88 FR 155 pgs. 55044-55048 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extension
Type: NOTICEVolume: 88Number: 155Pages: 55044 - 55048
Pages: 55044, 55045, 55046, 55047, 55048FR document: [FR Doc. 2023-17420 Filed 8-11-23; 8:45 am]
Agency: Federal Trade Commission
Official PDF Version: PDF Version
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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.
Footnotes:
1 ?Final Rule, 85 FR 50668 (Aug. 17, 2020).
[top] 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
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 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-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.
Footnotes:
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
Footnotes:
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 × 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.
Footnotes:
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.
[top] The time required to collect a signature from a patient confirming release of a prescription is estimated at
Footnotes:
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% × 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.
Footnotes:
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 × 36% = 16,200,000) are made from sellers other than the prescriber.
Footnotes:
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 × 73%) × 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 × 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.
Footnotes:
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.
Footnotes:
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 × 5 minutes)/60 minutes = 985,500 hours].
[top] 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
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 × 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.]
Footnotes:
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
Footnotes:
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 × $.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.
Footnotes:
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.
[top] 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,
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