[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31938-31941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11952]


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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 information collection requirements described below will 
be submitted to the Office of Management and Budget (OMB) for review, 
as required by the Paperwork Reduction Act (PRA). The FTC seeks public 
comments on its proposal to extend, for three years, the current PRA 
clearance for information collection requirements contained in the 
Contact Lens Rule. This clearance expires on September 30, 2016.

DATES: Comments must be received on or before July 19, 2016.

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 ``Contact Lens Rule: FTC 
File No. P054510'' on your comment, and file your comment online at 
https://ftcpublic.commentworks.com/ftc/contactlensrulepra by following 
the instructions on the web-based form. If you prefer to file your 
comment on paper, mail or deliver 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

[[Page 31939]]

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: Requests for copies of the collection 
of information and supporting documentation should be addressed to 
Alysa S. Bernstein, 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-
3289.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act (``PRA''), 
44 U.S.C. 3501-3520, federal agencies must get OMB approval for each 
collection of information they conduct, sponsor, or require. 
``Collection of information'' means 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). As required by section 
3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for 
public comment before requesting that OMB extend the existing PRA 
clearance for the information collection requirements associated with 
the Commission's rules and regulations under the Contact Lens Rule, 16 
CFR part 315 (OMB Control Number 3084-0127).
    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 on those who 
are to respond. All comments must be received on or before July 19, 
2016.
    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 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 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 to OMB.\1\ Thus, the Rule's disclosure 
and recordkeeping requirements remain the same.
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    \1\ The FTC most recently submitted clearance three years ago. 
78 FR 9391 (Feb. 8, 2013) and 78 FR 44122 (Jul. 23, 2013).
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    Estimated total annual hours burden: Approximately 1,796,764 hours.
    This figure is derived by adding 843,159 disclosure hours for 
contact lens prescribers to 953,605 recordkeeping hours for contact 
lens sellers, for a combined industry total of 1,796,764 hours. This is 
higher than estimates submitted to OMB in 2013 (the respective figure 
was 1,594,981 hours in July 2013). The higher estimate is due to an 
increase in the estimated number of contact lens wearers from 38 
million (2012) to 41 million (2015), and an increase in the estimated 
percentage of verification requests that require the prescribers to 
make an affirmative response.

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.\2\ Staff believes that the burden of complying with these 
requirements is relatively low.
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    \2\ 16 CFR 315.5.
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    As noted above, the number of contact lens wearers in the United 
States is estimated to be approximately 41 million.\3\ Therefore, 
assuming an annual contact lens exam for each contact lens wearer, 
approximately 41 million people would receive a copy of their 
prescription each year under the Rule.\4\
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    \3\ Jason J. Nichols, 2015 Annual Report: Contact Lenses 2015, 
Contact Lens Spectrum, Vol. 31, Jan. 2016, pp. 18-23, 18.
    \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 most prescriptions are valid a minimum 
of one year under the Rule, and use of a longer exam cycle would 
lead to an estimate of a lower number of exams and a reduced burden, 
we continue to estimate that patients seek exams every 12 months.
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    At an estimated one minute per prescription,\5\ the annual time 
spent by prescribers complying with the requirement to release 
prescriptions to patients would be approximately 683,333 hours. [(41 
million x 1 minute)/60 minutes = 683,333 hours]. This estimate likely 
overstates the actual burden because it includes the time spent by 
prescribers who already release prescriptions to patients in the 
ordinary course of business.
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    \5\ In the past, some commenters have suggested that prescribers 
spend three to five minutes providing a prescription to each 
patient. However, the Paperwork Reduction Act defines ``burden'' in 
such a way that it excludes any effort that would be expended 
regardless of a regulatory requirement. 5 CFR 1320.3(b)(2). In most 
instances, an eye care professional would already spend time 
inputting the prescription into the patient's file regardless of the 
Rule, and the extra burden imposed by the Rule is merely copying 
that prescription for the patient, which we estimate at one minute.
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    As stated above, prescribers may also be required to provide or 
verify contact lens prescriptions to sellers. According to recent 
survey data, approximately 35.6% of contact lens purchases are from a 
source other than the prescriber.\6\

[[Page 31940]]

Assuming that each of the 41 million contact lens wearers in the U.S. 
makes one purchase per year, this means that approximately 14,596,000 
contact lens purchases (41 million x 35.6%) are made from sellers other 
than the prescriber.
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    \6\ VisionWatch Eyewear U.S. Study, The Vision Council, Contact 
Lenses, December 2015, 11A.
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    Based on recent 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 1,598,262 
verification requests annually. [(14,596,000 x 73%) x 15% = 1,598,262 
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 
no more than an additional 15% of prescriptions. Using a combined 
response rate of 30%, the FTC estimates that prescribers' offices 
respond to approximately 3,196,524 requests annually.
    We estimate that responding to verification requests requires three 
minutes per request.\7\ Using that data, we estimate that these 
responses require an additional 159,826 hours annually. [(3,196,524 x 3 
minutes)/60 minutes = 159,826 hours].
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    \7\ This estimate is based on the Comment of Roger Jordan of the 
American Optometric Association, April 9, 2013, at 2, available on 
the FTC's Web site at https://www.ftc.gov/policy/public-comments/initiative-479.
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    Combining these hours with the hours spent disclosing prescriptions 
to consumers, we estimate a total of 843,159 hours for contact lens 
prescribers. [683,333 + 159,826 hours = 843,159 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.\8\
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    \8\ 5 CFR 1320.3(b)(2).
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2. Sellers

    As noted above, a seller may sell contact lenses only in accordance 
with a valid prescription that the seller (a) has received from the 
patient or prescriber, or (b) has 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.
    As stated previously, there are approximately 14,596,000 sales by 
non-prescriber sellers annually and approximately 73% of those sales 
require verification. Therefore, sellers verify approximately 
10,655,080 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 10,655,080 orders, 
contact lens sellers will spend a total of 887,923 burden hours 
complying with this portion of the requirement. [(10,655,080 orders x 5 
minutes)/60 minutes = 887,923 hours].
    This means that approximately 27% of the remaining sales to non-
prescriber sellers do not require verification and require the seller 
to keep only the prescription provided. Staff estimates that this 
recordkeeping burden requires at most one minute per order for 
3,940,920 orders, resulting in 65,682 burden hours. [(3,940,920 orders 
x 1 minute)/60 minutes = 65,682 hours].
    Combining burden hours for all orders, staff estimates a total of 
953,605 hours for contact lens sellers. This estimate likely 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. In addition, the estimate may overstate the time 
spent by sellers to the extent that records (e.g., verification 
requests) are generated and stored automatically and electronically, 
which staff understands is the case for some online sellers.
    Estimated total labor cost burden: Approximately $61,540,563.
    Commission staff derived labor costs by applying appropriate hourly 
cost figures to the burden hours described above. Based on information 
from the industry, staff estimates that optometrists account for 
approximately 85% of prescribers. Consequently, for simplicity, staff 
will focus on their average hourly wage in estimating prescribers' 
labor cost burden.
    According to Bureau of Labor Statistics, salaried optometrists earn 
an average wage of $55.65 per hour and general office clerks earn an 
average wage of $15.33 per hour.\9\
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    \9\ Press Release, Bureau of Labor Statistics, United States 
Department of Labor, Occupational Employment Statistics--May, 2015, 
available at http://www.bls.gov/news.release/ocwage.t01.htm.
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    Assuming that optometrists are performing the brunt of the labor 
for prescribers and office clerks are performing the labor for non-
prescriber sellers, estimated total labor cost attributable to the Rule 
would be approximately $61,254,481. [($55.65 x 843,159 prescriber hours 
= 46,921,798) + ($15.33 x 953,605 office clerk hours = 14,618,765) = 
$61,540,563].
    The contact lens market is a multibillion-dollar market. One survey 
estimates that contact lens sales in the U.S. in 2015 totaled 
$4,664,200,000 at the retail level.\10\ The total labor cost burden 
estimate of $61,540,563 represents approximately 1.3% of the overall 
retail market.
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    \10\ The Vision Council, US Optical Industry Report Card, 
December 2015.
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    Request for Comments:
    You can file a comment online or on paper. Write ``Contact Lens 
Rule: FTC File No. P054510'' on your comment. Your comment--including 
your name and your state--will be placed on the public record of this 
proceeding, including, to the extent practicable, on the public 
Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a 
matter of discretion, the Commission tries to remove individuals' home 
contact information from comments before placing them on the Commission 
Web site.
    Because your comment will be made public, you are solely 
responsible for making sure that your comment does not include any 
sensitive personal information, such as a 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

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not include any sensitive health information, such as medical records 
or other individually identifiable health information. In addition, do 
not include any ``[t]rade secret or any commercial or financial 
information which is . . . privileged or confidential,'' as discussed 
in 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). In particular, do not include 
competitively sensitive information such as costs, sales statistics, 
inventories, formulas, patterns, devices, manufacturing processes, or 
customer names.
    If you want the Commission to give your comment confidential 
treatment, you must file it in paper form, with a request for 
confidential treatment, and you must follow the procedure explained in 
FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential 
only if the FTC General Counsel, in his or her sole discretion, grants 
your request in accordance with the law and the public interest. Postal 
mail addressed to the Commission is subject to delay due to heightened 
security screening. As a result, the Commission encourages you to 
submit your comments online. To make sure that the Commission considers 
your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/contactlensrulepra by following the 
instructions on the Web-based form. If this Notice appears at http://www.regulations.gov, you also may file a comment through that Web site.
    If you file your comment on paper, write ``Contact Lens Rule: FTC 
File No. P054510'' on your comment and on the envelope, and mail it 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. If possible, submit your paper comment to the Commission by 
courier or overnight service.
    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 July 19, 2016. 
You can find more information, including routine uses permitted by the 
Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

David C. Shonka,
Acting General Counsel.
[FR Doc. 2016-11952 Filed 5-19-16; 8:45 am]
 BILLING CODE 6750-01-P