Further Amendments to General Regulations of the Food and Drug Administration To Incorporate Tobacco Products, 20901-20906 [2011-9044]
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Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules
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.
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).
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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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.
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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 https://
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 https://
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:
20901
products under the Tobacco Control
Act:
1. Add ‘‘tobacco products’’ to the list
of products covered by § 1.21(a) and
(c)(1) (21 CFR 1.21(a) and (c)(1)) and
§ 1.101(a) and (b) (21 CFR 1.101(a) and
(b));
2. Revise the definition of ‘‘product’’
in § 7.3(f) (21 CFR 7.3(f)) to include
tobacco products; and
3. Revise § 16.1(b) (21 CFR 16.1(b)) to
add provisions from the Tobacco
Control Act that allow for hearings.
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.
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 § 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 FDAregulated 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).
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
B. Section 1.101—Notification and
Recordkeeping
Section 1.101 outlines the notification
and recordkeeping requirements for
exports of FDA-regulated products.
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.
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Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules
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
§ 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 § 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 § 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 § 16.1 to include
certain instances in the Tobacco Control
Act where an opportunity for a hearing
is provided.
IV. Analysis of Impacts
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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
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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 FDAregulated 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
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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 § 7.3(f) would not impose
additional burdens on tobacco product
manufacturers.1 The proposed revision
to § 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 §§ 1.21(c), 7.3(f), and
16.1(b).
Additional costs would derive from
recordkeeping requirements as they
relate to some tobacco product exports
(§§ 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
Exports of Tobacco
Products ................
High
$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 (§ 1.101(b)).
1. Number of Affected Entities
The U.S. Department of Commerce
International Trade Administration
(ITA) reports that the total number of
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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(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.
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).
20903
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
recordkeeper
Cost factor
Number of
recordkeepers
Recordkeeping ...............................................
30 to 158 ............
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
3
Total
annual records
Hours per
recordkeeper
90 to 474 ............
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,
2
Annual cost
low—high
$71,438 to $376,242.
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
Cigarette
manufacturing
(NAICS 312221)
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Size Standards in Number of Employees ...................................................................................................
Total Number of Establishments .................................................................................................................
Percent Considered Small ...........................................................................................................................
Estimated Number of Affected Entities .......................................................................................................
< 1,000
15
67%
2
Other
tobacco product
manufacturing
(NAICS 312229)
< 500
83
99%
12
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.)
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).
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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Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules
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
Establishment Employee Size ............................................................................
Value of Shipments ($1,000) ..............................................................................
Number of Establishments .................................................................................
Average Value of Shipments ($1,000) ...............................................................
Unit Cost as Percent of Average Value of Shipments .......................................
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
31229
All ...........................
$34,562,900 ...........
15 ...........................
$2,304,193 .............
0.00% .....................
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 FDAregulated products, where appropriate.
1 to 19 ...................
$35,979 ..................
47 ...........................
$766 .......................
0.31% .....................
20 to 99.
$270,348.
20.
$13,517.
0.02%.
This proposed rule would amend
§ 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.
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TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN EXPORTERS OF TOBACCO PRODUCTS
21 CFR section
Number of
recordkeepers
Annual
frequency of
recordkeeping
Total annual
records
Hours per
recordkeeper
Total hours
1.101(b) ................................................................................
158
3
474
22
10,428
The Agency estimated the number of
respondents and burden hours
associated with the recordkeeping
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requirements by reviewing Agency
records and using Agency expert
resources, and conferring with another
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Federal Agency with experience and
information regarding tobacco product
exporters. FDA estimates that between
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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.
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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
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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, https://
www.cdc.gov/mmwr/preview/
mmwrhtml/00041035.htm, accessed
November 2010.
2. ITA, 2010, ‘‘Industry Trade Data and
Analysis,’’ https://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,’’ https://
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,’’
https://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,’’
https://www.sba.gov/content/table-smallbusiness-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,’’
https://factfinder.census.gov/servlet/
IBQTable?_bm=y&-geo_id=&-ds_name=
EC0231I4&-_lang=en, accessed October
2010.
7. ITA, https://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:
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
20905
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 § 1.21 by revising paragraph
(a) introductory text and paragraph
(c)(1) to read as follows:
§ 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 § 1.101 by revising
paragraph (a) and the heading of
paragraph (b) to read as follows:
§ 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 § 7.3(f) by revising the first
sentence to read as follows:
§ 7.3
Definitions.
*
*
*
*
*
(f) Product means an article subject to
the jurisdiction of the Food and Drug
Administration, including any food,
E:\FR\FM\14APP1.SGM
14APP1
20906
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules
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 § 16.1 by adding new
statutory provisions to the end of
paragraph (b)(1) to read as follows:
§ 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
POSTAL REGULATORY COMMISSION
39 CFR Part 3050
mstockstill on DSKH9S0YB1PROD with PROPOSALS
[Docket No. RM2011–9; Order No. 713]
Periodic Reporting
Postal Regulatory Commission.
Notice of proposed rulemaking;
availability of rulemaking petition.
AGENCY:
ACTION:
The Commission is
establishing a docket to consider a
proposed change in certain analytical
SUMMARY:
VerDate Mar<15>2010
17:31 Apr 13, 2011
Jkt 223001
methods used in periodic reporting.
This action responds to a Postal Service
rulemaking petition. Establishing this
docket will allow the Commission to
consider the Postal Service’s proposal
and comments from the public.
DATES: Comments are due: May 9, 2011.
ADDRESSES: Submit comments
electronically by accessing the ‘‘Filing
Online’’ link in the banner at the top of
the Commission’s Web site (https://
www.prc.gov) or by directly accessing
the Commission’s Filing Online system
at https://www.prc.gov/prc-pages/filingonline/login.aspx. Commenters who
cannot submit their views electronically
should contact the person identified in
FOR FURTHER INFORMATION CONTACT
section as the source for case-related
information for advice on alternatives to
electronic filing.
FOR FURTHER INFORMATION CONTACT:
Stephen L. Sharfman, General Counsel,
at 202–789–6820 (case-related
information) or DocketAdmins@prc.gov
(electronic filing assistance).
SUPPLEMENTARY INFORMATION: On April
6, 2011, the Postal Service filed a
petition pursuant to 39 CFR 3050.11
asking the Commission to initiate an
informal rulemaking proceeding to
consider changes in the analytical
methods approved for use in periodic
reporting.1
Proposal One 2 would propose to
modify the attribution of costs for Fee
Group E Post Office Boxes so that the
costs are considered institutional rather
than as part of the attributable costs of
Post Office Box Service. The Postal
Service asserts that its aim is to achieve
more equitable financing of Fee Group
E Post Office Boxes. It notes that the
proposal has no impact on the
methodology for the calculation of costs
for Fee Group E Post Office Boxes. Id.
at 1.
The Postal Service states that under
this proposal, Group E costs would be
paid for by all mailers, not just post
office box holders. It maintains that the
Group E costs methodology remains
consistent with Docket No. ACR2010
and Docket No. MC2010–20. Id.
Attachment at 1.
The Attachment to the Postal
Service’s Petition explains its proposal
in more detail, including its
background, objective, rationale, and
estimated impact. The Petition,
1 Petition of the United States Postal Service
Requesting Initiation of a Proceeding to Consider
Proposed Changes in Analytic Principles (Proposal
One), April 6, 2011 (Petition).
2 This is the first proposal filed after the FY 2010
Annual Compliance Report. It is the Postal Service’s
current practice to restart its proposal numbering
sequence.
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
including the attachments, is available
for review on the Commission’s Web
site, https://www.prc.gov.
Pursuant to 39 U.S.C. 505, James F.
Callow is designated as Public
Representative to represent the interests
of the general public in this proceeding.
Comments are due no later than May 9,
2011.
It is ordered:
1. The Petition of the United States
Postal Service Requesting Initiation of a
Proceeding to Consider Proposed
Changes in Analytic Principles
(Proposal One), filed April 6, 2011, is
granted.
2. The Commission establishes Docket
No. RM2011–9 to consider the matters
raised by the Postal Service’s Petition.
3. Interested persons may submit
comments on Proposal One no later
than May 9, 2011.
4. The Commission will determine the
need for reply comments after review of
the initial comments.
5. James F. Callow is appointed to
serve as the Public Representative to
represent the interests of the general
public in this proceeding.
6. The Secretary shall arrange for
publication of this Notice in the Federal
Register.
By the Commission.
Shoshana M. Grove,
Secretary.
[FR Doc. 2011–9058 Filed 4–13–11; 8:45 am]
BILLING CODE 7710–FW–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2010–0998; FRL–9295–4]
Approval and Promulgation of Air
Quality Implementation Plans; Indiana
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
a request submitted by the Indiana
Department of Environmental
Management on November 24, 2010, to
revise the Indiana State Implementation
Plan (SIP) under the Clean Air Act.
Indiana submitted revisions to the
particulate matter (PM) and sulfur
dioxide (SO2) limits for Cargill,
Incorporated (Cargill) at its facility in
Hammond (Lake County), Indiana.
Indiana’s SO2 revisions tighten emission
limits for some existing units at Cargill’s
Hammond facility and remove the
references to other emission units that
are no longer in operation, in
SUMMARY:
E:\FR\FM\14APP1.SGM
14APP1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping.................... 30 to 158................. 3 90 to 474................ 2 $71,438 to $376,242.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.)
---------------------------------------------------------------------------
\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.
----------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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,
https://www.cdc.gov/mmwr/preview/mmwrhtml/00041035.htm, accessed
November 2010.
2. ITA, 2010, ``Industry Trade Data and Analysis,'' https://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,'' https://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,'' https://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,'' https://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,'' https://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0231I4&-_lang=en,
accessed October 2010.
7. ITA, https://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
