Contact Lens Final Rule - Supplemental Supporting Statement - 6-25-2020-FINAL

Supplemental
Supporting Statement
Amendments to the Contact Lens Rule
16 CFR § 315
(OMB Control # 3084-0127)
(1-2) Necessity for Collecting the Information/Use of the Information
The Federal Trade Commission promulgated the Contact Lens Rule (“Rule”) pursuant to
the Fairness to Contact Lens Consumers Act (“FCLCA”), Public Law 108-164 (December 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. As mandated by the FCLCA, the Rule
requires contact lens prescribers to provide prescriptions to their patients upon the completion of
a contact lens fitting, and provide or verify such prescriptions to authorized third parties, such as
contact lens sellers. Sellers may provide contact lenses only in accordance with a valid
prescription that is presented directly to the seller or verified with the prescriber.
Section 315.3(a)(1) of the Rule requires a prescriber to provide a copy of the contact
lens prescription to the patient after completing a contact lens fitting, regardless of whether it was
requested by the patient. Section 315.3(a)(1) of the Rule tracks the language of the Act
verbatim.1 This provision, referred to as automatic prescription release, was intended to
empower consumers to comparison shop for contact lenses. However, even though the law and
implementing Rule (effective in 2004) already required that prescriptions be provided by the
prescribers to patients, there is no readily verifiable enforcement mechanism.
Based on twelve years of experience enforcing the Rule and careful consideration of
public comments during the rule review,2 the Commission determined that compliance with the
law’s automatic prescription release provision could be substantially improved.3 The
Commission concluded that the potential benefits of increasing the number of patients in
possession of their prescriptions were substantial: increased patient flexibility and choice in
shopping for lenses; a reduced number of verification requests, which many prescribers find
burdensome; a reduced likelihood of errors associated with incomplete or invalid prescriptions,
which can jeopardize patient eye health; and a reduction in the number and complications of

1
15 U.S.C. 7601(a)(1).
2

Contact Lens Rule, Request for Comment, 80 Fed. Reg. 53,272 (September 3, 2015) (“Request for
Comment”).

3

In fact, the Commission has received evidence that a majority of consumers—between 56-65% —are not
receiving their contact lens prescriptions automatically as required by law, and millions of consumers are
not receiving them at all. Supplemental Notice of Proposed Rulemaking, 84 Fed. Reg. 24,664 (May 28,
2019) (“SNPRM”).

2 

failed attempts at verification. Increasing prescription-release compliance also would likely spur
competition and innovation among contact lens sellers and manufacturers, and reduce attempts
by sellers to verify incorrect, expired, and invalid prescriptions, or to verify with the wrong
prescriber. The Commission also determined that the cumulative effect of increased automaticrelease compliance would thus be lower costs and improved convenience and flexibility for
patients, sellers, and prescribers, as well as increased accuracy of prescriptions presented to
sellers, thereby reducing potential consumer harm.
In 2016, the Commission proposed to amend the Rule to require that prescribers obtain a
signed acknowledgment after releasing a contact lens prescription and maintain each such
acknowledgment for a period of not less than three years.4 Requiring a signed acknowledgment
would increase the Commission’s ability to assess and verify compliance with the Rule.
In 2019, after a comprehensive review of additional public comments, workshop
transcripts, and various empirical surveys and analyses,5 the Commission proposed a
Supplemental Notice of Proposed Rulemaking (“SNPRM”) modifying its prior proposal for a
signed acknowledgment requirement by instituting a more flexible Confirmation of Prescription
Release provision.6 The modifications to the Rule proposed in the SNPRM required that
prescribers either (1) 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; (2) 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; (3) 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 (4) 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 was sent, received, or, if
provided via an online-patient portal, made accessible, downloadable, and printable by the
patient.
As discussed in the SNPRM, the Commission believed that this modified proposal
would achieve the goals of the original proposal while imposing less of a burden on prescribers.
Specifically, the modified proposal would improve compliance with the congressionallymandated automatic prescription release requirement, and thereby benefit consumers and

4
 Notice of Proposed Rulemaking, 81 Fed. Reg. 88,526 (Dec. 7, 2016) (“NPRM”).

5

Comments received in response to the NPRM are available at https://www.ftc.gov/policy/publiccomments/2016/10/initiative-677. Comments received in connection with the workshop are available at
https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lensmarketplace. See also Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed
Changes to the Contact Lens Rule, 82 Fed. Reg. 57,889 (Dec. 8, 2017).
6

See SNPRM (footnote 3).

3 

competition by ensuring that contact lens users have the ability to comparison shop for lenses.
Furthermore, the modified proposal would provide much-needed improvements to the
Commission’s ability to evaluate and enforce compliance with this core provision of the Rule.
Also, by allowing prescribers more options and flexibility, the modification would impose even
less of an overall burden on prescribers than the prior proposal, which the Commission had
determined was relatively minimal.7
After reviewing comments to the SNPRM, the Commission determined to retain the
Confirmation of Prescription Release requirement in the Final Rule, with a modification to
require, for instances when a patient refuses to sign a confirmation, that the prescriber note this
refusal and preserve such record as evidence of compliance. Furthermore, in response to issues
raised by commenters, the Final Rule also requires that in instances where prescriptions are
delivered electronically to consumers, prescribers must identify the specific method or methods
of electronic delivery to be used and keep evidence of patients’ consent for at least three years,
and that sellers who utilize automated telephone verification messages must record such calls and
preserve the recordings.
The requirement to collect patient signatures (both for Confirmation of Prescription
Release and consent to electronic prescription delivery), and the associated recordkeeping
requirements, each constitute an information collection as defined by 5 CFR 1320.3(c), as does
the requirement to record automated telephone verification messages. Accordingly, the
Commission is providing PRA burden estimates for these amendments to the Rule, as set forth
below.
(3) Consideration of Using Improved Technology to Reduce Burden
The Final Rule amendments permit the covered firms to use paper or electronic format to
reduce the burden of information collection. Moreover, in its SNPRM, 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 amendments 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 new recordkeeping requirements do not duplicate any other information collection
requirements imposed by the Commission. To the extent some state laws may already require

7
NPRM, 81 Fed. Reg. at 88,534, 88,557-58.

4 

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 new recordkeeping requirements in the Final Rule are designed to impose the
minimum burden on all affected members of the industry, regardless of size. For the most part, the
Act itself does not allow the Commission any latitude to treat small businesses differently just
because they are small businesses.8
While some contact lens prescribers subject to the Rule’s requirements are small
businesses, staff believes that everything consistent with the requirements of the Rule has been done
to minimize the compliance burden. Although the Act requires the Rule to apply to all covered
entities irrespective of whether they are small entities, the Commission sought and addressed
comments about minimizing impact on small businesses.

(6) Consequences of Conducting the Collection Less Frequently
The new recordkeeping requirements in the Final Rule would require that prescribers
and sellers retain the required records for a period of not less than three years. Staff believes
that a record retention period shorter than this would hamper the Commission’s ability to
confirm compliance with the Rule, because the statute of limitations applicable to Commission
rule violations is three years.9

(7) Circumstances Requiring Collection Inconsistent With Guidelines
The new information collection requirements in the Final Rule are consistent with all
applicable guidelines contained in 5 C.F.R. § 1320.5(d)(2). Under the Rule amendments, covered
entities are only required to maintain the records for three years. Instances where records are
required to be maintained longer than three years are mandated by individual state laws.10

8
The Commission’s Final Rule exempts businesses that do not have a direct or indirect financial interest in
the sale of lenses from the confirmation requirement, but this exemption is not based on the size of the
business.
9

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

10

See, e.g., 246 Mass. Code Regs. § 3.02 (requiring optometrists to maintain patient records for at least
seven years); Wash. Admin. Code § 246-851-290 (requiring optometrists to maintain records of eye exams
and prescriptions for at least five years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
maintain patient records for at least five years); Fla. Admin. Code r. 64B13-3.003(6) (requiring optometrists
to maintain patient records for at least five years).

5 

(8) Consultation Outside the Agency
On September 3, 2015, the Commission solicited comment on the Contact Lens Rule as
part of its periodic review of its rules and guides.11 As with other regulatory rule reviews, the
Commission sought comment on whether there is a continuing need for the Rule as currently
promulgated and about the Rule’s costs and benefits. The comment period closed on October 26,
2015. The Commission reviewed the 660 comments received in response to the initial request for
comments. Virtually all commenters agreed that there is a continuing need for the Rule and that it
benefits consumers and competition. The majority of commenters recommended some
modifications to the Rule in order to maximize the benefits to consumers and competition,
decrease the burden on businesses, protect consumers’ eye health, or improve overall compliance
with the Rule’s existing requirements.
The Commission subsequently published an NPRM on December 7, 2016. The sixty-day
comment period closed on January 30, 2017. In its NPRM, the Commission determined that the
overall weight of the evidence demonstrated a need to improve compliance with the Rule’s
automatic prescription release requirement, as well as a need to create a mechanism for monitoring
and enforcing that requirement. Accordingly, the NPRM proposed to amend the Rule to require
that prescribers request that patients sign an acknowledgement form upon receiving a copy of their
contact lens prescription, and maintain each such acknowledgement form for three years.12 In
response to the NPRM, the Commission received over 4,000 additional comments, many from
prescribers concerned about the burden of the proposed signed acknowledgment requirement.13
In light of the comments received on the NPRM, the Commission determined that it
would be beneficial to hold a public workshop on the Contact Lens Rule and the evolving contact
lens marketplace to explore issues raised throughout the comment process as well as topics related
to the evolution of the contact lens marketplace. On December 8, 2017, the Commission published
a Federal Register Notice announcing the March 7, 2018 workshop14 with a comment period
closing on April 6, 2018. The workshop included six panels, covering issues relating to the overall

11
2015 Request for Comment. Comments received in response to this request are available at
https://www.ftc.gov/policy/public-comments/2015/09/initiative-621.
12

The Commission also proposed a technical amendment, to remove the words “private label” from Section
315.5(e) to conform the language of the Rule to that of the FCLCA. In addition to seeking comment on
these proposals, the NPRM sought comment on the following issues: the provision of additional copies of
prescriptions, the amount of time for a prescriber to respond to such a request, the use of patient portals to
release prescriptions, and potential modifications to address concerns about automated telephone
verification calls.

13

Comments received in response to the NPRM are available at https://www.ftc.gov/policy/publiccomments/2016/10/initiative-677.
14

Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact
Lens Rule, 82 Fed. Reg. 57,889 (Dec. 8, 2017).

6 

contact lens marketplace, health and safety, competition, purchasing and verification, the proposed
signed acknowledgment and consumer choice, and the future of contact lens prescribing and
selling. In response to the Commission’s comment request and workshop, the Commission
received approximately 3,400 additional comments from a wide range of commenters, including
numerous consumers and prescribers, as well as industry associations, state attorneys general,
contact lens manufacturers, and retailers.15
After a thorough review of comments, workshop transcripts, and various empirical
surveys and analyses, the Commission issued a Supplemental Notice of Proposed Rulemaking, as
opposed to implementing a Final Rule.16 In response to the SNPRM, it received approximately
200 unique (and approximately 900 overall) comments.17 The Commission reviewed those
comments and considered the commenter concerns, and now issues a Final Rule containing some
modifications from the SNPRM stage. In addition to the modifications detailed above in Specific
Instructions #1-2 (Necessity for Collecting the Information/Use of the Information), the Final
Rule requires that sellers not only make the method of prescription presentation prominent, but
also clearly and prominently disclose such method. The method of presentation and the related
disclosure must be provided prior to requesting the prescriber’s contact information for verification
of a prescription. The method offered to present the prescription must be the same medium used to
place the order or by electronic mail, text message, or file upload.
(9) Payments and Gifts to Respondents
Not applicable.
(10-11) Assurances of Confidentiality/Matters of a Sensitive Nature
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

15
Comments received in response to the workshop notice, as well as transcripts of, and materials from, the
workshop, are available at https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-ruleevolving-contact-lens-marketplace.
16

In the SNPRM, the Commission modified its previous proposal for a Signed Acknowledgment by
instituting a more flexible Confirmation of Prescription Release provision. In addition, the SNPRM put
forth new proposals to modify the Rule by: (a) adding a definition of the term “provide to the patient a
copy,” to allow the prescriber to provide the patient with a digital copy of the patient’s prescription in lieu
of a paper copy; (b) providing forty business hours as the time period for which a prescriber must provide a
prescription upon request to a person designated to act on behalf of the patient; (c) creating new message
delivery and recordkeeping requirements for sellers using automated telephone verification messages; (d)
amending and clarifying the prohibition on seller alteration of prescriptions; and (e) requiring that sellers
provide a method that would allow patients to present their prescriptions to the seller.

17

Comments received in response to the SNPRM are available at
https://www.regulations.gov/docket?D=FTC-2019-0041.

7 

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 PRA. In any event, in such proceedings, records would be protected by law from
mandatory public disclosure.18
(12) Estimated Annual Hours Burden and Associated Labor Cost
Estimated Additional Annual Hours Burden: 875,000 total hours (derived from 93,750
and 31,250 hours, respectively, to obtain signatures confirming release and consenting to electronic
delivery plus 562,500 and 187,500 hours, respectively, to maintain such records for three years).

Commission staff estimates the PRA burden of the modifications based on its knowledge
of the eye-care industry. The staff believes there will be an additional burden on individual
prescribers’ offices to generate and present to patients the confirmations of prescription release, to
collect and maintain the confirmations of prescription release for a period of not less than three
years, and, in instances where a patient opts for electronic prescription delivery instead of paper, to
collect and preserve patient consents to electronic delivery. The number of contact lens wearers in
the United States is currently estimated to be approximately 45 million.19 Therefore, assuming an
annual contact lens exam for each contact lens wearer, every year approximately 45 million people
would either read and sign a Confirmation of Prescription Release or consent to receive their
prescription electronically.20

The Commission believes that generating and presenting the confirmation of prescription
release to patients will not require significant time. Creating the confirmation of prescription
release should be relatively straightforward for prescribers since the requirement is flexible in that
it allows any one of several different modalities and delivery methods to satisfy the requirement,
including adding the confirmation to existing documents that prescribers routinely provide (sales
receipts) or are already required to provide (prescriptions) to patients. The Commission’s
requirement is also flexible in that it does not prescribe other details such as the precise content or
language of the patient confirmation, but merely requires that, if provided to the patient in-person,
the confirmation from the consumer must be in writing. At the same time, the new amendment
does not require that prescribers spend time generating their own content for the confirmation,
since the Commission has provided draft language that prescribers are free to use to satisfy the
requirement, if they so desire. Furthermore, the requirement is flexible enough to cover situations

18
See, e.g., Section 21 of the FTC Act, 15 U.S.C. 57b-2; Exemption 6 of the Freedom of Information Act,
5 U.S.C. 552(b)(6).
19

Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts,
https://www.cdc.gov/contactlenses/fast-facts.html.  

20

In the past, some commenters have suggested that typical contact lens wearers obtain annual exams every
18 months or so, rather than one every year. Because most prescriptions are valid for a minimum of one
year under the Rule, Commission staff will continue to assume conservatively for purposes of PRA burden
estimation that patients seek exams every 12 months.

8 

where a contact lens fitting is completed remotely, since a prescriber can readily satisfy the
requirement by various methods, including email, text, or uploading the prescription to a patient
portal.
The four options for a prescriber to confirm a prescription release to a patient are set out in
§ 315.3(c) in the Final Rule. The first three options (§ 315.3(c)(1)(i), (ii), and (iii)), which direct a
prescriber to provide information to a patient in the form of a confirmation of prescription release,
are not disclosures constituting an information collection under the PRA because the FTC has
supplied the prescriber with draft language the prescriber can use to satisfy this requirement.21
However, as noted above, the collection of a patient’s signature and the associated recordkeeping
required constitutes an information collection as defined by OMB regulations that implement the
PRA. Nonetheless, the Commission believes it will require minimal time for a patient to read the
confirmation of prescription release and provide a signature. Based on public comments, a
consumer survey submitted to the Commission, and estimates by staff, the Commission estimates it
will take ten seconds for the consumer to read and provide a signature.
The fourth option, § 315.3(c)(1)(iv), does not constitute an information collection under
the PRA, since no new information is provided or requested of the patient. Excluding that from
consideration and assuming the remaining three options are exercised with equal frequency, threefourths or 75% of approximately 45 million annual prescription releases otherwise entail reading
and signing a confirmation statement. Thus, 93,750 hours, cumulatively (75% × 45 million
prescriptions yearly × ten seconds each) would be devoted to those tasks.22
Maintaining the signed confirmations for a period of not less than three years should not
impose a substantial new burden on individual prescribers and their office staff. The majority of
states already require that optometrists keep records of eye examinations for at least three years,23
and thus many prescribers who opt to include the confirmation of prescription release on the
prescription itself would be preserving that document, regardless. Similarly, most prescribers

21
“The public disclosure of information originally supplied by the Federal government to the recipient for
the purpose of disclosure to the public is not included within” the definition of “collection of information.”
5 CFR 1320.3(c)(2).
22

The FTC has previously accounted for and retains active OMB clearance regarding its separate PRA
burden estimates for prescriber release of prescriptions to patients (as opposed to the instant burden estimate
for the time to read and sign a confirmation statement) and seller verification recordkeeping estimated to be
1,045,650 hours for contact lens prescribers and 1,058,400 hours for contact lens sellers. On December 9,
2019, OMB approved the Rule’s existing information collection requirements through December 31, 2022.
OMB Control No. 3804-0127. See 84 FR 51162 (Sept. 27, 2019); Agency Information Collection
Activities; Submission for OMB Review.

23

See, e.g., 246 Mass. Code Regs. § 3.02 (requiring optometrists to maintain patient records for at least
seven years); Wash. Admin. Code § 246-851-290 (requiring optometrists to maintain records of eye exams
and prescriptions for at least five years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
maintain patient records for at least five years); Fla. Admin. Code r. 64B13-3.003(6) (requiring optometrists
to maintain patient records for at least five years).

9 

already retain customer sales receipts for financial recordkeeping purposes, and thus prescribers
who opt to include the confirmation of prescription release on the sales receipt also could be
retaining that document, regardless. Moreover, storing a one-page document per patient per year
should not require more than a few seconds, and an inconsequential, or de minimis, amount of
record space. As noted above, some prescribers might present the confirmation of prescription
release electronically, and such format would allow the confirmation to be preserved without any
additional burden. For other prescribers, the new recordkeeping requirement would likely require
that office staff either preserve the confirmation in paper format or electronically scan the signed
confirmation and save it as an electronic document. For prescribers who preserve the confirmation
electronically, Commission staff estimates that scanning and saving the document would consume
approximately one minute. Commission staff do not possess detailed information on the
percentage of prescribers’ offices that use paper forms, electronic forms, or that scan paper files
and maintain them electronically. Thus, for purposes of its PRA analysis, Commission staff
conservatively has assumed that all prescriber offices require a full minute per confirmation for
recordkeeping arising from the new requirements.
Excluding from PRA consideration the fourth option, §315.3(c)(1)(iv), as there is no
signature to obtain or retain, and assuming that prescribers elect the remaining options threefourths or 75% of the time, the recordkeeping burden for prescribers to scan and save such
confirmations amounts to 562,500 hours (75% × 45 million prescriptions yearly × one minute) per
year.
As noted previously, the fourth option for satisfying the Confirmation of Prescription
Release requirement does not necessitate that prescribers obtain or maintain a record of the
patient’s signature confirming receipt of her prescription. However, as explained in § 315.2, under
the Rule’s now-modified definition of Provide to the patient a copy, in order to avail themselves of
the fourth option, prescribers must obtain and maintain records or evidence of the patients’
affirmative consent to electronic delivery for three years. In order to remain as cautious as possible
in estimating the burden, the Commission has used the assumption that consumers will sign such
consents for electronic delivery pursuant to § 315.3(c)(1)(i)(D) for a full one quarter of the 45
million prescriptions released per year,24 and that this task would take the same amount of time as
to obtain and maintain a signature of the patient’s Confirmation of Prescription Release. Thus, the
Commission has allotted 218,750 hours25 for the time required for prescribers to obtain affirmative
consents and maintain records of same.
Therefore, the total estimated incremental PRA recordkeeping burden for prescribers and
their staff resulting from the Confirmation of Prescription Release modifications to the Rule
amounts to 875,000 total hours ((93,750 and 31,250 hours, respectively, to obtain signatures
confirming release and consenting to electronic delivery) plus (562,500 and 187,500 hours,

24
11,250,000 (45 million prescriptions × 25%).
25

31,250 hours (11,250,000 prescriptions yearly × 10 seconds) for obtaining the signature plus 187,500
hours (11,250,000 affirmative consents × one minute) for storing such records.

10 

respectively, to maintain such records for three years)).
Arguably, the overall burden of the Rule—including verification costs previously
approved by the Office of Management and Budget26—could lessen (or not increase by as much as
the incremental burden from the Rule modifications), given potentially offsetting effects presented
by the modifications. As some commenters have noted, the increased burden from the
Confirmation requirement would be lessened or even outweighed by a reduced verification burden,
because with more patients in possession of their prescriptions and able to present them to thirdparty sellers, fewer time-consuming verifications would be necessary.27 Based on some
commenter and Commission projections, a decrease of between 13%-23% in verifications could be
sufficient to offset the entire cost of the Confirmation of Prescription Release requirement.28
These estimates rely on a number of assumptions, however, not all of which are as yet confirmed
as accurate.29 Furthermore, the Commission does not possess empirical data or projections as to
how much the number of verifications will decline due to the Rule modifications, and thus cannot
predict whether the verification decrease—should it occur—would be sufficient to offset any or all
of the burden. Therefore, the Commission has not made an adjustment for offsetting effects and
benefits at this time.
The Confirmation of Prescription Release requirement’s exemption for prescribers who do
not have a direct or indirect financial interest in the sale of contact lenses will also reduce the
burden created by the new requirement. The Commission, however, does not currently possess
information as to how many prescribers would qualify for the exemption due to a lack of financial
interest in the sale of lenses. The Commission therefore has not reduced its PRA burden estimate
accordingly.

26
The Commission has estimated that prescribers’ offices spend five minutes per verification request, based
on information provided by the American Optometric Association. Agency Information Collection
Activities; Submission for OMB Review, 81 FR 62501 (Sept. 9, 2016). The Commission has also estimated
that sellers spend five minutes per verification request, and one minute on recordkeeping in non-verification
circumstances (to preserve the prescription when presented by a patient); OMB Control No. 3084-0127.
27

28

SNPRM at 24,678 [notes 183-190 and accompanying text].

See SNPRM, 84 FR at 24693-94 (analysis of verifications and projection of decrease sufficient to offset
burden); 1-800 CONTACTS (SNPRM Comment #135) (estimating that a reduction of 13%-15% in
verifications would offset the estimated costs of the proposal).
29
Id. at 24678. The calculation also does not take into account any of the benefit to consumers from having
their prescriptions and being able to choose from among competing sellers; the savings consumers might
achieve by purchasing lower-priced lenses; the improvements to health and safety due to a reduction in
errors associated with invalid prescriptions currently verified through passive verification; and the
Commission’s ability to assess and verify compliance with the Rule.

11 

Estimated Total Annual Labor Cost Burden: $19,900,000.
Commission staff derives labor costs by applying appropriate hourly cost figures to the
burden hours described above. The prescriber task to obtain patient signed acknowledgments
theoretically could be performed by medical professionals (e.g., optometrists, ophthalmologists) or
support staff (e.g., dispensing opticians, ophthalmic medical technicians). To estimate associated
labor costs, staff has conservatively assumed that optometrists would perform the task.30 Applying
a mean hourly wage of $57.6831 for optometrists to the above-noted estimate of 125,000 hours,
resultant aggregate labor costs to obtain patient signatures would be $7,210,000.
Commission staff assumes that office clerks will typically perform the labor pertaining to
the printing, scanning, and storing of prescription release confirmations. Applying a mean hourly
wage for office clerks of $16.92 per hour,32 to the above-noted estimate of 750,000 hours,
cumulative labor costs for those tasks would total $12,690,000.
Therefore, combining the aggregate labor costs for both prescribers and office staff to
obtain patient signed confirmations and preserve the associated records, the Commission estimates
the total labor burden of its rule modifications to be $19,900,000.
(13) Estimated Annual Capital or Other Non-Labor Costs
Estimated Total Annual Capital or Other Non-Labor Cost Burden: $591,300
The recordkeeping requirements detailed above regarding prescribers impose negligible
capital or other non-labor costs, as prescribers likely have already the necessary equipment and
supplies (e.g., prescription pads, patients’ medical charts, scanning devices, recordkeeping storage)
to act upon those requirements. However, the Final Rule’s new requirement that sellers who use
automated verification messages record the calls and preserve the recordings for three years will
likely require a minimal amount of capital and other non-labor costs to record the calls and store
them electronically. But sellers who utilize automated telephone messages for verification are
already availing themselves of sophisticated communication technology, and thus should not find it
daunting to implement technology to record such calls. Meanwhile the growth of digital recording
technology, and the capital investment required for recording equipment and record storage, is

30
It is not certain that this assumption is well founded. See CLR Panel IV Tr., SNPRM at 24,674 [note 126,
at 8] (statements of David Cockrell that, in his office, the staff handle all the verification calls). Many
prescribers may use office staff to handle verification calls, which would result in a significantly lower
burden calculation for prescribers’ offices than what the Commission previously calculated. Without more
empirical data as to who handles most verification requests, however, the Commission will continue to use
the estimate for prescribers, even if it might overstate the actual burden.
31

Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational Employment
Statistics – May 2018.

32

Id.

12 

rapidly declining and has been for some time.33 For purposes of calculating the PRA burden, the
Commission has estimated that each three-minute verification call costs five cents to record.34
According to recent survey data, approximately 36% of contact lens purchases are from a
source other than the prescriber.35 Assuming that each of the 45 million contact lens wearers in the
U.S. makes one purchase per year, this would mean that approximately 16,200,000 contact lens
purchases (45 million × 36%) are made annually from sellers other than the prescriber. Based on
prior discussions with industry, approximately 73% of sales by non-prescriber sellers require
verification, meaning that approximately 11,826,000 purchases would require verification calls,
faxes, or emails (16,200,000 × 73%). The Commission does not possess information as to the
percentage of verifications completed by telephone versus fax or email. Thus for purposes of its
PRA analysis, the Commission has assumed that all verifications are performed via telephone.
Furthermore, the Commission does not have information as to the percentage of telephone
verifications that are automated as opposed to live calls, and thus has assumed that all telephone
verifications are automated calls and subject to the new call-recording requirement.
Based on the aforementioned assumptions, the Commission estimates that the requirement
to record automated telephone messages will require recording 11,826,000 calls36 at an annual
capital and non-labor cost to third-party sellers, in the aggregate, of $591,300 (11,826,000 × $.05).
(14) Estimated Cost to Federal Government
Staff believes that the cost to the FTC for administering the Rule modifications will be
de minimis. Accordingly, Commission staff retains the previous estimate of $52,000 per year as
the cost to the Government for administering the prior version of the Rule. 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 year, and 15% of one Paralegal work year will be expended to
enforce the Rule’s requirements.

33
See Final Rule, Telemarketing Sales Rule, 68 FR 4622 (Jan. 29, 2003) (discussing the cost for recording
calls, and determining it was not a significant obstacle for telemarketers).
34

Despite a request for information, the Commission did not receive any comments providing empirical
data or cost figures that would help inform the estimated burden for recording calls. The Commission’s
estimate, therefore, is based on a relatively small survey of advertised prices for call recording, in which
prices varied from a quarter of one cent ($.0025) for each minute recorded to about 4/10th of a cent per
verification call, plus additional charges for storage, The costs of these services would vary considerably
depending on what other options are selected, how long storage is required, and the size of the order, among
other things, and the Commission does not vouch for the sufficiency of any of these services.

35

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

36

In some instances, sellers may have to call more than once to verify an order. In those instances,
however, only the recording of the successful verification would need be preserved.

13 

(15) Program Changes/Adjustments
As detailed above, the Commission estimates that the amendments in the Final Rule
will result in an additional 875,000 burden hours, annualized, and cumulative of all affected
manufacturers, $19,900,000 in associated labor costs, and $591,300 in capital/non-labor
costs. The estimated increase in burden is correlated with Rule modifications creating a
verifiable enforcement mechanism to ensure that pre-existing FCLCA and Rule requirements
that contact lens prescriptions be provided by the prescribers to patients are complied with.
(16) Plans for Tabulation and Publication
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
This is not applicable, since the Commission will display the expiration date of the
clearance.
(18) Exceptions to the “Certification for Paperwork Reduction Act Submissions”
Not applicable.