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View ICR - OIRA Conclusion

OMB Control No: 0938-1043	ICR Reference No: 202410-0938-012
Status: Active	Previous ICR Reference No: 202011-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Conditions of Participation for Critical Access Hospitals and Supporting Regulations (CMS-10239)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/16/2024
	Date Received in OIRA: 10/16/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2027	36 Months From Approved
Responses	79,589	0	0
Time Burden (Hours)	877,522	0	0
Cost Burden (Dollars)	0	0	0

Authorizing Statute(s): US Code: 42 USC 1395x(e) and (mm) Name of Law: Part E - Miscellaneous Provisions
   US Code: 42 USC 1395(a)(8) Name of Law: Conditions of and Limitations on Payment for Services
   US Code: 42 USC 1320b-8 Name of Law: Hospital Protocols for Organ Procurement and Standards for Organ Procurement Agencies
   US Code: 42 USC 1302 Name of Law: Rules and Regulations
   US Code: 42 USC 1395i-4(a-f) Name of Law: Medicare Rural Hospital Flexibility Program
   US Code: 42 USC 1395hh Name of Law: Regulations
   US Code: 42 USC 1395aa Name of Law: Use of State Agencies to determine compliance by providers of services with CoPs

Citations for New Statutory Requirements: None

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	79,589	-39,878	119,467
Annual Time Burden (Hours)	877,522	843,617	33,905
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This package has been updated to reflect changes in information collection requirements related to new or revised Conditions of Participation for CAHs. For this reinstatement, the total annual burden hours for industry is 894,922 hours and the annual burden costs are $73,650,118. The annual burden to industry increased from 33,905 hours to 894,922 hours. The increase in burden hours from the prior package is primarily due to new information collections associated with new CoPs for CAHs outlined in the two CMS rules referenced below. The new CoPs include multiple information collection requirements that are one-time burdens for developing new policies and protocols and ongoing reporting requirements, such as daily or biweekly reporting of respiratory illnesses as well as maternal deaths.

Annual Cost to Federal Government: $1,610,346

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: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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