340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process

Forms and Documents

Document Name	Status
Supporting Statement A 1.15.25.docx Supporting Statement A	2025-01-16

IC Document Collections

IC ID	Document Title	Status
273679	ADR Submission Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202501-0906-002
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: 340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process
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: 01/21/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	15	0
Time Burden (Hours)	38	0
Cost Burden (Dollars)	0	0

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Abstract: The purpose of this information collection is to obtain OMB approval for the initiation of the 340B ADR process and the uploading of the related documents. The 340B ADR Final Rule (89 Fed. Reg. 28,643 (Apr. 19, 2024) (to be codified at 42 C.F.R. part 10)) provides the requirements for filing a 340B ADR claim. While the rule was going through OMB review and clearance, OMB stated that the initiation of the ADR process, is subject to the Paperwork Reduction Act (PRA), so HRSA needs to do a PRA package for it. To initiate the 340B ADR process, a petitioner will email OPA’s designated mailbox with its 340B ID or Labeler code and contact information, the 340B ID or Labeler code and contact information of the opposing party, and a brief description of the claim. Once a petition is filed, OPA reviews the petition to make sure the claim meets the requirements for the 340B ADR process. Both the petitioner and opposing party will be required to upload certain documentation to a secure 340B ADR workspace in the 340B Office of Pharmacy Affairs Information System (340B OPAIS) to substantiate the claim. After an initial review of the claim and any supporting documentation, OPA staff will determine whether the requirements for filing a claim have been met, and if the claim is deemed complete, OPA will notify the parties. OMB has agreed that once the claim is assigned to a 340B ADR Panel for review, these subsequent steps are exempt from PRA requirements, pursuant to the exception for administrative actions or investigations involving an agency against specific individuals or entities.

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Authorizing Statute(s): US Code: 42 USC 256b(d)(1)(B)(iii) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0906-AB28	Final or interim final rulemaking	89 FR 28643	04/19/2024

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 64468	08/07/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 3881	01/15/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
ADR Submission

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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	15	0	0	15	0	0
Annual Time Burden (Hours)	38	0	0	38	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection

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Annual Cost to Federal Government: $4,052,273

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: 01/21/2025

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