Agency Information Collection Activities; Proposed Collection; Comment Request; Extension, 55044-55048 [2023-17420]

Download as PDF 55044 Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue, NW, Washington, DC 20551–0001, not later than August 29, 2023. A. Federal Reserve Bank of Kansas City (Jeffrey Imgarten, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001. Comments can also be sent electronically to KCApplicationComments@kc.frb.org: 1. Clark Bancshares, Inc., Clarks, Nebraska; to acquire substantially all of the assets of M & L Cave, Inc., d/b/a Silver Creek Insurance Agency, Silver Creek, Nebraska, and thereby engage in insurance agency activity located in a place that has a population not exceeding 5,000 pursuant to section 225.28(b)(11)(iii) of the Board’s Regulation Y. Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. [FR Doc. 2023–17336 Filed 8–11–23; 8:45 am] BILLING CODE P ddrumheller on DSK120RN23PROD with NOTICES1 BILLING CODE P FEDERAL TRADE COMMISSION ACTION: The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Jkt 259001 [FR Doc. 2023–17335 Filed 8–11–23; 8:45 am] Federal Trade Commission. Notice. AGENCY: Formations of, Acquisitions by, and Mergers of Bank Holding Companies 17:38 Aug 11, 2023 Board of Governors of the Federal Reserve System. Michele Taylor Fennell, Deputy Associate Secretary of the Board. Agency Information Collection Activities; Proposed Collection; Comment Request; Extension FEDERAL RESERVE SYSTEM VerDate Sep<11>2014 Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than September 13, 2023. A. Federal Reserve Bank of Kansas City (Jeffrey Imgarten, Assistant Vice President) One Memorial Drive, Kansas City, Missouri 64198–0001. Comments can also be sent electronically to KCApplicationComments@kc.frb.org: 1. Commerce Financial Company, Duncan, Oklahoma; to become a bank holding company by merging with Commerce Bancorp, Inc., Duncan, Oklahoma, thereby indirectly acquiring Bank of Commerce, Duncan, Oklahoma. In accordance with the Paperwork Reduction Act of 1995 (‘‘PRA’’), the Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’) is seeking public comment on its proposal to extend for an additional three years the Office of Management and Budget clearance for information collection requirements in its Contact Lens Rule (or Rule). That clearance expires on October 31, 2023. DATES: Comments must be filed by October 13, 2023. ADDRESSES: Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ‘‘Contact Lens Rule, PRA Comment, P145403,’’ on your comment, and file your comment online at https:// www.regulations.gov by following the instructions on the web-based form. If you prefer to file your comment on SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC–5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Paul Spelman, Attorney, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Mail Drop CC–10528, Washington, DC 20580, at (202) 326–2487. SUPPLEMENTARY INFORMATION: Title: Contact Lens Rule (Rule), 16 CFR part 315. OMB Control Number: 3084–0127. Type of Review: Extension of a currently approved collection. Abstract: The Rule was promulgated by the FTC pursuant to the Fairness to Contact Lens Consumers Act (FCLCA), Pub. L. 108–164 (Dec. 6, 2003), which was enacted to enable consumers to purchase contact lenses from the seller of their choice. The Rule became effective on August 2, 2004, and was most recently amended in 2020.1 As mandated by the FCLCA, the Rule requires the release and verification of contact lens prescriptions which are generally valid for one year and contains recordkeeping requirements applying to both prescribers and sellers of contact lenses. Specifically, the Rule requires that prescribers provide a copy of the prescription to the consumer upon the completion of a contact lens fitting, even if the patient does not request it, and verify or provide prescriptions to authorized third parties. The Rule also mandates that a contact lens seller may sell contact lenses only in accordance with a prescription that the seller either: (a) has received from the patient or prescriber; or (b) has verified through direct communication with the prescriber. Additional provisions in the Rule that constitute collections of information as defined by 5 CFR 1320.3(c) require that sellers who use calls containing automated verification messages record the entire call, and preserve such recordings for at least three years. In addition, the Rule requires that prescribers either: (a) obtain from patients, and maintain for a period of not less than three years, a signed confirmation of prescription release on a separate stand-alone 1 Final E:\FR\FM\14AUN1.SGM Rule, 85 FR 50668 (Aug. 17, 2020). 14AUN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices document; (b) obtain from patients, and maintain for a period of not less than three years, a patient’s signature on a confirmation of prescription release included on a copy of a patient’s prescription; (c) obtain from patients, and maintain for a period of not less than three years, a patient’s signature on a confirmation of prescription release included on a copy of a patient’s contact lens fitting sales receipt; or (d) provide each patient with a copy of the prescription via online portal, electronic mail, or text message, and for three years retain evidence that such prescription was sent, received, or, if provided via an online-patient portal, made accessible, downloadable, and printable by the patient. For prescribers who choose to offer an electronic method of prescription delivery, the Rule requires that such prescribers maintain records or evidence of affirmative consent by patients to such digital delivery for three years. The Rule also requires prescribers to document in their records the medical reasons for setting a contact lens prescription expiration date of less than one year, and requires contact lens sellers to maintain records for three years of all direct communications involved in obtaining verification of a contact lens prescription, as well as prescriptions, or copies thereof, which they receive directly from customers or prescribers. The information retained under the Rule’s recordkeeping requirements is used by the Commission to substantiate compliance with the Rule and may also provide a basis for the Commission to bring an enforcement action. Without the required records, it would be difficult either to ensure that entities are complying with the Rule’s requirements or to bring enforcement actions based on violations of the Rule. Likely Respondents: Contact lens prescribers and contact lens sellers. Estimated Annual Labor Hours Burden: 2,979,050 hours (derived from 1,920,650 contact lens prescriber hours + 1,058,400 contact lens seller hours). • Contact Lens Prescribers: 750,000 hours (45 million contact lens wearers × 1 minute per prescription release/60 minutes) + 93,750 hours (33,750,000 contact lens wearers × 10 seconds per confirmation of prescription release) + 31,250 hours (11,250,000 contact lens wearers × 10 seconds per affirmative consent to electronic prescription delivery) + 295,650 hours (3,547,800 verification requests × 5 minutes per response/60 minutes) + 750,000 hours recordkeeping = 1,920,650 hours. • Contact Lens Sellers: 985,500 hours (11,826,000 orders × 5 minutes per verification/60 minutes) + 72,900 VerDate Sep<11>2014 17:38 Aug 11, 2023 Jkt 259001 burden hours (4,374,000 orders × 1 minute recordkeeping/60 minutes) = 1,058,400 hours. Estimated Total Labor Cost Burden: Approximately $120,173,486 (derived from ($63.99 × 968,490 optometrist hours) + ($127.62 × 170,910 ophthalmologist hours) + ($19.78 × 1,839,650 office clerk hours)). Estimated Total Non-Labor Cost Burden: $591,300 (11,826,000 × $.05 per automated message recording). Estimated Total Annual Cost Burden: $120,764,786 ($120,173,486 labor cost + $591,300 non-labor cost). As required by section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), the FTC is providing this opportunity for public comment before requesting that OMB extend the existing clearance for the information collection requirements contained in the Rule. Burden Statement Estimated annual hours burden: 2,979,050 hours. This figure is derived by adding disclosure and recordkeeping-hours for contact lens prescribers to recordkeeping hours for contact lens sellers. This estimate is an increase from the 2,104,050 hours annual burden hours submitted to OMB in 2019. The increase is due to amendments to the Rule in 2020 which added new requirements for prescribers and sellers. 1. Prescribers and Their Office Staff The Rule requires prescribers to collect information and make disclosures in three ways. Upon completing a contact lens fitting, the Rule requires that prescribers (1) provide a copy of the contact lens prescription to the patient,2 (2) collect a patient’s signature on either a Confirmation of Prescription Release or a consent-to-electronic-prescriptionrelease and preserve such record, and (3) as directed by any person designated to act on behalf of the patient, provide or verify the contact lens prescription. Prescribers can verify a prescription either by responding affirmatively to a request for verification, or by not responding at all, in which case the prescription will be ‘‘passively verified’’ after eight business hours. Prescribers are also required to correct an incorrect prescription submitted by a seller, and notify a seller if the prescription 2 The 2020 amendments to the Contact Lens Rule altered the definition of ‘‘provide to the patient a copy’’ of the contact lens prescription to include electronic delivery of the prescription, such as via email, text, or by uploading it to a patient portal. In order to avail themselves of this option, prescribers must obtain and maintain evidence of the patients’ affirmative consent to electronic delivery for three years. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 55045 submitted for verification is expired or otherwise invalid. Staff believes that the burden of complying with these requirements is relatively low. The number of contact lens wearers in the United States is estimated by the Centers for Disease Control to be approximately 45 million.3 Therefore, assuming an annual contact lens exam for each contact lens wearer, approximately 45 million people would receive a copy of their prescription each year under the Rule and be required to either sign a Confirmation of Prescription Release or consent to electronic delivery of their prescription.4 At an estimated one minute per prescription, the annual time spent by prescribers complying with the requirement to release prescriptions to patients would be approximately 750,000 hours. [(45 million × 1 minute)/ 60 minutes = 750,000 hours]. Since the Rule requires that prescriptions be released automatically at completion of a fitting, the Commission—for purposes of calculating the PRA burden—assumes that prescription releases to patients are handled by the prescriber rather than the prescriber’s office staff.5 In all likelihood, this estimate overstates the actual burden because it includes the time spent by prescribers who already release prescriptions to patients in the ordinary course of business. Furthermore, this estimate allocates the same time for both paper and electronic delivery of prescriptions, even though the latter likely takes less time for the prescriber. The time required to collect a signature from a patient confirming release of a prescription is estimated at 3 Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, https:// www.cdc.gov/contactlenses/fast-facts.html. See also U.S. Food & Drug Administration, Focusing on Contact Lens Safety, https://www.fda.gov/ consumers/consumer-updates/focusing-contactlens-safety. 4 In the past, some commentators have suggested that typical contact lens wearers obtain annual exams every 18 months or so, not every year. However, because prescriptions under the Rule are valid for a minimum of one year, we continue to estimate that patients seek exams every 12 months. Staff believes a calculation that assumes adherence to the Rule will provide the best estimate of the Rule’s contemplated burden, even if, in practical terms, it overestimates the burden. 5 This assumption may be incorrect, particularly in instances where a contact lens fitting is not completed during the prescriber’s examination itself, but rather after the patient tests out the lenses for a few days. Nonetheless, the Commission does not have empirical data on what percentage of prescriptions are released by prescribers or by prescribers’ staff, and thus will calculate the PRA with the assumption that they are all released by the prescriber. E:\FR\FM\14AUN1.SGM 14AUN1 ddrumheller on DSK120RN23PROD with NOTICES1 55046 Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices ten seconds.6 It is estimated that 25% of patients would opt for electronic delivery of their prescriptions and thus would not need to sign a Confirmation of Prescription Release.7 The time spent by prescribers complying with the requirement to obtain signed confirmations from the other 75% of patients is approximately 93,750 hours annually [(75% × 45 million prescriptions yearly × 10 seconds) = 93,750 hours]. As noted above, it is estimated that approximately 25% of patients would opt for electronic delivery of their prescriptions. In order to opt for electronic delivery, patients are required to sign an affirmative consent to receive their prescription via email, text, or patient portal. The time required to collect an affirmative consent signature is estimated at ten seconds,8 and the annual time spent complying with the requirement to obtain such signatures is approximately 31,250 hours [(25% × 45 million prescriptions yearly × 10 seconds) = 31,250 hours]. Based on our knowledge of the industry and how the medical field operates, the Commission believes most signed patient consents are obtained by prescribers’ office staff rather than by the prescribers themselves. As stated above, prescribers may also be required to provide or verify contact lens prescriptions to sellers. According to survey data, approximately 36% of contact lens purchases are from a source other than the prescriber.9 Assuming that each of the 45 million contact lens wearers in the U.S. makes one purchase per year, this means that approximately 16,200,000 contact lens purchases (45 million × 36% = 16,200,000) are made from sellers other than the prescriber. Based on prior discussions with industry, approximately 73% of sales by non-prescriber sellers require verification, and prescribers affirmatively respond (by notifying the seller that the prescription is invalid or incorrect) to approximately 15% of those verification requests. Using a response rate of 15%, the FTC therefore estimates that prescribers’ offices respond to approximately 1,773,900 verification requests annually [(16,200,000 purchases × 73%) × 15% = 1,773,900 responses]. Additionally, some prescribers may voluntarily respond to verification requests and confirm prescriptions (as opposed to 6 85 FR 50709. 7 Id. 8 Id., note 584. J. Nichols & Deborah Fisher, ‘‘2018 Annual Report,’’ Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/ january-2019. simply letting the prescription passively verify). Because correcting or declining incorrect prescriptions is mandated by the Rule and occurs in response to approximately 15% of requests, staff assumes that prescribers voluntarily confirm prescriptions less often, and confirm at most an additional 15% of prescriptions (and, in all likelihood, significantly less). Using a combined response rate of 30%, the FTC estimates that prescribers’ offices respond to approximately 3,547,800 requests annually. According to prior industry comments,10 responding to verification requests requires approximately five minutes per request. Using that data, we estimate that these responses require an additional 295,650 hours annually. [(3,547,800 × 5 minutes)/60 minutes = 295,650 hours]. Based on investigations and anecdotal comments, FTC staff is aware that many verification requests are handled by office staff rather than by the prescribers themselves. FTC staff, however, does not possess reliable information as to what percentage of verification requests are performed by prescribers or their staff, and thus will allocate all such hours to prescribers. Lastly, the Rule and FCLCA also impose recordkeeping requirements on prescribers’ offices. First, they must maintain signed confirmations, or signed consent to electronic prescription delivery and proof that such prescriptions were delivered via email, text, or patient portal, for a period of three years. For purposes of PRA analysis, the Commission has used the assumption that all prescriber offices require a full minute to store and maintain each confirmation record, and a full minute to store and maintain each consent to electronic prescription delivery and proof of electronic prescription delivery.11 The Commission thus allots an additional 750,000 annual hours for prescribers’ offices to store and maintain records of patient confirmations and consents. The Commission believes these labor hours are most likely performed by prescribers’ office staff. The Rule also requires prescribers to document the specific medical reasons for setting a contact lens prescription expiration date shorter than the oneyear minimum established by the FCLCA. This burden is likely to be nil because the requirement applies only in cases when the prescriber invokes the medical judgment exception, which is expected to occur infrequently, and 9 Jason VerDate Sep<11>2014 17:38 Aug 11, 2023 Jkt 259001 10 Notice and Request for Comment, 81 FR 62501 (Sept. 9, 2016). 11 85 FR 5709. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 prescribers are likely to record this information in the ordinary course of business as part of their patients’ medical records. As mentioned previously, the OMB regulation that implements the PRA defines ‘‘burden’’ to exclude any effort that would be expended regardless of a regulatory requirement. Combining all hours spent annually disclosing prescriptions to consumers, obtaining confirmations of prescription release from consumers, obtaining affirmative consent to electronic prescription delivery from consumers, responding to verification requests, and maintaining records as required by the Rule, we estimate a total of 1,920,650 hours for all contact lens prescribers to comply with the Rule. [750,000 prescription-release hours + 93,750 confirmation-collection hours + 31,250 electronic-delivery-consent hours + 295,650 verification-response hours + 750,000 recordkeeping hours = 1,920,650 hours]. Of this total, we estimate 1,139,400 are prescriber labor hours, and 781,250 are labor hours performed by prescribers’ clerical office staff. 2. Sellers As noted above, a seller may sell contact lenses only in accordance with a valid prescription that the seller has (a) received from the patient or prescriber, or (b) verified through direct communication with the prescriber. The FCLCA also requires sellers to retain prescriptions and records of communications with prescribers relating to prescription verification for three years. As stated previously, there are approximately 16,200,000 sales by nonprescriber sellers annually and approximately 73% of such sales require verification. Therefore, sellers verify approximately 11,826,000 orders annually and retain two records for such sales: the verification request and any response from the prescriber. Staff estimates that sellers’ verification and recordkeeping for those orders will entail a maximum of five minutes per sale. At an estimated five minutes per sale to each of the approximately 11,826,000 orders, contact lens sellers will spend a total of 985,500 burden hours complying with this portion of the requirement. [(11,826,000 × 5 minutes)/60 minutes = 985,500 hours]. Approximately 27% of sales to nonprescriber sellers do not require verification and thus require only that the seller retain the prescription provided. Staff estimates that this recordkeeping burden requires at most one minute per order (in truth, in many E:\FR\FM\14AUN1.SGM 14AUN1 Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 cases this retention is electronic and automatic and will not require any time) for 4,374,000 orders [16,200,000 sales × 27%], resulting in 72,900 recordkeeping burden hours. [(4,374,000 orders × 1 minute)/60 minutes = 72,900 hours]. Combining burden hours for all orders [985,500 hours + 72,900 hours], staff estimates a total of 1,058,400 hours for contact lens sellers. It is likely that this estimate overstates the actual burden because it includes the time spent by sellers who already keep records pertaining to contact lens sales in the ordinary course of business, and those whose records are generated and preserved automatically when a customer orders online, which staff believes is the case for many online sellers. Estimated total labor cost burden: Approximately $120,173,486. This figure is derived from applying hourly wage figures for optometrists, ophthalmologists, and office clerical staff to the burden hours described above. This estimate is higher than the $84,548,448 labor cost estimate submitted to OMB in 2019 due to new information collection and recordkeeping requirements in the Rule, and to wage increases for optometrists, ophthalmologists, and office staff. According to Bureau of Labor Statistics (BLS), salaried optometrists earn an average wage of $63.99 per hour, ophthalmologists—which are listed by BLS under ‘‘surgeons’’—earn an average wage of $127.62 per hour, and general office clerks earn an average wage of $19.78 per hour.12 Based on our knowledge of the industry and the number of optometrists and ophthalmologists in the United States, we assume that of the 1,139,400 prescriber labor hours relating to the Rule, optometrists are performing 85% of such hours and ophthalmologists are performing the remaining 15% of prescriber hours. We credit general office clerks for performing the remaining hours, both for prescribers’ offices (781,250 hours) and for nonprescriber sellers (1,058,400 hours). Based on these assumptions and estimates above, the estimated total 12 Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational Employment and Wage Statistics—May 2022, https://www.bls.gov/news.release/ocwage.t01.htm. Median salaries for prescribers and clerks are slightly lower than average salaries and, consequently, would result in a lower overall burden imposed by the Rule. It is possible that medians are more representative since they do not include salary outliers that can distort the average. Salaries can also vary by region. However, since Contact Lens Rule PRA submissions have historically used national salary averages to estimate the burden, the FTC will continue to do so for this submission. VerDate Sep<11>2014 17:38 Aug 11, 2023 Jkt 259001 labor cost attributable to the Rule is approximately $120,173,486. [($63.99 × 968,490 optometrist hours = $61,973,675) + ($127.62 × 170,910 ophthalmologist hours = $21,811,534) + ($19.78 × 781,250 prescribers’ office clerk hours = $15,453,125) + ($19.78 × 1,058,400 sellers’ office clerk hours = $20,935,152) = $120,173,486.] Estimated annual non-labor cost burden: $591,300. Staff believes that the Rule’s disclosure and recordkeeping requirements described above impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already (e.g., prescription pads, patients’ medical charts, facsimile machines and paper, telephones, and recordkeeping facilities such as filing cabinets or other storage) to perform those requirements. The 2020 Rule amendments, however, modified the Rule to require that sellers who use automated verification messages record the calls and preserve the recordings for three years. The Commission does not believe that requiring sellers who use automated messages for verification to record the calls and preserve them will create a substantial burden. The requirement will not require additional labor time, since the calls will be for the same duration as they were previously, but may require capital and other nonlabor costs to record the calls and store them electronically. Based on comments supplied during the Rule modification process, the Commission estimates the cost to record each verification call at five cents apiece.13 Based on survey data, approximately 36% of contact lens purchases are from a source other than the prescriber. Assuming that each of the 45 million contact lens wearers in the U.S. makes on purchase per year, this would mean that approximately 16,200,000 contact lens purchases are made annually from sellers other than the prescribers. And since approximately 73% of sales by non-prescriber sellers require verification, this means that approximately 11,826,000 contact lens purchases would require verification calls, faxes, or emails. The Commission does not possess information as to the percentage of verifications completed by telephone versus fax or email, and thus for purposes of this analysis will assume that all verifications are performed via 13 85 FR 50711. It is possible this would be a onetime expense for sellers to invest in recording equipment, as opposed to an annual outlay. But in the absence of information as to how sellers manage such recordings, the Commission will assume, for the purpose of this PRA analysis, that recording expense is a recurring annual cost burden. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 55047 phone and deliver automated messages that are subject to the call-recording requirement. Based on the aforementioned assumptions, the Commission estimates that the requirement to record automated telephone verification messages will cost sellers, in aggregate, $591,300 (11,826,000 × $.05). Combining the annual labor cost burden with the non-labor cost burden, the total cost burden of the Rule is estimated at $120,764,786 ($120,173,486 + $591,300 = $120,764,786). To put this in perspective, a recent survey estimated that the U.S. contact lens market revenue is approximately $9.6 billion (not counting examination revenue) as of 2021, and growing at a steady pace.14 Therefore, the total cost burden estimate of $120,764,786, imposed by the Rule, while not insubstantial, represents a cost of approximately 1.3% of the overall retail revenue generated. Request for Comment Pursuant to Section 3506(c)(2)(A) of the PRA, the FTC invites comments on: (1) whether the disclosure and recordkeeping requirements are necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are valid; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information. For the FTC to consider a comment, we must receive it on or before October 13, 2023. Your comment, including your name and your state, will be placed on the public record of this proceeding, including the https:// www.regulations.gov website. You can file a comment online or on paper. Due to heightened security screening, postal mail addressed to the Commission will be subject to delay. We encourage you to submit your comments online through the https:// www.regulations.gov website. If you file your comment on paper, write ‘‘Contact Lens Rule, PRA Comment, P145403,’’ on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 14 See https://www.globenewswire.com/en/newsrelease/2022/09/05/2509723/0/en/Contact-LensesMarket-Size-Will-Achieve-USD-17-4-Billion-by2030-growing-at-6-9-CAGR-Exclusive-Report-byAcumen-Research-and-Consulting.html. Some estimates put the U.S. contact lens market as high as $17 billion, see https://www.visionmonday.com/ business/article/us-optical-retail-market-estimatedat-765-billion-in-the-vision-councils-firstcomprehensive-market-insights-report/. E:\FR\FM\14AUN1.SGM 14AUN1 ddrumheller on DSK120RN23PROD with NOTICES1 55048 Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices 600 Pennsylvania Avenue NW, Suite CC–5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Because your comment will become publicly available at https:// www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else’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 making sure 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 ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided by 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. Comments containing material for which confidential treatment is requested must (1) be filed in paper form, (2) be clearly labeled ‘‘Confidential,’’ and (3) comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment VerDate Sep<11>2014 17:38 Aug 11, 2023 Jkt 259001 has been posted publicly at www.regulations.gov, we cannot redact or remove your comment unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before October 13, 2023. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/ privacy-policy. Josephine Liu, Assistant General Counsel for Legal Counsel. [FR Doc. 2023–17420 Filed 8–11–23; 8:45 am] BILLING CODE 6750–01–P Purpose and Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Fees for Cruise Ship Operational Sanitation, Construction, and Renovation Inspections Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: General notice. AGENCY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation, construction, and renovation inspections for fiscal year (FY) 2024. These inspections are conducted by HHS/CDC’s Vessel Sanitation Program (VSP). VSP helps the cruise industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every passenger cruise vessel that has a foreign itinerary involving a U.S. port and carries 13 or more passengers is subject to twiceyearly unannounced operational sanitation inspections and, when SUMMARY: PO 00000 Frm 00042 Fmt 4703 necessary, reinspection. Cruise vessel design and equipment must meet VSP’s sanitary design criteria standards and routine operational inspection requirements. Cruise vessel owners or shipyards that build or renovate cruise vessels can request construction or renovation inspections of new or renovated vessels before their first or next operational inspection. DATES: These fees apply to inspections conducted from October 1, 2023, through September 30, 2024. FOR FURTHER INFORMATION CONTACT: CAPT Luis Rodriguez, Acting Chief, Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS 106–6, Atlanta, Georgia 30341– 3717; phone: 800–323–2132; email: vsp@cdc.gov. SUPPLEMENTARY INFORMATION: Sfmt 4703 HHS/CDC established the Vessel Sanitation Program (VSP) in the 1970s as a cooperative activity with the cruise industry. VSP helps the cruise industry prevent and control the introduction, transmission, and spread of gastrointestinal illnesses on cruise ships. VSP operates under the authority of the Public Health Service Act (Section 361 of the Public Health Service Act; 42 U.S.C. 264). Regulations found at 42 CFR 71.41 (Foreign Quarantine—Requirements Upon Arrival at U.S. Ports: Sanitary Inspection; General Provisions) state that carriers arriving at U.S. ports from foreign areas are subject to sanitary inspections to determine whether there exists rodent, insect, or other vermin infestations; contaminated food or water; or other insanitary conditions requiring measures for the prevention of the introduction, transmission, or spread of communicable diseases. The fee schedule for sanitation inspections of passenger cruise ships by VSP was first published in the Federal Register on November 24, 1987 (52 FR 45019). HHS/CDC began collecting fees on March 1, 1988. This notice announces fees for inspections conducted during FY 2024 (beginning on October 1, 2023, through September 30, 2024). E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55044-55048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17420]


=======================================================================
-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Extension

AGENCY: Federal Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 
(``PRA''), the Federal Trade Commission (``FTC'' or ``Commission'') is 
seeking public comment on its proposal to extend for an additional 
three years the Office of Management and Budget clearance for 
information collection requirements in its Contact Lens Rule (or Rule). 
That clearance expires on October 31, 2023.

DATES: Comments must be filed by October 13, 2023.

ADDRESSES: Interested parties may file a comment online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write ``Contact Lens Rule, PRA 
Comment, P145403,'' on your comment, and file your comment online at 
https://www.regulations.gov by following the instructions on the web-
based form. If you prefer to file your comment on paper, mail your 
comment to the following address: Federal Trade Commission, Office of 
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), 
Washington, DC 20580, or deliver your comment to the following address: 
Federal Trade Commission, Office of the Secretary, Constitution Center, 
400 7th Street, SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 
20024.

FOR FURTHER INFORMATION CONTACT: Paul Spelman, Attorney, Division of 
Advertising Practices, Bureau of Consumer Protection, Federal Trade 
Commission, 600 Pennsylvania Avenue NW, Mail Drop CC-10528, Washington, 
DC 20580, at (202) 326-2487.

SUPPLEMENTARY INFORMATION: 
    Title: Contact Lens Rule (Rule), 16 CFR part 315.
    OMB Control Number: 3084-0127.
    Type of Review: Extension of a currently approved collection.
    Abstract: The Rule was promulgated by the FTC pursuant to the 
Fairness to Contact Lens Consumers Act (FCLCA), Pub. L. 108-164 (Dec. 
6, 2003), which was enacted to enable consumers to purchase contact 
lenses from the seller of their choice. The Rule became effective on 
August 2, 2004, and was most recently amended in 2020.\1\ As mandated 
by the FCLCA, the Rule requires the release and verification of contact 
lens prescriptions which are generally valid for one year and contains 
recordkeeping requirements applying to both prescribers and sellers of 
contact lenses.
---------------------------------------------------------------------------

    \1\ Final Rule, 85 FR 50668 (Aug. 17, 2020).
---------------------------------------------------------------------------

    Specifically, the Rule requires that prescribers provide a copy of 
the prescription to the consumer upon the completion of a contact lens 
fitting, even if the patient does not request it, and verify or provide 
prescriptions to authorized third parties. The Rule also mandates that 
a contact lens seller may sell contact lenses only in accordance with a 
prescription that the seller either: (a) has received from the patient 
or prescriber; or (b) has verified through direct communication with 
the prescriber. Additional provisions in the Rule that constitute 
collections of information as defined by 5 CFR 1320.3(c) require that 
sellers who use calls containing automated verification messages record 
the entire call, and preserve such recordings for at least three years. 
In addition, the Rule requires that prescribers either: (a) obtain from 
patients, and maintain for a period of not less than three years, a 
signed confirmation of prescription release on a separate stand-alone

[[Page 55045]]

document; (b) obtain from patients, and maintain for a period of not 
less than three years, a patient's signature on a confirmation of 
prescription release included on a copy of a patient's prescription; 
(c) obtain from patients, and maintain for a period of not less than 
three years, a patient's signature on a confirmation of prescription 
release included on a copy of a patient's contact lens fitting sales 
receipt; or (d) provide each patient with a copy of the prescription 
via online portal, electronic mail, or text message, and for three 
years retain evidence that such prescription was sent, received, or, if 
provided via an online-patient portal, made accessible, downloadable, 
and printable by the patient. For prescribers who choose to offer an 
electronic method of prescription delivery, the Rule requires that such 
prescribers maintain records or evidence of affirmative consent by 
patients to such digital delivery for three years. The Rule also 
requires prescribers to document in their records the medical reasons 
for setting a contact lens prescription expiration date of less than 
one year, and requires contact lens sellers to maintain records for 
three years of all direct communications involved in obtaining 
verification of a contact lens prescription, as well as prescriptions, 
or copies thereof, which they receive directly from customers or 
prescribers.
    The information retained under the Rule's recordkeeping 
requirements is used by the Commission to substantiate compliance with 
the Rule and may also provide a basis for the Commission to bring an 
enforcement action. Without the required records, it would be difficult 
either to ensure that entities are complying with the Rule's 
requirements or to bring enforcement actions based on violations of the 
Rule.
    Likely Respondents: Contact lens prescribers and contact lens 
sellers.
    Estimated Annual Labor Hours Burden: 2,979,050 hours (derived from 
1,920,650 contact lens prescriber hours + 1,058,400 contact lens seller 
hours).
     Contact Lens Prescribers: 750,000 hours (45 million 
contact lens wearers x 1 minute per prescription release/60 minutes) + 
93,750 hours (33,750,000 contact lens wearers x 10 seconds per 
confirmation of prescription release) + 31,250 hours (11,250,000 
contact lens wearers x 10 seconds per affirmative consent to electronic 
prescription delivery) + 295,650 hours (3,547,800 verification requests 
x 5 minutes per response/60 minutes) + 750,000 hours recordkeeping = 
1,920,650 hours.
     Contact Lens Sellers: 985,500 hours (11,826,000 orders x 5 
minutes per verification/60 minutes) + 72,900 burden hours (4,374,000 
orders x 1 minute recordkeeping/60 minutes) = 1,058,400 hours.
    Estimated Total Labor Cost Burden: Approximately $120,173,486 
(derived from ($63.99 x 968,490 optometrist hours) + ($127.62 x 170,910 
ophthalmologist hours) + ($19.78 x 1,839,650 office clerk hours)).
    Estimated Total Non-Labor Cost Burden: $591,300 (11,826,000 x $.05 
per automated message recording).
    Estimated Total Annual Cost Burden: $120,764,786 ($120,173,486 
labor cost + $591,300 non-labor cost).
    As required by section 3506(c)(2)(A) of the PRA, 44 U.S.C. 
3506(c)(2)(A), the FTC is providing this opportunity for public comment 
before requesting that OMB extend the existing clearance for the 
information collection requirements contained in the Rule.

Burden Statement

    Estimated annual hours burden: 2,979,050 hours.
    This figure is derived by adding disclosure and recordkeeping-hours 
for contact lens prescribers to recordkeeping hours for contact lens 
sellers. This estimate is an increase from the 2,104,050 hours annual 
burden hours submitted to OMB in 2019. The increase is due to 
amendments to the Rule in 2020 which added new requirements for 
prescribers and sellers.

1. Prescribers and Their Office Staff

    The Rule requires prescribers to collect information and make 
disclosures in three ways. Upon completing a contact lens fitting, the 
Rule requires that prescribers (1) provide a copy of the contact lens 
prescription to the patient,\2\ (2) collect a patient's signature on 
either a Confirmation of Prescription Release or a consent-to-
electronic-prescription-release and preserve such record, and (3) as 
directed by any person designated to act on behalf of the patient, 
provide or verify the contact lens prescription. Prescribers can verify 
a prescription either by responding affirmatively to a request for 
verification, or by not responding at all, in which case the 
prescription will be ``passively verified'' after eight business hours. 
Prescribers are also required to correct an incorrect prescription 
submitted by a seller, and notify a seller if the prescription 
submitted for verification is expired or otherwise invalid. Staff 
believes that the burden of complying with these requirements is 
relatively low.
---------------------------------------------------------------------------

    \2\ The 2020 amendments to the Contact Lens Rule altered the 
definition of ``provide to the patient a copy'' of the contact lens 
prescription to include electronic delivery of the prescription, 
such as via email, text, or by uploading it to a patient portal. In 
order to avail themselves of this option, prescribers must obtain 
and maintain evidence of the patients' affirmative consent to 
electronic delivery for three years.
---------------------------------------------------------------------------

    The number of contact lens wearers in the United States is 
estimated by the Centers for Disease Control to be approximately 45 
million.\3\ Therefore, assuming an annual contact lens exam for each 
contact lens wearer, approximately 45 million people would receive a 
copy of their prescription each year under the Rule and be required to 
either sign a Confirmation of Prescription Release or consent to 
electronic delivery of their prescription.\4\
---------------------------------------------------------------------------

    \3\ Centers for Disease Control, Healthy Contact Lens Wear and 
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html. 
See also U.S. Food & Drug Administration, Focusing on Contact Lens 
Safety, https://www.fda.gov/consumers/consumer-updates/focusing-contact-lens-safety.
    \4\ In the past, some commentators have suggested that typical 
contact lens wearers obtain annual exams every 18 months or so, not 
every year. However, because prescriptions under the Rule are valid 
for a minimum of one year, we continue to estimate that patients 
seek exams every 12 months. Staff believes a calculation that 
assumes adherence to the Rule will provide the best estimate of the 
Rule's contemplated burden, even if, in practical terms, it 
overestimates the burden.
---------------------------------------------------------------------------

    At an estimated one minute per prescription, the annual time spent 
by prescribers complying with the requirement to release prescriptions 
to patients would be approximately 750,000 hours. [(45 million x 1 
minute)/60 minutes = 750,000 hours]. Since the Rule requires that 
prescriptions be released automatically at completion of a fitting, the 
Commission--for purposes of calculating the PRA burden--assumes that 
prescription releases to patients are handled by the prescriber rather 
than the prescriber's office staff.\5\ In all likelihood, this estimate 
overstates the actual burden because it includes the time spent by 
prescribers who already release prescriptions to patients in the 
ordinary course of business. Furthermore, this estimate allocates the 
same time for both paper and electronic delivery of prescriptions, even 
though the latter likely takes less time for the prescriber.
---------------------------------------------------------------------------

    \5\ This assumption may be incorrect, particularly in instances 
where a contact lens fitting is not completed during the 
prescriber's examination itself, but rather after the patient tests 
out the lenses for a few days. Nonetheless, the Commission does not 
have empirical data on what percentage of prescriptions are released 
by prescribers or by prescribers' staff, and thus will calculate the 
PRA with the assumption that they are all released by the 
prescriber.
---------------------------------------------------------------------------

    The time required to collect a signature from a patient confirming 
release of a prescription is estimated at

[[Page 55046]]

ten seconds.\6\ It is estimated that 25% of patients would opt for 
electronic delivery of their prescriptions and thus would not need to 
sign a Confirmation of Prescription Release.\7\ The time spent by 
prescribers complying with the requirement to obtain signed 
confirmations from the other 75% of patients is approximately 93,750 
hours annually [(75% x 45 million prescriptions yearly x 10 seconds) = 
93,750 hours].
---------------------------------------------------------------------------

    \6\ 85 FR 50709.
    \7\ Id.
---------------------------------------------------------------------------

    As noted above, it is estimated that approximately 25% of patients 
would opt for electronic delivery of their prescriptions. In order to 
opt for electronic delivery, patients are required to sign an 
affirmative consent to receive their prescription via email, text, or 
patient portal. The time required to collect an affirmative consent 
signature is estimated at ten seconds,\8\ and the annual time spent 
complying with the requirement to obtain such signatures is 
approximately 31,250 hours [(25% x 45 million prescriptions yearly x 10 
seconds) = 31,250 hours]. Based on our knowledge of the industry and 
how the medical field operates, the Commission believes most signed 
patient consents are obtained by prescribers' office staff rather than 
by the prescribers themselves.
---------------------------------------------------------------------------

    \8\ Id., note 584.
---------------------------------------------------------------------------

    As stated above, prescribers may also be required to provide or 
verify contact lens prescriptions to sellers. According to survey data, 
approximately 36% of contact lens purchases are from a source other 
than the prescriber.\9\ Assuming that each of the 45 million contact 
lens wearers in the U.S. makes one purchase per year, this means that 
approximately 16,200,000 contact lens purchases (45 million x 36% = 
16,200,000) are made from sellers other than the prescriber.
---------------------------------------------------------------------------

    \9\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,'' 
Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019.
---------------------------------------------------------------------------

    Based on prior discussions with industry, approximately 73% of 
sales by non-prescriber sellers require verification, and prescribers 
affirmatively respond (by notifying the seller that the prescription is 
invalid or incorrect) to approximately 15% of those verification 
requests. Using a response rate of 15%, the FTC therefore estimates 
that prescribers' offices respond to approximately 1,773,900 
verification requests annually [(16,200,000 purchases x 73%) x 15% = 
1,773,900 responses]. Additionally, some prescribers may voluntarily 
respond to verification requests and confirm prescriptions (as opposed 
to simply letting the prescription passively verify). Because 
correcting or declining incorrect prescriptions is mandated by the Rule 
and occurs in response to approximately 15% of requests, staff assumes 
that prescribers voluntarily confirm prescriptions less often, and 
confirm at most an additional 15% of prescriptions (and, in all 
likelihood, significantly less). Using a combined response rate of 30%, 
the FTC estimates that prescribers' offices respond to approximately 
3,547,800 requests annually.
    According to prior industry comments,\10\ responding to 
verification requests requires approximately five minutes per request. 
Using that data, we estimate that these responses require an additional 
295,650 hours annually. [(3,547,800 x 5 minutes)/60 minutes = 295,650 
hours]. Based on investigations and anecdotal comments, FTC staff is 
aware that many verification requests are handled by office staff 
rather than by the prescribers themselves. FTC staff, however, does not 
possess reliable information as to what percentage of verification 
requests are performed by prescribers or their staff, and thus will 
allocate all such hours to prescribers.
---------------------------------------------------------------------------

    \10\ Notice and Request for Comment, 81 FR 62501 (Sept. 9, 
2016).
---------------------------------------------------------------------------

    Lastly, the Rule and FCLCA also impose recordkeeping requirements 
on prescribers' offices. First, they must maintain signed 
confirmations, or signed consent to electronic prescription delivery 
and proof that such prescriptions were delivered via email, text, or 
patient portal, for a period of three years. For purposes of PRA 
analysis, the Commission has used the assumption that all prescriber 
offices require a full minute to store and maintain each confirmation 
record, and a full minute to store and maintain each consent to 
electronic prescription delivery and proof of electronic prescription 
delivery.\11\ The Commission thus allots an additional 750,000 annual 
hours for prescribers' offices to store and maintain records of patient 
confirmations and consents. The Commission believes these labor hours 
are most likely performed by prescribers' office staff.
---------------------------------------------------------------------------

    \11\ 85 FR 5709.
---------------------------------------------------------------------------

    The Rule also requires prescribers to document the specific medical 
reasons for setting a contact lens prescription expiration date shorter 
than the one-year minimum established by the FCLCA. This burden is 
likely to be nil because the requirement applies only in cases when the 
prescriber invokes the medical judgment exception, which is expected to 
occur infrequently, and prescribers are likely to record this 
information in the ordinary course of business as part of their 
patients' medical records. As mentioned previously, the OMB regulation 
that implements the PRA defines ``burden'' to exclude any effort that 
would be expended regardless of a regulatory requirement.
    Combining all hours spent annually disclosing prescriptions to 
consumers, obtaining confirmations of prescription release from 
consumers, obtaining affirmative consent to electronic prescription 
delivery from consumers, responding to verification requests, and 
maintaining records as required by the Rule, we estimate a total of 
1,920,650 hours for all contact lens prescribers to comply with the 
Rule. [750,000 prescription-release hours + 93,750 confirmation-
collection hours + 31,250 electronic-delivery-consent hours + 295,650 
verification-response hours + 750,000 recordkeeping hours = 1,920,650 
hours]. Of this total, we estimate 1,139,400 are prescriber labor 
hours, and 781,250 are labor hours performed by prescribers' clerical 
office staff.

2. Sellers

    As noted above, a seller may sell contact lenses only in accordance 
with a valid prescription that the seller has (a) received from the 
patient or prescriber, or (b) verified through direct communication 
with the prescriber. The FCLCA also requires sellers to retain 
prescriptions and records of communications with prescribers relating 
to prescription verification for three years.
    As stated previously, there are approximately 16,200,000 sales by 
non-prescriber sellers annually and approximately 73% of such sales 
require verification. Therefore, sellers verify approximately 
11,826,000 orders annually and retain two records for such sales: the 
verification request and any response from the prescriber. Staff 
estimates that sellers' verification and recordkeeping for those orders 
will entail a maximum of five minutes per sale. At an estimated five 
minutes per sale to each of the approximately 11,826,000 orders, 
contact lens sellers will spend a total of 985,500 burden hours 
complying with this portion of the requirement. [(11,826,000 x 5 
minutes)/60 minutes = 985,500 hours].
    Approximately 27% of sales to non-prescriber sellers do not require 
verification and thus require only that the seller retain the 
prescription provided. Staff estimates that this recordkeeping burden 
requires at most one minute per order (in truth, in many

[[Page 55047]]

cases this retention is electronic and automatic and will not require 
any time) for 4,374,000 orders [16,200,000 sales x 27%], resulting in 
72,900 recordkeeping burden hours. [(4,374,000 orders x 1 minute)/60 
minutes = 72,900 hours].
    Combining burden hours for all orders [985,500 hours + 72,900 
hours], staff estimates a total of 1,058,400 hours for contact lens 
sellers. It is likely that this estimate overstates the actual burden 
because it includes the time spent by sellers who already keep records 
pertaining to contact lens sales in the ordinary course of business, 
and those whose records are generated and preserved automatically when 
a customer orders online, which staff believes is the case for many 
online sellers.
    Estimated total labor cost burden: Approximately $120,173,486.
    This figure is derived from applying hourly wage figures for 
optometrists, ophthalmologists, and office clerical staff to the burden 
hours described above. This estimate is higher than the $84,548,448 
labor cost estimate submitted to OMB in 2019 due to new information 
collection and recordkeeping requirements in the Rule, and to wage 
increases for optometrists, ophthalmologists, and office staff.
    According to Bureau of Labor Statistics (BLS), salaried 
optometrists earn an average wage of $63.99 per hour, 
ophthalmologists--which are listed by BLS under ``surgeons''--earn an 
average wage of $127.62 per hour, and general office clerks earn an 
average wage of $19.78 per hour.\12\ Based on our knowledge of the 
industry and the number of optometrists and ophthalmologists in the 
United States, we assume that of the 1,139,400 prescriber labor hours 
relating to the Rule, optometrists are performing 85% of such hours and 
ophthalmologists are performing the remaining 15% of prescriber hours. 
We credit general office clerks for performing the remaining hours, 
both for prescribers' offices (781,250 hours) and for non-prescriber 
sellers (1,058,400 hours). Based on these assumptions and estimates 
above, the estimated total labor cost attributable to the Rule is 
approximately $120,173,486. [($63.99 x 968,490 optometrist hours = 
$61,973,675) + ($127.62 x 170,910 ophthalmologist hours = $21,811,534) 
+ ($19.78 x 781,250 prescribers' office clerk hours = $15,453,125) + 
($19.78 x 1,058,400 sellers' office clerk hours = $20,935,152) = 
$120,173,486.]
---------------------------------------------------------------------------

    \12\ Press Release, Bureau of Labor Statistics, United States 
Department of Labor, Occupational Employment and Wage Statistics--
May 2022, https://www.bls.gov/news.release/ocwage.t01.htm. Median 
salaries for prescribers and clerks are slightly lower than average 
salaries and, consequently, would result in a lower overall burden 
imposed by the Rule. It is possible that medians are more 
representative since they do not include salary outliers that can 
distort the average. Salaries can also vary by region. However, 
since Contact Lens Rule PRA submissions have historically used 
national salary averages to estimate the burden, the FTC will 
continue to do so for this submission.
---------------------------------------------------------------------------

    Estimated annual non-labor cost burden: $591,300.
    Staff believes that the Rule's disclosure and recordkeeping 
requirements described above impose negligible capital or other non-
labor costs, as the affected entities are likely to have the necessary 
supplies and/or equipment already (e.g., prescription pads, patients' 
medical charts, facsimile machines and paper, telephones, and 
recordkeeping facilities such as filing cabinets or other storage) to 
perform those requirements. The 2020 Rule amendments, however, modified 
the Rule to require that sellers who use automated verification 
messages record the calls and preserve the recordings for three years. 
The Commission does not believe that requiring sellers who use 
automated messages for verification to record the calls and preserve 
them will create a substantial burden. The requirement will not require 
additional labor time, since the calls will be for the same duration as 
they were previously, but may require capital and other non-labor costs 
to record the calls and store them electronically. Based on comments 
supplied during the Rule modification process, the Commission estimates 
the cost to record each verification call at five cents apiece.\13\
---------------------------------------------------------------------------

    \13\ 85 FR 50711. It is possible this would be a one-time 
expense for sellers to invest in recording equipment, as opposed to 
an annual outlay. But in the absence of information as to how 
sellers manage such recordings, the Commission will assume, for the 
purpose of this PRA analysis, that recording expense is a recurring 
annual cost burden.
---------------------------------------------------------------------------

    Based on survey data, approximately 36% of contact lens purchases 
are from a source other than the prescriber. Assuming that each of the 
45 million contact lens wearers in the U.S. makes on purchase per year, 
this would mean that approximately 16,200,000 contact lens purchases 
are made annually from sellers other than the prescribers. And since 
approximately 73% of sales by non-prescriber sellers require 
verification, this means that approximately 11,826,000 contact lens 
purchases would require verification calls, faxes, or emails. The 
Commission does not possess information as to the percentage of 
verifications completed by telephone versus fax or email, and thus for 
purposes of this analysis will assume that all verifications are 
performed via phone and deliver automated messages that are subject to 
the call-recording requirement. Based on the aforementioned 
assumptions, the Commission estimates that the requirement to record 
automated telephone verification messages will cost sellers, in 
aggregate, $591,300 (11,826,000 x $.05).
    Combining the annual labor cost burden with the non-labor cost 
burden, the total cost burden of the Rule is estimated at $120,764,786 
($120,173,486 + $591,300 = $120,764,786).
    To put this in perspective, a recent survey estimated that the U.S. 
contact lens market revenue is approximately $9.6 billion (not counting 
examination revenue) as of 2021, and growing at a steady pace.\14\ 
Therefore, the total cost burden estimate of $120,764,786, imposed by 
the Rule, while not insubstantial, represents a cost of approximately 
1.3% of the overall retail revenue generated.
---------------------------------------------------------------------------

    \14\ See https://www.globenewswire.com/en/news-release/2022/09/05/2509723/0/en/Contact-Lenses-Market-Size-Will-Achieve-USD-17-4-Billion-by-2030-growing-at-6-9-CAGR-Exclusive-Report-by-Acumen-Research-and-Consulting.html. Some estimates put the U.S. contact 
lens market as high as $17 billion, see https://www.visionmonday.com/business/article/us-optical-retail-market-estimated-at-765-billion-in-the-vision-councils-first-comprehensive-market-insights-report/.
---------------------------------------------------------------------------

Request for Comment

    Pursuant to Section 3506(c)(2)(A) of the PRA, the FTC invites 
comments on: (1) whether the disclosure and recordkeeping requirements 
are necessary, including whether the information will be practically 
useful; (2) the accuracy of our burden estimates, including whether the 
methodology and assumptions used are valid; (3) ways to enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) ways to minimize the burden of the collection of information.
    For the FTC to consider a comment, we must receive it on or before 
October 13, 2023. Your comment, including your name and your state, 
will be placed on the public record of this proceeding, including the 
https://www.regulations.gov website.
    You can file a comment online or on paper. Due to heightened 
security screening, postal mail addressed to the Commission will be 
subject to delay. We encourage you to submit your comments online 
through the https://www.regulations.gov website.
    If you file your comment on paper, write ``Contact Lens Rule, PRA 
Comment, P145403,'' on your comment and on the envelope, and mail it to 
the following address: Federal Trade Commission, Office of the 
Secretary,

[[Page 55048]]

600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), Washington, DC 
20580, or deliver your comment to the following address: Federal Trade 
Commission, Office of the Secretary, Constitution Center, 400 7th 
Street SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If 
possible, submit your paper comment to the Commission by courier or 
overnight service.
    Because your comment will become publicly available at https://www.regulations.gov, you are solely responsible for making sure that 
your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else'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 making sure 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 ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
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.
    Comments containing material for which confidential treatment is 
requested must (1) be filed in paper form, (2) be clearly labeled 
``Confidential,'' and (3) comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted publicly at www.regulations.gov, we cannot redact or remove 
your comment unless you submit a confidentiality request that meets the 
requirements for such treatment under FTC Rule 4.9(c), and the General 
Counsel grants that request.
    The FTC Act and other laws that the Commission administers permit 
the collection of public comments to consider and use in this 
proceeding as appropriate. The Commission will consider all timely and 
responsive public comments that it receives on or before October 13, 
2023. For information on the Commission's privacy policy, including 
routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023-17420 Filed 8-11-23; 8:45 am]
BILLING CODE 6750-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.