Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Mammography Facilities, Standards, and Lay Summaries for Patients Unchanged 35208523 3940842 24410106 Form and Instruction FDA 3422 GOVERNMENTAL ENTITY DECLARATION
New Burden from Rulemaking (Third-Party Disclosure) - Breast density reporting in lay summary (one-time burden)-900.12(c)(2) New 8691 95601 0
New Burden from Rulemaking (Third-Party Disclosure) - Facility closure; notification and records access-900.12(c)(4)(v) New 87 2784 0
New Burden from Rulemaking (Third-Party Disclosure) - New assessment categories and breast density reporting in mammography report (one-time burden)-900.12(c)(1)(iv)-(c)(1)(vi) New 8691 199893 0
New Burden from Rulemaking (Third-Party Disclosure) - Patient notification of significant risk (by State certification agency)--900.12(j)(2) New 5 500 0
New Burden from Rulemaking (Third-Party Disclosure) - Provision of personnel records --900.12(a)(4) New 608 49 0
New Burden from Rulemaking (Third-Party Disclosure) - Transfer of personnel records by closing facilities-900.12(a)(4) New 87 435 0
New Burden from Rulemaking (Third-Party Disclosure) - Transfer/provision of copies of mammograms and records upon patient's request-900.12(c)(4)(ii) and (c)(4)(iii) New 13106028 1048482 0
Total burden requested under this ICR: 48332720 5288586 24410106  
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