View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0906-0111
ICR Reference No:
202508-0906-002
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/HRSA
Agency Tracking No:
Title:
340B Rebate Model Pilot Program Application, Implementation, and Evaluation
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
08/22/2025
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/26/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/21/2025
Terms of Clearance:
Emergency information collection request approved for five months consistent with the understanding that the agency will immediately initiate the standard Paperwork Reduction Act (PRA) process (including 60-day and 30-day comment periods) in order to ensure that a standard clearance is in place by January 2026.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2026
6 Months From Approved
Responses
759,245
0
0
Time Burden (Hours)
1,518,760
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
HRSA’s Office of Pharmacy Affairs (OPA) is introducing this 340B Rebate Model Pilot Program to test the rebate model on selected drugs with an agreed-upon Maximum Fair Price (MFP) for price applicability year 2026 starting on January 1, 2026. This approach will test the rebate model in a methodical and thoughtful manner. This information collection request includes the collection of 340B Rebate Model Pilot Program plans, the collection of periodic sales data from drug manufacturers for OPA’s evaluation of the pilot program and for overall 340B Program surveillance, and the collection of data submitted by covered entities to manufacturers to request a rebate.
Emergency Justfication:
HRSA is seeking emergency clearance because HRSA will need to begin the information collection by October 2025. If HRSA does not receive emergency approval, then manufacturers may argue that they do not have the tools they need to effectuate nonduplication of the MFP and the 340B discount. HRSA has taken all practicable steps to consult with the public to minimize burden (including a 30-day comment period on the “340B Program Notice: Application Process for the 340B Rebate Model Pilot Program” (90 FR 36163). HRSA is submitting this ICR to the Office of Management and Budget for a 5-month emergency approval. Once this clearance is granted, HRSA will create a regular ICR for this collection.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 11001
Name of Law: Inflation Reduction Act
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
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
340B Rebate Model Pilot Program
ICR Summary of Burden
Total Approved
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
759,245
0
0
759,245
0
0
Annual Time Burden (Hours)
1,518,760
0
0
1,518,760
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
Annual Cost to Federal Government:
$48,256
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
Agency Contact:
Laura Cooper 301 443-2126 lcooper@hrsa.gov
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:
08/21/2025
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