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

Forms and Documents

Document Name	Status
1210-New PBM Supporting Statement 1.8.26.docx Supporting Statement A	2026-01-08

IC Document Collections

IC ID	Document Title	Status
276870	IT Infrastructure	New
276601	Audit	New
276600	Disclosures	New

ICR Details

OMB Control No:	ICR Reference No: 202507-1210-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: DOL/EBSA	Agency Tracking No:
Title: PBM Fee Disclosure Regulation under 408(b)(2)
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: 01/30/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,730,806	0
Time Burden (Hours)	919,725	0
Cost Burden (Dollars)	0	0

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Abstract: Providers of pharmacy benefit management services (PBMs) and affiliated providers of brokerage and consulting services are required to disclose information about their compensation to fiduciaries of self-insured group health plans subject to the Employee Retirement Income Security Act (ERISA). The disclosures would assist the fiduciaries in assessing the reasonableness of the contracts or arrangements with these service providers, including the reasonableness of the services providers’ compensation. These disclosure requirements would apply for purposes of ERISA’s statutory prohibited transaction exemption for services arrangements.

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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	Proposed rulemaking	91 FR 4348	01/30/2026

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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: 3

IC Title	Form No.	Form Name
Audit
Disclosures
IT Infrastructure

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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	2,730,806	0	0	0	2,730,806	0
Annual Time Burden (Hours)	919,725	0	0	0	919,725	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: There is a new collection of information.

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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: 01/30/2026

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