Mammography Standards Quality Act Requirements

Forms and Documents

Document Name	Status
Form FDA 3422 Governmental Entity Declaration Form and Instruction	Modified

IC Document Collections

IC ID	Document Title	Status
5881	Mammography Standards Quality Act Requirements - Reporting Form and Instruction	Modified	Governmental Entity Declaration
5881	Mammography Standards Quality Act Requirements - Reporting Form and Instruction	Modified
276642	Mammography Standards Quality Act Requirements - Third-Party Disclosure	New
276641	Mammography Standards Quality Act Requirements - Recordkeeping	New
259087	MQSA Revisions Final Rule March 2023	Removed

ICR Details

OMB Control No: 0910-0309	ICR Reference No: 202507-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202303-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Mammography Standards Quality Act Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/27/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2026
Responses	50,639,704	54,864,468
Time Burden (Hours)	4,748,336	5,069,194
Cost Burden (Dollars)	0	39,447,202

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Abstract: This information collection implements the Mammography Quality Standards Act through regulations that establish procedures whereby an entity can apply to become a Food and Drug Administration (FDA)-approved accreditation body to accredit facilities to be eligible to perform screening or diagnostic mammography services. The regulations also establish requirements and standards for accreditation bodies to ensure that all mammography facilities under the jurisdiction of the United States are adequately and consistently evaluated for compliance with national quality standards for mammography.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 57070	12/09/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 12427	03/13/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
MQSA Revisions Final Rule March 2023
Mammography Standards Quality Act Requirements - Recordkeeping
Mammography Standards Quality Act Requirements - Reporting	FDA 3422	Governmental Entity Declaration
Mammography Standards Quality Act Requirements - Third-Party Disclosure

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ICR Summary of Burden

	Total Request	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	50,639,704	54,864,468	0	0	-4,224,764	0
Annual Time Burden (Hours)	4,748,336	5,069,194	0	0	-320,858	0
Annual Cost Burden (Dollars)	0	39,447,202	0	0	-39,447,202	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: Our estimated burden for the information collection reflects an overall decrease of 4,224,764 hours and a corresponding decrease of 320,858 responses. We attribute this adjustment due to the number of certified mammography facilities. The estimated number of respondents in the tables are based on the number (8,931) of certified mammography facilities as of October 1, 2024. Title 21 CFR Part 900 Mammography, as amended, includes various reporting, recordkeeping, and third-party disclosure activities. In addition, there was a decrease in state certifiers from 5 to 4 - Illinois, Iowa, South Carolina, and Texas. ROCIS reflects a decrease in burden. The amount shown may not match the actual decrease because the numbers in the previous submission were miscalculated in both the burden table and ROCIS. This submission corrects those errors.

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Annual Cost to Federal Government: $15,215,424

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: 03/27/2026

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