Mammography Facilities, Standards, and Lay Summaries for Patients

ICR 201903-0910-026

OMB: 0910-0309

Federal Form Document

Forms and Documents
ICR Details
0910-0309 201903-0910-026
Historical Inactive 201608-0910-006
HHS/FDA CDRH
Mammography Facilities, Standards, and Lay Summaries for Patients
Revision of a currently approved collection   No
Regular
Comment filed on proposed rule and continue 04/01/2019
Retrieve Notice of Action (NOA) 03/30/2019
Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 10/31/2019
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

0910-AH04 Proposed rulemaking 84 FR 11669 03/28/2019

No

Yes
Miscellaneous Actions
No
In its proposed rule “Mammography Quality Standards Act; Amendments to Part 900 Regulations” (84 FR 11669) FDA is proposing to amend its mammography reporting requirements. The proposed revisions to the third-party disclosure burden described in section 12a of this ICR, would result in an increase of 1,347,744 hours to the estimated burden.

$11,906,454
No
    Yes
    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.
03/30/2019


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