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OMB Control No: 0915-0327	ICR Reference No: 202601-0915-001
Status: Received in OIRA	Previous ICR Reference No: 202208-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No: 20345
Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 01/12/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2026
Responses	141,651	109,982
Time Burden (Hours)	75,448	59,359
Cost Burden (Dollars)	0	0

Abstract: Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service (PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS (Secretary) that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed statutorily defined 340B ceiling prices. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that choose to participate in the 340B Program must comply with the requirements of section 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) of the PHS Act prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the covered entity.

Authorizing Statute(s): US Code: 42 USC 256b Name of Law: SUBPART VII—DRUG PRICING AGREEMENTS
PL: Pub.L. 102 - 585 601-602 Name of Law: Veterans Health Care Act of 1992

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 38167	08/07/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 714	01/08/2026
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	141,651	109,982	31,669
Annual Time Burden (Hours)	75,448	59,359	16,089
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Currently, there are 59,359 reporting and record keeping burden hours in the OMB inventory. HRSA is requesting 75,448 burden hours, an increase of 16,089 hours. This increase is due to an increase average burden hours per response for the “340B Registrations for STD/TB Clinics Form” and the “340B Registrations for Various Other Entity Types Form.” There was a small decline in burden in the "PPA and Addendum" form, which occurred because the number of respondents declined, as opposed to a change in average burden to the manufacturers.

Annual Cost to Federal Government: $4,611,195

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]? Yes

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

Agency Contact: Laura Cooper 301 443-2126 lcooper@hrsa.gov

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