Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products, 5171-5176 [2012-2289]
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Federal Register / Vol. 77, No. 22 / Thursday, February 2, 2012 / Rules and Regulations
List of Subjects in 14 CFR Part 71
FOR FURTHER INFORMATION CONTACT:
Scott Enander, Central Service Center,
Operations Support Group, Federal
Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort
Worth, TX 76137; telephone (817) 321–
7716.
SUPPLEMENTARY INFORMATION:
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The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) Part 71 by
changing the airport formerly known as
Jackson County-Reynolds Field to
Jackson County Airport-Reynolds Field,
and adjusting the geographic
coordinates within Class D airspace to
coincide with the FAA’s aeronautical
database. This is an administrative
change and does not affect the
boundaries, altitudes, or operating
requirements of the airspace, therefore,
notice and public procedures under 5
U.S.C. 553(b) are unnecessary.
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the U.S. Code. Subtitle 1,
Section 106, describes the authority of
the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more
detail the scope of the agency’s
authority. This rulemaking is
promulgated under the authority
described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it amends
controlled airspace at Jackson County
Airport-Reynolds Field, Jackson, MI.
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ACTION:
Airspace, Incorporation by reference,
Navigation (air).
subject to the annual revision of FAA
Order 7400.9 and publication of
conforming amendments.
5171
SUMMARY:
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9V, Airspace
Designations and Reporting Points,
dated August 9, 2011, and effective
September 15, 2011, is amended as
follows:
■
Final rule.
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 FDAregulated products.
DATES: This rule is effective April 2,
2012.
FOR FURTHER INFORMATION CONTACT:
Gerie A. Voss, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1 (877) CTP–1373,
gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
Food and Drug Administration
II. Legal Authority
Paragraph 5000
Class D Airspace.
*
*
*
*
*
AGL MI D Jackson, MI [Amended]
Jackson County Airport-Reynolds Field, MI
(Lat. 42°15′38″ N., long. 84°27′38″ W.)
That airspace extending upward from the
surface to and including 3,500 feet MSL
within a 4-mile radius of Jackson County
Airport-Reynolds Field. This Class D airspace
area is effective during the specific dates and
times established in advance by a Notice to
Airmen. The effective date and time will
thereafter be continuously published in the
Airport/Facility Directory.
Issued in Fort Worth, Texas, on January 12,
2012.
Walter L. Tweedy,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2012–1826 Filed 2–1–12; 8:45 am]
BILLING CODE 4910–13–P
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.
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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
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Tobacco Health Education Act of 1986
(CSTHEA) (15 U.S.C. 4402) as amended
by the Tobacco Control Act.
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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 § 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. 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-
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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
§ 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 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 § 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.
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.
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 § 7.3
of the regulations to define ‘‘product’’ to
also include tobacco products.
(Comment 2)—One comment stated
that FDA’s proposed change to § 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 § 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 § 7.3.
A. Introduction and Summary
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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 § 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
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
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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 § 7.3(f) will not
impose additional burdens on tobacco
product manufacturers.1 The 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 will derive from
recordkeeping requirements as they
relate to some tobacco product exports
(§ 1.101(a) (b)). The estimated annual
costs range is between $0.07 million and
$0.37 million, as further explained in
table 1 of this document.
TABLE 1—TOTAL ESTIMATED COSTS OF THE FINAL RULE
Annual cost
Cost factor
Low
Exports of Tobacco Products ..................................................................................................................................
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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 (§ 1.101(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
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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
and not the contaminated product that caused the
health complaints (Ref. 1).
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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High
$71,201
$374,991
(manufacturing and non-manufacturing)
companies as an upper bound for the
total number of respondents that will be
affected by the final 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 (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
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.
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shows that annual recordkeeping costs
for all respondents are estimated to be
reported by the Bureau of Labor
Statistics (Ref. 4), plus benefits and
overhead. Table 2 of this document
between $0.07 million and $0.37
million.
TABLE 2—ESTIMATED INCREMENTAL BURDEN FOR EXPORTERS
Cost factor
Number of
recordkeepers
Responses per
recordkeeper
Recordkeeping ..........
30 to 158 ...................
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
Total annual records
3
Hours per
recordkeeper
90 to 474 ...................
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)
Annual cost low–high
22
$71,201 to $374,991.
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
Cigarette
manufacturing
(NAICS 312221)
Size Standards in Number of Employees ...............................................................................................
Total Number of Establishments .............................................................................................................
Percent Considered Small .......................................................................................................................
Estimated Number of Affected Entities ...................................................................................................
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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
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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exporters. (See table 3 of this
document.)
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
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< 1,000
15
67%
2
Other tobacco
product
manufacturing
(NAICS 312229)
< 500
83
99%
12
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.
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TABLE 4—ESTIMATED AVERAGE VALUE OF SHIPMENTS FOR A TYPICAL MANUFACTURER
NAICS
Description
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 .......................................................................
All ................
$34,562,900
15 ................
$2,304,193 ..
0.00% ..........
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 FDAregulated 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 § 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
31229
1 to 19 .........
$35,979 .......
47 ................
$766 ............
0.31% ..........
20 to 99.
$270,348.
20.
$13,517.
0.02%.
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
Number of
recordkeepers
Annual frequency
of recordkeeping
Total annual
records
Hours per
recordkeeper
Total hours
1.101(b) ........................................
tkelley on DSK3SPTVN1PROD with RULES
21 CFR Section
158
3
474
22
10,428
The Agency estimates the number of
respondents and burden hours
associated with the recordkeeping
requirements by reviewing Agency
records and using Agency expert
resources, and conferring with another
Federal Agency with experience and
information regarding tobacco product
exporters. FDA estimates that between
30 and 158 establishments could be
involved in the exporting of tobacco
products and, based on previous
recordkeeping estimates in OMB control
number 0910–0482, ‘‘Export
Notification and Recordkeeping
Requirements,’’ each establishment may
have to maintain records up to 3 times
per year, at a total of 22 hours per
recordkeeper. The Agency estimates
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15:14 Feb 01, 2012
Jkt 226001
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
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
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
E:\FR\FM\02FER1.SGM
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Federal Register / Vol. 77, No. 22 / Thursday, February 2, 2012 / Rules and Regulations
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, https://www.cdc.gov/
mmwr/preview/mmwrhtml/
00041035.htm, last 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=EC0731I1&-_lang=en, last
accessed October 2010.
4. U.S. Bureau of Labor Statistics, 2010,
‘‘Occupational Employment Statistics,’’
https://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,’’
https://www.sba.gov/content/table-smallbusiness-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,’’ https://factfinder.census.gov/
servlet/IBQTable?_bm=y&-geo_id=&ds_name=EC0231I4&-_lang=en, last
accessed October 2010.
7. ITA, https://www.trade.gov/mas/ian/
smeoutlook/edbtechnicalnotes/
tg_ian_001929.asp, last accessed
November 2010.
List of Subjects
tkelley on DSK3SPTVN1PROD with RULES
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,
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15:14 Feb 01, 2012
Jkt 226001
Reporting and recordkeeping
requirements.
PART 7—ENFORCEMENT POLICY
4. The authority citation for part 7
continues to read as follows:
■
21 CFR Part 16
Administrative practice and
procedure.
Authority: 21 U.S.C. 321–393; 42 U.S.C.
241, 262, 263b–263n, 264.
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:
5. Amend § 7.3(f) by revising the first
sentence to read as follows:
■
§ 7.3
Definitions.
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.
*
*
*
*
(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. * * *
*
*
*
*
*
2. Amend § 1.21 by revising paragraph
(a) introductory text and paragraph
(c)(1) to read as follows:
PART 16—REGULATORY HEARING
BEFORE THE FOOD AND DRUG
ADMINISTRATION
§ 1.21
■
PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. The authority citation for part 1 is
revised to read as follows:
■
■
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.
* * *
*
*
*
*
*
PO 00000
Frm 00022
Fmt 4700
Sfmt 9990
*
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: 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
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02FER1
Agencies
[Federal Register Volume 77, Number 22 (Thursday, February 2, 2012)]
[Rules and Regulations]
[Pages 5171-5176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2289]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 7, and 16
[Docket No. FDA-2011-N-0121]
RIN 0910-AG60
Further Amendments to General Regulations of the Food and Drug
Administration to Incorporate Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending certain of
its general regulations to include tobacco products, where appropriate,
in light of FDA's authority to regulate these products under the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With
these amendments, tobacco products are subject to the same general
requirements that apply to other FDA-regulated products.
DATES: This rule is effective April 2, 2012.
FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1 (877) CTP-1373, gerie.voss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 14, 2011 (76 FR 20901), FDA issued
a proposed rule seeking to amend several provisions of its general
regulations to reflect the Agency's new authority and mandate regarding
tobacco products under the Tobacco Control Act (Pub. L. 11-31; 123
Stat. 1776). FDA received substantive comments to its proposal from
only one commenter. However, FDA does not believe that these comments
warrant making any changes to the regulatory language included in the
proposed rule.
Relevant portions of these comments are summarized and responded to
in the relevant section(s) of this document. To make it easier to
identify comments and FDA's responses, the word ``Comment,'' in
brackets, appears before the comment's description, and the word
``Response,'' in brackets, appears before FDA's response. Each comment
is numbered to help distinguish among different comments. The number
assigned to each comment is purely for organizational purposes and does
not signify the comment's value or importance.
II. Legal Authority
FDA is issuing this final rule under provisions of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Tobacco
Control Act (21 U.S.C. 321, 331, 333, 371, 381, 387, 387a, 387c, 387f,
387j, and 387k). FDA is also issuing this final rule under section 4 of
the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C.
1333) as amended by the Tobacco Control Act, and under section 3 of the
Comprehensive Smokeless
[[Page 5172]]
Tobacco Health Education Act of 1986 (CSTHEA) (15 U.S.C. 4402) as
amended by the Tobacco Control Act.
III. Description of Final Regulations
With this rule, FDA is finalizing several amendments to title 21 of
the Code of Federal Regulations (CFR), reflecting the Agency's
authority over tobacco products under the Tobacco Control Act. The
amendments are described in sections III.A, III.B, and III.C of this
document.
A. Section 1.21--Failure to Reveal Material Facts
Section 1.21(a) (21 CFR 1.21(a)) states that the labeling of FDA-
regulated products shall be deemed misleading if it fails to reveal
facts that are: ``* * * Material in light of other representations made
or suggested by statement, word, design, device or any combination
thereof; or [m]aterial with respect to consequences which may result
from use of the article under: The conditions prescribed in such
labeling or such conditions of use as are customary or usual.'' With
this final rule, FDA is amending Sec. 1.21(a) to provide that tobacco
product labeling also would be deemed misleading for similar failures
to reveal material facts. See section 903(a) of the Tobacco Control Act
(21 U.S.C. 387c(a)) (stating that a tobacco product shall be deemed to
be misbranded if its labeling is false or misleading). See also section
201(n) of the FD&C Act (21 U.S.C. 321(n)).
Section 1.21(c) describes statements that are not permissible on
labeling for FDA-regulated products. For example, paragraph (c)(1)
explains that this regulation does not ``[p]ermit a statement of
differences of opinion with respect to warnings * * *'' on FDA-
regulated products. This final rule amends this section to state that
tobacco product labeling, like the labeling of other FDA-regulated
products, also may not have a statement of differences of opinion
regarding the warnings on tobacco packages or advertisements. This
change is in accordance with sections 201 and 204 of the Tobacco
Control Act, amending the FCLAA, and the CSTHEA, respectively, as well
as section 903(a) generally. FDA already has issued a final rule to
implement section 201 of the Tobacco Control Act, amending 15 U.S.C.
1333. See the Federal Register of June 22, 2011 (76 FR 36628).
B. Section 1.101--Notification and Recordkeeping
Section 1.101 (21 CFR 1.101) outlines the notification and
recordkeeping requirements for exports of FDA-regulated products.
Section 1.101(a) pertains to all notifications and records required for
FDA-regulated products that may be exported under sections 801 or 802
of the FD&C Act (21 U.S.C. 381 and 382) and section 351 of the Public
Health Service Act (42 U.S.C. 262). Because section 103(l) of the
Tobacco Control Act specifically amends section 801 of the FD&C Act to
include ``tobacco products'' on the list of FDA-regulated products that
may be exported under this section, this final rule amends Sec.
1.101(a) and (b) to indicate that tobacco products exported under
section 801(e)(1) of the FD&C Act also would be subject to the
recordkeeping requirements of this regulation. Please note that this
revision to Sec. 1.101(b) does not alter the enforcement policy
described in the advance notice of proposed rulemaking that published
in the Federal Register of June 1, 2004 (69 FR 30842). Thus, with
regard to tobacco products, FDA intends to exercise enforcement
discretion, as it does with exports generally, regarding the
requirement for specific types of records under Sec. 1.101(b)(2)
demonstrating that the exported product is not in conflict with the
foreign country's laws.
(Comment 1)--One comment requested that FDA provide notice and an
opportunity to comment should it propose to end this period of
enforcement discretion as it applies to tobacco products.
(Response 1)--We note, previously, that this revision does not
alter our exercise of enforcement discretion, including with respect to
tobacco products and additional notice and comment with respect to this
issue is not necessary.
C. Section 7.3--Definitions
Section 7.3 (21 CFR 7.3) defines the term ``product'' to include
all the specific items that are subject to FDA's jurisdiction. This
final rule amends Sec. 7.3 of the regulations to define ``product'' to
also include tobacco products.
(Comment 2)--One comment stated that FDA's proposed change to Sec.
7.3 did not take into account the fundamental differences between
tobacco products and other regulated product categories and, therefore,
it should be amended accordingly. This comment also requested that FDA
make additional changes to part 7.
(Response 2)--FDA believes that its change to Sec. 7.3 is
necessary to ensure that tobacco products are subject to the same
general requirements that apply to other FDA-regulated products. The
differences between tobacco products and other regulated products do
not warrant any additional changes to Sec. 7.3. In circumstances where
FDA's requirements apply solely to tobacco products, that is noted in
the appropriate sections of the Agency's regulations. Further, FDA
believes that the other suggested revisions to part 7 included in this
comment are beyond the scope of this rulemaking.
D. Section 16.1--Scope
Section 16.1(b) (21 CFR 16.1(b)) lists the statutory and regulatory
provisions that provide for the opportunity for a regulatory hearing.
Sections 903(a)(8)(B)(ii), 906(e)(1)(B), 910(d)(1), and 911(j) of the
Tobacco Control Act all provide for the opportunity for a hearing. The
final rule amends Sec. 16.1 to include certain instances in the
Tobacco Control Act where an opportunity for a hearing is provided.
(Comment 3)--One comment requested that FDA also amend part 16 (21
CFR part 16) to provide an opportunity for a regulatory hearing if FDA
were to issue a Not Substantially Equivalent (NSE) determination for a
tobacco product introduced between February 15, 2007, and March 22,
2011.
(Response 3)--FDA declines to adopt this change. FDA is amending
part 16 to incorporate those specific circumstances in which the
Tobacco Control Act expressly provides for notice and an opportunity
for hearing. Section 910 of the Tobacco Control Act does not
specifically provide for notice and an opportunity for hearing with
respect to NSE orders; therefore, FDA declines to add section
910(a)(2)(B) to the list of circumstances that provide for a part 16
hearing.
IV. Analysis of Impacts
A. Introduction and Summary
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule will not be a
significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the requirements are
[[Page 5173]]
likely to impose a burden on a substantial number of affected small
entities, the Agency anticipates that the final rule will have a
significant economic impact on a substantial number of small entities
and has conducted a Final Regulatory Flexibility Analysis as required
under the Regulatory Flexibility Act.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
FDA has not quantified the benefits of this final rule. This rule
will impose compliance costs on producers of tobacco products as they
will be required to comply with recordkeeping requirements according to
general regulations that apply to other products that FDA regulates.
FDA updates the estimated costs presented in the proposed rule
published in the Federal Register of April 14, 2011, to incorporate the
most recent and publicly available wage rate data. The estimated annual
costs of complying with these requirements range from $71,201 to
$374,991.
B. Need for the Regulation
The Tobacco Control Act grants FDA authority to regulate tobacco
products, thereby enabling FDA to assess the effects of tobacco
products on the public health. The final rule ensures tobacco
manufacturers adhere to the regulations that apply to other FDA-
regulated products sold in the United States and exports of products
that are not allowed for sale in the United States. The final rule
clarifies FDA's practices and procedures with respect to voluntary
recalls of tobacco products. It also guarantees that tobacco product
manufacturers have the same rights as other FDA-regulated entities,
where appropriate, such as the right to regulatory hearings.
C. Benefits
FDA is unable to quantify the benefits of the amendments. Benefits
will derive from FDA's enhanced ability to carry out its obligations
and from clarifying certain FDA practices and procedures for tobacco
product manufacturers.
D. Costs
Section 7.3(f) clarifies and explains FDA's practices and
procedures with respect to recalls of tobacco products. FDA concludes
that tobacco product manufacturers follow recall procedures consistent
with current regulations and that the amendment to Sec. 7.3(f) will
not impose additional burdens on tobacco product manufacturers.\1\ The
revision to Sec. 16.1(b) allows for an informal hearing when FDA is
considering regulatory actions or decisions related to misbranding,
good manufacturing practice requirements, or withdrawal of a tobacco
product. No additional costs are expected to accrue from amendments to
Sec. Sec. 1.21(c), 7.3(f), and 16.1(b).
---------------------------------------------------------------------------
\1\ In 1995, a major tobacco product manufacturer voluntarily
recalled a few tobacco product lines when it was found that the
products might be contaminated. After several investigations a
Centers for Disease Control and Prevention (CDC) report concluded
that it was the use of the tobacco product and not the contaminated
product that caused the health complaints (Ref. 1).
---------------------------------------------------------------------------
Additional costs will derive from recordkeeping requirements as
they relate to some tobacco product exports (Sec. 1.101(a) (b)). The
estimated annual costs range is between $0.07 million and $0.37
million, as further explained in table 1 of this document.
Table 1--Total Estimated Costs of the Final Rule
------------------------------------------------------------------------
Annual cost
Cost factor ---------------------------------
Low High
------------------------------------------------------------------------
Exports of Tobacco Products........... $71,201 $374,991
------------------------------------------------------------------------
Section 1.101(a)(b) pertain to recordkeeping of documentation that
demonstrates that tobacco products not allowed for sale in the United
States are exported in accordance with appropriate regulations. In
addition, recordkeeping documents must demonstrate that: (1) The
product meets the foreign purchaser's specifications, (2) the product
does not conflict with the laws of the foreign country, (3) correct
labeling is placed outside of the shipping package, and (4) the product
is not sold or offered in the United States. These documents are
required to be retained (Sec. 1.101(b)).
1. Number of Affected Entities
The U.S. Department of Commerce International Trade Administration
(ITA) reports that the total number of (manufacturing and non-
manufacturing) U.S. companies exporting tobacco products (North
American Industry Classification System or NAICS code 3122) to the
world in 2007 was 158, which includes 30 manufacturers and 125 non-
manufacturers of tobacco products.\2\ Exporting manufacturers represent
approximately 38 percent of all manufacturing companies reported by the
2007 Economic Census in this NAICS category (Ref. 3). FDA takes the
total number of exporting manufacturing companies as a lower bound and
the total number of exporting (manufacturing and non-manufacturing)
companies as an upper bound for the total number of respondents that
will be affected by the final rule.
---------------------------------------------------------------------------
\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 (22 hours for recordkeeping) \3\
from previously reported estimates relating to drugs and medical
devices (August 7, 2008, 73 FR 46007). In valuing the time cost, FDA
uses the 2010 median hourly wage of $17.98 for Office and
Administrative Support Occupations (NAICS code 430000) in the tobacco
manufacturing industry (NAICS code 312200) as
[[Page 5174]]
reported by the Bureau of Labor Statistics (Ref. 4), plus benefits and
overhead. Table 2 of this document shows that annual recordkeeping
costs for all respondents are estimated to be between $0.07 million and
$0.37 million.
---------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.............. 22 $71,201 to $374,991.
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. Analysis of Alternatives
The simplest alternative is to exempt exporters of tobacco products
from the recordkeeping requirements according to general regulations
that apply to other exports that FDA regulates. Under this option,
there would be no immediate compliance costs or benefits. Compliance
costs for exporters of tobacco products are estimated to be between
$0.07 million and $0.37 million. The recordkeeping requirements for
exporters of tobacco products will have the benefit of allowing FDA to
carry out its obligations and to clarify practices and procedures for
tobacco product manufacturers.
F. Final Regulatory Flexibility Act Analysis
FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. This analysis serves as the Final Regulatory Flexibility
Analysis as required under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
The Small Business Administration (SBA) uses different definitions
of what a small entity is for different industries. Using 2009 SBA size
standard definitions, a firm categorized in NAICS code 312229 (Other
Tobacco Product Manufacturing) is considered small if it hires fewer
than 500 employees. On the other hand, firms classified in NAICS code
312221 (Cigarette Manufacturing) are considered small if they hire
fewer than 1,000 employees (Ref. 5).
The most current available data on the number of establishments by
employee size have not been released for the categories listed
previously in this document; thus, FDA uses data from the 2002 Economic
Census (Ref. 6) to determine the number of small entities. FDA notes
that the data are available at the establishment level rather than at
the firm level, and assumes that the typical manufacturing
establishment is roughly equivalent to the typical small manufacturing
firm. Statistics on the classification of establishments by employment
size show that in the year 2002, 67 to 99 percent of tobacco
manufacturing entities had fewer than 1,000 employees and will be
considered small by SBA. (See table 3 of this document.)
Table 3--Estimated Number of Small Entities Affected
------------------------------------------------------------------------
Other tobacco
Cigarette product
manufacturing manufacturing
(NAICS 312221) (NAICS 312229)
------------------------------------------------------------------------
Size Standards in Number of < 1,000 < 500
Employees......................
Total Number of Establishments.. 15 83
Percent Considered Small........ 67% 99%
Estimated Number of Affected 2 12
Entities.......................
------------------------------------------------------------------------
FDA also estimates the percent of small to medium-sized \4\
exporting companies to be 15 percent, using industry trade data for
NAICS code 3122 (Tobacco Products) made available by ITA. The estimated
number of affected exporting entities is determined by multiplying 0.15
by the total number of establishments. The estimates indicate that the
estimated number of affected entities ranges between 2 and 14
exporters. (See table 3 of this document.)
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
2. Economic Effect on Small Entities
FDA uses the total value of shipments data by employment size from
the 2002 Economic Census published by the U.S. Bureau of the Census to
determine the unit cost as a percent of the total value of shipment for
a typical manufacturer. The analysis of the effect on small versus
large entities is limited by the U.S. Bureau of the Census data
restrictions imposed to safeguard the confidentially of some
establishments in NAICS code 312221. Consequently, the average value of
shipments is presented for all establishments in NAICS code 312221 and
for establishments employing 1 to 19 and 20 to 99 employees,
separately. The average cost per entity is $2,814. It is estimated that
this average cost as a percent of average value of shipments for small
entities may be between 0.00 and 0.31 percent (see table 4 of this
document). The Agency concludes that this final rule will have a
significant impact on a substantial number of small entities, but the
impact is uncertain.
[[Page 5175]]
Table 4--Estimated Average Value of Shipments for a Typical Manufacturer
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
NAICS
--------------------------------------------------------------------------------
Description 31221.............. 31229
----------------------------------------------------------------------------------------------------------------
Establishment Employee Size.... All................ 1 to 19............ 20 to 99.
Value of Shipments ($1,000).... $34,562,900........ $35,979............ $270,348.
Number of Establishments....... 15................. 47................. 20.
Average Value of Shipments $2,304,193......... $766............... $13,517.
($1,000).
Unit Cost as Percent of Average 0.00%.............. 0.31%.............. 0.02%.
Value of Shipments.
----------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Annual frequency of Total annual Hours per
21 CFR Section recordkeepers recordkeeping records recordkeeper Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(b)....................................... 158 3 474 22 10,428
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Agency estimates the number of respondents and burden hours
associated with the recordkeeping requirements by reviewing Agency
records and using Agency expert resources, and conferring with another
Federal Agency with experience and information regarding tobacco
product exporters. FDA estimates that between 30 and 158 establishments
could be involved in the exporting of tobacco products and, based on
previous recordkeeping estimates in OMB control number 0910-0482,
``Export Notification and Recordkeeping Requirements,'' each
establishment may have to maintain records up to 3 times per year, at a
total of 22 hours per recordkeeper. The Agency estimates between 1,980
and 10,428 burden hours will be needed for tobacco product exporters to
create and maintain records demonstrating compliance with section
801(e)(1) of the FD&C Act. Therefore, FDA estimates that 158
respondents will require approximately 10,428 hours to comply with the
requirements of section 801(e)(1) of the FD&C Act.
The information collection provisions of this final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
VI. Executive Order 13132: Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that this final
rule does not contain policies that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency concludes that
this final rule
[[Page 5176]]
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.
VII. References
The following references have been placed on public display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested parties between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to Web sites after this document publishes
in the Federal Register).
1. CDC, 1996, ``Recall of Philip Morris Cigarettes, May 1995-March
1996,'' Morbidity and Mortality Weekly Report, 45(12): 251-254,
https://www.cdc.gov/mmwr/preview/mmwrhtml/00041035.htm, last 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=EC0731I1&-_lang=en, last accessed October 2010.
4. U.S. Bureau of Labor Statistics, 2010, ``Occupational Employment
Statistics,'' https://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,'' https://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,'' https://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0231I4&-_lang=en,
last 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, 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