[Federal Register Volume 77, Number 22 (Thursday, February 2, 2012)]
[Rules and Regulations]
[Pages 5171-5176]
[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<EMAIL_ADDRESS>
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

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

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).
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    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
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                                                   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

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
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                                                         Other tobacco
                                       Cigarette            product
                                     manufacturing       manufacturing
                                    (NAICS 312221)      (NAICS 312229)
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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.

                    Table 4--Estimated Average Value of Shipments for a Typical Manufacturer
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                                                             NAICS
                                --------------------------------------------------------------------------------
Description                      31221..............                    31229
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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
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1.101(b).......................................                 158                    3                  474                   22               10,428
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    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

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


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on May 3, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2006-24635

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  AVIATION SKYSERVICE INC. (Skyservice)		 	           Date
Filed:  Filed orally on April 20, 2006,

                                                                 and
confirmed in writing on April 25, 2006

Relief requested:  Exemption from 49 USC § 40109(g) to permit the
applicant to operate one, one-way, medical evacuation flight on behalf
of International SOS Assistance,  from St. Croix, U.S. Virgin Islands,
to Miami, Florida, on April 20, 2006.  The applicant states that the
flight would carry one patient and accompanying medical personnel.  The
applicant asserts International SOS Assistance needs the subject lift to
transport a U.S. citizen having a high-risk pregnancy and requiring
immediate medical treatment in Miami; that International SOS Assistance
advised it that no U.S. carrier having the necessary equipment and
personnel was available to operate this flight; and that Aviation
Skyservice has an air ambulance aircraft equipped with a neonatal
incubator for use in the event of an onboard delivery.

Applicant representative:  Don H. Hainbach,<PHONE_NUMBER>
DOT analyst:  Robert J. Finamore,<PHONE_NUMBER>

Responsive pleadings:  None.

Statutory Standards:  Under 49 USC § 40109(g), we may authorize a
foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 USC § 41102; that all possible
efforts have been made to place the traffic on U.S. carriers; and that
the transportation is necessary to avoid unreasonable hardship to the
traffic involved (an additional required finding, concerning emergency
transportation during labor disputes, was not relevant here).

DISPOSITION

Action: Approved.

Action date: April 20, 2006

Effective date of authority granted: April 20, 2006

Basis for approval:  On April 20, 2006, we orally granted Skyservice’s
request to operate the proposed one-way flight (described above), on
behalf of International SOS Assistance, and we confirm that action here.
 In taking our action of April 20, 2006, we found that the applicant’s
request met all the relevant criteria of 49 USC § 40109(g) for the
grant of an exemption of this type, and that the grant was required in
the public interest.  Specifically, we were persuaded that the need to
move the patient from St. Croix for immediate medical treatment in Miami
constituted an emergency not arising in the normal course of business.
Moreover, based on the information provided by International SOS
Assistance, we concluded that no U.S. carrier had aircraft available
that could be used to conduct the operations at issue here.  We also
found that grant of this authority would prevent unreasonable hardship
to the patient needing immediate treatment.  Finally, we found that the
applicant was qualified to perform its proposed operations.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached).

Action taken by:        				Michael W. Reynolds

Acting Assistant Secretary for Aviation

and International Affairs

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                       		       ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


Comment Info: =================

General Comment:I formally request an extension of the comment period, from 75 days to 365 days (under 21 CFR 10.40), as the significant number of items I plan on commenting on requires a substantial amount of time and research on my part to collect, analyze and document.


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Page 21236]
[FR Doc No: 2014-08402]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-135-000]

East Cheyenne Gas Storage, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on April 4, 2014, East Cheyenne Gas Storage, LLC
(East Cheyenne), 10370 Richmond Avenue, Suite 510, Houston, Texas
77042, filed in Docket No. CP14-135-000, a prior notice request
pursuant to sections 157.205 and 157.213 of the Commission's
regulations under the Natural Gas Act (NGA). East Cheyenne seeks
authorization to convert its well WP-D003-2 in Logan County, Colorado,
currently certificated as an injection/withdrawal well, to an
observation well. East Cheyenne proposes to perform these activities
under its blanket certificate issued in Docket No. CP10-34-000 [132
FERC ] 61,097 (2010)], all as more fully set forth in the application
which is on file with the Commission and open to public inspection.
    The filing may be viewed on the web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
James Hoff, Vice President, Reservoir Engineering, East Cheyenne Gas
Storage, LLC, 10370 Richmond Avenue, Suite 510, Houston, Texas 77042,
or by calling<PHONE_NUMBER> (telephone) or<PHONE_NUMBER> (fax)
<EMAIL_ADDRESS>    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. See, 18CFR 385.2001(a) (1) (iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.

    Dated: April 8, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-08402 Filed 4-14-14; 8:45 am]
BILLING CODE 6717-01-P