[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9391-9393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02823]


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FEDERAL TRADE COMMISSION


Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Federal Trade 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 
comment on its proposal to extend through May 31, 2016 the current OMB 
clearance for information collection requirements contained in its 
Contact Lens Rule. That clearance expires on May 31, 2013.

DATES: Comments must be received by April 9, 2013.

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.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be addressed to Alysa S. Bernstein, Attorney, and Bonnie 
McGregor, Federal Trade Investigator, Division of Advertising 
Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 
Pennsylvania Avenue NW., Washington, DC 20580, (202) 326-3289 
(Bernstein) and (202) 326-2356 (McGregor).

SUPPLEMENTARY INFORMATION: 

Proposed Information Collection Activities

    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 Federal Trade Commission (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 Contact Lens Rule (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 April 9, 
2013.
    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 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

[[Page 9392]]

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.

Burden Statement

    Commission staff estimates the paperwork burden of the FCLCA and 
Rule based on its knowledge of, and information from, the eye care 
industry. Staff believes there will be some burden on individual 
prescribers to provide contact lens prescriptions, although it involves 
merely writing a few items of information onto a slip of paper and 
handing it to the patient, or perhaps mailing or faxing it to a third 
party. In addition, there will be some recordkeeping burden on contact 
lens sellers--including retaining prescriptions or records of ``direct 
communications''--pertaining to each sale of contact lenses to 
consumers who received their original prescription from a third party 
prescriber.
    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. 
75 FR 19647 (Apr. 15, 2010) and 74 FR 68427 (Dec. 24, 2009).
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    Estimated total annual hours burden: 1,770,166 hours.
    Based upon staff knowledge of the industry, this figure is derived 
by adding 633,333 disclosure hours for contact lens prescribers to 
1,136,833 recordkeeping hours for contact lens sellers, for a combined 
industry total of 1,770,166 hours. This is higher than the estimates 
previously submitted to OMB (the similar figure was 850,000 hours in 
2009); and is due to both an increase in the estimated number of 
contact lens wearers from 34 million (2008) to 38 million (2012) and 
staff's belief that the percentage of sales in the industry that 
require obtaining or verifying a prescription is currently higher than 
what was previously estimated.
    As noted above, the number of contact lens wearers in the United 
States is estimated to be approximately 38 million.\2\ Therefore, 
assuming an annual contact lens exam for each contact lens wearer, 
approximately 38 million people would receive a copy of their 
prescription each year under the Rule. At an estimated one minute per 
prescription, the annual time spent by prescribers complying with the 
disclosure requirement would be 633,333 hours. [(38 million x 1 
minute)/60 minutes = 633,333.3 hours]
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    \2\ See Jason J. Nichols, Annual Report: Contact Lenses 2012, 
Contact Lens Spectrum, Jan. 2013, at 24.
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    As required by the FCLCA, the Rule also imposes two recordkeeping 
requirements. First, prescribers 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. The OMB regulation that implements the PRA 
defines ``burden'' to exclude any effort that would be expended 
regardless of a regulatory requirement. 5 CFR 1320.3(B)(3)(2).
    Second, the Rule requires contact lens sellers to maintain certain 
documents relating to contact lens sales. As noted above, a 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. The 
FCLCA 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 this requirement 
is low. Sellers who seek verification of contact lens prescriptions 
must retain one or two records for each contact lens sale: Either the 
relevant prescription itself, or the verification request and any 
response from the prescriber. Staff estimates that such recordkeeping 
will entail a maximum of five minutes per sale, including time spent 
preparing a file and actually filing the record(s).
    According to recent survey data, approximately 35.9% of consumers 
who purchase contacts lenses purchase those lenses from a source other 
than the doctor who originally wrote the prescription.\3\ This means 
that approximately 13,642,000 consumers--35.9% of the 38 million 
contact lens wearers in the United States--purchase their lenses from 
sellers other than the doctor who originally wrote their prescription.
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    \3\ See VisionWatch, The Vision Council, Contact Lenses, 11A-C 
(March 2012) (Research Report); VisionWatch, The Vision Council, 
Contact Lenses, 11A-C (Sept. 2012) (Research Report). The average of 
the figures given for each six-month period is 35.9%.
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    At an estimated five minutes per sale to each of 13.642 million 
consumers, contact lens sellers will spend a total of 1,136,833 burden 
hours complying with the recordkeeping requirement. [(13.642 million x 
5 minutes)/60 minutes = 1,136,833.3 hours] This estimate likely 
overstates the actual burden, however, 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 larger 
online sellers.
    Estimated labor costs: $48,602,000 (rounded to the nearest 
thousand).
    Commission staff derived labor costs by applying appropriate hourly 
cost figures to the burden hours described above. Staff estimates, 
based on information from the industry, 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 from May 2011, salaried 
optometrists earn an average wage of $51.79 per hour and general office 
clerks earn an average of $13.90 per hour.\4\
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    \4\ Press Release, Bureau of Labor Statistics, United States 
Department of Labor, Occupational Employment and Wages--May 2011, 
Table 1 (March 27, 2012), available at http://www.bls.gov/news.release/ocwage.htm.
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    With these categories of personnel, respectively, likely to perform 
the brunt of the disclosure (for optometrists) and recordkeeping (for 
office clerks) aspects of the Rule, estimated total labor cost 
attributable to the Rule would be approximately $48.6 million. [($51.79 
x 633,333.3 hours) + ($13.90 x 1,136,833.3 hours) = $48,602,314]
    The contact lens market is a multibillion dollar market; one recent

[[Page 9393]]

survey estimates that contact lens sales totaled $4,025,500,000 at the 
retail level between September 2011 and September 2012.\5\ Thus, the 
total labor cost burden estimate of $48.6 million represents 
approximately 1.2% of the overall market.
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    \5\ The Vision Council, Consumer Barometer, 2 (Sept. 2012) 
(Research Report). The market may, in fact, be larger; this number 
does not include dollars spent by consumers 17 years of age and 
younger.
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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

    You can file a comment online or on paper. Write ``Contact Lens 
Rule: FTC File No. P054510'' on your comment. Your comment B including 
your name and your state B 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, like anyone's Social Security number, 
date of birth, driver's license number or other state identification 
number or foreign country equivalent, passport number, financial 
account number, or credit or debit card number. You are also solely 
responsible for making sure that your comment does not include any 
sensitive health information, like 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 have to 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/contactensrulepra, 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 or 
deliver it to the following address: Federal Trade Commission, Office 
of the Secretary, Room H-113 (Annex J), 600 Pennsylvania Avenue NW., 
Washington, DC 20580. If possible, submit your paper comment to the 
Commission by courier or overnight service.
    Visit the Commission Web site at http://www.ftc.gov to read this 
Notice. 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 April 9, 2013. 
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.

Christian S. White,
Acting General Counsel.
[FR Doc. 2013-02823 Filed 2-7-13; 8:45 am]
BILLING CODE 6750-01-P