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
HHS/FDA
Mammography Facilities, Standards, and Lay Summaries for Patients
Extension without change of a currently approved collection   No
Regular
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
  
None

Not associated with rulemaking

  75 FR 11542 03/11/2010
75 FR 33811 06/15/2010
No

1
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
No
No

$6,172,000
No
No
No
Uncollected
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  No

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.
06/28/2010


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