Contact Lens Rule-Supporting Statement - 2019 - FINAL

Supporting Statement for Information Collection Provisions of
the Contact Lens Rule, 16 CFR Part 315
(OMB Control # 3084-0127)

(1) & (2)

Necessity for and Use of the Information Collected

The Fairness to Contact Lens Consumers Act (the “Act”), Pub. L. No. 108-164
(December 6, 2003), helps consumers by requiring the release and verification of contact lens
prescriptions, among other things. The Act directed the Federal Trade Commission (“FTC” or
“Commission”) to prescribe rules implementing the Act not later than 180 days after the Act
took effect on February 4, 2004.1 Accordingly, the Commission issued the Contact Lens Rule
(“Rule”), 16 C.F.R. Part 315, on July 2, 2004. As mandated by the Act, the Rule contains
disclosure and recordkeeping requirements applying to prescribers and sellers of contact lenses.
The extent to which these requirements are subject to the Paperwork Reduction Act, 44 U.S.C.
Chapter 35 (“PRA”), is described below.
(a) Disclosures
The Rule requires that contact lens prescribers provide patients with a copy of their
contact lens prescriptions upon completion of a contact lens fitting and provide prescriptions to,
or verify prescriptions with, third parties authorized to act on behalf of patients. The primary
purpose of the prescription release requirement is to enable consumers to purchase their contact
lenses from the seller of their choice. Without their prescription, consumers may be forced to
purchase lenses from their prescriber. By requiring prescribers to provide prescriptions to their
patients, the Act enables consumers to compare prices and modes of delivery among competing
sellers, and ultimately purchase their lenses from the seller of their choice.
(b) Recordkeeping
The Rule also implements recordkeeping requirements imposed by the Act. First, the Act
sets a minimum expiration date of one year for contact lens prescriptions, with an exception
based on the medical judgment of a prescriber with respect to a patient’s eye health. In cases in
which a prescriber sets an expiration date shorter than one year, the Rule requires the prescriber
to document in the patient’s record the medical reasons for the shorter period. The Rule further
requires that such records be kept for three years.
Second, the Act provides 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 with the prescriber. The Act, and hence the Rule, requires
contact lens sellers to maintain records of verification communications with prescribers. The
records to be kept depend on the mode of communication – telephone, facsimile, or email. The
Rule also requires sellers to keep the prescriptions they receive directly from the patient or
prescriber. The Rule requires that sellers keep these records for three years and make them

1

15 U.S.C. § 7607. 

available for inspection by the Commission, but does not otherwise require production of the
records.
The required records will allow the Commission to determine compliance with the Rule
and provide a basis for the Commission to bring an enforcement action. Without the required
records, it would be difficult to ensure that entities are complying with the Rule’s requirements
or to prove Rule violations.
(3)

Consideration of the Use of Information Technology to Reduce Burden

The Rule contemplates that covered entities may use information technologies in
complying with their recordkeeping obligations under the Act. Such technologies may help
reduce the burden of information collection imposed by the Act. For example, contact lens
sellers who seek to verify prescriptions via facsimile and/or email may use information
technology to create and/or retain those records as required by the Rule, and thereby reduce the
time it may take to produce and maintain verification requests. In addition, nothing in the Act or
Rule prohibits regulated entities from using the least burdensome information technology
available. Moreover, in its Notice of Proposed Rulemaking,2 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 Rule’s disclosure and 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 Rule’s disclosure and 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.
However, staff believes that the burdens imposed by the Rule on small businesses will be
relatively low. Based on staff’s knowledge of the eyewear industry, the small businesses

2

69 Fed. Reg. 5,440 (Feb. 4, 2004). 
2

affected by the Rule primarily consist of contact lens prescribers in solo or small practices. Their
burdens under the Rule primarily entail providing contact lens prescriptions to patients or their
agents, documenting in exceptional cases the medical reasons for setting a contact lens
prescription date of less than one year, and verifying prescriptions for some of their patients who
seek to purchase their contact lenses from another seller. The Rule permits some limitation on
prescription release and verification.
(6)

Consequences of Conducting the Collection Less Frequently

Less frequent “collection” would violate the express statutory language of the Fairness to
Contact Lens Consumers Act, 15 U.S.C. §§ 7601 et seq. Specifically, the Act’s requirements
that prescribers release contact lens prescriptions to their patients upon completion of a contact
lens fitting, and document the medical reasons for setting a contact lens prescription expiration
date shorter than one year, do not permit less frequent disclosure.3 Similarly, the Act’s
requirement that contact lens sellers retain records of all direct communications involved in
obtaining prescription verification does not permit less frequent collection of information.4
The Commission’s Rule requires that sellers retain the required records for a period of
three years. Staff believes that a record retention period shorter than three years would
hamper the Commission’s ability to verify contact lens prescribers’ and sellers’ compliance
with the Rule, because the statute of limitations applicable to Commission rule violations is
three years.5
(7)

Circumstances Requiring Collection Inconsistent With Guidelines

The collection of information in the Rule is consistent with all applicable guidelines
contained in 5 C.F.R. § 1320.5(d)(2).
(8)

Public Comments/Consultation Outside the Agency

On July 5, 2019, the FTC sought public comment on the Rule’s information collection
requirements and on the associated estimates of PRA burden. 84 Fed. Reg. 32,170. The FTC
received no comments that were germane to the issues that the agency sought comment on
pursuant to the PRA renewal request. Pursuant to OMB regulations, 5 CFR Part 1320, that
implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second opportunity for
public comment while seeking OMB approval to renew the pre-existing clearance for the Rule.
(9)

Payments and Gifts to Respondents
Not applicable.

3

See 15 U.S.C. §§ 7601, 7604.

4

See 15 U.S.C. § 7603(b).

5

See Section 19(d) of the FTC Act, 15 U.S.C. 57b(d). 
3

(10)

Assurances of Confidentiality

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
(11)

Matters of a Sensitive Nature

Not applicable. The Contact Lens Rule does not require the disclosure or production of
sensitive or confidential information to the Commission. To the extent that confidential
information covered by a recordkeeping requirement is collected by the Commission for law
enforcement purposes, the confidentiality provisions of Section 21 of the FTC Act, 15 U.S.C.
57b-2, will apply.
(12)

Estimated Annual Hours and Labor Cost Burden
Estimated annual hours burden: 2,104,050 hours.

This figure is derived by adding 1,045,650 disclosure hours for contact lens prescribers to
1,058,400 recordkeeping hours for contact lens sellers, for a combined industry total of
2,104,050 hours. This estimate is an increase from the 1,903,315 annual burden hours submitted
to OMB in 2016. The higher estimate is due to an increase in the estimated number of contact
lens wearers in the United States from 41 million to 45 million.7
1.

Prescribers

The Rule requires prescribers to make disclosures in two ways. Upon completing a
contact lens fitting, the Rule requires that prescribers (1) provide a copy of the contact lens
prescription to the patient, and (2) as directed by any person designated to act on behalf of the
patient, provide or verify the contact lens prescription. Prescribers can verify a prescription
either by responding affirmatively to a request for verification, or by not responding at all, in
which case the prescription will be “passively verified” after eight business hours. Prescribers
are also required to correct an incorrect prescription submitted by a seller, and notify a seller if

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

Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts,
https://www.cdc.gov/contactlenses/fast-facts.html.

4

the prescription submitted for verification is expired or otherwise invalid. Staff believes that the
burden of complying with these requirements is relatively low.
The number of contact lens wearers in the United States is now estimated by the Centers
for Disease Control to be approximately 45 million.8 Therefore, assuming an annual contact lens
exam for each contact lens wearer, approximately 45 million people would receive a copy of
their prescription each year under the Rule.9
At an estimated one minute per prescription, the annual time spent by prescribers
complying with the requirement to release prescriptions to patients would be approximately
750,000 hours. [(45 million × 1 minute)/60 minutes = 750,000 hours]. In all likelihood, this
estimate overstates the actual burden because it includes the time spent by prescribers who
already release prescriptions to patients in the ordinary course of business.
As stated above, prescribers may also be required to provide or verify contact lens
prescriptions to sellers. According to recent survey data, approximately 36% of contact lens
purchases are from a source other than the prescriber.10 Assuming that each of the 45 million
contact lens wearers in the U.S. makes one purchase per year, this means that approximately
16,200,000 contact lens purchases (45 million x 36%) are made from sellers other than the
prescriber.
Based on prior discussions with industry, approximately 73% of sales by non-prescriber
sellers require verification, and prescribers affirmatively respond (by notifying the seller that the
prescription is invalid or incorrect) to approximately 15% of those verification requests. Using a
response rate of 15%, the FTC therefore estimates that prescribers’ offices respond to
approximately 1,773,900 verification requests annually [(16,200,000 x 73%) x 15% = 1,773,900
responses]. Additionally, some prescribers may voluntarily respond to verification requests and
confirm prescriptions (as opposed to simply letting the prescription passively verify). Because
correcting or declining incorrect prescriptions is mandated by the Rule and occurs in response to
approximately 15% of requests, staff assumes that prescribers voluntarily confirm prescriptions
less often, and confirm at most an additional 15% of prescriptions (and, in all likelihood,
significantly less). Using a combined response rate of 30%, the FTC estimates that prescribers’
offices respond to approximately 3,547,800 requests annually.
According to the industry comments to the 2016 PRA submission, responding to
verification requests requires approximately five minutes per request. Using that data, we
estimate that these responses require an additional 295,650 hours annually. [(3,547,800 × 5

8

Id.  

9

In the past, some commentators have suggested that typical contact lens wearers obtain annual
exams every 18 months or so, not every year. However, because prescriptions under the Rule
are valid for a minimum of one year, we continue to estimate that patients seek exams every 12
months. Staff believes a calculation that assumes compliance with the Rule will provide the best
estimate of the Rule’s contemplated burden. 

10

Jason J. Nichols & Deborah Fisher, “2018 Annual Report,” Contact Lens Spectrum, Jan. 1,
2019, https://www.clspectrum.com/issues/2019/january-2019. 
5

minutes)/60 minutes = 295,650 hours]. Combining these hours with the hours spent disclosing
prescriptions to consumers, we estimate a total of 1,045,650 hours for all contact lens prescribers
to comply with the Rule. [750,000 hours + 295,650 hours = 1,045,650 hours].
Lastly, as required by the FCLCA, the Rule also imposes a recordkeeping requirement on
prescribers. They 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. As mentioned previously, the OMB regulation that implements the
PRA defines “burden” to exclude any effort that would be expended regardless of a regulatory
requirement.
2.

Sellers

As noted above, a seller may sell contact lenses only in accordance with a valid
prescription that the seller has (a) received from the patient or prescriber, or (b) verified through
direct communication with the prescriber. The FCLCA also 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 these requirements is relatively
low.
As stated previously, there are approximately 16,200,000 sales by non-prescriber sellers
annually and approximately 73% of those sales require verification. Therefore, sellers verify
approximately 11,826,000 orders annually and retain two records for such sales: the verification
request and any response from the prescriber. Staff estimates that sellers’ verification and
recordkeeping for those orders will entail a maximum of five minutes per sale. At an estimated
five minutes per sale to each of the approximately 11,826,000 orders, contact lens sellers will
spend a total of 985,500 burden hours complying with this portion of the requirement.
[(11,826,000 × 5 minutes)/60 minutes = 985,500 hours].
Approximately 27% of sales to non-prescriber sellers do not require verification and thus
require only that the seller retain the prescription provided. Staff estimates that this
recordkeeping burden requires at most one minute per order (in many cases, this retention is
electronic and automatic and will not require any time) for 4,374,000 orders [16,200,000 sales ×
27%], resulting in 72,900 burden hours. [(4,374,000 orders × 1 minute)/60 minutes = 72,900
hours].
Combining burden hours for all orders [985,500 hours + 72,900 hours], staff estimates a
total of 1,058,400 hours for contact lens sellers. It is likely that this estimate overstates the
actual burden because it includes the time spent by sellers who already keep records pertaining
to contact lens sales in the ordinary course of business, and those whose records are generated
and preserved automatically when a customer orders online, which staff believes is the case for
many online sellers.
Estimated total labor cost burden: Approximately $84,548,448.
6

This figure is derived from applying hourly wage figures for optometrists,
ophthalmologists, and office clerical staff to the burden hours described above. This estimate is
higher than the $73,082,912 labor cost estimate submitted to OMB in 2016 due to an increase in
the estimated number of contact lens wearers in the United States and wage increases for
optometrists, ophthalmologists, and office staff.
According to Bureau of Labor Statistics, salaried optometrists earn an average wage of
$57.68 per hour, other physicians and surgeons—such as ophthalmologists—earn an average
wage of $98.02 per hour, and general office clerks earn an average wage of $16.92 per hour.11
Assuming that optometrists are performing 85% of the labor hours and ophthalmologists are
performing 15% the labor hours for prescribers, and office clerks are performing the labor for
non-prescriber sellers, estimated total labor cost attributable to the Rule would total
approximately $84,548,448. [$66,640,319 prescriber hours (($57.68 × 888,802.5 optometrist
hours = $51,266,128) + ($98.02 × 156,847.5 ophthalmologist hours = $15,374,192)) +
$14,618,765 for seller hours ($16.92 × 1,058,400 office clerk hours = $17,908,128) =
$84,548,448.]
A recent survey estimated that the U.S. contact lens market revenue is approximately
$5,012,800,000 (not counting examination revenue) in 2017.12 Therefore, the total labor cost
burden estimate of $84,548,448 imposed by the Rule represents a cost of approximately 1.69%
of the overall retail revenue generated.
(13)

Capital and Other Non-Labor Costs
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

11

Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational
Employment Statistics – May 2018, https://www.bls.gov/news.release/ocwage.t01.htm. Median
salaries for prescribers and clerks ($53.75 for optometrists, $96.58 for other physicians and
surgeons, and $15.74 for general office clerks) are lower than average salaries and,
consequently, would result in a lower overall burden imposed by the Rule. It is possible that
medians are more representative since they do not include outliers that can distort the mean.
Salaries can also vary by region. The average hourly wage for optometrists in New Mexico, for
instance, is $41.76 per hour, whereas optometrists in North Dakota earn an average of $84.18 per
hour. Id. https://www.bls.gov/oes/current/oes291041.htm. However, since Contact Lens Rule
PRA submissions have historically used national mean salaries to estimate the burden, the FTC
will continue to do so for this submission.  

12

“Vision Markets See Continued Growth in 2017, VisionWatch Says,” Vision Monday, March
20, 2018, http://www.visionmonday.com/business/research-and-stats/article/vision-markets-seecontinued-growth-in-2017-visionwatch-says/. See also, Steve Kodey, US Optical Market
Eyewear Overview, 4,
https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf. The
FTC does not possess market data for 2018. 
7

machines and paper, telephones, and recordkeeping facilities such as filing cabinets or other
storage).
(14)

Estimated Cost to the Federal Government

Staff estimates that the fiscal year cost to the FTC of enforcing the Rule’s requirements
will be approximately $52,000 per year. 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 or Adjustments

There are no program changes since the FTC’s prior clearance renewal in 2016. The
increased estimates for burden hours are largely due to an upward adjustment in the estimated
number of contact lens wearers (from 41 million in 2016 to 45 million in 2019). Additionally,
there is an upward adjustment in our annual labor costs stemming from slightly higher
estimated hourly rates.
(16)

Statistical Use of Information/Publication of Results

Not applicable. There are no plans to publish for statistical use any information required
by the Rule.
(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.

8