Mammography Facilities, Standards, and Lay Summaries for Patients

ICR 200703-0910-014

OMB: 0910-0309

Federal Form Document

Forms and Documents
Form and Instruction
Supporting Statement A
IC Document Collections
ICR Details
0910-0309 200703-0910-014
Historical Active 200402-0910-003
Mammography Facilities, Standards, and Lay Summaries for Patients
Revision of a currently approved collection   No
Approved without change 06/08/2007
Retrieve Notice of Action (NOA) 03/23/2007
OMB notes that the information collection requirements from 0910-0580 have been consolidated into this package. For 0910-0580, FDA will submit either an 83-D to discontinue or an 83-C to reduce the burden by the amount transferred into this collection (whichever is appropriate.)
  Inventory as of this Action Requested Previously Approved
06/30/2010 36 Months From Approved 06/30/2007
36,026,285 0 36,000,000
3,314,363 0 3,219,936
14,637,321 0 19,491,000

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

  71 FR 55488 09/22/2006
72 FR 7438 02/15/2007

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

  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 36,026,285 36,000,000 0 26,285 0 0
Annual Time Burden (Hours) 3,314,363 3,219,936 0 94,427 0 0
Annual Cost Burden (Dollars) 14,637,321 19,491,000 0 -4,853,679 0 0
Miscellaneous Actions
Miscellaneous Actions
This renewal request for the collection 0910-0309 also serves to consolidate the information collection requirements for 0910-0580. As a result of this consolidation, due to Agency discretion, there has been an increase in total burden estimate. The collection for 0910-0580 will be discontinued upon OMB approval of this collection. In addition a number of other factors contributed to the change in the number of hours among which were, the average number of mammography units per facility increased; the hours for performing additional mammography reviews and patient/physicians notifications as well as the associated operating cost were increased to better represent the actual burden on facilities and accreditation bodies.

Saleda Perryman


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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