Mammography Facilities, Standards, and Lay Summaries for Patients

Forms and Documents

Document Name	Status
Form Form FDA 3422 Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction	Unchanged
FDA-3422_08-26-20.pdf Supplementary Document	2020-09-22
GE Form 3422 old version strike out document 9-22-20.pdf Supplementary Document	2020-09-22
FDA 3422 83-C justification.docx Justification for No Material/Nonsubstantive Change	2020-09-22
0309_Suppporting Statement_2019.doc Supporting Statement A	2019-08-29

IC Document Collections

IC ID	Document Title	Status
5881	Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0309	ICR Reference No: 202009-0910-010
Status: Active	Previous ICR Reference No: 201907-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Mammography Facilities, Standards, and Lay Summaries for Patients
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/24/2020
	Date Received in OIRA: 09/23/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	10/31/2022	10/31/2022
Responses	35,208,523	0	35,208,523
Time Burden (Hours)	3,940,856	0	3,940,856
Cost Burden (Dollars)	26,303,177	0	26,303,177

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 263 Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18548	05/01/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 42931	08/19/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Mammography Facilities, Standards, and Lay Summaries for Patients	Form FDA 3422	GOVERNMENTAL ENTITY DECLARATION

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ICR Summary of Burden

	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	3,940,856	0	0	0	0
Annual Cost Burden (Dollars)	26,303,177	26,303,177	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $11,352,810

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/23/2020

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