Ophthalmic Practice Rules

Forms and Documents

Document Name	Status
Eyeglass Rule Final Rule SS_07-26-2024-FINAL.pdf Supporting Statement A	2024-07-26

IC Document Collections

IC ID	Document Title	Status
257581	Recordkeeping - Storing Consumer Consents for Electronic Delivery	Unchanged
257580	Recordkeeping - Obtaining Consumer Consents for Electronic Delivery	Modified
257579	Recordkeeping - Confirmation of Prescription Releases to Consumers	Unchanged
257578	Recordkeeping - Prescriber Confirmation of Prescription Release with Consumers	Modified
257577	Prescriber Disclosure to Consumers - Automatic Prescription Release	Unchanged

ICR Details

OMB Control No: 3084-0174	ICR Reference No: 202407-3084-001
Status: Received in OIRA	Previous ICR Reference No: 202212-3084-003
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	Date Submitted to OIRA: 07/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	247,500,000	0
Time Burden (Hours)	3,208,333	0
Cost Burden (Dollars)	0	0

---

Abstract: The Federal Trade Commission has issued a Final Rule amending 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 follow the longstanding requirement to release eyeglass prescriptions to consumers is an ongoing, prevalent problem, and that this failure causes harm to consumers and competition. The new information requirements are intended to ensure that 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 that 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 amendments to achieve consumer protection objectives while also minimizing burden on prescribers.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3084-AB37	Final or interim final rulemaking	89 FR 60742	07/26/2024

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 5

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

---

ICR Summary of Burden

	Total Request	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	247,500,000	0	0	247,500,000	0	0
Annual Time Burden (Hours)	3,208,333	0	0	3,208,333	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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 amendments are a program change that will result in an estimated 3,208,333 annual burden hours, $149,691,431 in annual labor costs, and negligible capital/non-labor costs.

---

Annual Cost to Federal Government: $70,000

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

---

Common Form ICR:  No

---

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: 07/26/2024

---