Mammography Standards Quality Act Requirements

Forms and Documents

Document Name	Status
Form FDA 3422 Governmental Entity Declaration Form and Instruction	Unchanged
Form FDA 3422 Mammography Standards Quality Act Requirements Form and Instruction	Unchanged
MQSA FRIA March 2023.pdf Supplementary Document	2023-03-12
MQSA FRIA March 2023.pdf Supplementary Document	2023-03-12
0309 MQSA Final Rule March 2023 SSA RIN AH04.docx Supporting Statement A	2023-03-12
0309 MQSA Final Rule March 2023 SSA RIN AH04.docx Supporting Statement A	2023-03-12

IC Document Collections

IC ID	Document Title	Status
5881	Mammography Standards Quality Act Requirements Form and Instruction	Unchanged	Governmental Entity Declaration
5881	Mammography Standards Quality Act Requirements Form and Instruction	Unchanged
259087	MQSA Revisions Final Rule March 2023	New

ICR Details

OMB Control No: 0910-0309	ICR Reference No: 202303-0910-007
Status: Active	Previous ICR Reference No: 202210-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Mammography Standards Quality Act Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/15/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/13/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	36 Months From Approved	11/30/2025
Responses	54,864,468	0	44,879,674
Time Burden (Hours)	5,069,194	0	3,969,520
Cost Burden (Dollars)	39,447,202	0	33,528,188

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Abstract: This information collection request supports agency rulemaking to update implementing regulations under the Mammography Quality Standards Act of 1992 (MQSA). The revisions are intended to incorporate current science and mammography best practices.

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Authorizing Statute(s): US Code: 42 USC 263b Name of Law: Certification of Mammography Facilities
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH04	Final or interim final rulemaking	88 FR 15126	03/10/2023

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
MQSA Revisions Final Rule March 2023
Mammography Standards Quality Act Requirements	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	54,864,468	44,879,674	0	0	9,984,794	0
Annual Time Burden (Hours)	5,069,194	3,969,520	0	0	1,099,674	0
Annual Cost Burden (Dollars)	39,447,202	33,528,188	0	0	5,919,014	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: The information collection reflects program changes resulting from agency rulemaking. To account for the changing regulatory provisions we have increased our estimated annual number of responses by 9,984,794, our estimated annual number of hours by 1,099,674, and have accounted for respondent costs of $5,919,014 attributable to implementation of the new requirements.

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Annual Cost to Federal Government: $11,811,450

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: 03/13/2023

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