Agency Information Collection Activities; Submission for OMB Review; New Collection, 5893-5897 [2024-01798]

Download as PDF Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices ENVIRONMENTAL PROTECTION AGENCY [FRL—11696–01–OA] Meeting of the Local Government Advisory Committee’s Small Communities Advisory Subcommittee Environmental Protection Agency (EPA). ACTION: Notification of public meeting. AGENCY: Pursuant to the Federal Advisory Committee Act (FACA), EPA hereby provides notice of a meeting of the Local Government Advisory Committee (LGAC) and its Small Community Advisory Subcommittee (SCAS) on the dates and times described below. These meetings will be open to the public. For information on public attendance and participation, please see the registration information under SUPPLEMENTARY INFORMATION. DATES: The SCAS will meet virtually February 9th, 2024, starting at 1 p.m. through 2 p.m. Eastern Standard Time. The LGAC will have a virtual meeting February 15th, from 2:30–4 p.m. Eastern Standard Time. FOR FURTHER INFORMATION CONTACT: Paige Lieberman, Designated Federal Officer (DFO) of the Local Government Advisory Committee, at LGAC@epa.gov or 202–564–9957 or Lynzi Barnes, DFO of the Small Community Advisory Subcommittee, at barnes.edlynzia@ epa.gov or (773) 638–9158. Information on Accessibility: For information on access or services for individuals requiring accessibility accommodations, please send an email to LGAC@epa.gov. To request accommodation, please do so five (5) business days prior to the meeting, to give EPA as much time as possible to process your request. SUPPLEMENTARY INFORMATION: Content: The SCAS will review draft recommendations from the LGAC involving the Lead and Copper Rule Improvements. The SCAS will deliberate and provide additional feedback to the LGAC recommendations before they are finalized. The LGAC will discuss recommendations on the Lead and Copper Rule Improvements with a goal to finalize and send to the EPA Administrator. The LGAC will also receive a new charge from EPA’s Office of Environmental Justice and External Civil Rights. Meeting materials and recommendations will be posted online closer to the meeting dates. Registration: Both meetings will be held virtually through Microsoft Teams. Members of the public who wish to participate should register by contacting khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:23 Jan 29, 2024 Jkt 262001 Paige Lieberman, Designated Federal Officer (DFO) of the Local Government Advisory Committee, at LGAC@epa.gov or 202–564–9957 or Lynzi Barnes, DFO of the Small Community Advisory Subcommittee, at barnes.edlynzia@ epa.gov or (773) 638–9158 within 24 hours of the meeting start time. The agenda and other supportive meeting materials will be available online at https://www.epa.gov/ocir/localgovernment-advisory-committee-lgac and can be obtained by written request to the DFO. In the event of cancellation for unforeseen circumstances, please contact the DFO or check the website above for reschedule information. Edlynzia Barnes, Designated Federal Officer, Office of Congressional and Intergovernmental Relations. [FR Doc. 2024–01779 Filed 1–29–24; 8:45 am] BILLING CODE 6560–50–P 5893 Portions Closed to the Public • Annual Report on Contracts. • Annual Report on Whistleblower Activity. Ashley Waldron, Secretary to the Board. [FR Doc. 2024–01772 Filed 1–29–24; 8:45 am] BILLING CODE 6705–01–P FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Notice of Board Meeting February 2, 2024, at 11:00 a.m. 77 K Street NE, Washington, DC 20002. STATUS: Closed to the public. FOR FURTHER INFORMATION CONTACT: Kimberly Weaver, Director, Office of External Affairs, (202) 942–1640. SUPPLEMENTARY INFORMATION: DATES: ADDRESSES: Board Meeting Agenda FARM CREDIT SYSTEM INSURANCE CORPORATION Board of Directors Meeting Notice of the forthcoming regular meeting of the Board of Directors of the Farm Credit System Insurance Corporation (FCSIC), is hereby given in accordance with the provisions of the Bylaws of the FCSIC. DATES: 10 a.m., Wednesday, February 7, 2024. ADDRESSES: You may observe the open portions of this meeting in person at 1501 Farm Credit Drive, McLean, Virginia 22102–5090, or virtually. If you would like to virtually attend, at least 24 hours in advance, visit FCSIC.gov, select ‘‘News & Events,’’ then select ‘‘Board Meetings.’’ From there, access the linked ‘‘Instructions for board meeting visitors’’ and complete the described registration process. FOR FURTHER INFORMATION CONTACT: If you need more information or assistance for accessibility reasons, or have questions, contact Ashley Waldron, Secretary to the Board. Telephone: 703– 883–4009. TTY: 703–883–4056. SUPPLEMENTARY INFORMATION: Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public. The following matters will be considered: SUMMARY: Portions Open to the Public • Approval of Minutes for December 13, 2023. • Review and Setting of Insurance Premium Accrual Rates. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Closed Session 1. Information covered under 5 U.S.C. 552b(c)(9)(B). Authority: 5 U.S.C. 552b(e)(1). Dated: January 25, 2024. Dharmesh Vashee, General Counsel, Federal Retirement Thrift Investment Board. [FR Doc. 2024–01784 Filed 1–29–24; 8:45 am] BILLING CODE P FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; New Collection Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’). ACTION: Notice. AGENCY: In accordance with the Paperwork Reduction Act of 1995 (‘‘PRA’’), the Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’) is submitting to the Office of Management and Budget (‘‘OMB’’) its proposal to seek OMB clearance for information collection requirements contained in the Federal Cigarette Labeling and Advertising Act (‘‘FCLAA’’). The FCLAA requires the FTC to review plans for the rotation of health warnings on cigarette packaging and advertising. The current provisional clearance expires on January 31, 2024, and the FTC intends to seek OMB renewal for three years. DATES: Comments must be received on or before February 29, 2024. ADDRESSES: Interested parties may file a comment online or on paper, by SUMMARY: E:\FR\FM\30JAN1.SGM 30JAN1 5894 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Shira Modell, General Attorney, Division of Advertising Practices, Bureau of Consumer Protection, (202) 725–2162, smodell@ftc.gov. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES A. Background The Federal Cigarette Labeling and Advertising Act, 15 U.S.C. 1331 et seq. (2006 ed.) (‘‘FCLAA’’) tasks the FTC with reviewing the rotation of statutorily-prescribed Surgeon General’s health warnings on cigarette packaging and in advertisements, and requires the FTC to collect certain information from manufacturers, packagers, and importers importing for sale, distributing, or advertising cigarettes in the United States. Because this information collection requirement is statutorily prescribed, OMB clearance was not required for the requirement to submit information to be effective.1 Nonetheless, the FTC recently decided to obtain OMB clearance for this statutorily mandated information collection. Accordingly, on July 28, 2023, the FTC obtained from OMB (i) approval of an expedited provisional clearance for this information collection (OMB Control Number: 3084–0175, Title: Information Collection under the Federal Cigarette Labeling and Advertising Act), and (ii) a waiver under 5 CFR 1320.13(d) of the requirement to publish a notice of the emergency clearance request. On September 6, 2023, the FTC published a Federal Register notice with a 60-day comment period soliciting comments from the public concerning the proposed collections of information (hereinafter, ‘‘Federal Register Notice’’). See 88 FR 60941 (September 6, 2023). In response to this Federal Register Notice, 1 An agency not having obtained OMB clearance for a statutorily-mandated information collection requirement does not excuse a respondent’s failure to comply with the requirement. U.S. v. Ionia Management S.A., 498 F. Supp. 2d 477, 489 (D. Conn. 2007); accord 5 CFR 1320.6(e) (where information collection requirements are imposed by statute, an agency’s not having complied with the requirements of the PRA is not a defense against the assessment of a penalty). VerDate Sep<11>2014 17:23 Jan 29, 2024 Jkt 262001 the FTC received four responsive, nonduplicative comments.2 B. Comments Three of the four comments express the commenters’ strong support for the information collection, noting that the collection of the information is useful and necessary for the purpose of the promotion of public health.3 One of the four comments expresses concerns pertaining to the information collection.4 In the remainder of this section, the Commission provides summaries of the four comments and the Commission’s responses to the comments. I. Individual Commenters Comments: Two of the four comments the Commission received express strong support for the information collection, and explain that the commenters had personally witnessed the effects of tobacco addiction on others.5 Response: The Commission shares the commenters’ concern about the importance of informing consumers about the health risks associated with cigarette smoking through display of the Surgeon General’s health warnings on cigarette packaging and advertising. II. Comment by State Attorneys General Comment: The Offices of the Attorneys General for the States of Maryland, Arizona, Arkansas, California, Colorado, Connecticut, Hawaii, Illinois, Montana, Missouri, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, and Washington (hereinafter, collectively referred to as ‘‘State AGOs’’) submitted a joint comment, noting that the information collection (‘‘FCLAA information collection’’) is useful and necessary for the purpose of the promotion of public health, and aids State governments in their regulation of cigarette manufacturers seeking to sell cigarettes in the States.6 The State AGOs note that 2 See Comment FTC–2023–0056–0007, https:// www.regulations.gov/comment/FTC-2023-00560007 (Sept. 27, 2023) [hereinafter Comment from Anonymous]; Comment FTC–2023–0056–0009, https://www.regulations.gov/comment/FTC-20230056-0009 (Nov. 6, 2023) [hereinafter State AGO Comment]; Comment FTC–2023–0056–0006, https://www.regulations.gov/comment/FTC-20230056-0006 (Sept. 23, 2023) [hereinafter JD Comment]; Comment FTC–2023–0056–0010, https://www.regulations.gov/comment/FTC-20230056-0010 (Nov. 6, 2023) [hereinafter ITG Brands & Commonwealth Brands Comment]. 3 See State AGO Comment; see also JD Comment; Comment from Anonymous. 4 See ITG Brands & Commonwealth Brands Comment. 5 See JD Comment; Comment from Anonymous. 6 See State AGO Comment. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 most States publish a directory of cigarette brands that have been approved for sale in their respective States, and require manufacturers to submit certain information, including approval letters from the FTC showing that the manufacturers have submitted plans that the FTC found to be compliant with the FCLAA.7 According to the State AGOs, the submission of the approval letters (1) promotes public health by ensuring that cigarette brands a manufacturer seeks to sell in the State will bear required health warnings that alert consumers to the risks cigarettes pose to the smoker’s health and the health of people nearby; (2) informs States about the cigarette brands a manufacturer intends to sell during the upcoming year; (3) serves as a tool for States to verify that cigarettes listed on their directory of approved brands are, in fact, legal for sale in the United States; and (4) provides a level of assurance to the reviewing States that a manufacturer is a business that is in good standing, capable of meeting its regulatory obligations with different government agencies, and committed to operating legally. Response: The FTC appreciates the comment, which underscores the necessity of this information collection. I. Comment by ITG Brands, LLC, and Commonwealth Brands, LLC Comment: ITG Brands, LLC, submitted a public comment on behalf of itself and its affiliate, Commonwealth Brands, LLC, voicing the following concerns pertaining to this information collection. First, the two cigarette companies assert that the Notice’s apparent position that rotation plans must identify brand styles by name exceeds FTC’s statutory authority and is unnecessary. According to the two cigarette companies, the text of 15 U.S.C. 1333© only requires that rotation plans sufficiently explain how cigarette manufacturers will comply with their quarterly or simultaneous rotation obligations. The two cigarette companies assert that because the text of 15 U.S.C. 1333(c)(1) does not employ the term ‘‘brand style,’’ the statute does not suggest that any element of a rotation plan must be brand-specific. In support of this argument, they note that, in 1985, the FTC approved a number of rotation plans that include language continuing to permit those cigarette 7 State AGO Comment (citing Md. Code Ann., Bus. Reg. sections 16–501 to –508; Ohio Rev. Code Ann. section 1346.05 et seq.; 35 Pa. Stat. Ann. sections 5702.101 et seq.; S.C. Code Ann. sections 11–48–30; Tenn. Code Ann. sections 67–4–2601 et seq.). E:\FR\FM\30JAN1.SGM 30JAN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices manufacturers to introduce new brands and brand styles without having to seek prior approval or submit sample packaging. Second, the two cigarette companies argue that the Federal Register Notice’s apparent position that cigarette manufacturers must submit packaging for new brands and brand styles and packaging changes for existing brand styles, exceeds the FTC’s statutory authority and is unnecessary. Noting that 15 U.S.C. 1333(c) does not specify that cigarette manufacturers must submit ‘‘packages’’ to the FTC for approval, the two cigarette companies contend that Congress would have expressly required cigarette manufacturers to submit ‘‘packages,’’ if it had intended them to do so. The two companies assert that FTC appears to be using the rotation plan requirement of 15 U.S.C. 1333(c) to enforce the warning label requirements of paragraphs (a) and (b) of 15 U.S.C. 1333, although 15 U.S.C. 1333(c) only requires manufacturers to submit a plan ensuring compliance with the subsection’s rotation requirements. According to the two cigarette companies, 15 U.S.C. 1333(c) does not require the plan to cover the manufacturer’s compliance with paragraphs (a) and (b) of 15 U.S.C. 1333. The two cigarette companies argue that ‘‘the FTC seems to recognize this by its treatment of the major tobacco companies, as on information and belief the FTC has not required them to submit sample packaging before implementing packaging changes since 1985.’’ Third, the two cigarette companies assert that the information collection imposes a substantial burden on cigarette manufacturers beyond the burden stated in the Federal Register Notice. The two companies contend that the Commission’s analysis fails to account for the costs cigarette manufacturers incur as a result of submitting packaging for the agency’s review and that even the collection activities accounted for in the burden analysis are drastically underestimated. For example, the two cigarette companies assert that the submission of ‘‘revised packaging and plan documents involves . . . far more than the 8 hours that the FTC estimates, with a more accurate estimate based on ITG and Commonwealth’s experience requiring up to 20 to 40 hours per submission.’’ The companies’ estimate includes, among other things, the time spent making printing arrangements for packaging samples and addressing any changes requested by the FTC. The two companies also assert that, due to the fact that the FTC requires cigarette manufacturers to submit actual VerDate Sep<11>2014 17:23 Jan 29, 2024 Jkt 262001 packaging samples, rather than PDFs of packaging samples, the introduction of new brand styles requires a special print run from an outside printing company. According to the two companies, samples of actual packaging for new products are often not available until shortly before the intended launch of such products and require up to three months of lead time for printing ‘‘and additional expense for printing a complete sample set from $8,000 to $25,000 per variant.’’ The two cigarette companies state that the aggregate burden in time and expense resulting from this is substantial when cigarette companies introduce several new brand styles a year. Moreover, the companies assert that, since the plans of Philip Morris and RJR/Lorillard permit those manufacturers to introduce new brands and brand styles without having to seek prior approval or submit sample packaging, other cigarette companies— such as ITG Brands, LLC, and Commonwealth Brands, LLC— experience a substantial competitive burden as a result of this delay. Fourth, the two cigarette companies argue that the FTC should minimize these burdens by (1) allowing all manufacturers to adopt rotation plans that permit the introduction of new brands or brand styles without further submission to the Commission as long as the rotation plan explains how the warnings on such new products will be appropriately rotated, and (2) no longer requiring manufacturers to submit ‘‘every packaging change [to the FTC] for review and approval.’’ The two cigarette companies contend that doing so would be consistent with the regulations the U.S. Food and Drug Administration (‘‘FDA’’) has issued in light of the pending transfer of statutory authority concerning the display of health warnings. The two companies claim that in a final rule, titled ‘‘Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,’’ the FDA took the position that, ‘‘in lieu of a supplement to an approved plan for a new brand, manufacturers may reference in their initial plan ‘all brands’ in their product listing(s) . . . and incorporate any new brands into their approved plan, so long as no other changes are made to the plan.’’ 8 Response: The two companies are correct that section 1333(c)(1) does not explicitly mention brand styles. However, section 1333(b)(1), which addresses the format of packaging warnings, specifically states that the 8 ITG Brands & Commonwealth Brands Comment (citing 85 FR 15638 (Mar. 18, 2020)). PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 5895 health warning statements must be in ‘‘conspicuous and legible type in contrast by typography, layout, or color with all other printed material on the package.’’ Accordingly, to ensure that the Surgeon General’s health warnings on cigarette packs and cartons are conspicuous, since at least 1991, the Commission has required manufacturers and importers to submit health warning plans for all new cigarette brands and brand styles, and has reviewed the packaging submitted with those plans by the manufacturers and importers before that packaging is sent out into the marketplace. As a practical matter, no other system would efficiently effectuate Congress’s intent that the warnings be conspicuous on cigarette packaging. Moreover, section 1333(c)(2) of the FCLAA does expressly use the term ‘‘brand style’’ with respect to a manufacturer or importer that is applying for permission to use the alternative to quarterly rotation. Section 1333(c)(2)(A) sets forth the requirements that must be met to qualify for the alternative ‘‘with respect to a brand style of cigarettes,’’ 9 including that the number of cigarettes ‘‘of such brand style’’ sold in the previous fiscal year is less than one-quarter of 1 percent of all cigarettes sold in the U.S. that year. The Commission believes it has the authority under FCLAA to review the format of packaging warnings in order to ensure that the Act’s statutory requirements are satisfied. Paragraph (a)(1) of section 1333 sets forth the requisite wording of the four packaging warnings, and paragraph (b)(1) of section 1333 sets forth the aforementioned format requirements applicable to the ‘‘label statements’’ required by paragraph (a)(1). Paragraph (c)(1) of section 1333 then refers to the ‘‘label statements’’ specified in paragraph (a)(1), and provides that the label statements are required to be rotated ‘‘on packages of each brand of cigarettes manufactured by the manufacture or importer’’ in accordance with a plan approved by the Commission that ensures ‘‘that all of the labels required . . . will be displayed by the manufacturer or importer.’’ 10 Read together, these provisions provide the basis for the Commission to require that manufacturers and importers submit packaging samples to ensure that the rotation plan meets the statutorily prescribed rotation and formatting requirements. In order to do so for new brands and brand styles, the Commission must have the ability to 9 15 U.S.C. 1333(c)(2)(A) (emphasis added). 15 U.S.C. 1333(c)(1) (emphasis added). 10 See E:\FR\FM\30JAN1.SGM 30JAN1 5896 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices require cigarette manufacturers and importers to submit updated rotation plans and packaging samples. With regard to the companies’ argument that the information collection imposes a substantial burden on cigarette manufacturers beyond the burden stated in the Federal Register Notice, the Commission notes the following. First, ‘‘[s]amples of products or of any other physical objects,’’ which, by definition, includes packaging samples, do not constitute ‘‘information’’ for purposes of the PRA,11 and any costs related to the preparation and submission of any such samples should not be included in a burden analysis prepared for purposes of the PRA.12 Second, the companies’ estimate that, in the context of the introduction of new brands and brand styles, the preparation and submission of an amended plan takes approximately 20 to 40 hours— i.e., up to a full workweek—is likely not reflective of the industry average. The amendment of an existing rotation plan to add a new brand or brand style is generally relatively quick and simple, and cigarette manufacturers can use their existing approved rotation plans as templates. A company with an approved plan for rotating the warnings quarterly on its packaging must merely identify the new brand style being added to that plan and submit the packaging for that new brand style; 13 if the company wishes to add a new brand to its plan, it must also identify the warning that will be assigned to that brand during each quarter of the year. If the company wishes to use the option provided by section 1333(c)(2) and display the four warnings an equal number of times during the year on the packaging of certain brand styles, it must provide information sufficient to show that its sales satisfy both of the criteria in 15 U.S.C. 1333(c)(2)(A), provide packaging, and explain—again, as it has done previously—how it will ensure that all four warnings will be equally displayed during the one-year period beginning on khammond on DSKJM1Z7X2PROD with NOTICES 11 See 5 CFR 1320.3(c) (‘‘Collection of information means . . . the obtaining, causing to be obtained, soliciting, or requiring the disclosure to an agency, third parties or the public of information by or for an agency. . . .’’) (emphasis omitted) (emphasis added), CFR 1320.3(h)(2) (‘‘ ‘Information’ does not generally include . . . [s]amples of products or of any other physical objects.’’). 12 See 5 CFR 1320.3(b)(1) (defining the term ‘‘burden’’ as ‘‘the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency’’) (emphasis added). 13 The Commission’s insistence on actual packaging, rather than just artwork, reflects its experience that colors can be different in artwork than in final packaging, and that those differences can affect whether the warnings are conspicuous. VerDate Sep<11>2014 17:23 Jan 29, 2024 Jkt 262001 the date the plan is approved (for example, by using printing plates that produce an even number of all four warnings simultaneously on each print run). Third, the two cigarette companies’ estimate includes activities that do not result from a collection of information. Specifically, because, as indicated above, the submission of the samples does not constitute a collection of information for purposes of the PRA,14 the two cigarette companies’ estimate erroneously includes time spent making printing arrangements.15 Furthermore, when a plan submitted to the Commission cannot be approved in its original form, FTC staff usually provides the cigarette manufacturer with specific, individualized guidance as to the changes necessary for Commission approval. As the PRA exempts ‘‘request[s] for facts or opinions addressed to a single person’’ and ‘‘[f]acts or opinions obtained or solicited through nonstandardized follow-up questions designed to clarify responses to approved collections of information,’’ 16 the time spent incorporating requested changes into the companies’ proposals should not be reflected in the burden estimate for this information collection.17 Fourth, the Commission questions the companies’ assertion that the preparation of their plans requires the assistance of outside counsel. For the years 2017 through 2021—the most recent years for which the two companies’ plans are on the public record—their plans were all signed by in-house counsel. Although some manufacturers and importers do use outside counsel to file their plans, they presumably do so because it makes more sense from a business perspective than using in-house personnel. The companies also fail to explain why the submission to the Commission of the packaging that they intend to use for new products requires a significant lead time for printing that would not otherwise be incurred. Even if the Commission were to allow manufacturers to adopt rotation plans that permit the introduction of new brands or brand styles without further submission to the Commission, manufacturers and importers would nonetheless have to create, print, and then review any packaging for new varieties or redesigned packaging for existing varieties for compliance with 14 See supra note 13. supra note 15. 16 See 5 CFR 1320.3(h)(6), (9). 17 See supra note 15. 15 See PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 the FCLAA’s format requirements.18 The two companies also fail to explain why the expense associated with the preparation of sample packaging by an outside printing company would not still be incurred if the companies were to review their own new packaging for compliance with FCLAA (rather than submit them to the Commission for approval). The companies also argue that the fact that they are required to seek Commission approval prior to the introduction of new brand styles or packaging causes them to suffer a ‘‘substantial competitive burden.’’ However, consideration of whether the requirement imposes a competitive burden is beyond the scope of a burden analysis under the PRA, which defines the term ‘‘burden’’ more narrowly.19 Furthermore, the two companies’ final argument—that is, that requiring Commission approval for the introduction of new brand styles is inconsistent with the approach that the FDA proposed in light of the pending transfer of statutory authority concerning the display of health warnings 20—is equally beyond the scope of this notice. The FDA’s proposed approach is based on the Family Smoking Prevention and Tobacco Control Act, Public Law 111– 31, tit. II, sec. 201 (June 22, 2009) (hereinafter, ‘‘FSPTCA’’), which differs from the FCLAA in significant aspects.21 Accordingly, as the Commission does not find the two companies’ arguments to be convincing, the Commission declines to adjust the estimates that were included in its expedited provisional clearance request and approved by OMB on July 28, 2023. C. Overview of Information Collection Title of Collection: Information Collection under the Federal Cigarette Labeling and Advertising Act. OMB Control Number: 3084–0175. Type of Review: Extension without change of currently approved collection. 18 As noted supra note 13, the preparation and submission of packaging samples does not constitute a collection of information for purposes of the PRA, and, thus, should be disregarded for purposes of this burden analysis. 19 For a definition of the term ‘‘burden,’’ see 44 U.S.C. 3502(2) and 5 CFR 1320.3(b)(1). 20 ITG Brands & Commonwealth Brands Comment (citing 85 FR 15638 (Mar. 18, 2020)). 21 For example, the FSPTCA provides precise details as to the size, font, location, and color of the nine warning statements that will ultimately replace the current four Surgeon General’s warnings. See 15 U.S.C. 1333(a)(2) (2009 ed.). Additionally, only the FCLAA specifically requires the annual submission of information demonstrating that the manufacturer or importer continues to qualify for equalization of the health warnings. E:\FR\FM\30JAN1.SGM 30JAN1 5897 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices khammond on DSKJM1Z7X2PROD with NOTICES Abstract: The Federal Cigarette Labeling and Advertising Act, 15 U.S.C. 1331 et seq. (2006 ed.) (‘‘FCLAA’’), requires cigarette manufacturers, packagers, and importers to place one of four statutorily-prescribed Surgeon General’s health warnings on cigarette packaging and in advertisements, on a rotational basis in accordance with plans reviewed and approved by the FTC. Each manufacturer, packager, and importer (hereinafter, also referred to as ‘‘respondents’’) wishing to import for sale or distribute cigarettes in the United States is required to submit a plan to the FTC that (1) explains how the respondent intends to comply with the statutory requirement to display the statutorily-prescribed health warnings on its packaging, (2) identifies each of the respondent’s brands and brand styles, (3) includes a schedule (or other explanation) showing the warnings that will be assigned to each brand during each quarter of the year, and (4) specifies when in the manufacturing process the respondent will consult its rotation schedule for that particular brand in order to assign the appropriate quarterly warning. Respondents wishing to engage in advertising of cigarettes in the United States are required to submit to the FTC a plan that (1) includes a rotation schedule for the four statutorily-prescribed health warnings for each brand the respondent intends to advertise, (2) specifies how the respondent will determine which health warnings will appear on different kinds of advertisements, and (3) specifies how the respondent will handle advertisements that feature more than one of the respondent’s brands. The FCLAA also provides for an alternative method for displaying the required health warnings on packaging—that is, equalization. Specifically, manufacturers, packagers, and importers may seek the FTC’s approval to display the health warnings on a particular cigarette brand style an equal number of times. In order to obtain approval for equalization, respondents must submit an additional plan to the FTC that establishes (1) that their sales satisfy the statutory- prescribed requirements for equalization, and (2) how the respondent will ensure that all four health warnings will be equally displayed during the one-year period following the plan’s approval (e.g., by using printing plates that produce an even number of all four warnings simultaneously on each print run). Respondents seeking to equalize must submit new plans annually to demonstrate that their sales continue to qualify for equalization. The Commission uses the information to assess—as it is required to do under the FCLAA—whether a manufacturer or importer will display the Surgeon General’s health warnings in compliance with the governing statutory provisions in the FCLAA. Affected Public: Private Sector: Businesses and other for-profit entities. Estimated Annual Burden Hours: 328. Estimated Annual Labor Costs: $16,695. Estimated Annual Non-Labor Costs: $0. D. Request for Comment Pursuant to OMB regulations, 5 CFR part 1320, which implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second opportunity for public comment while submitting to OMB its request for clearance for the information collection requirements contained in the FCLAA. For more details about the requirements and the basis for the calculations summarized above, see 88 FR 60941. Your comment—including your name and your state—will be placed on the public record of this proceeding. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone’s Social Security number; date of birth; driver’s license number or other state identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for ensuring that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any ‘‘[t]rade secret or any commercial or financial information which is . . . privileged or confidential’’—as provided in Section 6(f) of the FTC Act 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including, in particular, competitively sensitive information, such as costs, sales statistics, inventories, formulas, patterns devices, manufacturing processes, or customer names. Josephine Liu, Assistant General Counsel for Legal Counsel. [FR Doc. 2024–01798 Filed 1–29–24; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9145–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2023 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. SUMMARY: Addenda Contact I. CMS Manual Instructions ...................................................................................... II. Regulation Documents Published in the Federal Register ................................ III. CMS Rulings ....................................................................................................... IV. Medicare National Coverage Determinations ..................................................... V. FDA-Approved Category B IDEs ......................................................................... VI. Collections of Information ................................................................................... VII. Medicare-Approved Carotid Stent Facilities ...................................................... VIII. American College of Cardiology—National Cardiovascular Data Registry Sites. IX. Medicare’s Active Coverage-Related Guidance Documents ............................. X. One-time Notices Regarding National Coverage Provisions .............................. Ismael Torres .......................................... Terri Plumb ............................................. Tiffany Lafferty ........................................ Wanda Belle, MPA ................................. John Manlove ......................................... William Parham ...................................... Sarah Fulton, MHS ................................. Sarah Fulton, MHS ................................. (410) (410) (410) (410) (410) (410) (410) (410) Lori Ashby, MA ....................................... JoAnna Baldwin, MS .............................. (410) 786–6322 (410) 786–7205 VerDate Sep<11>2014 17:23 Jan 29, 2024 Jkt 262001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1 Phone No. 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749

Agencies

[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Notices]
[Pages 5893-5897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01798]


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FEDERAL TRADE COMMISSION


Agency Information Collection Activities; Submission for OMB 
Review; New Collection

AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').

ACTION: Notice.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 
(``PRA''), the Federal Trade Commission (``FTC'' or ``Commission'') is 
submitting to the Office of Management and Budget (``OMB'') its 
proposal to seek OMB clearance for information collection requirements 
contained in the Federal Cigarette Labeling and Advertising Act 
(``FCLAA''). The FCLAA requires the FTC to review plans for the 
rotation of health warnings on cigarette packaging and advertising. The 
current provisional clearance expires on January 31, 2024, and the FTC 
intends to seek OMB renewal for three years.

DATES: Comments must be received on or before February 29, 2024.

ADDRESSES: Interested parties may file a comment online or on paper, by

[[Page 5894]]

following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Written comments and 
recommendations for the proposed information collection should be sent 
within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting 
``Currently under 30-day Review--Open for Public Comments'' or by using 
the search function.

FOR FURTHER INFORMATION CONTACT: Shira Modell, General Attorney, 
Division of Advertising Practices, Bureau of Consumer Protection, (202) 
725-2162, [email protected].

SUPPLEMENTARY INFORMATION:

A. Background

    The Federal Cigarette Labeling and Advertising Act, 15 U.S.C. 1331 
et seq. (2006 ed.) (``FCLAA'') tasks the FTC with reviewing the 
rotation of statutorily-prescribed Surgeon General's health warnings on 
cigarette packaging and in advertisements, and requires the FTC to 
collect certain information from manufacturers, packagers, and 
importers importing for sale, distributing, or advertising cigarettes 
in the United States.
    Because this information collection requirement is statutorily 
prescribed, OMB clearance was not required for the requirement to 
submit information to be effective.\1\ Nonetheless, the FTC recently 
decided to obtain OMB clearance for this statutorily mandated 
information collection. Accordingly, on July 28, 2023, the FTC obtained 
from OMB (i) approval of an expedited provisional clearance for this 
information collection (OMB Control Number: 3084-0175, Title: 
Information Collection under the Federal Cigarette Labeling and 
Advertising Act), and (ii) a waiver under 5 CFR 1320.13(d) of the 
requirement to publish a notice of the emergency clearance request. On 
September 6, 2023, the FTC published a Federal Register notice with a 
60-day comment period soliciting comments from the public concerning 
the proposed collections of information (hereinafter, ``Federal 
Register Notice''). See 88 FR 60941 (September 6, 2023). In response to 
this Federal Register Notice, the FTC received four responsive, non-
duplicative comments.\2\
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    \1\ An agency not having obtained OMB clearance for a 
statutorily-mandated information collection requirement does not 
excuse a respondent's failure to comply with the requirement. U.S. 
v. Ionia Management S.A., 498 F. Supp. 2d 477, 489 (D. Conn. 2007); 
accord 5 CFR 1320.6(e) (where information collection requirements 
are imposed by statute, an agency's not having complied with the 
requirements of the PRA is not a defense against the assessment of a 
penalty).
    \2\ See Comment FTC-2023-0056-0007, https://www.regulations.gov/comment/FTC-2023-0056-0007 (Sept. 27, 2023) [hereinafter Comment 
from Anonymous]; Comment FTC-2023-0056-0009, https://www.regulations.gov/comment/FTC-2023-0056-0009 (Nov. 6, 2023) 
[hereinafter State AGO Comment]; Comment FTC-2023-0056-0006, https://www.regulations.gov/comment/FTC-2023-0056-0006 (Sept. 23, 2023) 
[hereinafter JD Comment]; Comment FTC-2023-0056-0010, https://www.regulations.gov/comment/FTC-2023-0056-0010 (Nov. 6, 2023) 
[hereinafter ITG Brands & Commonwealth Brands Comment].
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B. Comments

    Three of the four comments express the commenters' strong support 
for the information collection, noting that the collection of the 
information is useful and necessary for the purpose of the promotion of 
public health.\3\ One of the four comments expresses concerns 
pertaining to the information collection.\4\ In the remainder of this 
section, the Commission provides summaries of the four comments and the 
Commission's responses to the comments.
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    \3\ See State AGO Comment; see also JD Comment; Comment from 
Anonymous.
    \4\ See ITG Brands & Commonwealth Brands Comment.
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I. Individual Commenters

    Comments: Two of the four comments the Commission received express 
strong support for the information collection, and explain that the 
commenters had personally witnessed the effects of tobacco addiction on 
others.\5\
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    \5\ See JD Comment; Comment from Anonymous.
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    Response: The Commission shares the commenters' concern about the 
importance of informing consumers about the health risks associated 
with cigarette smoking through display of the Surgeon General's health 
warnings on cigarette packaging and advertising.

II. Comment by State Attorneys General

    Comment: The Offices of the Attorneys General for the States of 
Maryland, Arizona, Arkansas, California, Colorado, Connecticut, Hawaii, 
Illinois, Montana, Missouri, New Mexico, Ohio, Oklahoma, Oregon, 
Pennsylvania, Rhode Island, South Carolina, Tennessee, and Washington 
(hereinafter, collectively referred to as ``State AGOs'') submitted a 
joint comment, noting that the information collection (``FCLAA 
information collection'') is useful and necessary for the purpose of 
the promotion of public health, and aids State governments in their 
regulation of cigarette manufacturers seeking to sell cigarettes in the 
States.\6\ The State AGOs note that most States publish a directory of 
cigarette brands that have been approved for sale in their respective 
States, and require manufacturers to submit certain information, 
including approval letters from the FTC showing that the manufacturers 
have submitted plans that the FTC found to be compliant with the 
FCLAA.\7\ According to the State AGOs, the submission of the approval 
letters (1) promotes public health by ensuring that cigarette brands a 
manufacturer seeks to sell in the State will bear required health 
warnings that alert consumers to the risks cigarettes pose to the 
smoker's health and the health of people nearby; (2) informs States 
about the cigarette brands a manufacturer intends to sell during the 
upcoming year; (3) serves as a tool for States to verify that 
cigarettes listed on their directory of approved brands are, in fact, 
legal for sale in the United States; and (4) provides a level of 
assurance to the reviewing States that a manufacturer is a business 
that is in good standing, capable of meeting its regulatory obligations 
with different government agencies, and committed to operating legally.
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    \6\ See State AGO Comment.
    \7\ State AGO Comment (citing Md. Code Ann., Bus. Reg. sections 
16-501 to -508; Ohio Rev. Code Ann. section 1346.05 et seq.; 35 Pa. 
Stat. Ann. sections 5702.101 et seq.; S.C. Code Ann. sections 11-48-
30; Tenn. Code Ann. sections 67-4-2601 et seq.).
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    Response: The FTC appreciates the comment, which underscores the 
necessity of this information collection.

I. Comment by ITG Brands, LLC, and Commonwealth Brands, LLC

    Comment: ITG Brands, LLC, submitted a public comment on behalf of 
itself and its affiliate, Commonwealth Brands, LLC, voicing the 
following concerns pertaining to this information collection.
    First, the two cigarette companies assert that the Notice's 
apparent position that rotation plans must identify brand styles by 
name exceeds FTC's statutory authority and is unnecessary. According to 
the two cigarette companies, the text of 15 U.S.C. 1333(copyright) only 
requires that rotation plans sufficiently explain how cigarette 
manufacturers will comply with their quarterly or simultaneous rotation 
obligations. The two cigarette companies assert that because the text 
of 15 U.S.C. 1333(c)(1) does not employ the term ``brand style,'' the 
statute does not suggest that any element of a rotation plan must be 
brand-specific. In support of this argument, they note that, in 1985, 
the FTC approved a number of rotation plans that include language 
continuing to permit those cigarette

[[Page 5895]]

manufacturers to introduce new brands and brand styles without having 
to seek prior approval or submit sample packaging.
    Second, the two cigarette companies argue that the Federal Register 
Notice's apparent position that cigarette manufacturers must submit 
packaging for new brands and brand styles and packaging changes for 
existing brand styles, exceeds the FTC's statutory authority and is 
unnecessary. Noting that 15 U.S.C. 1333(c) does not specify that 
cigarette manufacturers must submit ``packages'' to the FTC for 
approval, the two cigarette companies contend that Congress would have 
expressly required cigarette manufacturers to submit ``packages,'' if 
it had intended them to do so. The two companies assert that FTC 
appears to be using the rotation plan requirement of 15 U.S.C. 1333(c) 
to enforce the warning label requirements of paragraphs (a) and (b) of 
15 U.S.C. 1333, although 15 U.S.C. 1333(c) only requires manufacturers 
to submit a plan ensuring compliance with the subsection's rotation 
requirements. According to the two cigarette companies, 15 U.S.C. 
1333(c) does not require the plan to cover the manufacturer's 
compliance with paragraphs (a) and (b) of 15 U.S.C. 1333. The two 
cigarette companies argue that ``the FTC seems to recognize this by its 
treatment of the major tobacco companies, as on information and belief 
the FTC has not required them to submit sample packaging before 
implementing packaging changes since 1985.''
    Third, the two cigarette companies assert that the information 
collection imposes a substantial burden on cigarette manufacturers 
beyond the burden stated in the Federal Register Notice. The two 
companies contend that the Commission's analysis fails to account for 
the costs cigarette manufacturers incur as a result of submitting 
packaging for the agency's review and that even the collection 
activities accounted for in the burden analysis are drastically 
underestimated.
    For example, the two cigarette companies assert that the submission 
of ``revised packaging and plan documents involves . . . far more than 
the 8 hours that the FTC estimates, with a more accurate estimate based 
on ITG and Commonwealth's experience requiring up to 20 to 40 hours per 
submission.'' The companies' estimate includes, among other things, the 
time spent making printing arrangements for packaging samples and 
addressing any changes requested by the FTC.
    The two companies also assert that, due to the fact that the FTC 
requires cigarette manufacturers to submit actual packaging samples, 
rather than PDFs of packaging samples, the introduction of new brand 
styles requires a special print run from an outside printing company. 
According to the two companies, samples of actual packaging for new 
products are often not available until shortly before the intended 
launch of such products and require up to three months of lead time for 
printing ``and additional expense for printing a complete sample set 
from $8,000 to $25,000 per variant.'' The two cigarette companies state 
that the aggregate burden in time and expense resulting from this is 
substantial when cigarette companies introduce several new brand styles 
a year. Moreover, the companies assert that, since the plans of Philip 
Morris and RJR/Lorillard permit those manufacturers to introduce new 
brands and brand styles without having to seek prior approval or submit 
sample packaging, other cigarette companies--such as ITG Brands, LLC, 
and Commonwealth Brands, LLC--experience a substantial competitive 
burden as a result of this delay.
    Fourth, the two cigarette companies argue that the FTC should 
minimize these burdens by (1) allowing all manufacturers to adopt 
rotation plans that permit the introduction of new brands or brand 
styles without further submission to the Commission as long as the 
rotation plan explains how the warnings on such new products will be 
appropriately rotated, and (2) no longer requiring manufacturers to 
submit ``every packaging change [to the FTC] for review and approval.'' 
The two cigarette companies contend that doing so would be consistent 
with the regulations the U.S. Food and Drug Administration (``FDA'') 
has issued in light of the pending transfer of statutory authority 
concerning the display of health warnings. The two companies claim that 
in a final rule, titled ``Tobacco Products; Required Warnings for 
Cigarette Packages and Advertisements,'' the FDA took the position 
that, ``in lieu of a supplement to an approved plan for a new brand, 
manufacturers may reference in their initial plan `all brands' in their 
product listing(s) . . . and incorporate any new brands into their 
approved plan, so long as no other changes are made to the plan.'' \8\
---------------------------------------------------------------------------

    \8\ ITG Brands & Commonwealth Brands Comment (citing 85 FR 15638 
(Mar. 18, 2020)).
---------------------------------------------------------------------------

    Response: The two companies are correct that section 1333(c)(1) 
does not explicitly mention brand styles. However, section 1333(b)(1), 
which addresses the format of packaging warnings, specifically states 
that the health warning statements must be in ``conspicuous and legible 
type in contrast by typography, layout, or color with all other printed 
material on the package.'' Accordingly, to ensure that the Surgeon 
General's health warnings on cigarette packs and cartons are 
conspicuous, since at least 1991, the Commission has required 
manufacturers and importers to submit health warning plans for all new 
cigarette brands and brand styles, and has reviewed the packaging 
submitted with those plans by the manufacturers and importers before 
that packaging is sent out into the marketplace. As a practical matter, 
no other system would efficiently effectuate Congress's intent that the 
warnings be conspicuous on cigarette packaging.
    Moreover, section 1333(c)(2) of the FCLAA does expressly use the 
term ``brand style'' with respect to a manufacturer or importer that is 
applying for permission to use the alternative to quarterly rotation. 
Section 1333(c)(2)(A) sets forth the requirements that must be met to 
qualify for the alternative ``with respect to a brand style of 
cigarettes,'' \9\ including that the number of cigarettes ``of such 
brand style'' sold in the previous fiscal year is less than one-quarter 
of 1 percent of all cigarettes sold in the U.S. that year.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 1333(c)(2)(A) (emphasis added).
---------------------------------------------------------------------------

    The Commission believes it has the authority under FCLAA to review 
the format of packaging warnings in order to ensure that the Act's 
statutory requirements are satisfied. Paragraph (a)(1) of section 1333 
sets forth the requisite wording of the four packaging warnings, and 
paragraph (b)(1) of section 1333 sets forth the aforementioned format 
requirements applicable to the ``label statements'' required by 
paragraph (a)(1). Paragraph (c)(1) of section 1333 then refers to the 
``label statements'' specified in paragraph (a)(1), and provides that 
the label statements are required to be rotated ``on packages of each 
brand of cigarettes manufactured by the manufacture or importer'' in 
accordance with a plan approved by the Commission that ensures ``that 
all of the labels required . . . will be displayed by the manufacturer 
or importer.'' \10\ Read together, these provisions provide the basis 
for the Commission to require that manufacturers and importers submit 
packaging samples to ensure that the rotation plan meets the 
statutorily prescribed rotation and formatting requirements. In order 
to do so for new brands and brand styles, the Commission must have the 
ability to

[[Page 5896]]

require cigarette manufacturers and importers to submit updated 
rotation plans and packaging samples.
---------------------------------------------------------------------------

    \10\ See 15 U.S.C. 1333(c)(1) (emphasis added).
---------------------------------------------------------------------------

    With regard to the companies' argument that the information 
collection imposes a substantial burden on cigarette manufacturers 
beyond the burden stated in the Federal Register Notice, the Commission 
notes the following. First, ``[s]amples of products or of any other 
physical objects,'' which, by definition, includes packaging samples, 
do not constitute ``information'' for purposes of the PRA,\11\ and any 
costs related to the preparation and submission of any such samples 
should not be included in a burden analysis prepared for purposes of 
the PRA.\12\
---------------------------------------------------------------------------

    \11\ See 5 CFR 1320.3(c) (``Collection of information means . . 
. the obtaining, causing to be obtained, soliciting, or requiring 
the disclosure to an agency, third parties or the public of 
information by or for an agency. . . .'') (emphasis omitted) 
(emphasis added), CFR 1320.3(h)(2) (`` `Information' does not 
generally include . . . [s]amples of products or of any other 
physical objects.'').
    \12\ See 5 CFR 1320.3(b)(1) (defining the term ``burden'' as 
``the total time, effort, or financial resources expended by persons 
to generate, maintain, retain, or disclose or provide information to 
or for a Federal agency'') (emphasis added).
---------------------------------------------------------------------------

    Second, the companies' estimate that, in the context of the 
introduction of new brands and brand styles, the preparation and 
submission of an amended plan takes approximately 20 to 40 hours--i.e., 
up to a full workweek--is likely not reflective of the industry 
average. The amendment of an existing rotation plan to add a new brand 
or brand style is generally relatively quick and simple, and cigarette 
manufacturers can use their existing approved rotation plans as 
templates. A company with an approved plan for rotating the warnings 
quarterly on its packaging must merely identify the new brand style 
being added to that plan and submit the packaging for that new brand 
style; \13\ if the company wishes to add a new brand to its plan, it 
must also identify the warning that will be assigned to that brand 
during each quarter of the year. If the company wishes to use the 
option provided by section 1333(c)(2) and display the four warnings an 
equal number of times during the year on the packaging of certain brand 
styles, it must provide information sufficient to show that its sales 
satisfy both of the criteria in 15 U.S.C. 1333(c)(2)(A), provide 
packaging, and explain--again, as it has done previously--how it will 
ensure that all four warnings will be equally displayed during the one-
year period beginning on the date the plan is approved (for example, by 
using printing plates that produce an even number of all four warnings 
simultaneously on each print run).
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    \13\ The Commission's insistence on actual packaging, rather 
than just artwork, reflects its experience that colors can be 
different in artwork than in final packaging, and that those 
differences can affect whether the warnings are conspicuous.
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    Third, the two cigarette companies' estimate includes activities 
that do not result from a collection of information. Specifically, 
because, as indicated above, the submission of the samples does not 
constitute a collection of information for purposes of the PRA,\14\ the 
two cigarette companies' estimate erroneously includes time spent 
making printing arrangements.\15\ Furthermore, when a plan submitted to 
the Commission cannot be approved in its original form, FTC staff 
usually provides the cigarette manufacturer with specific, 
individualized guidance as to the changes necessary for Commission 
approval. As the PRA exempts ``request[s] for facts or opinions 
addressed to a single person'' and ``[f]acts or opinions obtained or 
solicited through nonstandardized follow-up questions designed to 
clarify responses to approved collections of information,'' \16\ the 
time spent incorporating requested changes into the companies' 
proposals should not be reflected in the burden estimate for this 
information collection.\17\
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    \14\ See supra note 13.
    \15\ See supra note 15.
    \16\ See 5 CFR 1320.3(h)(6), (9).
    \17\ See supra note 15.
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    Fourth, the Commission questions the companies' assertion that the 
preparation of their plans requires the assistance of outside counsel. 
For the years 2017 through 2021--the most recent years for which the 
two companies' plans are on the public record--their plans were all 
signed by in-house counsel. Although some manufacturers and importers 
do use outside counsel to file their plans, they presumably do so 
because it makes more sense from a business perspective than using in-
house personnel.
    The companies also fail to explain why the submission to the 
Commission of the packaging that they intend to use for new products 
requires a significant lead time for printing that would not otherwise 
be incurred. Even if the Commission were to allow manufacturers to 
adopt rotation plans that permit the introduction of new brands or 
brand styles without further submission to the Commission, 
manufacturers and importers would nonetheless have to create, print, 
and then review any packaging for new varieties or redesigned packaging 
for existing varieties for compliance with the FCLAA's format 
requirements.\18\ The two companies also fail to explain why the 
expense associated with the preparation of sample packaging by an 
outside printing company would not still be incurred if the companies 
were to review their own new packaging for compliance with FCLAA 
(rather than submit them to the Commission for approval).
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    \18\ As noted supra note 13, the preparation and submission of 
packaging samples does not constitute a collection of information 
for purposes of the PRA, and, thus, should be disregarded for 
purposes of this burden analysis.
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    The companies also argue that the fact that they are required to 
seek Commission approval prior to the introduction of new brand styles 
or packaging causes them to suffer a ``substantial competitive 
burden.'' However, consideration of whether the requirement imposes a 
competitive burden is beyond the scope of a burden analysis under the 
PRA, which defines the term ``burden'' more narrowly.\19\ Furthermore, 
the two companies' final argument--that is, that requiring Commission 
approval for the introduction of new brand styles is inconsistent with 
the approach that the FDA proposed in light of the pending transfer of 
statutory authority concerning the display of health warnings \20\--is 
equally beyond the scope of this notice. The FDA's proposed approach is 
based on the Family Smoking Prevention and Tobacco Control Act, Public 
Law 111-31, tit. II, sec. 201 (June 22, 2009) (hereinafter, 
``FSPTCA''), which differs from the FCLAA in significant aspects.\21\
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    \19\ For a definition of the term ``burden,'' see 44 U.S.C. 
3502(2) and 5 CFR 1320.3(b)(1).
    \20\ ITG Brands & Commonwealth Brands Comment (citing 85 FR 
15638 (Mar. 18, 2020)).
    \21\ For example, the FSPTCA provides precise details as to the 
size, font, location, and color of the nine warning statements that 
will ultimately replace the current four Surgeon General's warnings. 
See 15 U.S.C. 1333(a)(2) (2009 ed.). Additionally, only the FCLAA 
specifically requires the annual submission of information 
demonstrating that the manufacturer or importer continues to qualify 
for equalization of the health warnings.
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    Accordingly, as the Commission does not find the two companies' 
arguments to be convincing, the Commission declines to adjust the 
estimates that were included in its expedited provisional clearance 
request and approved by OMB on July 28, 2023.

C. Overview of Information Collection

    Title of Collection: Information Collection under the Federal 
Cigarette Labeling and Advertising Act.
    OMB Control Number: 3084-0175.
    Type of Review: Extension without change of currently approved 
collection.

[[Page 5897]]

    Abstract: The Federal Cigarette Labeling and Advertising Act, 15 
U.S.C. 1331 et seq. (2006 ed.) (``FCLAA''), requires cigarette 
manufacturers, packagers, and importers to place one of four 
statutorily-prescribed Surgeon General's health warnings on cigarette 
packaging and in advertisements, on a rotational basis in accordance 
with plans reviewed and approved by the FTC. Each manufacturer, 
packager, and importer (hereinafter, also referred to as 
``respondents'') wishing to import for sale or distribute cigarettes in 
the United States is required to submit a plan to the FTC that (1) 
explains how the respondent intends to comply with the statutory 
requirement to display the statutorily-prescribed health warnings on 
its packaging, (2) identifies each of the respondent's brands and brand 
styles, (3) includes a schedule (or other explanation) showing the 
warnings that will be assigned to each brand during each quarter of the 
year, and (4) specifies when in the manufacturing process the 
respondent will consult its rotation schedule for that particular brand 
in order to assign the appropriate quarterly warning. Respondents 
wishing to engage in advertising of cigarettes in the United States are 
required to submit to the FTC a plan that (1) includes a rotation 
schedule for the four statutorily-prescribed health warnings for each 
brand the respondent intends to advertise, (2) specifies how the 
respondent will determine which health warnings will appear on 
different kinds of advertisements, and (3) specifies how the respondent 
will handle advertisements that feature more than one of the 
respondent's brands.
    The FCLAA also provides for an alternative method for displaying 
the required health warnings on packaging--that is, equalization. 
Specifically, manufacturers, packagers, and importers may seek the 
FTC's approval to display the health warnings on a particular cigarette 
brand style an equal number of times. In order to obtain approval for 
equalization, respondents must submit an additional plan to the FTC 
that establishes (1) that their sales satisfy the statutory-prescribed 
requirements for equalization, and (2) how the respondent will ensure 
that all four health warnings will be equally displayed during the one-
year period following the plan's approval (e.g., by using printing 
plates that produce an even number of all four warnings simultaneously 
on each print run). Respondents seeking to equalize must submit new 
plans annually to demonstrate that their sales continue to qualify for 
equalization.
    The Commission uses the information to assess--as it is required to 
do under the FCLAA--whether a manufacturer or importer will display the 
Surgeon General's health warnings in compliance with the governing 
statutory provisions in the FCLAA.
    Affected Public: Private Sector: Businesses and other for-profit 
entities.
    Estimated Annual Burden Hours: 328.
    Estimated Annual Labor Costs: $16,695.
    Estimated Annual Non-Labor Costs: $0.

D. Request for Comment

    Pursuant to OMB regulations, 5 CFR part 1320, which implement the 
PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second 
opportunity for public comment while submitting to OMB its request for 
clearance for the information collection requirements contained in the 
FCLAA. For more details about the requirements and the basis for the 
calculations summarized above, see 88 FR 60941.
    Your comment--including your name and your state--will be placed on 
the public record of this proceeding. Because your comment will be made 
public, you are solely responsible for making sure that your comment 
does not include any sensitive personal information, such as anyone's 
Social Security number; date of birth; driver's license number or other 
state identification number or foreign country equivalent; passport 
number; financial account number; or credit or debit card number. You 
are also solely responsible for ensuring that your comment does not 
include any sensitive health information, such as medical records or 
other individually identifiable health information. In addition, your 
comment should not include any ``[t]rade secret or any commercial or 
financial information which is . . . privileged or confidential''--as 
provided in Section 6(f) of the FTC Act 15 U.S.C. 46(f), and FTC Rule 
4.10(a)(2), 16 CFR 4.10(a)(2)--including, in particular, competitively 
sensitive information, such as costs, sales statistics, inventories, 
formulas, patterns devices, manufacturing processes, or customer names.

Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2024-01798 Filed 1-29-24; 8:45 am]
BILLING CODE 6750-01-P
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