PBM Fee Disclosure Regulation under 408(b)(2)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
1210-0173 PBM Supporting Statement 9.9.26.docx	Supporting Statement A	Uploaded 2026-10-21	Available
Proposed Rule- Public Comments.docx	Public Comments	Uploaded 2026-04-15	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
276870	IT Infrastructure		Unchanged
276601	Audit		Modified
276600	Disclosures		Modified

ICR Details

OMB Control No: 1210-0173	ICR Reference No: 202609-1210-001
Status: Received in OIRA	Previous ICR Reference No: 202507-1210-001
Agency/Subagency: DOL/EBSA	Agency Tracking No:
Title: PBM Fee Disclosure Regulation under 408(b)(2)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/02/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	424,111	0
Time Burden (Hours)	425,773	0
Cost Burden (Dollars)	0	0

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Abstract: The Department is issuing a final regulation that will require providers of pharmacy benefit management services and affiliated providers of brokerage and consulting services to disclose information about their compensation to fiduciaries of large, self-insured group health plans subject to the Employee Retirement Income Security Act (ERISA). Pharmacy spending is a major driver of overall healthcare costs for employers and is growing faster than medical and surgical spending. These disclosure requirements apply for purposes of ERISA’s statutory prohibited transaction exemption for service arrangements under section 408(b)(2). These disclosures are needed so that fiduciaries can assess the reasonableness of contracts or arrangements with these service providers, including the reasonableness of the service providers’ compensation. As directed in section 12 of President Trump’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First, the Department is issuing this rule to improve employer health plan transparency into the direct and indirect compensation received by pharmacy benefit managers. This final rule will affect sponsors and other fiduciaries of large, self-insured group health plans and certain service providers to such plans.

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Authorizing Statute(s): EO: EO 14273 Name/Subject of EO: Lowering Drug Prices by Once Again Putting Americans First
   US Code: 29 USC 1135 Name of Law: Employee Retirement Income Security Act of 1974
   US Code: 29 USC 1108 Name of Law: Employee Retirement Income Security Act of 1974
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1210-AB37	Final or interim final rulemaking	91 FR 69092	11/02/2026

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 69092	11/02/2026
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Audit
Disclosures
IT Infrastructure

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ICR Summary of Burden

table that charts list 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	424,111	0	0	0	424,111	0
Annual Time Burden (Hours)	425,773	0	0	0	425,773	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 Department is issuing the final rule.

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Annual Cost to Federal Government: $0

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: 11/02/2026

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