[Federal Register Volume 75, Number 72 (Thursday, April 15, 2010)]
[Notices]
[Pages 19647-19649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8647]


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FEDERAL TRADE COMMISSION


 Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').

ACTION: Notice and request for comment.

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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 
is seeking public comments on its proposal to extend through May 31, 
2013, the current PRA clearance for information collection requirements 
contained in its Contact Lens Rule. That clearance expires on May 31, 
2010.

DATES: Comments must be received on or before May 17, 2010.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form, by following the instructions in the 
Request for Comments part of the SUPPLEMENTARY INFORMATION section 
below. Comments in electronic form should be submitted by using the 
following Web link: (https://public.commentworks.com/ftc/contactlensrulepra2) (and following the instructions on the web-based 
form). Comments in paper form should be mailed or delivered to the 
following address: Federal Trade Commission, Office of the Secretary, 
Room H-135 (Annex J), 600 Pennsylvania Avenue, NW, Washington, DC 
20580, in the manner detailed in the SUPPLEMENTARY INFORMATION below.

FOR FURTHER INFORMATION CONTACT: Requests for copies of the collection 
of information and supporting documentation should be addressed to 
Karen Jagielski, Attorney, Division of Advertising Practices, Bureau of 
Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, 
NW., NJ- 3212, Washington, DC 20580, (202) 326-2509.

SUPPLEMENTARY INFORMATION:

Background

    Under the PRA, 44 U.S.C. 3501-3520, federal agencies must obtain 
approval from OMB for each collection of information they conduct or 
sponsor. ``Collection of information'' means agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 
1320.3(c).
    On December 24, 2009, the FTC sought comment on the information 
collection requirements associated with the Contact Lens Rule (the 
Rule), 16 CFR part 315. No comments were received. Pursuant to the OMB 
regulations, 5 CFR Part 1320, that implement the PRA, the FTC is 
providing this second opportunity for public comment while seeking OMB 
approval to renew the pre-existing clearance for the Rule (OMB Control 
No. 3084-0095). All comments should be filed as prescribed in the 
ADDRESSES section above and in the Request for

[[Page 19648]]

Comments (found below), and must be received on or before May 17, 2010.
    The Rule was promulgated by the FTC pursuant to the Fairness to 
Contact Lens Consumers Act (``FCLCA''), Pub. L. 108-164 (December 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 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.

Request for Comments

    Interested parties are invited to submit written comments 
electronically or in paper form. Comments should refer to ``Contact 
Lens Rule: FTC File No. P054510'' to facilitate the organization of 
comments. Please note that your comment -- including your name and your 
state -- will be placed on the public record of this proceeding, 
including on the publicly accessible FTC Web site, at (http://www.ftc.gov/os/publiccomments.shtm).
    Because comments will be made public, they should not include any 
sensitive personal information, such as an individual'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. Comments also 
should not include any sensitive health information, such as medical 
records or other individually identifiable health information. In 
addition, comments should not include any ``[t]rade secret or any 
commercial or financial information which is obtained from any person 
and which is privileged or confidential. . .,'' as provided in Section 
6(f) of the Federal Trade Commission Act (``FTC Act''), 15 U.S.C. 
46(f), and Commission Rule 4.10(a)(2), 16 CFR 4.10(a)(2). 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).
    Because paper mail addressed to the FTC is subject to delay due to 
heightened security screening, please consider submitting your comments 
in electronic form. Comments filed in electronic form should be 
submitted by using the following Web link: (https://public.commentworks.com/ftc/contactlensrulepra2) (and following the 
instructions on the web-based form). If this Notice appears at (http://www.regulations.gov), you may also file an electronic comment through 
that Web site. The Commission will consider all comments that 
regulations.gov forwards to it.
    A comment filed in paper form should include the ``Contact Lens 
Rule: FTC File No. P054510'' reference both in the text and on the 
envelope, and should be mailed or delivered to the following address: 
Federal Trade Commission, Office of the Secretary, Room H-135 (Annex 
J), 600 Pennsylvania Avenue, NW, Washington, DC 20580. The FTC is 
requesting that any comment filed in paper form be sent by courier or 
overnight service, if possible, because U.S. postal mail in the 
Washington area and at the Commission is subject to delay due to 
heightened security precautions.
    Comments on any proposed recordkeeping, or disclosure requirements 
that are subject to Paperwork Reduction Act review by the Office of 
Management and Budget should additionally be submitted to: Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Attention: Desk Officer for Federal Trade Commission. Comments should 
be submitted via facsimile to (202) 395-5167 because U.S. postal mail 
at the OMB is subject to delays due to heightened security precautions.
    The FTC Act and other laws 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, whether filed in paper or electronic 
form. Comments received will be available to the public on the FTC's 
Web site, to the extent practicable, at (http://www.ftc.gov/os/publiccomments.shtm). As a matter of discretion, the Commission makes 
every effort to remove home contact information for individuals from 
the public comments it receives before placing those comments on the 
FTC's Web site. More information, including routine uses permitted by 
the Privacy Act, may be found in the FTC's privacy policy at (http://www.ftc.gov/ftc/privacy.shtm).

Burden Statement

    Commission staff estimates the paperwork burden of the FCLCA and 
Rule based on its knowledge of 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.
    Estimated total annual hours burden: 850,000 hours (rounded to the 
nearest thousand). Based upon staff knowledge of the industry, this 
figure is derived by adding approximately 567,000 disclosure hours for 
contact lens prescribers to approximately 283,000 recordkeeping hours 
for contact lens sellers, for a combined industry total of 850,000 
hours. This is slightly lower than the estimates previously submitted 
to OMB (the similar figure was 950,000 hours in 2006); and is due to a 
drop in the estimated number of contact lens wearers from 36 million 
(2006) to 34 million (2008).
    No provisions in the Rule have been amended since staff's prior 
submission to OMB. The Rule's disclosure and recordkeeping 
requirements, therefore, remain the same. As noted above, the number of 
contact lens wearers in the

[[Page 19649]]

United States is estimated to be approximately 34 million.\1\ 
Therefore, assuming an annual contact lens exam for each contact lens 
wearer, 34 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 a maximum of 567,000 hours. [(34 million x 1 
minute)/60 minutes = 566,667 hours]
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    \1\ See Contact Lenses, Frequently Asked Questions, Nov. 2009, 
available at (http://www.allaboutvision.com/faq/contactlens.htm.) 
See also Nichols, J. ``Annual Report: Contact Lenses 2008,'' Contact 
Lens Spectrum, Jan. 2009, available at (http://www.clspectrum.com/article.aspx?article=102473).
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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).
    Staff also believes that, based on its knowledge of the industry, 
this burden will fall primarily on mail order and Internet-based 
sellers of contact lenses, as they are the entities in the industry 
most reliant on obtaining or verifying contact lens prescriptions. 
Based on conversations with the industry, staff estimates that these 
entities currently account for approximately 10% of sales in the 
contact lens market\2\ and, by extension, that approximately 3.4 
million consumers--10% of the 34 million contact lens wearers in the 
United States--purchase their lenses from them.
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    \2\ The FTC's February 2005 study, ``The Strength of Competition 
in the Rx Sale of Contact Lenses: An FTC Study,'' cites various data 
that, averaged together, suggests that approximately 10% of contact 
lens sales are by online and mail-order sellers. The report is 
available online at (http://www.ftc.gov/reports/contactlens/050214contactlensrpt.pdf).
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    At an estimated five minutes per sale to each of 3.4 million 
consumers, contact lens sellers will spend a total of 283,300 burden 
hours complying with the recordkeeping requirement. [(3.4 million x 5 
minutes)/60 minutes = 283,333.3 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: $32,317,000 (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 its knowledge of the industry, that optometrists account for 
approximately 75% 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 2008, salaried 
optometrists earn an average wage of $50.58 per hour and general office 
clerical personnel earn an average of $12.90 per hour.\3\
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    \3\ Mean and median worker hourly wages for optometrists and 
general office clerks are drawn from the Bureau of Labor Statistics 
(BLS) Occupational Employment and Statistics Survey, May 2008, based 
on BLS-sampled data it collected over a 3-year period. See (http://www.bls.gov/news.release/pdf/ocwage.pdf) (Table 1).
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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 $32.8 million. [($50.58 
x 566,666.7 hours) + ($12.90 x 283,333.3 hours) = $32,317,000]
    The contact lens market is a multibillion dollar market; one recent 
survey estimates that contact lens sales totaled $2.37 billion from Jan 
1, 2006 to Dec 31, 2006.\4\ Thus, the total labor cost burden estimate 
of $32.3 million represents approximately 1.5% of the overall market.
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    \4\ The Vision Council of America and Jobson Optical Research 
have conducted large scale continuous consumer research under the 
name VisionWatch, which reports on the vision care industry. The 
basis for this statistic is on file with the Federal Trade 
Commission.
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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).

Willard Tom,
General Counsel.
[FR Doc. 2010-8647 Filed 4-14-10: 8:45 am]
BILLING CODE: 6750-01-S