[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Rules and Regulations]
[Pages 73951-73955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30039]
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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: Direct final rule.
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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: http://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
http://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 http://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, [email protected].
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 http://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
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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\
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21 U.S.C.
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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.
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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.
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\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