[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Notices]
[Pages 14812-14814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5819]
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FEDERAL TRADE COMMISSION
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Federal Trade Commission.
ACTION: Notice.
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SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') is
seeking public comments on its proposal to extend the current Office of
Management and Budget (``OMB'') clearance for information collection
requirements contained in its Contact Lens Rule (``Rule'') from April
30, 2007 through April 30, 2010. The information collection
requirements described below will be submitted to OMB for review as
required by the Paperwork Reduction Act (``PRA'').
DATES: Comments must be received on or before April 30, 2007.
ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Contact Lens Rule: FTC File No. R411002,''
to facilitate the organization of comments. A comment filed in paper
form should include this reference both in the text and on the envelope
and should be mailed or delivered, with two complete copies, to the
following address: Federal Trade Commission, Office of the Secretary,
Room H-135 (Annex J), 600 Pennsylvania Ave., NW., Washington, DC 20580.
Because U.S. Postal Mail in the Washington area and at the Commission
is subject to lengthy delays due to heightened security precautions,
please consider submitting your comments in electronic form, as
prescribed below. However, if the comment contains any material for
which confidential treatment is requested, it must be filed in paper
form, and the first page of the document must be clearly labeled
``Confidential.'' \1\
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\1\ Commission Rule 4.2(d), 16 CFR 4.2(d). 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 Commission Rule 4.9(c), 16 CFR 4.9(c).
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Comments filed in electronic form should be submitted by following
the instructions on the web-based form at https://secure.commentworks.com/ContactLensRule/. To ensure that the Commission
considers an electronic comment, you must file it on the web-based form
at the https://secure.commentworks.com/ContactLensRule/ weblink. If
this notice appears at 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.
Comments also should be submitted to: Office of Management and
Budget, ATTN: Desk Officer for the Federal Trade Commission. Comments
should be submitted by facsimile to (202) 395-6974 because U.S. Postal
Mail is subject to lengthy 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. All timely and responsive public comments will be
considered by the Commission and will be available, to the extent
practicable, to the public on the FTC Web site at http://www.ftc.gov.
As a matter of discretion, the FTC makes every effort to remove home
contact information for individuals from the public comments it
receives before placing those comments
[[Page 14813]]
on the FTC 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.htm.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be addressed to Karen Jagielski, Attorney, Division of
Advertising Practices, Bureau of Consumer Protection, Federal Trade
Commission, 600 Pennsylvania Avenue, NW., Washington, DC 20580, (202)
326-2509.
SUPPLEMENTARY INFORMATION: 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). As required by section 3506(c)(2)(A)
of the PRA, the FTC is providing the opportunity for public comment
while awaiting OMB action on the Commission's request to extend the
existing paperwork clearance for the regulations noted herein.
In its first Notice published in the Federal Register on December
18, 2006, 71 FR 75754, the FTC sought public comments on its proposal
to extend through April 30, 2010 its current OMB clearance for
information collection requirements contained in its Rule. The FTC has
received no public comments. The FTC is providing this second
opportunity for public comment while seeking OMB approval to extend the
existing paperwork clearance for the Rule. All comments should be filed
as prescribed in the ADDRESSES section above, and must be received on
or before April 30, 2007.
The Rule, 16 CFR part 315, 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.
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.
Burden Statement
Estimated total annual hours burden: 950,000 hours (rounded to the
nearest thousand).
In its 2003 PRA-related Federal Register Notice and corresponding
submission to OMB, FTC staff estimated that the annual paperwork burden
for the various disclosure and recordkeeping requirements under the
FCLCA and then-proposed Rule would be approximately 600,000 disclosure
hours for contact lens prescribers and approximately 300,000
recordkeeping hours for contact lens sellers, a combined industry total
of 900,000 hours.
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. However, the number of contact lens wearers
in the United States has increased to approximately 38 million.\2\
Therefore, assuming an annual contact lens exam for each contact lens
wearer, 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 a maximum of 633,333 hours. [(38 million x 1
minute)/60 minutes = 633,333 hours]
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\2\ See Statistics on Eyeglasses and Contact Lenses, All About
Vision, August, 2006, available at http://www.allaboutvision.com/resources/statistics-eyewear.htm. See also Barr, J. ``2004 Annual
Report,'' Contact Lens Spectrum, Jan. 2005, available at http://www.clspectrum.com/article.aspx?article=12733.
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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).
[[Page 14814]]
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 3.8
million consumers--10% of the 38 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 3.8 million
consumers, contact lens sellers will spend a total of 316,667 burden
hours complying with the recordkeeping requirement. [(3.8 million x 5
minutes)/60 minutes = 316,667 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: $32,819,000 (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 2005, salaried
optometrists earn an average wage of $45.91 per hour and clerical
personnel earn an average of $11.82 per hour.\4\ With these categories
of personnel, respectively, likely to perform the brunt of the
disclosure and recordkeeping aspects of the Rule, estimated total labor
cost attributable to the Rule would be approximately $32.8 million.
[($45.91 x 633,333 hours) + ($11.82 x 316,667 hours) = $32,819,322]
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\4\ Optometrist hourly wages are drawn from the Bureau of Labor
Statistics (BLS) Occupational Employment and Statistics Survey, May
2005, based on BLS-sampled data it collected over a 3-year period.
See http://www.bls.gov/news.release/pdf/ocwage.pdf (Table 1).
Relevant clerical hourly rates are unavailable from that survey,
however, and are drawn instead from the BLS National Compensation
Survey, June 2005 (with 2005 as the most recent whole year
information available, and June the focal median point). See http://www.bls.gov/ncs/ocs/sp/ncbl0832.pdf (Table 1.1).
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The contact lens market is a multi-billion 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 $32.8 million represents approximately 1% 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).
William Blumenthal,
General Counsel.
[FR Doc. E7-5819 Filed 3-28-07; 8:45 am]
BILLING CODE 6750-01-P