Mammography Facilities, Standards, and Lay Summaries for Patients

ICR 201006-0910-002

OMB: 0910-0309

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0309 201006-0910-002
Historical Active 200703-0910-014
Mammography Facilities, Standards, and Lay Summaries for Patients
Extension without change of a currently approved collection   No
Approved without change 10/01/2010
Retrieve Notice of Action (NOA) 06/28/2010
OMB notes that FDA complied with the previous terms of clearance.
  Inventory as of this Action Requested Previously Approved
10/31/2013 36 Months From Approved 09/30/2010
35,391,604 0 36,026,285
3,858,703 0 3,314,363
19,768,411 0 14,637,321

The Mammography Quality Standards Act Final Regulations establishes quality standards for mammography facilities, accreditation bodies and State certification agencies (21 CFR 900).

US Code: 42 USC 263 Name of Law: null

Not associated with rulemaking

  75 FR 11542 03/11/2010
75 FR 33811 06/15/2010

IC Title Form No. Form Name
Mammography Facilities, Standards, and Lay Summaries for Patients FDA 3422 Governmental Entity

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 35,391,604 36,026,285 0 0 -634,681 0
Annual Time Burden (Hours) 3,858,703 3,314,363 0 0 544,340 0
Annual Cost Burden (Dollars) 19,768,411 14,637,321 0 0 5,131,090 0

Daniel Gitteson 3017965156 [email protected]


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