[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57057-57058]
[FR Doc No: 2011-23490]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0164]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Guidance for Industry on Studies To Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative
Metabolism Studies in Laboratory Animals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (206) entitled
``Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals'' (VICH GL47).
This guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This VICH
guidance document is intended to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary drugs produced by laboratory animals used for toxicological
testing for the purpose of comparison to the residues of veterinary
drugs in edible tissues of food-producing animals.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
(206) entitled ``Guidance for Industry on Studies to Evaluate
the Metabolism and Residue Kinetics of Veterinary Drugs in Food-
Producing Animals: Comparative Metabolism Studies in Laboratory
Animals'' (VICH GL47). In recent years, many important initiatives have
been undertaken by regulatory authorities and industry associations to
promote the international harmonization of regulatory requirements. FDA
has participated in efforts to enhance harmonization and has expressed
its commitment to seek scientifically based harmonized technical
procedures for the development of pharmaceutical products. One of the
goals of harmonization is to identify and then reduce differences in
technical requirements for drug development among regulatory agencies
in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
VICH is concerned with developing harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and includes input from both regulatory
and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal
Health Institute, the Japanese Veterinary Pharmaceutical Association,
the Japanese Association of Veterinary Biologics, and the Japanese
Ministry of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of

Canada, and one representative from the industry of Canada. The VICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation for Animal Health (IFAH). An
IFAH representative also participates in the VICH Steering Committee
meetings.

 II. Guidance on Comparative Metabolism Studies in Laboratory Animals

    In the Federal Register of April 12, 2010 (75 FR 18507), FDA
published a notice of availability for a draft guidance entitled
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals (VICH GL47),''
which gave interested persons until May 12, 2010, to comment on the
draft guidance. FDA received a few comments on the draft guidance and
those comments as well as those received by other VICH member
regulatory agencies were considered as the guidance was finalized. At a
meeting held in February 2011, the VICH Steering Committee endorsed the
final guidance for industry (VICH GL47). The guidance announced in this
notice finalizes the draft guidance dated April 12, 2010.
    This VICH guidance document is one of a series developed to
facilitate the mutual acceptance by national/regional regulators of
residue chemistry data for veterinary drugs used in food-producing
animals. This guidance was prepared after consideration of the current
national/regional requirements and recommendations for evaluating
veterinary drug residues in the European Union, Japan, the United
States, Australia, New Zealand, and Canada.
    The objective of this guidance is to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary drugs produced by laboratory animals. The purpose of the
comparative metabolism studies is to compare the metabolites of the
animals used for toxicological testing to the residues of the
veterinary drugs in edible tissues of food-producing animals in order
to determine if the laboratory animals used for toxicological testing
have been exposed to the metabolites that humans can be exposed to as
residues in products of food-producing animal origin.
    The human food safety evaluation of veterinary drug residues helps
ensure that food derived from treated food-producing animals is safe
for human consumption. As part of the data collection process, studies
should be conducted to characterize the metabolites to which laboratory
animals are auto-exposed during the toxicological testing of the
veterinary drug. The purpose of these studies is to determine whether
the metabolites that people will consume from tissues of target food-
producing animals are also produced by metabolism in the laboratory
animals used for the safety testing.

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised
to conform to FDA's good guidance practices regulation (21 CFR 10.115).
For example, the document has been designated ``guidance'' rather than
``guideline.'' In addition, guidance documents must not include
mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    This guidance represents the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB control number 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23490 Filed 9-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 23, 2009 (Volume 74, Number 245)]
[Rules and Regulations]
[Page 68150-68155]
[DOCID:fr23de09-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 27

[Docket No. USCG-2009-0891]
RIN 1625-AB40

Federal Civil Penalties Inflation Adjustment Act--2009
Implementation

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is adjusting fines and other civil monetary
penalties to reflect the impact of inflation. These adjustments are
made in accordance with the Federal Civil Penalties Inflation
Adjustment Act of 1990, as amended by the Debt Collection Improvement
Act of 1996.

DATES: This final rule is effective 30 days after December 23, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2009-0891 and are 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. You may also find this
docket on the Internet by going to http://www.regulations.gov,
inserting USCG-2009-0891 in the ``Keyword'' box, and then clicking
``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Heather Young, CG-5232, Coast Guard; telephone 202-372-
1022, 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:

Table of Contents for Preamble

I. Abbreviations
II. Background
III. Method of Calculation
IV. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Abbreviations

------------------------------------------------------------------------
           Abbreviation                          Explanation
------------------------------------------------------------------------
CFR...............................  Code of Federal Regulations.
CMPs..............................  Civil Monetary Penalties.
CPI-U.............................  Consumer Price Index for All Urban
                                     Consumers, Not Seasonally Adjusted,
                                     U.S. City Average.
RFA...............................  Regulatory Flexibility Act.
U.S.C.............................  United States Code.
------------------------------------------------------------------------

II. Background

    Congress has established fines or other civil monetary penalties
(CMPs) for those who violate Federal laws and regulations. However, the
deterrent value of these fines and penalties diminishes over time from
the effects of inflation. To address this problem, Congress enacted the
Federal Civil Penalties Inflation Adjustment Act, Public Law 101-410,
104 Stat. 890, Sec. Sec.  1-6, as amended by the Debt Collection
Improvement Act of 1996, Public Law 104-134, 110 Stat. 1321, Sec.
31001(s)(1); 28 U.S.C. 2461. These statutes require Federal agencies to
adjust their CMPs for inflation at least once every four years, using a
nondiscretionary statutory formula, thus making further direct
involvement by Congress unnecessary.
    This final rule is published without a prior notice of proposed
rulemaking or public comment period. Pursuant to the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good
cause exists for dispensing with notice and comment in this rulemaking.
This rulemaking implements the Federal Civil Penalties Inflation
Adjustment Act of 1990, as amended by the Debt Collection Improvement
Act of 1996. These statutes require certain actions with respect to
adjusting CMPs for inflation and do not allow for discretion in
implementation, so that prior notice and comment is unnecessary and
contrary to the public interest.

III. Method of Calculation

    The method for calculating the effects of inflation on fines and
penalties is very specifically prescribed by statutes, which allow no
discretion. The statutes specify the inflation measure to be used, the
method for the calculation of the inflation adjustment, and the method
for the numerical rounding of the results.
    The statutes require the use of the change in the Consumer Price
Index for All Urban Consumers (CPI-U) as the inflation measure for
these calculations. The CPI-U is calculated and published by the U.S.
Department of Labor, Bureau of Labor Statistics, and uses the period of
1982 to 1984 as the base level where the CPI-U = 100.
    The inflation adjustment prescribed by the statutes is calculated
as the difference between the CPI-U for the month of June of the
calendar year preceding the adjustment and the CPI-U for the month of
June of the calendar year in which the amount of the civil monetary
penalty was last set or adjusted pursuant to law. Since the last
inflation adjustment was made in 2003 and the year preceding this
adjustment is 2008, the current inflation adjustment equals the
increase in the CPI-U (not seasonally adjusted) from June, 2003 to
June, 2008:

(CPI-U2008 - CPI-U2003) / CPI-U2003 =
(218.815 - 183.7) / (183.7) = .1912 = 19.12%

    With certain exceptions, each of the approximately 140 civil fines
and penalties were adjusted by multiplying their 2003 values by 1.1912.
The exceptions included: Two penalties of 19 U.S.C. 1581(d) that were
enacted under the Tariff Act of 1930 and are exempt from inflation
adjustments; four penalties applicable to bridge owners whose increases
are defined within their respective statutes; and three penalties
established in 2006 which are not eligible for inflation adjustment
until 2010.
    The final step is to round the inflation-adjusted fines and
penalties according to the rounding rules prescribed by the statutes.
The statutes specify that numbers are rounded according to the nearest:
    1. Multiple of $10 in the case of penalties less than or equal to
$100;
    2. Multiple of $100 in the case of penalties greater than $100 but
less than or equal to $1,000;
    3. Multiple of $1,000 in the case of penalties greater than $1,000
but less than or equal to $10,000;
    4. Multiple of $5,000 in the case of penalties greater than $10,000
but less than or equal to $100,000;
    5. Multiple of $10,000 in the case of penalties greater than
$100,000 but less than or equal to $200,000; and
    6. Multiple of $25,000 in the case of penalties greater than
$200,000.
    Because of the rounding rules, some fines and penalties may not
increase from their 2003 values. For example, a fine of $1,000 in 2003
would increase to $1,191.20 with the 2008 adjustment. However, for
fines and penalties greater than $1,000 but less than or equal to
$10,000, the inflation adjusted value is rounded to the nearest $1,000;
so the penalty, with rounding, remains at $1,000.

IV. 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.

A. 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.
    We expect the economic impact of this rule to be so minimal that a
full regulatory assessment is unnecessary. This rule concerns civil
monetary penalties imposed for violating Federal law and regulations
which have no impact on law-abiding persons. While the expense of a
fine or penalty imposed for violations of civil statutes is borne by
the violator, these expenses are completely avoidable by complying with
the law.

B. Small Entities

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires
agencies to consider whether regulatory actions 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. An RFA analysis is not required when a
rule is exempt from notice and comment rulemaking under 5 U.S.C.
553(b). The Coast Guard determined that this rule is exempt from notice
and comment rulemaking pursuant to 5 U.S.C. 553(b)(B). Therefore, an
RFA analysis is not required for this rule. The Coast Guard,
nonetheless, expects that this final rule will not have a significant
economic impact on a substantial number of small entities.

C. 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.

D. 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).

E. 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.

F. 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. This rule affects only those who
violate Federal law or regulations, and involves no discretion on the
part of the Coast Guard.

G. 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.

H. 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.

I. 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.

J. 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.

K. 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.

L. Technical Standards

    The National Technology Transfer and Advancement Act (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.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

M. 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 (42 U.S.C. 4321-4370f), and have concluded 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
rule is categorically excluded under section 2.B.2, figure 2-1,
paragraph (34)(a) of the Instruction. This rule involves regulations
which are editorial or procedural, such as those updating addresses or
establishing application procedures. 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 27

    Administrative practice and procedure, Penalties.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 27 as follows:

PART 27--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

0
1. The the authority citation for part 27 continues to read:

    Authority: Secs. 16, Public Law 101410, 104 Stat. 890, as
amended by Sec. 31001(s)(1), Public Law 104134, 110 Stat. 1321 (28
U.S.C. 2461 note); Department of Homeland Security Delegation No.
0170.1, sec. 2 (106).

0
2. Revise Sec.  27.3 to read as follows:

Sec.  27.3  Penalty Adjustment Table.

    Table 1 identifies the statutes administered by the Coast Guard
that authorize a civil monetary penalty. The ``adjusted maximum
penalty'' is the maximum penalty authorized by the Federal Civil
Penalties Inflation Adjustment Act of 1990, as amended, as determined
by the Coast Guard.

                              Table 1--Civil Monetary Penalty Inflation Adjustments
----------------------------------------------------------------------------------------------------------------
                                                                                Adjusted
                                                                                maximum
                     U.S. Code citation                       Civil monetary penalty description  penalty amount
                                                                                ($)
----------------------------------------------------------------------------------------------------------------
14 U.S.C. 88(c).............................................  Saving Life and Property..........          $8,000
14 U.S.C. 645(i)............................................  Confidentiality of Medical Quality           4,000
                                                               Assurance Records (first offense).
14 U.S.C. 645(i)............................................  Confidentiality of Medical Quality          30,000
                                                               Assurance Records (subsequent
                                                               offenses).
16 U.S.C. 4711(g)(1)........................................  Aquatic Nuisance Species in Waters          35,000
                                                               of the United States.
19 U.S.C. 70................................................  Obstruction of Revenue Officers by           3,000
                                                               Masters of Vessels.
19 U.S.C. 70................................................  Obstruction of Revenue Officers by             700
                                                               Masters of Vessels--Minimum
                                                               Penalty.
19 U.S.C. 1581(d)...........................................  Failure to Stop Vessel When                  5,000
                                                               Directed; Master, Owner,
                                                               Operator, or Person in Charge (1).
19 U.S.C. 1581(d)...........................................  Failure to Stop Vessel When                  1,000
                                                               Directed; Master, Owner,
                                                               Operator, or Person in Charge--
                                                               Minimum Penalty (1).
33 U.S.C. 471...............................................  Anchorage Ground/Harbor                        110
                                                               Regulations General.
33 U.S.C. 474...............................................  Anchorage Ground/Harbor                        300
                                                               Regulations St. Mary's River.
33 U.S.C. 495(b)............................................  Bridges/Failure to Comply with              25,000
                                                               Regulations (2).
33 U.S.C. 499(c)............................................  Bridges/Drawbridges (2)...........          25,000
33 U.S.C. 502(c)............................................  Bridges/Failure to Alter Bridge             25,000
                                                               Obstructing Navigation (2).
33 U.S.C. 533(b)............................................  Bridges/Maintenance and Operation           25,000
                                                               (2).
33 U.S.C. 1208(a)...........................................  Bridge to Bridge Communication;                800
                                                               Master, Person in Charge, or
                                                               Pilot.
33 U.S.C. 1208(b)...........................................  Bridge to Bridge Communication;                800
                                                               Vessel.
33 U.S.C. 1232(a)...........................................  PWSA Regulations..................          40,000
33 U.S.C. 1236(b)...........................................  Vessel Navigation: Regattas or               8,000
                                                               Marine Parades; Unlicensed Person
                                                               in Charge.
33 U.S.C. 1236(c)...........................................  Vessel Navigation: Regattas or               8,000
                                                               Marine Parades; Owner Onboard
                                                               Vessel.
33 U.S.C. 1236(d)...........................................  Vessel Navigation: Regattas or               3,000
                                                               Marine Parades; Other Persons.
33 U.S.C. 1319..............................................  Pollution Prevention..............          40,000
33 U.S.C. 1319(2)(A)........................................  Pollution Prevention (per                   15,000
                                                               violation).
33 U.S.C. 1319(2)(A)........................................  Pollution Prevention (Maximum--             40,000
                                                               repeated violations).
33 U.S.C. 1319(2)(B)........................................  Pollution Prevention (per day of            15,000
                                                               violation).
33 U.S.C. 1319(2)(B)........................................  Pollution Prevention (Maximum--            190,000
                                                               repeated violations).
33 U.S.C. 1321(b)(6)(B)(i)..................................  Oil/Hazardous Substances:                   15,000
                                                               Discharges (Class I per
                                                               violation).
33 U.S.C. 1321(b)(6)(B)(i)..................................  Oil/Hazardous Substances:                   40,000
                                                               Discharges (Class I total under
                                                               paragraph).
33 U.S.C. 1321(b)(6)(B)(ii).................................  Oil/Hazardous Substances:                   15,000
                                                               Discharges (Class II per day of
                                                               violation).
33 U.S.C. 1321(b)(6)(B)(ii).................................  Oil/Hazardous Substances:                  190,000
                                                               Discharges (Class II total under
                                                               paragraph).
33 U.S.C. 1321(b)(7)(A).....................................  Oil/Hazardous Substances:                   40,000
                                                               Discharges (per day of violation)
                                                               Judicial Assessment.
33 U.S.C. 1321(b)(7)(A).....................................  Oil/Hazardous Substances:                    1,100
                                                               Discharges (per barrel of oil or
                                                               unit discharged) Judicial
                                                               Assessment (3).

33 U.S.C. 1321(b)(7)(B).....................................  Oil/Hazardous Substances: Failure           40,000
                                                               to Carry Out Removal/Comply With
                                                               Order (Judicial Assessment).
33 U.S.C. 1321(b)(7)(C).....................................  Oil/Hazardous Substances: Failure           40,000
                                                               to Comply with Regulation Issued
                                                               Under 1321(j) (Judicial
                                                               Assessment).
33 U.S.C. 1321(b)(7)(D).....................................  Oil/Hazardous Substances:                    4,000
                                                               Discharges, Gross Negligence (per
                                                               barrel of oil or unit discharged)
                                                               Judicial Assessment.
33 U.S.C. 1321(b)(7)(D).....................................  Oil/Hazardous Substances:                  130,000
                                                               Discharges, Gross Negligence--
                                                               Minimum Penalty (Judicial
                                                               Assessment).
33 U.S.C. 1322(j)...........................................  Marine Sanitation Devices;                   3,000
                                                               Operating.
33 U.S.C. 1322(j)...........................................  Marine Sanitation Devices; Sale or           8,000
                                                               Manufacture.
33 U.S.C. 1608(a)...........................................  International Navigation Rules;              8,000
                                                               Operator.
33 U.S.C. 1608(b)...........................................  International Navigation Rules;              8,000
                                                               Vessel.
33 U.S.C. 1908(b)(1)........................................  Pollution from Ships; General.....          40,000
33 U.S.C. 1908(b)(2)........................................  Pollution from Ships; False                  8,000
                                                               Statement.
33 U.S.C. 2072(a)...........................................  Inland Navigation Rules; Operator.           8,000
33 U.S.C. 2072(b)...........................................  Inland Navigation Rules; Vessel...           8,000
33 U.S.C. 2609(a)...........................................  Shore Protection; General.........          40,000
33 U.S.C. 2609(b)...........................................  Shore Protection; Operating                 15,000
                                                               Without Permit.
33 U.S.C. 2716a(a)..........................................  Oil Pollution Liability and                 40,000
                                                               Compensation.
42 U.S.C. 9609(a)...........................................  Hazardous Substances, Releases,             35,000
                                                               Liability, Compensation (Class I).
42 U.S.C. 9609(b)...........................................  Hazardous Substances, Releases,             35,000
                                                               Liability, Compensation (Class
                                                               II).
42 U.S.C. 9609(b)...........................................  Hazardous Substances, Releases,            100,000
                                                               Liability, Compensation (Class II
                                                               subsequent offense).
42 U.S.C. 9609(c)...........................................  Hazardous Substances, Releases,             35,000
                                                               Liability, Compensation (Judicial
                                                               Assessment).
42 U.S.C. 9609(c)...........................................  Hazardous Substances, Releases,            100,000
                                                               Liability, Compensation (Judicial
                                                               Assessment subsequent offense).
46 U.S.C. App 1505(a)(2)....................................  Safe Containers for International            8,000
                                                               Cargo.
46 U.S.C. App 1712(a).......................................  International Ocean Commerce                 6,000
                                                               Transportation--Common Carrier
                                                               Agreements per violation.
46 U.S.C. App 1712(a).......................................  International Ocean Commerce                30,000
                                                               Transportation--Common Carrier
                                                               Agreements per violation--Willful
                                                               violation.
46 U.S.C. App 1712(b).......................................  International Ocean Commerce                60,000
                                                               Transportation--Common Carrier
                                                               Agreements--Fine for tariff
                                                               violation (per shipment).
46 U.S.C. App 1805(c)(2)....................................  Suspension of Passenger Service...          70,000
46 U.S.C. 2110(e)...........................................  Vessel Inspection or Examination             8,000
                                                               Fees.
46 U.S.C. 2115..............................................  Alcohol and Dangerous Drug Testing           7,000
46 U.S.C. 2302(a)...........................................  Negligent Operations: Recreational           6,000
                                                               Vessels.
46 U.S.C. 2302(a)...........................................  Negligent Operations: Other                 30,000
                                                               Vessels.
46 U.S.C. 2302(c)(1)........................................  Operating a Vessel While Under the           7,000
                                                               Influence of Alcohol or a
                                                               Dangerous Drug.
46 U.S.C. 2306(a)(4)........................................  Vessel Reporting Requirements:               8,000
                                                               Owner, Charterer, Managing
                                                               Operator, or Agent.
46 U.S.C. 2306(b)(2)........................................  Vessel Reporting Requirements:               1,100
                                                               Master (3).
46 U.S.C. 3102(c)(1)........................................  Immersion Suits...................           8,000
46 U.S.C. 3302(i)(5)........................................  Inspection Permit (3).............           1,100
46 U.S.C. 3318(a)...........................................  Vessel Inspection; General........           8,000
46 U.S.C. 3318(g)...........................................  Vessel Inspection; Nautical School           8,000
                                                               Vessel.
46 U.S.C. 3318(h)...........................................  Vessel Inspection; Failure to Give           1,100
                                                               Notice IAW 3304(b) (3).
46 U.S.C. 3318(i)...........................................  Vessel Inspection; Failure to Give           1,100
                                                               Notice IAW 3309(c) (3).
46 U.S.C. 3318(j)(1)........................................  Vessel Inspection; Vessel >= 1600           15,000
                                                               Gross Tons.
46 U.S.C. 3318(j)(1)........................................  Vessel Inspection; Vessel < 1600             3,000
                                                               Gross Tons.
46 U.S.C. 3318(k)...........................................  Vessel Inspection; Failure to               15,000
                                                               Comply with 3311(b).
46 U.S.C. 3318(l)...........................................  Vessel Inspection; Violation of              8,000
                                                               3318(b)-3318(f).
46 U.S.C. 3502(e)...........................................  List/count of Passengers..........             110
46 U.S.C. 3504(c)...........................................  Notification to Passengers........          15,000
46 U.S.C. 3504(c)...........................................  Notification to Passengers; Sale               800
                                                               of Tickets.
46 U.S.C. 3506..............................................  Copies of Laws on Passenger                    300
                                                               Vessels; Master.
46 U.S.C. 3718(a)(1)........................................  Liquid Bulk/Dangerous Cargo.......          40,000
46 U.S.C. 4106..............................................  Uninspected Vessels...............           8,000
46 U.S.C. 4311(b)(1)........................................  Recreational Vessels (maximum for          300,000
                                                               related series of violations).
46 U.S.C. 4311(b)(1)........................................  Recreational Vessels; Violation of           6,000
                                                               4307(a).
46 U.S.C. 4311(c)...........................................  Recreational vessels (3)..........           1,100
46 U.S.C. 4507..............................................  Uninspected Commercial Fishing               8,000
                                                               Industry Vessels.
46 U.S.C. 4703..............................................  Abandonment of Barges (3).........           1,100
46 U.S.C. 5116(a)...........................................  Load Lines........................           8,000
46 U.S.C. 5116(b)...........................................  Load Lines; Violation of 5112(a)..          15,000
46 U.S.C. 5116(c)...........................................  Load Lines; Violation of 5112(b)..           8,000
46 U.S.C. 6103(a)...........................................  Reporting Marine Casualties.......          35,000
46 U.S.C. 6103(b)...........................................  Reporting Marine Casualties;                 8,000
                                                               Violation of 6104.
46 U.S.C. 8101(e)...........................................  Manning of Inspected Vessels;                1,100
                                                               Failure to Report Deficiency in
                                                               Vessel Complement (3).
46 U.S.C. 8101(f)...........................................  Manning of Inspected Vessels......          15,000
46 U.S.C. 8101(g)...........................................  Manning of Inspected Vessels;               15,000
                                                               Employing or Serving in Capacity
                                                               not Licensed by USCG.
46 U.S.C. 8101(h)...........................................  Manning of Inspected Vessels;                1,100
                                                               Freight Vessel < 100 GT, Small
                                                               Passenger Vessel, or Sailing
                                                               School Vessel (3).

46 U.S.C. 8102(a)...........................................  Watchmen on Passenger Vessels (3).           1,100
46 U.S.C. 8103(f)...........................................  Citizenship Requirements..........             800
46 U.S.C. 8104(i)...........................................  Watches on Vessels; Violation of            15,000
                                                               8104(a) or (b).
46 U.S.C. 8104(j)...........................................  Watches on Vessels; Violation of            15,000
                                                               8104(c), (d), (e), or (h).
46 U.S.C. 8302(e)...........................................  Staff Department on Vessels.......             110
46 U.S.C. 8304(d)...........................................  Officer's Competency Certificates.             110
46 U.S.C. 8502(e)...........................................  Coastwise Pilotage; Owner,                  15,000
                                                               Charterer, Managing Operator,
                                                               Agent, Master, or Individual in
                                                               Charge.
46 U.S.C. 8502(f)...........................................  Coastwise Pilotage; Individual....          15,000
46 U.S.C. 8503..............................................  Federal Pilots....................          40,000
46 U.S.C. 8701(d)...........................................  Merchant Mariners Documents.......             800
46 U.S.C. 8702(e)...........................................  Crew Requirements.................          15,000
46 U.S.C. 8906..............................................  Small Vessel Manning..............          35,000
46 U.S.C. 9308(a)...........................................  Pilotage: Great Lakes; Owner,               15,000
                                                               Charterer, Managing Operator,
                                                               Agent, Master, or Individual in
                                                               Charge.
46 U.S.C. 9308(b)...........................................  Pilotage: Great Lakes; Individual.          15,000
46 U.S.C. 9308(c)...........................................  Pilotage: Great Lakes; Violation            15,000
                                                               of 9303.
46 U.S.C. 10104(b)..........................................  Failure to Report Sexual Offense..           8,000
46 U.S.C. 10314(a)(2).......................................  Pay Advances to Seamen............             800
46 U.S.C. 10314(b)..........................................  Pay Advances to Seamen;                        800
                                                               Remuneration for Employment.
46 U.S.C. 10315(c)..........................................  Allotment to Seamen...............             800
46 U.S.C. 10321.............................................  Seamen Protection; General........           7,000
46 U.S.C. 10505(a)(2).......................................  Coastwise Voyages: Advances.......           7,000
46 U.S.C. 10505(b)..........................................  Coastwise Voyages: Advances;                 7,000
                                                               Remuneration for Employment.
46 U.S.C. 10508(b)..........................................  Coastwise Voyages: Seamen                    7,000
                                                               Protection; General.
46 U.S.C. 10711.............................................  Effects of Deceased Seamen........             300
46 U.S.C. 10902(a)(2).......................................  Complaints of Unfitness...........             800
46 U.S.C. 10903(d)..........................................  Proceedings on Examination of                  110
                                                               Vessel.
46 U.S.C. 10907(b)..........................................  Permission to Make Complaint......             800
46 U.S.C. 11101(f)..........................................  Accommodations for Seamen.........             800
46 U.S.C. 11102(b)..........................................  Medicine Chests on Vessels........             800
46 U.S.C. 11104(b)..........................................  Destitute Seamen..................             110
46 U.S.C. 11105(c)..........................................  Wages on Discharge................             800
46 U.S.C. 11303(a)..........................................  Log Books; Master Failing to                   300
                                                               Maintain.
46 U.S.C. 11303(b)..........................................  Log Books; Master Failing to Make              300
                                                               Entry.
46 U.S.C. 11303(c)..........................................  Log Books; Late Entry.............             200
46 U.S.C. 11506.............................................  Carrying of Sheath Knives.........              80
46 U.S.C. 12151(a)..........................................  Documentation of Vessels                    15,000
                                                               (violation per day) (4).
46 U.S.C. 12151(c)..........................................  Engaging in Fishing After                  130,000
                                                               Falsifying Eligibility (fine per
                                                               day) (4).
46 U.S.C. 12309(a)..........................................  Numbering of Undocumented Vessels--          6,000
                                                               Willful violation.
46 U.S.C. 12309(b)..........................................  Numbering of Undocumented Vessels            1,100
                                                               (3).
46 U.S.C. 12507(b)..........................................  Vessel Identification System......          15,000
46 U.S.C. 14701.............................................  Measurement of Vessels............          30,000
46 U.S.C. 14702.............................................  Measurement; False Statements.....          30,000
46 U.S.C. 31309.............................................  Commercial Instruments and                  15,000
                                                               Maritime Liens (3).
46 U.S.C. 31330(a)(2).......................................  Commercial Instruments and                  15,000
                                                               Maritime Liens; Mortgagor.
46 U.S.C. 31330(b)(2).......................................  Commercial Instruments and                  35,000
                                                               Maritime Liens; Violation of
                                                               31329.
46 U.S.C. 70119.............................................  Port Security.....................          30,000
46 U.S.C. 70119(b)..........................................  Port Security--Continuing                   50,000
                                                               Violations (4).
49 U.S.C. 5123(a)(1)........................................  Hazardous Materials: Related to             60,000
                                                               Vessels--Maximum Penalty.
49 U.S.C. 5123(a)(1)........................................  Hazardous Materials: Related to                300
                                                               Vessels--Minimum Penalty.
49 U.S.C. 5123(a)(2)........................................  Hazardous Materials: Related to            110,000
                                                               Vessels--Penalty from Fatalities,
                                                               Serious Injuries/Illness or
                                                               Substantial Damage to Property
                                                               (5).
----------------------------------------------------------------------------------------------------------------
(1) Enacted under the Tariff Act of 1930, exempt from inflation adjustments.
(2) These penalties increased in accordance with the statute to: $10,000 in 2005, $15,000 in 2006, $20,000 in
  2007, and $25,000 in 2008 and thereafter.
(3) These penalties did not qualify for an adjustment under the rounding rules of the Act.
(4) These penalties were enacted in 2006 and did not qualify for an adjustment.
(5) These penalties were enacted or amended in 2005 were rounded based on the CPI change from 2005 to 2008.

    Dated: December 10, 2009.
K.S. Cook,
Rear Admiral, Director of Prevention Policy, U.S. Coast Guard.
[FR Doc. E9-30493 Filed 12-22-09; 8:45 am]

BILLING CODE 9110-04-P


                      EPA/HQ Summary  -  Meeting with CVS

Attendees

CVS:		 	Nicole Wilkinson, Liz Ash

Troutman Sanders:	Greg Blount

EPA/HQ: 	Jessica Young, Kristin Fitzgerald, Narendra Chaudhari, Tiffany Kollar, Brian Knieser, Laura Stanley

Date:			January 23, 2018, afternoon

Location:  		EPA/HQ

Summary

EPA HQ met with representatives of CVS and their outside counsel to discuss the Hazardous Waste Pharmaceuticals Proposed Rule.

CVS told EPA that they had met with the Office of Management and Budget (OMB) in December 2017.

CVS noted that they manage pharmaceuticals as hazardous waste starting at the store when they are damaged or leaking, dropped on the floor


                                Opening Remarks                                                      Public Hearing on Maryland State Implementation Plan  For 2011 Base Year Emissions Inventory for the Maryland Portion of the Philadelphia-Wilmington-Atlantic City, PA-NJ-DE-MD Ozone NAAQS Nonattainment Area

                            Date: November 18, 2016                                        	                        Timothy Wallace, Hearing Officer                                                             Maryland Department of the Environment

If the court reporter would turn on the equipment, we will begin. Good Afternoon.

On behalf of the Maryland Department of the Environment, Air and Radiation

Management Administration, I would like to welcome everyone present to this

public hearing. This public hearing is being held pursuant to federal law found at

42 U. S. C. § 7410(a) and 40 CFR Parts 51.102 and 251. It is also being held in

conformance with the State Administrative Procedure Act, under the State

Government Article, beginning at Section 10-101.

Notice of this public hearing has appeared as follows:

   (1)  On the Maryland Department of the Environment website, "Public Hearing,               Meetings, and Request for Comments" page on October 14, 2016 and               remained on the website through today's hearing.           (2)  In the Maryland Register, Volume 43, Issue 21, Friday, October 14, 2016.

      My name is Timothy Wallace. I am a Regulatory and Compliance Engineer         in the Maryland Department of the Environment, Air and Radiation Management

Administration's Air Quality Planning Program. I will serve as hearing officer for

today's hearing.

      First, I would like to ask all in attendance to please sign-in at the back, if you        haven't  already done so. This will help us to keep an accurate record of the people

who participate in our proceedings here today. Also, a full copy of the proposed

SIP is available on the back table for your information.

      The hearing will proceed in the following order.  First, Ms. Alexandra Brun,         a  Natural Resource Planner  with the  Planning Program of the Air and Radiation

Management Administration will read the Department's statement into the record.

      After Ms. Alexandra Brun is finished reading the Department's statement, I

will first call on any elected official or government official who wants to make a

statement. Then, I will call upon anyone else who indicated on the sign-in sheet

that he or she would like to make a statement.

             When giving your statement, please come up to the table, identify yourself        and your affiliation, and give your statement loudly and clearly so the court

reporter is sure to catch your words. Hearing procedure does not call for question

and answer sessions. Statements recorded at this hearing event will be answered in

writing and published with the final State Implementation Plan document. Are

there any procedural questions?

Once all questions have been taken -- if there are any -- you are ready to  begin.

      If the court reporter would begin we will go on record to receive comment.         Ms. Alexandra Brun will proceed with the Department's statement. Again, there

are copies on the back table you may use to read along.

(While Ms. Alexandra Brun reads her statement you get up and walk to the back and Pick up the sign in sheets. You are looking to see who said they would like to make a comment. When she is finished her presentation, you thank her and look to call on any elected officials who wanted to make a statement first. If there are no elected officials, you call on the first person that wanted to comment.)

      I will now call on _____________________________.        After calling on all those who wanted to make a statement say the following:

      Now is there anyone who would like to make a statement, but did not

indicate so on the sign-in sheet?

(If no one wants to make statement, say:)

      No one has indicated that they wish to make a statement, is there anyone

who would now like to make a statement, even if they did not indicate so on the

sign-in sheets.

(After all statements have been presented, say)

      Let the record reflect that a statement has been taken from all who wish to        make one. This will conclude this public hearing. Let the record reflect that it is

now (The correct time) o'clock and this hearing on the State Implementation Plan

stands closed at the end of these proceedings on November  18, 2016. Also, at 5:00

pm today, the official comment period for the document of record will completely.


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58491-58492]
[FR Doc No: 2011-24185]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG11-125-000.
    Applicants: Alliant Energy Corporate Services, Inc.
    Description: Self-Certification of EG Exempt Wholesale Generator
Status of Alliant Energy Corporate Services, Inc on behalf of Franklin
County Wind, LLC.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5059.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 05, 2011.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-4516-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits tariff filing per
35.12: BPA Interconnection Agreement--Orcas Island to be effective 10/
1/2011.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5000.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 05, 2011.

    Docket Numbers: ER11-4517-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits tariff filing per
35.12: BPA Network Integratn TX Service Agreemt for Orcas, Original
Serv Agreemt No 526 to be effective 10/1/2011.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 05, 2011.

    Docket Numbers: ER11-4518-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits tariff filing per
35.12: BPA Network Operating Agreement for Orcas, Original Service
Agreemt No 527 to be effective 10/1/2011.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5002.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 05, 2011.

    Docket Numbers: ER11-4519-000.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Company submits tariff filing
per 35.13(a)(2)(iii): FPL and OUC First Revised Service Agreement No.
297 to be effective 10/1/2011.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5038.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 22, 2011.

    Docket Numbers: ER11-4520-000.
    Applicants: Grant Energy, Inc.
    Description: Grant Energy, Inc. submits tariff filing per 35.1:
Grant Energy Market Based Rates Re-file to be effective 9/14/2011.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5044.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 05, 2011.

    Docket Numbers: ER11-4521-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits tariff filing per
35.13(a)(2)(iii): Queue Position No. S38--Original Service Agreement
No. 3053 to be effective 8/15/2011.
    Filed Date: 09/14/2011.
    Accession Number: 20110914-5066.
    Comment Date: 5 p.m. Eastern Time on Wednesday, October 05, 2011.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and

385.214) on or before 5 p.m. Eastern time on the specified comment
date. Protests may be considered, but intervention is necessary to
become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 14, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-24185 Filed 9-20-11; 8:45 am]
BILLING CODE 6717-01-P