FDA Mammography Standards Quality Act Requirements Comment Request

Content

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office
of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments (including recommendations) on the collection of information by April 13, 2026.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the
search function. The OMB control number for this information collection is 0910-0309.

FOR FURTHER INFORMATION CONTACT:

Amber Barrett, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and
clearance.

Mammography Quality Standards Act Requirements—21 CFR Part 900

OMB Control Number 0910-0309—Extension

The Mammography Quality Standards Act (Pub. L. 102-539) requires the establishment of a Federal certification and inspection
program for mammography facilities; standards for accreditation and certification bodies for mammography facilities; and standards
for mammography equipment, personnel, and practices, including quality assurance. Implementing regulations are found in part
900 (21 CFR part 900). The regulations are intended to assure safe, reliable, and accurate mammography on a nationwide level.
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 complaint 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.

FDA meets with its National Mammography Quality Assurance Advisory Committee (NMQAAC) for the purposes of advising FDA's mammography
program on advances in mammography technology and procedures and on appropriate quality standards for mammography facilities.
NMQAAC is made up of representatives of the mammography community, consumer and industry groups, and government. The meetings
are open to the public and time is allotted for public statements on issues of concern in the mammography field. The chairperson
may also call upon attendees to contribute to the committee discussions.

FDA also regularly meets or holds teleconferences with its approved accreditation bodies and State certification agencies
to discuss issues of mutual concern. We also engage with the Conference of State Radiation Program Directors (CRCPD), a professional
organization of State agencies concerned with radiation protection. The CRCPD has established a standing Mammography Committee,
which meets with FDA mammography staff at least once a year.

Finally, in recent years, FDA mammography staff have met several times with representatives of manufacturers working on the
new applications of digital technology in mammography to resolve problems preventing the making of that technology generally
available. FDA mammography staff have also worked with representatives of the manufacturers to develop quality assurance manuals
for full field digital mammography units.

In the
Federal Register
of December 9, 2025 (90 FR 57070), FDA published a 60-day notice requesting public comment on the proposed collection of information.
No comments were received.

FDA estimates the burden of this collection of information as follows:

| Activity/21 CFR section/FDA form No. | Number of
respondents | Number of
responses perrespondent | Total
annualresponses | Average burden per response | Total hours |
| --- | --- | --- | --- | --- | --- |
| PART 900, MAMMOGRAPHY | | | | | |
| Subpart A, Accreditation | | | | | |
| Notification of intent to become an AB—900.3(b)(1) | 0.33 | 1 | 0.33 | 1 | 1 |
| Application for approval as an AB; full 2 —900.3(b)(3) | 0.33 | 1 | 0.33 | 320 | 106 |
| Application for approval as an AB; limited 3 —900.3(b)(3) | 5 | 1 | 5 | 30 | 150 |
| AB renewal of approval—900.3(c) | 1 | 1 | 1 | 15 | 15 |
| AB application deficiencies—900.3(d)(2) | 0.1 | 1 | 0.1 | 30 | 3 |
| AB resubmission of denied applications—900.3(d)(5) | 0.1 | 1 | 0.1 | 30 | 3 |
| Letter of intent to relinquish accreditation authority—900.3(e) | 0.1 | 1 | 0.1 | 1 | 1 |
| Summary report describing all facility assessments—900.4(f) | 338 | 1 | 338 | 7 | 2,366 |
| AB reporting to FDA; facility 4 —900.4(h) | 8,931 | 1 | 8,931 | 1 | 8,931 |
| AB reporting to FDA; AB 5 —900.4(h) | 5 | 1 | 5 | 10 | 50 |
| AB financial records—900.4(i)(2) | 1 | 1 | 1 | 16 | 16 |
| Former AB new application—900.6(c)(1) | 0.1 | 1 | 0.1 | 60 | 6 |
| Total Subpart A | | | | | 11,648 |
| Subpart B, Quality and Standards Certification | | | | | |
| Reconsideration of accreditation following appeal—900.15(d)(3)(ii) | 1 | 1 | 1 | 2 | 2 |
| Application for alternative standard—900.18(c) | 2 | 1 | 2 | 2 | 4 |
| Alternative standard amendment—900.18(e) | 10 | 1 | 10 | 1 | 10 |
| Total Subpart B | | | | | 16 |
| Subpart C, States as Certifiers | | | | | |
| Certification agency application—900.21(b) | 0.33 | 1 | 0.33 | 320 | 106 |
| Certification agency application deficiencies—900.21(c)(2) | 0.1 | 1 | 0.1 | 30 | 3 |
| Certification electronic data transmission—900.22(h) | 5 | 200 | 1000 | 0.083 (5 minutes) | 83 |
| Changes to standards—900.22(i) | 2 | 1 | 2 | 30 | 60 |
| Certification agency minor deficiencies—900.24(b) | 1 | 1 | 1 | 30 | 30 |
| Appeal of adverse action taken by FDA—900.25(a) | 0.2 | 1 | 0.2 | 16 | 3 |
| Total Subpart C | | | | | 285 |
| Inspection fee exemption—FDA Form 3422 | 355 | 1 | 355 | 0.25 (15 minutes) | 89 |
| Total | | | | | 12,038 |
| 1 Numbers have been rounded. | | | | | |
| 2 One-time burden. | | | | | |
| 3 Refers to accreditation bodies applying to accredit specific full-field digital mammography units. | | | | | |
| 4 Refers to the facility component of the burden for this requirement. | | | | | |
| 5 Refers to the AB component of the burden for this requirement. | | | | | |

| Activity/21 CFR section | Number of
recordkeepers | Number of
records perrecordkeeper | Total
annualrecords | Average burden per recordkeeping | Total hours 1 |
| --- | --- | --- | --- | --- | --- |
| Part 900, MAMMOGRAPHY | | | | | |
| Subpart A, Accreditation | | | | | |
| AB transfer of facility records—900.3(f)(1) | 0.1 | 1 | 0.1 | 1 | 1 |
| Consumer complaints system; AB—900.4(g) | 5 | 1 | 5 | 1 | 5 |
| Total Subpart A | | | | | 6 |
| Subpart B, Quality and Standards Certification | | | | | |
| Documentation of interpreting physician initial requirements—900.12(a)(1)(i)(B)(2) | 89 | 1 | 89 | 8 | 712 |
| Documentation of interpreting physician personnel requirements—900.12(a)(4) | 8,931 | 4 | 35,724 | 1 | 35,724 |
| Permanent medical record—900.12(c)(4) | 8,931 | 1 | 8,931 | 1 | 8,931 |
| Procedures for cleaning equipment—900.12(e)(13) | 8,931 | 52 | 464,412 | 0.083 (5 minutes) | 38,546 |
| Audit program—900.12(f) | 8,931 | 1 | 8,931 | 16 | 142,896 |
| Consumer complaints system; facility—900.12(h)(2) | 8,931 | 2 | 17,862 | 1 | 17,862 |
| Total Subpart B | | | | | 244,671 |
| Subpart C, States as Certifiers | | | | | |
| Certification agency conflict of interest—900.22(a) | 4 | 1 | 4 | 1 | 4 |
| Processes for suspension and revocation of certificates—900.22(d) | 4 | 1 | 4 | 1 | 4 |
| Processes for appeals—900.22(e) | 4 | 1 | 4 | 1 | 4 |
| Processes for additional mammography review—900.22(f) | 4 | 1 | 4 | 1 | 4 |
| Processes for patient notifications—900.22(g) | 3 | 1 | 3 | 1 | 3 |
| Evaluation of certification agency—900.23 | 4 | 1 | 4 | 20 | 80 |
| Appeals—900.25(b) | 4 | 1 | 4 | 1 | 4 |
| Total Subpart C | | | | | 103 |
| Total | | | | | 244,774 |
| 1 Total hours have been rounded. | | | | | |

| Activity/21 CFR section | Number of
respondents | Number of
disclosuresperrespondent | Total annual
disclosures | Average burden per disclosure | Total hours 1 |
| --- | --- | --- | --- | --- | --- |
| PART 900, MAMMOGRAPHY | | | | | |
| Subpart A, Accreditation | | | | | |
| Notification of facilities that AB relinquishes its accreditation—900.3(f)(2) | 0.1 | 1 | 0.1 | 200 | 20 |
| Clinical images; facility 2 —900.4(c), 900.11(b)(1), and 900.11(b)(2) | 2,955 | 1 | 2,955 | 1.44 | 4,255 |
| Clinical images; AB 3 —900.4(c) | 5 | 1 | 5 | 416 | 2,080 |
| Phantom images; facility 2 —900.4(d), 900.11(b)(1), and 900.11(b)(2) | 2,955 | 1 | 2,955 | 0.72 (43 minutes) | 2,128 |
| Phantom images; AB 3 —900.4(d) | 5 | 1 | 5 | 208 | 1,040 |
| Annual equipment evaluation and survey; facility 2 —900.4(e), 900.11(b)(1), and 900.11(b)(2) | 8,931 | 1 | 8,931 | 1 | 8,931 |
| Annual equipment evaluation and survey; AB 3 —900.4(e) | 5 | 1 | 5 | 1,730 | 8,650 |
| Total Subpart A | | | | | 27,104 |
| Subpart B, Quality Standards and Certification | | | | | |
| Provisional mammography facility certificate extension application—900.11(b)(3) | 2 | 1 | 2 | 0.5 (30 minutes) | 1 |
| Mammography facility certificate reinstatement application—900.11(c) | 288 | 1 | 288 | 5 | 1,440 |
| Provision of personnel records to IPs—900.12(a)(4) | 615 | 1 | 615 | 0.08 (5 minutes) | 49 |
| Transfer of personnel records by closing facilities—900.12(a)(4) | 190 | 1 | 190 | 5 | 950 |
| New assessment categories and breast density reporting in mammography report (one-time burden)—900.12(c)(1)(iv) to (vi) | 8,931 | 1 | 8,931 | 23 | 205,413 |
| Lay summary of examination—900.12(c)(2) | 8,931 | 5,085 | 45,414,135 | 0.083 (5 minutes) | 3,769,373 |
| Breast density reporting in lay summary (one-time burden)—900.12(c)(2) | 8,931 | 1 | 8,931 | 11 | 98,241 |
| Lay summary of examination; patient refusal 4 —900.12(c)(2) | 89 | 1 | 89 | 0.5 (30 minutes) | 45 |
| Transfer/provision of copies of mammograms and records upon patient's request—900.12(c)(4)(ii) and (iii) | 8,931 | 520 | 4,644,120 | 0.08 (5 minutes) | 371,530 |
| Facility closure; notification and records access—900.12(c)(4)(v) | 190 | 1 | 190 | 32 | 6,080 |
| Report of unresolved serious complaints—900.12(h)(4) | 20 | 1 | 20 | 1 | 20 |
| Information regarding compromised quality; facility 2 —900.12(j)(1) | 20 | 1 | 20 | 200 | 4,000 |
| Information regarding compromised quality; AB 3 —900.12(j)(1) | 20 | 1 | 20 | 320 | 6,400 |
| Patient notification of serious risk—900.12(j)(2) | 7 | 1 | 7 | 100 | 700 |
| Reconsideration of accreditation—900.15(c) | 5 | 1 | 5 | 2 | 10 |
| Total Subpart B | | | | | 4,464,252 |
| Subpart C, States as Certifiers | | | | | |
| Notification of requirement to correct major deficiencies—900.24(a) | 0.4 | 1 | 0.4 | 200 | 80 |
| Notification of loss of approval; major deficiencies—900.24(a)(2) | 0.15 | 1 | 0.15 | 100 | 15 |
| Notification of probationary status—900.24(b)(1) | 0.3 | 1 | 0.3 | 200 | 60 |
| Notification of loss of approval; minor deficiencies—900.24(b)(3) | 0.15 | 1 | 0.15 | 100 | 15 |
| Total Subpart C | | | | | 170 |
| Total | | | | | 4,491,526 |
| 1 Total hours have been rounded. | | | | | |
| 2 Refers to the facility component of the burden for this requirement. | | | | | |
| 3 Refers to the AB component of the burden for this requirement. | | | | | |
| 4 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. | | | | | |
Our estimated burden for the information collection reflects an overall decrease of 4,225,729 hours and a corresponding decrease
of 321,202 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.

Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-04939 Filed 3-12-26; 8:45 am] BILLING CODE 4164-01-P

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