Contact Lens Rule

Forms and Documents

Document Name	Status
Contact Lens Rule-Supporting Statement - 9-08-2016-FINAL.pdf Supporting Statement A	2016-09-08

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	Modified
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	Modified
179023	Contact Lens Rule: Prescribers with disclosure obligations to contact lens wearers	Modified

ICR Details

OMB Control No: 3084-0127	ICR Reference No: 201609-3084-001
Status: Historical Active	Previous ICR Reference No: 201307-3084-002
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/19/2016
	Date Received in OIRA: 09/09/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	36 Months From Approved	10/31/2016
Responses	58,792,524	0	52,685,613
Time Burden (Hours)	1,903,315	0	1,594,981
Cost Burden (Dollars)	0	0	0

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Abstract: The Rule implements 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. Sellers who seek verification of contact lens prescriptions must retain one or two records for each contact lens sale: Either the relevant prescription itself, or the verification request and any response from the prescriber.

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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:
	81 FR 31938	05/20/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 62501	09/09/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

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

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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	58,792,524	52,685,613	0	0	6,106,911	0
Annual Time Burden (Hours)	1,903,315	1,594,981	0	0	308,334	0
Annual Cost Burden (Dollars)	0	0	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 are no program changes since the FTC’s prior clearance renewal in 2013. The increased estimates for burden hours are largely due to an upward adjustment in the estimated number of contact lens wearers (from 38 million in 2013 to 41 million in 2016) and staff’s belief that the percentage of sales in the industry that requires an original prescriber to correct a prescription from a third-party seller is currently higher than what was previously estimated (from 5.1% in 2013 to 15% in 2016) along with the instances where an original prescriber voluntarily confirms a request to a third-party seller that is already correct (from 5.1% in 2013 to 15% in 2016). Additionally, there is an increase in the estimated amount of time that prescribers spend responding to verification requests from third-party sellers (from 3 minutes per request in 2013 to 5 minutes per request in 2016). Finally, there is an upward adjustment in our annual labor costs stemming from updated labor categories that now include ophthalmologists as a portion of prescribers’ costs. Previously, such costs were covered exclusively by optometrists which have a lower mean hourly rate.

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Annual Cost to Federal Government: $52,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 09/09/2016

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