Contact Lens Rule SS - 12_15_2023-FINAL

Supporting Statement for Information Collection Provisions of
the Contact Lens Rule, 16 C.F.R. Part 315
(OMB Control # 3084-0127)
The Federal Trade Commission (“FTC” or “Commission”) requests approval for a threeyear extension of an existing clearance relating to the disclosure and recordkeeping requirements
under the Contact Lens Rule (“Rule”), 16 C.F.R. Part 315. There is no change in the instrument
collection.
(1) & (2)

Necessity for and Use of the Information Collected

The Fairness to Contact Lens Consumers Act (the “Act”), Pub. L. No. 108-164
(December 6, 2003), helps consumers by requiring the release and verification of contact lens
prescriptions, among other things. The Act directed the Federal Trade Commission (“FTC” or
“Commission”) to prescribe rules implementing the Act not later than 180 days after the Act
took effect on February 4, 2004.1 Accordingly, the Commission issued the Contact Lens Rule
(“Rule”), 16 C.F.R. Part 315, on July 2, 2004. The Rule was most recently reissued in
amended form in 2020.2 As mandated by the Act, the Rule contains disclosure and
recordkeeping requirements applying to prescribers and sellers of contact lenses. The extent to
which these requirements are subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35
(“PRA”), is described below.
(a) Disclosures
The Rule requires that contact lens prescribers provide patients with a copy of their
contact lens prescriptions upon completion of a contact lens fitting and provide prescriptions to,
or verify prescriptions with, third parties authorized to act on behalf of patients. The primary
purpose of the prescription release requirement is to enable consumers to purchase their contact
lenses from the seller of their choice. Without their prescription, consumers may be forced to
purchase lenses from their prescriber. By requiring prescribers to provide prescriptions to their
patients, the Act enables consumers to compare prices and modes of delivery among competing
sellers, and ultimately purchase their lenses from the seller of their choice. In addition, the Rule,
as amended in 2020, now requires that prescribers either: (a) obtain from patients a signed
confirmation of prescription release on a separate stand-alone document; (b) obtain from patients
a signature on a confirmation of prescription release included on a copy of a patient’s
prescription; (c) obtain from patients a 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.3 The primary
1

15 U.S.C. § 7607.

2

Final Rule, Contact Lens Rule, 85 FR 50668 (Aug. 17, 2020).

3

Id.

purpose of the confirmation requirement is to ensure that patients receive their prescriptions, and
to enable the Commission to verify that this is occurring. For prescribers who choose to offer an
electronic method of prescription delivery, the Rule requires that such prescribers collect
affirmative consent from patients to such digital delivery.
(b) Recordkeeping
The Rule also implements recordkeeping requirements imposed by the Act. First, the Act
sets a minimum expiration date of one year for contact lens prescriptions, with an exception
based on the medical judgment of a prescriber with respect to a patient’s eye health. In cases in
which a prescriber sets an expiration date shorter than one year, the Rule requires the prescriber
to document in the patient’s record the medical reasons for the shorter period. The Rule further
requires that such records be kept for three years.
Second, the Act provides 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 with the prescriber. The Act, and hence the Rule, requires
contact lens sellers to maintain records of verification communications with prescribers. The
records to be kept depend on the mode of communication – telephone, facsimile, or email. The
Rule also requires sellers to keep the prescriptions they receive directly from the patient or
prescriber. The Rule requires that sellers keep these records for three years and make them
available for inspection by the Commission, but does not otherwise require production of the
records.
Third, the Rule requires that contact lens prescribers collect and maintain confirmations
of prescription release, or an electronic record showing the prescription was provided
electronically, for a period of not less than three years. 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 a period of not
less than three years.
The required records will allow the Commission to determine compliance with the Rule
and provide a basis for the Commission to bring an enforcement action. Without the required
records, it would be difficult to ensure that entities are complying with the Rule’s requirements
or to prove Rule violations.
(3)

Consideration of the Use of Information Technology to Reduce Burden

The Rule contemplates that covered entities may use information technologies in
complying with their recordkeeping obligations under the Act. Such technologies may help
reduce the burden of information collection imposed by the Act. For example, contact lens
sellers who seek to verify prescriptions via facsimile and/or email may use information
technology to create and/or retain those records as required by the Rule, and thereby reduce the
time it may take to produce and maintain verification requests. Similarly, contact lens prescribers
2

may present confirmations of prescription release in digital format, and maintain electronic
records of patient receipt. In addition, nothing in the Act or Rule prohibits regulated entities
from using the least burdensome information technology available. Moreover, in its 2004 Notice
of Proposed Rulemaking,4 and its subsequent proposals to revise the Rule,5 the Commission
specifically sought comments on ways to minimize the burden of the Rule’s collections of
information through the use of information technology.
Consistent with the Government Paperwork Reduction Elimination Act, Pub L. No. 105227, Title XVII, 112 Stat. 2681-749, nothing in the Rule prescribes that the disclosures be made,
records be filed or kept, or signatures be executed, on paper or in any particular format that
would preclude the use of electronic methods to comply with the Rule’s requirements.
(4)

Efforts to Identify Duplication

The Rule’s disclosure and recordkeeping requirements do not duplicate any other
information collection requirements imposed by the Commission. To the extent some state laws
may already require prescription release, and/or recordkeeping, similar to that required by the
Act, prescribers and sellers likely can comply with both requirements through a single release or
record-keeping system, thereby avoiding duplication.
(5)

Efforts to Minimize Burden on Small Organizations

The Rule’s disclosure and recordkeeping requirements are designed to impose the
minimum burden on all affected members of the industry, regardless of size. The Act itself does
not allow the Commission any latitude to treat small businesses differently, such as by
exempting a particular category of firm or setting forth a lesser standard of compliance for any
category of firm.
However, staff believes that the burdens imposed by the Rule on small businesses will be
relatively low. Based on staff’s knowledge of the eyewear industry, the small businesses
affected by the Rule primarily consist of contact lens prescribers in solo or small practices. Their
burdens under the Rule primarily entail providing contact lens prescriptions to patients or their
agents, providing and preserving patient confirmations of prescription receipt, documenting in
exceptional cases the medical reasons for setting a contact lens prescription date of less than one
year, and verifying prescriptions for some of their patients who seek to purchase their contact
lenses from another seller. The Rule permits some limitation on prescription release and
verification.

4

69 FR 5440 (Feb. 4, 2004).

5

See e.g., Supplemental Notice of Proposed Rulemaking, 84 FR 24664 (May 28, 2019); Notice of
Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016).
3

(6)

Consequences of Conducting the Collection Less Frequently

Less frequent “collection” would violate the express statutory language of the Fairness to
Contact Lens Consumers Act, 15 U.S.C. §§ 7601 et seq. Specifically, the Act’s requirements
that prescribers release contact lens prescriptions to their patients upon completion of a contact
lens fitting, and document the medical reasons for setting a contact lens prescription expiration
date shorter than one year, do not permit less frequent disclosure.6 Similarly, the Act’s
requirement that contact lens sellers retain records of all direct communications involved in
obtaining prescription verification does not permit less frequent collection of information.7
The Commission’s Rule requires that sellers retain the required records for a period of
three years. Staff believes that a record retention period shorter than three years would
hamper the Commission’s ability to verify contact lens prescribers’ and sellers’ compliance
with the Rule, because the statute of limitations applicable to Commission rule violations is
three years.8
(7)

Circumstances Requiring Collection Inconsistent With Guidelines

The collection of information in the Rule is consistent with all applicable guidelines
contained in 5 C.F.R. § 1320.5(d)(2).
(8)

Public Comments/Consultation Outside the Agency

On August 14, 2023, the FTC sought public comment on the Rule’s information
collection requirements and on the associated estimates of PRA burden. 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.9
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
6

See 15 U.S.C. §§ 7601, 7604.

7

See 15 U.S.C. § 7603(b).

8

See Section 19(d) of the FTC Act, 15 U.S.C. 57b(d).

9

American Optometric Association (PRA Comment #7) available at
https://www.regulations.gov/comment/FTC-2023-0049-0007.
4

portal, email, or text message).10 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.11
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.12 The
FTC’s estimate of ten seconds was derived from two sources. The first was a similar previouslyapproved 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.13 The
HIPAA acknowledgment requirement,14 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.15 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.16
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,
10

16 C.F.R. 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.

11

16 C.F.R. 315.3(c)(ii).

12

85 FR 50709.

13

Standards for Privacy of Individually Identifiable Health Information, 67 FR 53182, 53261 (Aug. 14,
2002) (implementing 45 C.F.R. 164.520(c)(2)(ii)).

14

45 C.F.R. 164.520(c)(2)(ii).

15

Standards for Privacy of Individually Identifiable Health Information, 67 FR 53182, 53240-43 (Aug.
14, 2002) (implementing 45 C.F.R. 164.520(c)(2)(ii)).

16

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.
5

on average, twelve seconds to review those two sentences, and 90% of respondents read it in 20
seconds or less.17 Additionally, 90% of consumers surveyed indicated they understood the
proposed acknowledgement statement, and 94% indicated that they had no follow-up
questions.18 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 twosentence 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.19
In its new PRA comment, however, the AOA contends that the FTC “significantly
underestimated” how long it would take to confirm prescription releases.20 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.21
AOA’s comment accords with some written and verbal comments provided to the
Commission during an ongoing review of the Eyeglass Rule,22 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

17

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_t
he_contact_lens_rule_rulemaking_proceeding.pdf (SSI online survey of 500 respondents). Twelve
seconds was the average, the median was 10 seconds.
18

Id. at 18.

19

84 FR 24693.

20

AOA (PRA Comment #7), supra note 9.

21

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.

22

This is officially the Ophthalmic Practice Rules, 16 C.F.R. Part 456.
6

instance, at a 2023 FTC workshop on the Eyeglass Rule, 23 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.24 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.
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.”25
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.”26 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
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,

23

“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].
24

Montaquila, ER Workshop Transcript at 23-24.

25

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-2023-00010038; 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.”).
26

NAROC (ER NPRM Comment #24) available at https://www.regulations.gov/comment/FTC-20230001-0024. 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.”).
7

thank you.”27
Discussion of the Comments and Evidence Regarding the Time Required
In considering how much time it takes to complete the confirmation-of-prescriptionrelease 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 signedacknowledgment, 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.28
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
27

Neville, ER Workshop Transcript at 28-29.

28

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.
8

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.”29 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.).30 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.”
According to Workshop Panelist Dr. Montaquila, the AOA template is a common form
used to obtain patient confirmations.31 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.
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.32
29

See AOA Contact Lens Rule Compliance Toolkit, sample template, 8, available at
https://documents.aoa.org/Documents/CLCS/Contact-Lens-Rule-Compliance-Toolkit.pdf.

30

Id.

31

Montaquila, ER Workshop transcript at 23.

32

See supra notes 15-16.
9

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.
(9)

Payments and Gifts to Respondents
Not applicable.

(10)

Assurances of Confidentiality

Not applicable. No assurance of confidentiality is necessary because although the
Contact Lens Rule requires regulated entities to disclose and/or maintain records, it does not
require the submission of any such records to the agency. Thus, to the extent, if any, that the
agency may require production of such records for law enforcement purposes in specific
proceedings, such production would not constitute an information collection activity within the
meaning of the Paperwork Reduction Act. In any event, in such proceedings, records would be
protected by law from mandatory public disclosure.33
(11)

Matters of a Sensitive Nature

Not applicable. The Contact Lens Rule does not require the disclosure or production of
sensitive or confidential information to the Commission. To the extent that confidential
information covered by a recordkeeping requirement is collected by the Commission for law
enforcement purposes, the confidentiality provisions of Section 21 of the FTC Act, 15 U.S.C.
57b-2, will apply.
(12)

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 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
33

See, e.g., Section 21 of the FTC Act, 15 U.S.C. 57b-2; Exemption 7(A) of the Freedom of Information
Act, 5 U.S.C. 552(b)(7)(A).
10

the contact lens prescription to the patient,34 (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.
The number of contact lens wearers in the United States is estimated by the Centers for
Disease Control to be approximately 45 million.35 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.36
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.37 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

34

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.

35

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.
36

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.

37

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.
11

though the latter likely takes less time for the prescriber.38
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.39 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) = 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, 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) = 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.40
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.41 Assuming that each of the 45 million contact lens
38

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.”)

39

In prior PRA submissions, the task of collecting a patient signature on a confirmation-of-prescriptionreceipt 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?”).

40

See supra note 39.

41

Jason J. Nichols & Deborah Fisher, “2018 Annual Report,” Contact Lens Spectrum, Jan. 1, 2019,
https://www.clspectrum.com/issues/2019/january-2019.
12

wearers in the U.S. makes one purchase per year, this means that approximately 16,200,000
contact lens purchases (45 million × 36% = 16,200,000) are made from sellers other than the
prescriber.
Based on prior discussions with industry, approximately 73% of sales by non-prescriber
sellers require verification, and prescribers affirmatively respond (by notifying the seller that the
prescription is invalid or incorrect) to approximately 15% of those verification requests. Using a
response rate of 15%, the FTC therefore estimates that prescribers’ offices respond to
approximately 1,773,900 verification requests annually [(16,200,000 purchases × 73%) × 15% =
1,773,900 responses]. Additionally, some prescribers may voluntarily respond to verification
requests and confirm prescriptions (as opposed to 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,42 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 time to
prescribers.
Lastly, the Rule and FCLCA also impose recordkeeping requirements on prescribers’
offices. First, they must maintain signed confirmations, or signed consent to electronic
prescription delivery and proof that such prescriptions were delivered via email, text, or patient
portal, for a period of three years. For purposes of PRA analysis, the Commission has used the
assumption that all prescriber offices require a full minute to store and maintain each
confirmation record, and a full minute to store and maintain each consent to electronic
prescription delivery and proof of electronic prescription delivery.43 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
42

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

43

85 FR 5709.
13

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 × 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 × 27%], resulting in 72,900 recordkeeping burden hours. [(4,374,000 orders ×
1 minute)/60 minutes = 72,900 hours]
Combining burden hours for all orders [985,500 hours + 72,900 hours], staff estimates a
total of 1,058,400 hours for contact lens sellers. It is likely that this estimate overstates the
actual burden because it includes the time spent by sellers who already keep records pertaining
to contact lens sales in the ordinary course of business, and those whose records are generated
and preserved automatically when a customer orders online, which staff believes is the case for
many online sellers.
14

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.44 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.45 We credit general office clerks for
performing the remaining hours, both for prescribers’ offices (1,000,000 hours) and for nonprescriber sellers (1,058,400 hours). Based on these assumptions and estimates above, the
estimated total labor cost attributable to the Rule is approximately $117,606,598. [($63.99 ×
888,803 optometrist hours = $56,874,504) + ($127.62 × 156,848 ophthalmologist hours =
$20,016,942) + ($19.78 × 1,000,000 prescribers’ office clerk hours = $19,780,000) + ($19.78 ×
1,058,400 sellers’ office clerk hours = $20,935,152) = $117,606,598.]
(13)

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
44

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.

45

See Proposed Collection Request, 81 FR 31938, 31940 (May 20, 2016); Proposed Collection Request,
84 FR 32170, 32172 (July 5, 2019).
15

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.46
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).
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).47 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.
(14)

Estimated Cost to the Federal Government

Staff estimates that the fiscal year cost to the FTC of enforcing the Rule’s requirements
will be approximately $52,000 per year. This estimate is based on the assumption that 15-20%
of one Attorney work year, 2.5% of one Economist work year, 15% of one Investigator work
46

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.

47

See https://www.globenewswire.com/en/news-release/2022/09/05/2509723/0/en/Contact-LensesMarket-Size-Will-Achieve-USD-17-4-Billion-by-2030-growing-at-6-9-CAGR-Exclusive-Report-byAcumen-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-at765-billion-in-the-vision-councils-first-comprehensive-market-insights-report/.
16

year, and 15% of one Paralegal work year will be expended to enforce the Rule’s requirements.
(15)

Program Changes or Adjustments

There is an upward adjustment in our annual burden hours from 2,979,050 (2020) to
3,104,050 (2023). The annual labor costs stemming from slightly higher estimated burden
hours and average hourly rates go from $104,448,448 (2020) to $117,606,598 (2023).
(16)

Statistical Use of Information/Publication of Results

Not applicable. There are no plans to publish for statistical use any information required
by the Rule.
(17)

Requested Permission Not to Display the Expiration Date for OMB Approval

The OMB control number and expiration date associated with this PRA submission will
be displayed on the Federal government’s electronic PRA docket at www.reginfo.gov. There are
no government forms or other documents upon which display of the control number and
expiration date would be appropriate.
(18)

Exceptions to the “Certification for Paperwork Reduction Act Submissions”
Not applicable.

17