Contact Lens Rule

Forms and Documents

Document Name	Status
Contact Lens Final Rule - Supplemental Supporting Statement - 6-25-2020-FINAL.pdf Supporting Statement A	2020-08-14

IC Document Collections

IC ID	Document Title	Status
32352	Contact Lens Rule: Third Party Sellers (not original prescribers) with recordkeeping obligations when verification not required	Unchanged
243198	Prescriber's record retention obligations to contact lens wearers who consent to electronic delivery of Confirmation of Prescription Release requirement	New
243195	Part II of Prescriber's disclosure obligations to contact lens wearers who consent to electronic delivery of Confirmation of Prescription Release requirement	New
243194	Prescribers' Record Retention Requirement	New
243193	Part II of Prescriber's disclosure obligations to contact lens wearers who read, sign and return a confirmation statement	New
207881	Contact Lens Rule: Third Party Sellers (not original prescribers) where verification and retention required	Modified
207880	Contact Lens Rule: Prescribers responding to verification requests	Unchanged
179023	Contact Lens Rule: Prescribers with disclosure obligations to contact lens wearers	Unchanged

ICR Details

OMB Control No: 3084-0127	ICR Reference No: 202008-3084-001
Status: Active	Previous ICR Reference No: 201910-3084-001
Agency/Subagency: FTC	Agency Tracking No:
Title: Contact Lens Rule
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/16/2020
	Date Received in OIRA: 08/17/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	12/31/2022
Responses	154,747,800	0	64,747,800
Time Burden (Hours)	2,979,050	0	2,104,050
Cost Burden (Dollars)	591,300	0	0

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Abstract: 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. On June 23, 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.

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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:
3084-AB36	Final or interim final rulemaking	85 FR 50668	08/17/2020

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

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

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ICR Summary of Burden

	Total Approved	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	154,747,800	64,747,800	0	90,000,000	0	0
Annual Time Burden (Hours)	2,979,050	2,104,050	0	875,000	0	0
Annual Cost Burden (Dollars)	591,300	0	0	591,300	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: 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 Fairness to Contact Lens Consumer Act and Contact Lens 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.

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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

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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: 08/17/2020

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