[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