Contact Lens Rule

Forms and Documents

Document Name	Status
Contact Lens Rule - Supporting Statement - 2013 - FINAL.pdf Supporting Statement A	2013-07-23

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	New
207880	Contact Lens Rule: Prescribers responding to verification requests	New
179023	Contact Lens Rule: Prescribers with disclosure obligations to contact lens wearers	Modified

ICR Details

OMB Control No: 3084-0127	ICR Reference No: 201307-3084-002
Status: Historical Active	Previous ICR Reference No: 201004-3084-002
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: 09/10/2013
	Date Received in OIRA: 07/23/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved	09/30/2013
Responses	52,685,613	0	37,400,000
Time Burden (Hours)	1,594,981	0	850,000
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:
	78 FR 9391	02/08/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 44122	07/23/2013
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	52,685,613	37,400,000	0	0	15,285,613	0
Annual Time Burden (Hours)	1,594,981	850,000	0	0	744,981	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: The current estimate of 1,594,981 annual burden hours is higher than the estimates submitted to OMB in 2009 (the similar figure was 850,000 hours in 2009). There are no program changes. The increased estimates for burden hours and labor costs from the FTC's prior clearance request are due to an increase in the estimated number of contact lens wearers [34 million (2008) to 38 million (2012)], staff's belief that the percentage of sales in the industry that requires obtaining or verifying a prescription is currently higher than what was previously estimated (10% in 2009 and 35.9% in 2012), and the first time inclusion into the estimate of time that prescribers' offices expend responding to verification requests from other sellers (see the IC category for Contact Lens Rule: Prescribers responding to verification requests).

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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: 07/23/2013

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