Notice2026-04939
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Standards Quality Act Requirements
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Published
March 13, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 49 (Friday, March 13, 2026)</title>
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[Federal Register Volume 91, Number 49 (Friday, March 13, 2026)]
[Notices]
[Pages 12427-12429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04939]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#2b7b796a785f4a4d4d6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="39696b786a4d585f5f795f5d581751514a175e564f">[email protected]</span></a>.
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
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Number of Total
Activity/21 CFR section/FDA Number of responses per annual Average burden per Total hours
form No. respondents respondent responses response
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PART 900, MAMMOGRAPHY
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Subpart A, Accreditation
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Notification of intent to 0.33 1 0.33 1....................... 1
become an AB--900.3(b)(1).
Application for approval as an 0.33 1 0.33 320..................... 106
AB; full \2\--900.3(b)(3).
Application for approval as an 5 1 5 30...................... 150
AB; limited \3\--900.3(b)(3).
AB renewal of approval-- 1 1 1 15...................... 15
900.3(c).
AB application deficiencies-- 0.1 1 0.1 30...................... 3
900.3(d)(2).
AB resubmission of denied 0.1 1 0.1 30...................... 3
applications--900.3(d)(5).
Letter of intent to relinquish 0.1 1 0.1 1....................... 1
accreditation authority--
900.3(e).
Summary report describing all 338 1 338 7....................... 2,366
facility assessments--900.4(f).
[[Page 12428]]
AB reporting to FDA; facility 8,931 1 8,931 1....................... 8,931
\4\--900.4(h).
AB reporting to FDA; AB \5\-- 5 1 5 10...................... 50
900.4(h).
AB financial records-- 1 1 1 16...................... 16
900.4(i)(2).
Former AB new application-- 0.1 1 0.1 60...................... 6
900.6(c)(1).
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Total Subpart A............ ........... .............. .......... ........................ 11,648
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Subpart B, Quality and Standards Certification
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Reconsideration of 1 1 1 2....................... 2
accreditation following
appeal--900.15(d)(3)(ii).
Application for alternative 2 1 2 2....................... 4
standard--900.18(c).
Alternative standard amendment-- 10 1 10 1....................... 10
900.18(e).
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Total Subpart B............ ........... .............. .......... ........................ 16
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Subpart C, States as Certifiers
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Certification agency 0.33 1 0.33 320..................... 106
application--900.21(b).
Certification agency 0.1 1 0.1 30...................... 3
application deficiencies--
900.21(c)(2).
Certification electronic data 5 200 1000 0.083 (5 minutes)....... 83
transmission--900.22(h).
Changes to standards--900.22(i) 2 1 2 30...................... 60
Certification agency minor 1 1 1 30...................... 30
deficiencies--900.24(b).
Appeal of adverse action taken 0.2 1 0.2 16...................... 3
by FDA--900.25(a).
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Total Subpart C............ ........... .............. .......... ........................ 285
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Inspection fee exemption--FDA 355 1 355 0.25 (15 minutes)....... 89
Form 3422.
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Total...................... ........... .............. .......... ........................ 12,038
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\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
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Number of Total
Activity/21 CFR section Number of records per annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping \1\
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Part 900, MAMMOGRAPHY
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Subpart A, Accreditation
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AB transfer of facility 0.1 1 0.1 1..................... 1
records--900.3(f)(1).
Consumer complaints system; 5 1 5 1..................... 5
AB--900.4(g).
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Total Subpart A........... .............. .............. .......... ...................... 6
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Subpart B, Quality and Standards Certification
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Documentation of interpreting 89 1 89 8..................... 712
physician initial
requirements--900.12(a)(1)(i)
(B)(2).
Documentation of interpreting 8,931 4 35,724 1..................... 35,724
physician personnel
requirements--900.12(a)(4).
Permanent medical record-- 8,931 1 8,931 1..................... 8,931
900.12(c)(4).
Procedures for cleaning 8,931 52 464,412 0.083 (5 minutes)..... 38,546
equipment--900.12(e)(13).
Audit program--900.12(f)...... 8,931 1 8,931 16.................... 142,896
Consumer complaints system; 8,931 2 17,862 1..................... 17,862
facility--900.12(h)(2).
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Total Subpart B........... .............. .............. .......... ...................... 244,671
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Subpart C, States as Certifiers
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Certification agency conflict 4 1 4 1..................... 4
of interest--900.22(a).
Processes for suspension and 4 1 4 1..................... 4
revocation of certificates--
900.22(d).
Processes for appeals-- 4 1 4 1..................... 4
900.22(e).
Processes for additional 4 1 4 1..................... 4
mammography review--900.22(f).
Processes for patient 3 1 3 1..................... 3
notifications--900.22(g).
Evaluation of certification 4 1 4 20.................... 80
agency--900.23.
Appeals--900.25(b)............ 4 1 4 1..................... 4
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Total Subpart C........... .............. .............. .......... ...................... 103
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Total................. .............. .............. .......... ...................... 244,774
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\1\ Total hours have been rounded.
[[Page 12429]]
Table 3--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden per Total hours
Activity/21 CFR section respondents per disclosures disclosure \1\
respondent
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PART 900, MAMMOGRAPHY
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Subpart A, Accreditation
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Notification of facilities that 0.1 1 0.1 200..................... 20
AB relinquishes its
accreditation--900.3(f)(2).
Clinical images; facility \2\-- 2,955 1 2,955 1.44.................... 4,255
900.4(c), 900.11(b)(1), and
900.11(b)(2).
Clinical images; AB \3\-- 5 1 5 416..................... 2,080
900.4(c).
Phantom images; facility \2\-- 2,955 1 2,955 0.72 (43 minutes)....... 2,128
900.4(d), 900.11(b)(1), and
900.11(b)(2).
Phantom images; AB \3\-- 5 1 5 208..................... 1,040
900.4(d).
Annual equipment evaluation and 8,931 1 8,931 1....................... 8,931
survey; facility \2\--
900.4(e), 900.11(b)(1), and
900.11(b)(2).
Annual equipment evaluation and 5 1 5 1,730................... 8,650
survey; AB \3\--900.4(e).
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Total Subpart A............ ........... ............ ............ ........................ 27,104
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Subpart B, Quality Standards and Certification
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Provisional mammography 2 1 2 0.5 (30 minutes)........ 1
facility certificate extension
application--900.11(b)(3).
Mammography facility 288 1 288 5....................... 1,440
certificate reinstatement
application--900.11(c).
Provision of personnel records 615 1 615 0.08 (5 minutes)........ 49
to IPs--900.12(a)(4).
Transfer of personnel records 190 1 190 5....................... 950
by closing facilities--
900.12(a)(4).
New assessment categories and 8,931 1 8,931 23...................... 205,413
breast density reporting in
mammography report (one-time
burden)--900.12(c)(1)(iv) to
(vi).
Lay summary of examination-- 8,931 5,085 45,414,135 0.083 (5 minutes)....... 3,769,373
900.12(c)(2).
Breast density reporting in lay 8,931 1 8,931 11...................... 98,241
summary (one-time burden)--
900.12(c)(2).
Lay summary of examination; 89 1 89 0.5 (30 minutes)........ 45
patient refusal \4\--
900.12(c)(2).
Transfer/provision of copies of 8,931 520 4,644,120 0.08 (5 minutes)........ 371,530
mammograms and records upon
patient's request--
900.12(c)(4)(ii) and (iii).
Facility closure; notification 190 1 190 32...................... 6,080
and records access--
900.12(c)(4)(v).
Report of unresolved serious 20 1 20 1....................... 20
complaints--900.12(h)(4).
Information regarding 20 1 20 200..................... 4,000
compromised quality; facility
\2\--900.12(j)(1).
Information regarding 20 1 20 320..................... 6,400
compromised quality; AB \3\--
900.12(j)(1).
Patient notification of serious 7 1 7 100..................... 700
risk--900.12(j)(2).
Reconsideration of 5 1 5 2....................... 10
accreditation--900.15(c).
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Total Subpart B............ ........... ............ ............ ........................ 4,464,252
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Subpart C, States as Certifiers
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Notification of requirement to 0.4 1 0.4 200..................... 80
correct major deficiencies--
900.24(a).
Notification of loss of 0.15 1 0.15 100..................... 15
approval; major deficiencies--
900.24(a)(2).
Notification of probationary 0.3 1 0.3 200..................... 60
status--900.24(b)(1).
Notification of loss of 0.15 1 0.15 100..................... 15
approval; minor deficiencies--
900.24(b)(3).
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Total Subpart C............ ........... ............ ............ ........................ 170
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Total.................. ........... ............ ............ ........................ 4,491,526
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\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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