[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Proposed Rules]
[Pages 73984-73987]
From the Federal Register Online via the Government Publishing 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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#7f181a0d161a5109100c0c3f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="432426312a266d352c3030032527226d2b2b306d242c35">[email protected]</span></a>.

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 http://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


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