[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