Amendments to General Regulations of the Food and Drug Administration, 73984-73987 [2010-30040]
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Proposed Rules
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:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
amend 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. This proposed
rule is a companion document to the
direct final rule published elsewhere in
this issue of the Federal Register.
DATES: Submit either electronic or
written comments by February 14, 2011.
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:
SUMMARY:
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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
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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. Why is this rule being issued as a
companion proposed rule?
This proposed rule is a companion to
the direct final rule regarding
amendments to general regulations that
is published in the final rules section of
this issue of the Federal Register. The
direct final rule and this companion
proposed rule are identical. This
companion proposed rule provides the
procedural framework to finalize the
rule in the event that the direct final
rule receives any significant adverse
comment and is withdrawn. We are
publishing the direct final rule because
the rule is noncontroversial, and we do
not anticipate that it will receive any
significant adverse comments. If no
significant adverse comment is received
in response to the direct final rule, no
further action will be taken related to
this proposed rule. Instead, we will
publish a confirmation document
within 30 days after the comment
period ends confirming when the direct
final rule will go into effect.
If we receive any significant adverse
comment regarding the direct final rule,
we will withdraw the direct final rule
within 30 days after the comment
period ends and proceed to respond to
all of the comments under this
companion proposed rule using usual
notice-and-comment rulemaking
procedures under the Administrative
Procedure Act (APA) (5 U.S.C. 553). The
comment period for this companion
proposed rule runs concurrently with
the direct final rule’s comment period.
Any comments received under this
companion proposed rule will also be
considered as comments regarding the
direct final rule.
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 a change. In determining
whether an adverse comment is
significant and warrants terminating a
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direct final rulemaking, we will
consider whether the comment raises an
issue serious enough to warrant a
substantive response in a notice-andcomment process in accordance with
the APA. 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.
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, November 21, 1997). This
guidance document may be accessed at
https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125166.htm.
II. 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.
III. What does this companion
proposed rule do?
FDA proposes to make 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
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Proposed Rules
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.
IV. What is the legal authority for this
proposed rule?
FDA is issuing this proposed 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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V. What is the environmental impact of
this proposed 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
proposed rule?
FDA has examined the impacts of the
proposed 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 proposed 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 the proposed rule
would not impose any new
requirements on tobacco product
manufacturers, retailers, or distributors,
the Agency proposes to certify that the
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
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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 proposed rule to result in any 1year 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 proposed rule?
FDA has analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. FDA
has determined that the proposed rule,
if finalized, would not contain policies
that would 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 proposed 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 proposed 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.
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73985
21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
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, it is proposed that
21 CFR parts 1, 14, and 17 be amended
to read as follows:
PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. 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.
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:
§ 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.
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:
*
*
*
*
*
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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§ 14.55 Termination of advisory
committees.
PART 17—CIVIL MONEY PENALTIES
HEARINGS
*
*
*
*
*
(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.
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:
§ 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.
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) ..........
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333(b)(2)(A) .................
333(b)(2)(B) .................
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 .......................
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.
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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).
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73987
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
333 note .......................
N/A
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 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.
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
10,000 (not adjusted).
2009
250 (not adjusted).
2009
500 (not adjusted).
2009
1,000 (not adjusted).
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. 2010–30040 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Part 2550
RIN 1210–AB38
Target Date Disclosure
Employee Benefits Security
Administration, Labor.
ACTION: Proposed regulation.
AGENCY:
The Department published in
the Federal Register of October 24, 2007
a final regulation (the qualified default
investment alternative regulation)
providing relief from certain fiduciary
responsibilities for fiduciaries of
participant-directed individual account
plans who, in the absence of directions
from a participant, invest the
participant’s account in a qualified
default investment alternative. On
October 20, 2010, the Department
published a final regulation that
requires the disclosure of certain plan
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SUMMARY:
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and investment-related information,
including fee and expense information,
to participants and beneficiaries in
participant-directed individual account
plans (the participant-level disclosure
regulation). This document contains
proposed amendments to the qualified
default investment alternative
regulation to provide more specificity as
to the information that must be
disclosed in the required notice to
participants and beneficiaries
concerning investments in qualified
default investment alternatives,
including target date or similar
investments. This document also
contains a proposed amendment to the
participant-level disclosure regulation
that would require the disclosure of the
same information concerning target date
or similar investments to all participants
and beneficiaries in participant-directed
individual account plans.
DATES: Written comments on the
proposed regulation should be received
by the Department of Labor no later than
January 14, 2011.
ADDRESSES: To facilitate the receipt and
processing of comments, EBSA
encourages interested persons to submit
their comments electronically to eORI@dol.gov, or by using the Federal
eRulemaking portal https://
www.regulations.gov (following
instructions for submission of
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comments). Persons submitting
comments electronically are encouraged
not to submit paper copies. Persons
interested in submitting comments on
paper should send or deliver their
comments (preferably three copies) to:
Office of Regulations and
Interpretations, Employee Benefits
Security Administration, Room N–5655,
U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210, Attention: Target Date
Amendments. All comments will be
available to the public, without charge,
online at https://www.regulations.gov
and https://www.dol.gov/ebsa, and at the
Public Disclosure Room, Employee
Benefits Security Administration, U.S.
Department of Labor, Room N–1513,
200 Constitution Avenue, NW.,
Washington, DC 20210.
FOR FURTHER INFORMATION CONTACT:
Kristen L. Zarenko, Office of
Regulations and Interpretations,
Employee Benefits Security
Administration, (202) 693–8500. This is
not a toll-free number.
SUPPLEMENTARY INFORMATION:
A. Background
Section 624(a) of the Pension
Protection Act of 2006 (Pension
Protection Act) added a new section
404(c)(5) to ERISA. Section 404(c)(5)(A)
of ERISA provides that, for purposes of
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]]>Agencies
[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Proposed Rules]
[Pages 73984-73987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30040]
[[Page 73984]]
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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: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
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. This proposed rule is a companion document to the direct
final rule published elsewhere in this issue of the Federal Register.
DATES: Submit either electronic or written comments by February 14,
2011.
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. Why is this rule being issued as a companion proposed rule?
This proposed rule is a companion to the direct final rule
regarding amendments to general regulations that is published in the
final rules section of this issue of the Federal Register. The direct
final rule and this companion proposed rule are identical. This
companion proposed rule provides the procedural framework to finalize
the rule in the event that the direct final rule receives any
significant adverse comment and is withdrawn. We are publishing the
direct final rule because the rule is noncontroversial, and we do not
anticipate that it will receive any significant adverse comments. If no
significant adverse comment is received in response to the direct final
rule, no further action will be taken related to this proposed rule.
Instead, we will publish a confirmation document within 30 days after
the comment period ends confirming when the direct final rule will go
into effect.
If we receive any significant adverse comment regarding the direct
final rule, we will withdraw the direct final rule within 30 days after
the comment period ends and proceed to respond to all of the comments
under this companion proposed rule using usual notice-and-comment
rulemaking procedures under the Administrative Procedure Act (APA) (5
U.S.C. 553). The comment period for this companion proposed rule runs
concurrently with the direct final rule's comment period. Any comments
received under this companion proposed rule will also be considered as
comments regarding the direct final rule.
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 a 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 APA. 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.
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, November
21, 1997). This guidance document may be accessed at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
II. 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.
III. What does this companion proposed rule do?
FDA proposes to make 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
[[Page 73985]]
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.
IV. What is the legal authority for this proposed rule?
FDA is issuing this proposed 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).
V. What is the environmental impact of this proposed 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 proposed rule?
FDA has examined the impacts of the proposed 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 proposed 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 the proposed rule would not impose any new
requirements on tobacco product manufacturers, retailers, or
distributors, the Agency proposes to certify that the 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
proposed 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 proposed rule?
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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 proposed 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 proposed 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.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 1, 14, and 17 be amended to read as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
1. 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.
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.
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
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 Sec. 14.55 by adding paragraph (f) to read as follows:
[[Page 73986]]
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
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 Sec. 17.1 by adding paragraph (j) to read as follows:
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.
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.
[[Page 73987]]
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.
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. 2010-30040 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P
