Notice2025-22276
Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Standards Quality Act Requirements
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Published
December 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Mammography Quality Standards Act.
Full Text
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<title>Federal Register, Volume 90 Issue 234 (Tuesday, December 9, 2025)</title>
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[Federal Register Volume 90, Number 234 (Tuesday, December 9, 2025)]
[Notices]
[Pages 57070-57074]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22276]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4942]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
Mammography Quality Standards Act.
DATES: Either electronic or written comments on the collection of
information must be submitted by February 9, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 9, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-4942 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Mammography Standards Quality Act
Requirements.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#f7a7a5b6a483969191b7919396d99f9f84d9909881"><span class="__cf_email__" data-cfemail="5c0c0e1d0f283d3a3a1c3a383d7234342f723b332a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
[[Page 57071]]
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of
Activity/21 CFR section/FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Part 900, MAMMOGRAPHY
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Subpart A, Accreditation
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Notification of intent to become an AB-- 0.33 1 0.33 1....................................... 0.33
900.3(b)(1).
Application for approval as an AB; full \2\-- 0.33 1 0.33 320..................................... 106
900.3(b)(3).
Application for approval as an AB; limited 5 1 5 30...................................... 150
\3\--900.3(b)(3).
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-- 0.1 1 0.1 30...................................... 3
900.3(d)(5).
Letter of intent to relinquish accreditation 0.1 1 0.1 1....................................... 1
authority--900.3(e).
Summary report describing all facility 338 1 338 7....................................... 2,366
assessments--900.4(f).
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
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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 accreditation following 1 1 1 2....................................... 2
appeal--900.15(d)(3)(ii).
Application for alternative standard-- 2 1 2 2....................................... 4
900.18(c).
Alternative standard amendment--900.18(e)..... 10 1 10 1....................................... 10
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Total Subpart B........................... .............. .............. .............. ........................................ 16
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[[Page 57072]]
Subpart C, States as Certifiers
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Certification agency application--900.21(b)... 0.33 1 0.33 320..................................... 106
Certification agency application deficiencies-- 0.1 1 0.1 30...................................... 3
900.21(c)(2).
Certification electronic data transmission-- 5 200 1000 0.083 (5 minutes)....................... 83
900.22(h).
Changes to standards--900.22(i)............... 2 1 2 30...................................... 60
Certification agency minor deficiencies-- 1 1 1 30...................................... 30
900.24(b).
Appeal of adverse action taken by FDA-- 0.2 1 0.2 16...................................... 3
900.25(a).
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Total Subpart C........................... .............. .............. .............. ........................................ 285
Inspection fee exemption--FDA Form 3422....... 355 1 355 0.25 (15 minutes)....................... 89
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Total..................................... .............. .............. .............. ........................................ 12,0381,692
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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.
Table 2--Estimated Annual Recordkeeping Burden
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Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records \1\
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Part 900, MAMMOGRAPHY
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Subpart A, Accreditation
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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
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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 physician 89 1 89 8....................................... 712
initial requirements--900.12(a)(1)(i)(B)(2).
Documentation of interpreting physician 8,931 4 35,724 1....................................... 35,724
personnel requirements--900.12(a)(4).
Permanent medical record--900.12(c)(4)........ 8,931 1 8,931 1....................................... 8,931
Procedures for cleaning equipment-- 8,931 52 464,412 0.083 (5 minutes)....................... 38,546
900.12(e)(13).
Audit program--900.12(f)...................... 8,931 1 8,931 16...................................... 142,896
Consumer complaints system; facility-- 8,931 2 17,862 1....................................... 17,862
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 of interest-- 4 1 4 1....................................... 4
900.22(a).
Processes for suspension and revocation of 4 1 4 1....................................... 4
certificates--900.22(d).
Processes for appeals--900.22(e).............. 4 1 4 1....................................... 4
Processes for additional mammography review-- 4 1 4 1....................................... 4
900.22(f).
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
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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 57073]]
Table 3--Estimated Annual Third-Party Disclosure Burden
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Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures \1\
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Part 900, MAMMOGRAPHY
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Subpart A, Accreditation
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Notification of facilities that AB 0.1 1 0.1 200................................... 20
relinquishes its accreditation--900.3(f)(2).
Clinical images; facility \2\--900.4(c), 2,955 1 2,955 1.44.................................. 4,255
900.11(b)(1), and 900.11(b)(2).
Clinical images; AB \3\--900.4(c)............ 5 1 5 416................................... 2,080
Phantom images; facility \2\--900.4(d), 2,955 1 2,955 0.72 (43 minutes)..................... 2,128
900.11(b)(1), and 900.11(b)(2).
Phantom images; AB \3\--900.4(d)............. 5 1 5 208................................... 1,040
Annual equipment evaluation and survey; 8,931 1 8,931 1..................................... 8,931
facility \2\--900.4(e), 900.11(b)(1), and
900.11(b)(2).
Annual equipment evaluation and survey; AB 5 1 5 1,730................................. 8,650
\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 facility certificate 2 1 2 0.5 (30 minutes)...................... 1
extension application--900.11(b)(3).
Mammography facility certificate 288 1 288 5..................................... 1,440
reinstatement application--900.11(c).
Provision of personnel records to IPs-- 615 1 615 0.08 (5 minutes)...................... 49
900.12(a)(4).
Transfer of personnel records by closing 190 1 190 5..................................... 950
facilities--900.12(a)(4).
New assessment categories and breast density 8,931 1 8,931 23.................................... 205,413
reporting in mammography report (one-time
burden)--900.12(c)(1)(iv) to (vi).
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- 8,931 1 8,931 11.................................... 98,241
time burden)--900.12(c)(2).
Lay summary of examination; patient refusal 89 1 89 0.5 (30 minutes)...................... 45
\4\--900.12(c)(2).
Transfer/provision of copies of mammograms 8,931 520 4,644,120 0.08 (5 minutes)...................... 371,530
and records upon patient's request--
900.12(c)(4)(ii) and (iii).
Facility closure; notification and records 190 1 190 32.................................... 6,080
access--900.12(c)(4)(v).
Report of unresolved serious complaints-- 20 1 20 1..................................... 20
900.12(h)(4).
Information regarding compromised quality; 20 1 20 200................................... 4,000
facility \2\--900.12(j)(1).
Information regarding compromised quality; AB 20 1 20 320................................... 6,400
\3\--900.12(j)(1).
Patient notification of serious risk-- 7 1 7 100................................... 700
900.12(j)(2).
Reconsideration of accreditation--900.15(c).. 5 1 5 2..................................... 10
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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 correct major 0.4 1 0.4 200................................... 80
deficiencies--900.24(a).
Notification of loss of approval; major 0.15 1 0.15 100................................... 15
deficiencies--900.24(a)(2).
Notification of probationary status-- 0.3 1 0.3 200................................... 60
900.24(b)(1).
Notification of loss of approval; minor 0.15 1 0.15 100................................... 15
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.
[[Page 57074]]
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.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22276 Filed 12-8-25; 8:45 am]
BILLING CODE 4164-01-P
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