Source: https://www.federalregister.gov/documents/2010/11/30/2010-30039/amendments-to-general-regulations-of-the-food-and-drug-administration
Timestamp: 2017-09-20 13:22:43
Document Index: 463941132

Matched Legal Cases: ['art 17', 'ART 17', 'art 1', '§\u20091', '§\u20091', 'art 14', '§\u200914', '§\u200914', 'art 17', '§\u200917', '§\u200917', '§\u200917', '§\u200917']

Federal Register :: Amendments to General Regulations of the Food and Drug Administration
A Rule by the Food and Drug Administration on 11/30/2010
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.
75 FR 73951
73951-73955 (5 pages)
Docket No. FDA-2010-N-0560
0910-AG55
2010-30039
FDA-2010-N-0560
I. What is the background of the rule?
II. What does this direct final rulemaking do?
III. What are the procedures for issuing a direct final rule?
IV. What is the legal authority for this rule?
V. What is the environmental impact of this rule?
VI. What is the economic impact of this rule?
VIII. What are the federalism impacts of this rule?
IX. How do you submit comments on this rule?
21 CFR Part 17
PART 17—CIVIL MONEY PENALTIES HEARINGS
https://www.federalregister.gov/d/2010-30039 https://www.federalregister.gov/d/2010-30039
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.
You may submit comments, identified by Docket No. FDA-2010-N-0560 and/or RIN number 0910-AG55, by any of the following methods:
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.
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.
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.
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.
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.
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).Start Printed Page 73953
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.
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.).
The authority citation for part 1 is revised to read as follows:
2. In § 1.1, revise paragraph (b); and in the first sentence of paragraph (c), remove “
3. Amend § 1.20 by revising the introductory text to read as follows:
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:
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.
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:
Start Printed Page 73954
§ 17.1
(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
Former maximum penalty amount (in dollars)1
Date of last penalty figure or adjustment
Adjusted maximum penalty amount (in dollars)
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).
Start Printed Page 73955
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.
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.”
[FR Doc. 2010-30039 Filed 11-29-10; 8:45 am]