Document ID: FDA-2011-N-0121-0001
Agency: fda
Document Type: Proposed Rule
Title: Further Amendments to General Regulations of Food and Drug Administration to Incorporate Tobacco Products
Posted Date: 2011-04-14T04:00Z

[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Proposed Rules]
[Pages 20901-20906]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9044]

[[Page 20901]]

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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: Proposed rule.

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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.

DATES: Submit either electronic or written comments on the proposed 
rule by June 13, 2011. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 (the PRA) by May 16, 2011, 
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0121 and/or Regulatory Information Number (RIN) number 0910-AG60, by 
any of the following methods, except that comments on information 
collection issues under the PRA must be submitted to the Office of 
Regulatory Affairs, Office of Management and Budget (OMB) (see the 
``Paperwork Reduction Act of 1995'' section of this document).

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 No. FDA-2011-N-0121 and RIN 0910-AG60 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., 
Rockville, MD 20850, 1-877-CTP-1373, gerie.voss@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    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 the tobacco industry. In 
order to effectuate these purposes, FDA is seeking to amend several 
provisions of its general regulations to reflect the Agency's new 
authority and mandate regarding tobacco products.

II. Legal Authority

    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, 371, 
381, 387, 387a, 387c, 387f, 387j and 387k); FDA is also issuing this 
proposed 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 Tobacco 
Health Education Act of 1986 (15 U.S.C. 4402) as amended by the Tobacco 
Control Act.

II. Description of Proposed Regulations

    FDA proposes to make the following amendments to title 21 of the 
Code of Federal Regulations (CFR), reflecting the Agency's authority 
over tobacco products under the Tobacco Control Act:
    1. Add ``tobacco products'' to the list of products covered by 
Sec.  1.21(a) and (c)(1) (21 CFR 1.21(a) and (c)(1)) and Sec.  1.101(a) 
and (b) (21 CFR 1.101(a) and (b));
    2. Revise the definition of ``product'' in Sec.  7.3(f) (21 CFR 
7.3(f)) to include tobacco products; and
    3. Revise Sec.  16.1(b) (21 CFR 16.1(b)) to add provisions from the 
Tobacco Control Act that allow for hearings.

A. Section 1.21--Failure To Reveal Material Facts

    Section 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.'' FDA is proposing to 
amend 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. The proposed rule would amend this paragraph 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 initiated a rulemaking 
proceeding to implement section 201 of the Tobacco Control Act, 
amending 15 U.S.C. 1333). See the Federal Register of November 12, 2010 
(75 FR 69524).

B. Section 1.101--Notification and Recordkeeping

    Section 1.101 outlines the notification and recordkeeping 
requirements for exports of FDA-regulated products.

[[Page 20902]]

Section 1.101(a) pertains to all notifications and records required for 
FDA-regulated products that may be exported under section 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, the proposed rule would amend 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 exercise of enforcement 
discretion described in the advance notice of proposed rulemaking that 
published in the Federal Register of June 1, 2004 (69 FR 30842).

C. Section 7.3--Definitions

    Section 7.3 defines the term ``product'' to include all the 
specific items that are subject to FDA's jurisdiction. The proposed 
change to Sec.  7.3 of the regulations would define ``product'' to also 
include tobacco products.

D. Section 16.1--Scope

    Section 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 proposed 
rule would amend Sec.  16.1 to include certain instances in the Tobacco 
Control Act where an opportunity for a hearing is provided.

IV. Analysis of Impacts

A. Introduction and Summary

    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 as defined by 
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 requirements are likely to 
impose a burden on a substantial number of affected small entities, the 
Agency proposes to certify that the final rule will have a significant 
economic impact on a substantial number of small entities and has 
conducted an Initial 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 $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.
    FDA has not quantified the benefits of this proposed rule. This 
proposed rule would impose compliance costs on producers of tobacco 
products as they would have to comply with recordkeeping requirements 
according to general regulations that apply to other products that FDA 
regulates. The estimated annual costs of complying with these 
requirements range from $71,438 to $376,242.

B. Need for the Proposed Rule

    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 proposed amendments would ensure 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 proposed 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 proposed amendments. 
Benefits would 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 tentatively 
concludes that tobacco product manufacturers follow recall procedures 
consistent with current regulations and that the proposed amendment to 
Sec.  7.3(f) would not impose additional burdens on tobacco product 
manufacturers.\1\ The proposed 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 would derive from recordkeeping requirements as 
they relate to some tobacco product exports (Sec. Sec.  1.101(a) and 
(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 Rule
------------------------------------------------------------------------
                                                        Annual cost
                   Cost factor                   -----------------------
                                                      Low        High
------------------------------------------------------------------------
Exports of Tobacco Products.....................    $71,438    $376,242
------------------------------------------------------------------------

    Sections 1.101(a) and (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

[[Page 20903]]

(manufacturing and nonmanufacturing) 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 nonmanufacturers 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 
nonmanufacturing) companies as an upper bound for the total number of 
respondents that would be affected by the proposed 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 (2 hours for recordkeeping) from 
previously reported estimates relating to drugs and medical devices (73 
FR 46007, August 7, 2008). In valuing the time cost, FDA uses the 2009 
median hourly wage of $18.04 for Office and Administrative Support 
Occupations (Standard Occupational Classification code 430000) in the 
tobacco manufacturing industry (NAICS code 312200) as 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.

                                                   Table 2--Estimated Incremental Burden for Exporters
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                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................               2  $71,438 to $376,242.
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E. Analysis of Alternatives

    The simplest alternative would be to exempt exporters of tobacco 
products from the proposed 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 proposed 
recordkeeping requirements for exporters of tobacco products would have 
the benefit of allowing FDA to carry out its obligations and to clarify 
practices and procedures for tobacco product manufacturers.

F. Initial Regulatory Flexibility Act Analysis

    FDA has examined the economic implications of this proposed 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 Initial Regulatory Flexibility 
Analysis as required under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
    The U.S. 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; 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 would 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 \3\ 
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 would range between 2 and 12 
exporters. (See table 3 of this document.)
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    \3\ 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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[[Page 20904]]

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). The Agency 
tentatively concludes that this proposed rule would have a significant 
economic impact on a substantial number of small entities, but the 
impact is uncertain.

                    Table 4--Estimated Average Value of Shipments for a Typical Manufacturer
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
          Description                                                 NAICS
                               ---------------------------------------------------------------------------------
                                           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         0.00%.....................  0.31%....................  0.02%.
 Average Value of Shipments.
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3. Additional Flexibility Considered
    In this section, we discuss an alternative that would present 
possible reductions in costs which would be channeled through small 
entities. Exempting exporters of tobacco products from recordkeeping 
requirements would 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 would provide evidence 
that tobacco product manufacturers export according to regulations that 
apply to other FDA-regulated products.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A 
description of these provisions is 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.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    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 proposed 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 proposed rulemaking will 
subject tobacco products to the same general requirements that apply to 
other FDA-regulated products, where appropriate.
    This proposed rule would amend 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.

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

    The Agency estimated 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

[[Page 20905]]

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. Therefore, 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.

VI. Executive Order 13132: Federalism

    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 tentatively concludes 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.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h), (i), and (k) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

VIII. Comments

    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.

IX. 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): pp. 251-254, 
http://www.cdc.gov/mmwr/preview/mmwrhtml/00041035.htm, 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=EC0231I4&-_lang=en, accessed October 2010.
4. U.S. Bureau of Labor Statistics, 2009, ``Occupational Employment 
Statistics,'' http://data.bls.gov/oes, accessed October 15, 2010.
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, 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, 
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, it is 
proposed that 21 CFR parts 1, 7, and 16 be amended 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. 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.

    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.
* * * * *
    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

    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.

    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,

[[Page 20906]]

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

    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.

    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: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9044 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P