Ophthalmic Practice Rules

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Eyeglass Rule NPRM Supporting Statement 1-3-23-FINAL.pdf	Supporting Statement A	Uploaded 2023-01-03	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257581	Recordkeeping - Storing Consumer Consents for Electronic Delivery		New
257580	Recordkeeping - Obtaining Consumer Consents for Electronic Delivery		New
257579	Recordkeeping - Confirmation of Prescription Releases to Consumers		New
257578	Recordkeeping - Prescriber Confirmation of Prescription Release with Consumers		New
257577	Prescriber Disclosure to Consumers - Automatic Prescription Release		New

ICR Details

OMB Control No: 3084-0174	ICR Reference No: 202212-3084-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: FTC	Agency Tracking No:
Title: Ophthalmic Practice Rules
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 02/23/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/03/2023
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. Resubmit when proposed rule is finalized.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Trade Commission has issued a Notice of Proposed Rulemaking (“NPRM”) to amend the Ophthalmic Practice Rules (“Eyeglass Rule” or “Rule”) to add new information collection and recordkeeping requirements for ophthalmologists and optometrists, and is requesting approval for the New Collection. The FTC has determined after numerous proceedings that prescribers’ failure to release eyeglass prescriptions to consumers is an ongoing, prevalent problem, and that this failure causes harm to consumers and competition. The proposed information requirements are intended to ensure consumers automatically receive a copy of their eyeglass prescription at the end of their eye exam so that they can comparison-shop and purchase eyeglasses from the seller of their choice. The requirements are further intended to ensure prescribers retain records of electronic prescription release and of patients’ confirmations of prescription receipt sufficient to demonstrate prescribers’ compliance with the Rule and its disclosure requirements. The FTC has structured the proposed amendments to achieve consumer protection objectives while also minimizing burden on prescribers.

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Authorizing Statute(s): US Code: 15 USC §§ 41-58, as amended Name of Law: Federal Trade Commission Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3084-AB37	Proposed rulemaking	88 FR 248	01/03/2023

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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: 5

table that charts list of burden

IC Title	Form No.	Form Name
Prescriber Disclosure to Consumers - Automatic Prescription Release
Recordkeeping - Confirmation of Prescription Releases to Consumers
Recordkeeping - Obtaining Consumer Consents for Electronic Delivery
Recordkeeping - Prescriber Confirmation of Prescription Release with Consumers
Recordkeeping - Storing Consumer Consents for Electronic Delivery

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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 proposed amendments added to existing disclosure requirements, will result in an estimated 2,979,167 burden hours annualized, $122,528,562 in labor costs, and negligible capital/non-labor costs.

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Annual Cost to Federal Government: $53,289

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: 01/03/2023

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