# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Standards Quality Act Requirements

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2026-04939

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** March 13, 2026
- **Citation:** 91 FR 12427

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4942]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Standards Quality Act Requirements

AGENCY:

Food and Drug Administration, HHS.

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:

Table 1—Estimated Annual Reporting Burden

Activity/21 CFR section/FDA form No.

Number of
respondents

Number of
responses per
respondent

Total
annual
responses

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.

Table 2—Estimated Annual Recordkeeping Burden

Activity/21 CFR section

Number of
recordkeepers

Number of
records per
recordkeeper

Total
annual
records

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.

Table 3—Estimated Annual Third-Party Disclosure Burden

Activity/21 CFR section

Number of
respondents

Number of
disclosures
per
respondent

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

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2026-04939. Public record. Not legal advice.