southeast Corner: 41[deg]29.005' N, 071[deg]19.975' W.
    (i) * * *
    (iii) Should any part of an anchored vessel extend into the
recommended vessel route in the East Passage of Narragansett Bay, a
securite call notifying mariners of the vessel's exact position and
status shall be made at least hourly on VHF channels 13 and 16.
    (iv) As much as practicable, vessels anchoring will do so in the
following order:
    Primary anchoring point: 41[deg]29.25' N, 071[deg]20.15' W;
    Secondary anchoring point: 41[deg]29.38' N, 071[deg]20.45' W;
    Tertiary anchoring point: 41[deg]29.15' N, 071[deg]20.50' W.

    Note: ``Anchoring point'' is the intended position of the anchor
at rest on the bottom of the anchorage. All coordinates referenced
use datum: NAD 83.

* * * * *
    (d) * * *
    (2) Anchors must not be placed outside the anchorage areas, nor
shall any vessel be so anchored that any portion of the hull or rigging
shall at any time extend outside the boundaries of the anchorage area.
However, Anchorage D is exempt from this requirement; see paragraph
(a)(4) of this section.
* * * * *

    Dated: September 13, 2011.
Daniel A. Neptun,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2011-24729 Filed 9-26-11; 8:45 am]
BILLING CODE 9110-04-P


Summary of Presentation ° Brief Outline of the EPA Final Rule ° Challenge of Intentional Dosing Studies ° Application of Subpart K ( Subpart A)

° Selected NAS Recommendations ° Some Questions for Consideration Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

The Final Human Studies Rule Effective April 7, 2006, expands the protections for subjects of " third party" human research and:

1. Extends protections of the Common Rule to intentional dosing pesticide research submitted to the EPA;

2. Prohibits new research involving intentional exposure of pregnant women or children to EPA regulated compounds;

3. Requires submission of protocols for covered human research prior to study initiation; and 4. Establishes an independent Human Studies Review Board to review the scientific and ethical aspects of research proposals and reports of completed research with human subjects submitted to and by the EPA. The Final Human Studies Rule ( 2)

Forbids EPA relying on human research data that would be prohibited or considered unethical for regulatory decision making,

except for narrowly defined circumstances.

  e. g., if children were at risk from exposure to a substance.

  e. g., if data collected from an otherwise unethical study justified setting a more restrictive standard for pesticide tolerance. Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

40 CFR 26: EPA Final Rule ° Research supported or conducted by EPA   Subpart A ( all research)

  Subpart B ( intent. exposure: preg. woman, fetus, child)

  Subpart C ( observational research: preg. woman, fetus)

  Subpart D ( observational research: children)

° Third Party Research ( submitted to EPA)

  Subpart K ( intentional exposure to pesticides, after 4 7

06: non pregnant adult)

  Subpart L ( intentional exposure to pesticides: pregnant woman, fetus, child)

  Subpart M ( after 4 7 06, reports of any human research)

  Subpart O ( EPA administrative action for noncompliance)

  Subpart P ( EPA review of protocols under Subpart K)

  Subpart Q ( EPA use of data from intentional exposure) Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

Subpart A ( 40 CFR § 26.1xx)

° Subpart A applies to all research that is supported or conducted by the EPA.

° There are no differences between the EPA Subpart A and Subpart A of 45 CFR § 46 ( HHS), thus " The Common Rule." Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

Subpart B ( 40 CFR § 26.2xx)

° Prohibits EPA from supporting or conducting any research involving intentional exposure of pregnant woman ( and her fetus) or child.

° Two definitions worth noting:

  " Intentional human exposure"  " exposure to the substance  would not have occurred but for the human subject's participation in the study."

  " Child" is " a person who has not attained the age of 18 years." Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

Subpart K ( 40 CFR 26.11xx)

° Research ( after 4 7 06): intentional exposure of non pregnant human adult to pesticides   Exemption for existing data, 40CFR § 26.1101( b)

° Differences ( 3) between Subparts K and A   IC: " informed of the identity of the pesticide and the nature of its pesticidal function"

  Subpart K does not contain a waiver of written documentation of informed consent. continued Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

Subpart K ( 40 CFR 26.11xx)

° Differences: Subparts K and A ( continued)

  Submit to EPA after IRB review/ approval and before initiating research ( 40CFR § 26.1125)

° Discussion of: ( 1) risks; ( 2) measures to minimize risks; ( 3)

benefits, and to whom they accrue; ( 4) alternative means of obtaining data; and ( 5) balance of risks and benefits.

° All subject information; written consent agreements ° Subject recruitment; any advertisements to be used ° How information presented to potential human subjects ° All correspondence between IRB, investigators or sponsors ° IRB notification that research reviewed and approved Federal Register 71( 24): 6138 76; February 6, 2006; Effective April 7, 2006.

Subpart L ( 40 CFR 26.12xx)

° Prohibits third parties from supporting or conducting research ( after 4 7 06) intended for submission to EPA involving intentional exposure to pesticides of pregnant woman ( and her fetus) or child Summary of Presentation ° Brief Outline of the EPA Final Rule ° Challenge of Intentional Dosing Studies ° Application of Subpart K ( Subpart A)

° Selected NAS Recommendations ° Some Questions for Consideration Intentional Dosing Studies The conduct of intentional dosing studies has broad implications for:

1) The EPA's regulatory decision making process; and 2) Non therapeutic research involving human participants in general. Intentional Dosing Studies ( 2)

° The risk benefit analysis of intentional dosing studies is challenging in part because when studies are conducted by third parties it is important to distinguish between " potential benefits" that will improve public health and safety and those that are purely for commercial interest. Intentional Dosing Studies ( 3)

° In some cases human dosing studies are needed to ensure the quality and accuracy of the EPA's decision making process.

° However, they may also be initiated for strictly commercial interests to produce a new competitive product or to revise regulatory standards. Intentional Dosing Studies ( 4)

° Intentional dosing studies may share many of the same characteristics as phase I clinical trials   the goal of an intentional dosing study is to assess a pesticide's safety and toxicity at various dosage levels.

° Even though intentional dosing experiments may not be designed to diagnose, treat, or prevent disease, they could yield knowledge with social and scientific import. Summary of Presentation ° Brief Outline of the EPA Final Rule ° Challenge of Intentional Dosing Studies ° Application of Subpart K ( Subpart A)

° Selected NAS Recommendations ° Some Questions for Consideration 40 CFR 26.1111 Subpart K: Criteria for IRB Approval ° Risks to subjects are minimized   By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and ° Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,

and the importance of the knowledge that may reasonably be expected to result. continued 40 CFR 26.1111 Subpart K: Criteria for IRB Approval ° Selection of subjects is equitable.

° Informed consent from each prospective subject.

° Informed consent appropriately documented.

° If appropriate, adequate provision for monitoring the data collected to ensure the safety of subjects.

° If appropriate, adequate provisions to protect subject privacy and maintain data confidentiality.

° If some or all subjects vulnerable to coercion or undue influence, include additional safeguards to protect rights and welfare of these subjects. Summary of Presentation ° Brief Outline of the EPA Final Rule ° Challenge of Intentional Dosing Studies ° Application of Subpart K ( Subpart A)

° Selected NAS Recommendations ° Some Questions for Consideration Selected NAS Recommendations Intentional Human Dosing Studies for EPA Regulatory Purposes:

Scientific and Ethical Issues 2004 3 1 Scientific Validity of Intentional Human Dosing Studies ° Important scientific or policy question not answered by animal study or human observational study.

° Meets current scientific standards   Address research question;

  Appropriate sample for study endpoint; and   Adequate statistical power.

° Good clinical practice, safety monitoring.

° Report all documents and data to EPA. 4 1 Studies to Improve Accuracy of EPA's Decisions Without Public Health or Environmental Benefit ° Human dosing study intended to reduce interspecies uncertainty factor has societal benefit ONLY if it improves scientific accuracy of EPA's animal to human extrapolation.

° Studies that are to be used only to improve the accuracy of an RfD, and that otherwise provide no health or environmental benefit, can be justified only if they pose no identifiable risk or have reasonable certainty of no harm. 4 2 Studies for Potential Public Health or Environmental Benefit ° IRB review for potential health or environmental benefit.

° Can have somewhat higher level of risk.

° Cannot cause lasting harm to subjects. Examples of Public Health or Environmental Benefits ° More stringent regulatory standard.

° New public health measure adopted.

° New product that protects public health.

° Improved scientific accuracy of risk assessment. 5 1 Criteria for Scientific and Ethical Acceptability ° Highest Scientific and ethical standards   Prior animal & human observational studies;

  Need knowledge from human intentional dosing studies;

  Design & analysis (& power) to detect effects;

  Balance risks $ benefits; minimize risks;

  Equitable subject selection;

  Free and informed consent; and   IRB review. 5 2 Participant Selection Criteria ° Equitable subject selection.

° Vulnerable populations justified, with added measures for protection.

° Populations at increased risks justified,

with added measures to decrease risks.

° Subpart D requirements.

  Note: Research on children less than 18 years of age prohibited by EPA Final Rule. 5 3 Payment for participation ° Payments not so high as to be undue inducement.

° Payments not so low that only attractive to economically disadvantaged subjects.

° Payments reviewed for principles of justice and respect for persons.

° EPA should make guidelines re: payment

for risk, as well as time & inconvenience? 5 4 Best Practices in Informed Consent ° EPA to develop, disseminate, encourage or require adoption of best practices for informed consent. 5 5 Compensation for Research Related Injury ° Subjects should receive needed medical care for research related injuries at no cost to subjects.

° EPA should study if broader compensation for research related injuries is needed. Summary of Presentation ° Brief Outline of the EPA Final Rule ° Challenge of Intentional Dosing Studies ° Application of Subpart K ( Subpart A)

° Selected NAS Recommendations ° Some Questions for Consideration Some Questions for Consideration 1. What is the research, and what is standard practice?

° Pesticide handlers   are pesticide appliers doing their regular jobs and being monitored or is the application process or pesticide used different from their standard job?

° Insect repellents used by many, but not all, campers,

hikers, etc.

2. Minimal risk definition ° Does HSRB want to use the current OHRP interpretation or should we re visit this? Some Questions for Consideration ( continued)

3. Minimizing risks   Is follow up post exposure or post monitoring a long enough duration to see adverse events if they are to occur?

4. Societal/ scientific value   Without sample size , difficult to determine the value/ validity of the resultant data.

  Is appropriate control used for the study's design? Some Questions for Consideration ( continued)

5. Informed consent process   What measures are in place to avoid coercion or undue influence?

  What is relationship between researcher and subjects?

  Bilingual researchers vs. interpreters ( co workers?)

  Comprehension of risks and discomforts 6. Informed consent form   What is literacy rate in English or other languages among intended research subjects?

  Is consent process more than reading the form? Some Questions for Consideration ( continued)

7. Remuneration   How much is too much? ( undue influence?)

  How little is too little? ( Respect vs Justice)


[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Page 41270]
[FR Doc No: 2014-16558]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-2333-000]

Rushmore Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Rushmore Energy, 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 July 29, 2014.
    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 review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 9, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-16558 Filed 7-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 16, 2010 (Volume 75, Number 157)]
[Notices]
[Page 49929-49930]
[DOCID:fr16au10-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13760-000]

Music Mountain Hydro, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

August 9, 2010.
    On May 18, 2010, Music Mountain Hydro, LLC filed an application for
a preliminary permit, pursuant to section 4(f) of the Federal Power
Act, proposing to study the feasibility of the Music

Mountain Pumped Storage Hydroelectric Project, located in Mohave
County, in the state of Arizona. 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 project would consist of the following developments:
    (1) Two artificial, lined reservoirs joined by approximately 10,430
feed of conduit; (2) an upper dam with a height of 160 ft and 1,848 ft
length at crest; (3) a lower embankment with a height of 50 ft and
6,336 ft at length of crest; (4) an upper reservoir having a surface
area of 112 acres and a storage capacity of 6,885 acre-feet and maximum
water surface elevation of 5,715 feet mean sea level; (5) a lower
reservoir having a surface area of 69 acres and a storage capacity of
6,885 acre-feet and maximum water surface elevation of 4,940 feet mean
sea level; (6) a proposed powerhouse containing three new pump/turbine
generating units having an installed capacity of 350-megawatts; (7)
dependent on the interconnection; a proposed 1-mile, single-circuit 500
kilovolt transmission line, an 8.5 mile, single-circuit 500 kilovolt
transmission line, or an 8.5 mile, single-circuit 345 kilovolt
transmission line. The proposed development would have an average
annual generation of 1,073,100 megawatt-hours.
    Applicant Contact: Matthew Shapiro, CEO, Music Mountain Hydro LLC,
1210 W. Franklin St., Ste. 2, Boise, ID 83702; phone:<PHONE_NUMBER>.
    FERC Contact: Mary Greene,<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.
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/ferconline.asp) under the ``eFiling''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.'' For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>call toll-free at<PHONE_NUMBER>; or,
for TTY, contact<PHONE_NUMBER>. Although the Commission strongly
encourages electronic filing, documents may also be paper-filed. To
paper-file, mail an original and eight copies to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, 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 number (P-13760) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-20142 Filed 8-13-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71446-71448]
[FR Doc No: 2019-27962]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1980]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map       Date of modification   Community
                                          No.               community          repository             revision                                   No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona: Pinal..................  Town of Florence     The Honorable Tara  Public Works        https://msc.fema.gov/  Mar. 6, 2020.........       040084
                                   (19-09-2018P).       Walter, Mayor,      Department, 224     portal/advanceSearch.
                                                        Town of Florence,   West 20th Street,
                                                        P.O. Box 2670,      Florence, AZ
                                                        Florence, AZ        85132.
                                                        85132.
California:
    Alameda.....................  City of Dublin (19-  The Honorable       Public Works        https://msc.fema.gov/  Mar. 16, 2020........       060705
                                   09-0927P).           David G. Haubert,   Department, 100     portal/advanceSearch.
                                                        Mayor, City of      Civic Plaza,
                                                        Dublin, 100 Civic   Dublin, CA 94568.
                                                        Plaza, Dublin, CA
                                                        94568.
    Alameda.....................  City of Pleasanton   The Honorable       Engineering         https://msc.fema.gov/  Mar. 16, 2020........       060012
                                   (19-09-0927P).       Jerry Thorne,       Department, 200     portal/advanceSearch.
                                                        Mayor, City of      Old Bernal
                                                        Pleasanton, P.O.    Avenue,
                                                        Box 520,            Pleasanton, CA
                                                        Pleasanton, CA      94566.
                                                        94566.
    Contra Costa................  Unincorporated       The Honorable John  Contra Costa        https://msc.fema.gov/  Mar. 13, 2020........       060025
                                   Areas of Contra      M. Gioia,           County, Public      portal/advanceSearch.
                                   Costa County (19-    Chairman, Board     Works Department,
                                   09-1287P).           of Supervisors,     255 Glacier
                                                        Contra Costa        Drive, Martinez,
                                                        County, 11780 San   CA 94553.
                                                        Pablo Avenue,
                                                        Suite D, El
                                                        Cerrito, CA 94530.
    Los Angeles.................  City of Hidden       The Honorable       Building and        https://msc.fema.gov/  Mar. 18, 2020........       060125
                                   Hills (18-09-        Larry G. Weber,     Safety              portal/advanceSearch.
                                   1642P).              Mayor, City of      Department, 6165
                                                        Hidden Hills,       Spring Valley
                                                        6165 Spring         Road, Hidden
                                                        Valley Road,        Hills, CA 91302.
                                                        Hidden Hills, CA
                                                        91302.
    San Diego...................  Unincorporated       The Honorable       San Diego County    https://msc.fema.gov/  Mar. 13, 2020........       060284
                                   Areas of San Diego   Dianne Jacob,       Flood Control       portal/advanceSearch.
                                   County (19-09-       Chair, Board of     District,
                                   0630P).              Supervisors, San    Department of
                                                        Diego County,       Public Works,
                                                        1600 Pacific        5510 Overland
                                                        Highway, Room       Avenue, Suite
                                                        335, San Diego,     410, San Diego,
                                                        CA 92101.           CA 92123.
Florida:
    Bay.........................  City of Panama City  The Honorable Mike  City Hall, 110      https://msc.fema.gov/  Mar. 11, 2020........       120013
                                   Beach (19-04-        Thomas, Mayor,      South Arnold        portal/advanceSearch.
                                   4255P).              City of Panama      Road, Panama City
                                                        City Beach, 110     Beach, FL 32413.
                                                        South Arnold
                                                        Road, Panama City
                                                        Beach, FL 32413.
    Bay.........................  Unincorporated       Mr. Robert Majka,   Bay County          https://msc.fema.gov/  Mar. 11, 2020........       120004
                                   Areas of Bay         Jr., County         Planning and        portal/advanceSearch.
                                   County (19-04-       Manager, Bay        Zoning, 707 Jenks
                                   4490P).              County, 840 West    Avenue, Suite B,
                                                        11th Street,        Panama City, FL
                                                        Panama City, FL     32401.
                                                        32401.
    Nassau......................  Unincorporated       The Honorable       Nassau County,      https://msc.fema.gov/  Mar. 12, 2020........       120170
                                   Areas of Nassau      Daniel B. Leeper,   Building            portal/advanceSearch.
                                   County (19-04-       Vice-Chairman,      Department, 96161
                                   4060P).              Nassau County       Nassau Place,
                                                        Commissioner,       Yulee, FL 32097.
                                                        96135 Nassau
                                                        Place, Suite 1,
                                                        Yulee, FL 32097.
Illinois:
    DuPage......................  City of Naperville   The Honorable       City Hall, 400      https://msc.fema.gov/  Mar. 12, 2020........       170213
                                   (19-05-3885P).       Steve Chirico,      South Eagle         portal/advanceSearch.
                                                        Mayor, City of      Street,
                                                        Naperville, 400     Naperville, IL
                                                        South Eagle         60540.
                                                        Street,
                                                        Naperville, IL
                                                        60540.
    Williamson..................  City of Carterville  The Honorable       City Hall, 103      https://msc.fema.gov/  Mar. 13, 2020........       170716
                                   (19-05-2993P).       Bradley Robinson,   South Division      portal/advanceSearch.
                                                        Mayor, City of      Street,
                                                        Carterville, 103    Carterville, IL
                                                        South Division      62918.
                                                        Street,
                                                        Carterville, IL
                                                        62918.
Indiana:
    Allen.......................  City of Fort Wayne   The Honorable Tom   Department of       https://msc.fema.gov/  Mar. 11, 2020........       180003
                                   (19-05-4349P).       Henry, Mayor,       Planning            portal/advanceSearch.
                                                        City of Fort        Services, 200
                                                        Wayne, 200 East     East Berry
                                                        Berry Street,       Street, Suite
                                                        Suite 420, Fort     150, Fort Wayne,
                                                        Wayne, IN 46802.    IN 46802.
    Morgan......................  Unincorporated       Mr. Norman Voyles,  Morgan County       https://msc.fema.gov/  Mar. 6, 2020.........       180176
                                   Areas of Morgan      Morgan County       Administration      portal/advanceSearch.
                                   County (19-05-       Commissioner, 180   Building, 180
                                   3282P).              South Main          South Main
                                                        Street, Suite       Street,
                                                        112,                Martinsville, IN
                                                        Martinsville, IN    46151.
                                                        46151.
New York:
    Westchester.................  Town of Bedford (18- The Honorable       Town Planning       https://msc.fema.gov/  Mar. 20, 2020........       360903
                                   02-1615P).           Chris Burdick,      Office, 425         portal/advanceSearch.
                                                        Supervisor, Town    Cherry Street,
                                                        of Bedford, 321     Bedford, NY 10507.
                                                        Bedford Road,
                                                        Bedford Hills, NY
                                                        12550.

    Westchester.................  Village of Mount     The Honorable Gina  Village Engineer,   https://msc.fema.gov/  Mar. 20, 2020........       360918
                                   Kisco (18-02-        D. Picinich,        104 Main Street,    portal/advanceSearch.
                                   1615P).              Mayor, Village of   Mount Kisco, NY
                                                        Mount Kisco, 104    10549.
                                                        Main Street,
                                                        Mount Kisco, NY
                                                        10549.
Texas: Tarrant..................  City of Fort Worth   The Honorable       Department of       https://msc.fema.gov/  Mar. 12, 2020........       480596
                                   (19-06-0709P).       Betsy Price,        Transportation      portal/advanceSearch.
                                                        Mayor, City of      and Public Works,
                                                        Fort Worth, 200     1000 Throckmorton
                                                        Texas Street,       Street, Fort
                                                        Fort Worth, TX      Worth, TX 76102.
                                                        76102.
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[FR Doc. 2019-27962 Filed 12-26-19; 8:45 am]
BILLING CODE 9110-12-P