[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Proposed Rules]
[Pages 24521-24523]
[FR Doc No: 2016-09677]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0131]
RIN 1625-AA00

Safety Zone, Shallowbag Bay; Manteo, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
on the navigable waters of Shallowbag Bay, in Manteo, NC. This proposed
safety zone would restrict vessel movement from a portion of Shallowbag
Bay River during the Manteo July 4th Celebration Fireworks display.
This action is necessary for the safety of life and property on the
surrounding navigable waters during the fireworks display. The Coast
Guard invites comments on this proposed rule.

DATES: Comments and related material must be received by the Coast
Guard on or before May 11, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0131 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LCDR Derek J. Burrill, Coast Guard
Sector North Carolina, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On July 4, 2016 fireworks will be launched from a barge located in
Shallowbag Bay in Manteo, North Carolina as part of the Manteo July 4th
Celebration. The Captain of the Port North Carolina (COTP) proposes to
establish a temporary safety zone on specified waters of Shallowbag Bay
within a 200 yard radius of a barge anchor. This safety zone would be
effective and enforced from 9:00 p.m. to 10:30 p.m. on July 4, 2016
with a rain date of July 5, 2016. Access to the safety zone would be
restricted during the specified date and time.
    The purpose of this temporary safety zone is to ensure the safety
of vessels and spectators from hazards associated with the fireworks
display, such as accidental discharge of fireworks, dangerous
projectiles, and falling hot embers or other debris.
    The legal basis for the rule is the Coast Guard's authority to
establish safety zones: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Public
Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 9:00 p.m. to
10:30 p.m. on July 4, 2016 with a rain date being July 5, 2016. The
safety zone would cover all navigable waters within 200 yards of barge
anchor. The duration of the zone is intended to ensure the safety of
vessels and these navigable waters before, during, and after the
scheduled 9:30 to 10:00 p.m. fireworks display. All persons and vessels
would need to comply with the instructions of the COTP or his
designated representative. Except for vessels authorized by the COTP or
his designated representative, no person or vessel would be allowed to
enter or remain in the safety zone. Notification of the temporary
safety zone would be provided to the public via marine information
broadcasts.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
would be able to safely transit around this safety zone which would
impact a small designated area of Shallowbag Bay, Manteo, North
Carolina for less than 1 hour. Moreover, the Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone, and the rule would allow vessels to seek permission to enter the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    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 this proposed rule. 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 the person listed in the FOR FURTHER INFORMATION

CONTACT section. 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.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. 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 would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. 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 (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. This proposed rule involves: A safety
zone lasting less than 2 hours that would prohibit entry within 200
yards of a fireworks barge. Normally such actions are categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of
Commandant Instruction M16475.lD. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add temporary Sec.  165.T05-0437 to read as follows:

Sec.  165.T05-0437  Safety Zone, Shallowbag Bay; Manteo, NC.

    (a) Definitions. For the purposes of this section, ``Captain of the
Port'' means the Commander, Sector North Carolina. ``Representative''
means any Coast Guard commissioned, warrant, or petty officer who has
been authorized to act on the behalf of the Captain of the Port.
    (b) Location. The following area is a safety zone: All waters on
Shallowbag Bay within a 200 yard radius of a barge anchor in position
35[deg]54'31'' N., longitude 075[deg]39'46'' W. (NAD 1983).
    (c) Regulations. (1) The general regulations contained in Sec.
165.23 of this part apply to the area described in paragraph (b) of
this section.
    (2) Persons or vessels requesting entry into or passage through any
portion of the safety zone must first request authorization from the
Captain of the Port, or a designated representative. The Captain of the
Port or his designated representative can be contacted at telephone
number<PHONE_NUMBER> or by radio on VHF Marine Band Radio, channels 13
and 16.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 9:00
p.m. to 10:30 p.m. on July 4, 2016 or a rain date of July 5, 2016
unless cancelled earlier by the Captain of the Port.

    Dated: April 7, 2016.
J.S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2016-09677 Filed 4-25-16; 8:45 am]
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[Federal Register: August 10, 2007 (Volume 72, Number 154)]
[Notices]
[Page 45045-45046]
[DOCID:fr10au07-82]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8453-2; Docket ID No. EPA-HQORD-2007-0667]

Climate and Land Use Change Effects on Ecological Resources in
Three Watersheds: A Synthesis Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 30-day public comment period for the draft
document titled, ``Climate and Land Use Change Effects on Ecological
Resources in Three Watersheds: A Synthesis Report'' (EPA/600/R-07/086).
The document was prepared by the National Center for Environmental
Assessment within EPA's Office of Research and Development.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. EPA intends to consider any public comments
submitted in accordance with this notice when revising the document.

DATES: The 30-day public comment period begins August 10, 2007, and
ends September 10, 2007. Technical comments should be in writing and

must be received by EPA by September 10, 2007.

ADDRESSES: The draft ``Climate and Land Use Change Effects on
Ecological Resources in Three Watersheds: A Synthesis Report'' is
available primarily via the Internet on the National Center for
Environmental Assessment's home page under the Recent Additions and the
Data and Publications menus at http://www.epa.gov/ncea. A limited

number of paper copies are available from the Technical Information
Staff of the National Center for Environmental Assessment (NCEA-TIS).
Please contact the Technical Information Staff by telephone at 202-564-
3261 or by facsimile at<PHONE_NUMBER>. If you are requesting a paper
copy, please provide your name, your mailing address, and the draft
document title, ``Climate and Land Use Change Effects on Ecological
Resources in Three Watersheds: A Synthesis Report.''
    Comments may be submitted electronically via http://www.regulations.gov
, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    For technical information, contact Susan Julius, NCEA, telephone:
202-564-3394; facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    Effects of global change drivers differ by place and in scale,
necessitating place-specific impacts information to enable stakeholders
to respond appropriately. Place and scale also determine appropriate
adaptation strategies and expected outcomes. This report is a synthesis
of three watershed case-study assessments conducted by Global Change
Research Program (GCRP) to advance the capability of managers to
consider climate and land use change in watershed management decisions.
The goal of this report is three-fold: (1) To understand the potential
impacts of global changes and the availability of effective responses
at the watershed scale across different geographic regions, (2) to
learn how GCRP and other research programs might improve the process of
conducting future assessments, and (3) to improve GCRP's and other
research programs' understanding about effective ways to inject climate
change impacts and adaptation information into decision-making
processes. Toward that end, this report compares and contrasts methods
and processes employed by the three case study teams to learn effective
analytic, project management, and decision support approaches.

II. How to Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2007-
0667, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit one
unbound original with pages numbered consecutively, and three copies of
the comments. For attachments, provide an index, number pages
consecutively with the comments, and submit an unbound original and
three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2006-0667. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov
, including any personal information provided,

unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ``anonymous

access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov
, your e-mail address will be automatically captured

and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm    Docket: Documents in the docket are listed in the http://.

http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the

EPA Headquarters Docket Center.

    Dated: August 2, 2007.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
 [FR Doc. E7-15675 Filed 8-9-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13067-13068]
[FR Doc No: 2013-04422]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0172]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Foreign Clinical Studies Not Conducted Under an
Investigational New Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in FDA's regulations on foreign clinical studies not
conducted under an investigational new drug application (IND).

DATES: Submit either electronic or written comments on the collection
of information by April 29, 2013.

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

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Foreign Clinical Studies Not Conducted Under an IND--(OMB Control
Number 0910-0622)--Reinstatement

    Under 312.120 (21 CFR 312.120), FDA accepts foreign clinical
studies not conducted under an IND as support for an IND or application
for marketing approval for a drug or biological product if the studies
are conducted in accordance with good clinical practices (GCP),
including review and approval by an independent ethics committee (IEC).
    Under Sec.  312.120(a), FDA accepts as support for an IND or
application for marketing approval a well-designed and well-conducted
foreign clinical study not conducted under an IND if the study is
conducted in accordance with GCP, and we are able to validate the data
from the study through an onsite inspection if necessary. GCP includes
review and approval by an IEC before initiating a study, continuing
review of an ongoing study by an IEC, and obtaining and documenting the
freely given informed consent of the subject before initiating a study.
    Under Sec.  312.120(b), a sponsor of a non-IND foreign study who
wants to rely on that study as support for an IND or application for
marketing approval must provide the following information to FDA: (1)
The investigator's qualifications; (2) a description of the research
facilities; (3) a detailed summary of the protocol and results of the
study and, should FDA request, case records maintained by the
investigator or additional background data such as hospital or other
institutional records; (4) a description of the drug substance and drug
product used in the study, including a description of the components,
formulation, specifications, and, if available, bioavailability of the
specific drug product used in the clinical study; (5) if the study is
intended to support the effectiveness of a drug product, information
showing that the study is adequate and well controlled under Sec.
314.126; (6) the name and address of the IEC that reviewed the study
and a statement that the IEC meets the definition in Sec.  312.3; (7) a
summary of the IEC's decision to approve or modify and approve the
study, or to provide a favorable opinion; (8) a description of how
informed consent was obtained; (9) a description of what incentives, if
any,

were provided to subjects to participate in the study; (10) a
description of how the sponsor(s) monitored the study and ensured that
the study was carried out consistently with the study protocol; and
(11) a description of how investigators were trained to comply with GCP
and to conduct the study in accordance with the study protocol, and a
statement on whether written commitments by investigators to comply
with GCP and the protocol were obtained.
    Section 312.120(c) specifies how sponsors or applicants can request
a waiver for any of the requirements under Sec.  312.120(a)(1) and (b).
Under Sec.  312.120(c)(1), a waiver request must contain at least one
of the following: (1) An explanation why the sponsor's or applicant's
compliance with the requirement is unnecessary or cannot be achieved,
(2) a description of an alternative submission or course of action that
satisfies the purpose of the requirement, or (3) other information
justifying a waiver. A waiver request may be submitted in an IND or in
an information amendment to an IND, or in an application or in an
amendment or supplement to an application submitted under 21 CFR part
314 or 601. Section 312.10 sets forth requirements for sponsors who
request waivers from FDA for compliance with any of the provisions in
part 312, and Sec.  314.90 sets forth requirements for applicants who
request waivers from FDA for compliance with Sec. Sec.  314.50 through
314.81.
    FDA has approval for the submission of these waiver requests under
OMB control numbers 0910-0014 for part 312 and 0910-0001 for part 314.
In addition to the reporting requirements set forth in table 1 of this
document, there is also a recordkeeping provision in Sec.  312.120(d)
stating how long sponsors and applicants must retain records required
by Sec.  312.120. In addition, Sec.  312.120(b) states that any signed
written commitments by investigators must be maintained by the sponsor
or applicant and made available for Agency review upon request, and
also specifies sponsor recordkeeping of IEC-related information. Under
Sec.  312.120(d), if a study is submitted in support of an application
for marketing approval, records must be retained for 2 years after an
Agency decision on that application; if a study is submitted in support
of an IND but not an application for marketing approval, records must
be retained for 2 years after the submission of the IND. The retention
requirements in Sec.  312.57(c) for records and reports required under
part 312 apply to these provisions, and are approved under OMB control
number 0910-0014.
    We estimate that 237 companies will submit a total of approximately
1,185 non-IND foreign clinical studies in support of an IND or
application for marketing approval for a drug or biological product.
Hour burden estimates vary due to differences in size, complexity, and
duration across studies, and we estimate that complying with Sec.
312.120 would take sponsors between 18 and 32 hours annually for each
non-IND foreign clinical trial, totaling 37,920 hours (32 x 1,185).
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.120............................................................             237                5            1,185               32           37,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04422 Filed 2-25-13; 8:45 am]
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[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Page 20396]
[FR Doc No: 2022-07400]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM19-12-000]

Revisions to the Filing Process for Commission Forms; Notice of
eFORMS Update

    As provided for in the July 17, 2020 Order on Technical Conference,
notice is hereby given of a technical update to the taxonomy code
necessary for submitting Form No. 60.\1\ This update is available at
the eForms portal at https://ecollection.ferc.gov/. In particular, the
Release 2.0 taxonomy code for Form No. 60 has been corrected to change
the period type for DividendRate from instant to duration so that it is
consistent with how the transaction is reported.
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    \1\ Revisions to the Filing Process for Comm'n Forms, 172 FERC ]
61,059 (2020) (July 17, 2020 Order on Technical Conference).

    Dated: April 1, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-07400 Filed 4-6-22; 8:45 am]
BILLING CODE 6717-01-P


Page 1 of 2 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 Date: September 29, 2005 PC Code: 038901, 038903, 038904, 038905 DP Barcode: D322027 MEMORANDUM Subject: Endothall: Addendum to the drinking water assessment dated May 5, 2004.

To: Robert McNally, Chief Special Review Branch Special Review and Reregistration Division ( 7508C)

From: James Breithaupt, Agronomist Dana Spatz, Senior Chemist Environmental Risk Branch II Environmental Fate and Effects Division ( 7507C)

Thru: Tom Bailey, Chief Environmental Risk Branch II Environmental Fate and Effects Division ( 7507C)

For most pesticides, modeled concentrations in surface water and ground water are generally higher than monitored concentrations. However for endothall, the apparent measured concentrations in surface water and ground water were higher than modeled values for at least some samples reported above the minimum reporting limit ( MRL). When this occurs, further analysis and discussion is warranted.

Modeling for surface water concentrations is normally based on PRZM EXAMS where a treated terrestrial field drains to a farm pond or Index Reservoir. It does not address direct application to water. For these aquatic uses, the peak concentration is the target application rate, while a simple first order half life model is applied to estimate an annual mean concentration. The direct application of endothall to water bodies, including drinking water reservoirs, was modeled assuming uniform application over the entire reservoir at the maximum label rate. Based on the result of the direct application scenario, the estimated maximum surface water derived drinking water concentrations are 5 mg/ L ( peak) and 0.545 mg/ L ( annual mean).

Based on NCOD data from the Office of Water, the peak surface water source drinking water concentration was 2.9 mg/ L, while the mean of the 8 detections out of 5,112 samples ( a 0.16% Page 2 of 2 detection frequency) was 0.87 mg/ L. This mean value is higher than the model predicted annual mean. However, if the entire dataset was considered in these statistics, rather than just the 8 detections, mean concentrations would be considerably lower. Albeit, concentrations in this range may be the result of direct application to water ( with application rates up to 5 mg/ L) and withdrawal from an intake in the flowpath from the treatment zone.

For ground water, monitored values were also greater than modeled concentrations. In NCOD monitoring data, the observed peak water concentration was 4.6 mg/ L, while the mean of the 7 detections out of 27,494 samples ( 0.03% detection frequency) was 0.67 mg/ L. Again, if the entire dataset was considered in these statistics, rather than just the 7 detections, mean concentrations would be considerably lower.

SCI GROW modeling assumes a terrestrial application with subsequent leaching through the soil profile into ground water. For endothall, the result was 0.086 ug/ L ( ppb). This SCI GROW estimate assumes application of two pounds of acid equivalents/ acre, which is the maximum labeled seasonal rate for endothall for terrestrial use. Terrestrial application of at least 7,800 lbs of acid equivalent per acre would be required to reach the mean detection reported in NCOD. Assuming these monitored values are valid exposure estimates, it is virtually impossible that terrestrial use led to these concentrations. The persistence of endothall in the field is only 7 19 days, which would allow degradation prior to reaching ground water in almost all environmental conditions. In terrestrial field dissipation studies, endothall only leached into the 4 8 inch soil depth in a California study and into the 8 12 inch soil depth at a Pennsylvania site. In comparison, wells would be drawing water from much greater depths than 8 12 inches.

One possible explanation for these monitored ground water concentrations would be that the well drew water directly from the treated water body carrying residues of endothall acid through the soil. Unless there is a direct hydrologic link from surface water to a ground water well, direct applications to water could not lead to this occurrence. A direct hydrologic link between surface water and high production municipal wells would be rare.

Uncertainties There are a number of variables which may contribute to the uncertainty in reported drinking and ground water monitoring data. These may include, but are not limited to, unconfirmed errors in analysis, unverifiable transcription errors, reporting discrepancies, and reliance upon data from samples collected before current procedures were in place. Historically, it has been demonstrated from compliance and occurrence data from treated water systems that detections of very low frequency may be generally categorized as ' outliers'. Although this trend may not apply to endothall, the potential for the above errors is plausible.


[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Notices]
[Page 18246]
[DOCID:fr09ap10-132]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rules 7a-15 thru 7a-37, OMB Control No. 3235-0132, SEC File No.
270-115.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rules 7a-15 through 7a-37 (17 CFR 260.7a-15--260.7a-37) under the
Trust Indenture Act of 1939 set forth the general requirements relating
to applications, statements and reports that must be filed under the
Act by issuers of, and trustees to, qualified indentures under the Act.
The respondents are persons and entities subject to requirements of the
Trust Indenture Act. Rules 7a-15 through 7a-37 are disclosure
guidelines and do not directly result in any collection of information.
The Rules are assigned only one burden hour for administrative
convenience.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, VA 22312; or send an e-mail to: PRA_
<EMAIL_ADDRESS>
    Dated: April 5, 2010.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-8156 Filed 4-8-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Page 66295]
[FR Doc No: 2021-25405]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 12514-087, 12514-089]

Northern Indiana Public Service Company LLC; Notice of
Effectiveness of Withdrawal of Temporary Variance Requests

    On September 13, 2021, Northern Indiana Public Service Company LLC
(NIPSCO) filed a request for a temporary variance from the required
surface elevation of Lake Shafer in Article 403 of the license for the
Norway-Oakdale Project. On October 8, 2021, NIPSCO filed a request for
a second temporary variance from the U.S. Fish and Wildlife Service's
Technical Assistance Letter requirement that generation cease during an
Abnormal Low Flow event to allow NIPSCO to continue its concrete
restoration work at Oakdale Dam. On November 1, 2021, NIPSCO filed a
notice of withdrawal of both temporary variance requests.
    No motion in opposition to the notice of withdrawal has been filed,
and the Commission has taken no action to disallow the withdrawal.
Pursuant to Rule 216(b) of the Commission's Rules of Practice and
Procedure,\1\ the withdrawal of the temporary variance requests became
effective on November 16, 2021, and this proceeding is hereby
terminated.
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    \1\ 18 CFR 385.216(b) (2020).

    Dated: November 16, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-25405 Filed 11-19-21; 8:45 am]
BILLING CODE 6717-01-P