[Federal Register Volume 71, Number 242 (Monday, December 18, 2006)]
[Notices]
[Pages 75754-75755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21514]


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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 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 
Federal Trade Commission (``FTC'' or ``Commission'') is seeking public 
comments on its proposal to extend through April 30, 2010 the current 
OMB clearance for information collection requirements contained in its 
Contact Lens Rule (``Rule''). That clearance expires on April 30, 2007.

DATES: Comments must be filed by February 16, 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, Room H-135 (Annex J), 600 
Pennsylvania Ave., NW., Washington, DC 20580. Because paper mail in the 
Washington area and at the Commission is subject to delay, 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 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.
    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 public on the 
FTC Web site, to the extent practicable, 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 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 Keith Fentonmiller, Attorney, Division of 
Advertising Practices, Bureau of Consumer Protection, Federal Trade 
Commission, 600 Pennsylvania Avenue, NW., Washington, DC 20580, (202) 
326-2775.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act (``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 C.F.R. 1320.3(c). As required by section 
3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for 
public comment before requesting that OMB extend the existing paperwork 
clearance for the regulations noted herein.
    The FTC invites comments on: (1) Whether the required collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information has practical utility; 
(2) the accuracy of the agency's estimate of the burden of the required 
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 in 
the ADDRESSES section above, and must be received on or before February 
16, 2007.
    The Contact Lens Rule (``Rule''), 16 CFR Part 315, was promulgated 
by the FTC pursuant to the Fairness to Contact Lens Consumers Act 
(``FCLCA''), Pub. L. No. 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

[[Page 75755]]

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. Thus, the Rule's disclosure and recordkeeping 
requirements remain the same. However, the number of contact lens 
wearers in the United States has increased to approximately 38 
million.\2\ Thus, 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. Essentially, 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 3.8 
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. Thus, 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\ The Bureau of Labor Statistics are available online at: 
http://www.bls.gov/oes/current/oes_nat.htm#b43-0000.
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    The contact lens market is a multi-billion dollar market; one 
recent survey estimates that contact lens sales totaled $2.35 billion 
from June 2005 to June 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 vision care industry and is 
available at http://visionsite.org/s_vision/doc.asp?CID=791&DID=2524.
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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. E6-21514 Filed 12-15-06; 8:45 am]
BILLING CODE 6750-01-P