Contact Lens Rule

OMB Control No: 3084-0127	ICR Reference No: 202312-3084-003
Status: Received in OIRA	Previous ICR Reference No: 202008-3084-001
Agency/Subagency: FTC	Agency Tracking No:
Title: Contact Lens Rule
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/20/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2023
Responses	143,497,800	154,747,800
Time Burden (Hours)	3,104,050	2,979,050
Cost Burden (Dollars)	591,300	591,300

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Abstract: The Federal Trade Commission (“FTC” or “Commission”) requests approval for a three-year extension of an existing clearance relating to the disclosure and recordkeeping requirements under the Contact Lens Rule (“Rule”), 16 C.F.R. Part 315. There is no change in the instrument collection. The 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. On June 23, 2020, the Federal Trade Commission announced a Final Rule amendment 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.

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Authorizing Statute(s): PL: Pub.L. 108 - 164 1-12 Name of Law: Fairness to Contact Lens Consumers Act

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 55044	08/14/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 88076	12/20/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title Form No. Form Name Contact Lens Rule: Prescribers responding to verification requests Contact Lens Rule: Third Party Sellers (not original prescribers) where verification and retention required Contact Lens Rule: Part I of Prescribers' disclosure obligations to contact lens wearers Contact Lens Rule: Third Party Sellers (not original prescribers) with recordkeeping obligations when verification not required Part II of Prescribers' disclosure obligations to contact lens wearers who read, sign and return a confirmation statement Part III of Prescribers' disclosure obligations to contact lens wearers who consent to electronic delivery of Confirmation of Prescription Release requirement Prescriber's record retention obligations to contact lens wearers who consent to electronic delivery of Confirmation of Prescription Release requirement Prescribers' Record Retention Requirement

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	143,497,800	154,747,800	0	0	-11,250,000	0
Annual Time Burden (Hours)	3,104,050	2,979,050	0	0	125,000	0
Annual Cost Burden (Dollars)	591,300	591,300	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There is an upward adjustment in our annual burden hours from 2,979,050 (2020) to 3,104,050 (2023). The annual labor costs stemming from slightly higher estimated burden hours and average hourly rates go from $104,448,448 (2020) to $117,606,598 (2023).

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Annual Cost to Federal Government: $52,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Paul Spelman 202 325-2486 [email protected]

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Common Form ICR:  No

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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:
		(a) It is necessary for the proper performance of agency functions;
		(b) It avoids unnecessary duplication;
		(c) It reduces burden on small entities;
		(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
		(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
		(f) It indicates the retention periods for recordkeeping requirements;
		(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
			(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;
		(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
		(i) It uses effective and efficient statistical survey methodology (if applicable); and
		(j) It makes appropriate use of information technology.
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.
Certification Date: 12/20/2023

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