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.

Likely Respondents: Contact lens prescribers and contact lens sellers.

Estimated Annual Labor Hours Burden: 3,216,888 hours (derived from 2,070,288 contact lens prescriber hours + 1,146,600 contact lens seller hours).

• Contact Lens Prescribers: 750,000 hours (45 million contact lens wearers × 1 minute per prescription release/60 minutes) + 187,500 hours (33,750,000 contact lens wearers × 20 seconds per confirmation of prescription release/3600 seconds) + 62,500 hours (11,250,000 contact lens wearers × 20 seconds per affirmative consent to electronic prescription delivery/3600 seconds) + 320,288 hours (3,843,450 verification requests × 5 minutes per response/60 minutes) + 750,000 hours recordkeeping = 2,070,288 hours.
• Contact Lens Sellers: 1,146,600 (derived from 1,067,625 hours (12,811,500 orders × 5 minutes per verification/60 minutes) + 78,975 burden hours (4,738,500 orders × 1 minute recordkeeping/60 minutes) = 1,146,600) hours.

Estimated Total Labor Cost Burden: Approximately $133,334,992 (derived from $61,908,147 ($68.05 × 909,745 optometrist hours) + $23,514,733 ($146.47 × 160,543 ophthalmologist hours) + $47,912,112 ($22.32 × 2,146,600 prescriber and seller office clerk hours)).

Estimated Total Non-Labor Cost Burden: $640,575 (derived from 12,811,500 orders × $.05 per automated message recording).

Estimated Total Annual Cost Burden: $133,975,567 (derived from $133,334,992 labor cost + $640,575 non-labor cost).

The Contact Lens Rule was promulgated by the FTC pursuant to the Fairness to Contact Lens Consumers Act (“FCLCA”), Public Law 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: (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 document; or (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; or (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. Additionally, contact lens sellers are required 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.

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: 3,216,888 hours.

This figure is derived by adding 2,070,288 disclosure, verification, and recordkeeping-hours for contact lens prescribers to 1,146,600 verification and recordkeeping hours for contact lens sellers. This estimate is an increase from the 3,104,050 hours annual burden hours submitted to OMB in 2023.

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 believe 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 and Prevention to be approximately 45 ( printed page 65211) 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—continues to assume 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 twenty 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] Based on our knowledge of the industry and how the medical field operates, the Commission believes most signed patient confirmations are obtained by prescribers' office staff rather than by the prescribers themselves. The time spent by prescribers' staff complying with the requirement to obtain signed confirmations from the other 75% of patients is approximately 187,500 hours annually [(75% × 45 million prescriptions yearly × 20 seconds) / 3600 seconds = 187,500 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 twenty seconds,^[8] and the annual time spent complying with the requirement to obtain such signatures is approximately 62,500 hours [(25% × 45 million prescriptions yearly × 20 seconds) / 3600 seconds = 62,500 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 39% 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 17,550,000 contact lens purchases (45 million × 39% = 17,550,000) 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 1,921,725 verification requests annually [(17,550,000 purchases × 73%) × 15% = 1,921,725 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 3,843,450 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 320,288 hours annually [(3,843,450 × 5 minutes) / 60 minutes = 320,288 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, even though this may result in an estimated labor cost that is higher than in actuality.

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 ( printed page 65212) 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 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 2,070,288 hours for all contact lens prescribers to comply with the Rule [750,000 prescription-release hours + 187,500 confirmation-collection hours + 62,500 electronic-delivery-consent hours + 320,288 verification-response hours + 750,000 recordkeeping hours = 2,070,288 hours]. Of this total, we estimate 1,070,288 are labor hours performed by prescribers and 1,000,000 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 17,550,000 sales by non-prescriber sellers annually and approximately 73% of such sales require verification. Therefore, sellers verify approximately 12,811,500 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 12,811,500 orders, contact lens sellers will spend a total of 1,067,625 burden hours complying with this portion of the requirement [(12,811,500 × 5 minutes) / 60 minutes = 1,067,625 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 cases this retention is electronic and automatic and will not require any time) for 4,738,500 orders [17,550,000 sales × 27%], resulting in 78,975 recordkeeping burden hours [(4,738,500 orders × 1 minute) / 60 minutes = 78,975 hours].

Combining burden hours for all orders [1,067,625 hours + 78,975 hours], staff estimates a total of 1,146,600 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 $133,334,992.

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 $117,606,598 labor cost estimate submitted to OMB in 2023 due to wage increases for optometrists, ophthalmologists, and office staff, and an increase in the percentage estimate of contact lens sales made by sellers other than the prescriber.

According to Bureau of Labor Statistics (BLS), salaried optometrists earn an average wage of $68.05 per hour, ophthalmologists—which are listed by BLS under “surgeons”—earn an average wage of $146.47 per hour, and general office clerks earn an average wage of $22.32 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 1,070,288 total prescriber labor hours relating to the Rule's prescription release requirement (750,000 hours) and response to verification requests (320,288 hours), 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 (1,000,000 hours) and for non-prescriber sellers (1,146,600 hours). Based on these assumptions and estimates above, the estimated total labor cost attributable to the Rule is approximately $133,334,992 [($68.05 × 909,745 optometrist hours = $61,908,147) + ($146.47 × 160,543 ophthalmologist hours = $23,514,733) + ($22.32 × 1,000,000 prescribers' office clerk hours = $22,320,000) + ($22.32 × 1,146,600 sellers' office clerk hours = $25,592,112) = $133,334,992].

Estimated annual non-labor cost burden: $640,575.

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 ( printed page 65213) cost to record each verification call at five cents apiece.^[13]

Based on survey data, approximately 39% 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 17,550,000 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 12,811,500 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, $640,575 (12,811,500 × $.05).

Combining the annual labor cost burden with the non-labor cost burden, the total cost burden of the Rule is estimated at $133,975,567 ($133,334,992 + $640,575 = $133,975,567). This is higher than the $118,197,898 cost submitted to OMB in 2023 due to rising wage rates and an increase in the estimated percentage of sales to non-prescriber sellers.

To put the total cost in perspective, a recent survey estimated that the U.S. contact lens market revenue is approximately $4.4 billion as of 2025, and growing at a healthy pace.^[14] Therefore, the total cost burden estimate of $133,975,567, imposed by the Rule, while not insubstantial, represents just approximately 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 December 14, 2026. Your comment, including your name and your state, will be placed on the public record of this proceeding, including the 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 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, 600 Pennsylvania Avenue NW, Mail Stop H-144 (Annex E), Washington, DC 20580.

Because your comment will become publicly available at 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 December 14, 2026. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see www.ftc.gov/​site-information/​privacy-policy.

91 FR 65209