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View ICR - OIRA Conclusion

OMB Control No: 0910-0309	ICR Reference No: 202507-0910-007
Status: Active	Previous ICR Reference No: 202303-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Mammography Standards Quality Act Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/20/2026
	Date Received in OIRA: 03/27/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	05/31/2026
Responses	50,639,704	0	54,864,468
Time Burden (Hours)	4,748,336	0	5,069,194
Cost Burden (Dollars)	0	0	39,447,202

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	50,639,704	54,864,468	-4,224,764
Annual Time Burden (Hours)	4,748,336	5,069,194	-320,858
Annual Cost Burden (Dollars)	0	39,447,202	-39,447,202

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: No

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall decrease of 4,224,764 hours and a corresponding decrease of 320,858 responses. We attribute this adjustment due to the number of certified mammography facilities. The estimated number of respondents in the tables are based on the number (8,931) of certified mammography facilities as of October 1, 2024. Title 21 CFR Part 900 Mammography, as amended, includes various reporting, recordkeeping, and third-party disclosure activities. In addition, there was a decrease in state certifiers from 5 to 4 - Illinois, Iowa, South Carolina, and Texas. ROCIS reflects a decrease in burden. The amount shown may not match the actual decrease because the numbers in the previous submission were miscalculated in both the burden table and ROCIS. This submission corrects those errors.

Annual Cost to Federal Government: $15,215,424

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. Yes

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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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