Agency Information Collection Activities; Proposed Collection; Comment Request; Extension, 88076-88082 [2023-27877]
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88076
Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices
Title: Section 76.934(e), Petitions for
Extension of Time.
Form Number: Not applicable.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities; and State, local, or tribal
governments.
Number of Respondents and
Responses: 20 respondents; 10
responses.
Frequency of Response: On occasion
reporting requirement; Third party
disclosure requirement.
Estimated Time per Response: 4
hours.
Total Annual Burden: 80 hours.
Total Annual Cost: None.
Needs and Uses: The information
collection requirements contained
under 47 CFR 76.934(e) states that small
cable systems may obtain an extension
of time to establish compliance with
rate regulations provided that they can
demonstrate that timely compliance
would result in severe economic
hardship. Requests for the extension of
time should be addressed to the local
franchising authorities (‘‘LFAs’’)
concerning rates for basic service tiers.
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
Advertising Requirements, False
Advertising, Misrepresentation of
Insured Status, and Misuse of the FDIC’s
Name or Logo.
Summary Agenda
No substantive discussion of the
following items is anticipated. The
Board will resolve these matters with a
single vote unless a member of the
Board of Directors requests that an item
be moved to the discussion agenda.
Disposition of Minutes of a Board of
Directors’ Meeting Previously
Distributed.
Summary reports, status reports, and
reports of actions taken pursuant to
authority delegated by the Board of
Directors.
CONTACT PERSON FOR MORE INFORMATION:
Direct requests for further information
concerning the meeting to Debra A.
Decker, Executive Secretary of the
Corporation, at 202–898–8748.
Authority: 5 U.S.C. 552b.
Dated at Washington, DC, on December 14,
2023.
Federal Deposit Insurance Corporation.
James P. Sheesley,
Assistant Executive Secretary.
[FR Doc. 2023–28157 Filed 12–18–23; 4:15 pm]
BILLING CODE 6714–01–P
[FR Doc. 2023–27902 Filed 12–19–23; 8:45 am]
FEDERAL MARITIME COMMISSION
Notice of Agreements Filed
FEDERAL DEPOSIT INSURANCE
CORPORATION
Sunshine Act Meetings
2 p.m. on December 20,
2023.
This Board meeting will be open
to public observation only by webcast.
Visit https://www.fdic.gov/news/boardmatters/video.html for a link to the
webcast. FDIC Board Members and staff
will participate from FDIC
Headquarters, 550 17th Street NW,
Washington, DC.
Observers requiring auxiliary aids
(e.g., sign language interpretation) for
this meeting should email
DisabilityProgram@fdic.gov to make
necessary arrangements.
STATUS: Open to public observation via
webcast.
MATTERS TO BE CONSIDERED: The Federal
Deposit Insurance Corporation’s Board
of Directors will meet to consider the
following matters:
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PLACE:
Discussion Agenda
Memorandum and resolution re:
Proposed 2024 FDIC Operating Budget.
Memorandum and resolution re: Final
Rule on FDIC Official Signs and
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Dated: December 15, 2023.
Carl Savoy,
Federal Register Alternate Liaison Officer.
[FR Doc. 2023–27959 Filed 12–19–23; 8:45 am]
BILLING CODE 6730–02–P
FEDERAL TRADE COMMISSION
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extension
Federal Trade Commission.
Notice.
AGENCY:
ACTION:
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.
SUMMARY:
BILLING CODE 6712–01–P
TIME AND DATE:
Panama, El Salvador, Nicaragua and
Mexico from the geographic scope of the
agreement. The Amendment changes
the authority that Maersk had to charter
space to Network to now authorizing
Network to charter space to Maersk. The
Amendment deletes obsolete language
from the agreement and adds new
language, revises the notice for
termination and updates the persons to
whom the notice is to be provided. The
Amendment also restates the
Agreement.
Proposed Effective Date: 1/26/2024.
Location: https://www2.fmc.gov/FMC.
Agreements.Web/Public/
AgreementHistory/25450.
The Commission hereby gives notice
of filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit
comments, relevant information, or
documents regarding the agreements to
the Secretary by email at Secretary@
fmc.gov, or by mail, Federal Maritime
Commission, 800 North Capitol Street,
Washington, DC 20573. Comments will
be most helpful to the Commission if
received within 12 days of the date this
notice appears in the Federal Register,
and the Commission requests that
comments be submitted within 7 days
on agreements that request expedited
review. Copies of agreements are
available through the Commission’s
website (www.fmc.gov) or by contacting
the Office of Agreements at (202) 523–
5793 or tradeanalysis@fmc.gov.
Agreement No.: 201325–001.
Agreement Name: Sealand/Network
Space Charter Agreement.
Parties: Maersk A/S; Network
Shipping, Ltd.
Filing Party: Wayne Rohde; Cozen
O’Connor.
Synopsis: The Amendment changes
the name of the agreement and deletes
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Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices
Paul
Spelman, Attorney, Division of
Advertising Practices, Bureau of
Consumer Protection, Federal Trade
Commission, (202) 326–2889,
pspelman@ftc.gov.
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.
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
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FOR FURTHER INFORMATION CONTACT:
1 Final
Rule, 85 FR 50668 (Aug. 17, 2020).
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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
× 1 minute per prescription release/60
minutes) + 187,500 hours (33,750,000
contact lens wearers × 20 seconds per
confirmation of prescription release) +
62,500 hours (11,250,000 contact lens
wearers × 20 seconds per affirmative
consent to electronic prescription
delivery) + 295,650 hours (3,547,800
verification requests × 5 minutes per
response/60 minutes) + 750,000 hours
recordkeeping = 2,045,650 hours.
• Contact Lens Sellers: 985,500 hours
(11,826,000 orders × 5 minutes per
verification/60 minutes) + 72,900
burden hours (4,374,000 orders × 1
minute recordkeeping/60 minutes) =
1,058,400 hours.
Estimated Total Labor Cost Burden:
Approximately $117,606,598 (derived
from ($63.99 × 888,803 optometrist
hours) + ($127.62 × 156,848
ophthalmologist hours) + ($19.78 ×
1,000,000 prescribers’ office clerk hours)
+ ($19.78 × 1,058,400 sellers’ office
clerk hours).
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Estimated Total Non-Labor Cost
Burden: $591,300 (11,826,000 × $.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
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 onesentence 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
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 patientacknowledgment-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
2 American Optometric Association (PRA
Comment #7) available at https://
www.regulations.gov/comment/FTC-2023-00490007.
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).
5 85 FR 50709.
6 Standards for Privacy of Individually
Identifiable Health Information, 67 FR 53182, 53261
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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
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,
(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 10second 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.
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.
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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
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
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
12 84
FR 24693.
(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.
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].
13 AOA
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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.
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
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
17 Montaquila,
ER Workshop Transcript at 23–24.
Taxpayers Union (ER NPRM
Comment #28) available at https://
www.regulations.gov/comment/FTC-2023-00010028. 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.’’).
19 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.’’).
18 National
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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
Discussion of the Comments and
Evidence Regarding the Time Required
In considering how much time it takes
to complete the confirmation-ofprescription-release requirement for this
Paperwork Reduction Act purpose, the
Commission has evaluated the evidence
in the record, including the previouslyapproved 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 selfselected 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,
20 Neville,
ER Workshop Transcript at 28–29.
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that cannot be concluded from the
survey.21
The Commission also has concerns
that some of the time prescribers ascribe
to patients reading and signing the
confirmation is, in fact, due to nonmandated 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 onesentence 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.’’
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.
22 See AOA Contact Lens Rule Compliance
Toolkit, sample template, 8, available at https://
documents.aoa.org/Documents/CLCS/Contact-LensRule-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.
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 10second 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
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
24 Montaquila,
25 See
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recordkeeping hours for contact lens
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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-prescriptionrelease 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.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
At an estimated one minute per
prescription, the annual time spent by
prescribers complying with the
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.
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-contactlens-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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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.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
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
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.’’)
31 In prior PRA submissions, the task of collecting
a patient signature on a confirmation-ofprescription-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,
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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.32
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 × 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
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?’’).
32 See supra note 40.
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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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 × 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.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.
The Rule also requires prescribers to
document the specific medical reasons
for setting a contact lens prescription
expiration date shorter than the oneyear 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
34 Notice and Request for Comment, 81 FR 62501
(Sept. 9, 2016).
35 85 FR 5709.
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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 nonprescriber 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 nonprescriber 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)
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88081
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.
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 nonprescriber sellers (1,058,400 hours).
Based on these assumptions and
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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ddrumheller on DSK120RN23PROD with NOTICES1
estimates above, the estimated total
labor cost attributable to the Rule is
approximately $117,606,597 [($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].
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 nonlabor 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
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
38 85 FR 50711. It is possible this would be a onetime 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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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).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.
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,
39 See https://www.globenewswire.com/en/newsrelease/2022/09/05/2509723/0/en/Contact-LensesMarket-Size-Will-Achieve-USD-17-4-Billion-by2030-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.vision
monday.com/business/article/us-optical-retailmarket-estimated-at-765-billion-in-the-visioncouncils-first-comprehensive-market-insightsreport/.
PO 00000
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to 5 U.S.C. 1009(d), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended, and the Determination of
the Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, CDC, pursuant to Public Law
92–463. The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)–
PAR 20–280, Cooperative Research
Agreements Related to the World Trade
Center Health Program (U01); RFA–OH–
24–002, Exploratory/Developmental
Grants on Lifestyle Medicine Research
Related to the World Trade Center
Health Program (R21); RFA–OH–24–
003, Exploratory/Developmental Grants
Related to the World Trade Center
Survivors (R21–No Applications with
Responders Accepted); and RFA–OH–
24–004, World Trade Center Health
Program Mentored Research Scientist
Career Development Award (K01).
Dates: March 19–21, 2024.
Times: 11 a.m.–6 p.m., EDT.
Place: Video-Assisted Meeting.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Laurel Garrison, M.P.H., Scientific
Review Officer, Office of Extramural
Programs, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
5555 Ridge Avenue, Cincinnati, Ohio
45213. Telephone: (513) 533–8324;
Email: LGarrison@cdc.gov.
The Director, Office of Strategic
Business Initiatives, Office of the Chief
E:\FR\FM\20DEN1.SGM
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Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extension
AGENCY: Federal Trade Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (PRA),
the Federal Trade Commission (FTC or Commission) is seeking public
comment on its proposal to extend for an additional three years the
Office of Management and Budget clearance for 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.
---------------------------------------------------------------------------
\1\ Final Rule, 85 FR 50668 (Aug. 17, 2020).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\24\ Montaquila, ER Workshop transcript at 23.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.'')
---------------------------------------------------------------------------
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?'').
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\33\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,''
Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019.
---------------------------------------------------------------------------
Based on prior discussions with industry, approximately 73% of
sales by non-prescriber sellers require verification, and prescribers
affirmatively respond (by notifying the seller that the prescription is
invalid or incorrect) to approximately 15% of those verification
requests. Using a response rate of 15%, the FTC therefore estimates
that prescribers' offices respond to approximately 1,773,900
verification requests annually [(16,200,000 purchases 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.
---------------------------------------------------------------------------
\34\ Notice and Request for Comment, 81 FR 62501 (Sept. 9,
2016).
---------------------------------------------------------------------------
Lastly, the Rule and FCLCA also impose recordkeeping requirements
on prescribers' offices. First, they must maintain signed
confirmations, or signed consent to electronic prescription delivery
and proof that such prescriptions were delivered via email, text, or
patient portal, for a period of three years. For purposes of PRA
analysis, the Commission has used the assumption that all prescriber
offices require a full minute to store and maintain each confirmation
record, and a full minute to store and maintain each consent to
electronic prescription delivery and proof of electronic prescription
delivery.\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.
---------------------------------------------------------------------------
\35\ 85 FR 5709.
---------------------------------------------------------------------------
The Rule also requires prescribers to document the specific medical
reasons for setting a contact lens prescription expiration date shorter
than the one-year minimum established by the FCLCA. This burden is
likely to be nil because the requirement applies only in cases when the
prescriber invokes the medical judgment exception, which is expected to
occur infrequently, and prescribers are likely to record this
information in the ordinary course of business as part of their
patients' medical records. As mentioned previously, the OMB regulation
that implements the PRA defines ``burden'' to exclude any effort that
would be expended regardless of a regulatory requirement.
Combining all hours spent annually disclosing prescriptions to
consumers, obtaining confirmations of prescription release from
consumers, obtaining affirmative consent to electronic prescription
delivery from consumers, responding to verification requests, and
maintaining records as required by the Rule, we estimate a total of
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