Contact Lens NPRM - Supporting Statement - 2016 - FINAL

Supporting Statement
Proposed Amendments to the Contact Lens Rule
16 CFR § 315
(OMB Control # 3084-0127)
(1-2) Necessity for Collecting the Information/Use of the Information
The Federal Trade Commission promulgated the Contact Lens Rule (“Rule”) pursuant to
the Fairness to Contact Lens Consumers Act (“FCLCA”), Public Law 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 contact lens prescribers to provide prescriptions to their patients upon the completion of
a contact lens fitting, and provide or verify such prescriptions to authorized third parties, such as
contact lens sellers. Sellers may provide contact lenses only in accordance with a valid
prescription that is presented directly to the seller or verified with the prescriber.
Section 315.3(a)(1) of the Rule requires a prescriber to provide a copy of the contact lens
prescription to the patient after completing a contact lens fitting, regardless of whether it was
requested by the patient. Section 315.3(a)(1) of the Rule tracks the language of the Act
verbatim.1 This provision, referred to as automatic prescription release, was intended to
empower consumers to comparison shop for contact lenses. Based on twelve years of experience
enforcing the Rule and after carefully considering the 660 comments that were submitted
pursuant to the ongoing periodic review of the Rule,2 the Commission believes that the overall
weight of evidence indicates that compliance with the automatic prescription release provision
could be substantially improved.
To further the goals of the FCLCA, the Commission proposes to amend the Rule to require
that contact lens prescribers obtain a signed acknowledgment after releasing a contact lens
prescription to a patient, and maintain each such acknowledgment for a period of not less than
three years. Such signed acknowledgments shall be available for inspection by the Federal Trade
Commission, its employees, and its representatives. The Commission believes this provision will
help inform patients of their right to their prescriptions, increase the number of patients who
receive their prescriptions, and, consequently, increase the number of purchases made with initial
presentations of complete and valid prescriptions, thus reducing the number of verifications by
third-party sellers. The Commission believes that requiring signed acknowledgments would also
improve the Commission’s verification and enforcement ability. The addition of a signed
acknowledgment requirement would accomplish the desired objectives with little increased
burden on prescribers.

1
15 U.S.C. 7601(a)(1).
2
Contact Lens Rule, Request for Comment, 80 Fed. Reg. 53,272 (September 3, 2015).

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The proposed requirement that the prescriber request the patient acknowledge receipt of the
contact lens prescription would be triggered once the prescriber has presented the prescription to
the patient. The patient would receive the prescription prior to being asked to sign the
acknowledgment form, and signing the acknowledgment form is not a condition to obtaining the
prescription. If the patient refuses to sign or cannot sign the acknowledgment form, the prescriber
must note the refusal or inability on the acknowledgment form and must maintain the form.
The proposed acknowledgment form may be either paper or in electronic format. The
acknowledgment form, whether paper or electronic, must be entitled “Patient Receipt of Contact
Lens Prescription,” and must state, “My eye care professional provided me with a copy of my
contact lens prescription at the completion of my contact lens fitting. I understand that I am free to
purchase contact lenses from the seller of my choice.” The acknowledgment form shall be in a
format that allows either conventional or electronic signatures. The covered firms (contact lens
prescribers) may maintain copies of the acknowledgment forms in paper or electronically.
(3) Consideration of Using Improved Technology to Reduce Burden
The proposed amendments permit the covered firms to use paper or electronic format to
reduce the burden of information collection. Moreover, in its Notice of Proposed Rulemaking,
the Commission specifically sought comments on ways to minimize the burden of the Rule’s
collections of information through the use of information technology.
Consistent with the Government Paperwork Reduction Elimination Act, Pub L. No. 105227, Title XVII, 112 Stat. 2681-749, nothing in the Rule prescribes that the disclosures be made,
records be filed or kept, or signatures be executed, on paper or in any particular format that
would preclude the use of electronic methods to comply with the Rule’s requirements.

(4) Efforts to Identify Duplication
The proposed recordkeeping requirements do not duplicate any other information collection
requirements imposed by the Commission. To the extent some state laws may already require
prescription release, and/or recordkeeping, similar to that required by the Act, prescribers and
sellers likely can comply with both requirements through a single release or record-keeping
system, thereby avoiding duplication.
(5) Efforts to Minimize Burden on Small Organizations
The proposed recordkeeping requirements are designed to impose the minimum burden on
all affected members of the industry, regardless of size. The Act itself does not allow the
Commission any latitude to treat small businesses differently, such as by exempting a particular
category of firm or setting forth a lesser standard of compliance for any category of firm.

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While some contact lens prescribers subject to the Rule’s requirements are small businesses,
staff believes that everything consistent with the requirements of Rule has been done to minimize
compliance burden. Although the Act requires the Rule to apply to all covered firms whether they
are small entities or not, the Commission is seeking comment about minimizing impact on small
businesses.

(6) Consequences of Conducting the Collection Less Frequently
The proposed recordkeeping requirement would require that sellers retain the required
records for a period of not less than three years. Staff believes that a record retention period
shorter than this would hamper the Commission’s ability to verify contact lens prescribers’
compliance with the Rule, because the statute of limitations applicable to Commission rule
violations is three years.3

(7) Circumstances Requiring Collection Inconsistent With Guidelines
The proposed amendment’s information collection requirements are consistent with all
applicable guidelines contained in 5 C.F.R. § 1320.5(d)(2). Under the proposed rule amendments,
the Commission’s Rule would only require that covered entities maintain the form for three years.
Instances where records are required to be maintained longer than three years are mandated by
individual state laws.4
(8) Consultation Outside the Agency
In developing the proposed requirements, the Commission considered 660 comments from
individuals and entities representing a wide range of viewpoints, including prescribing eye care
practitioners (ophthalmologists and optometrists), opticians and other eye wear industry members,
sellers of contact lenses (both online and brick-and-mortar), contact lens manufacturers, and
consumer and competition advocates.5 Virtually all commenters agreed that there is a continuing
need for the Rule and that it benefits consumers and competition. The majority of commenters
recommended some modifications to the Rule in order to maximize the benefits to consumers and
competition, decrease the burden on businesses, protect consumers’ eye health, or improve overall
compliance with the Rule’s existing requirements.

3
See Section 19(d) of the FTC Act, 15 U.S.C. 57b(d).
4
See, e.g., 246 Mass. Code Regs. § 3.02 (requiring optometrists to maintain patient records for at least
seven years); Wash. Admin. Code § 246-851-290 (requiring optometrists to maintain records of eye exams
and prescriptions for at least five years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to
maintain patient records for at least five years); Fla. Admin. Code r. 64B13-3.003(6) (requiring optometrists
to maintain patient records for at least five years).
5
See supra note 2.

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(9) Payments and Gifts to Respondents
Not applicable.
(10-11) Assurances of Confidentiality/Matters of a Sensitive Nature
Not applicable. No assurance of confidentiality is necessary because although the Contact
Lens Rule requires regulated entities to disclose and/or maintain records, it does not require the
submission of any such records to the agency. Thus, to the extent, if any, that the agency may
require production of such records for law enforcement purposes in specific proceedings, such
production would not constitute an information collection activity within the meaning of the
Paperwork Reduction Act. In any event, in such proceedings, records would be protected by
law from mandatory public disclosure.6
(12) Estimated Annual Hours Burden and Associated Labor Cost
Estimated Additional Annual Hours Burden: 683,333 hours.
Commission staff estimates the paperwork burden of the proposed modifications based on
its knowledge of the eye care industry. The staff believes there will be an additional burden on
individual prescribers’ offices to maintain the signed acknowledgment forms for a period of not
less than three years.
The number of contact lens wearers in the United States is currently estimated to be
approximately 41 million.7 Therefore, assuming an annual contact lens exam for each contact
lens wearer, approximately 41 million people would read and sign an acknowledgment form
every year.8
Maintaining the form for a period of not less than three years does also not impose a
substantial new burden on individual prescribers and their office staff. The majority of states
already require that optometrists maintain records of eye examinations for at least three years,9
and adding a one-page acknowledgment form per patient per year should not take more than a
few seconds of time, and an inconsequential, or de minimis, amount of record space. The

6
See, e.g., Section 21 of the FTC Act, 15 U.S.C. 57b-2; Exemption 6 of the Freedom of Information Act,
5 U.S.C. 552(b)(6).
7
Jennifer R. Cope et al., “Contact Lens Wearer Demographics and Risk Behaviors for Contact LensRelated Eye Infections—United States, 2014,” Morb. Mortal. Wkly. Rep. 64(32):865-70, 866 (Aug. 21,
2015). See also Vision Council, “Consumer Barometer,” Sept. 2015 (estimating that 16.2% of American
adults wear contact lenses).
8
In the past, some commenters have suggested that typical contact lens wearers obtain annual exams
every 18 months or so, rather than one every year. However, because most prescriptions are valid for a
minimum of one year under the Rule, and use of a longer exam cycle would lead to an estimate of a lower
number of signed acknowledgment forms and a reduced burden, we continue to estimate that patients seek
exams every 12 months.
9
See supra note 4.

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Commission notes, however, that for optometrists who maintain all records in an electronic
format, the new recordkeeping requirement would likely require that office staff electronically
scan the signed acknowledgment form and save it as an electronic document. The Commission
estimates this scanning and saving would take approximately one minute. Other prescribers
might present the acknowledgment form electronically, and such format would allow the signed
acknowledgment to be preserved without any additional burden.
The Commission does not possess any information regarding the percentage of prescribers’
offices that use paper forms, electronic forms, or that scan paper files and maintain them
electronically. Therefore, for purposes of this notice, staff will assume that all prescriber offices
require a full one minute per form per year for record maintenance purposes arising from the
proposed modifications.
As noted above, the number of contact lens wearers in the United States is currently
estimated to be approximately 41 million. Therefore, assuming one signed acknowledgment
form for each contact lens wearer per year, prescribers’ offices, collectively, would have to spend
approximately 41 million minutes, or 683,333 hours, per year maintaining records of eye
examinations (recordkeeping requirement).
In all likelihood, the actual overall increased burden on prescribers may be less than
683,333 hours, because increasing the number of patients in possession of their prescriptions
should correspondingly increase the number of consumers who provide their prescriptions to
third-party sellers when purchasing contact lenses. This, in turn, should reduce the number of
verification requests that third-party sellers would otherwise make to prescribers. Based on
current estimates, responding to verification requests requires that prescribers spend
approximately five minutes per request.10 The Commission, however, does not presently have
enough information to devise a reliable estimate for how many more consumers are likely to
present third-party sellers with a complete copy of their prescription following the proposed Rule
modification. Therefore, for purposes of calculating the burden, the Commission, at this time,
will not credit the expected reduction in verification burden.
Estimated Additional Annual Labor Cost Burden: $10,475,495.
Commission staff derives labor costs by applying appropriate hourly cost figures to the
burden hours described above. The Commission assumes that office clerks will perform most of
the labor when it comes to printing, disseminating, and storing the acknowledgment forms for
prescribers’ offices. According to Bureau of Labor Statistics, general office clerks earn an
average wage of $15.33 per hour.11 Based on this data, the estimated total additional labor cost

10
See American Optometric Association, Comment in response to the Agency Information Collection
Activities; Proposed Collection; Comment Request, 81 FR 31938 (May 20, 2016),
https://www.ftc.gov/policy/public-comments/initiative-665.
11
Press Release, U.S. Dep’t of Labor, Bureau of Labor Statistics, “Occupational Employment Statistics—
May 2015,” http://www.bls.gov/news.release/ocwage.t01.htm.

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attributable to the proposed modifications to the Rule would amount to approximately
$10,475,495.
While not insubstantial, this amount constitutes just under one-fourth of one percent of the
estimated overall retail market for contact lens sales in the United States.12 Furthermore, the
burden is likely to be less, since many prescribers’ offices will not require a full three minutes to
present, receive back, and store the acknowledgment forms. And, as noted above, increasing the
number of patients in possession of their prescriptions should correspondingly increase the
number of consumers who provide their prescriptions to third-party sellers when purchasing
contact lenses. This, in turn, could potentially reduce the number of verification requests made
to prescribers, and the time prescribers spend responding.
(13) Estimated Annual Capital or Other Non-labor Costs
Staff believes that the Rule’s 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).
(14) Estimated Cost to Federal Government
Staff believes that the cost to the FTC for administering the proposed Rule changes will
be de minimis. Accordingly, Commission staff retains the previous estimate of $52,000 per
year as the cost to the Government for implementing the Rule. This estimate is based on the
assumption that 15-20% of one Attorney work year, 2.5% of one Economist work year, 15% of
one Investigator work year, and 15% of one Paralegal work year will be expended to enforce the
Rule’s requirements.
(15) Program Changes/Adjustments
The proposed amendments will result in an estimated additional 683,333 hours burden
hours, annualized, and cumulative of all affected manufacturers, $10,475,495 in associated
labor costs, and negligible capital/non-labor costs.
(16) Plans for Tabulation and Publication
Not applicable. There are no plans to publish for statistical use any information required
by the Rule.

12
According to The Vision Council, the contact lens sales market in the United States in 2015 totaled
$4,664,200,000 at the retail level. See The Vision Council, “U.S. Optical Industry Report Card,” Dec.
2015. The estimated additional burden of $10,475,495 thus amounts to approximately 0.22% of the total
market.

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(17) Requested Permission Not to Display the Expiration Date for OMB Approval
This is not applicable, since the Commission will display the expiration date of the
clearance.
(18) Exceptions to the “Certification for Paperwork Reduction Act Submissions”
Not applicable.

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