Mammography Facilities, Standards, and Lay Summaries for Patients

ICR 201907-0910-018

OMB: 0910-0309

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0309 201907-0910-018
Historical Active 201608-0910-006
HHS/FDA CDRH
Mammography Facilities, Standards, and Lay Summaries for Patients
Extension without change of a currently approved collection   No
Regular
Approved without change 10/08/2019
Retrieve Notice of Action (NOA) 09/09/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
35,208,523 0 35,208,523
3,940,856 0 3,940,842
26,303,177 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

  84 FR 18548 05/01/2019
84 FR 42931 08/19/2019
Yes

1
IC Title Form No. Form Name
Mammography Facilities, Standards, and Lay Summaries for Patients Form 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) 3,940,856 3,940,842 0 0 14 0
Annual Cost Burden (Dollars) 26,303,177 24,410,106 0 0 1,893,071 0
No
No
There are no program changes. The hour burden has been adjusted to account for a slight increase in the number of respondents for § 900.3(c) “AB renewal of approval.” This resulted in a 14-hour increase to the burden estimate. Additionally, we updated the capital costs and operating and maintenance costs by adjusting them for inflation since the last update to those estimates.* This adjustment resulted in a $1,893,071 increase to the estimated capital and operating and maintenance costs ($24,410,106 previously; $26,303,177 current extension request). * Using the Bureau of Labor and Statistics CPI Inflation Calculator (https://www.bls.gov/data/inflation_calculator.htm). Updates were calculated from July 2013 (date of submission to OMB of the last update to the “Estimate of the Other Total Annual Cost to Respondents and/or Recordkeepers/Capital Costs” section of the burden estimate) to January 2019. The estimates are rounded to the nearest dollar.

$11,352,810
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
09/09/2019


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