73984 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 14, and 17 

[Docket No. FDA–2010–N–0560] 

RIN 0910–AG55 

Amendments to General Regulations 

of the Food and Drug Administration 

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. This proposed 

rule is a companion document to the 

direct final rule published elsewhere in 

this issue of the Federal Register. 

DATES: Submit either electronic or 

written comments by February 14, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0560 and/or RIN number 0910–AG55, 

by any of the following methods: 

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 number and Regulatory 

Information Number (RIN) 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., 

rm. 240G, Rockville, MD 20850, 1–877– 

CTP–1373, gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why is this rule being issued as a 

companion proposed rule? 

This proposed rule is a companion to 

the direct final rule regarding 

amendments to general regulations that 

is published in the final rules section of 

this issue of the Federal Register. The 

direct final rule and this companion 

proposed rule are identical. This 

companion proposed rule provides the 

procedural framework to finalize the 

rule in the event that the direct final 

rule receives any significant adverse 

comment and is withdrawn. We are 

publishing the direct final rule because 

the rule is noncontroversial, and we do 

not anticipate that it will receive any 

significant adverse comments. If no 

significant adverse comment is received 

in response to the direct final rule, no 

further action will be taken related to 

this proposed rule. Instead, we will 

publish a confirmation document 

within 30 days after the comment 

period ends confirming when the direct 

final rule will go into effect. 

If we receive any significant adverse 

comment regarding the direct final rule, 

we will withdraw the direct final rule 

within 30 days after the comment 

period ends and proceed to respond to 

all of the comments under this 

companion proposed rule using usual 

notice-and-comment rulemaking 

procedures under the Administrative 

Procedure Act (APA) (5 U.S.C. 553). The 

comment period for this companion 

proposed rule runs concurrently with 

the direct final rule’s comment period. 

Any comments received under this 

companion proposed rule will also be 

considered as comments regarding the 

direct final rule. 

A significant adverse comment is 

defined as a comment that explains why 

the rule would be inappropriate, 

including challenges to the rule’s 

underlying premise or approach, or 

would be ineffective or unacceptable 

without a change. In determining 

whether an adverse comment is 

significant and warrants terminating a 

direct final rulemaking, we will 

consider whether the comment raises an 

issue serious enough to warrant a 

substantive response in a notice-andcomment process in accordance with 

the APA. Comments that are frivolous, 

insubstantial, or outside the scope of the 

rule will not be considered significant 

or adverse under this procedure. For 

example, a comment recommending an 

additional change to the rule will not be 

considered a significant adverse 

comment, unless the comment states 

why the rule would be ineffective 

without the additional change. In 

addition, if a significant adverse 

comment applies to part of a rule and 

that part can be severed from the 

remainder of the rule, we may adopt as 

final those parts of the rule that are not 

the subject of a significant adverse 

comment. 

You can find additional information 

about FDA’s direct final rulemaking 

procedures in the guidance document 

entitled ‘‘Guidance for FDA and 

Industry: Direct Final Rule Procedures’’ 

(62 FR 62466, November 21, 1997). This 

guidance document may be accessed at 

http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

II. What is the background of the rule? 

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 tobacco products. In order to 

effectuate these purposes, FDA is 

amending several provisions of its 

general regulations to reflect the 

Agency’s new authority and mandate 

regarding tobacco products. 

III. What does this companion 

proposed rule do? 

FDA proposes to make the following 

amendments to its existing general 

regulations, reflecting the Agency’s 

authority over tobacco products under 

the Tobacco Control Act: 

1. Revising 21 CFR 1.1(b) to ensure 

the applicability of definitions 

contained in the Tobacco Control Act; 

2. Removing the reference to 

‘‘package’’ in 21 CFR 1.1(c), as this 

definition now also is covered by the 

Tobacco Control Act and is no longer 

provided solely by the Fair Packaging 

and Labeling Act; 

3. Revising 21 CFR 1.20 to exclude 

from this definition of ‘‘package’’ the 


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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Proposed Rules 73985 

term ‘‘package’’ as defined in section 

900(13) of the Tobacco Control Act (21 

U.S.C. 387q(13)); 

4. Adding paragraph (f) to 21 CFR 

14.55 to identify the Tobacco Products 

Scientific Advisory Committee as a 

permanent statutory advisory 

committee; and 

5. Adding paragraph (j) to 21 CFR 17.1 

and revising 21 CFR 17.2 to reflect 

FDA’s authority to impose civil 

monetary penalties on tobacco-related 

violations. 

IV. What is the legal authority for this 

proposed rule? 

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, 387, 387a, and 

387q). 

V. What is the environmental impact of 

this proposed rule? 

The Agency has determined under 21 

CFR 25.30(h) and (i) 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. 

VI. What is the economic impact of this 

proposed rule? 

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 

under 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 rule 

would not impose any new 

requirements on tobacco product 

manufacturers, retailers, or distributors, 

the Agency proposes to certify that the 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

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. 

VII. Paperwork Reduction Act of 1995 

FDA concludes that the regulatory 

revisions and amendments identified in 

this document are not subject to review 

by the Office of Management and 

Budget because they do not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

VIII. What are the federalism impacts 

of this proposed rule? 

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 has concluded 

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. 

IX. How do you submit comments on 

this proposed rule? 

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. 

List of Subjects 

21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

21 CFR Part 17 

Administrative practice and 

procedure, Penalties. 

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, 14, and 17 be amended 

to read 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. 1453, 1454, 1455; 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, 393; 42 

U.S.C. 216, 241, 243, 262, 264. 

2. In § 1.1 revise paragraph (b); and in 

the first sentence of paragraph (c), 

remove ‘‘package in § 1.20 and of’’ to 

read as follows: 

§ 1.1 General. 

* * * * * 

(b) The definitions and interpretations 

of terms contained in sections 201 and 

900 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321 and 387) 

shall be applicable also to such terms 

when used in regulations promulgated 

under that act. 

3. Amend § 1.20 by revising the 

introductory text to read as follows: 

§ 1.20 Presence of mandatory label 

information. 

Except as otherwise provided by 

section 900(13) of the Family Smoking 

Prevention and Tobacco Control Act (21 

U.S.C. 387(13)) defining ‘‘package,’’ the 

term package means any container or 

wrapping in which any food, drug, 

device, or cosmetic is enclosed for use 

in the delivery or display of such 

commodities to retail purchasers, but 

does not include: 

* * * * * 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

4. The authority citation for part 14 

continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155 

5. Amend § 14.55 by adding 

paragraph (f) to read as follows: 


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73986 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Proposed Rules 

§ 14.55 Termination of advisory 

committees. 

* * * * * 

(f) The Tobacco Products Scientific 

Advisory Committee is a permanent 

statutory advisory committee 

established by section 917 of the Family 

Smoking Prevention and Tobacco 

Control Act (21 U.S.C. 387q) (Pub. L. 

111–31) and is not subject to 

termination and renewal under 

paragraph (a) of this section. 

PART 17—CIVIL MONEY PENALTIES 

HEARINGS 

6. The authority citation for part 17 

continues to read as follows: 

Authority: 21 U.S.C. 331, 333, 337, 351, 

352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 

U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554, 

555, 556, 557. 

7. Amend § 17.1 by adding paragraph 

(j) to read as follows: 

§ 17.1 Scope. 

* * * * * 

(j) Section 303(f) of the act authorizing 

civil money penalties for any person 

who violates a requirement of the 

Family Smoking Prevention and 

Tobacco Control Act which relates to 

tobacco products. 

8. Revise § 17.2 to read as follows: 

§ 17.2 Maximum penalty amounts. 

The following table shows maximum 

civil monetary penalties associated with 

the statutory provisions authorizing 

civil monetary penalties under the act or 

the Public Health Service Act. 

CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS

U.S.C. section 

Former 

maximum 

penalty 

amount 

(in dollars) 1

Assessment method 

Date of last 

penalty figure 

or adjustment 

Adjusted maximum 

penalty amount 

(in dollars) 

21 U.S.C. 

333(b)(2)(A) ................. 55,000 For each of the first two violations in any 10-year period 2008 60,000. 

333(b)(2)(B) ................. 1,100,000 For each violation after the second conviction in any 10- 

year period.

2008 1,200,000. 

333(b)(3) ...................... 110,000 Per violation ...................................................................... 2008 120,000. 

333(f)(1)(A) .................. 16,500 Per violation ...................................................................... 2008 16,500 (not adjusted). 

333(f)(1)(A) .................. 1,100,000 For the aggregate of violations ........................................ 2008 1,200,000. 

333(f)(2)(A) .................. 55,000 Per individual .................................................................... 2008 60,000. 

333(f)(2)(A) .................. 275,000 Per ‘‘any other person’’ ..................................................... 2008 300,000. 

333(f)(2)(A) .................. 550,000 For all violations adjudicated in a single proceeding ....... 2008 600,000. 

333(f)(3)(A) .................. 10,000 For all violations adjudicated in a single proceeding ....... 2007 10,000 (not adjusted). 

333(f)(3)(B) .................. 10,000 For each day the violation is not corrected after a 30- 

day period following notification until the violation is 

corrected.

2007 10,000 (not adjusted). 

333(f)(4)(A)(i) ............... 250,000 Per violation ...................................................................... 2007 250,000 (not adjusted). 

333(f)(4)(A)(i) ............... 1,000,000 For all violations adjudicated in a single proceeding ....... 2007 1,000,000 (not adjusted). 

333(f)(4)(A)(ii) .............. 250,000 For the first 30-day period (or any portion thereof) of 

continued violation following notification.

2007 250,000 (not adjusted). 

333(f)(4)(A)(ii) .............. 1,000,000 For any 30-day period, where the amount doubles for 

every 30-day period of continued violation after the 

first 30-day period.

2007 1,000,000 (not adjusted). 

333(f)(4)(A)(ii) .............. 10,000,000 For all violations adjudicated in a single proceeding ....... 2007 10,000,000 (not adjusted). 

333(f)(9)(A) .................. 1 N/A Per violation ...................................................................... 2009 15,000 (not adjusted). 

333(f)(9)(A) .................. N/A For all violations adjudicated in a single proceeding ....... 2009 1,000,000 (not adjusted). 

333(f)(9)(B)(i)(I) ............ N/A Per violation ...................................................................... 2009 250,000 (not adjusted). 

333(f)(9)(B)(i)(I) ............ N/A For all violations adjudicated in a single proceeding ....... 2009 1,000,000 (not adjusted). 

333(f)(9)(B)(i)(II) ........... N/A For the first 30-day period (or any portion thereof) of 

continued violation following notification.

2009 250,000 (not adjusted). 

333(f)(9)(B)(i)(II) ........... N/A For any 30-day period, where the amount doubled for 

every 30-day period of continued violation after the 

first 30-day period.

2009 1,000,000 (not adjusted). 

333(f)(9)(B)(i)(II) ........... N/A For all violations adjudicated in a single proceeding ....... 2009 10,000,000 (not adjusted). 

333(f)(9)(B)(ii)(I) ........... N/A Per violation ...................................................................... 2009 250,000 (not adjusted). 

333(f)(9)(B)(ii)(I) ........... N/A For all violations adjudicated in a single proceeding ....... 2009 1,000,000 (not adjusted). 

333(f)(9)(B)(ii)(II) .......... N/A For the first 30-day period (or any portion thereof) of 

continued violation following notification.

2009 250,000 (not adjusted). 

333(f)(9)(B)(ii)(II) .......... N/A For any 30-day period, where the amount doubled for 

every 30-day period of continued violation after the 

first 30-day period.

2009 1,000,000 (not adjusted). 

333(f)(9)(B)(ii)(II) .......... N/A For all violations adjudicated in a single proceeding ....... 2009 10,000,000 (not adjusted). 

333(g)(1) ...................... 250,000 For the first violation in any 3-year period ....................... 2007 250,000 (not adjusted). 

333(g)(1) ...................... 500,000 For each subsequent violation in any 3-year period ........ 2007 500,000 (not adjusted). 

333 note ....................... N/A For the second violation (following a first violation with 

warning) within a 12-month period by a retailer with 

an approved training program.

2009 250 (not adjusted). 

333 note ....................... N/A For the third violation within a 24-month period by a retailer with an approved training program.2009 500 (not adjusted). 

333 note ....................... N/A For the fourth violation within a 24-month period by a retailer with an approved training program.2009 2,000 (not adjusted). 

333 note ....................... N/A For the fifth violation within a 36-month period by a retailer with an approved training program.2009 5,000 (not adjusted). 


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CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS— 

Continued 

U.S.C. section 

Former 

maximum 

penalty 

amount 

(in dollars) 1

Assessment method 

Date of last 

penalty figure 

or adjustment 

Adjusted maximum 

penalty amount 

(in dollars) 

333 note ....................... N/A For the six or subsequent violation within a 48-month 

period by a retailer with an approved training program.

2009 10,000 (not adjusted). 

333 note ....................... N/A For the first violation by a retailer without an approved 

training program.

2009 250 (not adjusted). 

333 note ....................... N/A For the second violation within a 12-month period by a 

retailer without an approved training program.

2009 500 (not adjusted). 

333 note ....................... N/A For the third violation within a 24-month period by a retailer without an approved training program.2009 1,000 (not adjusted). 

333 note ....................... N/A For the fourth violation within a 24-month period by a retailer without an approved training program.2009 2,000 (not adjusted). 

333 note ....................... N/A For the fifth violation within a 36-month period by a retailer without an approved training program.2009 5,000 (not adjusted). 

333 note ....................... N/A For the six or subsequent violation within a 48-month 

period by a retailer without an approved training program.

2009 10,000 (not adjusted). 

335b(a) ........................ 275,000 Per violation for an individual ........................................... 2008 300,000. 

335b(a) ........................ 1,100,000 Per violation for ‘‘any other person’’ ................................. 2008 1,200,000. 

360pp(b)(1) .................. 1,100 Per violation per person ................................................... 2008 1,100 (not adjusted). 

360pp(b)(1) .................. 330,000 For any related series of violations .................................. 2008 355,000. 

42 U.S.C. 

263b(h)(3) .................... 11,000 Per violation ...................................................................... 2008 11,000 (not adjusted). 

300aa–28(b)(1) ............ 110,000 Per occurrence ................................................................. 2008 120,000. 

1 Maximum penalties assessed under The Family Smoking Prevention and Tobacco Control Act do not have a ‘‘former maximum penalty.’’ 

Dated: November 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30040 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2550 

RIN 1210–AB38 

Target Date Disclosure 

AGENCY: Employee Benefits Security 

Administration, Labor. 

ACTION: Proposed regulation. 

SUMMARY: The Department published in 

the Federal Register of October 24, 2007 

a final regulation (the qualified default 

investment alternative regulation) 

providing relief from certain fiduciary 

responsibilities for fiduciaries of 

participant-directed individual account 

plans who, in the absence of directions 

from a participant, invest the 

participant’s account in a qualified 

default investment alternative. On 

October 20, 2010, the Department 

published a final regulation that 

requires the disclosure of certain plan 

and investment-related information, 

including fee and expense information, 

to participants and beneficiaries in 

participant-directed individual account 

plans (the participant-level disclosure 

regulation). This document contains 

proposed amendments to the qualified 

default investment alternative 

regulation to provide more specificity as 

to the information that must be 

disclosed in the required notice to 

participants and beneficiaries 

concerning investments in qualified 

default investment alternatives, 

including target date or similar 

investments. This document also 

contains a proposed amendment to the 

participant-level disclosure regulation 

that would require the disclosure of the 

same information concerning target date 

or similar investments to all participants 

and beneficiaries in participant-directed 

individual account plans. 

DATES: Written comments on the 

proposed regulation should be received 

by the Department of Labor no later than 

January 14, 2011. 

ADDRESSES: To facilitate the receipt and 

processing of comments, EBSA 

encourages interested persons to submit 

their comments electronically to eORI@dol.gov, or by using the Federal 

eRulemaking portal http:// 

www.regulations.gov (following 

instructions for submission of 

comments). Persons submitting 

comments electronically are encouraged 

not to submit paper copies. Persons 

interested in submitting comments on 

paper should send or deliver their 

comments (preferably three copies) to: 

Office of Regulations and 

Interpretations, Employee Benefits 

Security Administration, Room N–5655, 

U.S. Department of Labor, 200 

Constitution Avenue, NW., Washington, 

DC 20210, Attention: Target Date 

Amendments. All comments will be 

available to the public, without charge, 

online at http://www.regulations.gov 

and http://www.dol.gov/ebsa, and at the 

Public Disclosure Room, Employee 

Benefits Security Administration, U.S. 

Department of Labor, Room N–1513, 

200 Constitution Avenue, NW., 

Washington, DC 20210. 

FOR FURTHER INFORMATION CONTACT: 

Kristen L. Zarenko, Office of 

Regulations and Interpretations, 

Employee Benefits Security 

Administration, (202) 693–8500. This is 

not a toll-free number. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 624(a) of the Pension 

Protection Act of 2006 (Pension 

Protection Act) added a new section 

404(c)(5) to ERISA. Section 404(c)(5)(A) 

of ERISA provides that, for purposes of 


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