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OMB Control No: 0938-1435	ICR Reference No: 202405-0938-018
Status: Historical Inactive	Previous ICR Reference No: 202303-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Dispute Resolution for Discarded Drug Refunds (CMS-10835)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 07/01/2024
	Date Received in OIRA: 05/20/2024
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	36 Months From Approved	06/30/2026
Responses	10	0	10
Time Burden (Hours)	400	0	400
Cost Burden (Dollars)	0	0	0

Abstract: Manufacturers of drugs or biologicals for which refunds are owed may submit an error report to CMS. CMS will use this information to evaluate the refund amount and make any corrections or adjustments to the refund amount if CMS finds there was indeed an error. CMS would evaluate error reports and would decide whether the information (such as number of discarded billing units or refund amount calculation) requires correction based on the information provided. CMS proposes that if we find that a different refund amount is owed than what was stated on the report, we would issue a new report with updated discarded amounts and/or refund. CMS also proposes that if we disagree with the dispute, we would notify the manufacturer that refund amount on the report is still owed and should be paid.

Authorizing Statute(s): PL: Pub.L. 117 - 9 90004 Name of Law: Infrastructure Investment and Jobs Act

Citations for New Statutory Requirements: PL: Pub.L. 117 - 9 90004 Name of Law: Infrastructure Investment and Jobs Act

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV07	Proposed rulemaking	88 FR 52262	08/07/2023

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 52262	08/07/2023
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Applications: Initial Year
Applications: Subsequent Years
Error Report Submission

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: In the August 7, 2023 (88 FR 52262) CY 2024 PFS proposed rule (CMS-1784-P; RIN 0938-AV07), we are proposing an application process through which each manufacturer can request that we consider increasing the applicable percentage for a particular drug based on unique circumstances. In the initial year, we estimate that the burden per respondent/applicant of drafting and submitting the unique circumstance application to be 5 hours. We anticipate 25 applications in the initial year that applications are available. In the initial year, we estimate a one-time burden of 125 hours (25 applications x 5 hr per respondent/applicant) at a cost of $6,970 (125 hr x $55.76/hr) to draft and submit the application. Once a manufacturer has applied for a drug and a decision has been made regarding whether an increased applicable percentage is appropriate, the manufacturer would not need to apply again. In subsequent years we would expect a smaller number of applications. When evaluating the approval dates of these 25 drugs, we find that there is a range of 0 to 4 drugs per year approved that would be expected to owe a refund of more than $50,000 per year. From 2010—2020, the mean number of such approvals is 1.45 per year. If rounded up, we estimate that we would typically receive 2 applications per year except the initial application year. In this regard we estimate an annual burden of 10 hours (2 applications x 5 hr per respondent/applicant) at a cost of $558 (10 hr x $55.76/hr) to draft and submit the application.

Annual Cost to Federal Government: $25,462

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: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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