Document ID: FDA-2011-N-0121-0006
Agency: fda
Document Type: Rule
Title: Further Amendments to General Regulations to Incorporate Tobacco Products
Posted Date: 2012-02-02T05:00Z

[Federal Register Volume 77, Number 22 (Thursday, February 2, 2012)]
[Rules and Regulations]
[Pages 5171-5176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2289]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 7, and 16

[Docket No. FDA-2011-N-0121]
RIN 0910-AG60

Further Amendments to General Regulations of the Food and Drug 
Administration to Incorporate Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: 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 are subject to the same general 
requirements that apply to other FDA-regulated products.

DATES: This rule is effective April 2, 2012.

FOR FURTHER INFORMATION CONTACT:  Gerie A. Voss, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 1 (877) CTP-1373, gerie.voss@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 14, 2011 (76 FR 20901), FDA issued 
a proposed rule seeking to amend several provisions of its general 
regulations to reflect the Agency's new authority and mandate regarding 
tobacco products under the Tobacco Control Act (Pub. L. 11-31; 123 
Stat. 1776). FDA received substantive comments to its proposal from 
only one commenter. However, FDA does not believe that these comments 
warrant making any changes to the regulatory language included in the 
proposed rule.
    Relevant portions of these comments are summarized and responded to 
in the relevant section(s) of this document. To make it easier to 
identify comments and FDA's responses, the word ``Comment,'' in 
brackets, appears before the comment's description, and the word 
``Response,'' in brackets, appears before FDA's response. Each comment 
is numbered to help distinguish among different comments. The number 
assigned to each comment is purely for organizational purposes and does 
not signify the comment's value or importance.

II. Legal Authority

    FDA is issuing this final rule under provisions of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Tobacco 
Control Act (21 U.S.C. 321, 331, 333, 371, 381, 387, 387a, 387c, 387f, 
387j, and 387k). FDA is also issuing this final rule under section 4 of 
the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 
1333) as amended by the Tobacco Control Act, and under section 3 of the 
Comprehensive Smokeless

[[Page 5172]]

Tobacco Health Education Act of 1986 (CSTHEA) (15 U.S.C. 4402) as 
amended by the Tobacco Control Act.

III. Description of Final Regulations

    With this rule, FDA is finalizing several amendments to title 21 of 
the Code of Federal Regulations (CFR), reflecting the Agency's 
authority over tobacco products under the Tobacco Control Act. The 
amendments are described in sections III.A, III.B, and III.C of this 
document.

A. Section 1.21--Failure to Reveal Material Facts

    Section 1.21(a) (21 CFR 1.21(a)) states that the labeling of FDA-
regulated products shall be deemed misleading if it fails to reveal 
facts that are: ``* * * Material in light of other representations made 
or suggested by statement, word, design, device or any combination 
thereof; or [m]aterial with respect to consequences which may result 
from use of the article under: The conditions prescribed in such 
labeling or such conditions of use as are customary or usual.'' With 
this final rule, FDA is amending Sec.  1.21(a) to provide that tobacco 
product labeling also would be deemed misleading for similar failures 
to reveal material facts. See section 903(a) of the Tobacco Control Act 
(21 U.S.C. 387c(a)) (stating that a tobacco product shall be deemed to 
be misbranded if its labeling is false or misleading). See also section 
201(n) of the FD&C Act (21 U.S.C. 321(n)).
    Section 1.21(c) describes statements that are not permissible on 
labeling for FDA-regulated products. For example, paragraph (c)(1) 
explains that this regulation does not ``[p]ermit a statement of 
differences of opinion with respect to warnings * * *'' on FDA-
regulated products. This final rule amends this section to state that 
tobacco product labeling, like the labeling of other FDA-regulated 
products, also may not have a statement of differences of opinion 
regarding the warnings on tobacco packages or advertisements. This 
change is in accordance with sections 201 and 204 of the Tobacco 
Control Act, amending the FCLAA, and the CSTHEA, respectively, as well 
as section 903(a) generally. FDA already has issued a final rule to 
implement section 201 of the Tobacco Control Act, amending 15 U.S.C. 
1333. See the Federal Register of June 22, 2011 (76 FR 36628).

B. Section 1.101--Notification and Recordkeeping

    Section 1.101 (21 CFR 1.101) outlines the notification and 
recordkeeping requirements for exports of FDA-regulated products. 
Section 1.101(a) pertains to all notifications and records required for 
FDA-regulated products that may be exported under sections 801 or 802 
of the FD&C Act (21 U.S.C. 381 and 382) and section 351 of the Public 
Health Service Act (42 U.S.C. 262). Because section 103(l) of the 
Tobacco Control Act specifically amends section 801 of the FD&C Act to 
include ``tobacco products'' on the list of FDA-regulated products that 
may be exported under this section, this final rule amends Sec.  
1.101(a) and (b) to indicate that tobacco products exported under 
section 801(e)(1) of the FD&C Act also would be subject to the 
recordkeeping requirements of this regulation. Please note that this 
revision to Sec.  1.101(b) does not alter the enforcement policy 
described in the advance notice of proposed rulemaking that published 
in the Federal Register of June 1, 2004 (69 FR 30842). Thus, with 
regard to tobacco products, FDA intends to exercise enforcement 
discretion, as it does with exports generally, regarding the 
requirement for specific types of records under Sec.  1.101(b)(2) 
demonstrating that the exported product is not in conflict with the 
foreign country's laws.
    (Comment 1)--One comment requested that FDA provide notice and an 
opportunity to comment should it propose to end this period of 
enforcement discretion as it applies to tobacco products.
    (Response 1)--We note, previously, that this revision does not 
alter our exercise of enforcement discretion, including with respect to 
tobacco products and additional notice and comment with respect to this 
issue is not necessary.

C. Section 7.3--Definitions

    Section 7.3 (21 CFR 7.3) defines the term ``product'' to include 
all the specific items that are subject to FDA's jurisdiction. This 
final rule amends Sec.  7.3 of the regulations to define ``product'' to 
also include tobacco products.
    (Comment 2)--One comment stated that FDA's proposed change to Sec.  
7.3 did not take into account the fundamental differences between 
tobacco products and other regulated product categories and, therefore, 
it should be amended accordingly. This comment also requested that FDA 
make additional changes to part 7.
    (Response 2)--FDA believes that its change to Sec.  7.3 is 
necessary to ensure that tobacco products are subject to the same 
general requirements that apply to other FDA-regulated products. The 
differences between tobacco products and other regulated products do 
not warrant any additional changes to Sec.  7.3. In circumstances where 
FDA's requirements apply solely to tobacco products, that is noted in 
the appropriate sections of the Agency's regulations. Further, FDA 
believes that the other suggested revisions to part 7 included in this 
comment are beyond the scope of this rulemaking.

D. Section 16.1--Scope

    Section 16.1(b) (21 CFR 16.1(b)) lists the statutory and regulatory 
provisions that provide for the opportunity for a regulatory hearing. 
Sections 903(a)(8)(B)(ii), 906(e)(1)(B), 910(d)(1), and 911(j) of the 
Tobacco Control Act all provide for the opportunity for a hearing. The 
final rule amends Sec.  16.1 to include certain instances in the 
Tobacco Control Act where an opportunity for a hearing is provided.
    (Comment 3)--One comment requested that FDA also amend part 16 (21 
CFR part 16) to provide an opportunity for a regulatory hearing if FDA 
were to issue a Not Substantially Equivalent (NSE) determination for a 
tobacco product introduced between February 15, 2007, and March 22, 
2011.
    (Response 3)--FDA declines to adopt this change. FDA is amending 
part 16 to incorporate those specific circumstances in which the 
Tobacco Control Act expressly provides for notice and an opportunity 
for hearing. Section 910 of the Tobacco Control Act does not 
specifically provide for notice and an opportunity for hearing with 
respect to NSE orders; therefore, FDA declines to add section 
910(a)(2)(B) to the list of circumstances that provide for a part 16 
hearing.

IV. Analysis of Impacts

A. Introduction and Summary

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 final rule will not be a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the requirements are

[[Page 5173]]

likely to impose a burden on a substantial number of affected small 
entities, the Agency anticipates that the final rule will have a 
significant economic impact on a substantial number of small entities 
and has conducted a Final Regulatory Flexibility Analysis as required 
under the Regulatory Flexibility Act.
    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 $136 million, using the most current (2010) 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.
    FDA has not quantified the benefits of this final rule. This rule 
will impose compliance costs on producers of tobacco products as they 
will be required to comply with recordkeeping requirements according to 
general regulations that apply to other products that FDA regulates. 
FDA updates the estimated costs presented in the proposed rule 
published in the Federal Register of April 14, 2011, to incorporate the 
most recent and publicly available wage rate data. The estimated annual 
costs of complying with these requirements range from $71,201 to 
$374,991.

B. Need for the Regulation

    The Tobacco Control Act grants FDA authority to regulate tobacco 
products, thereby enabling FDA to assess the effects of tobacco 
products on the public health. The final rule ensures tobacco 
manufacturers adhere to the regulations that apply to other FDA-
regulated products sold in the United States and exports of products 
that are not allowed for sale in the United States. The final rule 
clarifies FDA's practices and procedures with respect to voluntary 
recalls of tobacco products. It also guarantees that tobacco product 
manufacturers have the same rights as other FDA-regulated entities, 
where appropriate, such as the right to regulatory hearings.

C. Benefits

    FDA is unable to quantify the benefits of the amendments. Benefits 
will derive from FDA's enhanced ability to carry out its obligations 
and from clarifying certain FDA practices and procedures for tobacco 
product manufacturers.

D. Costs

    Section 7.3(f) clarifies and explains FDA's practices and 
procedures with respect to recalls of tobacco products. FDA concludes 
that tobacco product manufacturers follow recall procedures consistent 
with current regulations and that the amendment to Sec.  7.3(f) will 
not impose additional burdens on tobacco product manufacturers.\1\ The 
revision to Sec.  16.1(b) allows for an informal hearing when FDA is 
considering regulatory actions or decisions related to misbranding, 
good manufacturing practice requirements, or withdrawal of a tobacco 
product. No additional costs are expected to accrue from amendments to 
Sec. Sec.  1.21(c), 7.3(f), and 16.1(b).
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    \1\ In 1995, a major tobacco product manufacturer voluntarily 
recalled a few tobacco product lines when it was found that the 
products might be contaminated. After several investigations a 
Centers for Disease Control and Prevention (CDC) report concluded 
that it was the use of the tobacco product and not the contaminated 
product that caused the health complaints (Ref. 1).
---------------------------------------------------------------------------

    Additional costs will derive from recordkeeping requirements as 
they relate to some tobacco product exports (Sec.  1.101(a) (b)). The 
estimated annual costs range is between $0.07 million and $0.37 
million, as further explained in table 1 of this document.

            Table 1--Total Estimated Costs of the Final Rule
------------------------------------------------------------------------
                                                   Annual cost
              Cost factor              ---------------------------------
                                              Low              High
------------------------------------------------------------------------
Exports of Tobacco Products...........         $71,201         $374,991
------------------------------------------------------------------------

    Section 1.101(a)(b) pertain to recordkeeping of documentation that 
demonstrates that tobacco products not allowed for sale in the United 
States are exported in accordance with appropriate regulations. In 
addition, recordkeeping documents must demonstrate that: (1) The 
product meets the foreign purchaser's specifications, (2) the product 
does not conflict with the laws of the foreign country, (3) correct 
labeling is placed outside of the shipping package, and (4) the product 
is not sold or offered in the United States. These documents are 
required to be retained (Sec.  1.101(b)).
1. Number of Affected Entities
    The U.S. Department of Commerce International Trade Administration 
(ITA) reports that the total number of (manufacturing and non-
manufacturing) U.S. companies exporting tobacco products (North 
American Industry Classification System or NAICS code 3122) to the 
world in 2007 was 158, which includes 30 manufacturers and 125 non-
manufacturers of tobacco products.\2\ Exporting manufacturers represent 
approximately 38 percent of all manufacturing companies reported by the 
2007 Economic Census in this NAICS category (Ref. 3). FDA takes the 
total number of exporting manufacturing companies as a lower bound and 
the total number of exporting (manufacturing and non-manufacturing) 
companies as an upper bound for the total number of respondents that 
will be affected by the final rule.
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    \2\ As firms sometimes export multiple products, a single firm 
can be represented in multiple products; thus, exporter counts may 
not add up to the total (Ref. 2).
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2. Estimated Economic Costs on Affected Entities
    In estimating the burden, FDA uses the number of responses per 
respondent (3), and time per response (22 hours for recordkeeping) \3\ 
from previously reported estimates relating to drugs and medical 
devices (August 7, 2008, 73 FR 46007). In valuing the time cost, FDA 
uses the 2010 median hourly wage of $17.98 for Office and 
Administrative Support Occupations (NAICS code 430000) in the tobacco 
manufacturing industry (NAICS code 312200) as

[[Page 5174]]

reported by the Bureau of Labor Statistics (Ref. 4), plus benefits and 
overhead. Table 2 of this document shows that annual recordkeeping 
costs for all respondents are estimated to be between $0.07 million and 
$0.37 million.
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    \3\ The proposed rule inadvertently listed 2 hours for 
recordkeeping in this section. The total economic effect, however, 
was accurate and the proper number of 22 hours was listed in the 
Paperwork Reduction Act (PRA) section.

                                                   Table 2--Estimated Incremental Burden for Exporters
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                                                                   Responses per                                 Hours per
             Cost factor               Number of  recordkeepers     recordkeeper      Total annual records      recordkeeper      Annual cost low-high
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Recordkeeping........................  30 to 158...............                  3  90 to 474..............                 22  $71,201 to $374,991.
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E. Analysis of Alternatives

    The simplest alternative is to exempt exporters of tobacco products 
from the recordkeeping requirements according to general regulations 
that apply to other exports that FDA regulates. Under this option, 
there would be no immediate compliance costs or benefits. Compliance 
costs for exporters of tobacco products are estimated to be between 
$0.07 million and $0.37 million. The recordkeeping requirements for 
exporters of tobacco products will have the benefit of allowing FDA to 
carry out its obligations and to clarify practices and procedures for 
tobacco product manufacturers.

F. Final Regulatory Flexibility Act Analysis

    FDA has examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act. If a rule will have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act requires Agencies to analyze regulatory 
options that would lessen the economic effect of the rule on small 
entities. This analysis serves as the Final Regulatory Flexibility 
Analysis as required under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
    The Small Business Administration (SBA) uses different definitions 
of what a small entity is for different industries. Using 2009 SBA size 
standard definitions, a firm categorized in NAICS code 312229 (Other 
Tobacco Product Manufacturing) is considered small if it hires fewer 
than 500 employees. On the other hand, firms classified in NAICS code 
312221 (Cigarette Manufacturing) are considered small if they hire 
fewer than 1,000 employees (Ref. 5).
    The most current available data on the number of establishments by 
employee size have not been released for the categories listed 
previously in this document; thus, FDA uses data from the 2002 Economic 
Census (Ref. 6) to determine the number of small entities. FDA notes 
that the data are available at the establishment level rather than at 
the firm level, and assumes that the typical manufacturing 
establishment is roughly equivalent to the typical small manufacturing 
firm. Statistics on the classification of establishments by employment 
size show that in the year 2002, 67 to 99 percent of tobacco 
manufacturing entities had fewer than 1,000 employees and will be 
considered small by SBA. (See table 3 of this document.)

          Table 3--Estimated Number of Small Entities Affected
------------------------------------------------------------------------
                                                         Other tobacco
                                       Cigarette            product
                                     manufacturing       manufacturing
                                    (NAICS 312221)      (NAICS 312229)
------------------------------------------------------------------------
Size Standards in Number of                  < 1,000               < 500
 Employees......................
Total Number of Establishments..                  15                  83
Percent Considered Small........                 67%                 99%
Estimated Number of Affected                       2                  12
 Entities.......................
------------------------------------------------------------------------

    FDA also estimates the percent of small to medium-sized \4\ 
exporting companies to be 15 percent, using industry trade data for 
NAICS code 3122 (Tobacco Products) made available by ITA. The estimated 
number of affected exporting entities is determined by multiplying 0.15 
by the total number of establishments. The estimates indicate that the 
estimated number of affected entities ranges between 2 and 14 
exporters. (See table 3 of this document.)
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    \4\ ITA defines small firms as those with fewer than 100 
employees and medium-sized firms as those that employ from 100 to 
499 workers (Ref. 7).
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2. Economic Effect on Small Entities
    FDA uses the total value of shipments data by employment size from 
the 2002 Economic Census published by the U.S. Bureau of the Census to 
determine the unit cost as a percent of the total value of shipment for 
a typical manufacturer. The analysis of the effect on small versus 
large entities is limited by the U.S. Bureau of the Census data 
restrictions imposed to safeguard the confidentially of some 
establishments in NAICS code 312221. Consequently, the average value of 
shipments is presented for all establishments in NAICS code 312221 and 
for establishments employing 1 to 19 and 20 to 99 employees, 
separately. The average cost per entity is $2,814. It is estimated that 
this average cost as a percent of average value of shipments for small 
entities may be between 0.00 and 0.31 percent (see table 4 of this 
document). The Agency concludes that this final rule will have a 
significant impact on a substantial number of small entities, but the 
impact is uncertain.

[[Page 5175]]

                    Table 4--Estimated Average Value of Shipments for a Typical Manufacturer
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                                                             NAICS
                                --------------------------------------------------------------------------------
Description                      31221..............                    31229
----------------------------------------------------------------------------------------------------------------
Establishment Employee Size....  All................  1 to 19............  20 to 99.
Value of Shipments ($1,000)....  $34,562,900........  $35,979............  $270,348.
Number of Establishments.......  15.................  47.................  20.
Average Value of Shipments       $2,304,193.........  $766...............  $13,517.
 ($1,000).
Unit Cost as Percent of Average  0.00%..............  0.31%..............  0.02%.
 Value of Shipments.
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3. Additional Flexibility Considered
    In this section, we discuss an alternative to reduce costs for 
small entities. Exempting exporters of tobacco products from 
recordkeeping requirements can result in an estimated annual savings of 
0.02 to 0.31 percent of the cost of the value of shipments for small-
sized firms. However, these recordkeeping requirements will provide 
evidence that tobacco product manufacturers export according to 
regulations that apply to other FDA-regulated products.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the PRA (44 U.S.C. 3501-3520). The title, description, and respondent 
description of the information collection provisions are given in the 
following paragraphs with an estimate of the annual recordkeeping 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Further Amendments to General Regulations of the Food and 
Drug Administration to Incorporate Tobacco Product Issues--21 CFR 
1.101.
    Description: On June 22, 2009, the President signed the Tobacco 
Control Act into law. In this rule, 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 Tobacco 
Control Act. The amendments in this rulemaking will subject tobacco 
products to the same general requirements that apply to other FDA-
regulated products, where appropriate.
    This rule amends Sec.  1.101(b), among other sections, to require 
persons who export human drugs, biologics, devices, animal drugs, 
cosmetics, and tobacco products that may not be sold in the United 
States to maintain records demonstrating their compliance with the 
requirements in section 801(e)(1) of the FD&C Act. Section 801(e)(1) 
requires exporters to keep records demonstrating that the exported 
product: (1) Meets with the foreign purchaser's specifications, (2) 
does not conflict with the laws of the foreign country, (3) is labeled 
on the outside of the shipping package that is intended for export, and 
(4) is not sold or offered for sale in the United States. These 
criteria also could be met by maintaining other documentation, such as 
letters from a foreign government Agency or notarized certifications 
from a responsible company official in the United States stating that 
the exported product does not conflict with the laws of the foreign 
country.
    Description of Respondents: Manufacturers, distributors, and other 
persons who export tobacco products not intended for sale in the United 
States.
    Comments: A few comments were received which were beyond the scope 
of this collection of information, did not address PRA issues, and were 
not addressed in this rule.

                                      Table 5--Estimated Annual Recordkeeping Burden Exporters of Tobacco Products
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                                                      Number of       Annual frequency of      Total annual          Hours per
                 21 CFR Section                     recordkeepers        recordkeeping           records            recordkeeper         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(b).......................................                 158                    3                  474                   22               10,428
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Agency estimates the number of respondents and burden hours 
associated with the recordkeeping requirements by reviewing Agency 
records and using Agency expert resources, and conferring with another 
Federal Agency with experience and information regarding tobacco 
product exporters. FDA estimates that between 30 and 158 establishments 
could be involved in the exporting of tobacco products and, based on 
previous recordkeeping estimates in OMB control number 0910-0482, 
``Export Notification and Recordkeeping Requirements,'' each 
establishment may have to maintain records up to 3 times per year, at a 
total of 22 hours per recordkeeper. The Agency estimates between 1,980 
and 10,428 burden hours will be needed for tobacco product exporters to 
create and maintain records demonstrating compliance with section 
801(e)(1) of the FD&C Act. Therefore, FDA estimates that 158 
respondents will require approximately 10,428 hours to comply with the 
requirements of section 801(e)(1) of the FD&C Act.
    The information collection provisions of this final rule have been 
submitted to OMB for review as required by section 3507(d) of the PRA.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

VI. Executive Order 13132: Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that this final 
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 concludes that 
this final rule

[[Page 5176]]

does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VII. References

    The following references have been placed on public display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested parties between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to Web sites after this document publishes 
in the Federal Register).

1. CDC, 1996, ``Recall of Philip Morris Cigarettes, May 1995-March 
1996,'' Morbidity and Mortality Weekly Report, 45(12): 251-254, 
http://www.cdc.gov/mmwr/preview/mmwrhtml/00041035.htm, last accessed 
November 2010.
2. ITA, 2010, ``Industry Trade Data and Analysis,'' http://www.trade.gov/mas/ian/EDB/Reports/2007/table14_allmarkets_allcategories.html, last accessed November 2010.
3. U.S. Census Bureau American FactFinder, 2007, ``Sector 31: 
EC0731I1: Manufacturing: Industry Series: Detailed Statistics by 
Industry for the United States: 2007,'' http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0731I1&-_lang=en, last accessed October 2010.
4. U.S. Bureau of Labor Statistics, 2010, ``Occupational Employment 
Statistics,'' http://www.bls.gov/oes/oes_dl.htm, last accessed June 
13, 2011.
5. SBA, 2010, ``Table of Small Business Size Standards Matched to 
North American Industry Classification System Code,''  http://www.sba.gov/content/table-small-business-size-standards, last 
accessed March 2, 2011.
6. U.S. Census Bureau American FactFinder, 2002, ``2002 Economic 
Census: Sector 31: Manufacturing: Industry Series: Industry 
Statistics by Employment Size: 2002,'' http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0231I4&-_lang=en, 
last accessed October 2010.
7. ITA, http://www.trade.gov/mas/ian/smeoutlook/edbtechnicalnotes/tg_ian_001929.asp, last accessed November 2010.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 7

    Administrative practice and procedure, Consumer protection, 
Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
1, 7, and 16 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 is revised to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 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, 387c, 393; 42 
U.S.C. 216, 241, 243, 262, 264.

0
2. Amend Sec.  1.21 by revising paragraph (a) introductory text and 
paragraph (c)(1) to read as follows:

Sec.  1.21  Failure to reveal material facts.

    (a) Labeling of a food, drug, device, cosmetic, or tobacco product 
shall be deemed to be misleading if it fails to reveal facts that are:
* * * * *
    (c) * * *
    (1) Permit a statement of differences of opinion with respect to 
warnings (including contraindications, precautions, adverse reactions, 
and other information relating to possible product hazards) required in 
labeling for food, drugs, devices, cosmetics, or tobacco products under 
the Federal Food, Drug, and Cosmetic Act.
* * * * *

0
3. Amend Sec.  1.101 by revising paragraph (a) and the heading of 
paragraph (b) to read as follows:

Sec.  1.101  Notification and recordkeeping.

    (a) Scope. This section pertains to notifications and records 
required for human drug, biological product, device, animal drug, food, 
cosmetic, and tobacco product exports under sections 801 or 802 of the 
Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or 
section 351 of the Public Health Service Act (42 U.S.C. 262).
    (b) Recordkeeping requirements for human drugs, biological 
products, devices, animal drugs, foods, cosmetics, and tobacco products 
exported under or subject to section 801(e)(1) of the Federal Food, 
Drug, and Cosmetic Act. * * *
* * * * *

PART 7--ENFORCEMENT POLICY

0
4. The authority citation for part 7 continues to read as follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 
264.

0
5. Amend Sec.  7.3(f) by revising the first sentence to read as 
follows:

Sec.  7.3  Definitions.

* * * * *
    (f) Product means an article subject to the jurisdiction of the 
Food and Drug Administration, including any food, drug, and device 
intended for human or animal use, any cosmetic and biologic intended 
for human use, any tobacco product intended for human use, and any item 
subject to a quarantine regulation under part 1240 of this chapter. * * 
*
* * * * *

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
6. The authority citation for part 16 continues to read as follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
7. Amend Sec.  16.1 by adding new statutory provisions to the end of 
paragraph (b)(1) to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (1) * * *
    Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic 
Act relating to the misbranding of tobacco products.
    Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act 
relating to the establishment of good manufacturing practice 
requirements for tobacco products.
    Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act 
relating to the withdrawal of an order allowing a new tobacco product 
to be introduced or delivered for introduction into interstate 
commerce.
    Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating 
to the withdrawal of an order allowing a modified risk tobacco product 
to be introduced or delivered for introduction into interstate 
commerce.
* * * * *

    Dated: January 27, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2289 Filed 2-1-12; 8:45 am]
BILLING CODE 4160-01-P