Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules 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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2011–N–0121 and RIN 

0910–AG60 for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Gerie A. Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–CTP–1373, 

gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Tobacco Control Act was enacted 

on June 22, 2009, amending the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) and providing FDA with the 

authority to regulate tobacco products 

(Pub. L. 11–31; 123 Stat. 1776). In 

enacting the Tobacco Control Act, 

Congress sought to ensure that FDA had 

authority to provide effective oversight 

and to impose appropriate regulatory 

controls on the tobacco industry. In 

order to effectuate these purposes, FDA 

is seeking to amend several provisions 

of its general regulations to reflect the 

Agency’s new authority and mandate 

regarding tobacco products. 

II. Legal Authority 

FDA is issuing this proposed rule 

under provisions of the FD&C Act, as 

amended by the Tobacco Control Act 

(21 U.S.C. 321, 331, 333, 371, 381, 387, 

387a, 387c, 387f, 387j and 387k); FDA 

is also issuing this proposed rule under 

section 4 of the Federal Cigarette 

Labeling and Advertising Act (FCLAA) 

(15 U.S.C. 1333) as amended by the 

Tobacco Control Act and under section 

3 of the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 

(15 U.S.C. 4402) as amended by the 

Tobacco Control Act. 

II. Description of Proposed Regulations 

FDA proposes to make the following 

amendments to title 21 of the Code of 

Federal Regulations (CFR), reflecting the 

Agency’s authority over tobacco 

products under the Tobacco Control 

Act: 

1. Add ‘‘tobacco products’’ to the list 

of products covered by § 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. 

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). 

B. Section 1.101—Notification and 

Recordkeeping 

Section 1.101 outlines the notification 

and recordkeeping requirements for 

exports of FDA-regulated products. 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

20902 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules 

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). 

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 

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 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 

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

Cost factor 

Annual cost 

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 (§ 1.101(b)). 

1. Number of Affected Entities 

The U.S. Department of Commerce 

International Trade Administration 

(ITA) reports that the total number of 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules 20903 

2As 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). 

(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). 

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

Cost factor Number of 

recordkeepers 

Responses 

per 

recordkeeper 

Total 

annual records 

Hours per 

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

Cigarette 

manufacturing 

(NAICS 312221) 

Other 

tobacco product 

manufacturing 

(NAICS 312229) 

Size Standards in Number of Employees ................................................................................................... < 1,000 < 500 

Total Number of Establishments ................................................................................................................. 15 83 

Percent Considered Small ........................................................................................................................... 67% 99% 

Estimated Number of Affected Entities ....................................................................................................... 2 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.) 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

20904 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 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 ($1,000) ............................................................... $2,304,193 ............. $766 ....................... $13,517. 

Unit Cost as Percent of Average Value of Shipments ....................................... 0.00% ..................... 0.31% ..................... 0.02%. 

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 FDAregulated products, where appropriate. 

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. 

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 

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 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules 20905 

30 and 158 establishments could be 

involved in the exporting of tobacco 

products and, based on previous 

recordkeeping estimates in OMB control 

number 0910–0482, ‘‘Export Notification 

and Recordkeeping Requirements,’’ each 

establishment may have to maintain 

records up to 3 times per year, at a total 

of 22 hours per recordkeeper. Therefore, 

the Agency estimates between 1,980 and 

10,428 burden hours will be needed for 

tobacco product exporters to create and 

maintain records demonstrating 

compliance with section 801(e)(1) of the 

FD&C Act. Therefore, FDA estimates 

that 158 respondents will require 

approximately 10,428 hours to comply 

with the requirements of section 

801(e)(1) of the FD&C Act. 

VI. Executive Order 13132: Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would have substantial direct 

effects on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, the Agency tentatively 

concludes that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. Environmental Impact 

The Agency has determined under 21 

CFR 25.30(h), (i), and (k) that this action 

is of a type that does not individually 

or cumulatively have a significant effect 

on the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VIII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IX. References 

The following references have been 

placed on public display in the Division 

of Dockets Management (see 

ADDRESSES), and may be seen by 

interested parties between 9 a.m. and 4 

p.m., Monday through Friday. (FDA has 

verified the Web site addresses, but FDA 

is not responsible for any subsequent 

changes to Web sites after this 

document publishes in the Federal 

Register. 

1. CDC, 1996, ‘‘Recall of Philip Morris 

Cigarettes, May 1995–March 1996,’’ 

Morbidity and Mortality Weekly Report, 

45(12): pp. 251–254, http:// 

www.cdc.gov/mmwr/preview/ 

mmwrhtml/00041035.htm, accessed 

November 2010. 

2. ITA, 2010, ‘‘Industry Trade Data and 

Analysis,’’ http://www.trade.gov/mas/

ian/EDB/Reports/2007/

table14_allmarkets_allcategories.html, 

last accessed November 2010. 

3. U.S. Census Bureau American FactFinder, 

2007, ‘‘Sector 31: EC0731I1: 

Manufacturing: Industry Series: Detailed 

Statistics by Industry for the United 

States: 2007,’’ http:// 

factfinder.census.gov/servlet/ 

IBQTable?_bm=y&-geo_id=&-ds_name=

EC0231I4&-_lang=en, accessed October 

2010. 

4. U.S. Bureau of Labor Statistics, 2009, 

‘‘Occupational Employment Statistics,’’ 

http://data.bls.gov/oes, accessed October 

15, 2010. 

5. SBA, 2010, ‘‘Table of Small Business Size 

Standards Matched to North American 

Industry Classification System Code,’’ 

http://www.sba.gov/content/table-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,’’ 

http://factfinder.census.gov/servlet/ 

IBQTable?_bm=y&-geo_id=&-ds_name=

EC0231I4&-_lang=en, accessed October 

2010. 

7. ITA, http://www.trade.gov/mas/ian/

smeoutlook/edbtechnicalnotes/tg_ian

_001929.asp, last accessed November 

2010. 

List of Subjects 

21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

21 CFR Part 7 

Administrative practice and 

procedure, Consumer protection, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 16 

Administrative practice and 

procedure. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR parts 1, 7, and 16 be amended 

as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

1. The authority citation for part 1 is 

revised to read as follows: 

Authority: 15 U.S.C. 1333, 1453, 1454, 

1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 

321, 331, 333, 334, 335a, 343, 350c, 350d, 

352, 355, 360b, 362, 371, 374, 381, 382, 387, 

387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 

264. 

2. Amend § 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, 

mstockstill on DSKH9S0YB1PROD with PROPOSALS

20906 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Proposed Rules 

1Petition of the United States Postal Service 

Requesting Initiation of a Proceeding to Consider 

Proposed Changes in Analytic Principles (Proposal 

One), April 6, 2011 (Petition). 

2This 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. 

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 

[Docket No. RM2011–9; Order No. 713] 

Periodic Reporting 

AGENCY: Postal Regulatory Commission. 

ACTION: Notice of proposed rulemaking; 

availability of rulemaking petition. 

SUMMARY: The Commission is 

establishing a docket to consider a 

proposed change in certain analytical 

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 (http:// 

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, 

including the attachments, is available 

for review on the Commission’s Web 

site, http://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 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: 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 

mstockstill on DSKH9S0YB1PROD with PROPOSALS