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View ICR - OIRA Conclusion

OMB Control No: 0938-1435	ICR Reference No: 202408-0938-007
Status: Active	Previous ICR Reference No: 202405-0938-018
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
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: Approved without change	Conclusion Date: 11/15/2024
	Date Received in OIRA: 08/08/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2027	36 Months From Approved	06/30/2026
Responses	37	0	10
Time Burden (Hours)	535	0	400
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	37	10	27
Annual Time Burden (Hours)	535	400	135
Annual Cost Burden (Dollars)	0	0	0

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 CY 2024 PFS final rule, we finalized 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) to draft and submit the application. In subsequent years we expect a smaller number of applications. In this regard we estimate an annual burden of 10 hours (2 applications x 5 hr per respondent/applicant) 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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