Agency Information Collection Activities; Proposed Collection; Comment Request; Extension, 55044-55048 [2023-17420]
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Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
BHC Act.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors,
Ann E. Misback, Secretary of the Board,
20th Street and Constitution Avenue,
NW, Washington, DC 20551–0001, not
later than August 29, 2023.
A. Federal Reserve Bank of Kansas
City (Jeffrey Imgarten, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001. Comments
can also be sent electronically to
KCApplicationComments@kc.frb.org:
1. Clark Bancshares, Inc., Clarks,
Nebraska; to acquire substantially all of
the assets of M & L Cave, Inc., d/b/a
Silver Creek Insurance Agency, Silver
Creek, Nebraska, and thereby engage in
insurance agency activity located in a
place that has a population not
exceeding 5,000 pursuant to section
225.28(b)(11)(iii) of the Board’s
Regulation Y.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2023–17336 Filed 8–11–23; 8:45 am]
BILLING CODE P
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BILLING CODE P
FEDERAL TRADE COMMISSION
ACTION:
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Jkt 259001
[FR Doc. 2023–17335 Filed 8–11–23; 8:45 am]
Federal Trade Commission.
Notice.
AGENCY:
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
17:38 Aug 11, 2023
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Extension
FEDERAL RESERVE SYSTEM
VerDate Sep<11>2014
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in the BHC Act
(12 U.S.C. 1842(c)).
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than September 13, 2023.
A. Federal Reserve Bank of Kansas
City (Jeffrey Imgarten, Assistant Vice
President) One Memorial Drive, Kansas
City, Missouri 64198–0001. Comments
can also be sent electronically to
KCApplicationComments@kc.frb.org:
1. Commerce Financial Company,
Duncan, Oklahoma; to become a bank
holding company by merging with
Commerce Bancorp, Inc., Duncan,
Oklahoma, thereby indirectly acquiring
Bank of Commerce, Duncan, Oklahoma.
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 information collection
requirements in its Contact Lens Rule
(or Rule). That clearance expires on
October 31, 2023.
DATES: Comments must be filed by
October 13, 2023.
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. Write ‘‘Contact Lens Rule, PRA
Comment, P145403,’’ on your comment,
and file your comment online at https://
www.regulations.gov by following the
instructions on the web-based form. If
you prefer to file your comment on
SUMMARY:
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paper, mail your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex J), Washington, DC
20580, or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street, SW,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Paul
Spelman, Attorney, Division of
Advertising Practices, Bureau of
Consumer Protection, Federal Trade
Commission, 600 Pennsylvania Avenue
NW, Mail Drop CC–10528, Washington,
DC 20580, at (202) 326–2487.
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.
Abstract: The Rule was promulgated
by the FTC pursuant to the Fairness to
Contact Lens Consumers Act (FCLCA),
Pub. L. 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
1 Final
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Rule, 85 FR 50668 (Aug. 17, 2020).
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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: 2,979,050 hours (derived from
1,920,650 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) + 93,750 hours (33,750,000
contact lens wearers × 10 seconds per
confirmation of prescription release) +
31,250 hours (11,250,000 contact lens
wearers × 10 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 = 1,920,650 hours.
• Contact Lens Sellers: 985,500 hours
(11,826,000 orders × 5 minutes per
verification/60 minutes) + 72,900
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burden hours (4,374,000 orders × 1
minute recordkeeping/60 minutes) =
1,058,400 hours.
Estimated Total Labor Cost Burden:
Approximately $120,173,486 (derived
from ($63.99 × 968,490 optometrist
hours) + ($127.62 × 170,910
ophthalmologist hours) + ($19.78 ×
1,839,650 office clerk hours)).
Estimated Total Non-Labor Cost
Burden: $591,300 (11,826,000 × $.05 per
automated message recording).
Estimated Total Annual Cost Burden:
$120,764,786 ($120,173,486 labor cost +
$591,300 non-labor cost).
As required by section 3506(c)(2)(A)
of the PRA, 44 U.S.C. 3506(c)(2)(A), the
FTC is providing this opportunity for
public comment before requesting that
OMB extend the existing clearance for
the information collection requirements
contained in the Rule.
Burden Statement
Estimated annual hours burden:
2,979,050 hours.
This figure is derived by adding
disclosure and recordkeeping-hours for
contact lens prescribers to
recordkeeping hours for contact lens
sellers. This estimate is an increase from
the 2,104,050 hours annual burden
hours submitted to OMB in 2019. The
increase is due to amendments to the
Rule in 2020 which added new
requirements for prescribers and 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,2 (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
2 The 2020 amendments to the Contact Lens Rule
altered the definition of ‘‘provide to the patient a
copy’’ of the contact lens prescription to include
electronic delivery of the prescription, such as via
email, text, or by uploading it to a patient portal.
In order to avail themselves of this option,
prescribers must obtain and maintain evidence of
the patients’ affirmative consent to electronic
delivery for three years.
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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.3 Therefore,
assuming an annual contact lens exam
for each contact lens wearer,
approximately 45 million people would
receive a copy of their prescription each
year under the Rule and be required to
either sign a Confirmation of
Prescription Release or consent to
electronic delivery of their
prescription.4
At an estimated one minute per
prescription, the annual time spent by
prescribers complying with the
requirement to release prescriptions to
patients would be approximately
750,000 hours. [(45 million × 1 minute)/
60 minutes = 750,000 hours]. Since the
Rule requires that prescriptions be
released automatically at completion of
a fitting, the Commission—for purposes
of calculating the PRA burden—assumes
that prescription releases to patients are
handled by the prescriber rather than
the prescriber’s office staff.5 In all
likelihood, this estimate overstates the
actual burden because it includes the
time spent by prescribers who already
release prescriptions to patients in the
ordinary course of business.
Furthermore, this estimate allocates the
same time for both paper and electronic
delivery of prescriptions, even though
the latter likely takes less time for the
prescriber.
The time required to collect a
signature from a patient confirming
release of a prescription is estimated at
3 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.
4 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.
5 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 empirical data on 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.
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ten seconds.6 It is estimated that 25% of
patients would opt for electronic
delivery of their prescriptions and thus
would not need to sign a Confirmation
of Prescription Release.7 The time spent
by prescribers complying with the
requirement to obtain signed
confirmations from the other 75% of
patients is approximately 93,750 hours
annually [(75% × 45 million
prescriptions yearly × 10 seconds) =
93,750 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 ten seconds,8 and the
annual time spent complying with the
requirement to obtain such signatures is
approximately 31,250 hours [(25% × 45
million prescriptions yearly × 10
seconds) = 31,250 hours]. Based on our
knowledge of the industry and how the
medical field operates, the Commission
believes most signed patient consents
are obtained by prescribers’ office staff
rather than by the prescribers
themselves.
As stated above, prescribers may also
be required to provide or verify contact
lens prescriptions to sellers. According
to survey data, approximately 36% of
contact lens purchases are from a source
other than the prescriber.9 Assuming
that each of the 45 million contact lens
wearers in the U.S. makes one purchase
per year, this means that approximately
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
6 85
FR 50709.
7 Id.
8 Id.,
note 584.
J. Nichols & Deborah Fisher, ‘‘2018
Annual Report,’’ Contact Lens Spectrum, Jan. 1,
2019, https://www.clspectrum.com/issues/2019/
january-2019.
simply letting the prescription passively
verify). Because correcting or declining
incorrect prescriptions is mandated by
the Rule and occurs in response to
approximately 15% of requests, staff
assumes that prescribers voluntarily
confirm prescriptions less often, and
confirm at most an additional 15% of
prescriptions (and, in all likelihood,
significantly less). Using a combined
response rate of 30%, the FTC estimates
that prescribers’ offices respond to
approximately 3,547,800 requests
annually.
According to prior industry
comments,10 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 hours 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.11 The
Commission thus allots an additional
750,000 annual hours for prescribers’
offices to store and maintain records of
patient confirmations and consents. The
Commission believes these labor hours
are most likely performed by
prescribers’ office staff.
The Rule also requires prescribers to
document the specific medical reasons
for setting a contact lens prescription
expiration date shorter than the 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
9 Jason
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10 Notice and Request for Comment, 81 FR 62501
(Sept. 9, 2016).
11 85 FR 5709.
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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 1,920,650
hours for all contact lens prescribers to
comply with the Rule. [750,000
prescription-release hours + 93,750
confirmation-collection hours + 31,250
electronic-delivery-consent hours +
295,650 verification-response hours +
750,000 recordkeeping hours =
1,920,650 hours]. Of this total, we
estimate 1,139,400 are prescriber labor
hours, and 781,250 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
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cases this retention is electronic and
automatic and will not require any time)
for 4,374,000 orders [16,200,000 sales ×
27%], resulting in 72,900 recordkeeping
burden hours. [(4,374,000 orders × 1
minute)/60 minutes = 72,900 hours].
Combining burden hours for all orders
[985,500 hours + 72,900 hours], staff
estimates a total of 1,058,400 hours for
contact lens sellers. It is likely that this
estimate overstates the actual burden
because it includes the time spent by
sellers who already keep records
pertaining to contact lens sales in the
ordinary course of business, and those
whose records are generated and
preserved automatically when a
customer orders online, which staff
believes is the case for many online
sellers.
Estimated total labor cost burden:
Approximately $120,173,486.
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.12 Based on our
knowledge of the industry and the
number of optometrists and
ophthalmologists in the United States,
we assume that of the 1,139,400
prescriber labor hours relating to the
Rule, optometrists are performing 85%
of such hours and ophthalmologists are
performing the remaining 15% of
prescriber hours. We credit general
office clerks for performing the
remaining hours, both for prescribers’
offices (781,250 hours) and for nonprescriber sellers (1,058,400 hours).
Based on these assumptions and
estimates above, the estimated total
12 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 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.
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labor cost attributable to the Rule is
approximately $120,173,486. [($63.99 ×
968,490 optometrist hours =
$61,973,675) + ($127.62 × 170,910
ophthalmologist hours = $21,811,534) +
($19.78 × 781,250 prescribers’ office
clerk hours = $15,453,125) + ($19.78 ×
1,058,400 sellers’ office clerk hours =
$20,935,152) = $120,173,486.]
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.13
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
13 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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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).
Combining the annual labor cost
burden with the non-labor cost burden,
the total cost burden of the Rule is
estimated at $120,764,786 ($120,173,486
+ $591,300 = $120,764,786).
To put this in perspective, a recent
survey estimated that the U.S. contact
lens market revenue is approximately
$9.6 billion (not counting examination
revenue) as of 2021, and growing at a
steady pace.14 Therefore, the total cost
burden estimate of $120,764,786,
imposed by the Rule, while not
insubstantial, represents a cost of
approximately 1.3% of the overall retail
revenue generated.
Request for Comment
Pursuant to Section 3506(c)(2)(A) of
the PRA, the FTC invites comments on:
(1) whether the disclosure and
recordkeeping requirements are
necessary, including whether the
information will be practically useful;
(2) the accuracy of our burden estimates,
including whether the methodology and
assumptions used are valid; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) ways to minimize the burden of the
collection of information.
For the FTC to consider a comment,
we must receive it on or before October
13, 2023. Your comment, including your
name and your state, will be placed on
the public record of this proceeding,
including the https://
www.regulations.gov website.
You can file a comment online or on
paper. Due to heightened security
screening, postal mail addressed to the
Commission will be subject to delay. We
encourage you to submit your comments
online through the https://
www.regulations.gov website.
If you file your comment on paper,
write ‘‘Contact Lens Rule, PRA
Comment, P145403,’’ on your comment
and on the envelope, and mail it to the
following address: Federal Trade
Commission, Office of the Secretary,
14 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 put the U.S. contact lens market as high
as $17 billion, see https://www.visionmonday.com/
business/article/us-optical-retail-market-estimatedat-765-billion-in-the-vision-councils-firstcomprehensive-market-insights-report/.
E:\FR\FM\14AUN1.SGM
14AUN1
ddrumheller on DSK120RN23PROD with NOTICES1
55048
Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex J), Washington, DC
20580, or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will become
publicly available at https://
www.regulations.gov, you are solely
responsible for making sure that your
comment does not include any sensitive
or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including, in particular, competitively
sensitive information, such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must (1) be filed in paper
form, (2) be clearly labeled
‘‘Confidential,’’ and (3) comply with
FTC Rule 4.9(c). In particular, the
written request for confidential
treatment that accompanies the
comment must include the factual and
legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
VerDate Sep<11>2014
17:38 Aug 11, 2023
Jkt 259001
has been posted publicly at
www.regulations.gov, we cannot redact
or remove your comment unless you
submit a confidentiality request that
meets the requirements for such
treatment under FTC Rule 4.9(c), and
the General Counsel grants that request.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before October 13, 2023. For
information on the Commission’s
privacy policy, including routine uses
permitted by the Privacy Act, see
https://www.ftc.gov/site-information/
privacy-policy.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023–17420 Filed 8–11–23; 8:45 am]
BILLING CODE 6750–01–P
Purpose and Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Fees for Cruise Ship Operational
Sanitation, Construction, and
Renovation Inspections
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces fees
for vessel sanitation, construction, and
renovation inspections for fiscal year
(FY) 2024. These inspections are
conducted by HHS/CDC’s Vessel
Sanitation Program (VSP). VSP helps
the cruise industry fulfill its
responsibility for developing and
implementing comprehensive sanitation
programs to minimize the risk for acute
gastroenteritis. Every passenger cruise
vessel that has a foreign itinerary
involving a U.S. port and carries 13 or
more passengers is subject to twiceyearly unannounced operational
sanitation inspections and, when
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
necessary, reinspection. Cruise vessel
design and equipment must meet VSP’s
sanitary design criteria standards and
routine operational inspection
requirements. Cruise vessel owners or
shipyards that build or renovate cruise
vessels can request construction or
renovation inspections of new or
renovated vessels before their first or
next operational inspection.
DATES: These fees apply to inspections
conducted from October 1, 2023,
through September 30, 2024.
FOR FURTHER INFORMATION CONTACT:
CAPT Luis Rodriguez, Acting Chief,
Vessel Sanitation Program, National
Center for Environmental Health,
Centers for Disease Control and
Prevention, 4770 Buford Highway NE,
MS 106–6, Atlanta, Georgia 30341–
3717; phone: 800–323–2132; email:
vsp@cdc.gov.
SUPPLEMENTARY INFORMATION:
Sfmt 4703
HHS/CDC established the Vessel
Sanitation Program (VSP) in the 1970s
as a cooperative activity with the cruise
industry. VSP helps the cruise industry
prevent and control the introduction,
transmission, and spread of
gastrointestinal illnesses on cruise
ships. VSP operates under the authority
of the Public Health Service Act
(Section 361 of the Public Health
Service Act; 42 U.S.C. 264). Regulations
found at 42 CFR 71.41 (Foreign
Quarantine—Requirements Upon
Arrival at U.S. Ports: Sanitary
Inspection; General Provisions) state
that carriers arriving at U.S. ports from
foreign areas are subject to sanitary
inspections to determine whether there
exists rodent, insect, or other vermin
infestations; contaminated food or
water; or other insanitary conditions
requiring measures for the prevention of
the introduction, transmission, or
spread of communicable diseases.
The fee schedule for sanitation
inspections of passenger cruise ships by
VSP was first published in the Federal
Register on November 24, 1987 (52 FR
45019). HHS/CDC began collecting fees
on March 1, 1988. This notice
announces fees for inspections
conducted during FY 2024 (beginning
on October 1, 2023, through September
30, 2024).
E:\FR\FM\14AUN1.SGM
14AUN1
Agencies
[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55044-55048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17420]
=======================================================================
-----------------------------------------------------------------------
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
information collection requirements in its Contact Lens Rule (or Rule).
That clearance expires on October 31, 2023.
DATES: Comments must be filed by October 13, 2023.
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. Write ``Contact Lens Rule, PRA
Comment, P145403,'' on your comment, and file your comment online at
https://www.regulations.gov by following the instructions on the web-
based form. If you prefer to file your comment on paper, mail your
comment to the following address: Federal Trade Commission, Office of
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J),
Washington, DC 20580, or deliver your comment to the following address:
Federal Trade Commission, Office of the Secretary, Constitution Center,
400 7th Street, SW, 5th Floor, Suite 5610 (Annex J), Washington, DC
20024.
FOR FURTHER INFORMATION CONTACT: Paul Spelman, Attorney, Division of
Advertising Practices, Bureau of Consumer Protection, Federal Trade
Commission, 600 Pennsylvania Avenue NW, Mail Drop CC-10528, Washington,
DC 20580, at (202) 326-2487.
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.
Abstract: The Rule was promulgated by the FTC pursuant to the
Fairness to Contact Lens Consumers Act (FCLCA), Pub. L. 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
[[Page 55045]]
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: 2,979,050 hours (derived from
1,920,650 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) +
93,750 hours (33,750,000 contact lens wearers x 10 seconds per
confirmation of prescription release) + 31,250 hours (11,250,000
contact lens wearers x 10 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 =
1,920,650 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 $120,173,486
(derived from ($63.99 x 968,490 optometrist hours) + ($127.62 x 170,910
ophthalmologist hours) + ($19.78 x 1,839,650 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 ($120,173,486
labor cost + $591,300 non-labor cost).
As required by section 3506(c)(2)(A) of the PRA, 44 U.S.C.
3506(c)(2)(A), the FTC is providing this opportunity for public comment
before requesting that OMB extend the existing clearance for the
information collection requirements contained in the Rule.
Burden Statement
Estimated annual hours burden: 2,979,050 hours.
This figure is derived by adding disclosure and recordkeeping-hours
for contact lens prescribers to recordkeeping hours for contact lens
sellers. This estimate is an increase from the 2,104,050 hours annual
burden hours submitted to OMB in 2019. The increase is due to
amendments to the Rule in 2020 which added new requirements for
prescribers and 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,\2\ (2) collect a patient's signature on
either a Confirmation of Prescription Release or a consent-to-
electronic-prescription-release and preserve such record, and (3) as
directed by any person designated to act on behalf of the patient,
provide or verify the contact lens prescription. Prescribers can verify
a prescription either by responding affirmatively to a request for
verification, or by not responding at all, in which case the
prescription will be ``passively verified'' after eight business hours.
Prescribers are also required to correct an incorrect prescription
submitted by a seller, and notify a seller if the prescription
submitted for verification is expired or otherwise invalid. Staff
believes that the burden of complying with these requirements is
relatively low.
---------------------------------------------------------------------------
\2\ 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.\3\ Therefore, assuming an annual contact lens exam for each
contact lens wearer, approximately 45 million people would receive a
copy of their prescription each year under the Rule and be required to
either sign a Confirmation of Prescription Release or consent to
electronic delivery of their prescription.\4\
---------------------------------------------------------------------------
\3\ 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.
\4\ 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.\5\ In all likelihood, this estimate
overstates the actual burden because it includes the time spent by
prescribers who already release prescriptions to patients in the
ordinary course of business. Furthermore, this estimate allocates the
same time for both paper and electronic delivery of prescriptions, even
though the latter likely takes less time for the prescriber.
---------------------------------------------------------------------------
\5\ 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 empirical data on 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.
---------------------------------------------------------------------------
The time required to collect a signature from a patient confirming
release of a prescription is estimated at
[[Page 55046]]
ten seconds.\6\ It is estimated that 25% of patients would opt for
electronic delivery of their prescriptions and thus would not need to
sign a Confirmation of Prescription Release.\7\ The time spent by
prescribers complying with the requirement to obtain signed
confirmations from the other 75% of patients is approximately 93,750
hours annually [(75% x 45 million prescriptions yearly x 10 seconds) =
93,750 hours].
---------------------------------------------------------------------------
\6\ 85 FR 50709.
\7\ Id.
---------------------------------------------------------------------------
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 ten seconds,\8\ and the annual time spent
complying with the requirement to obtain such signatures is
approximately 31,250 hours [(25% x 45 million prescriptions yearly x 10
seconds) = 31,250 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.
---------------------------------------------------------------------------
\8\ Id., note 584.
---------------------------------------------------------------------------
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.\9\ 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.
---------------------------------------------------------------------------
\9\ 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 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,\10\ 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 hours to prescribers.
---------------------------------------------------------------------------
\10\ 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.\11\ The Commission thus allots an additional 750,000 annual
hours for prescribers' offices to store and maintain records of patient
confirmations and consents. The Commission believes these labor hours
are most likely performed by prescribers' office staff.
---------------------------------------------------------------------------
\11\ 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
1,920,650 hours for all contact lens prescribers to comply with the
Rule. [750,000 prescription-release hours + 93,750 confirmation-
collection hours + 31,250 electronic-delivery-consent hours + 295,650
verification-response hours + 750,000 recordkeeping hours = 1,920,650
hours]. Of this total, we estimate 1,139,400 are prescriber labor
hours, and 781,250 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
[[Page 55047]]
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 $120,173,486.
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.\12\ Based on our knowledge of the
industry and the number of optometrists and ophthalmologists in the
United States, we assume that of the 1,139,400 prescriber labor hours
relating to the Rule, optometrists are performing 85% of such hours and
ophthalmologists are performing the remaining 15% of prescriber hours.
We credit general office clerks for performing the remaining hours,
both for prescribers' offices (781,250 hours) and for non-prescriber
sellers (1,058,400 hours). Based on these assumptions and estimates
above, the estimated total labor cost attributable to the Rule is
approximately $120,173,486. [($63.99 x 968,490 optometrist hours =
$61,973,675) + ($127.62 x 170,910 ophthalmologist hours = $21,811,534)
+ ($19.78 x 781,250 prescribers' office clerk hours = $15,453,125) +
($19.78 x 1,058,400 sellers' office clerk hours = $20,935,152) =
$120,173,486.]
---------------------------------------------------------------------------
\12\ 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 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.
---------------------------------------------------------------------------
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.\13\
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\13\ 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).
Combining the annual labor cost burden with the non-labor cost
burden, the total cost burden of the Rule is estimated at $120,764,786
($120,173,486 + $591,300 = $120,764,786).
To put this in perspective, a recent survey estimated that the U.S.
contact lens market revenue is approximately $9.6 billion (not counting
examination revenue) as of 2021, and growing at a steady pace.\14\
Therefore, the total cost burden estimate of $120,764,786, imposed by
the Rule, while not insubstantial, represents a cost of approximately
1.3% of the overall retail revenue generated.
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\14\ 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 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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Request for Comment
Pursuant to Section 3506(c)(2)(A) of the PRA, the FTC invites
comments on: (1) whether the disclosure and recordkeeping requirements
are necessary, including whether the information will be practically
useful; (2) the accuracy of our burden estimates, including whether the
methodology and assumptions used are valid; (3) ways to enhance the
quality, utility, and clarity of the information to be collected; and
(4) ways to minimize the burden of the collection of information.
For the FTC to consider a comment, we must receive it on or before
October 13, 2023. Your comment, including your name and your state,
will be placed on the public record of this proceeding, including the
https://www.regulations.gov website.
You can file a comment online or on paper. Due to heightened
security screening, postal mail addressed to the Commission will be
subject to delay. We encourage you to submit your comments online
through the https://www.regulations.gov website.
If you file your comment on paper, write ``Contact Lens Rule, PRA
Comment, P145403,'' on your comment and on the envelope, and mail it to
the following address: Federal Trade Commission, Office of the
Secretary,
[[Page 55048]]
600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), Washington, DC
20580, or deliver your comment to the following address: Federal Trade
Commission, Office of the Secretary, Constitution Center, 400 7th
Street SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If
possible, submit your paper comment to the Commission by courier or
overnight service.
Because your comment will become publicly available at https://www.regulations.gov, you are solely responsible for making sure that
your comment does not include any sensitive or confidential
information. In particular, your comment should not include any
sensitive personal information, such as your or anyone else's Social
Security number; date of birth; driver's license number or other state
identification number, or foreign country equivalent; passport number;
financial account number; or credit or debit card number. You are also
solely responsible for making sure that your comment does not include
any sensitive health information, such as medical records or other
individually identifiable health information. In addition, your comment
should not include any ``trade secret or any commercial or financial
information which . . . is privileged or confidential''--as provided by
section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2),
16 CFR 4.10(a)(2)--including, in particular, competitively sensitive
information, such as costs, sales statistics, inventories, formulas,
patterns, devices, manufacturing processes, or customer names.
Comments containing material for which confidential treatment is
requested must (1) be filed in paper form, (2) be clearly labeled
``Confidential,'' and (3) comply with FTC Rule 4.9(c). In particular,
the written request for confidential treatment that accompanies the
comment must include the factual and legal basis for the request, and
must identify the specific portions of the comment to be withheld from
the public record. See FTC Rule 4.9(c). Your comment will be kept
confidential only if the General Counsel grants your request in
accordance with the law and the public interest. Once your comment has
been posted publicly at www.regulations.gov, we cannot redact or remove
your comment unless you submit a confidentiality request that meets the
requirements for such treatment under FTC Rule 4.9(c), and the General
Counsel grants that request.
The FTC Act and other laws that the Commission administers permit
the collection of public comments to consider and use in this
proceeding as appropriate. The Commission will consider all timely and
responsive public comments that it receives on or before October 13,
2023. For information on the Commission's privacy policy, including
routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2023-17420 Filed 8-11-23; 8:45 am]
BILLING CODE 6750-01-P