Amendments to General Regulations of the Food and Drug Administration, 73951-73955 [2010-30039]
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations
(D) The name of each exchange, if
any, with which the statement, report,
or document is filed;
(iii) The copies of the confidential
portion and the application filed in
accordance with this paragraph shall be
enclosed in a separate envelope marked
‘‘Confidential Treatment’’ and addressed
to Executive Secretary, Federal Deposit
Insurance Corporation, Washington, DC
20429.
(3) Pending the determination by the
FDIC as to the objection filed in
accordance with paragraph (c)(2)(ii) of
this section, the confidential portion
will not be disclosed by the FDIC.
(4) If the FDIC determines that the
objection shall be sustained, a notation
to that effect will be made at the
appropriate place in the statement,
report, or document.
(5) If the FDIC determines that
disclosure of the confidential portion is
in the public interest, a finding and
determination to that effect will be
entered and notice of the finding and
determination will be sent by registered
or certified mail to the person.
(6) The confidential portion shall be
made available to the public:
(i) Upon the lapse of 15 days after the
dispatch of notice by registered or
certified mail of the finding and
determination of the FDIC described in
paragraph (c)(5) of this section, or the
date of the electronic filing, if prior to
the lapse of such 15 days the person
shall not have filed a written statement
that he intends in good faith to seek
judicial review of the finding and
determination;
(ii) Upon the lapse of 60 days after the
dispatch of notice by registered or
certified mail, or the date of the
electronic filing, of the finding and
determination of the FDIC, if the
statement described in paragraph
(c)(6)(i) of this section shall have been
filed and if a petition for judicial review
shall not have been filed within such 60
days; or
(iii) If such petition for judicial review
shall have been filed within such 60
days upon final disposition, adverse to
the person, of the judicial proceedings.
(7) If the confidential portion is made
available to the public, a copy thereof
shall be attached to each copy of the
statement, report, or document filed
with the FDIC and with each exchange
concerned.
22. Amend Section 335.801 by
revising paragraphs (b)(1), (b)(2),
(b)(6)(iv), and (b)(6)(v) to read as
follows:
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§ 335.801 Inapplicable SEC regulations;
FDIC substituted regulations; additional
information.
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(b) Electronic filings. (1) The FDIC
does not participate in the SEC’s
EDGAR (Electronic Data Gathering
Analysis and Retrieval) electronic filing
program (17 CFR part 232). The FDIC
permits voluntary electronically
transmitted filings and submissions of
correspondence and other materials in
electronic format to the FDIC, with the
exception of Beneficial Ownership
Reports (Forms 3, 4, and 5) for which
electronic filing is mandatory.
Beneficial Ownership Report filing
requirements are provided in paragraph
(b)(2) of this section.
(2) All reporting persons must
electronically file Beneficial Ownership
Reports (FDIC Forms 3, 4, and 5),
including amendments and exhibits
thereto, using the Internet-based
interagency Beneficial Ownership
Filings System, except that a reporting
person that has obtained a continuing
hardship exemption under these rules
may file the forms with the FDIC in
paper format. For electronic filing
purposes, FDIC Forms 3, 4, and 5 are
accessible at the Internet-based
interagency Web site for Beneficial
Ownership Filings at FDICconnect at
https://www2.fdicconnect.gov/
index.asp. These forms and the
instructions thereto are available for
printing and downloading at https://
www.fdic.gov/regulations/laws/forms. A
reporting person that has obtained a
continuing hardship exemption under
these rules may file the appropriate
forms with the FDIC in paper format.
Instructions for continuing hardship
exemptions are provided in paragraph
(b)(6) of this section.
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(6) * * *
(iv) Where a continuing hardship
exemption is granted with respect to an
exhibit only, the paper format exhibit
shall be filed with the FDIC under Form
SE (17 CFR part 249). The name of the
FDIC shall be substituted for the name
of the SEC on the form. Form SE shall
be filed as a paper cover sheet to all
exhibits to Beneficial Ownership
Reports submitted to the FDIC in paper
form pursuant to a hardship exemption.
(v) Form SE may be filed with the
FDIC up to six business days prior to,
or on the date of filing of, the electronic
form to which it relates but shall not be
filed after such filing date. If a paper
exhibit is submitted in this manner,
requirements that the exhibit be filed
with, provided with, or accompany the
electronic filing shall be satisfied. Any
requirements as to delivery or
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73951
furnishing the information to persons
other than the FDIC shall not be affected
by this section.
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By order of the Board of Directors.
Federal Deposit Insurance Corporation.
Dated at Washington, DC, this 9th day of
November 2010.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2010–30078 Filed 11–29–10; 8:45 am]
BILLING CODE 6714–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 14, and 17
[Docket No. FDA–2010–N–0560]
RIN 0910–AG55
Amendments to General Regulations
of the Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
The Food and Drug
Administration (FDA) is amending
certain of its general regulations to
include tobacco products, where
appropriate, in light of FDA’s authority
to regulate these products under the
Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act). With these amendments, tobacco
products will be subject to the same
general requirements that apply to other
FDA-regulated products. Elsewhere in
this issue of the Federal Register, we are
publishing a companion proposed rule
under FDA’s usual procedures for notice
and comment to provide a procedural
framework to finalize the rule in the
event we receive significant adverse
comment and withdraw this direct final
rule.
DATES: This rule is effective April 14,
2011. Submit either electronic or
written comments by February 14, 2011.
If we receive no significant adverse
comments within the specified
comment period, we intend to publish
a document confirming the effective
date of the final rule in the Federal
Register within 30 days after the
comment period on this direct final rule
ends. If we receive any timely
significant adverse comment, we will
withdraw this final rule in part or in
whole by publication of a document in
the Federal Register within 30 days
after the comment period ends.
SUMMARY:
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations
You may submit comments,
identified by Docket No. FDA–2010–N–
0560 and/or RIN number 0910–AG55,
by any of the following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
docket number and Regulatory
Information Number (RIN) for this
rulemaking. All comments received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Gerie A. Voss, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
rm. 240G, Rockville, MD 20850, 1–877–
CTP–1373, gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. What is the background of the rule?
The Tobacco Control Act was enacted
on June 22, 2009, amending the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) and providing FDA with the
authority to regulate tobacco products
(Pub. L. 11–31; 123 Stat. 1776). In
enacting the Tobacco Control Act,
Congress sought to ensure that FDA had
authority to provide effective oversight
and to impose appropriate regulatory
controls on tobacco products. In order to
effectuate these purposes, FDA is
amending several provisions of its
general regulations to reflect the
Agency’s new authority and mandate
regarding tobacco products.
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II. What does this direct final
rulemaking do?
In this direct final rule, FDA is
making the following amendments to its
existing general regulations, reflecting
the Agency’s authority over tobacco
products under the Tobacco Control
Act:
1. Revising 21 CFR 1.1(b) to ensure
the applicability of definitions
contained in the Tobacco Control Act;
2. Removing the reference to
‘‘package’’ in 21 CFR 1.1(c), as this
definition now also is covered by the
Tobacco Control Act and is no longer
provided solely by the Fair Packaging
and Labeling Act;
3. Revising 21 CFR 1.20 to exclude
from this definition of ‘‘package’’ the
term ‘‘package’’ as defined in section
900(13) of the Tobacco Control Act (21
U.S.C. 387q(13));
4. Adding paragraph (f) to 21 CFR
14.55 to identify the Tobacco Products
Scientific Advisory Committee as a
permanent statutory advisory
committee; and
5. Adding paragraph (j) to 21 CFR 17.1
and revising 21 CFR 17.2 to reflect
FDA’s authority to impose civil
monetary penalties on tobacco-related
violations.
III. What are the procedures for issuing
a direct final rule?
In the Federal Register of November
21, 1997 (62 FR 62466), FDA announced
the availability of the guidance
document entitled ‘‘Guidance for FDA
and Industry: Direct Final Rule
Procedures’’ that described when and
how FDA will employ direct final
rulemaking. We believe that this rule is
appropriate for direct final rulemaking
because it is intended to make
noncontroversial changes to existing
regulations. We anticipate no significant
adverse comments.
Consistent with FDA’s procedures on
direct final rulemaking, we are
publishing elsewhere in this issue of the
Federal Register a companion proposed
rule that is identical to the direct final
rule. The companion proposed rule
provides a procedural framework within
which the rule may be finalized in the
event the direct final rule is withdrawn
because of any significant adverse
comment. The comment period for this
direct final rule runs concurrently with
the comment period of the companion
proposed rule. Any comments received
in response to the companion proposed
rule will also be considered as
comments regarding this direct final
rule.
We are providing a comment period
on the direct final rule of 75 days after
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the date of publication in the Federal
Register. If we receive any significant
adverse comment, we intend to
withdraw this final rule before its
effective date by publication of a notice
in the Federal Register within 30 days
after the comment period ends. A
significant adverse comment is defined
as a comment that explains why the rule
would be inappropriate, including
challenges to the rule’s underlying
premise or approach, or would be
ineffective or unacceptable without
change. In determining whether an
adverse comment is significant and
warrants terminating a direct final
rulemaking, we will consider whether
the comment raises an issue serious
enough to warrant a substantive
response in a notice-and-comment
process in accordance with the
Administrative Procedure Act (APA) (5
U.S.C. 553). Comments that are
frivolous, insubstantial, or outside the
scope of the rule will not be considered
significant or adverse under this
procedure. For example, a comment
recommending an additional change to
the rule will not be considered a
significant adverse comment, unless the
comment states why the rule would be
ineffective without the additional
change. In addition, if a significant
adverse comment applies to part of a
rule and that part can be severed from
the remainder of the rule, we may adopt
as final those parts of the rule that are
not the subject of a significant adverse
comment.
If we withdraw the direct final rule,
all comments received will be
considered under the companion
proposed rule in developing a final rule
under the usual notice-and-comment
procedures under the APA. If we receive
no significant adverse comment during
the specified comment period, we
intend to publish a confirmation
document in the Federal Register
within 30 days after the comment
period ends.
You can find additional information
about FDA’s direct final rulemaking
procedures in the guidance document
entitled ‘‘Guidance for FDA and
Industry: Direct Final Rule Procedures’’
(62 FR 62466). This guidance document
may be accessed at https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125166.htm.
IV. What is the legal authority for this
rule?
FDA is issuing this direct final rule
under provisions of the FD&C Act, as
amended by the Tobacco Control Act
(21 U.S.C. 321, 331, 333, 387, 387a, and
387q).
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations
V. What is the environmental impact of
this rule?
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
The Agency has determined under 21
CFR 25.30(h) and (i) that this action is
of a type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
VIII. What are the federalism impacts
of this rule?
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
Agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
VI. What is the economic impact of this
rule?
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FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
Agency believes that this direct final
rule is not a significant regulatory action
under the Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this direct final rule
does not impose any new requirements
on tobacco product manufacturers,
retailers, or distributors, the Agency
certifies that the final rule will not have
a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $135
million, using the most current (2009)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
expenditure that would meet or exceed
this amount.
VII. Paperwork Reduction Act of 1995
FDA concludes that the regulatory
revisions and amendments identified in
this document are not subject to review
by the Office of Management and
Budget because they do not constitute a
‘‘collection of information’’ under the
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IX. How do you submit comments on
this rule?
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.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
73953
2. In § 1.1, revise paragraph (b); and in
the first sentence of paragraph (c),
remove ‘‘package in § 1.20 and of’’ to
read as follows:
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§ 1.1
General.
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(b) The definitions and interpretations
of terms contained in sections 201 and
900 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321 and 387)
shall be applicable also to such terms
when used in regulations promulgated
under that act.
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■ 3. Amend § 1.20 by revising the
introductory text to read as follows:
§ 1.20 Presence of mandatory label
information.
Except as otherwise provided by
section 900(13) of the Family Smoking
Prevention and Tobacco Control Act (21
U.S.C. 387(13)) defining ‘‘package,’’ the
term package means any container or
wrapping in which any food, drug,
device, or cosmetic is enclosed for use
in the delivery or display of such
commodities to retail purchasers, but
does not include:
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PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
4. The authority citation for part 14
continues to read as follows:
■
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155.
5. Amend § 14.55 by adding paragraph
(f) to read as follows:
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21 CFR Part 14
§ 14.55 Termination of advisory
committees.
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
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21 CFR Part 17
Administrative practice and
procedure, Penalties.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 1, 14,
and 17 are amended as follows:
PART 1—GENERAL ENFORCEMENT
REGULATIONS
The authority citation for part 1 is
revised to read as follows:
■
Authority: 15 U.S.C. 1453, 1454, 1455; 19
U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 333,
334, 335a, 343, 350c, 350d, 352, 355, 360b,
362, 371, 374, 381, 382, 387, 387a, 393; 42
U.S.C. 216, 241, 243, 262, 264.
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(f) The Tobacco Products Scientific
Advisory Committee is a permanent
statutory advisory committee
established by section 917 of the Family
Smoking Prevention and Tobacco
Control Act (21 U.S.C. 387q) (Pub. L.
111–31) and is not subject to
termination and renewal under
paragraph (a) of this section.
PART 17—CIVIL MONEY PENALTIES
HEARINGS
6. The authority citation for part 17
continues to read as follows:
■
Authority: 21 U.S.C. 331, 333, 337, 351,
352, 355, 360, 360c, 360f, 360i, 360j, 371; 42
U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554,
555, 556, 557.
7. Amend § 17.1 by adding paragraph
(j) to read as follows:
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations
Scope.
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(j) Section 303(f) of the act authorizing
civil money penalties for any person
who violates a requirement of the
Family Smoking Prevention and
Tobacco Control Act which relates to
tobacco products.
■
8. Revise § 17.2 to read as follows:
§ 17.2
Maximum penalty amounts.
The following table shows maximum
civil monetary penalties associated with
the statutory provisions authorizing
civil monetary penalties under the act or
the Public Health Service Act.
CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS
U.S.C. Section
Former
maximum
penalty
amount
(in dollars)1
Date of last
penalty figure
or adjustment
Assessment method
Adjusted maximum penalty
amount
(in dollars)
21 U.S.C.
55,000
1,100,000
333(b)(3) ......................
333(f)(1)(A) ..................
333(f)(1)(A) ..................
333(f)(2)(A) ..................
333(f)(2)(A) ..................
333(f)(2)(A) ..................
333(f)(3)(A) ..................
333(f)(3)(B) ..................
110,000
16,500
1,100,000
55,000
275,000
550,000
10,000
10,000
333(f)(4)(A)(i) ...............
333(f)(4)(A)(i) ...............
333(f)(4)(A)(ii) ..............
250,000
1,000,000
250,000
333(f)(4)(A)(ii) ..............
1,000,000
333(f)(4)(A)(ii) ..............
333(f)(9)(A) ..................
333(f)(9)(A) ..................
333(f)(9)(B)(i)(I) ............
333(f)(9)(B)(i)(I) ............
333(f)(9)(B)(i)(II) ...........
10,000,000
1 N/A
N/A
N/A
N/A
N/A
333(f)(9)(B)(i)(II) ...........
N/A
333(f)(9)(B)(i)(II) ...........
333(f)(9)(B)(ii)(I) ...........
333(f)(9)(B)(ii)(I) ...........
333(f)(9)(B)(ii)(II) ..........
N/A
N/A
N/A
N/A
333(f)(9)(B)(ii)(II) ..........
N/A
333(f)(9)(B)(ii)(II) ..........
333(g)(1) ......................
333(g)(1) ......................
333 note .......................
N/A
250,000
500,000
N/A
333 note .......................
N/A
333 note .......................
N/A
333 note .......................
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333(b)(2)(A) .................
333(b)(2)(B) .................
N/A
333 note .......................
N/A
333 note .......................
N/A
333 note .......................
N/A
333 note .......................
N/A
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For each of the first two violations in any 10-year period
For each violation after the second conviction in any 10year period.
Per violation ......................................................................
Per violation ......................................................................
For the aggregate of violations ........................................
Per individual ....................................................................
Per ‘‘any other person’’ .....................................................
For all violations adjudicated in a single proceeding .......
For all violations adjudicated in a single proceeding .......
For each day the violation is not corrected after a 30day period following notification until the violation is
corrected.
Per violation ......................................................................
For all violations adjudicated in a single proceeding .......
For the first 30-day period (or any portion thereof) of
continued violation following notification.
For any 30-day period, where the amount doubles for
every 30-day period of continued violation after the
first 30-day period.
For all violations adjudicated in a single proceeding .......
Per violation ......................................................................
For all violations adjudicated in a single proceeding .......
Per violation ......................................................................
For all violations adjudicated in a single proceeding .......
For the first 30-day period (or any portion thereof) of
continued violation following notification.
For any 30-day period, where the amount doubled for
every 30-day period of continued violation after the
first 30-day period.
For all violations adjudicated in a single proceeding .......
Per violation ......................................................................
For all violations adjudicated in a single proceeding .......
For the first 30-day period (or any portion thereof) of
continued violation following notification.
For any 30-day period, where the amount doubled for
every 30-day period of continued violation after the
first 30-day period.
For all violations adjudicated in a single proceeding .......
For the first violation in any 3-year period .......................
For each subsequent violation in any 3-year period ........
For the second violation (following a first violation with
warning) within a 12-month period by a retailer with
an approved training program.
For the third violation within a 24-month period by a retailer with an approved training program.
For the fourth violation within a 24-month period by a retailer with an approved training program.
For the fifth violation within a 36-month period by a retailer with an approved training program.
For the six or subsequent violation within a 48-month
period by a retailer with an approved training program.
For the first violation by a retailer without an approved
training program.
For the second violation within a 12-month period by a
retailer without an approved training program.
For the third violation within a 24-month period by a retailer without an approved training program.
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2008
2008
60,000.
1,200,000.
2008
2008
2008
2008
2008
2008
2007
2007
120,000.
16,500 (not adjusted).
1,200,000.
60,000.
300,000.
600,000.
10,000 (not adjusted).
10,000 (not adjusted).
2007
2007
2007
250,000 (not adjusted).
1,000,000 (not adjusted).
250,000 (not adjusted).
2007
1,000,000 (not adjusted).
2007
2009
2009
2009
2009
2009
10,000,000 (not adjusted).
15,000 (not adjusted).
1,000,000 (not adjusted).
250,000 (not adjusted).
1,000,000 (not adjusted).
250,000 (not adjusted).
2009
1,000,000 (not adjusted).
2009
2009
2009
2009
10,000,000 (not adjusted).
250,000 (not adjusted).
1,000,000 (not adjusted).
250,000 (not adjusted).
2009
1,000,000 (not adjusted).
2009
2007
2007
2009
10,000,000 (not adjusted).
250,000 (not adjusted).
500,000 (not adjusted).
250 (not adjusted).
2009
500 (not adjusted).
2009
2,000 (not adjusted).
2009
5,000 (not adjusted).
2009
10,000 (not adjusted).
2009
250 (not adjusted).
2009
500 (not adjusted).
2009
1,000 (not adjusted).
30NOR1
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations
73955
CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—
Continued
U.S.C. Section
Former
maximum
penalty
amount
(in dollars)1
333 note .......................
N/A
333 note .......................
N/A
333 note .......................
N/A
335b(a) ........................
335b(a) ........................
360pp(b)(1) ..................
360pp(b)(1) ..................
275,000
1,100,000
1,100
330,000
Date of last
penalty figure
or adjustment
Assessment method
For the fourth violation within a 24-month period by a retailer without an approved training program.
For the fifth violation within a 36-month period by a retailer without an approved training program.
For the six or subsequent violation within a 48-month
period by a retailer without an approved training program.
Per violation for an individual ...........................................
Per violation for ‘‘any other person’’ .................................
Per violation per person ...................................................
For any related series of violations ..................................
Adjusted maximum penalty
amount
(in dollars)
2009
2,000 (not adjusted).
2009
5,000 (not adjusted).
2009
10,000 (not adjusted).
2008
2008
2008
2008
300,000.
1,200,000.
1,100 (not adjusted).
355,000.
2008
2008
11,000 (not adjusted).
120,000.
42 U.S.C.
263b(h)(3) ....................
300aa–28(b)(1) ............
1 Maximum
11,000
110,000
Per violation ......................................................................
Per occurrence .................................................................
penalties assessed under The Family Smoking Prevention and Tobacco Control Act do not have a ‘‘former maximum penalty.’’
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30039 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
FEDERAL MINE SAFETY AND HEALTH
REVIEW COMMISSION
29 CFR Part 2700
Penalty Settlement Procedure
Federal Mine Safety and Health
Review Commission.
ACTION: Final rule.
AGENCY:
The Federal Mine Safety and
Health Review Commission (the
‘‘Commission’’) is an independent
adjudicatory agency that provides
hearings and appellate review of cases
arising under the Federal Mine Safety
and Health Act of 1977, or Mine Act.
Hearings are held before the
Commission’s Administrative Law
Judges, and appellate review is provided
by a five-member Review Commission
appointed by the President and
confirmed by the Senate. The
Commission is publishing a final rule to
streamline the process for settling civil
penalties assessed under the Mine Act.
DATES: The final rule takes effect on
December 30, 2010. The Commission
will accept written and electronic
comments received on or before
December 15, 2010.
ADDRESSES: Written comments should
be mailed to Michael A. McCord,
General Counsel, Office of the General
Counsel, Federal Mine Safety and
jdjones on DSK8KYBLC1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:07 Nov 29, 2010
Jkt 223001
Health Review Commission, 601 New
Jersey Avenue, NW., Suite 9500,
Washington, DC 20001, or sent via
facsimile to 202–434–9944. Persons
mailing written comments shall provide
an original and three copies of their
comments. Electronic comments should
state ‘‘Comments on Penalty Settlement
Rule’’ in the subject line and be sent to
mmccord@fmshrc.gov.
FOR FURTHER INFORMATION CONTACT:
Michael A. McCord, General Counsel,
Office of the General Counsel, 601 New
Jersey Avenue, NW., Suite 9500,
Washington, DC 20001; telephone 202–
434–9935; fax 202–434–9944.
SUPPLEMENTARY INFORMATION:
Background
On April 27, 2010, the Commission
published in the Federal Register an
interim rule regarding the Commission’s
civil penalty settlement procedures. 75
FR 21987. The Commission explained
that since 2006, the number of new
cases filed with the Commission has
dramatically increased, and that in
order to deal with that burgeoning
caseload, the Commission is considering
methods to simplify how it processes
civil penalty settlements. The interim
rule became effective on May 27, 2010,
and the Commission accepted
comments on the rule through June 28,
2010. The Commission received
comments from the Secretary of Labor
(the ‘‘Secretary’’) through the U.S.
Department of Labor’s Office of the
Solicitor, individual Conference and
Litigation Representatives (‘‘CLRs’’), and
a few members of the mining
community.
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
Under section 110(k) of the Mine Act,
30 U.S.C. 820(k), a proposed civil
penalty that has been contested before
the Commission may be settled only
with the approval of the Commission.
Under the Commission’s practice prior
to the effective date of the interim rule,
a party submitted to a Commission
Administrative Law Judge a motion to
approve a penalty settlement that
included for each violation the amount
of the penalty proposed by the
Department of Labor’s Mine Safety and
Health Administration (‘‘MSHA’’), the
amount of the penalty agreed to in
settlement, and facts in support of the
penalty agreed to by the parties. 29 CFR
2700.31(b) (2009). A Commission Judge
considered the motion and evaluated
the penalty agreed to by the parties
based on the criteria set forth in section
110(i) of the Mine Act, 30 U.S.C. 820(i).
If the Judge concluded that the
settlement was consistent with the
statutory criteria, the Judge issued a
decision approving the settlement and
setting forth the reasons for approval.
The interim rule changed the current
procedure by adding two new
requirements. First, in all penalty
proceedings, except for discrimination
proceedings arising under section 105(c)
of the Mine Act, 30 U.S.C. 815(c), or
proceedings against individuals
pursuant to section 110(c) of the Mine
Act, 30 U.S.C. 820(c), the interim rule
requires that a party filing a motion to
approve a penalty settlement submit a
proposed decision approving settlement
(‘‘proposed order’’) with the motion.
Second, it requires the filing party to
submit the motion and proposed order
electronically. The basic requirements
E:\FR\FM\30NOR1.SGM
30NOR1
]]>Agencies
[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Rules and Regulations]
[Pages 73951-73955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30039]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 14, and 17
[Docket No. FDA-2010-N-0560]
RIN 0910-AG55
Amendments to General Regulations of the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending certain of
its general regulations to include tobacco products, where appropriate,
in light of FDA's authority to regulate these products under the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With
these amendments, tobacco products will be subject to the same general
requirements that apply to other FDA-regulated products. Elsewhere in
this issue of the Federal Register, we are publishing a companion
proposed rule under FDA's usual procedures for notice and comment to
provide a procedural framework to finalize the rule in the event we
receive significant adverse comment and withdraw this direct final
rule.
DATES: This rule is effective April 14, 2011. Submit either electronic
or written comments by February 14, 2011. If we receive no significant
adverse comments within the specified comment period, we intend to
publish a document confirming the effective date of the final rule in
the Federal Register within 30 days after the comment period on this
direct final rule ends. If we receive any timely significant adverse
comment, we will withdraw this final rule in part or in whole by
publication of a document in the Federal Register within 30 days after
the comment period ends.
[[Page 73952]]
ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0560 and/or RIN number 0910-AG55, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
https://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd., rm. 240G,
Rockville, MD 20850, 1-877-CTP-1373, gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. What is the background of the rule?
The Tobacco Control Act was enacted on June 22, 2009, amending the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and providing FDA
with the authority to regulate tobacco products (Pub. L. 11-31; 123
Stat. 1776). In enacting the Tobacco Control Act, Congress sought to
ensure that FDA had authority to provide effective oversight and to
impose appropriate regulatory controls on tobacco products. In order to
effectuate these purposes, FDA is amending several provisions of its
general regulations to reflect the Agency's new authority and mandate
regarding tobacco products.
II. What does this direct final rulemaking do?
In this direct final rule, FDA is making the following amendments
to its existing general regulations, reflecting the Agency's authority
over tobacco products under the Tobacco Control Act:
1. Revising 21 CFR 1.1(b) to ensure the applicability of
definitions contained in the Tobacco Control Act;
2. Removing the reference to ``package'' in 21 CFR 1.1(c), as this
definition now also is covered by the Tobacco Control Act and is no
longer provided solely by the Fair Packaging and Labeling Act;
3. Revising 21 CFR 1.20 to exclude from this definition of
``package'' the term ``package'' as defined in section 900(13) of the
Tobacco Control Act (21 U.S.C. 387q(13));
4. Adding paragraph (f) to 21 CFR 14.55 to identify the Tobacco
Products Scientific Advisory Committee as a permanent statutory
advisory committee; and
5. Adding paragraph (j) to 21 CFR 17.1 and revising 21 CFR 17.2 to
reflect FDA's authority to impose civil monetary penalties on tobacco-
related violations.
III. What are the procedures for issuing a direct final rule?
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial changes to existing regulations. We
anticipate no significant adverse comments.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule that is identical to the direct final rule. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event the direct final rule is withdrawn because of
any significant adverse comment. The comment period for this direct
final rule runs concurrently with the comment period of the companion
proposed rule. Any comments received in response to the companion
proposed rule will also be considered as comments regarding this direct
final rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
final rule before its effective date by publication of a notice in the
Federal Register within 30 days after the comment period ends. A
significant adverse comment is defined as a comment that explains why
the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with the Administrative Procedure Act (APA) (5 U.S.C. 553). Comments
that are frivolous, insubstantial, or outside the scope of the rule
will not be considered significant or adverse under this procedure. For
example, a comment recommending an additional change to the rule will
not be considered a significant adverse comment, unless the comment
states why the rule would be ineffective without the additional change.
In addition, if a significant adverse comment applies to part of a rule
and that part can be severed from the remainder of the rule, we may
adopt as final those parts of the rule that are not the subject of a
significant adverse comment.
If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA. If we
receive no significant adverse comment during the specified comment
period, we intend to publish a confirmation document in the Federal
Register within 30 days after the comment period ends.
You can find additional information about FDA's direct final
rulemaking procedures in the guidance document entitled ``Guidance for
FDA and Industry: Direct Final Rule Procedures'' (62 FR 62466). This
guidance document may be accessed at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
IV. What is the legal authority for this rule?
FDA is issuing this direct final rule under provisions of the FD&C
Act, as amended by the Tobacco Control Act (21 U.S.C. 321, 331, 333,
387, 387a, and 387q).
[[Page 73953]]
V. What is the environmental impact of this rule?
The Agency has determined under 21 CFR 25.30(h) and (i) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. What is the economic impact of this rule?
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this direct final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this direct final rule does not impose any
new requirements on tobacco product manufacturers, retailers, or
distributors, the Agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. Paperwork Reduction Act of 1995
FDA concludes that the regulatory revisions and amendments
identified in this document are not subject to review by the Office of
Management and Budget because they do not constitute a ``collection of
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
VIII. What are the federalism impacts of this rule?
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
IX. How do you submit comments on this rule?
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.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
21 CFR Part 17
Administrative practice and procedure, Penalties.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 14, and 17 are amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
The authority citation for part 1 is revised to read as follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b,
362, 371, 374, 381, 382, 387, 387a, 393; 42 U.S.C. 216, 241, 243,
262, 264.
0
2. In Sec. 1.1, revise paragraph (b); and in the first sentence of
paragraph (c), remove ``package in Sec. 1.20 and of'' to read as
follows:
Sec. 1.1 General.
* * * * *
(b) The definitions and interpretations of terms contained in
sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 and 387) shall be applicable also to such terms when used in
regulations promulgated under that act.
* * * * *
0
3. Amend Sec. 1.20 by revising the introductory text to read as
follows:
Sec. 1.20 Presence of mandatory label information.
Except as otherwise provided by section 900(13) of the Family
Smoking Prevention and Tobacco Control Act (21 U.S.C. 387(13)) defining
``package,'' the term package means any container or wrapping in which
any food, drug, device, or cosmetic is enclosed for use in the delivery
or display of such commodities to retail purchasers, but does not
include:
* * * * *
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
4. The authority citation for part 14 continues to read as follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.
0
5. Amend Sec. 14.55 by adding paragraph (f) to read as follows:
Sec. 14.55 Termination of advisory committees.
* * * * *
(f) The Tobacco Products Scientific Advisory Committee is a
permanent statutory advisory committee established by section 917 of
the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387q)
(Pub. L. 111-31) and is not subject to termination and renewal under
paragraph (a) of this section.
PART 17--CIVIL MONEY PENALTIES HEARINGS
0
6. The authority citation for part 17 continues to read as follows:
Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.
0
7. Amend Sec. 17.1 by adding paragraph (j) to read as follows:
[[Page 73954]]
Sec. 17.1 Scope.
* * * * *
(j) Section 303(f) of the act authorizing civil money penalties for
any person who violates a requirement of the Family Smoking Prevention
and Tobacco Control Act which relates to tobacco products.
0
8. Revise Sec. 17.2 to read as follows:
Sec. 17.2 Maximum penalty amounts.
The following table shows maximum civil monetary penalties
associated with the statutory provisions authorizing civil monetary
penalties under the act or the Public Health Service Act.
Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
----------------------------------------------------------------------------------------------------------------
Former
maximum Date of last
U.S.C. Section penalty Assessment penalty figure Adjusted maximum penalty amount
amount (in method or adjustment (in dollars)
dollars)\1\
----------------------------------------------------------------------------------------------------------------
21 U.S.C.
----------------------------------------------------------------------------------------------------------------
333(b)(2)(A)................. 55,000 For each of the 2008 60,000.
first two
violations in
any 10-year
period.
333(b)(2)(B)................. 1,100,000 For each 2008 1,200,000.
violation after
the second
conviction in
any 10-year
period.
333(b)(3).................... 110,000 Per violation... 2008 120,000.
333(f)(1)(A)................. 16,500 Per violation... 2008 16,500 (not adjusted).
333(f)(1)(A)................. 1,100,000 For the 2008 1,200,000.
aggregate of
violations.
333(f)(2)(A)................. 55,000 Per individual.. 2008 60,000.
333(f)(2)(A)................. 275,000 Per ``any other 2008 300,000.
person''.
333(f)(2)(A)................. 550,000 For all 2008 600,000.
violations
adjudicated in
a single
proceeding.
333(f)(3)(A)................. 10,000 For all 2007 10,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(3)(B)................. 10,000 For each day the 2007 10,000 (not adjusted).
violation is
not corrected
after a 30-day
period
following
notification
until the
violation is
corrected.
333(f)(4)(A)(i).............. 250,000 Per violation... 2007 250,000 (not adjusted).
333(f)(4)(A)(i).............. 1,000,000 For all 2007 1,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(4)(A)(ii)............. 250,000 For the first 30- 2007 250,000 (not adjusted).
day period (or
any portion
thereof) of
continued
violation
following
notification.
333(f)(4)(A)(ii)............. 1,000,000 For any 30-day 2007 1,000,000 (not adjusted).
period, where
the amount
doubles for
every 30-day
period of
continued
violation after
the first 30-
day period.
333(f)(4)(A)(ii)............. 10,000,000 For all 2007 10,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(9)(A)................. \1\ N/A Per violation... 2009 15,000 (not adjusted).
333(f)(9)(A)................. N/A For all 2009 1,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(9)(B)(i)(I)........... N/A Per violation... 2009 250,000 (not adjusted).
333(f)(9)(B)(i)(I)........... N/A For all 2009 1,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(9)(B)(i)(II).......... N/A For the first 30- 2009 250,000 (not adjusted).
day period (or
any portion
thereof) of
continued
violation
following
notification.
333(f)(9)(B)(i)(II).......... N/A For any 30-day 2009 1,000,000 (not adjusted).
period, where
the amount
doubled for
every 30-day
period of
continued
violation after
the first 30-
day period.
333(f)(9)(B)(i)(II).......... N/A For all 2009 10,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(9)(B)(ii)(I).......... N/A Per violation... 2009 250,000 (not adjusted).
333(f)(9)(B)(ii)(I).......... N/A For all 2009 1,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(f)(9)(B)(ii)(II)......... N/A For the first 30- 2009 250,000 (not adjusted).
day period (or
any portion
thereof) of
continued
violation
following
notification.
333(f)(9)(B)(ii)(II)......... N/A For any 30-day 2009 1,000,000 (not adjusted).
period, where
the amount
doubled for
every 30-day
period of
continued
violation after
the first 30-
day period.
333(f)(9)(B)(ii)(II)......... N/A For all 2009 10,000,000 (not adjusted).
violations
adjudicated in
a single
proceeding.
333(g)(1).................... 250,000 For the first 2007 250,000 (not adjusted).
violation in
any 3-year
period.
333(g)(1).................... 500,000 For each 2007 500,000 (not adjusted).
subsequent
violation in
any 3-year
period.
333 note..................... N/A For the second 2009 250 (not adjusted).
violation
(following a
first violation
with warning)
within a 12-
month period by
a retailer with
an approved
training
program.
333 note..................... N/A For the third 2009 500 (not adjusted).
violation
within a 24-
month period by
a retailer with
an approved
training
program.
333 note..................... N/A For the fourth 2009 2,000 (not adjusted).
violation
within a 24-
month period by
a retailer with
an approved
training
program.
333 note..................... N/A For the fifth 2009 5,000 (not adjusted).
violation
within a 36-
month period by
a retailer with
an approved
training
program.
333 note..................... N/A For the six or 2009 10,000 (not adjusted).
subsequent
violation
within a 48-
month period by
a retailer with
an approved
training
program.
333 note..................... N/A For the first 2009 250 (not adjusted).
violation by a
retailer
without an
approved
training
program.
333 note..................... N/A For the second 2009 500 (not adjusted).
violation
within a 12-
month period by
a retailer
without an
approved
training
program.
333 note..................... N/A For the third 2009 1,000 (not adjusted).
violation
within a 24-
month period by
a retailer
without an
approved
training
program.
[[Page 73955]]
333 note..................... N/A For the fourth 2009 2,000 (not adjusted).
violation
within a 24-
month period by
a retailer
without an
approved
training
program.
333 note..................... N/A For the fifth 2009 5,000 (not adjusted).
violation
within a 36-
month period by
a retailer
without an
approved
training
program.
333 note..................... N/A For the six or 2009 10,000 (not adjusted).
subsequent
violation
within a 48-
month period by
a retailer
without an
approved
training
program.
335b(a)...................... 275,000 Per violation 2008 300,000.
for an
individual.
335b(a)...................... 1,100,000 Per violation 2008 1,200,000.
for ``any other
person''.
360pp(b)(1).................. 1,100 Per violation 2008 1,100 (not adjusted).
per person.
360pp(b)(1).................. 330,000 For any related 2008 355,000.
series of
violations.
----------------------------------------------------------------------------------------------------------------
42 U.S.C.
----------------------------------------------------------------------------------------------------------------
263b(h)(3)................... 11,000 Per violation... 2008 11,000 (not adjusted).
300aa-28(b)(1)............... 110,000 Per occurrence.. 2008 120,000.
----------------------------------------------------------------------------------------------------------------
\1\ Maximum penalties assessed under The Family Smoking Prevention and Tobacco Control Act do not have a
``former maximum penalty.''
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30039 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P
