[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Pages 32170-32173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14291]
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FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Proposed Collection;
Comment Request
AGENCY: Federal Trade Commission (FTC or Commission).
ACTION: Notice.
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SUMMARY: The FTC plans to ask the Office of Management and Budget (OMB)
to extend for an additional three years the current Paperwork Reduction
Act (PRA) clearance for information collection requirements contained
in the Contact Lens Rule (or Rule). The current clearance expires on
October 31, 2019.
DATES: Comments must be received on or before September 3, 2019.
ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Request for Comments part of the
SUPPLEMENTARY INFORMATION section below. Write ``Paperwork Reduction
Act: FTC File No. P072108'' 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: 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. 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. In addition, the Rule imposes recordkeeping
requirements on contact lens prescribers and sellers. For example, the
Rule requires prescribers to document in their patients' records the
medical reasons for setting a contact lens prescription expiration date
of less than one year. The Rule 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
[[Page 32171]]
or to bring enforcement actions based on violations of the Rule.
No substantive provisions in the Rule have been amended or changed
since staff's prior submission and OMB clearance in 2016.\1\ Thus, the
Rule's disclosure and recordkeeping requirements remain the same.
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\1\ OMB clearance for the current Rule expires October 31, 2019.
On May 28, 2019, the FTC published a Supplemental Notice of Proposed
Rulemaking (``SNPRM'') (84 FR 24664) which proposes amendments to
the Rule, and the FTC is separately seeking OMB's approval for the
information-collection requirements associated with those
amendments. Because the SNPRM was drafted prior to this Comment
Request, some of the data and estimates may differ in the two
documents. Should the Commission adopt the proposed amendments in
the SNPRM, it could alter or render moot the assumptions,
conclusions, and estimates put forth in this notice based on the
current Rule.
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Under the PRA, 44 U.S.C. 3501-3521, Federal agencies must get OMB
approval for each collection of information they conduct or sponsor.
``Collection of information'' includes agency requests or requirements
to submit reports, keep records, or provide information to a third
party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). The FTC is seeking renewed
clearance for the information collection requirements associated with
the Commission's Contact Lens Rule, 16 CFR part 315 (OMB Control Number
3084-0127).
Burden Statement
Estimated annual hours burden: 2,104,050 hours.
This figure is derived by adding 1,045,650 disclosure hours for
contact lens prescribers to 1,058,400 recordkeeping hours for contact
lens sellers, for a combined industry total of 2,104,050 hours. This
estimate is an increase from the 1,903,315 annual burden hours
submitted to OMB in 2016. The higher estimate is due to an increase in
the estimated number of contact lens wearers in the United States from
41 million to 45 million.\2\
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\2\ Centers for Disease Control, Healthy Contact Lens Wear and
Care, Fast Facts, https://www.cdc.gov/contactlenses/fast-facts.html.
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1. Prescribers
The Rule requires prescribers to make disclosures in two ways. Upon
completing a contact lens fitting, the Rule requires that prescribers
(1) provide a copy of the contact lens prescription to the patient, and
(2) 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 now
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.\4\
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\3\ Id.
\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 compliance with the Rule will provide the best estimate of
the Rule's contemplated burden.
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At an estimated one minute per prescription, the annual time spent
by prescribers complying with the requirement to release prescriptions
to patients would be approximately 750,000 hours. [(45 million x 1
minute)/60 minutes = 750,000 hours]. 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.
As stated above, prescribers may also be required to provide or
verify contact lens prescriptions to sellers. According to recent
survey data, approximately 36% of contact lens purchases are from a
source other than the prescriber.\5\ 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%) are made from sellers other than the prescriber.
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\5\ Jason J. Nichols & Deborah Fisher, ``2018 Annual Report,''
Contact Lens Spectrum, Jan. 1, 2019, https://www.clspectrum.com/issues/2019/january-2019.
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Based on prior discussions with industry, approximately 73% of
sales by non-prescriber sellers require verification, and prescribers
affirmatively respond (by notifying the seller that the prescription is
invalid or incorrect) to approximately 15% of those verification
requests. Using a response rate of 15%, the FTC therefore estimates
that prescribers' offices respond to approximately 1,773,900
verification requests annually [(16,200,000 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 the industry comments to the 2016 PRA submission,
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]. Combining these hours with the hours spent
disclosing prescriptions to consumers, we estimate a total of 1,045,650
hours for all contact lens prescribers to comply with the Rule.
[750,000 hours + 295,650 hours = 1,045,650 hours].
Lastly, as required by the FCLCA, the Rule also imposes a
recordkeeping requirement on prescribers. They must 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.
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. Staff believes that the
burden of complying with these requirements is relatively low.
[[Page 32172]]
As stated previously, there are approximately 16,200,000 sales by
non-prescriber sellers annually and approximately 73% of those 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 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 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 $84,548,448.
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 $73,082,912
labor cost estimate submitted to OMB in 2016 due to an increase in the
estimated number of contact lens wearers in the United States and wage
increases for optometrists, ophthalmologists, and office staff.
According to Bureau of Labor Statistics, salaried optometrists earn
an average wage of $57.68 per hour, other physicians and surgeons--such
as ophthalmologists--earn an average wage of $98.02 per hour, and
general office clerks earn an average wage of $16.92 per hour.\6\
Assuming that optometrists are performing 85% of the labor hours and
ophthalmologists are performing 15% the labor hours for prescribers,
and office clerks are performing the labor for non-prescriber sellers,
estimated total labor cost attributable to the Rule would total
approximately $84,548,448. [$66,640,319 prescriber hours (($57.68 x
888,802.5 optometrist hours = $51,266,128) + ($98.02 x 156,847.5
ophthalmologist hours = $15,374,192)) + $14,618,765 for seller hours
($16.92 x 1,058,400 office clerk hours = $17,908,128) = $84,548,448.]
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\6\ Press Release, Bureau of Labor Statistics, United States
Department of Labor, Occupational Employment Statistics--May 2018,
https://www.bls.gov/news.release/ocwage.t01.htm. Median salaries for
prescribers and clerks ($53.75 for optometrists, $96.58 for other
physicians and surgeons, and $15.74 for general office clerks) are
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 outliers
that can distort the mean. Salaries can also vary by region. The
average hourly wage for optometrists in New Mexico, for instance, is
$41.76 per hour, whereas optometrists in North Dakota earn an
average of $84.18 per hour. Id. https://www.bls.gov/oes/current/oes291041.htm. However, since Contact Lens Rule PRA submissions have
historically used national mean salaries to estimate the burden, the
FTC will continue to do so for this submission.
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A recent survey estimated that the U.S. contact lens market revenue
is approximately $5,012,800,000 (not counting examination revenue) in
2017.\7\ Therefore, the total labor cost burden estimate of $84,548,448
imposed by the Rule represents a cost of approximately 1.69% of the
overall retail revenue generated.
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\7\ ``Vision Markets See Continued Growth in 2017, VisionWatch
Says,'' Vision Monday, March 20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also, Steve Kodey, US Optical
Market Eyewear Overview, 4, https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf. The FTC does not
possess market data for 2018.
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Estimated annual non-labor cost burden: $0 or minimal.
Staff believes that the Rule's disclosure and recordkeeping
requirements 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).
Request for Comments
The FTC invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (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. In particular,
the FTC invites comments on (5) what percentage of sales by non-
prescriber sellers require verification; (6) what percentage of
verification requests are affirmatively responded to by prescribers
(either by notifying the seller that the prescription is valid, or by
notifying the seller that the prescription is invalid or incorrect);
(7) what percentage of contact lens prescriptions are written by
ophthalmologists as opposed to optometrists or other medical
specialties; (8) what percentage of verification requests received by
optometrists' offices are handled by optometrists and what percentage
are handled by office staff; (9) what percentage of verification
requests received by ophthalmologists' offices are handled by
ophthalmologists and what percentage are handled by office staff; and
(10) whether the FTC should rely on mean wage data or median wage data
in calculating the Rule's burden.
You can file a comment online or on paper. For the FTC to consider
your comment, we must receive it on or before September 3, 2019. Write
``Paperwork Reduction Act: FTC File No. P072108'' on your comment.
Postal mail addressed to the Commission is subject to delay due to
heightened security screening. As a result, we encourage you to submit
your comments online, or to send them to the Commission by courier or
overnight service. To make sure that the Commission considers your
online comment, you must file it through the https://www.regulations.gov website by following the instructions on the web-
based form. 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. As a matter of discretion, the Commission
tries to remove individuals' home contact information from comments
before placing them on www.regulations.gov.
If you file your comment on paper, write ``Paperwork Reduction Act:
FTC File No. P072108'' on your comment and on the envelope, and 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
[[Page 32173]]
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 be placed on the publicly accessible FTC
website at 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 be filed in paper form, must be clearly labeled
``Confidential,'' and must 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.\8\ 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.
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\8\ See FTC Rule 4.9(c).
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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 September 3,
2019. You can find more information, including routine uses permitted
by the Privacy Act, in the Commission's privacy policy, at https://www.ftc.gov/site-information/privacy-policy.
Heather Hippsley,
Deputy General Counsel.
[FR Doc. 2019-14291 Filed 7-3-19; 8:45 am]
BILLING CODE 6750-01-P