FTC to resubmit
when the rule is final and include the FR citation.
Inventory as of this Action
Requested
Previously Approved
12/31/2022
36 Months From Approved
12/31/2022
64,747,800
0
64,747,800
2,104,050
0
2,104,050
0
0
0
The Contact Lens Rule which was
effective in 2004, implemented the Fairness to Contact Lens
Consumer Act of 2003 (15.U.S.C. 7601-7610). The Act seeks to enable
consumers to purchase contact lenses from the seller of their
choice. Among other things, the Act requires contact lens
prescribers to provide contact lens prescriptions to their
patients, and to provide or verify contact lens prescriptions to
third parties designated by patients. During June 2020, the Federal
Trade Commission announced a Final Rule to enhance and further
ensure compliance with the Fairness to Contact Lens Consumers Act’s
requirement that prescribers automatically provide their patients
with a copy of their prescription upon completion of a contact lens
fitting. The Final Rule requires prescribers to request that their
patients confirm that they have received their prescription, and
allows flexibility in the way the prescription and confirmation are
provided. Prescribers must maintain proof that they satisfied the
confirmation of prescription release requirement for at least three
years. Eye doctors were already required by law to provide every
patient with a copy of his or her contact lens prescription,
allowing patients to comparison shop for lenses. This rule change
will help to ensure that eye doctors fulfill their obligations, and
will facilitate FTC enforcement of these important requirements. To
address concerns about third-party sellers verifying prescriptions
by leaving incomplete or incomprehensible automated telephone
messages with prescribers, sellers who use automated telephone
messages for verification must record the calls and preserve the
recordings for three years. This will likely require a minimal
amount of capital and other non-labor costs to record the calls and
store them electronically.
The Commission estimates that
the amendments in the Final Rule will result in an additional
875,000 annual burden hours for all affected original contact lens
prescribers, $19,900,000 in associated labor costs for prescribers,
and $591,300 in capital/non-labor costs for third-party sellers.
The estimated increase in burden is correlated with Rule
modifications creating a verifiable enforcement mechanism to ensure
that pre-existing FCLCA and Rule requirements that prescriptions be
provided by the prescribers to patients are complied with. To
further explain, the existing Rule already requires that
prescriptions be provided by the prescribers to patients but there
is no enforcement mechanism. The Rule amendment adds the
enforcement mechanism to what the Rule already required. With more
patients in possession of their prescriptions (due to increased
prescription release), and a greater ability to present them to
sellers, FTC staff anticipates a potential reduction in
time-consuming prescription verifications from sellers to
prescribers. Although FTC staff anticipates that these requirements
will impose some additional burden on individual prescribers’
offices to satisfy the confirmations of prescription release
requirements, FTC staff believes this burden will be relatively
small in the context of the overall market for contact lenses and
examinations. One survey estimated that the U.S. contact lens
market totaled approximately $5 billion (not counting examination
revenue) in 2017. See “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-see-continued-growth-in-2017-visionwatch-says/.
Accordingly, the incremental burden associated with the Rule
amendments would not have a significant impact on the contact lens
market.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Contact Lens Rule: Third Party Sellers (not original prescribers) with recordkeeping obligations when verification not required