Mammography Facilities, Standards, and Lay Summaries for Patients

ICR 201608-0910-006

OMB: 0910-0309

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2016-08-19
IC Document Collections
ICR Details
0910-0309 201608-0910-006
Historical Active 201307-0910-001
HHS/FDA CDRH
Mammography Facilities, Standards, and Lay Summaries for Patients
Extension without change of a currently approved collection   No
Regular
Approved without change 09/30/2016
Retrieve Notice of Action (NOA) 08/22/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 09/30/2016
35,208,523 0 35,208,523
3,940,842 0 3,940,842
24,410,106 0 24,410,106

Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer compliant mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis.

US Code: 42 USC 263 Name of Law: null
  
None

Not associated with rulemaking

  81 FR 36924 06/08/2016
81 FR 55463 08/19/2016
No

1
IC Title Form No. Form Name
Mammography Facilities, Standards, and Lay Summaries for Patients FDA 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 35,208,523 35,208,523 0 0 0 0
Annual Time Burden (Hours) 3,940,842 3,940,842 0 0 0 0
Annual Cost Burden (Dollars) 24,410,106 24,410,106 0 0 0 0
No
No

$11,906,454
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
08/22/2016


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