Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations 73951 

(D) The name of each exchange, if 

any, with which the statement, report, 

or document is filed; 

(iii) The copies of the confidential 

portion and the application filed in 

accordance with this paragraph shall be 

enclosed in a separate envelope marked 

‘‘Confidential Treatment’’ and addressed 

to Executive Secretary, Federal Deposit 

Insurance Corporation, Washington, DC 

20429. 

(3) Pending the determination by the 

FDIC as to the objection filed in 

accordance with paragraph (c)(2)(ii) of 

this section, the confidential portion 

will not be disclosed by the FDIC. 

(4) If the FDIC determines that the 

objection shall be sustained, a notation 

to that effect will be made at the 

appropriate place in the statement, 

report, or document. 

(5) If the FDIC determines that 

disclosure of the confidential portion is 

in the public interest, a finding and 

determination to that effect will be 

entered and notice of the finding and 

determination will be sent by registered 

or certified mail to the person. 

(6) The confidential portion shall be 

made available to the public: 

(i) Upon the lapse of 15 days after the 

dispatch of notice by registered or 

certified mail of the finding and 

determination of the FDIC described in 

paragraph (c)(5) of this section, or the 

date of the electronic filing, if prior to 

the lapse of such 15 days the person 

shall not have filed a written statement 

that he intends in good faith to seek 

judicial review of the finding and 

determination; 

(ii) Upon the lapse of 60 days after the 

dispatch of notice by registered or 

certified mail, or the date of the 

electronic filing, of the finding and 

determination of the FDIC, if the 

statement described in paragraph 

(c)(6)(i) of this section shall have been 

filed and if a petition for judicial review 

shall not have been filed within such 60 

days; or 

(iii) If such petition for judicial review 

shall have been filed within such 60 

days upon final disposition, adverse to 

the person, of the judicial proceedings. 

(7) If the confidential portion is made 

available to the public, a copy thereof 

shall be attached to each copy of the 

statement, report, or document filed 

with the FDIC and with each exchange 

concerned. 

■ 22. Amend Section 335.801 by 

revising paragraphs (b)(1), (b)(2), 

(b)(6)(iv), and (b)(6)(v) to read as 

follows: 

§ 335.801 Inapplicable SEC regulations; 

FDIC substituted regulations; additional 

information. 

* * * * * 

(b) Electronic filings. (1) The FDIC 

does not participate in the SEC’s 

EDGAR (Electronic Data Gathering 

Analysis and Retrieval) electronic filing 

program (17 CFR part 232). The FDIC 

permits voluntary electronically 

transmitted filings and submissions of 

correspondence and other materials in 

electronic format to the FDIC, with the 

exception of Beneficial Ownership 

Reports (Forms 3, 4, and 5) for which 

electronic filing is mandatory. 

Beneficial Ownership Report filing 

requirements are provided in paragraph 

(b)(2) of this section. 

(2) All reporting persons must 

electronically file Beneficial Ownership 

Reports (FDIC Forms 3, 4, and 5), 

including amendments and exhibits 

thereto, using the Internet-based 

interagency Beneficial Ownership 

Filings System, except that a reporting 

person that has obtained a continuing 

hardship exemption under these rules 

may file the forms with the FDIC in 

paper format. For electronic filing 

purposes, FDIC Forms 3, 4, and 5 are 

accessible at the Internet-based 

interagency Web site for Beneficial 

Ownership Filings at FDICconnect at 

https://www2.fdicconnect.gov/ 

index.asp. These forms and the 

instructions thereto are available for 

printing and downloading at http:// 

www.fdic.gov/regulations/laws/forms. A 

reporting person that has obtained a 

continuing hardship exemption under 

these rules may file the appropriate 

forms with the FDIC in paper format. 

Instructions for continuing hardship 

exemptions are provided in paragraph 

(b)(6) of this section. 

* * * * * 

(6) * * * 

(iv) Where a continuing hardship 

exemption is granted with respect to an 

exhibit only, the paper format exhibit 

shall be filed with the FDIC under Form 

SE (17 CFR part 249). The name of the 

FDIC shall be substituted for the name 

of the SEC on the form. Form SE shall 

be filed as a paper cover sheet to all 

exhibits to Beneficial Ownership 

Reports submitted to the FDIC in paper 

form pursuant to a hardship exemption. 

(v) Form SE may be filed with the 

FDIC up to six business days prior to, 

or on the date of filing of, the electronic 

form to which it relates but shall not be 

filed after such filing date. If a paper 

exhibit is submitted in this manner, 

requirements that the exhibit be filed 

with, provided with, or accompany the 

electronic filing shall be satisfied. Any 

requirements as to delivery or 

furnishing the information to persons 

other than the FDIC shall not be affected 

by this section. 

* * * * * 

By order of the Board of Directors. 

Federal Deposit Insurance Corporation. 

Dated at Washington, DC, this 9th day of 

November 2010. 

Robert E. Feldman, 

Executive Secretary. 

[FR Doc. 2010–30078 Filed 11–29–10; 8:45 am] 

BILLING CODE 6714–01–P 

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: Direct 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 will be subject to the same 

general requirements that apply to other 

FDA-regulated products. Elsewhere in 

this issue of the Federal Register, we are 

publishing a companion proposed rule 

under FDA’s usual procedures for notice 

and comment to provide a procedural 

framework to finalize the rule in the 

event we receive significant adverse 

comment and withdraw this direct final 

rule. 

DATES: This rule is effective April 14, 

2011. Submit either electronic or 

written comments by February 14, 2011. 

If we receive no significant adverse 

comments within the specified 

comment period, we intend to publish 

a document confirming the effective 

date of the final rule in the Federal 

Register within 30 days after the 

comment period on this direct final rule 

ends. If we receive any timely 

significant adverse comment, we will 

withdraw this final rule in part or in 

whole by publication of a document in 

the Federal Register within 30 days 

after the comment period ends. 


jdjones on DSK8KYBLC1PROD with RULES
73952 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations 

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. 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. 

II. What does this direct final 

rulemaking do? 

In this direct final rule, FDA is 

making 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 

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. 

III. What are the procedures for issuing 

a direct final rule? 

In the Federal Register of November 

21, 1997 (62 FR 62466), FDA announced 

the availability of the guidance 

document entitled ‘‘Guidance for FDA 

and Industry: Direct Final Rule 

Procedures’’ that described when and 

how FDA will employ direct final 

rulemaking. We believe that this rule is 

appropriate for direct final rulemaking 

because it is intended to make 

noncontroversial changes to existing 

regulations. We anticipate no significant 

adverse comments. 

Consistent with FDA’s procedures on 

direct final rulemaking, we are 

publishing elsewhere in this issue of the 

Federal Register a companion proposed 

rule that is identical to the direct final 

rule. The companion proposed rule 

provides a procedural framework within 

which the rule may be finalized in the 

event the direct final rule is withdrawn 

because of any significant adverse 

comment. The comment period for this 

direct final rule runs concurrently with 

the comment period of the companion 

proposed rule. Any comments received 

in response to the companion proposed 

rule will also be considered as 

comments regarding this direct final 

rule. 

We are providing a comment period 

on the direct final rule of 75 days after 

the date of publication in the Federal 

Register. If we receive any significant 

adverse comment, we intend to 

withdraw this final rule before its 

effective date by publication of a notice 

in the Federal Register within 30 days 

after the comment period ends. 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 

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-and-comment 

process in accordance with the 

Administrative Procedure Act (APA) (5 

U.S.C. 553). 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. 

If we withdraw the direct final rule, 

all comments received will be 

considered under the companion 

proposed rule in developing a final rule 

under the usual notice-and-comment 

procedures under the APA. If we receive 

no significant adverse comment during 

the specified comment period, we 

intend to publish a confirmation 

document in the Federal Register 

within 30 days after the comment 

period ends. 

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). This guidance document 

may be accessed at http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

IV. What is the legal authority for this 

rule? 

FDA is issuing this direct final 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). 


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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations 73953 

V. What is the environmental impact of 

this 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 

rule? 

FDA has examined the impacts of the 

final 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 direct final 

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 this direct final rule 

does not impose any new requirements 

on tobacco product manufacturers, 

retailers, or distributors, the Agency 

certifies that the final 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 final 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 rule? 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the 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 has concluded that the 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 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, 21 CFR parts 1, 14, 

and 17 are amended as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ 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: 

§ 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: 


jdjones on DSK8KYBLC1PROD with RULES
73954 Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations 

§ 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). 

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). 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Rules and Regulations 73955 

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 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. 2010–30039 Filed 11–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

FEDERAL MINE SAFETY AND HEALTH 

REVIEW COMMISSION 

29 CFR Part 2700 

Penalty Settlement Procedure 

AGENCY: Federal Mine Safety and Health 

Review Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Mine Safety and 

Health Review Commission (the 

‘‘Commission’’) is an independent 

adjudicatory agency that provides 

hearings and appellate review of cases 

arising under the Federal Mine Safety 

and Health Act of 1977, or Mine Act. 

Hearings are held before the 

Commission’s Administrative Law 

Judges, and appellate review is provided 

by a five-member Review Commission 

appointed by the President and 

confirmed by the Senate. The 

Commission is publishing a final rule to 

streamline the process for settling civil 

penalties assessed under the Mine Act. 

DATES: The final rule takes effect on 

December 30, 2010. The Commission 

will accept written and electronic 

comments received on or before 

December 15, 2010. 

ADDRESSES: Written comments should 

be mailed to Michael A. McCord, 

General Counsel, Office of the General 

Counsel, Federal Mine Safety and 

Health Review Commission, 601 New 

Jersey Avenue, NW., Suite 9500, 

Washington, DC 20001, or sent via 

facsimile to 202–434–9944. Persons 

mailing written comments shall provide 

an original and three copies of their 

comments. Electronic comments should 

state ‘‘Comments on Penalty Settlement 

Rule’’ in the subject line and be sent to 

mmccord@fmshrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Michael A. McCord, General Counsel, 

Office of the General Counsel, 601 New 

Jersey Avenue, NW., Suite 9500, 

Washington, DC 20001; telephone 202– 

434–9935; fax 202–434–9944. 

SUPPLEMENTARY INFORMATION: 

Background 

On April 27, 2010, the Commission 

published in the Federal Register an 

interim rule regarding the Commission’s 

civil penalty settlement procedures. 75 

FR 21987. The Commission explained 

that since 2006, the number of new 

cases filed with the Commission has 

dramatically increased, and that in 

order to deal with that burgeoning 

caseload, the Commission is considering 

methods to simplify how it processes 

civil penalty settlements. The interim 

rule became effective on May 27, 2010, 

and the Commission accepted 

comments on the rule through June 28, 

2010. The Commission received 

comments from the Secretary of Labor 

(the ‘‘Secretary’’) through the U.S. 

Department of Labor’s Office of the 

Solicitor, individual Conference and 

Litigation Representatives (‘‘CLRs’’), and 

a few members of the mining 

community. 

Under section 110(k) of the Mine Act, 

30 U.S.C. 820(k), a proposed civil 

penalty that has been contested before 

the Commission may be settled only 

with the approval of the Commission. 

Under the Commission’s practice prior 

to the effective date of the interim rule, 

a party submitted to a Commission 

Administrative Law Judge a motion to 

approve a penalty settlement that 

included for each violation the amount 

of the penalty proposed by the 

Department of Labor’s Mine Safety and 

Health Administration (‘‘MSHA’’), the 

amount of the penalty agreed to in 

settlement, and facts in support of the 

penalty agreed to by the parties. 29 CFR 

2700.31(b) (2009). A Commission Judge 

considered the motion and evaluated 

the penalty agreed to by the parties 

based on the criteria set forth in section 

110(i) of the Mine Act, 30 U.S.C. 820(i). 

If the Judge concluded that the 

settlement was consistent with the 

statutory criteria, the Judge issued a 

decision approving the settlement and 

setting forth the reasons for approval. 

The interim rule changed the current 

procedure by adding two new 

requirements. First, in all penalty 

proceedings, except for discrimination 

proceedings arising under section 105(c) 

of the Mine Act, 30 U.S.C. 815(c), or 

proceedings against individuals 

pursuant to section 110(c) of the Mine 

Act, 30 U.S.C. 820(c), the interim rule 

requires that a party filing a motion to 

approve a penalty settlement submit a 

proposed decision approving settlement 

(‘‘proposed order’’) with the motion. 

Second, it requires the filing party to 

submit the motion and proposed order 

electronically. The basic requirements 


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