ENFORCEMENT AND COMPLIANCE

DATA STANDARD

Standard No.:EX000.1-XXX

Version 2.2 – FINAL DRAFT

Date: February 7, 2008

The Exchange Network Leadership Council (ENLC) is a partnership among US
EPA, States and Tribal partners to promote the efficient sharing of
environmental information through the development and adoption of data
standards. More information about is available at   HYPERLINK
"http://www.exchangenetwork.net"  www.exchangenetwork.net

Foreword

The Exchange Network Leadership Council (ENLC) is a partnership among US
EPA, States and Tribal partners to develop and agree upon data standards
for environmental information collection and exchange.  The Council
seeks to promote efficient sharing of environmental information between
State, US EPA and Tribal partners through the development of data
standards.  More information about the ENLC is available at
http://www.exchangenetwork.net/standards.

1.0	INTRODUCTION

Environmental information is a key tool in the effective management of
our environmental resources and human health conditions.  As a result,
much effort goes into data acquisition, management, maintenance,
exchange, and oversight.  Greater access is the goal of many data
consumers, and data managers. Providers invest significant resources
meeting their requirements. In response, many data providers are
improving access as they post usable copies of their environmental
information on the web.  These efforts are a vast improvement over
previous conditions; however, there is a growing desire and need to both
provide and receive data in a clearly defined and a uniform way.  Data
from multiple sources can then be aggregated and used without the
inherent variations that exist between data sets across agencies.

1.1	Scope

This ENLC standard identifies and defines the major areas of enforcement
and compliance information that could be used for the exchange of data
among environmental agencies and other entities.  The purpose of the
standard is to provide a common lexicon, so that information about
functionally similar activities and/or instruments can be stored.

1.2	Revision History

Date	Version	Description

April 22, 2002	1-85727:1	Initial adoption by the Environmental Data
Standards Council

July 11, 2007	EX- 00000:XX.2	Assignment of a new data standard number
and format

February 08, 2008	EX-00000.XX.2.2	Change some permissible value lists to
example value lists

1.3	References

This standard relies on other standards to make it complete and provide
the necessary support. As such users should consider the Normative
Standards (references) noted below, integral to the Enforcement and
Compliance Data Standard. These include:

Representation of Date and Time [EX000013.1] Data Standard

Contact Information [EX000019.2] Data Standard

1.4	Terms and Definitions

For the purpose of this document, the following terms and definitions
apply.

Term						Definition

Civil Penalty					A monetary sanction that the violator is required to
pay

the government because of a violation, but not including a stipulated
penalty. The term includes penalties imposed through either an
administrative or a civil judicial proceeding, but does not include
fines, penalties, or monetary restitution imposed through a criminal
enforcement proceeding.

Collection					A claim that the defendant/respondent pay a previously

incurred debt or monetary obligation, such as an

imposed penalty, which has gone unpaid beyond the due date.

Compliance Assistance				Compliance Assistance includes activities,
tools, or

Technical assistance that provides clear and consistent

Information for helping the regulated community understand and meet its
regulatory obligations, or helping other compliance assistance providers
(including government agencies, contractors and grantees) to aid the
regulated community in complying with environmental regulations.
Although compliance assistance may also help the regulated communities
find cost-effective ways to comply with regulations and improve
environmental performance through the use of pollution prevention,
environmental management practices, and innovative technologies, at
least one objective of compliance assistance must be related to
achieving or advancing regulatory compliance.

Compliance Schedule				An enforceable schedule, contained in a Final
Order, for

The implementation of specific injunctive relief activities, specifying
milestones or deadlines for the completion thereof (including any
interim milestones).  The term, “Compliance Schedule,” as used in
the Enforcement/Compliance Data Standard, does not include a compliance
schedule issued as part of an environmental permit.

Compliance Status				A determination of a regulated entity’s
compliance with

Specific statutory or regulatory requirements.

Cost Recovery					A claim that the defendant/respondent reimburse the

Government for costs incurred in connection with certain

Activities, typically emergency or remedial response actions.

Enforcement Authority				The governmental entity that initiates an
enforcement

action.

Enforcement Status				The status of a regulatory authority’s
enforcement

Response related to violations determined to exist with ‘

Respect to a regulated community.

Information Request				An enforceable request for information to a
regulated

entity or potentially regulated entity about a site, facility,

or activity.

Injunctive Relief					An enforceable requirement obliging the

defendant/respondent to take, or refrain from taking,

certain specified actions.  Examples include installation

of pollution control equipment, performing a cleanup or

corrective action, eliminating a volatile discharge, submitting reports,
etc.  Injunctive Relief does not include any requirement to perform
Supplemental

Environmental Projects (SEP).  In the Enforcement and Compliance Data
Standard, the term “Injunctive Relief” does not include the
obligation to make penalty or cost recovery payments.  SEPs, penalties
and cost recovery obligations are captured in separate data elements.

Inspection					A visit to a facility or site for the purpose of
gathering

Information to determine compliance, including offsite

observations.

Investigation					An extraordinarily detailed assessment of a
facility’s or

facilities’ compliance status.

Penalty						A monetary sanction for failure to comply with

requirements, that the violator is required to pay to the

government.

Reporting Authority				The governmental entity that provides data
regarding its

enforcement and compliance activities.

Responsible Authority				The government official with authority to issue
a legal

instrument such as a complaint, Final Order, or information request.

Search Warrant					A judicial instrument authorizing access to a
facility or

site by government personnel or their agents for the

purpose of determining compliance and/or carrying out

response activities; this category includes warrants and

judicial orders in aid of access.

Settlement Agreement				An enforceable agreement between the parties to

ensure compliance that is executed by both parties

and approved by the tribunal or responsible authority.

Stipulated Penalty				A monetary sanction that the violator is required
to pay

to the government because of noncompliance with a

Final Order and which is paid pursuant to the explicit

terms of such Final Order.

Subpoena					A formal document issued to compel testimony and/or

to produce documents.

Supplemental Environmental Project (SEP)	An environmentally beneficial
action or project, not

otherwise required by law, agreed to be undertaken by

the defendant/respondent, often in lieu of a portion of a

penalty.

1.5	Implementation

Users are encouraged to use the XML registry housed on the Exchange
Network Web site ( HYPERLINK "http://www.exchangenetwork.net/"
http://www.exchangenetwork.net ) to download schema components for the
construction of XML schema flows.  In addition, the Environmental Data
Registry (http:// HYPERLINK "http://www.epa.gov/edr" www.epa.gov/edr )
provides the data standard structure and attributes in a downloadable
format that will facilitate database development activities.

1.6	Document Structure

The structure of this document is briefly described below:

a.	Section 2.0 Enforcement and Compliance Diagram, illustrates the
principal data groupings contained within Enforcement and Compliance
Data Standard.

b.	Section 3.0 Enforcement and Compliance Data Standards Table, provides
information on the high and intermediate levels of Enforcement and
Compliance data groupings, as well as their related data elements. Where
applicable, for each level of this data standard, a definition, XML tag,
note(s), example list of values and format are provided.  The format
column lists the required number of characters for the associated data
element, where “A” specifies alphanumeric, “N” designates
numeric, “G” is used for grouping and “D” for time and date
elements.

c.	Data Element Numbering. For purposes of clarity and to enhance
understanding of data standard hierarchy and relationships, each data
group is numerically classified from the primary to the elemental level.

d.	Code and Identifier Metadata: Metadata, defined here as data about
data or data elements, includes their descriptions and/or any needed
context setting information required to identify the origin, conditions
of use, interpretation, or understanding  the information being
exchanged or transferred.  (Adapted from ISO/IEC 2382-17:1999
Information Technology Vocabulary—Part 17: Databases 17.06.05
metadata).  Based on the business need, additional metadata may be
required to sufficiently describe an identifier or a code.  A note
regarding this additional metadata is included in the notes column for
identifier and code elements. Additional metadata for identifiers may
include:

• Identifier Context, which identifies the source or data system that
created or defined the identifier

Additional metadata for codes may include:

• Code List Identifier, which is a standardized reference to the
context or source of the set of codes

• Code List Version Identifier, which identifies the particular
version of the set of codes.

• Code List Version Agency Identifier, which identifies the agency
responsible for maintaining the set of codes

• Code List Name, which describes the corresponding name for which the
code represents

e.	Appendix A, Enforcement and Compliance Data Structure Diagram
illustrates the hierarchical classification of the Enforcement and
Compliance data standard.  This diagram enables business and technical
users of this standard to quickly understand its general content and
complexity.

2.0	ENFORCEMENT AND COMPLIANCE DIAGRAM

The figure below illustrates the major data groups associated with the
Enforcement and Compliance Data Standard.

 3.0	ENFORCEMENT AND COMPLIANCE DATA STANDARD TABLE

1.0	Compliance Monitoring Information

Definition: 	Information about the types of activities leading to or
resulting in a determination of the compliance status of a regulated
entity, facility, or group of facilities.

Relationships:  One of more compliance monitoring actions can detect a
violation

		Each compliance monitoring action can detect one or more violations

		A compliance monitoring action is taken with respect to a facility by
a reporting agency.

		A compliance monitoring action is associated with one or more
statute/section pairs, which serve to describe the

		environmental program(s) or interest(s) being furthered through the
action.

.Notes:		None.

XML Tag: ComplianceMonitoringInformation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

1.1 Compliance Monitoring Date	The calendar date that the compliance
monitoring action was performed or conducted. 	For actions such as
inspections or investigations, use the date on which the action was
completed.  For actions such as written requests for information, use
the date the request was signed by the Responsible Authority.

Refer to the Representation of Date and Time [EX000013.1] Data Standard
D(8)	ComplianceMonitoringDate

1.2 Compliance Monitoring Identifier	The unique alphanumeric identifier
that specifies a compliance monitoring action pertaining to a regulated
facility or entity.	Note: Based on the business need, additional
metadata may be required to sufficiently describe an identifier. This
additional metadata is described in the Introduction section 1.6.d.
A(20)	ComplianceMonitoringIdentifier

1.3 Compliance Monitoring Agency Name	The name of the agency,
department, or organization performing or conducting the compliance
monitoring action

A(100)	ComplianceMonitoringAgencyName

1.4 Compliance Monitoring Agency Type 	The type of agency performing or
conducting the compliance monitoring action.	Local agencies include
intrastate regional agencies (i.e., those with jurisdiction extending
across multiple local government boundaries).

EXAMPLE VALUES

U.S. EPA – United States Environmental Protection Agency.

Other Federal – Another agency of the United States.

State – State agency.

Interstate – Interstate agency

Local – Local agency.

Tribal - Tribal government agency.	A(13)	ComplianceMonitoringAgencyType

1.5 Compliance Monitoring Action Type	The type of compliance monitoring
action taken by a regulated agency.	Compliance monitoring action types
should accomplish one or more of the following objectives:

- Determine the compliance status of a regulated entity with a law,
rule, permit, enforcement order, compliance schedule or other legal
requirement.

- Obtain documentation to support a claim of noncompliance.

- Inform the regulated entity of potential and actual noncompliance.

- Provide information to the regulated entity on where and how to obtain
compliance assistance.

- Provide information to the regulated entity on how to conduct
self-policing.

Activities that may be categorized as “Information Requests”
include:

- Issuance of a subpoena for the production of documents or testimony.

- A requirement that a facility conduct testing or sampling (e.g., a
stack test).

Activities that may be categorized as a “Compliance Inspection”
include inspections pursuant to a search warrant or an order in aid of
access, inspections at a regulator’s office location, and offsite
observations of a facility or site.

Activities that may be categorized as an “Off-Site Review” include:

- The review of the reports of facility-conducted testing or sampling
tests submitted by the regulated entity.

- Review of self-reported information from regulated entities, including
information required to be submitted (e.g., Discharge Monitoring Report
[DMR] or CAA Title V self-certifications) and voluntarily submitted
information.

EXAMPLE VALUES

Information Request - An enforceable, written request for information to
a regulated entity or potentially regulated entity or about a site,
facility, or activity.

Compliance Inspection - A visit to a facility or site for the purpose of
gathering information to determine compliance including direct
observations of facility operations.

	A(24)	ComplianceMonitoringActionType

Compliance Investigation - An extraordinary, detailed assessment of a
regulated entity’s compliance status, which requires significantly
more time to complete than a typical compliance inspection (i.e.,
several weeks, as compared with one or a few days).

Offsite Record Review - A review of records, conducted at the government
agency’s offices, for the purpose of reviewing information to
determine compliance of a regulated entity.

1.6 Compliance Inspection Type	The type of compliance inspection
conducted.

	This data element issued only if the type of Compliance Monitoring
Action taken was “Compliance Inspection”

 Inspection to determine the compliance of a facility or regulated
entity with the terms of a previously-issued enforcement instrument
would be included here.

EXAMPLE VALUES

Compliance Evaluation Inspection – An Inspection designed to determine
compliance with legal requirements, which does not involve sampling.

Compliance Sampling Inspection – An inspection designed a determine
compliance with applicable statues and regulations, which involves
collection of physical samples of air, water, waste, etc.

Reconnaissance or Screening Inspection – An abbreviated, initial
inspection designed to obtain a preliminary overview of a facility’s
compliance program and status.

Case Development Inspection – An inspection designed to collect
specific information to support an ongoing or planned enforcement
action.	A(38)	ComplianceInspectionType

1.7 Off Site Record Review Type	The type of off-site record review
conducted.	This data element is used only if the Compliance Monitoring
Action taken was – “Off-Site Record Review.”  The data element
describes the way in which such records were acquired by the Compliance
Monitoring Agency.

Information requested by a regulatory agency would be categorized under
the Compliance Monitoring Action “Information Request.”

EXAMPLE VALUES

Required – The regulated entity was legally required to submit the
records.

Self-Policing Submission – The records reviewed were self-reported
information submitted by a regulated entity under EPA’s self-policing
policies (I.e., EPA’s Audit Policy or Small Business Compliance
Policy) or under State, Tribal, or Local analogs.

Voluntary – The records were self-reported information submitted
voluntarily by a regulated entity, but not pursuant to EPA’s
self-policing policies or State, Tribal, or Local analogs.	A(31)
OffSiteRecordReviewType

1.8 Compliance Monitoring Media Type 	The environmental program(s) with
respect to which the compliance monitoring action was taken.	Select all
applicable values.  Any compliance monitoring action for which two or
more environmental programs are selected represents a “multi-media”
compliance monitoring action.  Note that two or more distinct
environmental programs may occur under a single statue; e.g., National
Pollutant Discharge.  Elimination System (NPDES) and Wetlands under the
federal Clean Water Act; or Public Water Supply and Underground
Injection Control under the federal Safe Drinking Water Act.

EXAMPLE VALUES

Air Stationary Source

Air Mobile Source

Emergency and Community Right-to-Know

Hazardous Waste (RCRA)

National Pollutant Discharge Elimination System

Ocean Dumping

Solid Waste

Pesticides

Public Water Supply

Superfund

Toxic Substances

Underground Injection Control

Underground Storage Tanks

Wetlands

Other	A(47)	ComplianceMontioringMediaType

1.9 Citizen Complaint Indicator Code	The code that indicates whether a
compliance monitoring action was performed in response to a citizen
complaint or tip. 	Includes tips or other information received from
individuals, community groups, environmental groups, other facilities or
regulated entities, etc.

Permissible List of Values:

Y –Yes

N – NO	A(1)	CitizenComplaintIndicatorCode

1.10 Compliance Monitoring Action Reason	The reason for performing a
compliance monitoring action.

 	”Core Program” includes, e.g., when the regulatory agency monitors
all major sources on a routine basis; or a statute specifies the
frequency of routine monitoring for certain facilities; or the agency
selects some percentage of its monitoring based on random selection;
etc.

“Agency Priority” includes, e.g., monitoring actions taken with
respect to target pollutants; or actions taken in specially targeted
industries, geographic areas, communities, ecosystems, etc.

	A(26)	ComplianceMontioringActionReason

More than one of the Permissible Values may apply to a given Compliance
Monitoring Action.  For example, an inspection may be in support of an
Agency priority, but also fulfill core program obligations.  In that
case, the reporting agency may choose how to characterize the Reason;
ordinarily, in the example given, we would encourage selection of
“Agency Priority” as providing a more specific rationale.

EXAMPLE VALUES

Core Program – The compliance monitoring action was performed as part
of the Compliance Monitoring Agency’s core programmatic activities.

Agency Priority – The compliance monitoring action was performed in
furtherance of a priority or initiative of the Compliance Monitoring
Agency or a partner agency.

Selected Monitoring Action – The Compliance Monitoring Agency selected
the facility or regulated entity for compliance monitoring in response
to a referral from another unit within the Compliance Monitoring Agency
or another unit of government; in response to a citizen complaint or
tip; or for another reason specific to the regulated entity or facility
in question (e.g., monitoring compliance with a compliance schedule in a
previously-issued enforcement instruments; or because there is probable
cause to believe a violation exists).

1.11 Compliance Monitoring Action Priority Originator	The program that
established the priority that prompted the compliance monitoring action.
If the Reason for Compliance Monitoring Action is “Priority,”
identify the originator of the priority.	A(12)
ComplianceMonitoringActionPriorityOriginator

1.12 Compliance Monitoring Priority	The name of the priority that
prompted the compliance monitoring action.	If the Reason for Compliance
Monitoring Action is “Priority,” identify the priority by name.

Example values will include priorities established by EPA at the
National or EPA Regional level and priorities established by State,
Local, and/or Tribal agencies.

EXAMPLE VALUES

Clean Water Act/Wet Weather – The national priority area Clean Water
Act/Wet Weather that includes Combined Sewer Overflow (CSO) Policy, the
Sanitary Sewer Overflow (SSO) Enforcement Management System, and the
National Concentrated Animal Feeding Operations (CAFOs) Sector Strategy.

Safe Drinking Water Act/Microbial Rules – The national priority area
Safe Drinking Water Act/ Microbial Rules

Clean Air Act/NSR/PSD – The national priority area Clean Air Act/New
Source Review/Prevention of Significant Deterioration (NSR/PSD)

Clean Air Act/Air Toxics – The national priority area Clean Air
Act/Air Toxics	A(53)	ComplianceMonitoringPriority

Resource Conservation and Recovery Act/Permit Evaders – The national
priority area Resource Conservation and Recovery Act/Permit Evaders.

Petroleum Refining Sector – The national priority area Petroleum
Refining Sector.

1.13 Compliance Monitoring Action Outcome	The results from a compliance
monitoring action.	EXAMPLE VALUES

No Violation – No violation(s) detected.

Immediately Corrected – Violation(s) detected and immediately
corrected onsite.

No Immediately Corrected – Violation(s) detected but not immediately
corrected.

Under Review – A determination on compliance status is pending further
review, completion of an inspection report, etc.

No Compliance Monitoring (Facility Shut Down) – The facility is no
longer in operation.

No Compliance Monitoring (Access Denied) – The owner/operator denied
access to the facility.	A(45)	ComplianceMonitoringActionOutcome

2.0	Violation

	Definition: 	Noncompliance with one or more legally enforceable
obligations by a regulated entity, as determined by a

			responsible authority.  Included in this category are violations of
legally enforceable obligations under pre-existing

			Final Orders (e.g., violations of compliance schedules included in
enforcement orders.)

Relationships:  	Each violation is affiliated with a compliance
monitoring agency.

Each violation can be detected by one or more compliance monitoring
actions.

Each violation can be associated with zero or one or more permits.

Each violation may lead to zero or one or more enforcement actions. (Not
every violation results in an enforcement action.  The same violation
may be cited in several different, successive enforcement actions of
progressively greater severity [e.g., a Notice of Violation followed by
a Complaint and ultimately, a Final Order].)

Notes:		None.

XML Tag: Violation

Data Element Name	Data Element Definitions	Notes	Format 	XML Tags

2.1 Violation Determined Date	The calendar date the Responsible
Authority determines that a regulated entity is in violation of a
legally enforceable obligation.	This may be the same as, or different
than, the Compliance Monitoring Date

Refer to the Representation of Date and Time [EX000013.1] Data Standard
D(8)	ViolationDeterminedDate

2.2 Violation Class Type	The type of violation that is the subject of
the Violation Determined Date.	If reporting on a group of violations
rather than an individual violation and any of the violations within the
group are Significant or High Priority, select the permissible value
“Significant or High Priority Violation.”

	A(38)	ViolationClassType

Permissible Values:

Significant or High Priority Violation – The violation meets
applicable programmatic criteria for those terms, as set out by EPA.

Other – The violation does not meet applicable programmatic criteria
for “significant” or “high priority” violations.

2.3 Compliance Schedule Indicator Code	The code that indicates whether
the regulated entity is currently on a legally enforceable compliance
schedule (i.e., pursuant to a Final Order) for return to compliance with
the obligation that is the subject of the Violation Determined Date.	If
reporting on a group of violations rather than an individual violation
and if any such violations are subject to a Compliance Schedule, select
the permissible value “Yes.”

Permissible List of Values:

Y – Yes

N – No	A(1)	ComplianceScheduleIndicatorCode

2.4 Return to Compliance Schedule Date	The calendar date, specified in
the Compliance Schedule (if any), on which the regulated entity is
scheduled to return to compliance with respect to the legal obligation
that is the subject of the Violation Determined Date.	If reporting on a
group of violations rather than on an individual violation, then enter
the latest date by which such violations are to be corrected.

Refer to the Representation of Date and Time [EX000013.1] Data Standard
D(8)	ReturnComplianceScheduleDate

2.5 Return to Compliance Actual Date

	The calendar date, determined by the Responsible Authority, on which
the regulated entity actually returned to compliance with respect to the
legal obligation that is the subject of the Violation Determined Date.
If reporting on a group of violation rather than on an individual
violation, then enter the date on which all such violations are actually
corrected.

Refer to the Representation of Date and Time [EX000013.1] Data Standard
D(8)	ReturnComplianceActualDate

3.0	Enforcement Action General Information

Definition: 	Information about any kind of action taken to address
noncompliance with environmental laws by a regulated entity: asses
penalties for noncompliance; compel the recipient to perform or refrain
from certain actions; recover costs; and/or collect money owed to the
government under environmental laws.

Relationships:  Each enforcement action is related to one or more
specific determinations of noncompliance, or determinations of the need
for response or corrective action.

	Each enforcement action is related to zero or one or more permits
through a violation.

	Each enforcement action is related to one or more defendant(s)
respondent(s).

	Each enforcement action can be linked to zero or one or more
violations. (Some enforcement actions are not based on alleged
violations of law.  Examples include many “imminent-and-substantial
endangerment” actions, and other actions brought to compel the
implementation of a response action, or to recover government costs.)

	Each enforcement action has a single current enforcement status; but
each action may have had a different status at other past times during
the lifetime of that action.

Each enforcement action is taken with respect to zero, one or more
facilities. (Though not common, it is possible to take an enforcement
action against an entity that is not related to a specific regulated
“facility.”)

Each enforcement action must have one or more
defendant(s)/respondent(s).

Each enforcement action is associated with a statutory authority.

Notes:

XML Tag: EnforcementActionGeneralInformation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

3. 1 Enforcement Action Date	The calendar date the enforcement action
was issued or filed.	For actions, involving written documents, the
Enforcement Action Date is the date on which the document was signed by
the Responsible Authority, except for judicial actions it is the date
the action was filed in or entered by the court.  For an informal action
based only on oral notification, it is the date the regulated entity
actually received such notification.

Refer to the Representation of Date and Time [EX000013.1] Data Standard
D(8)	EnforcementActionDate

3. 2 Enforcement Action Identifier	The unique alphanumeric identifier
used in the applicable database to identify a specific enforcement
action pertaining to a regulated entity or facility.

A(20)	EnforcementActionIndentifier

3.3 Enforcement Action Name	The formal name of the enforcement action as
shown on the caption of the legal instrument. 	Example List of Values:

U.S. v. XYZ Company

State of --- v. XYZ Company

In the Matter of XYZ Corp

	A(200)	EnforcementActionName

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

3.4 Enforcement Agency Name	The full name of the agency, department, or
organization that submitted the enforcement action data to EPA.

A(100)	EnforcementAgencyName

3.5  Enforcement Agency Type	The type of agency that submitted the
enforcement action data the EPA.	Local agencies include intrastate
regional agencies (i.e., those with jurisdiction extending across
multiple local government boundaries).

EXAMPLE VALUES

US EPA – United States Environmental Protection Agency.

Other Federal – Another agency of the United States.

State – State agency.

Interstate – Interstate agency.

Local – Local agency.

Tribal – Tribal government agency.	A(13)	EnforcementAgencyType

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

3.6 Enforcement Agency Location	The U.S. Postal Service alphabetic code
that represents the U.S. state and territory in which a state or local
government enforcement agency operates.	If the Enforcement Agency Type
is “State” or “Local,” the enforcement agency should enter the
two-letter postal code for the state or territory, in which it is
located, even though its jurisdiction is not statewide.

Permissible  Values List:

Use the two-letter U.S. Postal code for the state or territory.

Refer to the Contact Information Data [EX000019.2] Data Standard	A(2)
EnforcementAgencyLocation

 	A9100)	FederalStatuteViolated

3.8 State Statute Violated	The state statute and section(s) alleged to
have been violated.

A(100)	StateStatuteViolated

3.9 Tribal Statute Violated	The tribal statute(s), ordinance(s) or
law(s) alleged to have been violated.

A(100)	TribalStatuteViolated

3.10 Local Statute Violated	The local statute(s), ordinances(s) or
law(s) alleged to have been violated.

A(100)	LocalStatuteViolated

3.11 Citation	The citation(s) of the violations alleged.	Use regulatory
citation, if applicable, otherwise use statutory citation.  Use
commonly accepted form of citation/	A(200)	Citation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

3.12 Noncompliance or Corrective Action Description	The narrative text
describing the noncompliance identified, or the response or corrective
action required.

A(200)	NoncomplianceCorrectiveActionDescriptionText

3.13 Enforcement Action Type	The type of action taken by the regulatory
agency.	EXAMPLE VALUES

Oral Notification of Violation – An oral notification to the regulated
entity of violation(s) of applicable laws where no further action is
contemplated assuming the entity achieves compliance in a timely manner.

Letter to Regulated Entity – A written notification to the regulated
entity of violation(s) of applicable laws, such as a warning letter,
where no further action is contemplated assuming the entity timely
achieves compliance.

Letter to State/Tribe – A written notification to a delegated or
authorized state, tribe or local government agency, about violation(s)
of applicable laws by a regulated entity within the jurisdiction of the
state or tribe.

	A(30)	EnforcementActionType

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

Written Notice of Violation – A written notice sent to a regulated
entity, initiating the enforcement process by informing the entity of
violation(s) of applicable law, and requesting that the regulated entity
take action to come into compliance, with the expectation of
             further follow-up action by the regulatory agency.

Demand for Stipulated Penalties – A written demand that a regulated
entity, which is subject to a previous Final Order, pay stipulated
penalties specified therein for violation(s) of its terms.

Judicial Referral – A formal written request to another agency or unit
of government to proceed with judicial enforcement (e.g., criminal or
civil judicial action) relating to the violation(s) in question.

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

Field Citation – A legal instrument issued by an inspector in the
field; it provides the Respondent a chance to certify a return to
compliance, and pay a reduced penalty, without further discussion with
the Regulatory Authority and without further litigation.

Complaint/Proposed Order – A legal instrument that formally initiates
a “two-step” legal procedure (in which the Respondent has the right
to a specified further process such as a hearing or trial), the
objective of which is to secure an independently enforceable Final
Order.  This type of Enforcement Action can be either administrative or
judicial.

Final Order – An administrative or judicial legal instrument that
formally concludes an enforcement action, and which imposes on the
recipient independently enforceable obligations.

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

Voluntary Compliance Agreement – A consent agreement in which a
regulated entity agrees to come into compliance, but which does not
invoke the legal enforcement authority of the government (i.e., the
agreement is enforceable only as contract).

4.0	Additional Enforcement Action Attributes

Definition: 	Attributes that provide additional descriptive information
about Enforcement Action Types “Notice of Violation,”
“Complaint/Proposed Order,” and/or “Final Order” only.

Relationships:  	Each Complaint/Proposed Order may be associated with
one or more Enforcement Action “relief sought” types (Data

		Elements 5.1 – Cash Civil Penalty Amount Sought, 6.1 – Cost
Recovery Amount Sought, 6.3 – Collection Amount

		Sought, and7.1 – Injunctive Relief Sought Description).

	XML Tag:

		Each Final Order may be associated with one or more Final Order Relief
Required types.

	Notes:		AdditionalEnforcementActionAttributes

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

4.1 Enforcement Action Forum	The legal forum in which the enforcement
action is brought.	EXAMPLE VALUES

Judicial – The action is brought in federal or state court.

Administrative – the action is brought before an administrative body
or tribunal; or the action is brought by an administrative agency and
does not involve a separate tribunal (e.g., a warning letter or Notice
of Violation (NOV).	A(14)	EnforcementActionForum

4.2  Enforcement Action Status	The current status of the enforcement
action.	EXAMPLE VALUES

Active – A Notice of Violation, Judicial Referral, or
Complaint/Proposed Order has been initiated, but a Final Order has not
yet been issued, nor has the Action been otherwise Concluded, Closed,
Superseded, or Combined.

	A(25)	EnforcementActionStatus

Concluded – The action has been concluded, but not yet closed.  An
enforcement action is concluded but not closed when a Notice of
Violation or a Final Order has been issued, but all actions requested in
such Notice or required in such Order have not yet been completed;
and/or the termination date in the Final Order (if specified) has not
yet passed; and the action has not been Superseded, Combined, Withdrawn,
or Dismissed.

Closed – All actions requested in a Notice of Violation, or required
in a Final Order, have been completed by the recipient; or the
termination date of the Final Order (if such a date specified) has
passed; or the action has been Withdrawn or Dismissed, or the
enforcement action has been superseded by, or combined into, another
related enforcement action addressing the same violation.

Stayed While Under Appeal – Where a Final Order has been appealed, and
its effective date has been stayed pending the outcome of the appeal,
this value should be used.

4.3  Enforcement Action Status Date	The calendar date of the most recent
Enforcement Action Status determination.	Refer to the Representation of
Date and Time [EX000013.1] Data Standard	D(8)
EnforcementActionStatusDate

4.4 Enforcement Action Resolution Type	The mechanism by which the
enforcement action is revealed.	EXAMPLE VALUES

Consent: A Final Order issued by the Responsible Authority, or the
tribunal, with the comment of the parties.

Adjudicated – A Final Order issued by the Responsible Authority, or
the tribunal, after adjudication (motion practice, trial, hearing,
etc.), where the matter has been contested by the Respondent.

Unilaterally Issued – A Final Order issued by the Responsible
Authority without the Respondent’s consent and without any proceedings
such as a hearing or trial.

Default- A Final Order issued by the Respondent Authority or the
tribunal as a consequence of the Respondent’s failure to timely carry
on with the subsequent procedural steps.

	A(19)	EnforcementActionResolutionType

Withdrawn – A Notice of Violation or a Complaint/Proposed Order that
is withdrawn by the Responsible Authority.

Dismissed – A Complaint/Proposed Order that is dismissed by the
Responsible Authority or tribunal.

 Superseded or Combined – An enforcement action has been superseded by
another related enforcement action (e.g., a Notice of Violation has been
superseded by a Complaint/Proposed Order or a Final Order); or has been
combined into another related enforcement action.

5.0	Enforcement Action Cash Penalty and Supplemental Environmental
Project (SEP) Information

Definition: Additional information about

   ** Any cash civil penalty sought through, and/or required pursuant
to, an Enforcement Action;

** Any stipulated penalty subsequently required to be paid as a
consequence of noncompliance by the     Defendant/Respondent with the
terms of a Final Order; and ‘

	  ** Any Supplemental Environmental Projects (SEP) required to be
performed pursuant to a Final Order.

Relationships:

Notes:

XML Tag: EnforcementActionCashPenaltyandSupplementalEnvironmentalProject

Data Element Name	Data Element Definitions	Notes	Format	XML Tag

5.1 Cash Civil Penalty Amount Sought	The dollar amount of any proposed
cash civil penalty set forth in a Compliance/Proposed Order.	The amount
sought is the amount initially proposed, requested or demanded by the
agency that initiates an enforcement action that seeks a penalty. The
amount required (see Data Element # 5.2 – Cash Penalty Amount
Required) is the amount ultimately agreed to in a settlement, or imposed
by the tribunal or other responsible authority.

Does not include:

**The value of Supplemental  Environmental Projects (SEP) that may be
included in a resolution of the enforcement actions;

**The value of any Stipulated Penalties that may be sought for
noncompliance with a Final Order; or

**The value of any injunctive relief that may be required by a Final
Order.	N(15)	CashCivilPenaltyAmountSought

5.2 Cash Civil  Penalty Amount  Required	The dollar amount of any cash
civil penalty, payment of which is required pursuant to a Final Order.
The figure to be reported is the amount required to be paid, whether or
not such penalty has been collected.

Does not include:

**The value of any Stipulated Penalties that may be required for
noncompliance with the Final Order;

**The value of any Supplemental Environmental  Project (SEP) included in
the Final Order; or

**The value of any injunctive relief required by the Final Order,	N(15)
CashCivilPenatlyAmountRequired

5.3 Stipulated Penalty Amount Required	The dollar amount of any cash
stipulated penalty, payment of which is required by the Enforcement
Agency, pursuant to the terms of a pre-existing Final Order.	A
Stipulated Penalty Amount Required figure should only be reported if the
Enforcement Agency has made a demand for payment thereof (whether or not
the amount has been collected); or the Defendant/Respondent has
self-assessed and paid such Penalties.  Stipulated penalties include
suspended or contingent penalties, payment of which is required only in
the event of subsequent noncompliance (after initial resolution of an
enforcement action).	N(15)	StipulatedPenaltyAmountRequired

5.4 SEPs Description	The narrative text describing any Supplemental
Environmental Projects required to be performed pursuant to a Final
Order.

A (2000)	SupplementalEnvironmentalProjectsDescriptionText

5.5 SEPs Value	The dollar value of any Supplemental Environmental
Projects (SEP) required to be performed pursuant to a Final Order.	This
is the estimated full cost to the Defendant/Respondent of implementing
any such SEPs.	N(15)	SupplementalEnvironmentalProjectsValue

5.6 SEPs  Penalty Assessment Value	The portion of the Supplemental
Environmental Projects (SEP) Value which is explicitly denominated as a
civil penalty assessed in a Final Order.	EPA does not denominate any
portion of the SEP Value as a civil penalty, so for EPA actions this
value will be zero.  However, other jurisdictions may denominate some
portion of the Required SEP Value as a penalty. Thus, the SEPs Penalty
Assessment Value may be any fraction of the SEPs Value from 0% to 100%,
although it is usually substantially less than 100%.	N(15)
SupplementalEnvironmentalProjectsPenaltyAssessmentValue

5.7 Total Civil Penalty Value	The total value of the civil penalty
required by a Final Order.	The value is the sum of the Cash Civil
Penalty Required Amount plus the Required SEPs Penalty Assessment Value.
 The Total Civil Penalty Value may be equal to or greater than the Cash
Civil Penalty Required Value.  (For EPA cases, it will be equal to the
Cash Civil Penalty Required Value.)	N(15)	TotalCivilPenaltyValue

6.0	Enforcement Action Cost Recovery and Collection Information

Definition:  Information about any cost recovery or collection sought
through, and/or required pursuant to, an Enforcement Action.

Relationships:

Notes:

XML Tag: EnforcementActionCostRecoveryandCollectionInformation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

6.1 Cost Recovery  Amount Sought	The dollar amount of any cost recovery
sought in a Complaint/Proposed Order.	If the enforcement action seeks
reimbursement of future government costs, not yet expended, and the
amount of such future costs can be reasonably accurately estimated, such
amount may be included here.	N(15)	CostRecoveryAmountSought

6.2 Cost Recovery Amount Required	The dollar amount of any cost recovery
required to be paid pursuant to a Final Order.	Report the amount
required in the Final Order, whether or not it has been collected.  If
the Enforcement Action resolution includes an enforceable obligation for
the Defendant/Respondent to reimburse future government costs, not yet
expended (e.g., upon presentation of a bill), and the amount of such
future costs can be reasonably and accurately estimated, such amount may
be included here.	N(15)	CostRecoveryAmountRequired

6.3 Collection Amount Sought	The dollar amount of the prior debt sought
to be collected through a Complaint/Proposed Order,

N(15)	CollectionAmountSought

6.4 Collection Amount Required	The dollar amount of any collection
payment required in a Final Order or other mechanism used to resolve the
collection Complaint/Proposed Order.	Report the amount required in the
Final Order, whether or not it has been collected.	N(15)
CollectionAmountRequired

7.0	Enforcement Action Injunctive Relief Information

Definition:  Information about any injunctive relief sought through,
and/or required pursuant to, an Enforcement Action, but not including
penalties, cost recovery, and Supplemental Environmental Project (SEP)
obligations.

Penalties, cost recovery and SEPs, are addressed in separate categories.

The environmental benefits anticipated from such Injunctive Relief are
covered in the Enforcement Action Compliance Milestones Information Data
Group.

Relationships:

Notes:

XML Tag:EnforcementActionInjunctiveReliefInformation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

7.1 Injunctive Relief Sought Description	Narrative description of the
injunctive relief sought through a Complaint/Proposed Order.	Does not
include penalties, cost recovery or Supplemental Environmental Project
(SEP).	A (2000)	InjunctiveReliefSoughtDescription

7.2 Injunctive Relief Required Description	Narrative description of the
injunctive relief required in a Final Order,	Does not include penalties,
cost recovery, or Supplemental Environmental Project (SEP),	A (2000)
InjunctiveReliefRequiredDescription

7.3  Injunctive Relief Value	The estimated dollar cost to the
Defendant/Respondent of carrying out all injunctive relief (not
including penalties, cost recovery or Supplemental Environmental
Projects) required pursuant to a Final Order,

N(15)	InjunctiveReliefValue

8.0	Enforcement Action Compliance Milestones Information

Definition:  Information about the status of implementation, by
Defendant/Respondent, of compliance actions required as milestones
included in a Final Order or other enforcement action resolution,
including Injunctive Relief.  Supplemental Environmental Projects (SEP),
Penalty or Cost Recovery payment required,

Relationships:

Notes:

XML Tag: EnforcementActionComplianceMilestonesInformation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

8.1 Compliance Milestones Status	The status of implementation by a
Defendant/Respondent, on a given date (the Compliance Milestones
Determination Date), of any compliance milestone actions required to
have been completed by the date, including injunctive relief,
Supplemental Environmental Projects, and penalty and cost recovery
payments required.	EXAMPLE VALUES

Implemented by Due Date(s) – All required milestone actions, the
deadlines for which are on or before the reporting date, were
implemented by the specified deadline date(s),

Implemented by Determination Date, but Later than Due Date(s) – One or
more milestone actions were not implemented by the date(s) specified in
the enforcement action resolution instrument, but such actions were
completed before the most recent Compliance Milestones Status
Determination Date,

	A(100)	ComplianceMilestonesStatus

8.2 Compliance Milestones Status Determination Date	The calendar date
the Responsible Authority last determined a regulated entity’s status
of compliance with the milestone obligations in an enforcement action
resolution instrument.	Refer to the Representation of Date and Time
[EX000013.1] Data Standard	D(8)
ComplianceMilestonesStatusDeterminationDate

Data Element Name	Data Element Definitions	Notes	Format	XML Tag

8.3 Compliance Milestones Violation Response Indicator	The code that
indicates whether the Enforcement Agency has taken action in response to
a Compliance Milestones Implementation Violation.	Such response action
may include a demand for stipulated penalties; further enforcement
action seeking additional civil penalties; further action seeking to
impose contempt sanctions; amendment or revision of the compliance
schedule to set new milestone dates; etc.

Permitted List of Values:

Y -  Yes

N – No	A(1)	ComplianceMilestonesViolationResponseIndicator

8.4 Compliance Milestones Completed Date	The calendar date, determined
by the Reporting Authority, on which all compliance milestone actions
required in an enforcement action resolution have actually been
completed, including all injunctive relief, SEPs, and all penalty or
cost recovery payments required.	Refer to the Representation of Date and
Time [EX000013.1] Data Standard	D(8)	ComplianceMilestonesCompletedDate

9.0 	Defendant/Respondent Affiliation Information

Definition: Information on the affiliation of the defendant(s) or
respondent(s) named in the enforcement action.

Relationships:  Each enforcement is linked to one or more
defendant/respondents and each defendant/respondent may be affiliated
with one or more facilities that are the subject of the enforcement
action. Additional information about each defendant/respondent (e.g.,
mailing address, DUNS Number, contact person, title, etc.) may be
recorded as defined in the Facility Site Identification Data Standard,
irrespective of whether or not the defendant/respondent is an owner or
operator of a facility that is the subject of the enforcement action
(e.g., where the defendant/respondent’s only affiliation to the
facility is as Generator or Transporter.)

Notes:

XML Tag: DefendantRespondentAffiliationInformation

Data Element Name	Data Element Definitions	Notes	Format	XML Tags

9.1 Affiliation of  Defendant/Respondent to Facility	The name that
describes the capacity or function that a defendant/respondent serves
for a facility that is the subject of the enforcement action.	The
Defendant/Respondent may be related to the subject facility in more than
one way; therefore, more than one permissible value may be selected.
For example, an owner of a facility may also be an operator.  Similarly,
the generator of wastes may also be the owner or operator of the
facility where the wastes were disposed.

Note that a waste transporter may also be the owner or operator of the
facility.  If the violations alleged are with respect to that facility,
the affiliation is as “Owner” and/or “Operator.” If the
violations alleged are with respect to the Defendant’s activities as
transporter to or from another facility, then the affiliation is
“Transporter.”

EXAMPLE VALUES:

Owner – The defendant or respondent is the owner of the facility.

Operator – The defendant or respondent is a generator of waste
material found at the subject facility.

Other- The defendant or respondent has an affiliation to the facility
other than the owner, operator, generator, or transporter.

	A(11)	AffiliationDefendantRespondentFacility

Appendix A

gram

		Enforcement and Compliance

		Standard No.: EX00000-XX

		Version 2.2 – Draft

10/26/2005 	Working Draft – Well Identification Data Standard

		Enforcement and Compliance

		Std No.: EX000.1-XXX

		Version 2.2 - Draft

  DATE \@ "M/d/yyyy"  2/14/2008 		Page   PAGE  4 		Page   PAGE  4

11/7/2007		Page   PAGE  41

11/7/2007		Page   PAGE  42

Enforcement and Compliance

Data Standard

3.0 Enforcement Action General Information

3.1  Enforcement Action Date

3.2  Enforcement Action Identifier

3.3  Enforcement Action Name

3.4  Enforcement Agency Name

3.5  Enforcement Agency Type

3.6 Enforcement Agency Location

3.7 Federal Agency Location

3.8 State Statute Violated

3.9 Tribal Statute Violated

3.10 Local Statute Violated

3.11 Citation

3.12 Noncompliance or Corrective Action Description

3.13 Enforcement Action Type

2.0 Violation

2.1  Violation Determined Date

2.2  Violation Class Type

2.3  Compliance Schedule Indicator Code

2.4  Return to Compliance Schedule Date

2.5  Return to Compliance Actual Date

1.0 Compliance Monitoring Information

1.1   Compliance Monitoring Date

1.2   Compliance Monitoring Identifier

1.3   Compliance Monitoring Agency Name

1.4   Compliance Monitoring Agency Type

1.5   Compliance Monitoring Action Type

1.6   Compliance Inspection Type

1.7 Off-Site Record Review Type

1.8   Compliance Monitoring Media Type

1.9   Citizen Complaint Indicator Code

1.10 Compliance Monitoring Action Reason

1.11 Compliance Monitoring Action Priority Originator

1.12 Compliance Monitoring Priority

1.13 Compliance Monitoring Action Outcome

5.0 Enforcement Action Cash Penalty and Supplemental Environmental
Project (SEP) Information

5.1 Cash Civil Penalty Amount Sought

5.2 Cash Civil Penalty Amount Required

5.3 Stipulated Penalty Amount Required

5.4 SEPs Description

5.5 SEPs Value

5.6 SEPs Penalty Assessment Value

5.7 Total Civil Penalty Value

4.0 Additional Enforcement Action  Attribute

4.1 Enforcement Action Forum

4.2 Enforcement Action Status

4.3  Enforcement Action Status Date

4.4 Enforcement Action Resolution Type

6.0 Enforcement Action Cost Recovery and Collection Information

6.1 Cost Recovery Amount Sought

6.2 Cost Recovery Amount Required

6.3 Collection Amount Sought

6.4 Collection Amount Required

7.0 Enforcement Action Injunctive Relief Information

7.1 Injunctive Relief Sought Description

7.2 Injunctive Relief Required Description

7.3 Injunctive Relief Value

8.0 Enforcement Action Compliance Milestones information

8.1 Compliance Milestones Status

8.2 Compliance Milestones Status Determination Date

8.3 Compliance Milestones Violation Response Indicator

8.4 Compliance Milestones Completed Date

9.0 Defendant/Respondent Affiliation Information

9.1 Affiliation of Defendant/Respondent to Facility


[Federal Register: December 29, 2009 (Volume 74, Number 248)]
[Rules and Regulations]
[Page 68686-68689]
[DOCID:fr29de09-10]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-1067]
RIN 1625-AA00

Safety Zone; Atlantic Intracoastal Waterway, Oak Island, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of the Atlantic Intracoastal Waterway at Oak Island, North
Carolina. All vessels are prohibited from transiting the zone near the
second crossing to Oak Island, North Carolina except as specifically
authorized by the Captain of the Port or a designated representative.
The safety zone is necessary to provide for the safety of mariners on
navigable waters during the installation of bridge girders at the new
high-level fixed highway bridge at the

second crossing to Oak Island, North Carolina.

DATES: This rule is effective December 29, 2009 through 5:30 p.m.
January 11, 2010, and applicable for purposes of enforcement from 7:30
a.m. December 7, 2009 through 5:30 p.m. January 11, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-1067 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-1067 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the 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, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail CWO4 Stephen Lyons, Waterways Management
Division Chief, Coast Guard Sector North Carolina; telephone (252) 247-
4525, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because immediate action is needed to provide
for the safety of life and property on navigable waters.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to public interest because hazards associated with the
girder installation, including potential falling debris and the use of
heavy equipment and machinery in the waterway, could lead to severe
injury, fatalities and/or destruction of public property. Therefore,
immediate action is needed to ensure the public's safety from the
hazards noted above.

Background and Purpose

    The State of North Carolina Department of Transportation awarded a
contract to Lee Construction Company of the Carolinas, Inc. of
Charlotte, North Carolina, to perform bridge girder installation at the
new high-level fixed highway bridge at the second crossing to Oak
Island, North Carolina. The contract provides for the installation of
bridge girders. The center girder installation is scheduled to begin on
December 7, 2009 and will be completed by January 11, 2010. The
contractor will be utilizing a deck barge with a 55' beam, a 450 ton
ringer crane on a stationary barge with an 85' beam, and an assist tug
to conduct the girder installation. This operation presents a potential
hazard to mariners from falling debris and the use of heavy equipment
and machinery. To provide for the safety of the public, the Coast Guard
will temporarily restrict access to this section of the Atlantic
Intracoastal Waterway during girder installation, scheduled daily from
7:30 a.m. until 11:30 a.m.

Discussion of Rule

    The Coast Guard is establishing a temporary safety zone to
encompass the waters of the Atlantic Intracoastal Waterway extending
250 yards in all directions from the main construction site at the
second crossing to Oak Island, North Carolina, located at Atlantic
Intracoastal Waterway Mile 316.6 (33[deg]55.63 N, 078[deg]9.37 W, NAD
1983). All vessels are prohibited from transiting this section of the
waterway while the safety zone is in effect. Entry into the zone will
not be permitted except as specifically authorized by the Captain of
the Port or a designated representative. To seek permission to transit
the area, mariners can contact Sector North Carolina at telephone
number<PHONE_NUMBER>. This zone will be enforced daily from 7:30 a.m.
until 11:30 a.m. while girder installation is in progress from December
7, 2009 through January 11, 2010. Notification of the safety zone will
be provided to the public via broadcast notice to mariners.

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.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, 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.
    Although this regulation will restrict access to the area, the
effect of this rule will not be significant because: (i) The safety
zone will be in effect for a limited duration of time, (ii) the Coast
Guard will give advance notification via maritime advisories so
mariners can adjust their plans accordingly, and (iii) vessels may be
granted permission to transit the area by the Captain of the Port or a
designated representative.

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 rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: The owners or operators of tug and barge,
recreational, and fishing vessels intending to transit the specified
portion of the Atlantic Intracoastal Waterway from 7:30 a.m. December
7, 2009 through 5:30 p.m. January 11, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reason: This
rule will be enforced for only a limited time each day. Although the
safety zone will apply to the entire width of the Atlantic Intracoastal
Waterway, vessel traffic can use alternate waterways to transit safely
around the safety zone. Before the effective period, the Coast Guard
will issue maritime advisories widely available to the users of the
waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can

better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this 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 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 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This 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 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 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this 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 concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule establishes a temporary safety
zone to protect the public from bridge construction operations. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 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. 1226, 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 and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.T05-1067 to read as follows:

Sec.  165.T05-1067  Safety Zone; Atlantic Intracoastal Waterway, Oak
Island, NC.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector North Carolina. Designated
representative means any Coast Guard commissioned, warrant, or petty
officer who has been authorized to act on behalf of the Captain of the
Port.
    (b) Location. The following area is a safety zone: The waters of
the Atlantic Intracoastal Waterway extending 250 yards in all
directions from the main construction site at the new high-level fixed
highway bridge at the second crossing to Oak Island, North Carolina,
located at Atlantic Intracoastal Waterway Mile 316.6 (33[deg]55.63 N.,
078[deg]9.37 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 requiring 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, unless the Captain of the Port previously announced via
Marine Safety Radio Broadcast on VHF Marine Band Radio channel 22
(157.1 MHz) that this regulation will not be enforced in that portion
of the safety zone. The Captain of the Port 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 daily from
7:30 a.m. until 11:30 a.m. while girder installation is in progress
throughout the effective period from 7:30 a.m. December 7, 2009 through
5:30 p.m. January 11, 2010 unless cancelled earlier by the Captain of
the Port. The exact daily times will be announced in Broadcast Notice
to Mariners.

    Dated: December 7, 2009.
J.E. Ryan,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. E9-30718 Filed 12-28-09; 8:45 am]

BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95156-95157]
[FR Doc No: 2016-31245]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2016-0934]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0007

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information without
change: 1625-0007, Characteristics of Liquid Chemicals Proposed for
Bulk Water Movement. Our ICR describes the information we seek to
collect from the public. Before submitting this ICR to OIRA, the Coast
Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before February 27,
2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2016-0934] to the Coast Guard 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.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE., Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.

    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2016-0934], and
must be received by February 27, 2017.

Submitting Comments

    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. Documents mentioned in this notice, and all public
comments, are 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.
    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).

Information Collection Request

    Title: Characteristics of Liquid Chemicals Proposed for Bulk Water
Movement.
    OMB Control Number: 1625-0007.
    Summary: Chemical manufacturers submit chemical data to the Coast
Guard. The Coast Guard evaluates the information for hazardous
properties of the chemical to be shipped via tank vessel. A
determination is made as to the kind and degree of precaution which
must be taken to protect the vessel and its contents.
    Need: 46 CFR parts 30 to 40, 151, 153, and 154 govern the
transportation of hazardous materials. The chemical industry constantly
produces new materials that must be moved by water. Each of these new
materials has unique characteristics that require special attention to
their mode of shipment.
    Forms: N/A.
    Respondents: Manufacturers of chemicals.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated annual burden remains 600 hours
a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: December 18, 2016.
Thomas P. Michelli,
Chief Information Officer, U.S. Coast Guard.
[FR Doc. 2016-31245 Filed 12-23-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Proposed Rules]
[Pages 30509-30511]
[FR Doc No: 2014-12178]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket No. USCG-2014-0142]
RIN 1625-AA01

Anchorage Regulations: Special Anchorage Areas, Marina del Rey
Harbor, California

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to disestablish the special anchorage
area at the north end of the main channel in Marina del Rey Harbor,
California. Several marina expansion projects have encroached upon the
anchorage. Vessels rarely use the anchorage due to a high volume of
traffic moving through it as vessels transit in and out of the harbor.
This proposed action will remove the anchorage area from the
regulations. Vessels may anchor in the harbor during storms, stress, or
other emergency situations.

DATES: Comments and related material must be received by the Coast
Guard on or before June 27, 2014.

ADDRESSES: You may submit comments identified by docket number USCG-
2014-0142 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Lieutenant Junior Grade Zachary Bonheim, Waterways
Management Division, U.S. Coast Guard District 11, telephone (510) 437-
2978, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. 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.

1. Submitting Comments

    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. You may submit your comments and material online at
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, 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 email address, or a
telephone 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,
type the docket number USCG-2014-0142 in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ 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.

2. 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,
type the docket number USCG-2014-0142 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. 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.

3. Privacy Act

    Anyone can search the electronic form of 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).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting 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.

B. Regulatory History and Information

    33 CFR 110.111 establishes a special anchorage area in the main
channel of Marina del Rey Harbor. The anchorage has the following
described boundaries: Beginning at the most northeasterly corner in
position 33[deg]58'58'' N, 118[deg]26'46'' W; thence southerly to
33[deg]58'53'' N, 118[deg]26'46'' W; thence southeasterly to
33[deg]58'52'' N, 118[deg]26'45'' W; thence southerly to 33[deg]58'39''
N, 118[deg]26'45'' W; thence westerly to 33[deg]58'38'' N,
118[deg]26'55'' W; thence northerly to 33[deg]59'00'' N,
118[deg]26'55'' W; thence easterly to the point of beginning.
    The anchorage area is reserved for yachts and other recreational
craft and for all types of small craft during storm, stress, or other
emergency. Single and fore-and-aft moorings are allowed in the area as
permitted by the director of the Department of Small Craft Harbors, Los
Angeles County.

C. Basis and Purpose

    The legal basis for this 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.
    The purpose of this proposed rule is to align the regulations with
the current and future configuration of the main channel and docking
facilities in Marina del Rey Harbor. Since this special anchorage area
was established, several projects have expanded docking facilities at
the north end of the channel. These docks now encroach on the anchorage
area, and future projects are planned to continue this expansion. It
has become necessary to either redefine the boundaries of the
anchorage, or remove it from the regulations.
    Vessel and facility operators in the harbor have given feedback
that the anchorage is very rarely used. Since the anchorage is in the
center of the main channel, a high volume of recreational vessel
traffic transits through the area on a consistent basis, making it both
impractical and unsafe for vessels to anchor there.
    Due to its limited use, the Coast Guard proposes to disestablish
the anchorage. This action will also reduce the regulatory burden on
the public by eliminating an unnescessary section from the CFR.

D. Discussion of Proposed Rule

    The Coast Guard is proposing to disestablish the special anchorage
area at the north end of the main channel in Marina del Rey Harbor,
California in 33 CFR 110.111. This action will remove 33 CFR 110.111
and reserve it for future use. The anchorage area will be removed from
all charts, publications and other navigational references. This
proposed rule will not prevent vessels from anchoring in the harbor
during storms, stress, or other emergency situations.

E. 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 or executive orders.

1. Regulatory Planning and Review

    This proposed 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, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. We anticipate that this
proposed rule will not have a significant impact on vessel owners and
operators, as it removes an obsolete anchorage area that is very rarely
used.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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 will not have a significant economic impact on a
substantial number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: The owners or operators of recreational
vessels intending to anchor in the affected area.
    The disestablishment of this anchorage would not have a significant
economic impact on a substantial number of small entitities for the
following reasons: Due to the high volume of vessel traffic transiting
through Marina del Rey's main channel, it is both impractical and
unsafe to utilize this anchorage. For this reason, very few
recreational vessels and other small craft anchor in the area. Vessels
will not be prevented from anchoring in the harbor during storms,
stress, or other emergency situations.
    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.

3. 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 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, above. 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.

4. Collection of Information

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

5. Federalism

    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
determined that this rule does not have implications for federalism.

6. 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.

7. 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.

8. Taking of Private Property

    This proposed rule would 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.

9. 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.

10. Protection of Children From Environmental Health Risks

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

11. Indian Tribal Governments

    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.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. 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. This proposed rule
involves disestablishing the special anchorage area at the north end of
the main channel in Marina del Rey Harbor, California. The anchorage is
rarely used and has been encroached upon by several docking facilities.
This rule is categorically excluded from further review under paragraph
34(f) of Figure 2-1 of the Commandant Instruction. A preliminary
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. 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 110.111 as follows:

PART 110--ANCHORAGE REGULATIONS

0
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.

Sec.  110.111  [Removed and Reserved]

0
2. Remove and reserve Sec.  110.111.

    Dated: April 30, 2014.
K.L. Schultz,
Rear Admiral, U.S. Coast Guard, Commander, Eleventh Coast Guard
District.
[FR Doc. 2014-12178 Filed 5-27-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Notices]
[Page 12954]
[FR Doc No: 2018-06041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0998]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by April
25, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0409.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring

OMB Control Number 0910-0409--Extension

    This information collection supports FDA regulations found in part
315 (21 CFR part 315). These regulations require manufacturers of
diagnostic radiopharmaceuticals to submit information that demonstrates
the safety and effectiveness of a new diagnostic radiopharmaceutical or
of a new indication for use of an approved diagnostic
radiopharmaceutical. The regulations also describe the types of
indications for diagnostic radiopharmaceuticals and some of the
criteria the Agency uses to evaluate the safety and effectiveness of a
diagnostic radiopharmaceutical under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) (FD&C Act) and section 351 of
the Public Health Service Act (42 U.S.C. 262) (the PHS Act).
Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables FDA to properly evaluate the safety and
effectiveness profiles of a new diagnostic radiopharmaceutical or a new
indication for use of an approved diagnostic radiopharmaceutical.
    The regulations clarify existing FDA requirements for approval and
evaluation of drug and biological products already in place under the
authorities of the FD&C Act and the PHS Act. The information, which is
usually submitted as part of a new drug application or biologics
license application or as a supplement to an approved application,
typically includes, but is not limited to, nonclinical and clinical
data on the pharmacology, toxicology, adverse events, radiation safety
assessments, and chemistry, manufacturing, and controls. The content
and format of an application for approval of a new drug are set forth
in Sec.  314.50 (21 CFR 314.50), and approved under OMB control number
0910-0001. This information collection supports part 315, currently
approved under OMB control number 0910-0409.
    Based on past submissions (human drug applications and/or new
indication supplements for diagnostic radiopharmaceuticals), we
estimate two submissions will be received annually. We estimate the
time needed to prepare a complete application for a diagnostic
radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth
of which, or 2,000 hours, is estimated to be spent preparing the
portions of the application that would be affected by these
regulations. The regulations do not impose any additional reporting
burden for safety and effectiveness information on diagnostic
radiopharmaceuticals beyond the estimated burden of 2,000 hours because
safety and effectiveness information is already required by Sec.
[thinsp]314.50 (collection of information approved under OMB control
number 0910-0001). In fact, clarification in these regulations of FDA's
criteria for evaluation of diagnostic radiopharmaceuticals is intended
to streamline overall information collection burdens, particularly for
diagnostic radiopharmaceuticals that may have well-established, low-
risk safety profiles, by enabling manufacturers to tailor information
submissions and avoid unnecessary clinical studies.
    In the Federal Register of November 2, 2017 (82 FR 50885), we
published a notice requesting public comment on the proposed
information collection. No comments were received. We therefore retain
the following estimated burden for the information collection.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Diagnostic Radiopharmaceuticals                2               1               2           2,000           4,000
 Sec.  Sec.   315.4, 315.5, and
 315.6..........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 contains estimates of the annual reporting burden for the
preparation of the safety and effectiveness sections of an application
that are imposed by the applicable regulations. This estimate does not
include time needed to conduct studies and clinical trials or other
research from which the reported information is obtained.
    The burden estimate has not changed since prior OMB approval.

    Dated: March 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06041 Filed 3-23-18; 8:45 am]
 BILLING CODE 4164-01-P