Agency Information Collection Activities; Proposed Collection; Comment Request; Extension, 88076-88082 [2023-27877]

Agencies

• FEDERAL TRADE COMMISSION

[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88076-88082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27877]


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FEDERAL TRADE COMMISSION


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

AGENCY: Federal Trade Commission.

ACTION: Notice.

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

DATES: Comments must be filed by January 19, 2024.

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. Written comments and 
recommendations for the proposed information collection should be sent 
within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting 
``Currently under 30-day Review--Open for Public Comments'' or by using 
the search function. The reginfo.gov web link is a United States 
Government website produced by the Office of Management and Budget 
(OMB) and the General Services Administration (GSA). Under PRA 
requirements, OMB's Office of Information and Regulatory Affairs (OIRA) 
reviews Federal information collections.

[[Page 88077]]


FOR FURTHER INFORMATION CONTACT: Paul Spelman, Attorney, Division of 
Advertising Practices, Bureau of Consumer Protection, Federal Trade 
Commission, (202) 326-2889, [email protected].

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.
    The 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.
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    \1\ Final Rule, 85 FR 50668 (Aug. 17, 2020).
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    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 
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: 3,104,050 hours (derived from 
2,045,650 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) + 
187,500 hours (33,750,000 contact lens wearers x 20 seconds per 
confirmation of prescription release) + 62,500 hours (11,250,000 
contact lens wearers x 20 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 = 
2,045,650 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 $117,606,598 
(derived from ($63.99 x 888,803 optometrist hours) + ($127.62 x 156,848 
ophthalmologist hours) + ($19.78 x 1,000,000 prescribers' office clerk 
hours) + ($19.78 x 1,058,400 sellers' 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 ($117,606,598 
labor cost + $591,300 non-labor cost).
    Request for Comment:
    On August 14, 2023, the FTC sought public comment on the 
information collection requirements associated with the Rule. 88 FR 
55044. The FTC received one comment germane to the issues that the 
agency sought comment on pursuant to the PRA renewal request. That 
comment was from the American Optometric Association (``AOA''), an 
organization representing more than 50,000 optometrists and optometric 
professionals. In its comment, the AOA contends that the 2020 Rule 
amendment requiring that prescribers obtain a signed confirmation-of-
prescription has created a greater compliance burden than previously 
projected by the FTC.\2\
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    \2\ American Optometric Association (PRA Comment #7) available 
at https://www.regulations.gov/comment/FTC-2023-0049-0007.
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    As noted above, the 2020 Rule amendments require that upon 
completion of a contact lens fitting, the prescriber must request that 
a patient sign a statement confirming receipt of their contact lens 
prescription (unless a digital copy of a prescription is provided to 
the patient via portal, email, or text message).\3\ The prescriber may, 
but is not required to, use the one-sentence confirmation statement, 
``My eye care professional provided me with a copy of my contact lens 
prescription at the completion of my contact lens fitting'' to satisfy 
the requirement, and such statement can be on a stand-alone document or 
included on a contact lens prescription or exam receipt.\4\
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    \3\ 16 CFR 315.3(c). In order to provide digital copies of 
prescriptions, the prescriber must first obtain a single signed 
consent-to-electronic-delivery from each patient.
    \4\ 16 CFR 315.3(c)(ii).
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    In approving the Rule amendments in 2020, the FTC estimated that 
the time required to collect a patient signature and confirmation of 
prescription takes ten seconds on average.\5\ The FTC's estimate of ten 
seconds was derived from two sources. The first was a similar 
previously-approved patient-acknowledgment-requirement under HIPAA, the 
Health Insurance Portability and Accountability Act, which requires, 
among other things, that each health provider obtain a patient 
signature confirming receipt of that provider's HIPAA Notice of Privacy 
Practices.\6\ The

[[Page 88078]]

HIPAA acknowledgment requirement,\7\ which has been in effect for more 
than 20 years, faced objections prior to implementation over concerns 
it would be burdensome and costly to implement.\8\ The U.S. Department 
of Health and Human Services rejected those contentions and determined 
that its signed acknowledgment would require just ten seconds to hand 
out and ten seconds to obtain a patient's signature.\9\
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    \5\ 85 FR 50709.
    \6\ Standards for Privacy of Individually Identifiable Health 
Information, 67 FR 53182, 53261 (Aug. 14, 2002) (implementing 45 CFR 
164.520(c)(2)(ii)).
    \7\ 45 CFR 164.520(c)(2)(ii).
    \8\ Standards for Privacy of Individually Identifiable Health 
Information, 67 FR 53182, 53240-43 (Aug. 14, 2002) (implementing 45 
CFR 164.520(c)(2)(ii)).
    \9\ Id. at 53240-43, 53260-61. HHS also calculated three cents 
per signed acknowledgment for the cost some doctors might incur for 
the paper. Id. at 53256. Since 2018, HHS has been considering a 
proposal to eliminate its signed-acknowledgment requirement as no 
longer necessary to compel providers to distribute Notices of 
Privacy Practices to patients, but HHS has not determined that the 
10-second time estimate for obtaining a patient signature is 
inaccurate. Request for Information on Modifying HIPAA Rules to 
Improve Coordinated Care, 83 FR 64302, 64302-03 (2018), https://www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/2018-27162.pdf#page=1. 
For a more fulsome discussion about the HHS proposal to eliminate 
its signed acknowledgment, and why this has little relevance with 
respect to the Contact Lens Rule, see CLR Final Rule, 85 FR 50684-
85, footnotes and accompanying text.
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    The second source for the FTC's estimate of 10 seconds was a 
consumer survey by the polling firm Survey Sampling International 
(``SSI'') of how long it took consumers to read a proposed two-sentence 
statement, ``My eye care professional provided me with a copy of my 
contact lens prescription at the completion of my contact lens fitting. 
I understand I am free to purchase contact lenses from the seller of my 
choice.'' The survey found that it took consumers, on average, twelve 
seconds to review those two sentences, and 90% of respondents read it 
in 20 seconds or less.\10\ Additionally, 90% of consumers surveyed 
indicated they understood the proposed acknowledgement statement, and 
94% indicated that they had no follow-up questions.\11\ The 
Commission's Final Rule did not include the second sentence of the 
surveyed confirmation statement, thereby shortening the final 
confirmation statement by nearly half, with the expected result that it 
might only take six or seven seconds for consumers to read and 
comprehend. Based on the survey average of 12 seconds to read the 
previously-proposed two-sentence statement, and on the approved HHS 
signed-acknowledgment estimate, the Commission, in its Rule amendments 
of 2020, estimated ten seconds to read and provide a signature for the 
Rule's one-sentence confirmation-of-prescription-release statement.\12\
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    \10\ 1-800 CONTACTS (Contact Lens Rule Workshop Comment #3207); 
Laurence C. Baker, ``Analysis of Costs and Benefits of the FTC 
Proposed Patient Acknowledgment and Recordkeeping Amendment to the 
Contact Lens Rule,'' 11 (2017), https://www.ftc.gov/system/files/summaries/initiatives/677/10192017_meeting_summary_from_mko_for_the_contact_lens_rule_rulemaking_proceeding.pdf (SSI online survey of 500 respondents). Twelve 
seconds was the average, the median was 10 seconds.
    \11\ Id. at 18.
    \12\ 84 FR 24693.
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    In its new PRA comment, however, the AOA contends that the FTC 
``significantly underestimated'' how long it would take to confirm 
prescription releases.\13\ According to the AOA, a 2023 survey it 
conducted of some of its member optometrists found that 84.8% indicate 
it takes 30 seconds or more to obtain the patient's signed 
confirmation, not counting additional time necessary to address patient 
questions about the form they are signing, and 69.9% of prescribers 
said patients ``typically'' have questions regarding the 
acknowledgment.\14\
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    \13\ AOA (PRA Comment #7), supra note 9.
    \14\ Id. According to AOA, the survey was conducted in-house by 
its Health Policy Institute and Research Departments, and 
distributed to member optometrists via AOA's weekly email newsletter 
with a link and invite to the survey titled ``Voice your concerns by 
Oct. 9: Complying with the FTC Contact Lens Rule.'' Of members who 
responded to the AOA's link request, 327 completed the survey.
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    AOA's comment accords with some written and verbal comments 
provided to the Commission during an ongoing review of the Eyeglass 
Rule,\15\ which includes a proposal to add a similar confirmation-of-
prescription-release requirement. The Commission's Eyeglass Rule review 
has examined, among other things, the burden arising from the existing 
Contact Lens Rule's confirmation-of-prescription-release requirement, 
and thus some of the comments received during the Eyeglass Rule review 
pertain to the Rule burden discussed herein. For instance, at a 2023 
FTC workshop on the Eyeglass Rule,\16\ panelist Dr. Stephen Montaquila, 
a Rhode Island optometrist, estimated that it takes his staff four 
minutes to complete the entire Contact Lens Rule process of printing 
out a patient's prescription, handing it to the patient, explaining why 
it needs to be signed, having the patient sign it, making a copy of it, 
and storing the signed copy as a record.\17\ Dr. Montaquila did not 
break down his estimate by task, so it is unclear how long he estimates 
it takes for a consumer to simply read and sign the confirmation 
statement, as opposed to the time it takes for his staff to print out 
the prescription and confirmation and store the confirmation as a 
record. As detailed in this submission, the Commission has allowed for 
one minute for prescribers to print out the prescription, and an 
additional minute for staff to store the signed confirmation.
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    \15\ This is officially the Ophthalmic Practice Rules, 16 CFR 
part 456.
    \16\ ``A Clear Look at the Eyeglass Rule,'' Public Workshop (May 
18, 2023), transcript available at https://www.ftc.gov/news-events/events/2023/05/clear-look-eyeglass-rule [hereinafter ER Workshop 
Transcript].
    \17\ Montaquila, ER Workshop Transcript at 23-24.
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    In addition, the National Taxpayers Union, an Alexandria, Virginia-
based advocacy organization, submitted a comment to the Eyeglass Rule 
review stating that while it generally supports the confirmation 
requirement, ``[G]iven the various reading speeds of customers who may 
be elderly or have limited proficiency in English, the 10 second 
estimate [used for the Contact Lens Rule's confirmation requirement] 
could prove low.'' \18\
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    \18\ National Taxpayers Union (ER NPRM Comment #28) available at 
https://www.regulations.gov/comment/FTC-2023-0001-0028. See also 
Prine (ER Workshop Comment #38) (simply stated that having patients 
sign a receipt of their prescription and then scan that into their 
chart ``took a lot of extra time'') available at https://www.regulations.gov/comment/FTC-2023-0001-0038; Michaels, ER 
Workshop Transcript at 9 (stating, ``There's a lot of time, effort, 
discussion around [the confirmation requirement]. I think that is 
something that is greatly underestimated in terms of how long it 
takes and how effort it takes to go through that process.'').
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    Some commenters, however, disagreed that it takes a significant 
amount of time to obtain a patient's signed confirmation. The National 
Association of Retail Optical Companies (``NAROC''), a trade 
association comprised of retail optical companies with co-located eye 
care services (such as LensCrafters, Costco Optical, and Walmart Vision 
Center), commented that thousands of optometrists affiliated in co-
location with NAROC member companies ``regularly comply with [Contact 
Lens Rule requirements] with little or no added cost or other burden on 
the eye care practice.'' \19\ According to NAROC representative and 
Eyeglass Rule Workshop panelist Joseph Neville, ``I've personally 
witnessed a couple of situations where the process for contact lenses 
seemed very easy. . . . the Rx was handed over at the front desk by the 
staff person, and the staff person maybe a bit simplistically said, 
``We'd like to ask you to sign this receipt for your

[[Page 88079]]

prescription. We're required to get your signature acknowledging that 
you've received it.'' And a couple of people, and again, anecdotes here 
that I witnessed on this, just said, ``Okay, fine, thank you.'' \20\
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    \19\ NAROC (ER NPRM Comment #24) available at https://www.regulations.gov/comment/FTC-2023-0001-0024. See also Consumer 
Action (ER NPRM Comment #26) (``we do not believe it is a burden on 
providers to obtain, document, and retain a consumer's affirmative 
receipt of their prescription.'').
    \20\ Neville, ER Workshop Transcript at 28-29.
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Discussion of the Comments and Evidence Regarding the Time Required

    In considering how much time it takes to complete the confirmation-
of-prescription-release requirement for this Paperwork Reduction Act 
purpose, the Commission has evaluated the evidence in the record, 
including the previously-approved HHS estimate for a similar signed-
acknowledgment, the comments in response to the PRA request for comment 
in the 60-Day Federal Register notice and the Contact Lens Rule and 
Eyeglass Rule rulemakings, and the two surveys mentioned above, one of 
consumer read-times and the other of prescriber-estimates for staff 
time.
    The Commission finds none of the comments, and neither survey, 
dispositive in and of itself. The surveys, in particular, are 
suggestive but not determinative. The SSI survey of consumer read-times 
on a computer monitor is helpful, but may not take into account elderly 
patients or those for whom English is not their first language. It also 
does not take into account the time it takes for prescribers' staff to 
hand a paper confirmation document to the patient and for the patient 
to sign it and hand it back. The AOA survey, meanwhile, very likely 
overestimates the time necessary to obtain a confirmation because of 
the manner in which the survey solicited its respondents. The 
prescribers were self-selected in response to an AOA invitation to 
``Voice your concerns'' about complying with the Contact Lens Rule. 
Because the poll only included prescribers who responded to this 
invitation, its findings may not be representative of the average 
prescriber. In fact, it is probable that a large number of those who 
responded were prescribers who have concerns about the patient-
confirmation requirement and the time it takes to obtain a 
confirmation, while prescribers who do not have concerns, or have fewer 
concerns, did not bother to respond. By framing the survey as an 
invitation to voice concerns about complying with the Rule, the survey 
has been transformed from a disinterested information-gathering tool 
into a motivating call to action. So while it is possible that 
prescribers who did not respond to the survey also share the concerns 
raised by survey respondents, that cannot be concluded from the 
survey.\21\
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    \21\ The Commission also notes that while the AOA states that it 
represents some 50,000 optometric professionals, only 327 members 
responded to AOA's invitation and completed the survey, which could 
indicate that most AOA members do not have concerns about complying 
with the Contact Lens Rule. However, there could be other reasons 
for the relatively small number of prescribers (in proportion to the 
total membership) who responded, so the Commission will not draw any 
inferences from the low response rate.
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    The Commission also has concerns that some of the time prescribers 
ascribe to patients reading and signing the confirmation is, in fact, 
due to non-mandated choices by prescribers with respect to the design 
of the confirmation statement. As noted above, the Rule merely requires 
that patients read and sign a simple statement confirming receipt of 
their prescription, and the Commission allowed that the one-sentence 
statement, ``My eye care professional provided me with a copy of my 
contact lens prescription at the completion of my contact lens 
fitting,'' would fully satisfy the requirement. According to the AOA 
survey, nearly 60% of prescribers use a separate form with a statement 
confirming receipt (as opposed to obtaining a patient signature on a 
prescription copy or sales receipt), but the survey did not specify or 
ask prescribers what confirmation statement they used on their form, 
making it difficult to determine the true average time it takes to 
comply with the confirmation-of-prescription-release requirement. 
Moreover, the AOA has supplied its members with a model template 
confirmation form that includes four additional paragraphs consisting 
of ``important information to review prior to receiving your contact 
lens prescription.'' \22\ This information includes various 
recommendations from the Centers for Disease Control and the Food and 
Drug Administration about healthy contact lens use (such as ``Take out 
your contacts and call your eye doctor if you have eye pain, 
discomfort, redness, or blurry vision'') as well as five bullet points 
listing some of the symptoms for an eye infection (``Irritated, red 
eyes, worsening pain in or around the eyes,'' etc.).\23\ While the 
document is titled ``Contact Lens Prescription Acknowledgment Form,'' 
only at the very end is there a statement, ``Sign below to acknowledge 
that you were provided a copy of your contact lens prescription at the 
completion of your contact lens fitting.''
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    \22\ See AOA Contact Lens Rule Compliance Toolkit, sample 
template, 8, available at https://documents.aoa.org/Documents/CLCS/Contact-Lens-Rule-Compliance-Toolkit.pdf.
    \23\ Id.
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    According to Workshop Panelist Dr. Montaquila, the AOA template is 
a common form used to obtain patient confirmations.\24\ If this is 
indeed the case, the Commission is not surprised that many prescribers 
report it takes patients 30 seconds or longer to read and sign, nor 
that patients might have questions, or be confused, as to why they now 
have to sign and acknowledge not just receipt of their prescription, 
but that they read these recommendations from the CDC and FDA. The 
additional information from these two other federal agencies may be 
useful for patients, but is not required by the Rule, nor considered 
part of the PRA burden of compliance.
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    \24\ Montaquila, ER Workshop transcript at 23.
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    Despite the aforementioned concerns about the reliability of the 
AOA survey in establishing the time it takes for a patient 
confirmation, the Commission does not discount the survey altogether, 
and views it as suggestive, and an additional indication that many 
prescribers sincerely believe the 10-second estimate does not 
accurately reflect the time required to obtain a patient's signed 
confirmation. The Commission has therefore decided to increase the 
estimated time to obtain a patient confirmation signature (and the time 
to collect an affirmative consent to electronic delivery, in instances 
where the prescription is provided digitally rather than in paper) from 
10 to 20 seconds. The Commission believes that 20 seconds may better 
reflect the time required for a patient to not just read a one-sentence 
confirmation, but also to physically sign and return the document to 
staff, and for any staff explanation as to why the patient's signature 
is required. The 20-second estimate may also better align with the 
original HIPAA estimate, which accorded 10 seconds to hand out the 
acknowledgment and another ten seconds to obtain a patient's signature 
and collect the document.\25\
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    \25\ See supra notes 15-16.
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    Pursuant to OMB regulations, 5 CFR part 1320, that implement the 
PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second 
opportunity for public comment while seeking OMB approval to renew the 
pre-existing clearance for the Rule.

Estimated Annual Hours and Labor Cost Burden

    Estimated annual hours burden: 3,104,050 hours.
    This figure is derived by adding disclosure and recordkeeping-hours 
for contact lens prescribers to

[[Page 88080]]

recordkeeping hours for contact lens 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,\26\ (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.
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    \26\ 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.
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    The number of contact lens wearers in the United States is 
estimated by the Centers for Disease Control to be approximately 45 
million.\27\ 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.\28\
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    \27\ 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.
    \28\ 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.
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    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.\29\ 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.\30\
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    \29\ 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 information as to 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.
    \30\ See Michaels, Workshop Transcript at 18 (noting that in his 
office, prescriptions are automatically uploaded to a patient portal 
``the very second the prescription is finalized.'')
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    The time required to collect a signature from a patient confirming 
release of a prescription is estimated at twenty seconds, as discussed 
above. 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. 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.\31\ 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% x 45 million prescriptions yearly x 20 seconds) = 
187,500 hours].
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    \31\ In prior PRA submissions, the task of collecting a patient 
signature on a confirmation-of-prescription-receipt was attributed 
to prescribers, but based on more recent conversations with 
prescribers and others in the industry, the Commission now believes 
that this task is more appropriately designated as performed by 
prescribers' office staff. This is further supported by comments 
during the Eyeglass Rule Workshop, such as that of panelist Dr. 
Montaquila, who noted that his staff completes the process ``from 
explaining why we're doing it to the patient, providing them with 
their prescription, making copies, providing their prescription back 
to them, and ultimately storing it. . . . Our staff has to explain, 
`You're signing this for this reason.'' Montaquila, ER Workshop 
Transcript at 22, 28. See also Neville, ER Workshop Transcript at 28 
(commenting that he has observed situations where the doctor pushed 
a button to have the prescription printed out at the front desk, the 
prescription was handed over at the desk by the staff person, and 
the staff person obtained the patient's signature on the 
confirmation.); AOA Report for Complying with the FTC Contact Lens 
Rule, (survey to prescribers, Question 3, ``Have you experienced 
challenges in training staff on the new requirements for the Contact 
Lens Rule?''; Question 9 ``How much time per day does your staff 
spend on addressing patient questions with the acknowledgment form 
and process?'').
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    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, and the annual time spent 
complying with the requirement to obtain such signatures is 
approximately 62,500 hours [(25% x 45 million prescriptions yearly x 20 
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.\32\
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    \32\ See supra note 40.
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    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.\33\ 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.
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    \33\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,'' 
Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019.
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    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

[[Page 88081]]

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,\34\ 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 time to prescribers.
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    \34\ Notice and Request for Comment, 81 FR 62501 (Sept. 9, 
2016).
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    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.\35\ 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.
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    \35\ 85 FR 5709.
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    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 
2,045,650 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-collection hours 
+ 295,650 verification-response hours + 750,000 recordkeeping hours = 
2,045,650 hours]. Of this total, we estimate 1,045,650 are prescriber 
labor hours, 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 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 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 $117,606,598.
    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.\36\ Based on our knowledge of the 
industry and the number of optometrists and ophthalmologists in the 
United States, we assume that of the 1,045,650 prescriber labor hours 
relating to the Rule, optometrists are performing 85% of such hours and 
ophthalmologists are performing the remaining 15% of prescriber 
hours.\37\ We credit general office clerks for performing the remaining 
hours, both for prescribers' offices (1,000,000 hours) and for non-
prescriber sellers (1,058,400 hours). Based on these assumptions and

[[Page 88082]]

estimates above, the estimated total labor cost attributable to the 
Rule is approximately $117,606,597 [($63.99 x 888,803 optometrist hours 
= $56,874,504) + ($127.62 x 156,848 ophthalmologist hours = 
$20,016,942) + ($19.78 x 1,000,000 prescribers' office clerk hours = 
$19,780,000) + ($19.78 x 1,058,400 sellers' office clerk hours = 
$20,935,152) = $117,606,598].
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    \36\ 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 significantly 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.
    \37\ See Proposed Collection Request, 81 FR 31938, 31940 (May 
20, 2016); Proposed Collection Request, 84 FR 32170, 32172 (July 5, 
2019).
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Capital and Other Non-Labor Costs

    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.\38\
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    \38\ 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.
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    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).

Total Costs to the Industry (Including Labor and Non-Labor Costs)

    Combining the annual labor cost burden with the non-labor cost 
burden, the total cost burden of the Rule is estimated at $118,197,898 
($117,606,598 + $591,300 = $118,197,898).
    This burden is not insubstantial, but to put it in perspective, a 
recent survey estimated the value of the U.S. contact lens market at 
approximately $9.6 billion (not counting examination revenue).\39\ 
Therefore, the total cost burden estimate of $118,197,898, imposed by 
the Rule, represents a cost of approximately 1.2% of the overall retail 
revenue generated through the sale of contact lenses.
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    \39\ 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 already 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/.
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    Your comment--including your name and your state--will be placed on 
the public record of this proceeding. Because your comment will be made 
public, you are solely responsible for making sure that your comment 
does not include any sensitive personal information, such as anyone's 
Social Security number; date of birth; driver's license number or other 
state identification number, or foreign country equivalent; passport 
number; financial account number; or credit or debit card number. You 
are also solely responsible for 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.

Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023-27877 Filed 12-19-23; 8:45 am]
BILLING CODE 6750-01-P