Contact Lens Rule

Forms and Documents

Document Name	Status
Contact Lens SNPRM - Supporting Statement - FINAL 2019.pdf Supporting Statement A	2019-05-28

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
236039	Prescribers' Record Retention Requirement	New
236038	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	Unchanged
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: 201905-3084-002
Status: Historical Inactive	Previous ICR Reference No: 201609-3084-001
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: Comment filed on proposed rule and continue	Conclusion Date: 09/10/2019
	Date Received in OIRA: 05/28/2019
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. Pursuant to 5 CFR 1320.11(c), OMB files this comment on this information collection request (ICR). The agency shall examine public comment in response to the NPRM and will describe in the supporting statement of its next collection any public comments received regarding the collection as well as why (or why it did not) incorporate the commenter’s recommendation. The next submission to OMB must include the draft final rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	36 Months From Approved	12/31/2019
Responses	58,792,524	0	58,792,524
Time Burden (Hours)	1,903,315	0	1,903,315
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. The Federal Trade Commission is seeking public comment to a Supplemental Notice of Proposed Rulemaking about newly proposed changes to the agency’s Contact Lens Rule. The new proposal follows an extensive review and consideration of thousands of public comments and material received by the Commission between 2015 and 2018, including surveys, studies, analyses, and information generated at an FTC workshop devoted to the Rule and the evolving contact lens marketplace. The Commission is now seeking comment on modifications to its earlier NPRM proposal to enhance 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 FTC believes the newly developed modifications will achieve the goals of its original proposal, while imposing less of a burden on prescribers.

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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	Proposed rulemaking	84 FR 24664	05/28/2019

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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: 6

IC Title	Form No.	Form Name
Contact Lens Rule: Prescribers with disclosure obligations to contact lens wearers
Prescribers' Record Retention Requirement
Contact Lens Rule: Prescribers responding to verification requests
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
Part II of Prescriber's disclosure obligations to contact lens wearers who read, sign and return a confirmation statement

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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 is now seeking comment on modifications to its earlier NPRM proposal to enhance 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 proposed amendments will result in an estimated additional 597,917 burden hours, annualized, and cumulative of all affected manufacturers, $13,244,727 in associated labor costs, and negligible capital/non-labor costs. Requiring a signed acknowledgment would increase the Commission’s ability to assess and verify compliance with the Rule. The FTC believes the newly developed modifications will achieve the goals of its original proposal, while imposing less of a burden on prescribers.

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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? 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: 05/28/2019

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