[Federal Register Volume 74, Number 246 (Thursday, December 24, 2009)]
[Notices]
[Pages 68427-68430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30573]


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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

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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. Those clearances expire on May 31, 
2010.

DATES: Comments must be received on or before February 22, 2010.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form, by following the instructions in the 
Request for Comments to 60-Day Notice 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/contactlensrulepra) (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 section 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:

Proposed Information Collection Activities

    Under the PRA, 44 U.S.C. 3501-3521, 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. Sec.  3502(3), 5 CFR 
Sec.  1320.3 (c). Because the number of entities affected by the 
Commission's requests will exceed ten, the Commission plans to seek OMB 
clearance under the PRA. As required by Sec.  3506(c)(2)(A) of the PRA, 
the Commission is providing this opportunity for public comment before 
requesting that OMB extend the existing paperwork clearance for the 
information collection requirements associated with the Commission's 
regulations under the Contact Lens Rule (``the Rule''), 16 CFR part 
315.
    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 orprescriber; 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.
    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.

Request for Comments to 60-Day Notice

    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, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. All comments should be filed as prescribed 
below, and must be received on or before February 22, 2010.
    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 FTC 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), 16 CFR 4.9(c).\1\
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    \1\The comment must be accompanied by an explicit request for 
confidential treatment, including the factual and legal basis for 
the request, and must identify the specific portions of the comment 
to be withheld from the public record. The request will be granted 
or denied by the Commission's General Counsel, consistent with 
applicable law and the public interest. See FTC Rule 4.9(c), 16 CPR 
4.9(c).
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    Because paper mail addressed to the FTC is subject to delay due to 
heightened security screening, please

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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/contactlensrulepra) (and following 
the instructions on the web-based form). To ensure that the Commission 
considers an electronic comment, you must file it on the web-based form 
at the web link: (https://public.commentworks.com/ftc/contactlensrulepra). If this Notice appears at (http://www.regulations.gov/search/index.jsp), you may also file an electronic 
comment through that website. The Commission will consider all comments 
that regulations.gov forwards to it. You may also visit the FTC Website 
at (http://www.ftc.gov) to read the Notice and the news release 
describing 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.
    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 
Website, 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 Website. 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

    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 Rules disclosure and recordkeeping requirements, 
therefore, remain the same. As noted above, the number of contact lens 
wearers in the United States is estimated to be approximately 34 
million.\2\ 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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    \2\See Contact Lenses, Frequently Asked Questions, November, 
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\3\ 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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    \3\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: $32,317,001 (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.

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    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.\4\
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    \4\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) = $32,317,001]
    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.\5\ Thus, the total labor cost burden estimate 
of $32.3 million represents approximately 1.5% of the overall market.
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    \5\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. E9-30573 Filed 12-23-09: 8:45 am]
BILLING CODE: 6750-01-S