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View ICR - OIRA Conclusion

OMB Control No: 0938-1443	ICR Reference No: 202611-0938-010
Status: Active	Previous ICR Reference No: 202509-0938-014
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Negotiation Program Drug Selection for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10844)
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: 11/09/2026
	Date Received in OIRA: 11/09/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2029	36 Months From Approved	11/30/2028
Responses	46	0	65
Time Burden (Hours)	4,760	0	3,677
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	46	65	-30	11
Annual Time Burden (Hours)	4,760	3,677	-292	1,375
Annual Cost Burden (Dollars)	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Collection burden has decreased due to the removed burden associated with a Small Biotech Exception. Additionally, for the Identification and Selection of Renegotiation-Eligible Drugs ICR Form, CMS included technical revisions. CMS replaced references to dates specific to a specific initial price applicability year and replaced the reference with terms language to reference the requirement in the final rule. These revisions did not impact the burden.

Annual Cost to Federal Government: $255,447

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: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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