[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 15126-15171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04550]



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Vol. 88

Friday,

No. 47

March 10, 2023

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 900





Mammography Quality Standards Act; Final Rule

  Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / Rules 
and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. FDA-2013-N-0134]
RIN 0910-AH04


Mammography Quality Standards Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a final rule to update the mammography regulations that were 
issued under the Mammography Quality Standards Act of 1992 (MQSA) and 
the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing 
updates to modernize the regulations by incorporating current science 
and mammography best practices. These updates are intended to improve 
the delivery of mammography services by strengthening the communication 
of healthcare information; allowing for more informed decision making 
by patients and providers (by requiring facilities to provide them with 
additional health information); helping to ensure the availability of 
qualified mammography personnel; bolstering the medical outcomes audit 
to provide feedback to improve mammography interpretations; modernizing 
technological aspects of the standards; and adding additional tools to 
deal with noncompliant facilities.

DATES: This rule is effective on September 10, 2024.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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: Preetham Sudhaker, Division of 
Mammography Quality Standards (DMQS), Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-5911.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Legal Authority
    C. Summary of the Major Provisions of the Final Rule
    D. Costs and Benefits of the Final Rule
II. Table of Abbreviations and Acronyms Commonly Used in This 
Document
III. Background
    A. Need for Amendments to Mammography Regulations
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule's Changes From the 
Proposed Rule
IV. Legal Authority
V. Comments to the Proposed Rule and FDA's Responses
    A. General Comments on the Proposed Rule
    B. Scope of MQSA Regulations
    C. Repeated Failure To Achieve Accreditation
    D. Retention and Release of Personnel Records
    E. Digital Accessories
    F. Facility Identification Information in Mammography Report and 
Lay Summary
    G. Final and Incomplete Assessments and Lay Summaries
    H. Deadlines for Mammography Reports
    I. Breast Density Notification--General Support for Density 
Notification
    J. Breast Density Notification Language
    K. Breast Density Notification and the Role of the Referring 
Healthcare Provider
    L. Format for Image Interpretation, Retention, Transfer of 
Original Images, and Release of Copies
    M. Deadlines for Image Transfer and the Release of Copies
    N. Facility Closure and Mammography Record Retention
    O. Mammography Medical Outcomes Audit
    P. Patient and Referring Provider Notification
    Q. Revocation of Certification
    R. Interpreting Physician Qualifications, Including Continuing 
Experience
    S. Cleaning of Mammography Equipment
    T. Availability and Clinical Role of Breast Imaging Modalities, 
Screening Mammography Guidelines
    U. Clinical Decision-Making
    V. Insurance Coverage
    W. Economic Impact of This Rule
    X. Federalism and the Relationship Between Federal and State 
Breast Density Reporting Requirements
    Y. Effective Date of This Rule
    Z. Miscellaneous Comments
VI. Effective Date and Compliance Date
VII. Economic Analysis of Impacts
    A. Introduction
    B. Summary and Accounting Statement
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Final Rule

    Mammography is an x-ray imaging examination used to identify signs 
of breast cancer. For patients to receive the full benefit of 
mammography, the service must be of high quality, including performance 
of the examination by qualified technologists, using equipment that is 
tested and properly functioning; interpretation by qualified 
physicians; and clear and prompt communication of results to patients 
and their referring healthcare providers. The MQSA establishes uniform 
baseline Federal standards designed to ensure, among other things, that 
all patients nationwide have access to quality mammography services. 
The MQSA implementing regulations address, among other things, 
standards for accreditation bodies and certifying agencies and 
mammography quality standards for facilities, such as qualifications of 
personnel at mammography facilities, standards for mammography 
equipment, the content and terminology for mammography reports, the 
requirement to establish a quality assurance program, standards and 
timing for quality assurance testing, standards for clinical image 
quality, recordkeeping, communication of results, and clinical image 
review by the facility's accrediting body. Based on technology changes 
in mammography and our experience with the administration of the MQSA 
program, FDA is modernizing and updating the regulations as well as 
improving the information, including breast density information, 
provided by mammography facilities to patients and their healthcare 
providers. This final rule requires that the summary of the mammography 
report written in lay terms (``lay summary'') that is provided to 
patients identifies whether the patient has dense or non-dense breast 
tissue and includes a prescribed paragraph on the significance of 
breast density. The rule also establishes four categories for reporting 
breast tissue density in the mammography report that is provided to the 
patient's referring healthcare provider.

B. Legal Authority

    The MQSA was enacted on October 27, 1992, and is codified, as 
amended in 1998 and 2004, under section 354 of the Public Health 
Service (PHS) Act. Public Law 102-539, 2, 106 (1992), codified as 
amended at 42 U.S.C. 263b. Under the MQSA, all mammography facilities, 
except facilities of the Department of Veterans Affairs (VA), must be 
accredited by an approved accreditation body (AB) and certified by FDA 
(or an approved State certification agency) to provide mammography 
services. FDA is amending the mammography regulations established under 
the PHS Act, and sections of the FD&C Act.

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C. Summary of the Major Provisions of the Final Rule

    FDA is making three categories of improvements to our mammography 
regulations: improvements that address changes in mammography 
technology; improvements that enhance enforcement of quality standards; 
and improvements in the way mammography results are categorized, 
reported, retained, and transferred to patients and healthcare 
providers. Specifically, in this final rule FDA is making the following 
amendments:
     New and amended provisions related to technology that, 
among other things, update several equipment and quality control 
provisions in the regulations to address current technology, including 
digital mammography;
     Improvements that enhance enforcement that, among other 
things:
    [cir] Require that mammograms submitted for interpretation be 
presented in the mammographic modality in which they were originally 
produced, and not be copied or digitized from hardcopy original images, 
which could adversely affect the accuracy of interpretation;
    [cir] Prohibit accreditation bodies from accepting an application 
for accreditation from a facility that has failed to become accredited 
after three consecutive attempts until 1 year after the most recent 
accreditation failure;
    [cir] Expressly state that a facility's certificate may be 
suspended or revoked due to a failure to comply with requests by FDA, 
the State certification agency, or the AB for records, including 
clinical images for an additional mammography review (AMR), or with 
requests by current or former facility personnel for records 
documenting their qualifications;
    [cir] Add the State certification agency as an entity that may 
initiate an AMR, which can help detect quality issues, and also to 
state expressly that FDA and the State certification agency can notify 
patients and their providers individually or through the mass media 
when a facility is unable or unwilling to perform a required patient 
and referring physician notification (PPN), which would help to ensure 
that patients and providers are informed of serious risks to human 
health resulting from mammography that fails to meet quality standards;
    [cir] Require that, before a facility closes or no longer provides 
mammography services, it must make arrangements for access by patients 
and healthcare providers to mammography images and reports; and
    [cir] Require facilities to provide personnel with copies of their 
MQSA qualification records, which are often needed to work at 
additional or new facilities.
     Improvements in the way mammography results are 
categorized, reported, retained, and transferred to patients and 
healthcare providers that, among other things:
    [cir] Require that the mammographic examination report include the 
facility name and location (at a minimum, the city, State, ZIP code, 
and telephone number of the facility), in order to help to ensure that 
healthcare providers can obtain the necessary information to enable 
them to assist patients in making informed healthcare decisions;
    [cir] Change the explanatory language in one final assessment 
category (``Benign'') to promote greater consistency and accuracy in 
the use of the category, and add three new categories of mammographic 
assessment to the existing categories in the regulations, which will 
allow mammography facilities to precisely classify and communicate 
findings;
    [cir] Add a specific, required timeframe for facilities to send 
mammography reports to healthcare providers and the summary written in 
lay terms to patients whose mammograms have either ``Suspicious'' or 
``Highly Suggestive of Malignancy'' final assessment categories, which 
could lead to earlier definitive tissue diagnosis of malignancy and 
earlier start of treatment, and avoid, for the patient, the anxiety of 
a protracted waiting period;
    [cir] Require reporting to patients and healthcare providers to 
include an assessment of breast density, in order to provide them with 
additional information about their mammography and the potential 
limitations of their mammogram results so that patients and their 
healthcare providers can make informed healthcare decisions by;
    [ssquf] Retaining the two categories of density in the patient lay 
summary, but changing the wording from the comparative terms ``high 
density'' and ``low density'' to ``dense'' and ``not dense,'' in order 
to align with clinical practice and improve clarity to the patient.
    [ssquf] Revising the written lay summary of the results provided to 
the patient to contain one of the following breast density notification 
statements. The non-dense breast notification (see Sec.  
900.12(c)(2)(iii) in this final rule) now states, ``Breast tissue can 
be either dense or not dense. Dense tissue makes it harder to find 
breast cancer on a mammogram and also raises the risk of developing 
breast cancer. Your breast tissue is not dense. Talk to your healthcare 
provider about breast density, risks for breast cancer, and your 
individual situation.'' The dense breast notification (see Sec.  
900.12(c)(2)(iv) in this final rule) now states, ``Breast tissue can be 
either dense or not dense. Dense tissue makes it harder to find breast 
cancer on a mammogram and also raises the risk of developing breast 
cancer. Your breast tissue is dense. In some people with dense tissue, 
other imaging tests in addition to a mammogram may help find cancers. 
Talk to your healthcare provider about breast density, risks for breast 
cancer, and your individual situation.''
    [ssquf] Requiring that the written report of the results of the 
mammographic examination provided to the healthcare provider include 
information concerning an overall assessment of breast density, 
classified in one of the following categories: (A) ``The breasts are 
almost entirely fatty.'' (B) ``There are scattered areas of 
fibroglandular density.'' (C) ``The breasts are heterogeneously dense, 
which may obscure small masses.'' (D) ``The breasts are extremely 
dense, which lowers the sensitivity of mammography.''
    [cir] Require each mammography facility to implement policies and 
procedures to minimize the loss of mammography images and reports 
because the loss of these records can have a significant, negative 
impact on clinical care, and also specify the timeframe within which 
facilities must transfer original mammograms and copies of reports to 
patients, healthcare providers, and others because delays in the 
transfer of these records can lead to delays in diagnosis or treatment; 
and
    [cir] Clarify the minimum information that facilities must collect 
during the mammography medical outcomes audit because calculating and 
tracking these values is important to the evaluation of accuracy in 
detecting breast cancer, allowing facilities and interpreting 
physicians to review their performance and enact quality improvement 
measures.

D. Costs and Benefits of the Final Rule

    The quantified benefits of this rule are derived from reduced 
mortality and breast cancer treatment costs resulting from the breast 
density reporting requirements. The estimate of annualized benefits 
over 10 years ranges from $12.99 million to $232.69 million at a 7 
percent discount rate and $8.50 million to $266.09 million at a 3 
percent discount rate. Other benefits that we are not able to quantify 
include reduced cancer morbidity and improvements in the accuracy of 
mammography by

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improving quality control and strengthening the medical audit. The 
costs of the final rule include costs to mammography facilities to 
comply with the requirements and costs associated with supplemental 
testing and biopsies resulting from the breast density requirements. 
The estimate of annualized costs over 10 years ranges from $28.87 
million to $45.42 million at a 7 percent discount rate with a primary 
value of $36.31 million. Using a 3 percent discount rate, the 
annualized costs range from $27.61 million to $44.16 million with a 
primary value of $35.05 million.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
   Abbreviation or acronym                   What it means
------------------------------------------------------------------------
AB...........................  Accreditation Body.
ACR..........................  American College of Radiology.
ACS..........................  American Cancer Society.
AMR..........................  Additional Mammography Review.
BICOE........................  Breast Imaging Centers of Excellence.
BI-RADS......................  Breast Imaging--Reporting and Data
                                System.
CAD..........................  Computer-Aided Detection.
CD...........................  Compact Discs.
CDC..........................  Centers for Disease Control and
                                Prevention.
CDR..........................  Cancer Detection Rate.
CDRH.........................  Center for Devices and Radiological
                                Health.
CFR..........................  Code of Federal Regulations.
CRCPD........................  Conference of Radiation Control Program
                                Directors, Inc..
DBT..........................  Digital Breast Tomosynthesis.
DICOM........................  Digital Imaging and Communication in
                                Medicine.
DMQS.........................  Division of Mammography Quality
                                Standards.
ERG..........................  Eastern Research Group.
FDA, Agency, or we...........  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FFDM.........................  Full-Field Digital Mammography.
FRIA.........................  Final Regulatory Impact Analysis.
HIPAA........................  Health Insurance Portability and
                                Accountability Act of 1996.
IP...........................  Interpreting Physician.
MBI..........................  Molecular Breast Imaging.
MQSA.........................  Mammography Quality Standards Act of
                                1992.
MQSRA........................  Mammography Quality Standards
                                Reauthorization Acts of 1998 and 2004.
MRI..........................  Magnetic Resonance Imaging.
NAPBC........................  National Accreditation Program for Breast
                                Centers.
NMQAAC.......................  National Mammography Quality Assurance
                                Advisory Committee.
OMB..........................  Office of Management and Budget.
PACS.........................  Picture Archiving and Communication
                                System.
PGHS.........................  Policy Guidance Help System.
PHS Act......................  Public Health Service Act.
PPN..........................  Patient and Referring Physician
                                Notification.
PPV..........................  Positive Predictive Value.
QC...........................  Quality Control.
QI...........................  Quality Indicator.
SCA..........................  State Certification Agency.
U.S.C........................  United States Code.
USPSTF.......................  U.S. Preventive Services Task Force.
VA...........................  Department of Veterans Affairs.
------------------------------------------------------------------------

III. Background

    According to the Centers for Disease Control and Prevention (CDC), 
in 2018, the most recent year for which numbers are available, over 
254,000 women were diagnosed with breast cancer, and more than 42,000 
women died of the disease (Ref. 1). According to the National Cancer 
Institute of the National Institutes of Health, in 2020, over 276,000 
women were projected to be diagnosed with breast cancer, and over 
42,000 women were projected to die of the disease (Ref. 2). Breast 
cancer is rare in men, with approximately 2,300 new cases and 500 
deaths reported in the United States in 2017, according to the CDC 
(Ref. 3). Among women, however, breast cancer is now the most common 
non-skin cancer and the second leading cause of cancer deaths after 
lung cancer (Ref. 4). There are also disparities in both the incidence 
of breast cancer, and in mortality from breast cancer, by both race and 
ethnicity. In 2019, the latest year for which incidence data are 
available, in the United States, 30,450 new cases of breast cancer were 
reported among Black, Non-Hispanic women, and 6,600 Black, Non-Hispanic 
women died of this cancer. For every 100,000 Black, Non-Hispanic women, 
128 new breast cancer cases were reported and 28 Black, Non-Hispanic 
women died of this cancer (Ref. 1). Health disparity and equity 
considerations may exist as they relate to mammography practice and 
density notification, and we have considered sociodemographic 
differences in mammography practice and outcomes. This final rule 
provides standard requirements that help to ensure that all patients 
and providers receive complete and consistent breast density 
information in mammography reports.
    Early detection of female breast cancer, typically involving 
mammography, is the best means of preventing deaths that can result if 
the diagnosis is delayed until the onset of more advanced symptoms 
(Ref. 5). Mammography is a type of medical imaging that uses x-rays to 
create images (mammograms) of the internal structures of the breasts. 
There are three types of mammography referred to in

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this document: screen-film mammography, full field digital mammography, 
and digital breast tomosynthesis. In screen-film mammography, x-rays 
are transmitted through the breast and expose a sheet of x-ray film 
enclosed in a cassette. In full field digital mammography, the x-rays 
go through to an image receptor that is a radiation-sensitive 
electronic device or plate. Images are displayed on a computer 
workstation, and can, for example, be digitally magnified. Digital 
breast tomosynthesis also uses an electronic image receptor and a 
computer workstation, and obtains multiple images at different angles 
around the breast, then uses a computer to reconstruct a series of 
parallel images that resemble slices through the breast.
    Mammography can help detect breast cancer in its earliest, most 
treatable stages, when it is too small to be felt or detected by any 
other method (Ref. 6).
    However, as noted by the Government Accountability Office (GAO), a 
mammogram is among the most difficult radiographic images to interpret 
(Ref. 7). The mammogram must be of high quality for accurate image 
interpretation. If the image quality is poor, the interpreter may miss 
a cancerous lesion. Such a false negative diagnosis could delay 
treatment and result in an avoidable death or increased morbidity. It 
is equally true that poor quality images or inaccurate interpretations 
can lead to a false positive diagnosis when normal tissue is 
misinterpreted as abnormal. This could lead to needless anxiety for the 
patient, costly additional testing, and unnecessary biopsies.

A. Need for Amendments to Mammography Regulations

    Most of the requirements in our mammography regulations are over 20 
years old. As described below and in the proposed rule (84 FR 11669, 
March 28, 2019), major developments in understanding relating to the 
importance of certain breast anatomy on breast cancer risk have 
occurred, and FDA believes these developments should be reflected in 
our nationwide standard. In addition, we are updating our mammography 
regulations in response to several gaps that we have identified as we 
have implemented the current regulations. Current regulations do not 
require that a notification of breast density be part of the report 
provided to the healthcare provider or the lay summary provided to the 
patient. However, there is increasing interest in breast density 
reporting, and States are taking action. Between 2009 and June 2021, 38 
States have passed laws mandating notification of breast density (Ref. 
8). These State laws impose requirements that vary from State to State. 
To ensure all patients receive breast density information from their 
mammograms, and that such required baseline information is consistent, 
FDA is amending the mammography reporting requirements to require that 
the written report of the results of the mammographic examination 
provided to the healthcare provider and the lay summary of the results 
provided to the patient also include information concerning patient 
breast density. FDA is also requiring that both the mammography report 
and lay summary include basic mammography facility identification 
information. Technology has also advanced since the regulations were 
issued, so the amended regulations will make changes to reflect current 
mammography best practices and technologies.

B. Summary of Comments to the Proposed Rule

    In the Federal Register of March 28, 2019, FDA published a rule 
proposing amendments to the MQSA regulations. The comment period for 
the proposed rule closed on June 26, 2019. FDA received many comments 
on the proposed rule from several entities including medical device 
associations, industry, medical and healthcare professional 
associations, public health advocacy groups, law firms, and 
individuals. While several comments object to particular sections or 
subsections of the proposed rule, almost all comments voice support for 
the objective intent of the proposed rule, to establish updates to 
modernize the MQSA regulations to incorporate current science and 
mammography best practices.
    Some comments raise concerns or request clarification regarding:
     the scope of the MQSA regulations,
     failure of facility accreditation,
     retention of personnel records,
     mammography reports (including assessment categories) and 
lay summaries,
     breast density notification to patients and referring 
providers,
     requirements for image retention, transfer of original 
images, and release of copies,
     the mammography medical outcomes audit,
     patient and provider notification,
     the availability and use of various imaging modalities, 
and
     issues related to clinical decision-making.

C. General Overview of the Final Rule's Changes From the Proposed Rule

    FDA considered all comments received on the proposed rule and made 
changes, primarily for clarity and accuracy and to improve 
understanding of breast density notification language to healthcare 
providers and patients. On its own initiative, FDA is also making minor 
technical changes to make the withdrawal provisions clearer. The 
changes from the proposed rule include the following significant 
revisions, additions, and removals to the codified section:
     add or substitute the term ``provider'' or ``healthcare 
provider'' in several paragraphs in place of references to referring 
physician (Sec. Sec.  900.2(c)(2), 900.2(k), 900.2(ii), 
900.4(f)(1)(ii)(B), and 900.12(j)),
     revise language to clarify that no AB shall accept an 
application for accreditation from a facility that has had three 
consecutive failures (Sec.  900.4(a)(6)(ii)),
     include additional language requiring that facilities must 
retain personnel qualification records of former employees for at least 
24 months (Sec.  900.12(a)(4)),
     remove the proposed term ``digital accessory components'' 
and clarify the premarket requirements for devices used in mammography 
(Sec.  900.12(b)(2)(i)),
     include additional language clarifying that the required 
final assessment statements are only the words or phrases in quotation 
marks (Sec.  900.12(c)(1)(iv)),
     revise the requirement that clinical findings or symptoms 
in a patient whose mammogram assessment is negative or benign shall be 
``documented and addressed,'' rather than ``explained'' (Sec.  
900.12(c)(1)(iv)(A) and (B)),
     correct the reference to the two categories of breast 
density that shall be included in the lay summary provided to the 
patient (Sec.  900.12(c)(2)),
     include additional language clarifying the deadline for 
sending the mammography report to a self-referred patient when the 
assessment is ``Suspicious'' or ``Highly Suggestive of Malignancy'' 
(Sec.  900.12(c)(2)(i)),
     include additional language clarifying the situations in 
which a facility must maintain a system for referring self-referred 
patients to a healthcare provider (Sec.  900.12(c)(2)(ii)),
     revise the breast density notification language that must 
be included in lay summaries provided to patients with non-dense and 
dense tissue, respectively (Sec.  900.12(c)(2)(iii) and (iv)),

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     add language clarifying the length of time a facility is 
required to maintain the original mammograms and mammography reports in 
a permanent medical record of the patient by clarifying it is for the 
longer of the applicable Federal timeframes, or the mandated State or 
local timeframes (Sec.  900.12(c)(4)(i)),
     add language clarifying that a facility that ceases to 
perform mammography but continues to operate as a medical entity may 
retain, rather than transfer, its mammography records (Sec.  
900.12(c)(4)(v)),
     add or substitute the term ``patient'' in place of 
references to ``women'' or ``woman'' (Sec. Sec.  900.12(c)(4)(v) and 
(f)(1)),
     add the word ``audit'' to clarify that the use of certain 
terms applies to the medical outcomes audit (Sec.  900.12(f)(1)), and
     include an amendment changing the name of Healthcare 
Financing Administration to Centers for Medicare & Medicaid Services 
and updating the Center for Devices and Radiological Health (CDRH) 
office's name (Sec.  900.15(d)(1)).

IV. Legal Authority

    The MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is 
codified under section 354 of the Public Health Service (PHS) Act (42 
U.S.C. 263b). Under the MQSA, all mammography facilities, except 
facilities of the VA, must be accredited by an approved AB and 
certified by FDA (or an approved State certification agency) to provide 
mammography services (42 U.S.C. 263b(b)(1) and (d)(1)(iv)). FDA is 
making these amendments to the mammography regulations (set forth in 
part 900 (21 CFR part 900)) under section 354 of the PHS Act, and 
sections of the FD&C Act (sections 519, 537, and 704(e); 21 U.S.C. 
360i, 360nn, and 374(e)).

V. Comments on the Proposed Rule and FDA's Responses

    We received several sets of comments on the proposed rule by the 
close of the comment period, each containing one or more comments on 
one or more issues. We received comments from medical device 
associations, industry, medical and healthcare professional 
associations, public health advocacy groups, law firms, and 
individuals. We describe and respond to comments in sections A through 
Z of this document. We have numbered each comment to help distinguish 
between different comments. We have grouped similar comments together 
under the same number so that FDA's responses could be addressed by 
topic, instead of each comment addressed independently, and, in some 
cases, we have separated different issues discussed in the same comment 
and designated them as distinct comments for purposes of our responses. 
The number assigned to each comment or comment topic is purely for 
organizational purposes and does not signify the comment's value or 
importance or the order in which comments were received or considered.

A. General Comments on the Proposed Rule

    (Comment 1) FDA received many comments that express support for the 
MQSA proposed rule. Some comments express support for requiring density 
notification to patients and for establishing a national standard for 
such notification. Other comments respectively express support for the 
changes to the assessment categories, equipment quality control (QC), 
and requirements related to the provision of copies of mammograms. Some 
comments express support for the changes to the patient and provider 
notification in the event of compromised mammographic quality, which 
may represent a serious risk to human health, including the 
notification of nonphysician referring healthcare providers. Another 
comment compliments FDA on proposing amendments to the regulations, but 
recommends more frequent changes to respond promptly to new 
information.
    (Response 1) FDA appreciates the public support for the rule. FDA 
notes that the notification requirement regarding breast tissue density 
will enhance communication between patients, interpreting physicians 
(IP), and referring providers about this important factor in the 
effectiveness of mammography, and ensure that required baseline 
information is consistent. FDA also concludes that the other amendments 
to the regulations (part 900), including the changes to the equipment 
QC, assessment categories, provision of copies of mammograms, and 
notification to nonphysician healthcare providers when necessary, will 
also contribute to improvement in the quality of mammography and of 
communication about mammography between patients, IPs, and providers. 
Regarding the recommendation for more frequent changes, FDA notes that 
it continues to engage with the National Mammography Quality Assurance 
Advisory Committee (NMQAAC) and the professional and patient 
mammography communities regarding the need for changes to the 
regulations, but the frequency of amendments to the regulations is 
based on public health need and Agency resources.
    (Comment 2) Several comments express opposition to the proposed 
rule, including the following concerns: (1) that patients will not 
understand that dense tissue is a normal variant, and that the proposed 
breast density notification will increase their anxiety; (2) that 
breast cancer information to be given to a patient should be determined 
only by the patient's healthcare provider, or that the new requirement 
places a burden on the healthcare provider; (3) that all medical tests 
should be interpreted by clinicians with years of training who can 
identify the findings that require intervention; (4) that ultrasound 
rather than digital breast tomosynthesis (DBT) is the method to screen 
for cancers that are not mammographically visible; and (5) that there 
is no clinical recommendation to change patient management based on 
density or to perform additional ultrasound and magnetic resonance 
imaging (MRI) for screening dense breasts, and that current evidence 
contradicts the suggestion that supplemental screening based on breast 
density reduces breast cancer mortality. The latter comment also 
recommends that FDA's suggestion that additional imaging based on 
density alone may reduce breast cancer mortality should be deleted from 
the cost and benefit information of the rule.
    (Response 2) FDA acknowledges the comments and responds according 
to the numbered topics identified in Comment 2:
    (1-2) We note that breast tissue density is an important factor in 
mammography, both because of the masking effect of dense tissue, which 
limits the sensitivity of mammography (Refs. 9 to 11), and because 
density is an independent risk factor for the development of breast 
cancer (Refs. 12 to 15). FDA concludes that patients benefit from 
having information about their breast anatomy, and should be informed 
of their density so that the patient and their healthcare provider can 
make informed and shared decisions about the patient's healthcare. This 
rulemaking provides consistent language for communicating that 
information, as FDA concludes that there is also a benefit from 
obtaining baseline information in a consistent manner.
    The requirement to notify patients about their density is a 
baseline standard and does not constrain a healthcare provider from 
further discussing density with the patient. FDA has determined that 
the benefit of informing patients of their density

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outweighs both the burden on healthcare providers to provide density 
information and the risk of patient anxiety. FDA also notes that the 
Agency received many comments in support of the proposed rule and the 
breast density notification to patients. FDA also notes that 38 States 
have passed laws mandating notification of breast density, which may 
mitigate any potential burden on healthcare providers in those states 
(Ref. 8).
    (3) The MQSA provides authority to FDA to ensure quality 
mammography, and FDA has determined that the initial and continuing 
qualification requirements for IPs in Sec.  900.12(a)(1) are sufficient 
to ensure that mammograms, including density observations, are 
interpreted by personnel with adequate training to ensure quality 
mammography.
    (4-5) FDA acknowledges there are conflicting comments about the 
utility of other imaging modalities besides DBT, such as ultrasound, 
for supplemental screening of women with dense breasts; however, this 
final rule does not specify any particular supplemental imaging 
modality or other particular clinical management of patients with dense 
breasts. FDA has not indicated any particular additional steps in a 
patient's care based only on the mammogram, as individual situations 
and risk factors vary. FDA does not agree that it is appropriate to 
require the lay summary to include a discussion of all possible breast 
imaging modalities that may be more effective for some patients than 
mammography, which would encompass a significant amount of information 
that may be overwhelming and difficult for patients to interpret (see 
also Responses 57 and 60). We believe that it is more appropriate for 
the healthcare provider to discuss this information with the patient 
and engage in shared clinical decision-making based on the patient's 
individual circumstances. In this final rule, to allow patients and 
their healthcare providers to make shared decisions appropriate for 
each patient, the notification to these patients in Sec.  
900.12(c)(2)(iv) simply states, in part, ``In some people with dense 
tissue, other imaging tests in addition to a mammogram may help find 
cancers,'' and advises the patient to discuss their individual 
situation with their provider (see also Response 62). FDA notes that 
there is conflicting evidence about the effect of supplemental 
screening on breast cancer mortality, including Chiu in 2010 (Ref. 16), 
which found that dense tissue was associated with increased mortality 
from breast cancer. Therefore, FDA disagrees with the assertion that 
additional imaging based on breast density is not relevant, or that the 
mortality information should be deleted from the economic cost and 
benefit analysis of the rule.
    (Comment 3) A comment opposes more mammography regulation, and 
asserts:* that MQSA duplicates an American College of Radiology (ACR) 
program which ``certifies'' mammography facilities; that FDA dictating 
what IPs should say in their reports constitutes the practice of 
medicine; and that MQSA regulations are driving physicians out of 
mammography and limiting access. This comment recommends that FDA limit 
itself to its ``original mandate'' to ensure that mammography units 
produce quality images at a reasonable radiation dose.
    (Response 3) FDA disagrees with the comment. The ACR does not 
certify mammography facilities. The MQSA and its implementing 
regulations distinguish between accreditation and certification (see 42 
U.S.C. 263b(e) and (q); part 900, subparts A and C; see also Response 
145). The ACR is one of several FDA-approved accreditation bodies. 
Accreditation, which mainly focuses on the quality of clinical images 
and phantom images, is one of the prerequisites for facility 
certification by FDA or a State certifying agency. FDA does not specify 
which assessment category an IP should assign to a mammogram because 
this is more appropriately left to the provider's interpretation in the 
course of clinical decision-making. However, FDA does provide for the 
specific phrasing of the final assessment statements, which is 
standardized in accordance with the MQSA (42 U.S.C. 263b(a)(3)(B)) to 
ensure clear consistent communication between patients, IPs, and 
referring healthcare providers. FDA does not track practice rates of 
IPs or other facility personnel, but is not aware of information 
showing a decrease in access to mammography services; according to MQSA 
national statistics (Ref. 17), from November 2003 to February 2022, 
there has been a 4 percent decrease in the total number of certified 
facilities across the United States but a 29 percent increase in the 
total number of mammograms performed. Therefore, FDA concludes that 
these amendments to the MQSA regulations are neither duplicative of the 
ACR program nor have the existing MQSA regulations had a negative 
impact on access to mammography.

B. Scope of the MQSA Regulations

    (Comment 4) Several comments address the scope of the MQSA 
regulations, including comments that support the objectives of the 
proposed rule and/or provide the following recommendations: (1) FDA's 
proposal should remove xeromammography from the examples of 
mammographic modalities, which accompany the definition provided in 
proposed Sec.  900.2(z), and replace it with full-field digital 
mammography (FFDM); (2) FDA should remove screen-film mammography from 
these examples of modalities; (3) comments that FDA should also add the 
example of DBT as a modality; (4) that mammography IPs should also be 
qualified in breast ultrasound; and (5) that FDA should consider 
requiring mammography facilities to meet additional quality standards, 
such as the ACR's Breast Imaging Centers of Excellence (BICOE) program 
or the American Cancer Society (ACS) National Accreditation Program for 
Breast Centers (NAPBC), in addition to MQSA certification requirements.
    (Response 4) The scope of FDA's authority over mammography 
facilities is established in the MQSA, and, as described in the 
following and organized according to the numbered topics identified in 
Comment 4, FDA is adopting limited changes to this rule:
    (1-3) The MQSA and its implementing regulations apply only to 
radiological equipment used in facilities to perform mammographic 
modalities, which do not include breast sonography or other non-
mammographic modalities (42 U.S.C. 263b(a)(5) and (6), (b)(1) and (2)). 
However, FDA agrees that the modality of DBT has reached wide clinical 
use and should be listed as an example of a mammographic modality in 
this rule. Xeromammography is no longer in clinical use in the United 
States, and screen-film mammography is in limited use. Therefore, in 
this final rule, FDA is revising the examples of mammographic 
modalities to remove xeromammography, and to list screen-film 
mammography, FFDM, and DBT, all of which are currently in clinical use 
in the United States (see Sec.  900.2(z) in this final rule). Other 
modalities are covered by the requirements of the FD&C Act, and may be 
subject to performance standards prescribed pursuant to section 534 
(Electronic Product Radiation Control (EPRC)) of the FD&C Act.
    (4) FDA disagrees with the recommendation to require mammography 
IPs to also be qualified in breast ultrasound. As noted, the MQSA does 
not provide for the establishment of requirements related to breast 
sonography for IPs, other personnel, or facilities.

[[Page 15132]]

    (5) FDA notes that the ACR BICOE program covers other breast 
imaging modalities and interventions in addition to mammography, and 
the ACS NAPBC covers additional breast imaging as well as other aspects 
of clinical breast care. Therefore, these programs are not implemented 
within the scope of the MQSA regulations.
    (Comment 5) Several comments recommend removing the exclusion of 
invasive interventions for biopsy or localization in Sec.  900.2(aa)(1) 
so that they are included within the scope of the MQSA regulations. A 
separate comment recommends that post-procedure mammograms for marker 
placement should not be regulated under the MQSA.
    (Response 5) FDA disagrees with these comments. The MQSA was 
enacted by Congress in 1992 due to evidence of poor quality in 
mammographic imaging in the United States at that time. However, since 
then, the implementation of the MQSA and the widespread adoption of 
digital imaging technologies and other technological and QC advances 
have contributed to quality improvement not only in screening and 
diagnostic mammography, but also in interventional mammography. The 
majority of personnel performing interventional mammography also 
perform non-interventional mammography and are therefore subject to the 
requirements of the MQSA. Currently, FDA is not aware of information 
showing significant quality problems with interventional mammography in 
the United States. At this time, FDA concludes that it is not necessary 
to introduce regulations covering interventional mammography.
    Unlike the targeted images of a small portion of the breast that 
are typically performed during localization or intervention, a post-
procedure mammogram typically includes the entire breast; may be 
performed using general mammography equipment rather than dedicated 
interventional equipment; and is often logged, reported, and charged as 
an independent examination, separate from the interventional procedure 
that precedes it. Therefore, FDA concludes that this post-procedure 
examination should continue to meet the quality standards mandated 
under the MQSA regulations. As discussed in Responses 32, 38, and 39, 
this final rule includes the assessment statement ``Post-Procedure 
Mammogram for Marker Placement,'' which may be appropriate for such 
mammograms (see Sec.  900.12(c)(1)(iv)(G)).
    (Comment 6) Several comments suggest that the MQSA regulations 
should be expanded to cover other imaging modalities in addition to 
mammography, including ultrasound and MRI.
    (Response 6) The MQSA was passed by Congress in 1992 in response to 
evidence of poor quality in mammographic imaging in the United States 
at that time (42 U.S.C. 263b). As we noted in Response 4, the MQSA 
applies only to mammographic imaging. As such, the MQSA does not 
provide for the establishment of requirements related to breast 
sonography or MRI, and the MQSA regulations have not been amended to 
include such modalities.
    (Comment 7) A comment recommends that medical offices be required 
to display posters depicting breast anatomy and to distribute 
literature regarding breast physical examination.
    (Response 7) FDA disagrees with the comment. FDA notes that the 
shared clinical decision-making process generally takes place between 
the patient and their referring healthcare provider or other clinical 
healthcare provider, not with the interpreting physician at the 
mammography facility, and therefore does not agree that there is a need 
to require posters of breast anatomy at mammography facilities, 
although facilities may choose to display patient education resources. 
Referring healthcare providers who order mammography studies, and are 
not themselves the reviewing physicians of the clinical images at issue 
(see 42 U.S.C. 263b(a)(8)), are not generally subject to the 
requirements specified in the MQSA and its implementing regulations. 
Clinical healthcare providers may provide such patient education 
resources if they choose to do so, but this recommendation is outside 
the scope of this final rulemaking.

C. Repeated Failure To Achieve Accreditation

    (Comment 8) Several comments express concerns with the number and 
type of accreditation failures after which an AB may not accept a 
facility's application for accreditation for 1 year. One comment 
recommends that this provision be revised to apply to a facility that 
has ``failed to become accredited after four consecutive failures''; 
another comment recommends that this be revised to apply to a facility 
which has ``failed to become accredited after four failed accreditation 
cycles''; and another comment recommends that this be revised to apply 
to a facility that has had ``three consecutive failures of 
accreditation granting cycles.'' Two of these comments also express 
concern over the effect of this provision on the timing of the AB's 
onsite visit to the facility to provide oversight and hands-on 
training.
    (Response 8) FDA disagrees with these comments. The Agency believes 
that a facility that has failed to become accredited after three 
consecutive attempts should not be permitted to become accredited until 
it has implemented all necessary corrective actions and any other 
necessary changes, such as additional training or personnel changes, 
specific to the facility's individual situation (see Sec.  
900.4(a)(6)(ii) in this final rule). The Agency believes that the 1-
year waiting period will allow the facility sufficient time to make 
these corrections. Regarding the terminology used for these failures, 
the Agency notes that the various FDA-approved ABs currently use 
different terms, such as ``deficiency'' and ``failure,'' for the 
initial failure to become accredited. Therefore, FDA concludes that the 
phrasing of the provision, ``If a facility has failed to become 
accredited after three consecutive attempts,'' is sufficiently clear 
and broad to apply to facilities accredited by any AB. Regarding the AB 
onsite visits to facilities, the various ABs currently have different 
policies for the timing of their onsite visits, each respectively 
approved by FDA. FDA notes that, upon publication of this final rule, 
the ABs can review and, if needed, revise their procedures to 
accommodate the change in the regulations, including to account for any 
procedures to address tracking the number of facility applications 
submitted to an AB, and submit their proposed policy changes to FDA for 
review and approval.
    (Comment 9) Some comments recommend that facilities not be allowed 
to switch ABs in order to avoid this 1-year exclusion after three 
consecutive failed attempts at accreditation.
    (Response 9) FDA agrees with this recommendation. Accordingly, we 
are revising Sec.  900.4(a)(6)(ii) to state ``If a facility has failed 
to become accredited after three consecutive attempts, no AB shall 
accept an application for accreditation from the facility for a period 
of 1 year from the date of the most recent accreditation failure.''
    (Comment 10) Some comments address the situation of a facility with 
more than one mammography unit, of which one unit fails to receive 
accreditation but one or more units receive accreditation. These 
comments recommend either that the facility be

[[Page 15133]]

permitted to continue to perform mammography with the remaining 
accredited unit(s), or that the facility's individual situation be 
evaluated by the AB to determine the appropriate course of action.
    (Response 10) We appreciate the comment, but note that the 
commenter misunderstood the proposed amendment. The provision that was 
proposed for revision refers to overall facility accreditation (see 
Sec.  900.4(a)(6)(ii) in both the proposed and final rule) as opposed 
to individual unit accreditation (see Sec. Sec.  900.4(e) and 
900.12(e)). FDA acknowledges that some reasons for the failure of a 
facility to receive accreditation, such as a mechanical deficiency in a 
mammography unit, may be limited to that particular unit, while other 
reasons for failure, such as poor patient positioning, may extend to 
the practice of mammography throughout the entire facility. The various 
FDA-approved ABs have policies to address the requirements for 
accreditation of a facility that has multiple mammography units. The 
ABs also have policies regarding the circumstances, including poor 
quality noted on accreditation images, which may prompt an AMR to 
assess the overall quality of mammography at a facility. FDA believes 
that if a facility fails three consecutive attempts to receive 
accreditation, it should be subject to a 1-year waiting period to allow 
the facility adequate time to address issues that have prevented 
accreditation (see also Response 8). FDA anticipates that the ABs may 
review their policies and procedures, and if needed, may decide to 
submit revised policies and procedures to FDA (see Sec.  900.4(a)(8)) 
to conform to this provision of the final rule; if the ABs do so, the 
Agency will review and consider the ABs' proposals.
    (Comment 11) A comment recommends that a facility under its third 
provisional certificate have all exams double-read by a qualified IP 
from an accredited and certified facility, until the applying facility 
either fails or receives accreditation.
    (Response 11) FDA disagrees with adding this requirement to the 
regulations. Such increased oversight of facilities with provisional 
certificates is not appropriate in this circumstance, considering that 
there are existing regulations requiring corrective action. Depending 
on the specific circumstances of the failure, the applying facility's 
AB will either have required the facility to perform corrective action 
after the first two failures, or will first have performed an AMR to 
determine the extent and severity of the quality problems at the 
facility (see Sec.  900.4(a)(1)(i)), and will have required corrective 
action (see Sec. Sec.  900.4(a)(1)(ii) and 900.4(b)(3)). Corrective 
action is individualized by the AB for the specific facility, but often 
includes requirements for additional training for the facility 
personnel. Therefore, FDA concludes that the IP and other personnel 
will be sufficiently trained to correct the quality problems at the 
facility.
    (Comment 12) A comment recommends clearer language about the 
facility's next steps, corrective action, ``necessary information,'' 
and the duration of effectiveness of a provisional certificate for a 
facility that has had a year-long waiting period after having failed to 
become accredited after three consecutive attempts. The same comment 
recommends clearer language about FDA's action if a facility fails 
accreditation for a third time, and also recommends that a facility be 
permanently ineligible to provide mammography services after a fourth 
failure.
    (Response 12) Regarding improving clarity about the process for 
reapplying for accreditation, FDA disagrees with this comment. The 
process is subject to the policies and procedures of each AB, and the 
Agency notes that the necessary information as well as the steps to 
apply for accreditation are clearly specified by each AB's policies and 
procedures (see, e.g., Sec.  900.4(e) and (f)). We further note that 
the duration of effectiveness of a provisional certificate is already 
discussed in current Sec.  900.11(b) and (c). Regarding the commenter's 
recommendation that a facility be ineligible to provide mammography 
services after a fourth failure, FDA concludes that a facility that has 
performed all required corrective action may reapply for accreditation, 
but notes that, in accordance with AB policies, an AB may take into 
account the facility's entire history and practice of mammography, such 
as a lack of improvement after multiple corrective actions, in 
considering a decision to suspend or revoke the facility's 
accreditation, or to revoke its application for accreditation (see 
Sec.  900.4(a) and (b)). Also, the AB must notify FDA if it believes 
that a facility's practice of mammography may pose a serious risk to 
human health (see Sec.  900.4(a)(2)). Likewise, the Agency may take 
into account the facility's entire history in determining that its 
practice poses a serious risk to human health and in considering the 
suspension or revocation of a facility's certificate (see Sec.  
900.14). Therefore, FDA concludes that a facility whose practice 
warrants such a determination will be identified, and appropriate 
accreditation and/or certificate actions will be taken. Finally, as 
noted in Responses 8 and 10, if the ABs review their policies and 
procedures in light of this provision of the final rule and decide to 
submit revised policies and procedures to FDA (see Sec.  900.4(a)(8)), 
the Agency will review and consider those policies and procedures.

D. Retention and Release of Personnel Records

    (Comment 13) Several comments were submitted that recommend 
specifying the amount of time that a facility must retain personnel 
records for employees that are no longer at that facility. Some 
comments recommend that facilities only be required to keep the records 
for former employees from the time of one inspection to the time of the 
next annual inspection. Another comment recommends that facilities only 
be required to give employees their records at the time of the 
employees' departure. Other comments recommend that facilities be 
required to keep personnel records for former employees for 24 months 
following the departure of that employee.
    (Response 13) FDA agrees that a minimum length of time should be 
included in the amendments to the regulations for the personnel records 
retention requirement. We note that previous employees may need access 
to these personnel records to document their MQSA qualifications to 
permit them to provide mammography services at other facilities. 
Accordingly, we conclude that former employees should have an 
opportunity to obtain their personnel records for a time period beyond 
the immediate date of their departure from a facility. After 
considering the comments on this requirement, we are revising and 
finalizing the provision as follows: ``Records of personnel no longer 
employed by the facility must be maintained for no less than 24 months 
from the date of the departure of an employee, and these records must 
be available for review at the time of any annual inspection occurring 
during those 24 months'' (see Sec.  900.12(a)(4) in this final rule). 
FDA has made this change to the codified language to clarify that the 
records must be available during an inspection that can occur at any 
point during the 24 months after which an employee departs, which 
better aligns with the records retention requirement and is distinct 
from any FDA determination regarding compliance with the MQSA and its 
implementing regulations that would

[[Page 15134]]

otherwise occur following the next annual inspection after the employee 
departs. FDA is also revising the provision to distinguish and clarify 
the requirements for providing such records to current and former 
employees, as follows: ``The facility shall provide copies of these 
personnel records to current interpreting physicians (IPs), radiologic 
technologists, and medical physicists upon their request. Facilities 
must provide personnel records to former employees if the former 
employees communicate their request within 24 months of the date of 
their departure. If it has been greater than 24 months and the facility 
has maintained those records, the facility must provide those records 
to former employees upon request.''
    (Comment 14) Rather than providing records after an employee 
leaves, a comment recommends that facilities should require a 
qualifications package for each employee that would only be retained 
until after the first inspection following the hiring of that employee, 
at which point the package should be given to the employee to retain, 
and any continuing experience or other information would be accumulated 
and maintained from the time that the qualifications package is given 
to the employee.
    (Response 14) FDA disagrees with this comment. Personnel 
qualifications under Sec.  900.12(a) include both initial and 
continuing requirements, and both components are reviewed at the time 
of inspection (Ref. 18). The personnel record keeping requirements 
apply to facilities, not individual personnel (see 42 U.S.C. 
263b(d)(1)(A)(ii)(III), (B)(ii)(II), and (g)(1)(C), and Sec.  
900.12(a)(4)). Therefore, each facility is required to document the 
qualifications of its personnel. Also, FDA is concerned that the 
comment's recommended changes would not be as effective as the current 
system in maintaining the necessary documentation of qualification of a 
facility's personnel.
    (Comment 15) A comment recommends that FDA specify a penalty for 
facilities that do not adhere to the personnel records requirement.
    (Response 15) FDA agrees with this comment. A facility that does 
not comply with the personnel records retention requirement (see Sec.  
900.12(a)(4) in this final rule) may receive a citation at the time 
that this failure is identified at inspection, in a manner similar to 
other comparable violations (Ref. 18). The totality and severity of 
violations identified at inspection determine the consequences for the 
facility.
    (Comment 16) A comment recommends that facilities should only need 
to provide personnel records to former employees if the employee 
submits the request in written format.
    (Response 16) FDA disagrees with this recommendation. FDA concludes 
that requiring requests from former employees for their personnel 
records to be transmitted in writing may be overly burdensome to both 
facilities and former employees because it may delay how quickly a 
facility would receive the request, and may reduce access to 
mammography by delaying how quickly those records could be provided to 
facilities evaluating the qualifications of new personnel. FDA believes 
that minimizing barriers to the provision of qualification records to 
former employees will facilitate the hiring of these personnel at other 
facilities, thus preserving patient access to mammography services.
    (Comment 17) A comment recommends that facilities give personnel 
records to personnel when the facility ceases performing mammography, 
and it also asks for clarification as to whether the phrase ``ceases to 
perform mammography'' refers to the facility or to specific personnel.
    (Response 17) The final rule states that ``Before a facility closes 
or ceases to perform mammography services, it must make arrangements 
for access by current and former personnel to their MQSA records,'' and 
that this may be accomplished by either ``the permanent transfer of 
these records to the personnel or the transfer of the records to a 
facility or other entity that will provide access to these records for 
no less than 24 months from the date of facility closure or cessation 
of mammography services'' (see Sec.  900.12(a)(4)). FDA believes that 
these two pathways provide adequate access for personnel to their MQSA 
records. The primary reason that personnel may require access to their 
qualification records is that they are continuing to practice 
mammography at other facilities. Therefore, the clause ``Before a 
facility closes or ceases to provide mammography services'' (see Sec.  
900.12(a)(4) in this final rule) refers to the closure or cessation of 
mammography services of a facility and not to the cessation of specific 
personnel from practicing mammography.
    (Comment 18) A comment requests that FDA provide guidance on how to 
demonstrate compliance with the requirement to provide access for 
personnel to their MQSA records when a facility closes or ceases 
mammography services.
    (Response 18) The Agency believes that the current regulations, and 
the regulations being revised at Sec.  900.12(a)(4) in this final rule, 
are clear on the requirements regarding personnel records for 
facilities that close or cease to provide mammography services. 
Facilities that close or cease to perform mammography services should 
inform their AB, which will assist them in complying with record 
retention obligations and other applicable MQSA requirements. (Ref. 
19.)

E. Digital Accessories

    (Comment 19) Several comments request that FDA provide additional 
clarification of the definition of a digital accessory component, or 
ask for clarity on whether specific equipment, such as display 
monitors, are included in this category.
    (Response 19) FDA defines an ``accessory'' of a device as ``A 
finished device that is intended to support, supplement, and/or augment 
the performance of one or more parent devices'' (Ref. 20). Because a 
device accessory is a ``device,'' we believe the broader term 
``devices'' is simpler and allows for a clearer understanding of the 
mammography regulations. In this final rule, we are revising Sec.  
900.12(b)(2)(i) for clarity, to state that ``All devices used in 
mammography must have met the applicable FDA premarket authorization 
requirements for medical devices of that type and intended use.'' This 
applies to devices used in the acquisition, processing, or display of 
digital mammographic images. For example, a display device used in the 
interpretation of digital mammographic images generally needs to have 
510(k) clearance prior to being used in a mammographic facility. Not 
all equipment needs clearance or approval; for example, some devices, 
such as medical image storage devices, may be exempted from premarket 
notification requirements. (It is important to consult the appropriate 
classification regulation to determine the premarket authorization 
requirements.)
    (Comment 20) Several comments recommend changing the effective date 
for the digital accessory component requirements from 18 months to 24 
months.
    (Response 20) FDA disagrees with the recommendation to extend the 
effective date to 24 months after publication of this final rule. FDA 
considers 18 months to be a reasonable amount of time for facilities to 
achieve compliance with this requirement, based on both previous 
experience with the 18-month effective date specified in the 1997 MQSA 
final rule (62 FR 55852, October

[[Page 15135]]

28, 1997) and the need for timely effectiveness of this rule.
    (Comment 21) Other comments recommend that, for QC testing of 
digital accessories, in addition to the use of QC procedures in the 
manufacturer's manual, the proposed rule should add an option to use 
the ACR QC manual.
    (Response 21) Alternative requirements for Sec.  900.12 quality 
standards are addressed in Sec.  900.18. The current ``ACR Digital 
Mammography Quality Control Manual for Full-Field Digital Mammography 
Systems and Supplement for Digital Breast Tomosynthesis Mammography 
Systems'' has been approved as applicable to any facility as 
alternative standard #24 (Ref. 21; see also Sec.  900.18(f)). The use 
of approved alternative standards such as the ACR QC manual as they 
relate to digital accessories remains acceptable; however, since the 
ACR manual may undergo future revisions, and a revision would have to 
undergo FDA review to determine whether it is at least as effective in 
ensuring quality mammography as the standard it proposes to replace, 
the current ACR manual is not specified in the codified section of the 
final rule.
    (Comment 22) A comment expresses concern that a facility using 
displays that are not specific for mammography or for a use that could 
include mammography would be in violation. Another comment suggests 
that, if a manufacturer QC procedure exists, there is no need for FDA 
premarket authorization of displays, and continues that there is no 
need for FDA premarket authorization for equipment since there are 
alternative standards for QC from the ACR. A comment also asserts that 
the process by which FDA clears or approves displays is not 
transparent.
    (Response 22) These comments tend to confuse two separate 
processes: (1) the premarket approval or clearance of a medical device 
as described in 21 CFR 807.81 and (2) the MQSA requirements for 
mammography facilities under 42 U.S.C. 263b and the implementing 
regulations under part 900. Medical devices are subject to FDA's 
medical device requirements, which may include premarket authorization. 
Mammography equipment must also meet MQSA regulatory requirements that 
govern its use in a mammography facility.
    FDA premarket authorization of a display intended for use in 
interpreting mammography images is a premarket device requirement; 
however, after this final rule becomes effective, any applicable 
premarket authorization requirements will also be required under the 
MQSA quality standards for use of the display for interpreting 
mammography images (see Sec.  900.12(b)(2)(i) in this final rule). 
Therefore, FDA agrees with the comment that a facility interpreting 
mammograms using a display that has not met the applicable FDA 
premarket authorization requirements for use in interpreting 
mammography images would generally be in violation of the MQSA quality 
standards regulations.
    The QC tests for a display are another MQSA quality standard 
required for use of that display for mammography interpretation (see 
Sec.  900.12(e)(6)), but the existence of QC tests for a display is 
generally not sufficient to satisfy all FDA premarket regulatory 
requirements that may apply to the device. Likewise, the existence of a 
QC program for other mammography equipment does not generally satisfy 
all the premarket regulatory requirements applicable to that equipment. 
Regarding the comment that states there are QC procedures available 
from ACR, we also note that facilities that adopt the ACR QC manual for 
the QC of their FFDM or DBT system may not limit the use of the manual 
to a single piece of equipment or accessory, such as a display, while 
following a different QC program (such as the manufacturer's QC manual) 
for the mammography unit (Refs. 21 and 22), and we reiterate that the 
existence of a QC program does not necessarily reflect that any 
applicable FDA premarket authorization requirements are being met.
    Regarding the comment on the clarity of FDA premarket review 
process for mammography displays, the premarket requirements for 
displays that are intended to be used in interpreting mammography 
images, among others, are discussed in 21 CFR 892.2050 and FDA's 
guidance ``Display Devices for Diagnostic Radiology'' (Ref. 23).
    (Comment 23) A comment states that the requirement that mammograms 
submitted for interpretation be ``presented in the mammographic 
modality'' in which they were originally produced is unclear, and 
suggests that mammograms are being read on a device not intended for 
mammography. The comment also recommends including a statement to 
caution facilities that they should be aware of potential compatibility 
issues in their imaging/reading chain.
    (Response 23) The requirement that mammograms be presented for 
interpretation in the mammographic modality in which they were 
originally produced means, for example, that screen-film mammograms 
must be presented for interpretation as the original hardcopy films, 
and not digitized or scanned. FDA does not agree that this requirement 
would reasonably be interpreted to mean that mammograms are being read 
on equipment not intended for mammography. FDA notes that all equipment 
used for mammography must be specifically designed for mammography (see 
Sec.  900.12(b)(2) in this final rule) and that all devices used in 
mammography (including displays, as discussed in Responses 19 and 22) 
must have met the applicable FDA premarket authorization requirements 
for medical devices of that type and intended use (see Sec.  
900.12(b)(2)(i) in this final rule). FDA agrees that facilities are 
responsible for ensuring that any equipment they use in the 
acquisition, processing, interpretation, retention, and retrieval of 
mammographic images be compatible, in order to facilitate mammography 
practice and to allow compliance with the record retention, transfer, 
and release provisions in Sec.  900.12(c)(4) of this final rule. The 
Agency does not believe it is necessary to include a cautionary 
statement in the final rule, as facilities in the course of their 
practice of mammography will readily be able to determine whether their 
equipment is interoperable.

F. Facility Identification Information in Mammography Report and Lay 
Summary

    (Comment 24) A comment requests clarification, in the case of a 
facility that is associated with a centralized entity that sends 
reports and summaries, as to whether the centralized entity may be the 
only name on the report or summary, whether an abbreviated name for the 
actual facility is acceptable, and whether an alias (e.g., ``Doing 
Business As'' or DBA) is required to appear on the report. The 
commenter also requests clarification of the required timeframe for a 
facility to report a name change.
    (Response 24) FDA distinguishes each mammography facility based on 
its physical location (see 42 U.S.C. 263b(a)(3) and Sec.  
900.12(c)(1)(ii) in this final rule). Healthcare networks that offer 
mammography services at several locations are accredited and certified 
as several separate facilities. The name recognized by FDA for a 
facility is the name under which the facility is accredited by its AB 
(see Sec.  900.11(b)). Therefore, the facility identification 
information in the report to the healthcare provider (see Sec.  
900.12(c)(1)(ii) in this final rule) and the lay summary sent to the 
patient (see Sec.  900.12(c)(2) in this final rule) must be unique to 
the actual facility where the

[[Page 15136]]

mammogram was performed, and must include the name under which the 
facility is accredited and certified. A change to a facility's name 
must be submitted to the facility's AB, and is subsequently conveyed to 
FDA by the AB (see Sec.  900.11(b)); therefore, the timeframe for 
reporting a name change, as well as the acceptability of an alias or 
DBA, are governed by the policies of the AB.
    (Comment 25) A comment recommends that FDA specify whether the 
report identification information is required for a ``consult report.''
    (Response 25) The commenter's reference to a ``consult report'' is 
not clear. Typically, a mammogram will be interpreted only once, and 
will have only a single report and a single lay summary. In some cases, 
a mammogram that has already been interpreted and for which a report 
and lay summary have been issued is subsequently presented to another 
IP for a repeat interpretation or ``second opinion.'' By referencing 
determinations made by an ``outside consultant,'' the commenter may 
either be referring to a later IP rendering such an additional opinion 
on an examination that has already been interpreted, or may be 
referring to an IP who is a contractor to a facility (rather than a 
facility employee) rendering the initial or sole interpretation. If the 
comment refers to the reinterpretation of a previously interpreted 
mammogram, the second (or subsequent) IP must also meet the existing 
personnel requirements of Sec.  900.12(a)(1), and must separately 
comply with the reporting requirements of Sec.  900.12(c) in this final 
rule. To help distinguish them from the original interpretation, we 
recommend that a second (or subsequent) report and lay summary be 
identified as a second opinion or similar term. If the comment refers 
to a report rendered by an IP who is a contractor or consultant to the 
facility rather than a facility employee, that IP must also meet all 
personnel requirements, and the report and lay summary must meet all 
reporting requirements.
    (Comment 26) Several comments address the required identification 
information in the lay summary. A comment asserts that most facilities 
already provide facility identification in the lay summary. Another 
comment recommends that the patient name and the facility information 
be required in the lay summary. A separate comment recommends that the 
summary include separately both the contact information of the facility 
or business where a patient can request images and records, and the 
actual physical location where the mammography services were provided. 
Another comment recommends that FDA not specify the information that is 
required ``at a minimum,'' but rather specify all required information, 
including the facility telephone number, email address, and 
instructions for clear communication.
    (Response 26) FDA agrees that there have been situations in which 
the facility information in the lay summary was inadequate. FDA 
concludes that the expanded requirements in Sec.  900.12(c)(2) of the 
final rule will enhance communication between the facility, the 
patient, and the referring provider, and lead to improved patient care. 
Because, as noted in Response 24, FDA identifies each facility by its 
unique location (see Sec.  900.12(a)(1), in both the proposed and final 
rule), the location of the facility where the mammogram was performed 
must be included in the lay summary. In response to the comment 
recommending that a facility's parent company information be included 
in the header, FDA does not agree that such additional information 
should be required because FDA identifies each facility by its unique 
location and not by any affiliation with a network or company. However, 
a facility may choose to include additional information about a 
healthcare network, affiliated site, or records storage site. In 
addition, FDA agrees with the recommendation that the facility 
telephone number be included with the lay summary, and notes that Sec.  
900.12(c)(2) of both the proposed and final rule include this 
requirement. Because in FDA's experience, some facilities do not have 
email addresses, and some others communicate through patient portals, 
FDA disagrees with the recommendation to require that the lay summary 
include an email address or instructions for clear communication 
between the patient and the facility. FDA notes that facilities may 
choose to include this additional contact information.
    (Comment 27) A comment recommends that the lay summary be required 
to include the name of the IP, so that patients will know who is 
involved with their care, and if dissatisfied, can request a different 
IP.
    (Response 27) FDA does not believe it is necessary to require the 
name of the IP as part of the lay summary. A facility may choose to 
include this information, but it is not required. The Agency notes that 
the lay summary is prepared after the examination has been interpreted, 
so adding the name of the IP to the lay summary will not intervene 
early enough for the patient to request a different IP. A patient who 
prefers a particular IP would have to discuss such a request with the 
facility staff before the mammogram is interpreted. After 
interpretation by the IP, FDA notes that the name of the IP is included 
in the report to the referring provider, per Sec.  900.12(c)(1)(iii), 
and the patient can request the name either from the facility or from 
the referring provider.

G. Final and Incomplete Assessments and Lay Summaries

    (Comment 28) A comment recommends that FDA clarify the limits of 
the required assessment language for each mammographic assessment 
category, and recommends that the rule preserve the concept that the 
assessment statement is required, while the explanatory language is not 
required to be included in the mammography report.
    (Response 28) For each assessment category, the required assessment 
statement is only the word or phrase in quotation marks (see Sec.  
900.12(c)(iv) in this final rule). As in the existing regulations, each 
assessment statement, identified in quotation marks, is followed by 
explanatory language, which is not in quotation marks; this explanatory 
language not in quotation marks is intended to provide an explanation 
of the assessment category in order to promote its consistent use, but 
it is not part of the assessment statement, and is not required to be 
included in the report to the referring healthcare provider nor in the 
lay summary to the patient. This format of an assessment statement in 
quotation marks followed by explanatory language outside the quotation 
marks was also used in the existing regulations, and FDA is not aware 
of significant confusion caused by this format. In both the proposed 
and final rule, Sec.  900.12(c)(1)(iv)(A) through (G), the explanatory 
language is distinguished from the assessment statement by the closing 
quotation mark at the end of the assessment. For added clarity, in this 
final rule we are revising Sec.  900.12(c)(1)(iv) to add the 
parenthetical clarification, ``the assessment statement is only the 
word or phrase within the quotation marks.'' We are also revising Sec.  
900.12(c)(1)(iv) to replace the colon with a period within the 
quotation marks surrounding each assessment statement, to further 
clarify the distinction between the required statement and its 
explanatory language.
    (Comment 29) A comment asserts that the negative and benign 
assessment categories are functionally equivalent and recommends 
combining them.
    (Response 29) FDA disagrees with this comment. Although we 
acknowledge

[[Page 15137]]

that in most instances there may be no difference in clinical 
management between patients with negative mammograms and those whose 
mammograms show benign findings, the Agency notes that IPs often 
distinguish between these examinations and identify benign findings if 
they are present; therefore, we conclude that the negative and benign 
assessment categories should remain separate.
    (Comment 30) A comment stated that the new ``Benign'' phrasing 
would be confusing to patients if sent to them. Another comment 
recommends that the verbiage explaining the term ``Benign'' not be 
required to be in the report.
    (Response 30) FDA disagrees with the comment that the ``Benign'' 
phrasing would be confusing to patients. We note that the explanatory 
language following the word ``Benign'' in Sec.  900.12(c)(1)(iv)(B) in 
this final rule is not part of the assessment statement. It is intended 
only to explain the category to IPs and other facility personnel, and 
is not required to be included in the report to the referring provider 
nor in the lay summary to the patient; therefore, patients are unlikely 
to be presented with such phrasing. We further note that even the word 
``Benign'' need not be stated to the patient; a patient summary in lay 
terms of either a negative or a benign report might say, for example, 
``Your mammogram is normal,'' ``Your mammogram shows no sign of 
cancer,'' or similar phrasing.
    (Comment 31) A comment recommends that, in the parenthetical 
statement ``if the interpreting physician is aware of clinical findings 
or symptoms, despite the benign assessment, these shall be explained'' 
(in proposed Sec.  900.12(c)(1)(iv)(B)), the word ``explained'' should 
be revised to ``documented.''
    (Response 31) FDA agrees in part with the comment. The 
parenthetical statement in the explanation of the benign assessment 
category is intended to mirror the existing parenthetical statement in 
the explanation of the negative assessment category (in Sec.  
900.12(c)(1)(iv)(A)), ``if the interpreting physician is aware of 
clinical findings or symptoms, despite the negative assessment, these 
shall be explained.'' However, FDA agrees with the commenter that the 
IP may not always be able to explain the clinical finding or symptom in 
a patient with a negative or benign mammogram. Furthermore, the IP may 
have clinical information from a patient history form or interview that 
is not yet known to the referring healthcare provider, and is therefore 
not addressed by the subsequent requirement in proposed Sec.  
900.12(c)(1)(vii) that ``All clinical questions raised by the referring 
healthcare provider shall be addressed in the report to the extent 
possible, even if the assessment is negative or benign.'' FDA believes 
that this pertinent clinical information should be documented and, if 
possible, explained or otherwise addressed. Therefore, the Agency 
concludes that these parenthetical statements should be retained, with 
revision as suggested, for the negative assessment category (see Sec.  
900.12(c)(1)(iv)(A)) and for the benign assessment category (see Sec.  
900.12(c)(1)(iv)(B)). As such, FDA is revising the parenthetical 
language in this final rule for the negative and benign categories, 
respectively, to state that ``if the interpreting physician is aware of 
clinical findings or symptoms, despite the negative assessment, these 
shall be documented and addressed,'' and ``if the interpreting 
physician is aware of clinical findings or symptoms, despite the benign 
assessment, these shall be documented and addressed.''
    (Comment 32) A comment requests confirmation that the new 
assessment categories are part of the alternative standard approved in 
2003. Another comment requests confirmation that the ``FDA-approved'' 
equivalent wording for assessment categories is still permitted, and 
asserts that IPs should have the option to report equivalent language 
rather than the assessment statements in the regulations.
    (Response 32) The new assessment statement ``Post-Procedure 
Mammogram for Marker Placement'' (Sec.  900.12(c)(1)(iv)(G)) is 
identical to alternative standard #12 approved by FDA in 2003 (Ref. 
24). The new assessment statements ``Incomplete: Need Additional 
Imaging Evaluation'' (Sec.  900.12(c)(1)(v)(A)) and ``Incomplete: Need 
Prior Mammograms for Comparison'' (Sec.  900.12(c)(1)(v)(B)) are 
derived from alternative standard #11 approved by FDA in 2003 (Ref. 
25). The statements ``Incomplete: Need Additional Imaging Evaluation'' 
and ``Incomplete: Need Prior Mammograms for Comparison'' represent the 
division of the single assessment statement in alternative standard #11 
into two new assessment statements. These statements reflect FDA's 
recognition that some mammograms require comparison for interpretation, 
while some mammograms require additional imaging to reach a final 
interpretation.
    The only authorized assessment statements are those in the quality 
standards and the approved alternative standards (Refs. 22 and 24; see 
also Sec. Sec.  900.12(c)(1)(iv) and 900.18). In addition, as described 
in the MQSA Policy Guidance Help System (PGHS), FDA has acknowledged 
that some closely worded variations of the approved assessment 
statements may generally be acceptable where the particular wording 
does not change the meaning of the category (Ref. 26).
    (Comment 33) A comment expresses concern that the reporting 
requirements, which seemingly would allow for an automated process of 
an IP selecting prepared comments that match the assessment categories, 
do not include an assessment statement or comment for patients with a 
history of breast cancer surgery who are subsequently undergoing 
routine screening.
    (Response 33) Although FDA places requirements on the wording of 
the assessment statement used to describe the assessment category 
selected by the IP to promote clarity of communication between the IP 
and the referring clinical healthcare provider, we anticipate that the 
mammography report may include additional information about the 
findings of the examination, before the concluding assessment 
statement. FDA agrees that, after an IP examines the images, the IP may 
select prepared statements that in the IP's judgment accurately 
describe the findings of the examination, and likewise may select the 
final assessment from a prepared list of the approved assessment 
statements. The Agency anticipates that there will be some mammograms 
whose findings necessitate additional nonstandard statements within the 
report, but the report must conclude with one of the standard approved 
assessment statements listed in Sec.  900.12(c)(1)(iv)(A) through (G). 
As applicable to the commenter's example, the patient's history of 
cancer and prior surgery, and any relevant post-surgical findings on 
the images, may be described in the report, but it must conclude with a 
final assessment chosen from the approved statements; for example, 
``Benign'' (see Sec.  900.12(c)(1)(iv)(B)) or ``Suspicious'' (see Sec.  
900.12(c)(1)(iv)(D)). The Agency does not believe it is necessary to 
add a unique assessment statement for patients with the history 
described by the commenter, as the statements listed in Sec.  
900.12(c)(1)(iv)(A) through (G) are adequate to encompass patients who 
have previously had breast cancer and those who have had surgery, 
whether for cancer or other reasons.
    (Comment 34) A comment mentions the potential limitations of a 
mammogram when a patient either cannot cooperate with or cannot 
understand instructions, and recommends that FDA add assessment 
categories that reflect these limitations,

[[Page 15138]]

including ``Benign with technical limitation'' and ``Normal with 
technical limitation.'' Similarly, another comment mentions the 
limitation of dense breast tissue and recommends that FDA add an 
assessment category for ``Normal but dense.''
    (Response 34) FDA agrees that some mammograms have technical 
limitations, but concludes that the limitations should be documented 
elsewhere in the report, not in the assessment statement. For clarity, 
the assessment statement should represent only the IP's final 
conclusion about the results of the examination. The limitation of 
breast density is addressed elsewhere in this final rule (see Sec.  
900.12(c)(1)(vi)(A) through (D)). In particular, the limitations 
conferred by dense tissue must be stated elsewhere in the report, using 
the language in Sec.  900.12(c)(1)(vi)(C) of the final rule, ``The 
breasts are heterogeneously dense, which may obscure small masses,'' or 
Sec.  900.12(c)(1)(vi)(D) of the final rule, ``The breasts are 
extremely dense, which lowers the sensitivity of mammography.''
    (Comment 35) Several comments address the assessment category 
``Suspicious,'' which the commenters erroneously refer to as a 
numerical category 4. These comments recommend that the use of 
alphanumeric subcategories 4a, 4b, and 4c be allowed, be encouraged, or 
be considered a legitimate option.
    (Response 35) FDA disagrees with the recommendations to permit or 
encourage the use of alphanumeric subcategories instead of the 
assessment statement ``Suspicious.'' All the required assessment 
statements under the MQSA quality standards are words or phrases, not 
numbers. Thus, the assessment statements are not identical to the 
numerical codes derived from ACR's Breast Imaging--Reporting and Data 
System (BI-RADS) (Refs. 26 and 27). BI-RADS is a practice guideline 
published by a professional society (the ACR), and is not associated 
with the MQSA quality standard requirements. While a numeric or 
alphanumeric BI-RADS assessment code in addition to the assessment 
statement may be used, one of the overall final assessment of findings 
statements as described in Sec.  900.12(c)(1)(iv) of this final rule 
must appear in the report.
    For example, in BI-RADS, category 4 (Suspicious) offers optional 
subcategories a through c, and phrases associated with each letter (4a: 
``Low suspicion for malignancy,'' 4b: ``Moderate suspicion for 
malignancy,'' and 4c: ``High suspicion for malignancy''), to further 
refine the level of suspicion (Ref. 28). However, for any mammogram 
that would receive an ACR BI-RADS code of either 4, 4a, 4b, or 4c, the 
assessment statement required under the MQSA quality standards is not a 
number or a letter, but the word ``Suspicious.'' Additionally, the 
phrase associated with each ACR BI-RADS code 4a through 4c is not an 
approved alternative standard for use as an assessment statement; while 
the final rule does not prohibit such a statement from being included 
in the report, the overall final assessment statement, ``Suspicious,'' 
would be the appropriate statement to include as the final assessment 
category of the mammogram (Ref. 29).
    (Comment 36) A comment recommends that FDA provide examples of when 
referral of a self-referred patient to a healthcare provider is 
mammographically indicated.
    (Response 36) The proposed Sec.  900.12(c)(2)(ii) stated that 
``Each facility that accepts patients who do not have a healthcare 
provider shall maintain a system for referring such patients to a 
healthcare provider when mammographically or clinically indicated.'' 
FDA believes that such referral is indicated when the mammographic 
findings warrant followup imaging or intervention sooner than at a 
routine screening interval. Therefore, for patients who do not have a 
healthcare provider and whose mammogram results are either probably 
benign, suspicious, or highly suggestive of malignancy, referral to a 
provider is generally mammographically indicated. For clarity, FDA is 
revising this provision to state, ``Each facility that accepts patients 
who do not have a healthcare provider shall maintain a system for 
referring such patients to a healthcare provider when clinically 
indicated, which shall include when such patients' mammogram assessment 
is either probably benign, suspicious, or highly suggestive of 
malignancy'' (see Sec.  900.12(c)(2)(ii) in this final rule).
    (Comment 37) A comment recommends that the lay summary inform the 
patient if risk factors such as density, pain, calcifications, 
discharge, and other items are identified on the mammogram.
    (Response 37) FDA does not believe it is necessary to require this 
information in the lay summary. The facility is required to send the 
patient a summary of the mammography report written in lay terms (see 
Sec.  900.12(c)(2) in this final rule). This final rule adds breast 
density notification language to the lay summary requirement, but it 
does not require that the lay summary mention patient symptoms or 
individual mammographic findings. FDA does not believe that it is 
appropriate to require specific language for the wide range of breast 
symptoms and mammographic findings that may be identified. For example, 
some of the items mentioned in the comment, such as pain and discharge, 
cannot be identified on a mammogram. The regulations require that the 
mammography report to the provider address findings, clinical questions 
raised by the referring healthcare provider, and recommendations for 
additional actions, if any, (see Sec. Sec.  900.12(c)(1)(iv)(A) and (B) 
and (vii) in this final rule). Some findings or symptoms may be present 
but not clinically significant. The referring healthcare provider, who 
receives the mammography report and is also familiar with the patient's 
history and physical findings, is best positioned to discuss the case 
with the patient.
    (Comment 38) Several comments address the proposed final assessment 
category ``Post Procedure Mammograms for Marker Placement.'' A comment 
asserts that the addition of an assessment category for a post-
procedure mammogram is unnecessary. Another comment asserts that the 
post-procedure mammogram is ``bundled into'' the interventional 
procedure and does not receive an assessment. A comment requests 
clarification on whether a mammogram documenting a biopsy clip or 
marker requires documentation.
    (Response 38) The assessment statement ``Post Procedure Mammograms 
for Marker Placement'' was approved as alternative standard #12 on 
September 17, 2003 (Ref. 24), under the mechanism described in current 
Sec.  900.18 for the approval of alternatives to the MQSA quality 
standards in Sec.  900.12. Since its approval in 2003, it has been 
available and acceptable for use as a final assessment statement. In 
this final rule, Sec.  900.12(c)(1)(iv)(G), FDA is adding the nearly 
identical assessment statement ``Post-Procedure Mammogram for Marker 
Placement'' to the implementing regulations. The situations in which 
this assessment should be given to any particular mammogram are more 
appropriate for the IP to determine in the course of clinical decision-
making. As FDA described in approval of the alternative standard, if a 
facility makes the post-procedure examination part of the 
interventional procedure instead of a separately charged examination, 
then the examination is not subject to the MQSA quality standard 
requirement and need not receive an assessment (Ref. 24). Nor would it 
require any report separate from the report of the

[[Page 15139]]

interventional procedure. However, when the post-procedure mammogram is 
logged or charged separately from the interventional procedure, this 
mammogram is a separate examination and requires a separate report.
    This ``Post-Procedure'' assessment category is useful to 
distinguish examinations that simply document the localization of a 
known abnormality or a known marker without contributing new diagnostic 
information, so that these examinations are not misconstrued as showing 
new or additional abnormalities. The availability of a post-procedure 
assessment category also helps maintain the accuracy of the medical 
outcomes audit required under Sec.  900.12(f). The audit requires 
followup for positive mammograms, defined in existing Sec.  900.2(mm) 
as mammograms receiving assessments of either ``Suspicious'' or 
``Highly Suggestive of Malignancy,'' but a post-procedure mammogram of 
a patient with a previously identified abnormality is not intended to 
be counted as a new positive result; this assessment category helps 
facilities to distinguish and exclude post-procedure mammograms from 
the audit.
    (Comment 39) Two comments object to FDA's mention of a 
``localization needle'' in the explanation of one potential use for 
this ``Post-Procedure Mammogram for Marker Placement'' final 
assessment, since spatial localization may not always be performed with 
a needle, and recommends revising this explanation to ``localization 
device'' or ``localization marker.'' Another comment asserts that a 
marker may not always deploy and recommends changing the wording of the 
assessment statement to ``Post procedure mammogram.''
    (Response 39) FDA agrees that some localization devices are not 
needles, and is clarifying our explanation of the assessment category 
as follows: this category is primarily used for a mammogram performed 
following a biopsy to confirm the deployment and position of a breast 
tissue marker. The other use of this final assessment category is for a 
mammogram performed to document the position of a localization needle 
or other marker. During preoperative localization, a needle or other 
temporary marker may be positioned to direct subsequent surgery for a 
nonpalpable lesion seen on earlier mammography. The post-procedure 
mammogram is performed as a guide to identify the suspicious site for 
the surgeon who will biopsy or excise the lesion and remove the needle 
or marker.
    The post-procedure mammogram is typically performed in an attempt 
to localize a device, such as a needle or other tissue marker, or to 
determine whether the device has deployed. FDA concludes that this 
intention is accurately captured by the phrasing ``Post-Procedure 
Mammogram for Marker Placement,'' even in cases in which the mammogram 
reveals that a marker failed to deploy. FDA notes that all mammographic 
views obtained in a single examination are typically referred to 
collectively as a ``mammogram,'' and therefore agrees in part with the 
comment that recommends changing the wording of the assessment 
statement to the singular ``Post procedure mammogram.'' Accordingly, we 
are revising the wording of the assessment statement to the singular 
``Post-Procedure Mammogram for Marker Placement'' (see Sec.  
900.12(c)(1)(iv)(G) in this final rule), in addition to clarifying the 
description as noted.
    (Comment 40) One comment asserts that a lay-language summary to the 
patient should not be required for a mammogram performed for marker 
placement, because the mammogram is performed for localization rather 
than for diagnosis, and receiving a lay summary of such an examination 
may confuse the patient.
    (Response 40) As discussed in Response 38, we have explained that 
if a facility makes the post-procedure mammogram a separately logged or 
charged examination rather than part of the interventional procedure, 
the mammogram is subject to all MQSA quality standard requirements, 
including a report to the referring healthcare provider and a summary 
of the report in lay language to the patient. The lay summary must be 
specific to the examination and report; for example, if the assessment 
statement in a report states that an examination was a post-procedure 
mammogram for marker placement, then the lay summary of that report 
should likewise mention the procedure or the marker placement, but it 
would not be appropriate to state that the mammogram results were 
abnormal, worrisome, suspicious for cancer, etc. FDA believes that a 
lay summary limited to discussing the fact that the mammogram was 
performed for localization after a procedure will not confuse a patient 
who has just undergone a procedure.
    (Comment 41) Several comments recommend that FDA revise the 
assessment statement ``Incomplete: Need prior mammograms for 
comparison'' (proposed Sec.  900.12(c)(1)(v)(B)) to replace 
``mammograms'' with ``breast imaging'' or ``breast examinations,'' to 
include other imaging modalities such as breast ultrasound.
    (Response 41) FDA disagrees with this recommendation. The Agency 
concludes that extending the assessment statement ``Incomplete: Need 
prior mammograms for comparison'' to a comparison with other breast 
imaging modalities, which may have been performed at multiple different 
imaging facilities and centers, could impose delays in obtaining those 
prior examinations and issuing the final interpretation of the 
mammogram. As addressed in Response 4, the MQSA and FDA's implementing 
regulations apply specifically to mammography facilities, so facilities 
where a patient's prior mammograms were performed would have retained 
those examinations, pursuant to the MQSA record retention requirement 
(see Sec.  900.12(c)(4)(i) in this final rule), and would presumably 
respond to the patient's request to transfer them or release copies of 
their records, pursuant to the MQSA record release requirements (see 
Sec.  900.12(c)(4)(ii) and (iii) in this final rule). In contrast, 
other imaging centers not subject to the MQSA quality standards are not 
required to release prior non-mammography imaging within these 
regulatory deadlines. Additionally, other imaging modalities may not 
provide the type of information that is directly comparable to the 
mammogram.
    (Comment 42) A comment requests confirmation that an Incomplete 
assessment statement, which the commenter cites as ``Category 0: 
Incomplete--need additional imaging evaluation and/or comparison with 
prior examination(s),'' remains acceptable. Similarly, another comment 
recommends that FDA allow facilities to choose whether to separate the 
two Incomplete assessment categories or to keep them grouped together.
    (Response 42) The first commenter's citation of the assessment 
statement is incorrect on two points. As we noted in Response 35, all 
approved assessment statements under the MQSA quality standards are 
words or phrases, not numeric or alphanumeric codes, so the numeral 
zero is not required as part of the assessment. Also, the Incomplete 
assessment statement approved by FDA in 2003 as alternative standard 
#11 does not refer to ``prior examinations,'' but to ``prior 
mammograms.'' Therefore, the phrasing cited by the first commenter is 
not acceptable. However, we note that even after the introduction of 
the two Incomplete assessment statements in this final rule, 
alternative standard #11 remains in effect, such that the

[[Page 15140]]

combined assessment statement ``Incomplete: Need additional imaging 
evaluation and/or prior mammograms for comparison'' may also be used. 
Therefore, FDA agrees with the second commenter that a facility may 
choose either to use one of the separate Incomplete assessment 
statements that appear in this final rule (see Sec.  900.12(c)(1)(v)(A) 
and (B)), or to use the combined statement as found in alternative 
standard #11, which remains an approved alternative standard.
    (Comment 43) A comment recommends that FDA expand and clarify its 
justification of the assessment category ``Incomplete: Need prior 
mammograms for comparison'' with a more evidence-based justification 
addressing the value of the comparison of a mammogram with prior 
mammograms. The proposed rule (under section V.E.3 of the Supplemental 
Materials) includes the statement, ``Comparison to previous 
examinations is sometimes required to make a final assessment.'' 
However, the comment recommends that FDA instead justify the value of 
comparison mammograms by using the statement, ``Evidence shows that 
comparison with a single prior exam, and more so with multiple prior 
examinations, improves accuracy, including a reduction in the recall 
rate and an improvement in sensitivity and predictive value.''
    (Response 43) The reference cited by the commenter (Ref. 30) 
demonstrates that comparison to two or more prior exams reduces the 
recall rate, and increases the cancer detection rate and a positive 
predictive value (PPV) known as PPV1. Although comparison to previous 
examinations is valuable, FDA does not believe that the recommended 
statement is fully supported by the cited reference. However, FDA 
agrees with the commenter's broader implication that there are many 
benefits to interpreting a mammogram in comparison to one or more of 
the patient's previous mammograms, including but not limited to 
improved accuracy and reduced recall rate. FDA believes that the final 
rule adequately reflects the value of making comparisons to previous 
mammograms when available.
    (Comment 44) Some comments express concern about the timing of 
interpretation of a mammogram following an assessment of ``Incomplete: 
Need prior mammograms for comparison.'' A comment asserts that a 
patient may not be able to obtain prior mammograms within 30 days, and 
another comment asserts that the rule would permit a total of 60 days 
from the performance of the examination to the final interpretation, 
assuming 30 days to obtain the prior examination and another 30 days to 
make the comparison and issue a final report, and that during that time 
the patient's insurance or healthcare provider may change. One of the 
commenters recommends that FDA impose a total limit of 30 days from the 
performance of the examination to the issuance of the final report, and 
one recommends that FDA monitor the use and benefit of the new 
assessment category.
    (Response 44) A facility is required to issue a report to the 
referring healthcare provider and a summary in lay terms to the patient 
no later than 30 days after the examination (Sec.  900.12(c)(3)(i)), 
and to issue a followup report no later than 30 days after issuing an 
initial report of ``Incomplete: Need prior mammograms for comparison,'' 
whether or not comparison views can be obtained (Sec.  
900.12(c)(1)(v)(B) in this final rule). However, we note that these 30-
day intervals are maximums, and represent baseline standards. There is 
no requirement that a facility wait a full 30 days for a patient to 
submit prior images, and likewise no requirement that a facility wait a 
full 30 days after receiving a prior comparison examination before 
issuing a final report. A facility may establish policies regarding a 
shorter interval to wait for prior examinations and a shorter interval 
in which to issue a final report after receiving comparison 
examinations, perhaps with exceptions for a patient's individual 
situation. Therefore, FDA concludes that the reporting deadlines stated 
in the regulations as proposed and finalized are adequate. FDA also 
notes that although the two ``Incomplete'' assessment statements are 
new to the quality standards regulations, they are derived from the 
``Incomplete'' assessment statement approved in alternative standard 
#11 in 2003 (Ref. 25) and in widespread use since that time. FDA is not 
aware of any concerns raised about the benefit of the use of this 
assessment category or concerns about the timing of the final report. 
The Agency further notes that the report is required to be sent to the 
healthcare provider who referred the patient for the mammogram, unless 
the patient informs the facility of a new or additional provider (Sec.  
900.12(c)(3)).
    (Comment 45) A comment expresses opposition to the new assessment 
statement ``Incomplete: Need prior mammograms for comparison,'' 
asserting that this will lead to an increase in the number of 
mammograms that either do not receive a final assessment within 30 
days, or do not receive one at all.
    (Response 45) FDA disagrees with this comment. First, as noted in 
Response 44, this assessment statement is derived from one that has 
already been eligible for use since 2003 under the approved alternative 
standard #11 (Ref. 25). Furthermore, in this final rule, use of the 
assessment statement ``Incomplete: Need prior mammograms for 
comparison'' in Sec.  900.12(c)(v)(B) also requires that ``a followup 
report with an assessment category identified in paragraphs 
(c)(1)(iv)(A) through (E) of this section must be issued within 30 
calendar days of the initial report whether or not comparison views can 
be obtained.'' Thus, the imperative to issue a final assessment for the 
examination within 30 days is directly linked to the initial use of 
this incomplete assessment category. As noted, since the time that 
alternative standard #11 was approved in 2003, FDA has not become aware 
of any concerns raised about the timing or issuance of the final 
report.

H. Deadlines for Mammography Reports

    (Comment 46) A comment recommends that the report to the healthcare 
provider and the lay summary to the patient should have the same 
deadline of 14 days. A separate comment recommends that screening 
mammograms should have a deadline for reports and lay summaries of 30 
days from the date of the examination. Another comment recommends that 
when prior mammograms are needed for comparison, the report should have 
a deadline of 14 days and the lay summary a deadline of 21 days, 
respectively, from the receipt of the prior mammogram, not from the 
date of the current examination.
    (Response 46) FDA disagrees with these comments. The deadline of 30 
days from the date of the examination (or from the date of the initial 
Incomplete report, if applicable) is a maximum and a baseline standard. 
As noted in Response 44, facilities may choose to establish policies of 
shorter deadlines for releasing prior examinations and for performing 
comparisons to prior examinations. FDA concludes that the deadline 
stated in this final rule is adequate. Aside from the specific audit 
provisions in Sec.  900.12(f), the MQSA and FDA's implementing 
regulations do not distinguish between mammograms whose clinical role 
is screening or diagnosis. All examinations must meet the reporting 
deadlines, and the commenter's recommendation of a 30-day deadline is 
generally consistent with the regulations. FDA concludes

[[Page 15141]]

that the deadline for the report should be linked to the date of the 
examination. This is because the receipt of prior comparison 
examinations may be unpredictable and inconsistent, and using the date 
of receipt of prior examinations as opposed to the date of the current 
examination for the reporting deadline could lead to delays in 
reporting.
    (Comment 47) Several comments note an inconsistency between, on the 
one hand, the 30-day deadlines for all mammography reports (Sec.  
900.12(c)(3)(i)) and lay summaries (Sec.  900.12(c)(2)), and on the 
other hand, the new earlier deadlines for the report of 14 days (in 
proposed Sec.  900.12(c)(3)(ii)) and lay summary of 21 days (in 
proposed Sec.  900.12(c)(2)) when a mammogram is interpreted as 
``Suspicious'' or ``Highly Suggestive of Malignancy.''
    (Response 47) FDA agrees with the comments and acknowledges that 
these proposed deadlines were inconsistent with respect to deadlines 
calculated from the date of the mammographic examination. Accordingly, 
in this final rule we are revising Sec.  900.12(c)(2) by deleting the 
words ``but in no case later than 21 calendar days from the date of the 
mammographic examination,'' and revising Sec.  900.12(c)(3)(ii) by 
deleting the words ``but in no case later than 14 calendar days from 
the date of the mammographic examination.'' All reports and lay 
summaries, regardless of the assessment of the mammogram, must be sent 
within 30 calendar days of the examination (see Sec.  900.12(c)(2) and 
(3)(ii) in this final rule). However, as noted in Response 46, this 30-
day deadline is a maximum and a baseline standard. In many facilities, 
the interpretation and communication of the results is typically 
performed much sooner than at 30 days. Accordingly, we consider the 
within-30-day timeframe of the mammographic examination to be 
appropriate, except in the following circumstances: We require that, 
for positive mammograms (defined as mammograms with an assessment 
category of either suspicious or highly suggestive of malignancy (see 
Sec.  900.2(mm)), the facility send both the report and the lay summary 
within 7 calendar days of the final interpretation of the mammogram. 
For these situations, the deadline for providing the lay summary is 
earlier than the general 30-day deadline from the date of the 
mammographic examination for all reports and lay summaries (see 
Sec. Sec.  900.12(c)(2) and (c)(3)(ii) in this final rule). As 
discussed in the proposed rule (84 FR 11676), FDA believes such action 
by the facility is appropriate for these two final assessment 
categories because they both indicate findings that warrant further 
evaluation.
    We have noted an additional inconsistency, regarding the deadlines 
for sending a report to a ``self-referred'' patient who has not 
identified a referring healthcare provider. A self-referred patient 
receives both the lay summary and the mammography report. As discussed 
above (in this response), the timeframe for sending the lay summary to 
any patient, including a self-referred patient, is within 30 days of 
the performance of the examination, and within 7 days of interpretation 
if the assessment is ``Suspicious'' or ``Highly Suggestive of 
Malignancy'' (see Sec.  900.12(c)(2) in this final rule). The timeframe 
for sending the report to the self-referred patient is within 30 days 
of the examination (see Sec.  900.12(c)(2)(i) in this final rule), but 
the proposed rule did not specify any change in that deadline when the 
results are suspicious or highly suggestive of malignancy. We are now 
adding the statement ``If the assessment of the mammography report is 
``Suspicious'' or ``Highly Suggestive of Malignancy,'' the facility 
shall send this report to the patient within 7 calendar days of the 
final interpretation of the mammograms'' (see Sec.  900.12(c)(2)(i) in 
this final rule). This addition makes the 30-day and 7-day deadlines 
consistent for sending the mammography report to either the referring 
provider (if a patient identifies a provider) or directly to a patient 
who has not identified a provider.

I. Breast Density Notification--General Support for Density 
Notification

    (Comment 48) FDA received comments that support the proposed 
requirements to provide information regarding breast density to both 
patients and their healthcare providers, with comments recommending 
that FDA finalize the regulations with the two categories of breast 
density in patient lay summaries and four categories in reports to 
healthcare providers as proposed.
    (Response 48) FDA appreciates the public support for the density 
notification requirement. FDA believes that receiving consistent 
baseline information regarding breast density is important for both 
patients and their healthcare providers to make informed shared 
decisions, and that the respective requirements for the report and lay 
summary strike an appropriate balance between providing sufficient 
information to healthcare providers while maintaining a clear message 
to patients. Therefore, in this final rule, FDA is requiring that the 
breast density notification use two categories of breast density in the 
lay summary to patients (see Sec.  900.12(c)(2)(iii) and (iv)) and four 
categories in the report to healthcare providers (see Sec.  
900.12(c)(1)(vi)(A) through (D)).
    (Comment 49) A comment states that the proposed rule creates a 
standard that is not backed by medical evidence.
    (Response 49) FDA disagrees with this comment. The commenter is 
referring to the requirement for breast density notification. Both the 
proposed amendments and this final rule do not specify the further 
management of patients with dense tissue, only that these patients and 
their providers must be notified of their breast density. As discussed 
in Response 62, the Agency is revising the notification to patients 
with dense breast tissue to reflect that ``In some people with dense 
tissue, other imaging tests in addition to a mammogram may help find 
cancers.'' (see Sec.  900.12(c)(2)(iv) in this final rule), which is 
supported by many scientific studies demonstrating increased cancer 
detection in dense breasts using supplemental imaging modalities (Refs. 
10, 11, 31, and 32). This increased detection facilitates earlier 
treatment of mammographically occult cancers, and may reduce morbidity 
from the tumor and its treatment.
    (Comment 50) Several comments recommend that the lay summary should 
contain simple, clear language, and several comments recommend that the 
density information should be placed at the top of the letter instead 
of following the result or assessment statement.
    (Response 50) FDA agrees with the recommendation that the lay 
summary should contain clear language. In this final rule, both of the 
revised notification statements for the lay summary are below the 
eighth grade reading level on the Flesch-Kincaid scale. We conclude 
that the notification language represents a balance of 
understandability and accuracy (see Sec.  900.12(c)(2)(iii) and (iv) in 
this final rule). However, the Agency does not agree that it is 
necessary to require that the breast density notification statement be 
placed in a specific location relative to other mammogram result 
information in the lay summary. We incidentally note that the lay 
summary is not required to include an assessment category or statement. 
Furthermore, given the range of mammogram results and recommendations 
that may need to be communicated by a facility to a patient, we 
conclude that it may be unduly restrictive to make this a requirement 
for facilities, and that it

[[Page 15142]]

may potentially be confusing to patients.
    (Comment 51) A comment recommends that an explanation of medical 
terms must be included in all lay summaries.
    (Response 51) FDA disagrees with the comment. We note that the 
language for the lay summary in this final rule excludes medical 
terminology that may not be understandable to a wide audience. We do 
not believe that it is necessary to require that an additional 
explanation of medical terms be included in a lay summary.
    (Comment 52) A comment recommends that the lay summary include 
additional information about mammography and its limitations.
    (Response 52) FDA disagrees with requiring this information in the 
lay summary. The language in this final rule for the lay summary 
includes the statement that ``Dense tissue makes it harder to find 
breast cancer on a mammogram,'' and FDA concludes that this statement 
is adequate in addressing the limitations of mammography as they relate 
to breast density. As is also stated in the breast density notification 
language (see Sec.  900.12(c)(2)(iii) and (iv) in this final rule), FDA 
recommends that patients speak to their healthcare provider after 
receiving the lay summary, and this discussion can include more 
information on mammography and its limitations.
    (Comment 53) A comment recommends that FDA work with individuals to 
improve the readability and understandability of any proposed language 
and describes existing breast density notification language as poor in 
understandability and causing confusion and misinformation.
    (Response 53) The breast density notification language in this 
final rule is the result of discussion between clinicians, patients, 
and FDA. Both the notification statement to patients with non-dense 
breasts (see Sec.  900.12(c)(2)(iii) in this final rule) and the 
notification statement to patients with dense breasts (see Sec.  
900.12(c)(2)(iv) in this final rule) are below the eighth grade reading 
level on the Flesch-Kincaid scale. We believe that these statements 
represent an appropriate balance between patient understandability and 
accuracy of the information conveyed. FDA cannot comment on the 
understandability of various State breast density notifications; 
however, FDA recommends that patients speak to their healthcare 
provider about any language that they do not understand.
    (Comment 54) A comment recommends that visual aids and medical 
cartoons for patients with low literacy should be included, to decrease 
health disparities.
    (Response 54) FDA acknowledges that patients of limited literacy 
may need assistance with the interpretation of the lay summary. 
However, FDA does not believe it is necessary to require this 
information in the summary. The requirements for the lay summary 
represent baseline standards; FDA recognizes that facilities may choose 
to provide additional information or explanation they feel is needed by 
their patients. The breast density notification language in this final 
rule is meant to be concise and clear, and adding visual aids and 
medical cartoons into the lay summary may potentially distract from the 
primary message regarding a patient's breast density and resulting 
recommendations. FDA notes that the interaction between a patient and 
their healthcare provider presents an appropriate opportunity to 
address questions that a patient may have regarding the lay summary. 
The required language in this final rule (Sec.  900.12(c)(2)(iii) and 
(iv)) includes such a recommendation to talk to a healthcare provider.
    (Comment 55) Several comments recommend that in addition to the 
breast density notification, FDA add patient education and a clear plan 
of management to the lay summary.
    (Response 55) FDA disagrees with the comment. We conclude that the 
language in this final rule provides a foundation for patients to be 
informed regarding their breast density when using mammography. The 
intent of the lay summary being required and provided to the patient is 
not to serve as an exhaustive resource regarding breast disease and its 
management. The lay summary includes the recommendation for the patient 
to talk to their healthcare provider, and we note that this interaction 
is an appropriate opportunity for additional patient education. 
Regarding the recommendation that the lay summary include a clear plan 
of management, FDA notes that the lay summary is generated by the 
breast imaging facility, whereas the plan of clinical management for 
each individual patient will be developed by the patient and their 
healthcare provider, and as such, it is not appropriate for this type 
of information to be included in the lay summary.
    (Comment 56) A comment recommends replacing the phrase, ``The 
breasts are almost entirely fatty,'' in Sec.  900.12(c)(1)(vi)(A), with 
the phrase, ``The breast tissue is of low density,'' asserting that the 
former statement has ``negative connotations'' to many patients.
    (Response 56) FDA disagrees with the comment. FDA notes that this 
category, and the others in Sec.  900.12(c)(1)(vi)(A) through (D), are 
already in widespread use in breast density reporting. Thus, FDA 
believes it would be confusing to replace the ``almost entirely fatty'' 
category with the ``low density'' sentence recommended by the 
commenter, as it would be unclear whether ``low density'' referred to 
the breast density category in Sec.  900.12(c)(1)(vi)(A), ``The breasts 
are almost entirely fatty,'' or the density category in Sec.  
900.12(c)(1)(vi)(B), ``There are scattered areas of fibroglandular 
density.'' Additionally, the breast density assessment statement in 
Sec.  900.12(c)(1)(vi)(A) is included only in the report intended for 
the healthcare provider, and not in the lay summary sent to the 
patient, so it will not be sent to patients with a referring provider. 
Self-referred patients will receive the lay summary as well as the 
report, which should help mitigate any unintended negative connotations 
of the report.
    (Comment 57) A comment questions the benefit of the density 
notification and recommends that FDA should involve more individuals in 
the drafting of density notification language, and that this language 
should describe the limitations of density assessment, the risks of 
overdiagnosis and overtreatment such as gadolinium exposure from MRI 
and radiation exposure from additional mammographic evaluation, and the 
lack of benefit of density notification. A comment recommends adding 
additional language educating patients about breast density, what it 
means to a patient, and how patients can take extra steps to protect 
themselves.
    (Response 57) FDA disagrees with the assertion of lack of benefit 
in informing patients and their healthcare providers of a patient's 
breast density. FDA considers it to be a benefit to inform patients 
about their breast anatomy. In addition, FDA considers it to be a 
benefit to inform patients in a consistent manner about their breast 
density. The language in the final rule is intended as a baseline for 
breast density information, which can be used by patients and their 
healthcare providers to help inform and guide patient care. FDA notes 
that the provider-patient interaction is an appropriate opportunity for 
further discussion of breast density and of the benefits and risks of 
possible further evaluation. We conclude that including too wide a 
range of information in the lay summary, particularly information that

[[Page 15143]]

may not be supported by a wide consensus in the scientific community or 
current information that may be subject to change with future advances 
in knowledge and understanding, may unnecessarily increase patient 
confusion and lead to reduced effectiveness of the breast density 
notification.
    (Comment 58) A comment recommends eliminating the recommendation in 
Sec.  900.12(c)(2)(iii) for patients with non-dense breast tissue to 
talk to their healthcare provider. Another comment recommends that 
patients should be directed to additional information on breast 
density, not just to their referring physician.
    (Response 58) The Agency believes it is important for patients to 
have an understanding of their breast density to promote informed and 
shared decision making about whether supplemental screening is 
appropriate based on each patient's individual circumstances, and 
speaking with their healthcare provider is an additional opportunity to 
accomplish this. The final rule does not prohibit facilities or 
healthcare providers from providing additional information on breast 
density to patients; however, FDA concludes that specific additional 
resources on breast density should not be codified in the final rule as 
a requirement to be provided as part of the lay summary, particularly 
since these sources of information may change or become outdated.
    (Comment 59) A comment asserts that there are conflicting reports 
of the density discussion at the 2011 NMQAAC meeting.
    (Response 59) FDA disagrees with the comment. A transcript of the 
2011 NMQAAC meeting is available (Ref. 33). The transcript shows there 
was general agreement on requiring density notification and advising 
patients to speak with their healthcare providers. In 2011, there was 
some disagreement among the members of the Committee on particular 
issues such as the definition of a dense breast, the degree of cancer 
risk conferred by dense breast tissue, and recommendations for further 
evaluation of patients with dense breasts. FDA notes that since 2011 
there is now greater consensus in the scientific and medical practice 
community on the categorization of breast density and the degree of 
risk it confers, and also greater availability of imaging modalities 
for supplemental screening (Ref. 31). This final rule only recommends 
that patients speak with their providers, and does not make any 
specific recommendations for further imaging or other evaluation, which 
is more appropriately reserved for the unique clinical decision-making 
process that takes place between a patient and their provider.
    (Comment 60) A comment recommends that there be four different 
patient notification statements in the lay summary rather than two. A 
comment recommends adding detailed explanatory information regarding 
breasts as ``dense'' or ``not dense,'' or adding a four-category 
patient density notification.
    (Response 60) FDA concludes that the two patient notification 
statements (i.e., informing patients that they have ``dense'' breast 
tissue or ``not dense'' breast tissue) provide a clear message to 
patients regarding their breast density, and that generating four 
different categories, each with unique language in the lay summary, 
would potentially add confusion for some patients, as well as an 
increased burden on facilities. FDA concludes that the language in this 
final rule for the lay summaries (Sec.  900.12(c)(2)(iii) and (iv)) 
provides an adequate baseline for breast density notification to 
patients given that the purpose of the letter is not to serve as a 
complete resource for breast density information and, further, that the 
inclusion of more detailed information might detract from the actual 
notification, including by dissuading patients from reading the notice 
at all, given its length.
    (Comment 61) A comment asserts that there is variability and 
limited reproducibility in the determination of dense versus non-dense 
breasts, and that if this variation is expressed as changing 
assessments, women may lose confidence in the screening mammography 
process.
    (Response 61) FDA acknowledges that for some patients there may be 
some degree of variability in the determination of breast density due 
to interobserver and intra-observer variability. FDA notes that there 
have been advancements in technology (e.g., density classification 
software devices) that may help mitigate such variability in 
assessment. In addition, we conclude that potential variability in 
density assessment does not outweigh the importance of communicating 
breast density to patients and their healthcare providers. FDA 
disagrees with the comment that patients will lose confidence in 
mammography if their breast density assessment changes. If a patient 
has any concerns regarding any aspect of the mammogram, including the 
breast density assessment, the patient may contact the referring 
provider or the mammography facility. This final rule contains 
requirements for facilities regarding providing mammogram studies and 
reports to patients upon request (Sec.  900.12(c)(4)).
    (Comment 62) A comment recommends that the final rule not contain 
the statement that some patients with high breast density may need 
other imaging tests in addition to mammography, as this is not 
supported by evidence, and may lead to false positives, overtreatment, 
and overdiagnosis.
    (Response 62) The language in the final rule is not intended to 
require additional imaging evaluation for patients with dense breasts, 
but rather to provide a baseline of information for discussion between 
a patient and their healthcare provider. Accordingly, we are revising 
this sentence of the notification to reflect that other imaging tests 
in addition to a mammogram may help find cancers, as opposed to stating 
that some patients with dense tissue ``may need'' additional imaging. 
The notification in this final rule states, in part, that ``In some 
people with dense tissue, other imaging tests in addition to a 
mammogram may help find cancers.'' (see Sec.  900.12(c)(2)(iv) in this 
final rule). The density notification requirement does not specify 
additional clinical management, but the Agency believes that the 
communication of breast density information is important for a patient 
to better understand their own situation and to facilitate joint 
decision-making by the patient and the healthcare provider.
    (Comment 63) A comment recommends that FDA withdraw the requirement 
for breast density notification to patients from the final rule until 
better evidence is available, asserting that breast density 
notification will cause undue worry for women without specific actions 
they can take.
    (Response 63) FDA disagrees with the recommendation to withdraw the 
requirement for breast density notification to patients. We conclude 
that there is already adequate support for informing patients of their 
breast density, and while we do not believe that it is appropriate for 
this final rule to contain requirements regarding specific followup 
imaging tests, this rule does contain the recommendation for a patient 
to discuss their breast density and individual situation with their 
healthcare provider.
    (Comment 64) A comment recommends that FDA allow variation in the 
wording of the breast density notification in the lay summary and 
states that the commenter's State already requires density reporting 
with the use of four density categories.

[[Page 15144]]

Another comment states that FDA already has density wording.
    (Response 64) FDA disagrees with the recommendation to allow 
variations in the wording of the density notification. The required 
breast density notification language in this final rule is intended to 
provide a uniform density notification; however, the final rule does 
not prohibit facilities from providing patients with additional 
information regarding breast density. FDA disagrees with the assertion 
that there was already density notification wording provided by FDA 
prior to the publication of this rule.
    (Comment 65) A comment recommends that increased risk of breast 
cancer be included in the lay summary for patients with dense breasts, 
and that qualifying words such as ``may'' be eliminated.
    (Response 65) FDA agrees with the recommendation to include a 
statement in the lay summary about the increased risk of breast cancer 
associated with dense tissue (see Response 75). We are revising the 
notification language in this final rule, including the sentence 
``Dense tissue makes it harder to find breast cancer on a mammogram and 
also raises the risk of developing breast cancer'' (see Sec.  
900.12(c)(2)(iii) and (iv) in this final rule). The word ``may'' is 
used in the revised statement that ``In some people with dense tissue, 
other imaging tests in addition to a mammogram may help find cancers'' 
(see Sec.  900.12(c)(2)(iv) in this final rule). FDA believes that this 
language in the lay summary is appropriate for communicating breast 
density information and recommendations without causing undue alarm to 
patients.
    (Comment 66) A comment recommends adding BI-RADS density categories 
to the MQSA regulations.
    (Response 66) We note that the breast density assessment statements 
in the report to the healthcare provider, as written in Sec.  
900.12(c)(1)(vi)(A) through (D) in this final rule, correspond to the 
wording of the density categories in the BI-RADS 5th edition (Ref. 34) 
(see also Response 35).
    (Comment 67) A comment recommends that facilities be required to 
have different lay summaries, for those given to patients at ``time of 
service'' and for those that are mailed.
    (Response 67) FDA does not agree that it is necessary to require 
facilities to have different versions of the lay summary based on when 
the letter is delivered to the patient. This final rule does not 
prohibit a facility from adopting such a practice, but the required 
language in Sec.  900.12(c)(2) must be included in any version of the 
lay summary.
    (Comment 68) A comment specifically recommends that the lay summary 
make it clear to a patient whether their breast density is high or low.
    (Response 68) As addressed in Responses 76 and 79, we are revising 
this final rule and replacing the wording of high density and low 
density with ``dense'' and ``not dense,'' respectively (see Sec.  
900.12(c)(2)(iii) and (iv) in this final rule). We conclude that these 
revised terms will be clearer to patients. FDA believes that the 
language in the final rule for the lay summaries is adequate and 
accomplishes its intent of communicating breast density information and 
recommendations to patients.
    (Comment 69) A comment recommends that before finalizing the rule, 
FDA should document the benefits of breast density notification and 
ensure that unintended harms are avoided.
    (Response 69) FDA notes that communicating breast density to 
patients is an important component of empowering them to make decisions 
regarding their healthcare, and is the primary benefit of the breast 
density notifications set forth in this rulemaking. As most States 
already have breast density notification requirements, which vary 
across the country (Ref. 8), FDA concludes that it is important to have 
a consistent baseline for the content of these notifications. Some 
patients with dense breast tissue and other risk factors may be advised 
by their providers (based on their individual risk factors) to undergo 
supplemental screening, such as with ultrasound, which has been shown 
to increase cancer detection, particularly of small and node-negative 
cancers (Ref. 32); this early detection may decrease morbidity from the 
cancers and their treatment.
    (Comment 70) A comment recommends that FDA should support 
development of an evidence base and guidelines for care for women with 
dense breasts, which can then be used to develop and provide 
educational materials to clinical providers in providing evidence-based 
supplemental screening recommendations.
    (Response 70) FDA disagrees with the comment. There are many 
existing resources, including recommendations from professional 
societies and a large base of literature, that already provide 
recommendations on care for patients with dense breasts (including, but 
not limited to Refs. 10, 12 to 14, 28, 31, and 33 to 37). The MQSA 
implementing regulations (including this final rule) are designed to 
ensure that patients in the United States have access to quality 
mammography services.
    (Comment 71) Some comments recommend that breast density 
notification should not be required in the lay summary sent to women in 
the non-dense categories, and that if FDA requires breast density 
notification to women in these categories, that verbiage describing the 
implications of having dense tissue be minimized.
    (Response 71) FDA disagrees with the comment. The Agency believes 
that it is important to communicate information regarding breast 
density to patients in all density categories. FDA concludes that the 
language in this final rule for the lay summary for patients who have 
non-dense breasts (see Sec.  900.12(c)(2)(iii)) is of an appropriate 
level of detail and provides context for the breast density 
notification.
    (Comment 72) A comment asserts that the way that risk is described 
by statisticians and epidemiologists, for example by comparing the risk 
of breast cancer between women whose breast tissue is at the extremes 
of greatest and least density, is misleading to the average lay person.
    (Response 72) FDA notes that the language in this final rule for 
breast density notification in the lay summary does not communicate 
risk information to patients in the manner in which the commenter 
asserts risk information is described by statisticians or 
epidemiologists. As addressed in Responses 68, 75, 76, and 79, we have 
revised the notification statements to patients with both dense and 
non-dense tissue to say, in part, ``Dense tissue . . . raises the risk 
of developing breast cancer'' (see Sec.  900.12(c)(2)(iii) and (iv) in 
this final rule).
    (Comment 73) Several comments recommend that information on next 
steps needs to be included with the dense tissue notification to 
patients. Another comment recommends that more specific recommendations 
be given beyond discussing breast density with a healthcare provider, 
that radiologists should be specific in recommending additional imaging 
studies, and that all possible imaging modalities that may be more 
effective than mammography should specifically be mentioned in the lay 
summary.
    (Response 73) The language in this final rule for the patient lay 
summary for patients with dense breasts (see Sec.  900.12(c)(2)(iv)) 
includes the recommendation to speak with the patient's healthcare 
provider regarding breast density, breast cancer risk, and the 
patient's individual situation. FDA concludes that it is not 
appropriate to indicate any additional steps in a

[[Page 15145]]

patient's care prior to this interaction and based only on the 
mammogram, as individual situations and risk factors vary. FDA does not 
agree that it is appropriate to require the lay summary to include a 
discussion of all possible breast imaging modalities that may be more 
effective for some patients than mammography, as this would require a 
significant amount of information that may be difficult for patients to 
interpret. We believe that it is more appropriate for the healthcare 
provider to discuss this information with the patient and engage in 
shared clinical decision-making based on the patient's individual 
circumstances. This rule does not prohibit a facility from providing 
further information to patients in addition to the required language in 
the final rule if the facility chooses to do so.

J. Breast Density Notification Language

    (Comment 74) Several comments recommend deleting the phrase ``more 
glands than fat in the breasts'' from Sec.  900.12(c)(2)(iii), 
asserting that it is inaccurate because: (1) the ratio of fat to 
glandular tissue is not always related to density on mammography due to 
regional variation of fat and glandular tissue as well as a fibrous 
tissue component; (2) fibrous tissue is distinct from glandular tissue 
and often accounts for the majority of the density seen on mammograms; 
and (3) dense breasts have more fat than dense tissue when quantified. 
Another comment asserts that the breast density depends upon other 
factors, such as the glandular tissue and stroma projecting together, 
the compliance of the breast under pressure of the compression paddle 
and the amount of fat in the macroscopic component of stroma.
    (Response 74) FDA acknowledges the presence of fibrous stroma in 
the composition of the breast, and agrees with the comments regarding 
the many anatomic, technical, and other factors that contribute to 
mammographic breast density. We also agree with the recommended 
deletion. Accordingly, we have deleted the phrase ``more glands than 
fat in the breasts'' from the density notifications in Sec.  
900.12(c)(2)(iii) and (iv) of this final rule. Additionally, this final 
rule does not use the term ``glandular tissue'' in either the 
assessment of breast tissue density in the report to the healthcare 
provider (see Sec.  900.12(c)(1)(vi)(A) through (D)) or the 
notification of density in the lay summary to the patient (see Sec.  
900.12(c)(2)(iii) and (iv)).
    (Comment 75) Several comments recommend modifying the language in 
the patient lay summary in proposed Sec.  900.12(c)(2)(iv) to include a 
statement that higher breast density raises a patient's risk of 
developing breast cancer.
    (Response 75) FDA agrees with the comments, and notes that studies 
show that women with dense breast tissue do have an elevated risk of 
developing breast cancer (Refs. 12 to 15). Accordingly, we have added 
to the patient notification language in Sec.  900.12(c)(2)(iii) and 
(iv) of this final rule, a statement that ``Dense tissue . . . raises 
the risk of developing breast cancer.''
    (Comment 76) Several comments recommend that FDA adopt the density 
notification language proposed by two commenters. This language 
includes: (1) a revision of FDA's proposed introductory sentences 
beginning with ``Some patients,'' out of concern that they will cause 
alarm to patients with non-dense breasts and confusion to patients with 
dense breasts; (2) a recommendation to include an elective option to 
use four density categories in States whose notification regulations 
require this; (3) a recommendation to substitute the term ``scattered 
fibroglandular tissue'' for the term ``scattered areas of 
fibroglandular density'' in the mammography report, to avoid patient 
confusion of the phrase ``scattered . . . density'' with tissue that is 
``dense''; (4) a recommendation that patients with non-dense breasts 
should not be advised to speak to their provider; (5) a recommendation 
that patients be advised to continue routine screening mammography; and 
(6) a recommendation to add a statement that risk factors such as 
density can change.
    (Response 76) FDA appreciates these comments. As described in the 
following and organized according to the numbered topics identified in 
Comment 76, we are revising some of the wording in the final rule for 
the lay summary.
    (1) We have modified the introductory language to remove the 
reference to ``Some patients,'' but we disagree with the assertion that 
providing some basic information about density will cause alarm to 
patients with non-dense breast tissue or confusion to patients with 
dense breast tissue.
    (2) As addressed in Responses 68 and 79, we have retained the two 
categories of density, but changed the wording from the comparative 
terms ``high density'' and ``low density'' to ``dense'' and ``not 
dense,'' in order to provide a clear message to the patient. We have 
also corrected Sec.  900.12(c)(2) to specify that the lay summary shall 
include ``an assessment of breast density as described in paragraphs 
(c)(2)(iii) and (iv) of this section'' (i.e., the two categories of 
``dense'' and ``not dense''). In States where notification using four 
density categories is required by State law, facilities may also 
provide that information to patients, but this is distinct from the 
notification paragraph required by this MQSA final rule.
    (3) As the commenter notes, the phrase ``scattered areas of 
fibroglandular density'' is only required in the report intended for 
the healthcare provider, where this phrase conforms to current clinical 
practice and should not cause confusion to healthcare providers. One of 
the goals of the MQSA and its implementing regulations is ensuring 
clear communication between the IP and the referring provider; 
therefore, the report is written using medical terminology. The phrase 
is not required in the lay summary to the patient; therefore, we do not 
agree that the phrase will cause patient confusion. For all patients, 
whether referred by a provider or self-referred, the lay summary will 
only contain a clear statement that the patient's breast tissue is 
``dense'' or ``not dense.'' Patients who are self-referred will also 
receive the report, but the lay summary should help avoid confusion. 
Even a patient who is self-referred for a mammogram may give the report 
to their healthcare provider; therefore, the precision of the report 
should not be sacrificed in order to tailor the language to the lay 
patient, who will also receive a lay summary.
    (4) Regarding the commenter's recommendation that FDA should remove 
the advice for patients whose tissue is assessed as ``not dense'' to 
discuss breast density with a healthcare provider, FDA disagrees with 
this recommendation, as we believe that this conversation is 
appropriate for patients in all density categories.
    (5) In response to the recommendation to add a statement 
instructing patients to continue routine screening mammograms, we 
believe that is part of a larger discussion, including regarding 
screening methods and time intervals, that should take place between a 
patient and the patient's healthcare provider.
    (6) In response to the recommendation to add a statement that 
breast density and other risk factors can change, FDA concludes that 
adding this statement in the lay summary may be confusing and may 
detract from the information provided regarding the current assessment 
of the patient's breast density.
    (Comment 77) Several comments recommend that not all women should 
be informed of breast density risks, and that notifying all women is 
ineffective

[[Page 15146]]

and doing so may cause confusion. Another comment recommends that 
breast density language should only be included in lay summaries to 
women with dense breast tissue.
    (Response 77) FDA disagrees with the comments. A primary goal of 
this provision of the final rule is to provide information to patients 
and their healthcare providers to help guide each individual patient's 
care. Therefore, as noted in Response 76, FDA believes that it is 
appropriate for patients in all density categories to discuss breast 
density with their healthcare providers. The intent of this final rule 
is to provide breast density information to all patients and their 
healthcare providers to help guide each patient's care.
    (Comment 78) A comment recommends that patients should be 
encouraged to discuss their mammography findings with their physician 
to determine what additional tests may be beneficial in their specific 
circumstances.
    (Response 78) FDA agrees with the comment, and concludes that the 
current wording in the final rule, Sec.  900.12(c)(2)(iii) and (iv), 
accomplishes this.
    (Comment 79) Several comments recommend using the terms ``dense'' 
and ``not dense'' rather than ``high density'' and ``low density.''
    (Response 79) FDA agrees with this recommendation to improve 
clarity and reflect clinical practice. Accordingly, as noted in 
Responses 68 and 76, we are revising the final rule to now state, in 
Sec.  900.12(c)(2)(iii), ``Your breast tissue is not dense,'' and in 
Sec.  900.12(c)(2)(iv), ``Your breast tissue is dense.''
    (Comment 80) A comment recommends clarification on whether FDA will 
provide acceptable alternative breast density reporting language, and 
requests that FDA consider replacing the breast density notification 
language with a list of required key information points proposed by one 
commenter.
    (Response 80) FDA disagrees with the comment. One of the intents of 
this rulemaking is to ensure that patients receive a consistent 
baseline of information regarding their breast density; additionally, 
the notification should be subject to straightforward verification 
during the MQSA inspection. Therefore, the Agency is not providing 
alternative breast density reporting language aside from that which is 
included in the final rule, nor changing the notification requirement 
from a required paragraph to a list of key points. FDA recognizes that 
individual States as well as facilities may choose to provide patients 
with additional information, beyond the information required in this 
final rule, where it does not conflict with the MQSA and its 
implementing regulations.
    (Comment 81) A comment recommends that FDA be cautious in the use 
of the word ``normal'' when referring to women with dense breasts, 
since dense breasts may be pathologic and should be a subject of 
research for disease prevention. Conversely, several comments recommend 
that lay summaries should state that dense breasts are not abnormal.
    (Response 81) FDA agrees that it is not necessary to characterize 
dense breast tissue as normal or abnormal, but rather to focus on 
communicating whether a patient has breast tissue that is dense or not 
dense. In this final rule, FDA does not use the words ``normal'' or 
``abnormal'' in the breast density notification statements for patients 
with either dense or non-dense breast tissue.
    (Comment 82) A comment recommends that the lay summary should 
emphasize that dense breasts are common and that most women with dense 
breasts do not reach the clinical threshold for having an elevated risk 
for breast cancer.
    (Response 82) FDA agrees that dense breast tissue is common; 
however, we disagree with the comment regarding elevated risk of 
cancer. We note that studies show that women with dense breast tissue 
do have an elevated risk of developing breast cancer (Refs. 12 to 15), 
and as noted in Response 75, we are revising the patient notification 
language (see Sec.  900.12(c)(2)(iii) and (iv) in this final rule) to 
include a statement that dense tissue raises the risk of developing 
breast cancer.
    (Comment 83) A comment recommends that FDA include recommendations 
to use FDA-cleared automated breast density assessment devices, and 
that instead of the four categories of breast density proposed for the 
report to the healthcare provider, breast density should be reported 
along a continuum based on such automated breast density devices.
    (Response 83) FDA acknowledges that there are various methods for 
the assessment of breast density, which may include automated processes 
such as FDA-cleared density assessment software devices. However, the 
categories in Sec.  900.12(c)(1)(vi)(A) and (D) of this final rule are 
consistent with the four ACR BI-RADS categories of breast composition, 
which are ``defined by the visually estimated content of 
fibroglandular-density tissue within the breasts'' (Ref. 34) and do not 
require automated assessment. The MQSA and implementing regulations do 
not require the purchase or use of specific products as a condition of 
facility certification, and ABs may not require the purchase or use of 
specific equipment or software as a condition of facility accreditation 
(see Sec.  900.4(a)(5)). Furthermore, not all facilities may have or be 
able to afford the same equipment or software, and requiring specific 
equipment could potentially limit access to mammography services. 
Finally, the four density categories in this final rule are in wide use 
in current clinical practice, and will be more readily understood by 
clinicians than a report of individual results along a continuum.
    (Comment 84) A comment recommends that the lay summary specify how 
dense breast tissue impacts the statistical accuracy of mammography.
    (Response 84) FDA disagrees with making this a requirement of the 
lay summary. The Agency notes that any information included in the lay 
summary must account for patient understandability. FDA concludes that 
including a discussion of statistics in the lay summary may detract 
from the effectiveness of the breast density notification and 
recommendations. Additionally, knowledge of breast conditions and 
disease processes is subject to change with ongoing research, and 
specific statistical information may become outdated and misleading. 
However, as noted in Response 52, we are revising the notifications to 
include the statement that ``Dense tissue makes it harder to find 
breast cancer on a mammogram. . . .'' (see Sec.  900.12(c)(2)(iii) and 
(iv) in this final rule). We believe that this language adequately 
conveys the existence of a masking effect of dense tissue on 
mammography.
    (Comment 85) Several comments recommend that the lay summary use 
four categories for breast density, similar to the report to the 
healthcare provider; however, the language used in the lay summary 
should be written at an appropriate education level. Another comment 
recommends adding the word ``significantly'' in reports for patients 
with extremely dense breasts.
    (Response 85) FDA does not consider it necessary to use four 
categories of breast density in a lay summary. In clinical practice, 
further management decisions are typically based on the distinction 
between non-dense and dense, i.e., two categories, as well as on other 
patient risk factors. The Agency believes that the two categories for 
breast density in the lay summary represent an appropriate balance 
between patient understanding and precision of the underlying 
information.

[[Page 15147]]

We believe that using four categories rather than two in the lay 
summary would not be more effective in communicating breast density 
information, and that doing so may be confusing to patients and 
burdensome to facilities. As noted in Response 60, we are revising 
Sec.  900.12(c)(2) to specify that the lay summary shall include ``an 
assessment of breast density as described in paragraphs (c)(2)(iii) and 
(iv) of this section,'' i.e., the two categories of ``dense'' and ``not 
dense,'' and have simplified the language used in these patient 
notifications.
    Similarly, we note that adding the word ``significantly'' would 
effectively divide the single category of dense breast tissue into two 
categories, and detract from the goal of providing a clear message to 
patients with dense breast tissue. Also, this may cause undue alarm to 
patients, as this term is subjective and will not be consistently 
interpreted by all patients. The healthcare provider will receive the 
report that assesses the density on a four-category scale, and can 
incorporate this information into their clinical recommendations to the 
patient.
    (Comment 86) A comment recommends that when a patient views their 
online medical chart from their primary care physician, rather than a 
report that describes their breast density, the patient's actual 
mammogram images should be displayed, and the patient can assess where 
their own density is located along a normal distribution.
    (Response 86) FDA agrees that patients should be informed and 
empowered in the decision-making related to their healthcare. 
Therefore, this final rule includes the requirement for mammography 
facilities to directly notify patients of their breast density in the 
lay summary (see Sec.  900.12(c)(2)(iii) and (iv)), not through viewing 
a primary care provider's medical chart. However, we disagree with 
including an image display requirement for several reasons. First, the 
primary care physician or other referring healthcare provider may not 
have the mammogram images, unless the patient has requested that the 
images be sent to that provider (see Sec.  900.12(c)(4)(ii) and (iii)). 
Also, requiring primary care physicians to display online medical 
charts in a specific manner is not within the scope of the MQSA; 
furthermore, not all patients may choose to access online charts even 
when these are made available. We also conclude that it is not 
reasonable to expect patients to assess their own breast density and 
generate plans for followup based on their self-assessment. Finally, we 
note that providing patients with the images from their mammogram 
studies when requested continues to be a requirement in the final rule 
(see Sec.  900.12(c)(4)(ii) and (iii)), so if patients choose to do so, 
they can directly obtain their mammogram images from the performing 
facility, without any need to use their primary care provider as an 
intermediary.
    (Comment 87) A comment recommends that, due to the variety of 
recommendations for patients with dense breasts, the lay summary should 
include a statement to follow the recommendations in the lay summary 
and in the report sent to the patient's healthcare provider.
    (Response 87) The Agency finds that the notification language in 
this final rule for patients assessed to have dense breast tissue (see 
Sec.  900.12(c)(2)(iv)) is adequate. In the course of the clinical 
decision-making, the referring provider will typically read and 
interpret the mammography report, including its recommendations, in the 
context of other clinical information about the patient. We also note 
that all patients will receive the lay summary, but most patients 
(except for those who are self-referred) will not receive the report 
that is sent to the referring healthcare provider. A referred patient 
would therefore not typically have the ability to independently follow 
the recommendations in that report. Although the lay summary does not 
explicitly state that patients should follow the recommendations in the 
report to the patient's healthcare provider, it does state that 
patients should speak with their healthcare provider. That interaction 
is an opportunity for the patient to receive recommendations from their 
healthcare provider.
    (Comment 88) A comment recommends that the lay summary should 
encourage patients and referring providers to discuss mammogram results 
with the radiologist who interpreted the mammogram. Another comment 
recommends that patients should have the opportunity to speak with the 
radiologist.
    (Response 88) FDA interprets the word ``radiologist'' to mean the 
IP, as the majority of qualified IPs under the MQSA and its 
implementing regulations are radiologists. We agree that the IP for a 
mammogram is a potential resource for both patients and their 
healthcare providers, and this final rule does not prohibit 
communication between these parties. However, we conclude that it is 
neither necessary nor practical to include a recommendation for 
patients and healthcare providers to discuss the results of every 
mammogram with the IP. Workflow varies across facilities; many 
mammograms are interpreted in batches at times when the imaged patients 
are not present, and many mammograms are interpreted at sites other 
than the facilities where the images were performed. Therefore, the IP 
may not be readily available to speak to all patients. The 
recommendations to encourage all patients to discuss their results with 
the IP, or to require the facility to provide an opportunity for the 
patient to speak with the IP, are likely to cause a significant burden 
on IPs and facilities, and could reduce access to mammography services. 
Furthermore, the referring healthcare provider is likely to have a more 
complete knowledge of each patient's history and risk factors than the 
IP, and it is therefore more appropriate for the patient to discuss 
their results with their provider. There is also no need for the lay 
summary to encourage the referring healthcare provider to discuss the 
results with the IP, as the provider does not receive the lay summary 
(but does receive the more detailed mammography report). Healthcare 
providers who require additional information after reading a 
mammography report can typically contact the IP.
    (Comment 89) A comment asserts that DBT is considered supplemental 
to conventional mammography, and recommends that this be made clear in 
the notification wording, to prevent a large increase in orders for 
screening breast ultrasound examinations.
    (Response 89) FDA disagrees with this comment. The choice of 
imaging modalities and the various clinical guidelines for breast 
cancer screening are more appropriately left to the judgment of the 
referring provider and the IP as part of the clinical decision-making 
process. However, FDA notes that many facilities that have DBT 
equipment use this DBT modality for primary screening of many or all of 
their patients, and do not reserve it only for supplemental screening. 
Furthermore, as noted in Response 108, with the exception of the 
medical outcomes audit (see Sec.  900.12(f)(1) in this final rule), the 
MQSA and its implementing regulations do not distinguish between 
screening and diagnostic mammograms. Under the MQSA and its 
implementing regulations, DBT is a mammographic modality, and is 
subject to MQSA quality standards and requirements, including the 
reporting requirements. Therefore, under this final rule, the lay 
summary for a DBT examination, just like the lay summary for a screen-
film mammogram or a full-field digital

[[Page 15148]]

mammogram, must include the breast density notification that is 
appropriate to the patient's breast tissue (see Sec.  900.12(c)(2)(iii) 
and (iv)). See also Response 2.
    (Comment 90) A comment recommends that, in addition to notifying 
patients about their breast density, the lay summary should also inform 
patients that ultrasound or MRI may be performed for additional 
screening. Another comment recommends that the lay summary should 
explicitly state that for women with dense breasts, it may be 
appropriate to consider additional imaging tests. Conversely, a comment 
notes that the U.S. Preventive Services Task Force (USPSTF) has not 
taken a definitive position regarding supplemental MRI or ultrasound.
    (Response 90) In Sec.  900.12(c)(2)(iv) of this final rule, the 
notification language for patients with dense breasts is being revised 
to include the statement that ``In some people with dense tissue, other 
imaging tests in addition to a mammogram may help find cancers.'' FDA 
believes that this information, in addition to the recommendation to 
discuss breast density with a patient's healthcare provider that is 
also included in Sec.  900.12(c)(2)(iv), provides a reasonable basis 
for the patient and the healthcare provider to determine an individual 
plan that takes into account that patient's breast density. FDA 
acknowledges that in current clinical practice, ultrasound and MRI 
examinations are frequently used as imaging modalities in breast 
evaluation; however, practice can change over time, and therefore we do 
not believe that it is necessary to specify these particular modalities 
in the lay summary, but rather, the various options may be discussed by 
the patient and the healthcare provider. In response to the comment 
recommending an explicit statement that it may be appropriate to 
consider additional imaging tests for women with dense breasts, FDA 
believes that the language in this final rule adequately communicates 
that other imaging tests may provide benefit in the evaluation of some 
patients with dense breast tissue. Finally, FDA agrees with the comment 
about the USPSTF. As noted above in Responses 2, 55, 62, and elsewhere, 
we have also not specified the further management of patients with 
dense breast tissue.
    (Comment 91) Several comments address the grade level, literacy 
level, and readability of the notification wording, in general or for 
particular patient populations. A comment expresses concern that the 
wording is above the fifth grade level and may cause misunderstanding, 
confusion, and fear. Another comment recommends that the breast density 
notification should adhere to FDA's best practices requirement to use 
plain language and should ensure that the readability is at or below 
the eighth grade level, or that FDA should explain why this 
notification is not subject to its general policy on risk 
communications, and continues that if the reading level exceeds the 
eighth grade level, FDA should issue a supplemental rule with modified 
breast density notification. Another comment asserts that the reading 
level recommended for U.S. women is the fifth to sixth grade level, and 
recommends that any prescribed language should undergo assessment with 
tools such as Flesch-Kincaid, Dale-Chall, or the Patient Education 
Materials Assessment. A similar comment recommends that the Agency 
should apply textual analysis tools to its proposed notification and 
consider how to address issues raised with understandability and 
readability. A comment recommends that if FDA conducted message 
testing, the results should be made available, and if it did not, it 
should undertake testing to determine whether the notification is 
capable of achieving its intended purpose. Another similar comment 
recommends that FDA should use accepted readability tools to analyze 
its notification language for readability and understandability, and 
test the notification among a diverse and representative set of 
mammography-eligible women, to ensure that it is clear and 
understandable to all women, and adequately explains all ``hard'' 
terms, particularly ``breast density.'' Another comment recommends that 
the Agency should test the notification with an adequate sample of 
African-American and Hispanic women.
    (Response 91) FDA acknowledges these comments. The notification 
language in this final rule is not intended to be a complete discussion 
of breast density, but rather to encourage further discussion between 
each individual patient and their healthcare provider. Readability 
testing was performed internally by FDA on an earlier draft of the 
breast density notifications, and although FDA modified the text of the 
breast density notification from the draft the committee reviewed, FDA 
incorporated the feedback it received to modify the required breast 
density notification statements to a lower grade reading level. Many 
factors, including but not limited to scientific accuracy, adequacy, 
and readability, were considered in composing the final patient density 
notifications in this rule. As noted in several responses, in this 
final rule we are revising both the non-dense and dense breast 
notifications. The non-dense breast notification (see Sec.  
900.12(c)(2)(iii) in this final rule) now states, ``Breast tissue can 
be either dense or not dense. Dense tissue makes it harder to find 
breast cancer on a mammogram and also raises the risk of developing 
breast cancer. Your breast tissue is not dense. Talk to your healthcare 
provider about breast density, risks for breast cancer, and your 
individual situation.'' The dense breast notification (see Sec.  
900.12(c)(2)(iv) in this final rule) now states, ``Breast tissue can be 
either dense or not dense. Dense tissue makes it harder to find breast 
cancer on a mammogram and also raises the risk of developing breast 
cancer. Your breast tissue is dense. In some people with dense tissue, 
other imaging tests in addition to a mammogram may help find cancers. 
Talk to your healthcare provider about breast density, risks for breast 
cancer, and your individual situation.'' Both of these notification 
statements are below the eighth grade reading level on the Flesch-
Kincaid readability scale, which is the average reading level among 
adults. FDA believes that these notifications and their reading level 
appropriately balance readability with scientific accuracy and adequacy 
of information. The Agency also notes that the wording of the 
notification statements in this final rule is simpler than most of the 
State breast density notification statements currently used across the 
country, which are written at a higher reading level (see Ref. 8 for 
the State notification statements). The simpler language of the Federal 
notification statements represents a baseline national standard for 
density notification. FDA notes that further information about 
appropriate reading levels is also addressed in the response to Comment 
92.
    (Comment 92) Several comments discuss the research literature on 
public health messaging in general and breast density notification in 
particular. A comment recommends that FDA consider the literature on 
how public health messages are received. Another comment recommends 
that FDA acknowledge the findings of the Boston University study and 
other research on the readability and understandability of public 
health messaging. A comment encourages the Agency to consult the 
researchers funded by the ACS who are studying the communication of 
breast density information to women. Another

[[Page 15149]]

comment recommends that FDA should assess the State breast density 
notification requirements to evaluate their benefits to public health, 
including reviewing the existing literature, and performing an 
assessment either alone or in partnership with other entities.
    (Response 92) FDA acknowledges these comments. We have reviewed 
some of the research on the readability and understandability of breast 
density notification, such as References 37 to 40, including the 
research of the Boston University group (including Refs. 42 to 44). As 
noted in Responses 52 and 91, FDA believes that the revised 
notification language in this final rule appropriately balances 
readability, accuracy, and adequacy, and is simpler than most of the 
State breast density notifications currently in effect across the 
country. The revised notification statements in this final rule (see 
Sec.  900.12(c)(2)(iii) and (iv)) are consistent with the 
recommendations of most of these researchers, including that the 
density notification should be written at a lower grade level than most 
current State density notifications. The Agency agrees with the Boston 
University researchers (see Ref. 43) that the notification in this 
final rule should not be the only information a patient receives about 
breast density, but rather is intended to establish a consistent 
national baseline standard and to encourage further discussion between 
each individual patient and their healthcare provider.
    (Comment 93) Several comments address the use of languages other 
than English. A comment recommends that FDA identify and require best 
practices for disseminating messages about breast density in multiple 
languages, to reduce anxiety and confusion. Another comment recommends 
that facilities should be urged or even required to translate the 
density information into the prevalent or dominant languages of their 
patient populations. Another comment asserts that there must be a 
Spanish translation, and recommends that translation into Mandarin, 
Hindi, or other commonly used languages should also be performed.
    (Response 93) FDA acknowledges that patients of limited English 
literacy may need assistance with the interpretation of the lay 
summary. However, FDA does not believe that it is necessary to add 
additional language requirements for the lay summary. The MQSA and its 
implementing regulations establish baseline national standards. Under 
the current regulations, the required statements in the mammography 
report, such as the final assessment statement, are in English. 
Likewise, the required statements on breast density that this final 
rule adds to the mammography report (Sec.  900.12(c)(1)(vi)) and the 
corresponding required breast density notification statements that this 
final rule adds to the lay summary (Sec.  900.12(c)(2)(iii) and (iv)) 
are in English. Facilities are encouraged to make every effort to 
communicate with their patients, and FDA recognizes that facilities may 
choose to provide patients with a translation of the breast density 
notification statement, but FDA does not believe it is practical for 
the Agency to regulate such translation. The English-language 
notification statement in this rule must be included in the lay summary 
regardless of any additional information or translation that a facility 
may elect to provide to the patient.

K. Breast Density Notification and the Role of the Referring Healthcare 
Provider

    (Comment 94) Several comments recommend that, in addition to breast 
density notification, FDA should require that the report to the 
healthcare provider include a recommendation that the healthcare 
provider perform a risk assessment.
    (Response 94) The reporting requirements in this final rule are 
intended to promote clear communication about the results of the 
mammogram, not to prescribe other aspects of patient care. FDA 
acknowledges that risk assessments may be an important component of 
care for some patients; however, the Agency generally defers to 
healthcare providers to determine when a risk assessment is appropriate 
for their patients, and so declines to require that such an express 
recommendation be included in mammography reports. As noted in several 
other responses, the notification statements to patients with dense or 
non-dense tissue both say, in part, ``Talk to your healthcare provider 
about breast density, risks for breast cancer, and your individual 
situation'' (see Sec.  900.12(c)(2)(iii) and (iv) in this final rule). 
We believe that the interaction between patients and their healthcare 
provider presents an appropriate opportunity for the healthcare 
provider to assess the patient's individual risk factors.
    (Comment 95) A comment asserts that most healthcare providers are 
not equipped to discuss potential options for further assessment with 
patients who are reported as having dense breasts.
    (Response 95) FDA disagrees with this comment. Many resources 
related to breast density are available to healthcare providers from 
various sources such as professional societies, continuing education 
courses, and articles in professional journals (including, but not 
limited to Refs. 10, 12 to 14, 28, and 31 to 37), so healthcare 
providers should generally be equipped to discuss with patients 
potential options for further assessment.
    (Comment 96) A comment asserts that there is little difference 
between heterogeneously dense breasts and extremely dense breasts, and 
that there is interobserver variability in assessing breast density.
    (Response 96) FDA acknowledges that in some cases there may be 
interobserver variability in breast density assessment (i.e., different 
IPs may assign different density categories to the same examination). 
However, we note that categorizing breast density is part of the IP's 
mammogram interpretation, and is not controlled by FDA. After the IP 
assigns a category, the final rule requires the category to be included 
in the mammography report, using the wording in this final rule (see 
Sec.  900.12(c)(1)(vi)(A) and (D)), to promote clarity of communication 
between the IP and referring healthcare provider. We also note that the 
two categories of breast density cited by the commenter, which appear 
in Sec.  900.12(c)(1)(vi)(C) and (D), respectively, as well as the 
other two categories in Sec.  900.12(c)(1)(vi)(A) and (B), are already 
in wide use and conform to current clinical practice.
    (Comment 97) A comment recommends that additional information and 
images regarding breast density be provided to clinicians and patients, 
and that FDA should consider providing, for clinicians, a reference to 
a specific article on breast density and the risk of interval cancer 
(Ref. 45).
    (Response 97) FDA disagrees in part with this comment. Patients are 
not trained to interpret mammograms; the patient's referring healthcare 
provider is best suited to explain the mammogram results to the patient 
and provide additional information as needed. For healthcare providers, 
some references are cited in this final rule (including, but not 
limited to Refs. 10, 12 to 14, 28, 31 to 37, and 45) and healthcare 
providers can also identify additional resources such as medical 
journal articles, continuing education courses, or practice guidelines 
from professional societies that are most current or most relevant to 
the specific situation of the healthcare provider's patient.

[[Page 15150]]

L. Format for Image Interpretation, Retention, Transfer of Original 
Images, and Release of Copies

    (Comment 98) A comment recommends clarification of the meaning and 
intent of the term ``original format'' as it relates to mammographic 
studies. Another comment recommends that digital images should not 
contain computer-aided detection (CAD) markings. A comment agrees with 
the proposed requirement to retain mammograms in the original modality 
in which they were obtained and not copied or digitized, and recommends 
that facilities be required to adhere to this requirement immediately 
upon publication of the rule rather than 18 months after publication of 
the rule.
    (Response 98) We note that neither the proposed rule nor this final 
rule uses the phrase ``original format.'' The rule states that 
mammograms must be presented for interpretation in the ``original 
mammographic modality'' in which they were performed (see Sec.  
900.12(c)(1)), must be retained in retrievable form in the mammographic 
modality in which they were produced (see Sec.  900.12(c)(4)(i)), and 
cannot be produced by copying or digitizing hardcopy originals (see 
Sec.  900.12(c)(4)(i)). For mammographic images obtained by screen-film 
mammography, this means that the original films that were performed and 
used for interpretation must be retained, and they cannot be copied, 
scanned, or digitized to meet the record retention requirement. 
Mammographic images obtained by FFDM or DBT must be retained in digital 
format. In the rare situations in which FFDM images, which are produced 
in a digital format, are then printed and interpreted on hardcopy film, 
the facility may choose to retain this hardcopy print alongside the 
digital data, but if this hardcopy in turn is scanned or digitized, 
such scan cannot be the sole record of the examination that is 
retained. To ensure compliance with the requirement to maintain the 
original mammograms in Sec.  900.12(c)(4)(i) and (ii), digital (FFDM or 
DBT) images must be retained such that the file format and all other 
characteristics of the original digital image files are preserved. 
Moreover, to ensure compliance with this requirement any CAD markings 
placed by computer software after the mammographic images are obtained, 
and which typically overlie and obscure portions of the image, must be 
removable and the images must be capable of being displayed without the 
CAD marks. A facility may choose to retain a set of the images with 
permanent CAD marks, but this set of images alone would not meet the 
retention requirement. FDA does not believe that these requirements 
should be effective earlier than the other provisions of the rule.
    (Comment 99) Several comments recommend requiring facilities to 
store and transfer images in Digital Imaging and Communication in 
Medicine (DICOM) format. A comment recommends that DICOM be required so 
that proprietary file formats, which receiving facilities may not be 
able to view, are not used.
    (Response 99) FDA disagrees with these comments. Although FDA 
acknowledges that DICOM is currently the predominant format used for 
image files in medical imaging, requiring the use of a specific file 
format in the MQSA regulations is overly restrictive and may limit the 
future development of alternative formats, including formats that offer 
improvements.
    (Comment 100) Comments were received that recommend the use of 
lossy compression for digital mammogram images.
    (Response 100) FDA disagrees with these comments. Section 
900.12(c)(4)(i) of this final rule states that a facility ``Shall . . . 
maintain the mammograms and mammography reports in a permanent medical 
record of the patient'' for a specified time period, and Sec.  
900.12(c)(4)(ii) states that a facility ``Shall upon request by, or on 
behalf of, the patient, permanently or temporarily transfer the 
original mammograms and copies of the patient's reports to a medical 
institution, a physician or healthcare provider of the patient, or to 
the patient directly'' during this time period. Thus, the facility must 
retain the original mammogram, and must have it available for transfer 
upon request. Because lossless compression permits complete 
reconstruction of the image data, images undergoing such compression 
would be generally considered to be ``original'' mammograms for the 
purposes of Sec.  900.12(c)(4) (this aligns with statements made by FDA 
in the PGHS (Refs. 46 to 48) regarding lossless compression of digital 
mammographic images). In contrast, images that have undergone lossy 
compression, which does not maintain all of the data related to the 
mammogram image files, would generally not be considered to be 
``original'' mammograms for the purposes of Sec.  900.12(c)(4). 
Transferring images that have undergone lossy compression would have 
potential consequences regarding the ability to process the digital 
mammogram files, and potential implications for the visualization of 
both normal tissue and abnormalities that may extend beyond the 
subjective image quality. While we acknowledge that data storage and 
transfer may pose significant considerations for facilities, we do not 
believe there is consensus on what loss of information is acceptable 
while maintaining the standards to be able to review and/or transfer 
the original mammogram images as required in the regulations.
    (Comment 101) FDA received several comments that requested 
clarification on the conditions by which digital mammogram files are 
transferred between facilities, including the permissibility of 
downloading images from one facility to another, digitization of 
comparison images, and uploading of digital mammogram images from a 
compact disc (CD) to a receiving facility's picture archiving and 
communication system (PACS). A separate comment recommends that FDA 
require that mammograms be available for electronic transfer rather 
than by using physical media such as a CD. Another comment recommends 
that FDA develop a cloud-based or electronic repository of mammogram 
images for all MQSA-certified facilities.
    (Response 101) Section 900.12(c)(4)(ii) and (iii) of this final 
rule address the transfer of original mammograms and release/provision 
of copies of mammograms, respectively. The Agency wishes to clarify its 
use of the terms transfer and release/provision of copies. In these 
regulations, ``transfer'' means the conveyance of the mammogram such 
that the sending facility no longer retains it. Screen-film 
examinations often are transferred; transfer of FFDM and DBT 
examinations is extremely rare because the original images are 
typically retained in the sending facility's PACS even when copies are 
released upon request. In the final rule, FDA distinguishes between 
``interpretation'' (i.e., initial, repeat, or additional review of a 
mammogram), for which an examination must be presented in the original 
mammographic modality in which it was performed (see Sec.  900.12(c)(1) 
in this final rule), and ``comparison'' (i.e., using a mammogram to aid 
in the interpretation of another exam), which is not subject to that 
requirement. Under the final rule, if transfer is requested, original 
mammograms must be transferred in the mammographic modality in which 
they were produced. Also, under the final rule, for interpretation 
purposes (including ``second opinion'' or additional interpretation), 
digital examinations must be presented to the IP in their

[[Page 15151]]

original digital modality. Thus, if a facility requests an FFDM or DBT 
examination in order to perform a second or additional interpretation 
at the request of the patient or their representative, the exam must be 
provided in its original modality (FFDM or DBT, respectively). We note 
that this may be accomplished either through transfer of the original 
images (which is rare), following the processes described in Sec. Sec.  
900.12(c)(4)(ii) and (iv) of this final rule, or through the release of 
a digital copy, following the processes described in Sec.  
900.12(c)(4)(iii) and (iv) of this final rule. FDA recognizes that many 
facilities may request the release of copies of mammograms not for 
interpretation of the requested exam, but for comparison purposes 
(i.e., in order to aid the interpretation of a subsequent exam); such 
release must follow the processes described in Sec.  900.12(c)(4)(iii) 
and (iv) (see also Response 102 below).
    Technical methods of either transfer or release are not prescribed 
by the final rule, and may include, but are not limited to the 
following (assuming such transfers/releases otherwise comply with 
applicable law): direct electronic transmission of digital mammogram 
files that is arranged between two facilities utilizing Health 
Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant 
and appropriate practices for privacy and data security; providing the 
requesting facility with HIPAA-compliant remote electronic access to 
the images in the PACS of the originating facility; the viewing of 
digital mammogram images located on a physical storage medium such as a 
CD; or the uploading of such images from a digital storage medium to a 
receiving facility's PACS. FDA views all of these methods as meeting 
the requirement to provide original digital images electronically. FDA 
disagrees with the comment recommending that FDA require facilities to 
have the capability to electronically transmit original images or 
copies, rather than transmit via physical media such as CD-ROM, as FDA 
believes such a requirement may be overly burdensome and could impact a 
facility's ability to operate, which could reduce patient access to 
mammography services. We also disagree with the recommendation that FDA 
should develop and maintain a repository of mammogram images performed 
at all MQSA-certified facilities. We note that while such a repository 
could facilitate image comparison between facilities, there are 
significant privacy concerns, and also concern for the expense and 
resources required to establish and maintain such a repository. In 
addition, it may be excessively burdensome for facilities to 
participate in such a repository when facilities are already required 
to retain original mammogram images.
    (Comment 102) A comment recommends that FDA develop a form asking 
if a facility is able to view hardcopy images, and a similar comment 
recommends that ``some consideration be given for facilities that no 
longer have equipment suitable for viewing hardcopy images.'' A comment 
also recommends that facilities should be required to transfer 2D 
images and images from other breast imaging modalities only, but should 
not be required to transmit DBT image sets due to their file size 
unless specifically requested.
    (Response 102) FDA disagrees with the recommendation to develop a 
form regarding hardcopy viewing capability. As discussed in Response 
101, this final rule includes different requirements when transferring 
original mammograms versus when releasing copies (see Sec.  
900.12(c)(4)(ii) and (iii) of this final rule). We reiterate that, in 
current practice, it is very rare for any facility to transfer a 
digital mammogram, whether FFDM or DBT. For these digital modalities, 
if a comparison is sought, typically only copies are provided, while 
the original images are retained by the performing facility, i.e., they 
are not transferred. The requirements in this final rule are less 
stringent for the release of copies than for transfer of the original 
examination. Either original images or exact copies of digital exams 
may be used for interpretation (such as a second opinion) or comparison 
(see Sec.  900.12(c)(1)). Copies of screen-film examinations may be 
used for comparison but not for interpretation (see Sec.  
900.12(c)(1)). However, FDA does not consider film copies of screen-
film examinations to be in the original mammographic modality for 
purposes of Sec.  900.12(c)(1), and thus such copies may be used for 
comparison but not for interpretation. As noted in Response 101, a 
facility may provide a digitized or scanned copy of a hardcopy 
original, such as a scan of a screen-film mammogram, either directly or 
via physical storage media. Therefore, a receiving facility that cannot 
view a hardcopy image may request a scanned or digitized copy for 
comparison purposes; the original film is only required if it is being 
submitted for interpretation, such as a second opinion. Note that this 
rule does not specify any requirement for the type of images that must 
be included when copies are released. Also, images from non-mammography 
imaging modalities are outside the scope of this rulemaking.

M. Deadlines for Image Transfer and the Release of Copies

    (Comment 103) Several comments were received regarding ``transfer'' 
of comparison studies between facilities. A comment states that 15 
calendar days is too long for a facility to transfer patient mammograms 
if a final report is required within 21 to 30 days. A comment notes 
that 15 calendar days is too accelerated a time for facilities to 
transfer large image files such as those associated with DBT image 
files when original images are requested for transfer. A comment agrees 
with requiring transfer of images within 15 days, but it recommends 
that FDA encourage facilities to transfer images within 7 days.
    (Response 103) FDA generally disagrees with these comments. As 
noted in Responses 101 and 102, this rule distinguishes between 
transfer of original examinations and release of copies. For digital 
(FFDM and DBT) examinations, it is very rare to transfer the original; 
when comparison is sought, typically a copy is released. However, under 
this rule, the required timeframe is the same for either the transfer 
of originals or the release of copies, and therefore this response 
addresses both scenarios.
    FDA believes that requiring the transfer of original mammogram 
studies, and the release of copies, within 15 calendar days of a 
request provides adequate time for a comparison to be made and a 
followup report to be issued (see Sec.  900.12(c)(4)(ii) and (iii)), 
because the receiving facility will be aware of the deadline for 
issuing the final report, and can prioritize making the necessary 
comparison upon receiving the prior examination. FDA also notes that 15 
days is the maximum amount of time allowed for a facility either to 
transfer original mammogram studies or to release copies, and is 
intended to be a baseline requirement, but we anticipate that the 
transfer or release will frequently occur in less than 15 days. FDA 
disagrees that 15 days is too little time for DBT studies to be 
transferred (or copies to be released) between facilities, despite the 
size of the image files, as the size of the file does not significantly 
affect the time required to provide electronic access to it, transmit 
it, or copy it. FDA believes that requiring the transfer of original 
examinations or the release of copies within 7 days may not allow 
adequate time for a facility to effect this transfer or release.

[[Page 15152]]

    (Comment 104) A comment recommends that the 15-day requirement for 
the transfer of patient files be reconsidered since some records are 
faxed or mailed and would be difficult for a facility to track, and 
because there are already specific rules for medical recordkeeping, 
making this requirement redundant.
    (Response 104) The 15-day deadline refers to the sending of (or 
provision of electronic access to) the requested records by the sending 
facility, not to their receipt by the receiving facility. FDA 
acknowledges that delivery time may be delayed by factors that are 
beyond the control of the sending facility, so the tracking time is not 
included in the required timeline. Given the importance of ensuring 
timely communication regarding final results of mammograms, FDA 
disagrees that a deadline for facsimile transmission or delivery of 
physical media is overly burdensome as to warrant the removal of this 
requirement from the regulations. Moreover, although there may be other 
applicable State and local medical recordkeeping requirements, such 
requirements are subject to change/repeal and there may be no 
requirements in certain States/localities. FDA believes it is important 
that there be consistent Federal regulations that clearly specify a 
timeframe in which a facility is required to transfer or release 
patient files, as this may have a significant impact on a patient's 
care and management.
    (Comment 105) A comment recommends that FDA provide a guidance 
document that explains how a facility can demonstrate compliance with 
the records transfer and release requirements, including the method of 
determining the dates at which relevant actions occur.
    (Response 105) We believe the records transfer and release 
requirements in this final rule, including the method of determining 
the dates at which relevant actions occur, are sufficiently clear. If 
facilities have specific questions about applicability to their 
situation, we believe such questions would be best addressed by 
directing the questions to FDA's MQSA Facility Hotline or the 
facility's AB.

N. Facility Closure and Mammography Record Retention

    (Comment 106) A comment recommends that FDA create standard forms 
for use by closing facilities to communicate with patients and 
healthcare providers. Another comment recommends that the patients of a 
facility that closes or ceases mammography services should be notified, 
and a comment recommends defining the term ``reasonable efforts'' to be 
made in notifying affected patients.
    (Response 106) Due to the variety of circumstances that may lead to 
the closure or cessation of mammography services at a facility, FDA 
believes that a standard form would not be feasible. This final rule 
requires that a facility that closes or ceases to provide mammography 
services notify its AB and certification agency of the arrangements 
that the facility has made, including making reasonable efforts to 
notify all affected patients (see Sec.  900.12(c)(4)(v)). FDA believes 
this process will enable the AB and certification agency to assess the 
specific circumstances of the facility to help ensure that reasonable 
efforts are made by the facility to notify affected patients. 
Reasonable efforts may include, but are not limited to, sending written 
notification to patients using a traceable method, speaking directly to 
patients by telephone, or asking referring providers to reach those 
patients who the facility was unable to contact directly after 
attempting the above methods. However, FDA acknowledges the wide range 
of circumstances and unique factors that may be related to the 
reasonableness of a facility's efforts to notify all affected patients, 
and therefore this final rule requires the facility to discuss its 
notification efforts with its AB and certifying agency.
    (Comment 107) A comment recommends that FDA include a requirement 
that before a facility closes or ceases performing mammography 
services, the facility must arrange for the permanent transfer of 
records to a facility that will provide access for at least 24 months.
    (Response 107) FDA disagrees with this comment. Section 
900.12(c)(4)(v) of the final regulations states that a facility that is 
closing or ceasing to perform mammography services must permanently 
transfer mammographic records to a patient or the patient's healthcare 
provider, or transfer the mammographic records to another facility or 
entity that will provide access to those records for the patient or the 
patient's healthcare provider for the time periods specified in Sec.  
900.12(c)(4)(i), which are longer than 24 months. Because mammography 
records can be of continuing value to a patient's care, the Agency 
believes that they should remain accessible for the same length of time 
whether they were performed at a facility that continues to perform 
mammography or whether they were performed at a facility that has 
closed or ceased to perform mammography. Therefore, the time periods 
for retention specified in Sec.  900.12(c)(4)(i) apply from the date of 
performance of the exam at the facility through the time after records 
are transferred from facilities that close or cease to perform 
mammography to another facility or entity that will provide access to 
patients and healthcare providers (see Sec.  900.12(c)(4)(v) of this 
final rule).
    FDA also believes that if a mammography facility that is part of a 
medical entity such as a radiology practice or hospital ceases to 
perform mammography, but the medical entity does not close, the medical 
entity may be able to continue to retain and release the mammography 
records in a manner consistent with the requirements in Sec.  
900.12(c)(4)(i) through (iv). Accordingly, we are revising the proposed 
requirement that a facility must make arrangements for access by 
patients and healthcare providers to their mammographic records before 
the facility closes or ceases to provide mammography services, in Sec.  
900.12(c)(4)(v), to add that ``If a facility ceases to perform 
mammography but continues to operate as a medical entity, and is able 
to satisfy the recordkeeping requirements of Sec.  900.12(c)(4)(i) 
through (iv), it may choose to continue to retain the medical records 
rather than transfer them to another facility, unless such a transfer 
is requested by, or on behalf of, the patient.''

O. Mammography Medical Outcomes Audit

    (Comment 108) Several comments recommend that FDA provide 
additional guidance regarding the medical outcomes audit, including 
clarification of the definition of a positive study, specifying which 
method should be used to calculate the PPV, and differentiating between 
screening and diagnostic mammogram studies when calculating PPV. 
Related comments recommend the use of a patient's screening interval, 
which may or may not be 1 year, as the time period over which to 
calculate PPV, and updating the definitions of positive and negative 
studies in the MQSA implementing regulations to conform to the 
definitions in the ACR BI-RADS 5th edition (Ref. 49).
    (Response 108) In Sec.  900.2(mm), a positive mammogram is defined 
as a mammogram that has an overall assessment of findings that are 
either ``suspicious'' or ``highly suggestive of malignancy.'' This 
definition was used in the discussion of the metrics for the outcomes 
audit within Sec.  900.12(f). The MQSA and its implementing regulations

[[Page 15153]]

apply to all mammograms, including those performed for either screening 
or diagnosis. In this final rule, only for the purposes of calculating 
the audit metrics, FDA has acknowledged the distinct clinical roles of 
screening mammography and diagnostic mammography. For clarification, in 
this final rule we are replacing the phrase ``For the purposes of these 
requirements'' in the medical audit outcomes provision with the phrase 
``For the purposes of these audit requirements'' (see Sec.  
900.12(f)(1) in this final rule).
    We note that the clinical practice community recognizes several 
different methods for calculating the PPV, including the PPV1, PPV2sc, 
PPV2dx, and PPV3 (Refs. 49 and 50.). Of these variants, the PPV2sc 
includes the outcomes of all biopsy recommendations, whether that 
recommendation resulted directly from a screening mammogram (a sequence 
that is clinically discouraged (Ref. 49) and rarely occurs in practice) 
or from a subsequent diagnostic mammogram performed after an abnormal 
screening mammogram. As stated in Sec.  900.12(f)(1)(i) in this final 
rule, FDA will require facilities to calculate the PPV as the percent 
of patients with positive mammograms who are diagnosed with breast 
cancer within 1 year of the date of the mammographic examination. This 
metric is essentially identical to the PPV2sc used by the clinical 
practice community, and uses a 1-year interval like the PPV2sc. The use 
of this metric is considered a minimum requirement; facilities are also 
permitted to calculate additional PPVs using other methods if they 
choose to do so. However, FDA disagrees with the recommendation to 
adopt definitions from a particular edition of a particular clinical 
practice guideline, to avoid restricting the future development of 
mammography practice.
    (Comment 109) Several comments also recommend clarification of the 
definition of cancer detection rate (CDR) and recommend separate 
calculations for CDR for screening and diagnostic mammogram studies.
    (Response 109) FDA recognizes that the clinical practice community 
uses various methods for calculating CDR, including calculating CDR 
only for screening mammograms, or separately for screening and 
diagnostic mammograms. The CDR calculation required by this final rule 
(see Sec.  900.12(f)(1)(ii) in this final rule) is a single calculation 
for CDR for screening mammograms. As with Response 108, regarding PPV, 
the calculation method for CDR in this final rule is also considered a 
minimum requirement. Facilities are permitted to calculate CDR using 
additional methods if they choose to do so. However, FDA also notes 
that the PPV required by Sec.  900.12(f)(1)(i) of this final rule is 
essentially equivalent to the CDR calculation for diagnostic 
mammograms, so by meeting the requirements of this final rule, 
facilities will be calculating both the CDR for screening mammograms 
and a value (i.e., PPV) using a calculation that is essentially 
equivalent to the calculation done for the CDR for diagnostic 
mammograms.
    (Comment 110) A comment states that in BI-RADS, a screening 
mammogram assessed as either category 0, 3, 4, or 5 (i.e., Incomplete, 
Probably Benign, Suspicious, or Highly Suggestive of Malignancy, 
respectively) is considered positive, and may be suggesting that FDA 
adopt this approach.
    (Response 110) This final rule states that recall rate will be 
calculated as the percentage of screening mammograms given an 
assessment of ``Incomplete: Need additional imaging evaluation'' (see 
Sec.  900.12(f)(1)(iii)). We note that assigning any of the other 
assessments mentioned by the commenter--Probably Benign, Suspicious, or 
Highly Suggestive of Malignancy--to a screening mammogram is clinically 
discouraged (Ref. 51) and rarely occurs in practice.
    (Comment 111) Several comments recommend that FDA offer further 
guidance on how facilities should interpret medical outcomes data and 
derive performance data. A comment recommends linking the medical 
outcomes data with cancer registries.
    (Response 111) The medical outcomes audit is intended to allow each 
facility to assess and improve its own performance. FDA's finalized 
metrics of PPV, CDR, and recall rate for the outcomes audit are minimum 
requirements; facilities are not restricted from calculating additional 
metrics if they choose to do so. Regarding the recommendation to link 
medical outcomes data with cancer registries, this is outside the scope 
of this rule, although the regulations do not prohibit facilities from 
adopting this practice.
    (Comment 112) Comments recommend that mammograms used for 
localization should have no numeric value and should be excluded from 
medical outcomes audits.
    (Response 112) FDA agrees that mammograms used for localization 
should be excluded from the medical outcomes audit, and the required 
calculations in Sec.  900.12(f)(1)(i) through (iii) in this final rule 
do not include mammograms that are in this category. As noted in 
Responses 38 and 108, only a mammogram that receives an overall 
assessment of either ``suspicious'' or ``highly suggestive of 
malignancy'' is defined as a positive mammogram (see Sec.  900.2(mm)). 
This final rule adds the assessment category ``Post-Procedure Mammogram 
for Marker Placement'' (see Sec.  900.12(c)(1)(iv)(G)), which may be 
assigned in the clinical scenario described in this comment. If a 
mammogram receives the assessment ``Post-Procedure Mammogram for Marker 
Placement,'' rather than the positive assessment of ``suspicious'' or 
``highly suggestive of malignancy,'' then it is not a positive 
mammogram, and should not be counted in any audit calculations that 
track the outcomes of positive mammograms.
    FDA also reiterates that all of the assessment statements in the 
MQSA regulations are comprised exclusively of words or phrases, as 
noted in Response 35, and do not include numeric values or codes (see 
Sec.  900.12(c)(1)(iv) and (v) of this final rule); code numbers are 
used together with assessments in some clinical practice guidelines, 
such as ACR BI-RADS, but are not part of the approved assessment 
statements.
    (Comment 113) A comment recommends maintaining the current medical 
outcomes audit requirements, as the comments states that additional 
requirements in the proposed regulations will result in inspection 
failures at facilities with limited resources.
    (Response 113) FDA disagrees with the comment. The Agency believes 
that it is appropriate to provide the additional requirements for the 
medical outcomes audit that are included in this final rule (see Sec.  
900.12(f)(1)). The three additional metrics in this final rule are 
widely acknowledged in the clinical practice community and are already 
in wide use in mammography practices. Because all certified facilities 
already perform a medical outcomes audit, which for many facilities 
already includes these specific metrics, we believe that adding these 
metrics to the requirements will not be unduly burdensome. Also, we 
note that although MQSA inspectors will check whether each facility is 
performing these calculations, those inspectors generally will not 
document the specific values obtained by the audit.
    (Comment 114) Several comments recommend additional clarification 
regarding the medical outcomes audit, including how it relates to 
annual facility inspection, how long it should be retained, and who has 
access to the audit.

[[Page 15154]]

    (Response 114) During a facility's annual inspection, the inspector 
generally will verify that a facility has completed its medical 
outcomes audit during the time period for which the annual inspection 
is evaluating the facility, or (in the event the inspection occurs 
during the first 2 years of the facility's operation) will verify that 
the facility has established the required audit procedures and 
designated an audit IP (Ref. 18). This final rule requires that 
facilities, at a minimum, calculate the PPV, CDR, and recall rate (see 
Sec.  900.12(f)(1) in this final rule), and the inspector generally 
will check whether these three metrics, at a minimum, have been 
calculated, or that the procedures for calculating them are in place, 
as applicable. However, FDA does not anticipate that the inspector will 
document the specific values obtained by the medical outcomes audit. 
The inspector will generally verify that the audit IP has notified each 
IP at the facility of their respective individual audit results and the 
facility's aggregate results, or, in the event the inspection occurs 
during the first 2 years of the facility's operation, generally will 
verify that the facility has established a procedure for such 
notification. The inspector generally will also verify that the audit 
IP has documented any followup actions taken, or that the facility has 
established a system for such documentation. Because the audit 
information is subject to inspection, at a minimum, the data must be 
retained by the facility until the MQSA inspection that covers that 
medical outcomes audit (see Sec.  900.12(f)(4)). After the MQSA 
inspection that covers that medical outcomes audit, the facility and 
the audit IP may determine any ongoing utility of the medical outcomes 
audit data, and may elect a longer retention time if this is deemed 
beneficial to the facility. As noted, Sec.  900.12(f)(3) requires that 
each IP be notified of that IP's respective individual audit results 
and the facility's aggregate results; beyond this requirement, the 
facility and the audit IP can determine who else, if anyone, may have 
access to the data.

P. Patient and Referring Provider Notification

    (Comment 115) A comment recommends that FDA and the State 
certification agency be required to directly notify patients and 
providers, and that they may use mass media only if all other options 
for direct notification have been exhausted, for PPNs, when a facility 
is not able or willing to perform the PPN.
    (Response 115) FDA disagrees with the comment. The Agency notes 
that some facilities that have been required to perform a PPN have 
reported that they were unable or unwilling to do so, but the 
circumstances of each facility differed. This provision of the rule 
(see Sec.  900.12(j)(2) of this final rule) expressly states that FDA 
or a State certification agency may notify the affected population if a 
facility is unable or unwilling to perform such notification. The 
requirement recommended in the comment could cause significant delays 
in notification of affected patients and their providers, related to 
both the attempt to identify all possible options and the practical 
considerations of performing individual notification. If a facility is 
unable or unwilling to perform a required PPN, FDA intends that State 
certification agencies and FDA will act in the manner that best serves 
the interests of public health and will consider the specific 
circumstances when selecting the method(s) for notification of patients 
and healthcare providers.
    (Comment 116) A comment recommends that the description of non-
physician healthcare providers in Sec.  900.12(j)(2) (i.e., ``other 
healthcare providers''), in the context of PPNs, be included earlier in 
the final regulations.
    (Response 116) FDA agrees with the comment. The reference to non-
physician healthcare providers in Sec.  900.12(j)(2) in this final rule 
revises this specific provision in the 1997 MQSA final rule (62 FR 
55852), which previously listed only patients and their referring 
physicians as parties who must be notified in the event of a PPN. This 
revision is intended to address notification of non-physician referring 
providers when their patients are among the affected PPN population. 
However, we agree that some earlier references in the regulations to 
referring physicians should also be revised to use or incorporate the 
term ``healthcare provider.'' In this final rule, FDA is either 
replacing the word ``physician'' with the term ``provider'' or 
``healthcare provider,'' or adding one of these terms in addition to 
``physician,'' in Sec. Sec.  900.2(c)(2), 900.2(k), 900.2(ii), 
900.4(f)(1)(ii)(B), and 900.12(j). Some other sections of the 
regulations already use the term ``provider,'' and FDA believes that 
this term in those instances remains accurate (see Sec. Sec.  
900.12(c)(1)(vi), 900.12(c)(2)(i) and (ii), 900.12(c)(3), 
900.12(c)(3)(i) and (ii), 900.12(c)(4)(ii)).

Q. Revocation of Certification

    (Comment 117) A comment recommends using boldface text to state 
that a State agency that is an FDA-approved State certification agency 
(SCA) under the States-as-certifiers provision may suspend or revoke a 
certificate.
    (Response 117) FDA understands the concern for readability of the 
regulations; however, FDA is unable to change the typeface and font 
used for display and printing of regulations in the CFR, as such 
stylistic issues are determined by the U.S. Government Publishing 
Office for the entire Federal government. For clarification, part 900, 
subpart C (``States as Certifiers'') establishes the procedures for a 
State to apply to become an FDA-approved SCA, and the requirements and 
standards for the SCA to use to ensure that all mammography facilities 
are adequately and consistently evaluated for compliance with quality 
standards at least as stringent as those established by FDA. SCAs are 
required to have appropriate criteria and processes for suspension and 
revocation of certificates and to have a process for appeals of 
inspection findings, enforcement actions, and adverse certification 
decisions (Sec.  900.22(d) and (e)). SCAs cannot suspend or revoke 
certificates under the authority in Sec.  900.14, but instead are 
required to have their own process for taking such actions.
    (Comment 118) A comment recommends that FDA define an operator of a 
facility.
    (Response 118) FDA disagrees with this recommendation. The exact 
role, responsibilities, and title of an operator varies depending on 
the specific circumstances of the individual facility and operator. 
Operators may include the lead IP, other IPs, QC technologist, other 
radiologic technologists, medical physicists, or other staff, depending 
on the circumstances. Operators may have varied responsibilities, 
including but not limited to ensuring that a facility's quality 
assurance program meets the requirements set forth in this final rule, 
interpreting mammograms, evaluating the performance of mammography 
equipment, positioning patients for radiographic examinations, or 
performing other staff responsibilities at a facility.
    (Comment 119) A comment recommends that a facility that has had its 
certificate revoked should not return to practice without probationary 
oversight.
    (Response 119) FDA disagrees with this recommendation. Before a 
facility whose certificate was revoked can return to the practice of 
mammography, it will have to comply with all corrective actions 
required by its AB. Additionally, under the MQSA, when a facility's 
certificate is revoked, the owners and operators of the facility at

[[Page 15155]]

the time of the revocation may not own or operate a mammography 
facility for 2 years (42 U.S.C. 263b(i)(3)). At the end of those 2 
years, those operators will have failed to maintain their 
qualifications under the MQSA and implementing regulations, and will be 
required to reestablish qualification, each according to the 
requirements for their profession (either Sec.  900.12(a)(1)(iv) for 
IPs; Sec. Sec.  900.12(a)(2)(iii)(D) and 900.12(a)(2)(iv)(B) for 
radiologic technologists; or Sec.  900.12(a)(3)(iv) for medical 
physicists) before they may resume practice at a certified facility. 
FDA thinks that the facility and its operators will have received 
sufficient training and completed sufficient corrective action before 
they are permitted to return to practice. Furthermore, upon returning 
to practice, the facility and personnel again become subject to all 
accreditation and certification requirements of the AB and FDA (or 
SCA).

R. Interpreting Physician Qualifications, Including Continuing 
Experience

    (Comment 120) Several comments were submitted regarding the 
continuing experience and continuing education requirements for IPs. 
Comments recommend: (1) increasing the number of mammographic 
examinations that an IP must interpret to satisfy the continuing 
experience requirement; (2) adding a requirement for a minimum number 
of diagnostic mammograms that must be read; (3) requiring continuous 
feedback to IPs on individual cases rather than only at the time of the 
annual medical outcomes audit; (4) requiring that IPs ``work up'' their 
own recalled cases; and (5) requiring that IPs at facilities with lower 
volumes and in low-income areas be exposed to more mammography 
examinations.
    (Response 120) (1) Regarding the number of mammographic 
examinations an IP must interpret to satisfy the continuing experience 
requirement, although FDA acknowledges that there may be certain 
benefits to increasing the continuing experience requirement, this must 
be weighed against a potential loss in access to mammography services 
if IPs are unable to satisfy these increased requirements. FDA believes 
that the current continuing experience requirements, as described in 
Sec.  900.12(a)(1)(ii), represent a reasonable balance between the 
goals of maintaining an IP's ongoing ability to interpret mammograms 
and preserving access to mammography services at facilities across the 
country.
    (2) Regarding an additional requirement for a minimum number of 
diagnostic mammograms versus screening mammograms, FDA again believes 
that while there may be certain benefits with such a requirement, 
establishing such a requirement may adversely impact the ability of IPs 
who work in varied settings to meet these requirements and to continue 
interpreting mammogram studies, again potentially impacting access to 
mammography services. Furthermore, as noted in Response 108, with the 
exception of the outcomes audit requirements (see Sec.  900.12(f) in 
this final rule), the MQSA regulations do not distinguish between 
mammograms performed for screening or diagnosis.
    (3) Regarding the recommendation for requiring continuous feedback 
on individual cases to IPs, FDA notes that there is a requirement in 
Sec.  900.12(i) that ``[c]linical images produced by any certified 
facility must continue to comply with the standards for clinical image 
quality established by that facility's accreditation body.'' To ensure 
compliance with such standards, facilities conduct regular periodic 
reviews of the image quality of samples of the images performed by each 
RT and the images accepted for interpretation by each IP (see Ref. 52). 
This is a mechanism for providing periodic image quality feedback to 
IPs. The Agency believes that this requirement, together with the 
requirement to provide IPs with outcomes feedback from the annual 
medical outcomes audit and the requirements for continuing education 
and continuing experience are reasonable and appropriate to ensure an 
IP's ongoing ability to interpret mammographic examinations.
    (4) Regarding the recommendation that IPs be required to work up 
their own recalled cases, FDA notes that workflow as well as personnel 
schedules vary across facilities; also, some facilities perform only 
screening and not diagnostic mammograms. Therefore, we believe that 
such a requirement would be significantly burdensome for facilities to 
implement, and may be both impractical and restrictive for scheduling, 
both for the IP and for the patient, which could lead to decreased 
access to mammography services.
    (5) Regarding IPs at lower volume facilities or in areas with a 
low-income population, such IPs are required to meet the continuing 
experience requirements (see Sec.  900.12(a)(2)(ii)). FDA believes that 
placing additional requirements on IPs at these facilities would be 
detrimental to these facilities' ongoing ability to operate and provide 
services to their patient populations. As with other MQSA requirements, 
the continuing experience requirement is a baseline national standard; 
the MQSA regulations do not prohibit IPs from obtaining additional 
experience nor facilities from requiring that their employees obtain 
additional experience.
    (Comment 121) A comment recommends that continuing education be 
specifically required to be obtained through active, case-based 
learning, and test sets with feedback.
    (Response 121) FDA disagrees with the comment, and so has not 
incorporated this requirement in the final rule. FDA believes that the 
continuing education requirements for IPs, as described in Sec.  
900.12(a)(1)(ii)(B), are appropriate and adequate to ensure the ongoing 
education of IPs in mammography. Adding specific requirements such as 
those recommended by the commenter may be overly burdensome, risking a 
decrease in personnel and in patient access to mammography services. 
FDA also notes that specific requirements for active, case-based 
learning and for test sets with user feedback may be confusing to IPs 
and facilities determining how to satisfy such requirements.
    (Comment 122) A comment recommends that double-reading be required 
for some IPs, such as newly trained IPs, requalifying IPs, or those who 
do not meet benchmarks.
    (Response 122) FDA disagrees with the comment, and has not added 
this requirement in the final rule. FDA believes that the requirements 
for initial qualification of IPs, as described in Sec.  
900.12(a)(1)(i), and for requalifying IPs, as described in Sec.  
900.12(a)(1)(iv), are adequate, and in both of these situations, there 
is already a requirement for interpretation of certain numbers of 
mammograms under the direct supervision of a qualified IP. The MQSA and 
part 900 do not contain specific benchmarks for the performance of IPs 
in the interpretation of mammograms, and while we note that careful 
review of the results of the annual medical outcomes audit may be 
beneficial for IPs and informative in guiding their selection of 
continuing education to address areas where improvement is needed, we 
do not agree that it is necessary to introduce a requirement for 
additional supervised interpretation for qualified IPs.

S. Cleaning of Mammography Equipment

    (Comment 123) A comment recommends that the MQSA regulations be 
more specific regarding when and how mammography equipment should be 
cleaned.

[[Page 15156]]

    (Response 123) FDA disagrees that more specificity is needed in 
these regulations regarding this issue. The regulations already 
describe processes that facilities must follow regarding cleaning and 
disinfecting mammography equipment (see Sec. Sec.  900.12(e)(11)(ii) 
and 900.12(e)(13)). The Agency is not aware of information showing that 
the existing requirements have led to contamination of equipment. This 
final rule does not provide additional requirements beyond those 
already specified because we believe that these requirements are 
adequate in their detail regarding the cleaning and disinfecting of 
mammography equipment.

T. Availability and Clinical Role of Breast Imaging Modalities, 
Screening Mammography Guidelines

    (Comment 124) A comment recommends that facilities should be 
required to offer 3D mammography (i.e., DBT) and ultrasonography within 
6 months of publication of this final rule; another comment recommends 
that facilities should be required to offer DBT within 10 years of 
publication of this rule; and a comment recommends that every 
mammography facility should be required to have at least one 3D 
mammography unit. A different comment suggests that a list of 
facilities offering advanced technologies, including 3D mammography, 
should be published.
    (Response 124) FDA disagrees with these comments. Various devices 
cleared or approved by FDA are respectively capable of performing 
examinations using different mammographic modalities, including screen-
film, FFDM, and DBT; the choice of the specific technology used to 
image each patient is a decision by the IP and the patient's referring 
healthcare provider, if any. FDA does not require facilities to offer 
specific equipment or particular imaging modalities. Additionally, as 
stated in the proposed rule, Executive Summary section I.A, the MQSA 
and implementing regulations are designed to ensure that all patients 
nationwide have access to quality mammography services, and FDA is 
concerned that instituting a requirement to use only more expensive 
technology (e.g., DBT) may place a significant financial burden on 
facilities, potentially impacting their ability to operate, which may 
then reduce patient access to mammography services. Regarding the 
recommendation to publish a list of facilities offering 3D mammography, 
FDA does offer a public database of all certified facilities (Ref. 53), 
but the Agency thinks that including information on the equipment at 
each facility would be impractical, as equipment changes at facilities 
may occur at irregular and potentially frequent intervals, including 
both the introduction and removal of equipment, which may impact the 
accuracy of the information in such a list.
    (Comment 125) Many comments recommend the use of specific medical 
imaging technologies, including 3D mammography and other modalities 
such as ultrasound and MRI, in varying clinical situations for the 
examination of patients with dense breasts. Specifically, several 
comments recommend that women with dense breasts should either have 
only 3D mammography performed, or have both 3D mammography and 
ultrasound performed, with a comment recommending that mammography and 
ultrasound should be performed every 3 months, or that imaging 
modalities other than mammography should be used. A comment recommends 
that information regarding the benefits of 3D mammography be provided 
to patients. Conversely, another comment recommends that 3D mammography 
be pulled from use until additional safety and efficacy studies have 
been performed due to its higher radiation dose compared to 2D imaging. 
Another comment recommends that patients be provided with information 
on ultrasound and that women should be able to choose to have either a 
mammogram or an ultrasound.
    (Response 125) FDA disagrees with incorporating these 
recommendations into the regulations. Certain 2D and 3D (i.e., DBT) 
mammography equipment has been approved or cleared by FDA following 
FDA's review of a premarket approval application or premarket 
notification (510(k)) submission. The choice of particular breast 
imaging modalities or screening time intervals, whether for patients 
with dense breasts or for any other patients, is a decision for 
healthcare providers to make in caring for their patients. Likewise, we 
defer to healthcare providers on provider-patient discussions regarding 
use of ultrasound or other tests when caring for their patients.
    (Comment 126) Several comments recommend that providers be notified 
of the possibility that additional imaging modalities may be needed.
    (Response 126) The consideration of the benefits, risks, and uses 
of various tests or imaging modalities is most appropriately left to 
the licensed healthcare provider. We decline to incorporate this 
recommendation.
    (Comment 127) Several comments recommend that patients be informed 
of other options for breast imaging such as molecular breast imaging 
(MBI), ultrasound, and MRI. A comment also recommends that patients be 
informed that their health insurance plan may not cover these tests.
    (Response 127) FDA disagrees with adding a requirement to the 
regulations to inform patients of other options for breast imaging, 
including because the options for breast imaging may change with 
technological advancements. The required density notification language 
in the final rule includes a recommendation that all patients discuss 
their individual situation with their healthcare provider (see Sec.  
900.12(c)(2)(iii) and (iv)), and advises patients with dense breasts 
that in some people with dense tissue, other imaging tests in addition 
to a mammogram may help find cancers (see Sec.  900.12(c)(2)(iv)). 
Insurance coverage and reimbursement are outside the scope of these 
regulations; furthermore, FDA is also concerned that including 
references to insurance coverage in the lay summary may distract from 
the information in the breast density notification.
    (Comment 128) Several comments suggest that MBI should be 
recommended to patients, be added to a list of supplemental screening 
methods, or have information about it provided to patients.
    (Response 128) FDA believes that decisions about the use of various 
imaging modalities, including whether or not to consider them, are more 
appropriate for the healthcare provider to make, as they can take into 
consideration their understanding of the specific patient and the 
patient's needs from their relationship with the patient and medical 
history.
    (Comment 129) A comment recommends that FDA approve thermography 
and ultrasound used together as an alternative to mammography.
    (Response 129) As we noted in various responses, the MQSA applies 
only to mammography activities. Accordingly, breast sonography and 
thermography are both outside the scope of this rulemaking and are both 
outside the scope of the MQSA. Additionally, FDA has issued a Safety 
Communication (Ref. 54) and a Consumer Update (Ref. 55) that warn that 
thermography is not an effective alternative to mammography, and that 
there is no valid scientific data to demonstrate that thermography 
devices, on their own or with another diagnostic test, are an effective 
screening tool for any medical condition, including the early detection 
of breast cancer. People who choose thermography instead of

[[Page 15157]]

mammography may miss the chance to detect breast cancer at its earliest 
and most treatable stages.

U. Clinical Decision-Making

    (Comment 130) A comment recommends that healthcare facilities be 
required to arrange mammography appointments for patients on the same 
day that a clinical breast exam is performed. Another comment 
recommends that healthcare providers be required to schedule followup 
appointments with patients reported to have dense breasts, and a 
comment recommends that physicians use shared decision-making with 
their patients. Several comments recommend that IPs be able to assume 
the role of healthcare provider for a patient with no referring 
provider, and that the IP should be able to order additional imaging 
studies such as ultrasound. A comment also recommends that patients be 
able to self-refer for supplemental breast imaging.
    (Response 130) FDA agrees that providing timely breast imaging 
services to patients is important. However, the scope of the MQSA is 
limited to the regulation of mammography facilities and their 
activities (see 42 U.S.C. 263b(a)(3)), as opposed to regulation of more 
general healthcare provider practices, such as the ordering of imaging 
studies or general followup with patients by their primary care 
physician or referring provider. Radiologist ordering of additional 
imaging studies and patient self-referral for imaging are both largely 
dependent on State or local requirements or specific facility policies 
and are outside the scope of this rulemaking (see also Responses 70, 
89, 90, 125, and 131).
    (Comment 131) A comment recommends that breast imaging centers 
should not refuse to perform annual mammography on patients with dense 
breasts. A comment recommends that facilities should interpret 
mammograms in real time and add ultrasound for patients with dense 
breasts. Another comment recommends that radiologists use all available 
technologies to determine breast density.
    (Response 131) The MQSA regulations do not take a position on the 
frequency or interval for screening mammography, as these vary and FDA 
generally defers to healthcare providers on such matters involving 
clinical decision-making with their patients. Similarly, other than the 
requirement to issue the report and lay summary (following 
interpretation of the mammogram) within respectively specified time 
periods (see Sec.  900.12(c)(2) and (3) in this final rule), the timing 
and workflow for the interpretation itself is generally outside the 
scope of this rule. FDA notes that imposing a requirement to interpret 
examinations in real time may be overly burdensome to many facilities 
and may impact their ability to operate, thus reducing patient access 
to mammography services. The recommendation to require facilities to 
add ultrasound or other non-mammographic breast imaging modalities is 
outside the scope of authority of the MQSA, and is addressed in 
responses to other comments (see Responses 2, 4, 6, 41). FDA also 
concludes that a requirement for facilities to use all available 
technologies, or any particular technology, to determine breast density 
is overly burdensome and would unnecessarily restrict facilities both 
in terms of the resources and time required to acquire the equipment 
and to implement such a requirement. Also, the MQSA regulations do not 
require the use of specific devices; similarly, no AB is permitted to 
require the use of specific devices or products as a condition of 
accreditation (see Sec.  900.4(a)(5)).
    (Comment 132) Comments recommend that mammography patients should 
be informed of the limitations and radiation risk of mammography and 
asked to provide consent prior to undergoing mammography, and that 
patients should be informed of the risk of overdiagnosis and 
overtreatment of breast cancer due to screening mammography.
    (Response 132) As noted in Response 131, the clinical indications 
used to decide when to perform a mammogram are more appropriate for the 
referring healthcare provider to consider. FDA notes that the 
healthcare provider who refers a patient for a mammogram can discuss 
with that patient the benefits and risks of the examination, including 
the implications of the potential results, and the patient and provider 
can utilize shared decision-making to determine whether to proceed with 
the examination. Additionally, although not addressed in the MQSA or 
its implementing regulations, a critical component of FDA premarket 
approval or clearance of any mammography equipment is a benefit-risk 
analysis that considers the radiation exposure associated with imaging 
with the device, among other information, before determining that the 
device meets the standard for approval, clearance, or marketing 
authorization when used according to its stated indications (Ref. 56).
    (Comment 133) A comment recommends that all mammograms should be 
performed as screening mammography.
    (Response 133) The MQSA was passed to improve the quality of 
mammography, regardless of the clinical scenario in which a particular 
mammogram is recommended or performed. With the exception of the 
medical outcomes audit, as discussed in Sec.  900.12(f)(1) in this 
final rule, the MQSA and its implementing regulations do not 
distinguish between screening and diagnostic mammography. As we noted 
in Response 131, the choice of a screening time interval and other 
clinical decisions related to mammography are more appropriate for the 
healthcare provider in the course of clinical decision-making with the 
patient.

V. Insurance Coverage

    (Comment 134) Many of these comments recommend the following: (1) 
insurance should cover all breast imaging services, including 
mammography, MRI, ultrasound, and breast biopsy procedures; (2) 
insurance should be required to reimburse for ``3D breast imaging'' 
(this term is not specific, but the commenter may be referring to DBT, 
which is a mammographic modality subject to MQSA); (3) insurance 
coverage should not be impacted by a patient having dense breasts; (4) 
insurance coverage should be mandated such that socioeconomic 
disparities in treatment and outcomes will not be worsened; (5) 
additional reimbursement per examination should be granted to 
facilities in rural and underserved areas to cover the cost of new 
equipment; and (6) genetic testing and patient education should be 
provided at no additional expense to the patient. Another comment 
suggests that FDA should limit the interest rate charged by equipment 
manufacturers for facilities that finance equipment purchases from 
them. Finally, several comments recommend requiring insurers, including 
Medicare/Medicaid, to increase reimbursement for screening mammography 
and to eliminate patient expense for annual mammograms for patients 
aged 40 to 74 years and for high-risk patients aged 25 to 40 years.
    (Response 134) FDA considers the recommendations within these 
comments to be outside the scope of its authority to regulate under the 
MQSA or other authorities. We recognize that healthcare costs are a 
significant concern to the public. FDA recommends that patients check 
with their insurance company regarding coverage before

[[Page 15158]]

undergoing mammography examinations.

W. Economic Impact of This Rule

    (Comment 135) A comment asserts that the costs associated with MQSA 
are high, and recommends that a less expensive way be found to 
encourage and mandate that facilities use ``decent'' equipment and 
personnel.
    (Response 135) To the extent the comment is about the cost of the 
proposed rule, FDA disagrees with the comment. As discussed in the 
proposed rule and elsewhere in this final rule, we considered costs and 
benefits. We conclude that the current final rule represents an 
appropriate balance between costs and benefits, with the goal of 
improving mammography quality and the public health.
    (Comment 136) One comment expresses support for the modernization 
of the MQSA regulations, but states that the ``breast x-ray examination 
fee is relatively high in the proposed rules, which ranges from $600 to 
$1,800,'' and recommends that the regulations provide examination 
methods that are less expensive than mammography.
    (Response 136) FDA appreciates the commenter's support for the 
regulations. We note that the commenter misunderstood the preliminary 
economic analysis, which estimated at between $615.44 and $1,819.96 the 
present value of the costs to each facility to implement the changes to 
the MQSA regulations; these costs do not represent a fee charged to a 
patient undergoing a mammogram. Furthermore, as we noted in Response 
134, issues of insurance coverage and reimbursement are outside the 
scope of FDA's authority.
    (Comment 137) Several comments state that the benefits estimated in 
the Preliminary Regulatory Impact Analysis related to fatalities and 
cost savings due to density reporting are not supported by existing 
evidence, and that the estimates of costs of overtreatment and 
overdiagnosis are omitted from the analysis.
    (Response 137) Recent research has shown that 7 percent to 11 
percent of patients who are informed that they have dense breasts 
undergo supplemental ultrasound screening (Refs. 57-59). Research 
studies have also shown that adjunct ultrasound screening in high-risk 
women with dense breasts results on average in the detection between 
2.75 to 3.90 additional cancers per 1,000 women (Refs. 11, 32, and 60 
to 62). Because survival rates are higher for cancers detected at an 
earlier stage, early cancer detection due to supplemental screening 
such as ultrasound for women with dense breasts may result in a 
reduction in cancer fatalities. We use this existing evidence to 
support our analysis related to quantified benefits of breast density 
reporting requirements. These potential outcomes are discussed 
qualitatively in the Final Regulatory Impact Analysis (FRIA) (Ref. 63). 
Additionally, the density notification requirement does not discuss 
additional clinical management beyond imaging. We believe that a 
discussion of overtreatment and overdiagnosis of cancer is outside the 
scope of this rulemaking, and so have not been addressed by this 
analysis.
    (Comment 138) A comment suggests that the analysis be revised to 
include distributional and equity effects.
    (Response 138) FDA recognizes that distributional and equity 
considerations may exist as they relate to mammography practice and 
density notification. We have revised the distribution section of the 
FRIA to include a qualitative discussion of sociodemographic 
differences in mammography practice and outcomes.

X. Federalism and the Relationship Between Federal and State Breast 
Density Reporting Requirements

    (Comment 139) Some comments recommend that FDA clarify the 
relationship between Federal and State breast density requirements, and 
specifically: (1) whether facilities must always use the Federal breast 
density notification language and (2) whether the Federal breast 
density notification requirements preempt State requirements. If there 
is preemption, a comment states that FDA should consider whether it has 
adequate evidence to justify such preemption, consistent with Executive 
Order 13132 (Ref. 64). Some of the comments submitted regarding 
preemption seem to be addressing express preemption, whereas others 
seem to be addressing implied preemption.
    (Response 139) With regard to the first question, all facilities 
providing mammography services will be required to comply with FDA's 
reporting requirements, regardless of whether there are applicable 
State requirements. Under Sec.  900.12(c)(1)(vi), (c)(2)(iii), and 
(iv), facilities must provide the breast density information specified 
in those regulations in mammography reports to healthcare providers and 
in lay summaries to patients. The regulations do not include exceptions 
for facilities in States with breast density reporting requirements. As 
discussed in Response 140, FDA believes these requirements are 
critical, among other things, to ensuring that patients and healthcare 
providers receive accurate, complete, and understandable breast density 
information.
    With regard to the second question, Federal law can expressly 
preempt State law when the text of a Federal statute explicitly 
manifests Congress's intent to displace state law. Federal law also can 
impliedly preempt State law when Congress's preemptive intent is 
implicit in the relevant Federal law's text, structure, and purpose. 
Courts have identified two subcategories of implied preemption--field 
preemption and conflict preemption. Field preemption occurs when a 
comprehensive scheme of Federal regulation implicitly precludes 
supplementary State regulation. Conflict preemption occurs when 
simultaneous compliance with Federal and State law is impossible 
(``impossibility preemption'') or when State law poses an obstacle to 
the accomplishment of Federal goals (``obstacle preemption'').
    Here, Congress included a preservation provision addressing State 
laws, which provides: ``Nothing in this section shall be construed to 
limit the authority of any State to enact and enforce laws relating to 
the matters covered by this section that are at least as stringent as 
this section or the regulations issued under this section.'' (42 U.S.C. 
263b(m)). Thus, the statute preserves any State law that is ``at least 
as stringent'' as the regulations issued by FDA under the MQSA. See 
also 138 Cong. Rec. 33615 (October 7, 1992) (``The bill allows and 
encourages states to carry out the certification program requirements 
and to implement standards no less stringent than those of the national 
program.'').
    Based on the preservation clause of the MQSA, FDA's reporting 
requirements do not preempt State reporting requirements that are ``at 
least as stringent'' as the Federal requirements. The provisions of the 
MQSA, however, do not resolve which State reporting requirements, if 
any, that are less stringent than the Federal requirements may be 
subject to preemption. That analysis would be informed by the specific 
provisions of the State laws in question, and FDA has not undertaken a 
50-state analysis of all current State breast density reporting laws. 
We note, however, that it is possible for a State breast density 
reporting law to be preempted based on these regulations. For example, 
if a State law theoretically were to prohibit facilities from providing 
a breast density notification to patients with non-dense breasts, we 
believe that law could be preempted because it would be impossible for 
facilities to comply with

[[Page 15159]]

both the Federal law (which requires such breast density reporting) and 
the State law (which forbids it). As another example, if a State were 
to require a breast density statement that directly contradicts or 
undermines a key message in FDA's breast-density reporting requirement 
(such as the message that ``dense tissue makes it harder to find breast 
cancer on a mammogram,'' or ``dense tissue . . . raises the risk of 
developing breast cancer,''), that State law could be preempted on the 
basis that it poses an obstacle to the accomplishment of FDA's goals in 
communicating clear, consistent, and understandable information about 
breast density to patients and healthcare providers.
    For further discussion of this final rule and the federalism 
principles expressed in Executive Order 13132, please see other 
responses in section X.
    (Comment 140) Several comments express concern with having 
potentially two different breast density notifications for patients and 
their healthcare providers, one required by Federal law and one 
required by State law. The comments note that different notifications 
could lead to patient confusion and be overly burdensome for 
facilities. For these and related reasons, some comments recommend that 
FDA include a clear statement that the Federal breast density reporting 
requirements preempt State requirements, while other comments recommend 
that FDA not require Federal breast density reporting language and 
allow State language to be used instead, at least in certain 
circumstances (e.g., so long as certain information is included in the 
notification). One comment proposes that FDA develop a ``waiver'' 
process to allow the State to apply to FDA to use its alternative 
notification.
    (Response 140) FDA declines to adopt these recommendations. As 
previously explained, all facilities providing mammography will be 
required to comply with FDA's reporting requirements, regardless of 
whether there are applicable State requirements. As such, all patients 
will receive information about their breast anatomy, and this 
rulemaking will require consistent baseline information be provided. 
But the statute does not authorize FDA to categorically assert 
preemption over all State reporting requirements. As discussed in 
Response 139, Congress specifically preserved State laws that are at 
least as stringent as Federal law. Depending upon the circumstances, 
some State laws could be found to be preempted, such as less stringent 
State laws that make it impossible to comply with both Federal and 
State requirements, or that stand as an obstacle to the accomplishment 
of Federal goals. FDA has not performed a State by State analysis to 
determine whether any specific, current State law may be subject to 
preemption. FDA notes that no comment proffered a State law that was 
asserted to be subject to preemption.
    We also disagree with the recommendation that FDA does not require 
Federal breast density report language and allow certain State breast 
density language to be used alone instead. Although FDA recognizes that 
many States have their own breast density reporting requirements, the 
Agency believes that consistent national breast density reporting 
requirements are critical in order to ensure that: (1) breast density 
reporting occurs in all States and (2) patients and healthcare 
providers receive accurate, complete, and understandable breast density 
information.
    First, the Agency believes it is important to ensure that patients 
receive a baseline set of key breast density information. Not all 
States currently have a breast density reporting requirement. If FDA 
does not require breast density reporting, in those States that also do 
not have reporting requirements, patients and their healthcare 
providers generally would not receive any breast density information, 
which raises significant public health concerns for all of the reasons 
set forth in this preamble, and the preamble to the proposed rule.
    Second, even in those States that already have a breast density 
reporting requirement, FDA believes there is value in having a single, 
consistent set of FDA-required information shared with the public. FDA 
breast density notification language is drafted by FDA subject-matter 
experts, contains the information FDA believes is critical to 
communicate, and is drafted using easily understandable language. FDA 
does not have the resources to monitor all State laws, particularly as 
they change over time, in order to ensure that the key information is 
being communicated consistently and effectively to patients and 
providers under State law. Requiring uniform breast density reporting 
on a Federal level ensures that patients and providers nationwide 
receive the appropriate information and avoids mistakes and gaps in 
critical information being communicated to patients and their 
healthcare providers.
    Regarding the comment that patients may be confused by receiving 
Federal and State notifications and the recommendation that FDA should 
take measures to avoid such confusion, we note that in this final rule 
we have simplified the notification statements to patients with either 
non-dense or dense tissue, using concise and understandable language, 
and have concluded both statements with the recommendation, ``Talk to 
your healthcare provider about breast density, risks for breast cancer, 
and your individual situation'' (see Sec.  900.12(c)(2)(iii) and (iv) 
in this final rule). We believe that the clear language and the 
recommendation to talk directly to the healthcare provider will 
minimize the likelihood of patient confusion.
    Regarding the potential burden on facilities, we believe the breast 
density notification requirement established in this final rule is 
simple for mammography facilities and Agency personnel to understand 
and implement. Ultimately, FDA anticipates that it will be easier for 
both facilities and the Agency if FDA requires uniform notification 
language, which consists of specific language for the overall 
assessment of breast density in the mammography report (see Sec.  
900.12(c)(1)(vi)) and four to five lines of text in the lay summary to 
patients (see Sec.  900.12(c)(2)(iii) and (iv)), as opposed to 
permitting State language to be used alone in certain circumstances. 
FDA is concerned that alternative approaches, such as requiring that 
specific information rather than specific statements be communicated to 
patients, would be complex, inefficient, and difficult to administer, 
and would consume unnecessary resources in the long term. Moreover, 
including FDA-required text in mammography reports and lay summaries 
will not be unduly burdensome for facilities, including because 
facilities will not need to expend resources in crafting their own 
language. Rather, facilities will have to add the FDA-required text.
    (Comment 141) Several comments note that it may be difficult for 
States and facilities to determine if State requirements are ``more 
stringent'' than Federal requirements, and request that FDA provide 
input to help determine what requirements are ``more stringent'' than 
the Federal requirements.
    (Response 141) As explained in Response 140, all facilities 
providing mammography services will be required to comply with FDA's 
reporting requirements, regardless of whether there are applicable 
State requirements. As discussed in Responses 139 and 140, FDA has not 
conducted a State-by-State preemption analysis or evaluated whether 
current State laws are more or less stringent than FDA breast density

[[Page 15160]]

reporting requirements. We note that FDA has defined ``[m]ore 
stringent,'' albeit in regard to language used in section 521 of the 
FD&C Act (21 U.S.C. 360k), as ``a requirement of greater 
restrictiveness or one that is expected to afford those who may be 
exposed to a risk of injury from a device a higher degree of protection 
than is afforded by a requirement applicable to the device under the 
act'' (21 CFR 808.3(c)).

Y. Effective Date of This Rule

    (Comment 142) A comment recommends that all provisions of the rule 
except the density notification should become effective 6 months after 
publication. Conversely, some comments assert that 18 months is an 
inadequate period of time for facilities to implement the new 
requirements under the rule. A separate comment recommends that FDA 
consult with equipment manufacturers regarding an appropriate 
implementation date.
    (Response 142) FDA disagrees with these recommendations. FDA does 
not anticipate that facilities would be able to implement all of the 
requirements of this rule into facility practice within 6 months 
without undue hardship. Based on FDA's experience with the effective 
date of the previous MQSA final rule (62 FR 55852), FDA concludes that 
18 months is a practical timeframe for this final rule to take effect 
(see also Response 20). Regarding the recommendation to consult with 
equipment manufacturers, FDA notes that, beyond meeting any applicable 
FDA premarket authorization requirements for medical devices, the 
provisions of this final rule do not necessitate the design or 
manufacture of any new equipment by manufacturers. Moreover, all 
members of the public, including equipment manufacturers, had an 
opportunity to comment on the proposed rule. As such, recognizing that 
FD&C Act requirements have been, and continue to be, applicable to 
medical devices generally, notwithstanding the provisions in this final 
rule, FDA does not believe that specific consultation is warranted.
    (Comment 143) Several comments recommend that the breast density 
notification requirements become effective earlier than 18 months after 
publication of the final rule, including specific recommendations for 
alternative timeframes of 30 days or 12 months. Another comment 
recommends allowing flexibility in the effective date of the breast 
density notification requirements due to the cost of making these 
changes.
    (Response 143) FDA disagrees with these comments. FDA notes that 
breast density notification is an important addition to the final 
regulations; however, we also note that facilities should be allowed 
adequate time to implement these requirements into their facility 
practice before the requirements become effective. In addition, the 
breast density notification requirements should not be subject to a 
separate scheduled effective date than other requirements in this final 
rule. Facilities are not precluded from including the required breast 
density notifications prior to 18 months if they choose to do so, and 
considering any applicable State requirements. Because of the 
importance of establishing a consistent national standard for density 
reporting and notification, FDA does not agree that a longer effective 
date of this provision is warranted. Although there may be financial 
considerations for a facility in transitioning to compliance with the 
breast density notification requirements, FDA has concluded that 18 
months is an adequate amount of time to make any necessary changes.

Z. Miscellaneous Comments

    (Comment 144) A comment recommends that FDA and the ACR focus on 
increasing the consistency and quality of MQSA inspections by 
inspectors.
    (Response 144) The ACR and other accreditation bodies are only 
involved in facility accreditation, not certification or inspection. 
Inspection is part of the process of certification, not accreditation. 
FDA trains all MQSA inspectors, both FDA employees and those who are 
State employees that perform MQSA inspections under State contracts 
with the Agency. FDA sends updated information to all inspectors 
whenever necessary. Furthermore, other FDA staff including Radiological 
Health representatives and auditors oversee and provide inspectional 
guidance to inspectors. The Agency concludes that these existing 
measures already promote consistency and quality in the MQSA inspection 
process.
    (Comment 145) A comment recommends that FDA become the sole AB, and 
hire some of the staff currently employed by the ACR AB.
    (Response 145) FDA disagrees with this comment. The MQSA and the 
implementing regulations distinguish between the separate 
responsibilities of the ABs and the certification agencies, which 
include FDA and the SCAs (see 42 U.S.C. 263b(e) and (q); part 900, 
subparts A and C). The ACR is one of several FDA-approved ABs. FDA (or 
an SCA) certifies facilities, after they have satisfied all necessary 
prerequisites, including accreditation by an AB.
    (Comment 146) A comment recommends that FDA analyze how to improve 
the quality of care for women through using technology to improve the 
quality of mammograms and the accuracy of interpretation, and 
recommends that random samples of mammograms from all facilities be 
sent to FDA radiologists for review.
    (Response 146) FDA disagrees with this comment. The ABs already 
initially and continually assess mammographic image quality at 
facilities they accredit, and are required to inform FDA of equipment 
or practices that may pose a serious risk to human health (see Sec.  
900.4(a)). At this time, FDA believes that the regulations afford FDA 
adequate opportunities to investigate any such occurrences and take 
action as necessary (see part 900, subpart B). The AB's 
responsibilities include not only reviews of the initial and renewal 
accreditation images, but also random image reviews of a sample of 
facilities accredited by the AB. The interpretation of a mammogram is a 
decision made by IPs, but we note that many of the MQSA regulatory 
requirements, including the initial and continuing qualifications for 
IPs and the annual medical outcomes audit, promote quality mammography 
practice by IPs.
    (Comment 147) A comment recommends that an independent commission 
review the relationship between the ACR and FDA for conflict of 
interest.
    (Response 147) FDA disagrees with this comment. The relationship 
between FDA and each of the ABs, including the ACR, is regulated by the 
MQSA and the implementing regulations and meets all applicable Federal 
ethics requirements (see, e.g., 18 U.S.C. 201, et seq.).
    (Comment 148) A comment asserts that improving mammography 
outcomes, such as lower rates of recalls and biopsies, could justify 
different clinical protocols, such as a younger screening age and 
shorter screening interval than are currently supported by the USPSTF.
    (Response 148) This comment is beyond the scope of this rulemaking. 
This final rule requires that each facility include recall rate and 
certain other metrics in the audit of its mammography medical outcomes 
(see Sec.  900.12(f)(1)(i) through (iii) in this final rule), but the 
MQSA quality standards do not specify benchmark or target values for 
these metrics. This rule requires that facilities compile this 
information and review it internally, to encourage their own quality 
improvement. However, decisions on which clinical practice guidelines, 
if any, to follow for such things as the

[[Page 15161]]

recommended age range or time interval for breast cancer screening with 
mammography are more appropriately for the healthcare provider to make.
    (Comment 149) A comment recommends that FDA propose special 
amendments to address ``cystic fibroid breast disease,'' because the 
commenter states that with this condition, her mammograms are more 
painful and are limited by the associated breast tissue density.
    (Response 149) The commenter is likely describing fibrocystic 
change, one of many conditions that may contribute to dense breast 
tissue. FDA disagrees with the recommendation to propose unique 
amendments to address a specific clinical condition apart from the 
requirements at Sec. Sec.  900.12(c)(1)(vi)(A) through (D) and 
900.12(c)(2)(iii) and (iv) in this final rule, which, as discussed in 
other responses throughout this final rule, are necessary to address 
the limitations of mammography in the presence of dense breast tissue 
caused by any etiology.
    (Comment 150) One commenter cites a news article that discusses a 
research study showing that breast cancer screening increases the 
detection of early-stage cancers rather than late-stage cancers.
    (Response 150) The intent of the MQSA is to ensure that the 
practice of mammography, across the country and whenever it is 
recommended by clinicians, meets consistent baseline quality standards. 
Decisions about whether to follow any recommendations or guidelines 
regarding patient age or interval for screening mammography are 
decisions more appropriate for the patient's clinical healthcare 
provider to make.
    (Comment 151) One comment states only ``Should be standard of care 
for all women.''
    (Response 151) The subject of the comment is not clear. FDA notes 
that the MQSA requirements apply consistently to all facilities that 
provide mammography services. Thus, every person who undergoes 
mammography at a certified facility in the United States can be assured 
that baseline national quality standards apply. However, decisions on 
whether to follow clinical practice guidelines, including 
recommendations for screening mammography at a certain age and/or a 
certain time interval, and any other clinical standards of care, are 
more appropriately made in the course of clinical decision-making by 
the provider and the patient.
    (Comment 152) A comment recommends that image quality must be held 
to the highest possible standard.
    (Response 152) FDA believes the amended regulations will continue 
to ensure appropriate national standards for quality mammography 
services. We note that provisions of the MQSA and its implementing 
regulations, including many that are not amended in this final rule, 
already address image quality. These include: the role of the ABs in 
clinical image review and phantom image review (Sec.  900.4), the eight 
image quality attributes that must be included in AB clinical image 
reviews (Sec.  900.4(c)(2)(i) through (viii)), personnel qualifications 
(Sec.  900.12(a)), equipment requirements (Sec.  900.12(b)), quality 
assurance requirements (Sec.  900.12(d) through (f)), and the general 
requirement that clinical images must continue to comply with the image 
quality standards of the facility's AB (Sec.  900.12(i)). We further 
note that some of these requirements related to the facility's 
responsibility to maintain clinical image quality were highlighted by 
the introduction in 2017 of FDA's Enhancing Quality Using the 
Inspection Program (EQUIP) initiative (Ref. 52).
    (Comment 153) A comment recommends that FDA should spend $2.5 
million per year for 10 years for public service announcements, 
advertisements, and a website.
    (Response 153) FDA disagrees with the comment. General patient 
outreach and education is not within the scope of this final 
rulemaking. The MQSA program certifies mammography facilities and is 
funded largely by the user fees paid by those certified facilities. 
However, we note that the MQSA program maintains a public website (Ref. 
65), and also occasionally uses email and social media to disseminate 
important information about the MQSA program. FDA also notes that the 
HHS Office of Women's Health, and the FDA Office of Women's Health are 
each committed to advancing issues regarding women's health and to 
providing health education materials through outreach activities and 
collaborative partnerships. Among other things, these offices use 
resources to maintain the programs and publish resources regarding 
cancer, mammography, and other relevant health issues.
    (Comment 154) A comment recommends that FDA should grant $500,000 
per year for 10 years to DenseBreast-Info for webinars and its website.
    (Response 154) FDA disagrees with the comment. As noted in Response 
153, general patient education and outreach are not within the scope of 
this rulemaking. Similarly, individual grant-making activities are also 
outside the scope of this rulemaking.
    (Comment 155) A comment recommends that FDA name this rule in 
memory of an advocate for breast density notification.
    (Response 155) FDA appreciates the comment. We acknowledge the 
important work done by advocates for breast density notification in 
educating the public about the significance of breast tissue density. 
However, we disagree with the recommendation to name this rule after 
any one individual. The title of the rule is based on the specific 
regulations being amended, but the rule is not ``named.''
    (Comment 156) A comment asserts that the ``FDA device pathway'' is 
very different from, and much slower than, the Center for Drug 
Evaluation and Research Fast Track program for drug approval.
    (Response 156) FDA acknowledges the comment, but notes that the 
pathways for premarket review of medical devices as they relate to 
those of drugs are outside the scope of this rulemaking. The MQSA is 
found under the Public Health Service Act in Title 42 of the U.S.C., 
and it is implemented by DMQS in FDA's CDRH. The authority for FDA's 
regulation of drugs and medical devices is found under the FD&C Act in 
Title 21 of the CFR.

VI. Effective Date and Compliance Date

    This rule is effective 18 months after the date of publication in 
the Federal Register. Mammography facilities will need to be in 
compliance with the amended MQSA regulations in this final rule by 
September 10, 2024.

VII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
The Office of Information and Regulatory Affairs has determined that 
this final rule is a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant

[[Page 15162]]

impact of a rule on small entities. Because many facilities that will 
be affected by this rule are defined as small businesses, we find that 
the final rule will have a significant economic impact on a substantial 
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $165 
million, using the most current (2021) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary and Accounting Statement

    The final rule will modernize mammography regulations by 
incorporating current science and mammography best practices to improve 
the delivery of mammography services. These updates include 
requirements on recordkeeping, reporting, and communication of results. 
This final rule also addresses procedural requirements in several areas 
related to quality control and management of mammography facilities.
    The benefits and costs associated with this final rule are 
summarized in table 1. The quantified benefits are derived from reduced 
mortality and breast cancer treatment costs resulting from the breast 
density reporting requirements. We use two methods of measuring the 
value of reduced mortality: the value per statistical life (VSL) 
approach and an approach based on the value of lost life years (LY). 
Under the VSL approach, the estimate of annualized benefits over 10 
years ranges from $42.00 million to $232.69 million at a 7 percent 
discount rate. Using a 3 percent discount rate, the annualized benefits 
range from $48.42 million to $266.09 million. Under the LY approach, 
the estimate of annualized benefits over 10 years ranges from $12.99 
million to $66.90 million at a 7 percent discount rate. Using a 3 
percent discount rate, the annualized benefits range from $8.50 million 
to $37.96 million. Because there is uncertainty in the literature about 
the most appropriate method for analyzing reduced mortality for the 
population affected by this final rule, we do not present a primary 
value and use estimates from both methods to create the range of values 
in table 1. The high estimate in table 1 is based on the VSL approach, 
which yields the higher-bound estimate of the two methods. The low 
estimate is based on the LY approach, which yields the lower-bound 
estimate of the two methods. Other benefits that we are not able to 
quantify include reduced cancer morbidity and improvements in the 
accuracy of mammography by improving quality control and strengthening 
the medical audit.
    The costs of the final rule include costs to mammography facilities 
to comply with the requirements of the regulation and costs associated 
with supplemental testing and biopsies resulting from the breast 
density requirements. The estimate of annualized costs over 10 years 
range from $28.87 million to $45.42 million at a 7 percent discount 
rate with a primary value of $36.31 million. Using a 3 percent discount 
rate, the annualized costs range from $27.61 million to $44.16 million 
with a primary value of $35.05 million.

                               Table 1--Summary of Benefits and Costs in Millions 2020 Dollars Over a 10-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Units
                                                                                   ---------------------------------------
                  Category                     Primary        Low          High                    Discount      Period                Notes
                                               estimate     estimate     estimate       Year         rate       covered
                                                                                      dollars     (percent)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year............  ...........       $12.99      $232.69         2020            7           10  .............................
                                                                 8.50       266.09         2020            3           10
    Annualized Quantified..................  ...........  ...........  ...........  ...........            7  ...........  .............................
                                                                                                           3
                                            ---------------------------------------
    Qualitative............................     Improvements in the accuracy of     ...........  ...........  ...........  .............................
                                              mammography and better management of
                                                    mammography facilities.
                                            ---------------------------------------
Costs:
    Annualized Monetized $/year............        36.31        28.87        45.42         2020            7           10  .............................
                                                   35.05        27.61        44.16         2020            3           10
    Annualized Quantified..................  ...........  ...........  ...........  ...........            7  ...........  .............................
                                                                                                           3
    Qualitative............................  ...........  ...........  ...........  ...........  ...........  ...........  .............................
Transfers:
    Federal Annualized Monetized $/year....  ...........  ...........  ...........  ...........            7  ...........  .............................
                                                                                                           3
                                            ------------------------------------------------------------------------------
    From/To................................  From:
                                             To:                                    ...........
                                            ------------------------------------------------------------------------------
    Other Annualized Monetized $/year......  ...........  ...........  ...........  ...........            7  ...........  .............................
                                                                                                           3
                                            ------------------------------------------------------------------------------
    From/To................................  From:
                                             To:                                    ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business: Annual cost per affected small entity estimated as $416-$727, which would represent a maximum of 1.2 percent of annual receipts.....

[[Page 15163]]

 
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 63) and at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs with an estimate of 
the annual third-party disclosure burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Mammography Facilities, Standards, and Lay Summaries for 
Patients; OMB Control Number 0910-0309.
    Description: FDA is amending its mammography reporting requirements 
to require that the mammography report provided to the healthcare 
provider and the lay summary provided to the patient include basic 
mammography facility identification information and information 
concerning patient breast density. This action is intended to 
facilitate communication among mammography facilities, healthcare 
providers, and patients; facilitate the retrieval of mammography 
images; and help ensure that healthcare providers and patients obtain 
the necessary information from the mammography facility to enable a 
patient and their healthcare provider to make informed healthcare 
decisions. FDA also is including categories be added to the list of 
assessments that facilities are required to use in the mammography 
report. In addition, FDA is amending its requirements related to the 
transfer and provision of mammography records, the transfer and 
provision of personnel records upon request or facility closure, and 
FDA notification and mammographic records access upon facility closure.
    Description of Respondents: Respondents to this information 
collection are facilities that perform mammographic examinations and 
State certification agencies. As of July, 1, 2022, FDA internal data on 
facilities showed that there were 8,781 facilities certified to perform 
mammography (Ref. 65).
    FDA estimates the burden of this collection of information as 
follows:

                                                                       Table 2--Estimated Annual Recordkeeping Burden \1\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                                Total operating
                    Activity; 21 CFR section                         Number of     Number of  records    Total annual     Average  burden     Total hours     Total capital     and maintenance
                                                                   recordkeepers    per  recordkeeper      records      per  recordkeeping                        costs              costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mammography medical outcomes audit--900.12(f)...................           8,781                   1            8,781                  16          140,496       $2,496,452          $5,807,650
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Number of                                                                             Total operating
  Activity; 21 CFR section       Number of     disclosures per    Total annual    Average  burden per    Total hours    Total capital   and maintenance
                                respondents       respondent       disclosures        disclosure                            costs            costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provision of personnel                   615                  1             615  0.08 (5 minutes)....              49  ..............            $55,682
 records to IPs--
 900.12(a)(4).
Transfer of personnel                     88                  1              88  5...................             440  ..............  .................
 records by closing
 facilities--900.12(a)(4).
New assessment categories              8,781                  1           8,781  23..................         201,963     $37,166,396  .................
 and breast density
 reporting in mammography
 report (one-time burden)--
 900.12(c)(1)(iv) to (vi).
Breast density reporting in            8,781                  1           8,781  11..................          96,591       6,844,077  .................
 lay summary (one-time
 burden)--900.12(c)(2).
Transfer/provision of copies           8,781              1,135       9,966,435  0.08 (5 minutes)....         797,315  ..............  .................
 of mammograms and records
 upon patient's request--
 900.12(c)(4)(ii) and (iii).
Facility closure;                         88                  1              88  32..................           2,816  ..............             55,682
 notification and records
 access--900.12(c)(4)(v).

[[Page 15164]]

 
Patient notification of                    5                  1               5  100.................             500  ..............  .................
 significant risk (by State
 certification agency)--
 900.12(j)(2).
                             ---------------------------------------------------------------------------------------------------------------------------
    Total...................  ..............  .................  ..............  ....................       1,099,674      44,010,473            111,364
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers have been rounded.

    Personnel records--Sec.  900.12(a)(4): Under Sec.  900.12(a)(4), 
facilities are required to maintain records of training and experience 
regarding personnel who work or have worked at the facility as IPs, 
radiologic technologists, or medical physicists. Facilities must 
maintain records of personnel no longer employed by the facility for no 
less than 24 months from the date of the departure of an employee, and 
these records must be available for review at the time of any annual 
inspection occurring during those 24 months.
    Also, under Sec.  900.12(a)(4), facilities shall provide copies of 
personnel records to current or former interpreting personnel 
(physician, radiological technologist and medical physicist) upon their 
request. We estimate that there are, on average, seven interpreting 
personnel per facility (approximately 61,467 total). We estimate that 1 
percent of these personnel (615 personnel annually) will request the 
records and that it will take approximately 5 minutes to provide the 
copies for each request.
    Additionally, under Sec.  900.12(a)(4), facilities must provide 
personnel records to former employees if the former employees 
communicate their request within 24 months of the date of their 
departure. If it has been greater than 24 months and the facility has 
maintained those records, the facility must provide those records to 
former employees upon request.
    Finally, under Sec.  900.12(a)(4), before a facility closes or 
ceases to provide mammography services, it will have to make 
arrangements for personnel to access their MQSA personnel records. This 
access may be provided by the permanent transfer of these records to 
the personnel or the transfer of the records to a facility or other 
entity that will provide access to these records. We estimate that 
annually 1 percent of the total facilities will close or cease to 
provide mammography services and that it will take each of the 
facilities approximately 5 hours to transfer the records.
    Medical records and mammography reports--Sec.  900.12(c)(1) through 
(4): Section 900.12(c)(1), Contents and terminology, sets forth the 
requirement for facilities to prepare a written report of the results 
of each mammographic examination performed under its certificate. 
Section 900.12(c)(1) requires that the report include patient 
identifying information, date of examination, facility name and 
location, the final assessment of findings (or classification as to why 
no final assessment can be made), name of the IP, and recommendations 
to the healthcare provider.
    This final rule includes two additional final assessment categories 
and an additional classification in the mammography report and also 
requires an assessment of breast density in the report (Sec.  
900.12(c)(1)(iv) through (vi)). We estimate a one-time burden for 
facilities to update their existing mammography reports with these new 
categories. Based on the Eastern Research Group (ERG), Inc.'s report, 
we believe this will take 23 hours per facility (Refs. 66 and 67).
    Under the final rule, if the final assessment is ``Suspicious'' or 
``Highly Suggestive of Malignancy,'' the facility must provide the 
report to the healthcare provider, or if the referring healthcare 
provider is unavailable, to a responsible designee (Sec.  
900.12(c)(3)(ii)) within a specified timeframe. The provision of the 
report to the healthcare provider was not included in the currently 
approved information collection burden, OMB control number 0910-0309, 
because it was considered usual and customary practice and was part of 
the standard of care prior to the implementation of the regulations 
(see 5 CFR 1320.3(b)(2)). Provision of the mammography report to 
healthcare providers continues to be part of the standard of care and 
remains the usual and customary business practice.
    Under Sec.  900.12(c)(2), Communication of mammography results to 
the patients, within 30 days of the mammographic examination, each 
facility shall provide each patient a summary of the mammography report 
written in lay terms. If the final assessment is ``Suspicious'' or 
``Highly Suggestive of Malignancy,'' the facility shall provide the 
patient a summary of the mammography report within a specified 
timeframe (Sec.  900.12(c)(2)). The summary shall include the name of 
the patient and name, address, and telephone number of the facility. 
The requirements for the lay summary to include this information do not 
result in a change to the currently approved information collection 
burden for Sec.  900.12(c)(2).
    Section 900.12(c)(2) also requires facilities to provide an 
assessment of breast density (as described in Sec.  900.12(c)(2)(iii) 
to (iv)) in the lay summary. We estimate a one-time burden for 
facilities to update their existing lay summaries with the breast 
density assessments. Based on the ERG report, we believe this will take 
11 hours per facility (Refs. 65 and 66).
    Also, under Sec.  900.12(c)(2)(ii), each facility that accepts 
patients who do not have a healthcare provider shall maintain a system 
for referring such patients to a healthcare provider when clinically 
indicated.
    The requirements in Sec.  900.12(c)(2)(iii) and (iv) to provide an 
explanation of the breast density assessment identified in Sec.  
900.12(c)(1)(vi) are not considered to be ``collections of 
information'' because the language is originally supplied by the 
Federal government for the purpose of disclosure to members of the 
public (5 CFR 1320.3(c)(2)).
    Under Sec.  900.12(c)(4)(i), facilities that perform mammograms 
must maintain mammographic records. The rule requires that facilities 
implement policies and procedures to minimize the possibility of record 
loss and requires that records be maintained in the modality in which 
they were produced.
    Under Sec.  900.12(c)(4)(ii), facilities shall, upon request by or 
on behalf of the patient, transfer or release the mammograms and copies 
of the patient's reports to a medical institution, a physician or 
healthcare provider of the patient, or to the patient directly. Under 
Sec.  900.12(c)(4)(ii) and (iii), facilities must transfer original 
mammograms (and copies of associated reports) or provide copies of 
mammograms (and copies of associated reports) within a specified period 
of time. Copies of mammograms must be in the same modality in which 
they

[[Page 15165]]

were produced. Moreover, for digital mammograms or digital breast 
tomosynthesis, the facility must be able to provide the recipient with 
original digital images electronically if the examination is being 
transferred for final interpretation. We estimate that approximately 
one third of patients will request transfer or release of the records 
and it will take approximately 5 minutes per request. To calculate the 
estimated number of requests, we use the estimated number of screening 
mammograms (29,890,141) (Ref. 62) divided by 3. This results in 
approximately 9,963,380 requests, or an average of 1,135 requests per 
facility.
    Under Sec.  900.12(c)(4)(v), before a facility closes or ceases to 
provide mammography services, it must make arrangements for access by 
patients and healthcare providers to their mammographic records. 
Additionally, the facility must notify its accreditation body and 
certification agency in writing of the arrangements it has made and 
must make reasonable efforts to notify all affected patients. If a 
facility ceases to perform mammography but continues to operate as a 
medical entity, and is able to satisfy the recordkeeping requirements 
of Sec.  900.12(c)(4)(i) through (iv), it may choose to continue to 
retain the medical records rather than transfer them to another 
facility, unless such a transfer is requested by, or on behalf of, the 
patient. We estimate that 1 percent of facilities per year will close 
and that it will take each facility approximately 32 hours to provide 
notification and access to the records.
    Quality assurance-mammography medical outcomes audit--Sec.  
900.12(f): Section 900.12(f)(1) requires each facility to establish a 
system to collect and review outcome data for all mammographic 
examinations performed, including followup on the disposition of all 
positive mammograms and correlation of pathology results with the IP's 
mammography report. The rule clarifies that positive predictive value, 
cancer detection rate, and recall rate must be collected during this 
audit.
    Additional mammography review and patient and referring provider 
notification--Sec.  900.12(j): Under Sec.  900.12(j)(1), if FDA or the 
State certification agency believes that mammographic quality at a 
facility has been compromised and may present a significant risk to 
human health, the facility must provide clinical images and other 
relevant information for review by the accreditation body or the State 
certification agency.
    Under Sec.  900.12(j)(2), when FDA has determined that the quality 
of mammography performed by the facility poses a significant risk to 
human health, a facility may be required to notify all patients who 
received mammograms at the facility or those patients who are 
determined to be at risk due to the quality of their mammography, and 
their referring physicians or healthcare providers, of the deficiencies 
and resulting potential harm, appropriate remedial measures, and other 
relevant information. Also under the rule, State certification agencies 
(along with FDA) may notify patients and their providers if a facility 
is unable or unwilling to do so.
    We received several comments related to the proposed rule. 
Descriptions of the comments and our responses are provided in section 
V of this final rule, Comments to the Proposed Rule and FDA's Response. 
Comments and responses related to the provisions that underlie the 
information collection are described in the following sections: V.A, 
regarding general comments; V.D, regarding retention and release of 
personnel records; V.E, regarding digital accessories; V.F, regarding 
facility identification information in mammography report and lay 
summary; V.G, regarding final and incomplete assessments and lay 
summaries; V.H, regarding deadlines for mammography reports; V.I, 
regarding breast density notification--general support for density 
notification; V.J, regarding breast density notification language; V.K, 
regarding breast density notification and the role of the referring 
healthcare provider; V.L, regarding format for image interpretation, 
retention, transfer, and release of copies; V.M, regarding deadlines 
for image transfer and the release of copies; V.N, regarding facility 
closure and mammography record retention; V.O, regarding mammography 
medical outcomes audit; V.P, regarding patient and referring provider 
notification; V.Q, regarding revocation of certification; V.X, 
regarding federalism and the relationship between Federal and State 
breast density reporting requirements; and V.Y, regarding timeframe for 
implementation of this rule. We have not made changes to the estimated 
burden as a result of the comments.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

    The MQSA established minimum national quality standards for 
mammography. The MQSA replaced a patchwork of Federal, State, and 
private standards with uniform Federal standards designed to ensure 
that all patients nationwide receive adequate quality mammography 
services. FDA has worked very closely with State officials in 
developing the national standards for the MQSA program and has sought 
and obtained input from States at every step of the process.
    FDA issued final rules implementing the MQSA on October 28, 1997 
(``Quality Mammography Standards,'' 62 FR 55852) and February 6, 2002 
(``State Certification of Mammography Facilities,'' 67 FR 5446). As 
required by Executive Order 13132 (August 4, 1999), FDA prepared a 
federalism assessment in this latter final rule and determined that the 
rule was consistent with the federalism principles expressed in 
Executive Order 13132 (Ref. 64).
    This final rule amends, among other things, the requirements in the 
MQSA for reporting to healthcare providers and patients to ensure that 
patients receive all necessary information after their mammograms, 
including an assessment of breast density, while not unduly burdening 
the mammography facility.
    Although certain provisions impact Federal-State relations, FDA 
does not believe that they impose any additional, significant burden on 
the States. The division of responsibilities between FDA, the States, 
and State agencies will not change as the regulations will continue to 
provide for necessary uniformity of minimum national standards and, at 
the same time, provide maximum flexibility to states administering the 
States as Certifier program within their State, and State agencies 
serving as accreditation bodies.
    On November 4, 2011, FDA convened a public meeting of the NMQAAC 
where possible amendments to the MQSA regulations, including breast 
density reporting, were discussed (Ref. 33). This meeting was open to 
the public, and time was allotted for public statements on issues of 
concern in the mammography field. FDA has also met and held 
teleconferences several times a year with its approved accreditation 
bodies and State certification agencies to discuss issues of mutual 
concern.
    The Agency also has long enjoyed a good relationship with the 
Conference of Radiation Control Program Directors,

[[Page 15166]]

Inc. (CRCPD), which is the professional organization of the 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.
    For the reasons discussed previously, FDA believes that this final 
rule is consistent with the federalism principles expressed in 
Executive Order 13132.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display 
in the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

* 1. CDC, ``Breast Cancer Statistics.'' Available at https://www.cdc.gov/cancer/breast/statistics.
* 2. National Institutes of Health, National Cancer Institute, 
``Surveillance, Epidemiology, and End Results Program.'' Available 
at https://seer.cancer.gov/statfacts/html/breast.html.
* 3. CDC, ``Male Breast Cancer Incidence and Mortality, United 
States--2013-2017,'' U.S. Cancer Statistics Data Briefs, No. 19, 
October 2020. Available at https://www.cdc.gov/cancer/uscs/about/data-briefs/no19-male-breast-cancer-incidence-mortality-UnitedStates-2013-2017.htm.
* 4. CDC, ``United States Cancer Statistics: Data Visualizations.'' 
Available at https://gis.cdc.gov/Cancer/USCS/DataViz.html.
5. Michaelson, J.S., M. Silverstein, J. Wyatt, et al., ``Predicting 
the Survival of Patients with Breast Carcinoma Using Tumor Size,'' 
Cancer, 2002; 95(4): 713-723.
6. ACS, ``Can Breast Cancer Be Found Early?'' Available at https://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-detection.
* 7. Government Accountability Office, ``GAO-06-724 Mammography: 
Current Nationwide Capacity Is Adequate, but Access Problems May 
Exist in Certain Locations (July 2006).'' Available at https://www.gao.gov/new.items/d06724.pdf.
8. DenseBreast Info website. Legislative Information. Available at 
https://densebreast-info.org/legislation.aspx.
9. Kolb, T.M., J. Lichy, J.H. Newhouse, ``Comparison of the 
Performance of Screening Mammography, Physical Examination, and 
Breast U.S. and Evaluation of Factors that Influence Them: an 
Analysis of 27,825 Patient Evaluations,'' Radiology 2002; 225: 165-
175.
10. Leconte, I., et al., ``Mammography and Subsequent Whole-Breast 
Sonography of Nonpalpable Breast Cancers: The Importance of 
Radiologic Breast Density,'' American Journal of Radiology 2003; 
180: 1675-1679.
11. Berg, W. et al., ``Combined Screening with Ultrasound and 
Mammography vs. Mammography Alone in Women at Elevated Risk of 
Breast Cancer,'' Journal of the American Medical Association, 2008; 
299(18); 2151-2163. Available at https://jamanetwork.com/journals/jama/fullarticle/181896.
12. McCormack, V.A. and I. dos Santos Silva, ``Breast Density and 
Parenchymal Patterns as Markers of Breast Cancer Risk: A Meta-
Analysis,'' Cancer Epidemiol Biomarkers and Prevention. 2006; 15: 
1159-1169.
13. Boyd, N.F., H. Guo, L.J. Martin, et al., ``Mammographic Density 
and the Risk and Detection of Breast Cancer,'' New England Journal 
of Medicine. 2007; 356: 227-236.
14. Vachon C., C. van Gils, T. Sellers, et al., ``Mammographic 
Density, Breast Cancer Risk and Risk Prediction,'' Breast Cancer 
Research. 2007; 9: 217.
* 15. Centers for Disease Control and Prevention, ``What are the 
Risk Factors for Breast Cancer? '' Available at https://www.cdc.gov/cancer/breast/basic_info/risk_factors.htm.
16. Chiu, S.Y., et al., ``Effect of Baseline Breast Density on 
Breast Cancer Incidence, Stage, Mortality, and Screening Parameters: 
25-Year Follow-up of a Swedish Mammographic Screening,'' Cancer 
Epidemiology, Biomarkers, and Prevention, 2010: 19(5): 1219-28. 
Available at https://www.researchgate.net/publication/43226895_Effect_of_Baseline_Breast_Density_on_Breast_Cancer_Incidence_Stage_Mortality_and_Screening_Parameters_25-Year_Follow-up_of_a_Swedish_Mammographic_Screening.
* 17. MQSA National Statistics, available at https://www.fda.gov/radiation-emitting-products/mqsa-insights/mqsa-national-statistics.
* 18. MQSA Inspection Procedures, Version 7.0, Revision June 2015, 
available at https://www.fda.gov/radiation-emitting-products/facility-certification-and-inspection-mqsa/inspection-procedures.
* 19. MQSA PGHS. Available at Policy Guidance Help System--Before a 
facility permanently stops performing mammography, what actions 
should it take to avoid future MQSA problems and how should it deal 
with retention of mammographic medical records?
* 20. FDA guidance on ``Medical Device Accessories,'' issued on 
December 20, 2017. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways.
* 21. MQSA Alternative Standard #24, approved on July 13, 2018. 
Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/24-approval-alternative-standard-using-quality-assurance-program-recommended-acr-digital-mammography.
* 22. FDA MQSA Alternative Standards website. Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/alternative-standards-mqsa.
* 23. FDA guidance ``Display Devices for Diagnostic Radiology,'' 
issued on October 2, 2017, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/display-devices-diagnostic-radiology.
* 24. MQSA Alternative Standard #12, approved on September 17, 2003. 
Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-12-assessment-category-post-procedure-mammograms-marker-placement.
* 25. MQSA Alternative Standard #11, approved on August 29, 2003. 
Available at https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-11-modifications-assessment-categories-used-medical-reports.
* 26. MQSA PGHS. Available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Is_it_necessary_to_include_an_assessment_code_(e.g., 
_0,_1,_2,_3,_4,_5_or_N,_B,_P,_S,_M,_A),_in_addition_to_the_assessment
_category,_on_all_mammography_reports__Is_there....htm.
27. D'Orsi, C.J., et al., ACR BI-RADS Atlas, Breast Imaging 
Reporting and Data System, 5th Edition. Reston, VA: American College 
of Radiology, 2013.
28. Sickles, E.A., et al., ``Mammography.'' In: ACR BI-RADS Atlas, 
Breast Imaging Reporting and Data System. Reston, VA: American 
College of Radiology, 2013, pp. 153-4.

[[Page 15167]]

* 29. MQSA PGHS. Available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/The_American_College_of_Radiology_Breast_Imaging_Reporting_and_Data_System_BIRADS_suggests_that_facilities_subdivide_the_Suspicious_assessment_category_into_one_of_three_subca.htm.
30. Hayward, J.H., et al., ``Improving Screening Mammography 
Outcomes Through Comparison With Multiple Prior Mammograms,'' 
American Journal of Roentgenology, 2016; 207: 918-924. Available at 
https://www.ajronline.org/doi/full/10.2214/AJR.15.15917.
31. Berg, W.A. and J. A. Harvey, ``Breast Density and Supplemental 
Screening (White Paper),'' Society of Breast Imaging, issued on May 
1, 2017. Available at https://www.sbi-online.org/white-papers/breast-density-and-supplemental-screening.
32. Butler, R.S. and Hooley, R.J., 2020. Screening Breast 
Ultrasound: Update After 10 Years of Breast Density Notification 
Laws. American Journal of Roentgenology, 214(6), pp.1424-1435.
* 33. Transcript of 2011 NMQAAC meeting. Available at https://wayback.archive-it.org/7993/20170404143636/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/UCM282944.pdf.
34. Sickles, E.A., et al. ``Mammography.'' In: ACR BI-RADS Atlas, 
Breast Imaging Reporting and Data System. Reston, VA: American 
College of Radiology, 2013, pp. 123-6.
35. California Breast Density Information Group, ``Breast Density, 
Breast Cancer Risk, and California Breast Density Notification Law 
SB 1538: Scenarios for Clinicians,'' 2013. Available at: For Health 
Care Providers: Density Scenarios [verbar] Department of Radiology 
(unc.edu).
36. DenseBreast Info website, ``Cancer Detection by Screening 
Method.'' Available at https://densebreast-info.org/screening-technologies/cancer-detection-by-screening-method/.
37. Berg, W.A., E.A. Rafferty, S.M. Friedewald, et al., ``Screening 
Algorithms in Dense Breasts: AJR Expert Panel Narrative Review,'' 
American Journal of Roentgenology, 2021; 216: 275-294, and 
associated video lecture available at https://www.youtube.com/watch?v=aGIFTa6xMeY.
38. Saraiya A., G.L. Baird, and A.P. Lourenco, ``Breast Density 
Notification Letters and websites: Are They Too `Dense? ','' Journal 
of the American College of Radiology 16: 717, May 2019.
39. Capello, N.M., D. Richetelli, and C.I. Lee, ``The Impact of 
Breast Density Reporting Laws on Women's Awareness of Density-
Associated Risks and Conversations Regarding Supplemental Screening 
With Providers,'' Journal of the American College of Radiology 
16(2): 139-146, February 2019. Available at: https://doi.org/10.1016/j.jacr.2018.08.009.
40. Nguyen D.L., E.B. Ambinder, M.K. Jones, L.A. Mullen, and S.C. 
Harvey, ``Improving State-Mandated Breast Density Notifications,'' 
Journal of the American College of Radiology 173): 384-390, March 
2020. Available at: https://doi.org/10.1016/j.jacr.2019.08.023.
41. Kyanko, K.A., J. Hoag, S.H. Busch, J.A. Aminawung, et al., 
``Dense Breast Notification Laws, Education, and Women's Awareness 
and Knowledge of Breast Density: A Nationally Representative 
Survey,'' Journal of General Internal Medicine, 2020 July; 
35(7):1940-1945. DOI: 10.1007/s11606-019-05590-7.
42. Kressin, N.R., C.M. Gunn, and T.A. Battaglia, ``Content, 
Readability, and Understandability of Dense Breast Notifications by 
State,'' Journal of the American Medical Association 315: 1786, 
April 26, 2016.
43. Kressin, N.R., J.B. Wormwood, T.A. Battaglia, and C.M. Gunn, 
``Differences in Breast Density Awareness, Knowledge, and Plans 
[Letter]'', Journal of General Internal Medicine 2020; 35(8): 2473. 
DOI: 10.1007/s11606-020-05840-z.
44. Kressin, N.R., T.A. Battaglia, J.B. Wormwood, P.J. Slanetz, and 
C.M. Gunn, ``Dense Breast Notification Laws' Association With 
Outcomes in the US Population: A Cross-Sectional Study,'' Journal of 
the American College of Radiology, 2021 May; 18(5): 685-695. DOI: 
10.1016/j.jacr.2020.11.012.
45. Kerlikowske, K., W. Zhu, A. Tosteson, et al., ``Identifying 
Women with Dense Breasts at High Risk of Interval Cancers,'' Annals 
of Internal Medicine, 2015 May 19; 162(10): 673-681. Available at 
Identifying Women with Dense Breasts at High Risk of Interval 
Cancers--PMC (nih.gov).
* 46. MQSA PGHS, available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Can_a_facility_use_lossless_compression_to_store_FFDM_images_for_retention_purposes_.htm.
* 47. MQSA PGHS, available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Can_a_facility_use_lossless_compression_to_transmit_images_to_the_patient_or_other_medical_institutions_for_final_interpretation_.htm.
* 48. MQSA PGHS, available at https://www.accessdata.fda.gov/cdrh_docs/presentations/pghs/Can_a_facility_use_lossy_compression_to_store_FFDM_images_for_retention_purposes_.htm.
49. Sickles, E.A., et al., ``ACR BI-RADS Follow-Up and Outcome 
Monitoring.'' In: ACR BI-RADS Atlas: Breast Imaging Reporting and 
Data System, 5th ed. Reston, VA, American College of Radiology, 
2013, pp. 18-19.
50. D'Orsi, C.J., ``Audit.'' Lecture presented at Institute of 
Medicine Workshop on Assessing and Improving Imaging Interpretation 
in Breast Cancer Screening, Washington, DC, May 12-13, 2015. Lecture 
slides available at https://www.nationalacademies.org/event/05-12-2015/assessing-and-improving-imaging-interpretation-in-breast-cancer-screening.
51. Sickles, E.A. et al., ``Mammography.'' In: ACR BI-RADS Atlas, 
Breast Imaging Reporting and Data System. Reston, VA: American 
College of Radiology, 2013, pp. 136-7, 150-1.
*52. FDA EQUIP web pages. Available at https://www.fda.gov/radiation-emitting-products/facility-certification-and-inspection-mqsa/inspection-news.
* 53. FDA database of certified mammography facilities. Available at 
https://www.fda.gov/radiation-emitting-products/consumer-information-mqsa/search-certified-facility.
* 54. FDA Safety Communication, issued February 25, 2019. Available 
at 2022-06-16 13:39 [verbar] Archive of FDA (pagefreezer.com).
* 55. FDA Consumer Update, issued October 27, 2017. Available at 
https://www.fda.gov/consumers/consumer-updates/breast-cancer-screening-thermogram-no-substitute-mammogram.
* 56. FDA Class II Special Controls Guidance on Full-Field Digital 
Mammography System, issued March 27, 2012. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/class-ii-special-controls-guidance-document-full-field-digital-mammography-system-guidance-industry.
57. Hooley, R.J., K.L. Greenberg, R.M. Stackhouse, et al., 
``Screening US [ultrasonography] in Patients with Mammographically 
Dense Breasts: Initial Experience with Connecticut Public Act 09-
41,'' Radiology, 2012; 265(1):59-69.
58. Weigert, J. and S. Steenbergen, ``The Connecticut Experiment: 
The Role of Ultrasound in the Screening of Women with Dense 
Breasts,'' Breast Journal, 2012; 18(6):517-22.
59. Saulsberry, L. et al. 2019. ``The Impact of Breast Density 
Notification Laws on Supplemental Breast Imaging and Breast 
Biopsy.'' Journal of General Internal Medicine, 34(8), pp. 1441-
1451.
60. Scheel et al. ``Screening Ultrasound as an Adjunct to 
Mammography in Women with Mammographically Dense Breasts.'' American 
Journal of Obstetrics and Gynecology 212.1 (2015): 9-17.
61. Houssami, N. and Lee, C.I., 2018. ``The Impact of Legislation 
Mandating Breast Density Notification--Review of the Evidence.'' The 
Breast, 42, pp. 102-112.
62. Keating, N.L. and Pace, L.E., 2019. ``New Federal Requirements 
to Inform Patients About Breast Density: Will They Help Patients?'' 
JAMA, 321(23), pp. 2275-2276.
* 63. FDA, FRIA, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
* 64. Executive Order 13132, Federalism, August 4, 1999, available 
at https://www.govinfo.gov/content/pkg/FR-1999-08-10/pdf/99-20729.pdf.
* 65. FDA MQSA home page. Available at https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program.
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and the

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Impacts of Proposed Revisions to Regulations Implementing the 
Mammography Quality Standards Act.'' Final Report, July 19, 2012. 
[ERG, 2012a]
* 67. ERG, Inc. ``Proposed Density Notification Addition to 
Regulations Implementing the Mammography Quality Standards Act: 
Addendum to the Final Report.'' July 17, 2012. [ERG, 2012b]

List of Subjects in 21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
900 is amended as follows:

PART 900--MAMMOGRAPHY

0
1. The authority citation for part 900 continues to read as follows:

    Authority:  21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.


0
2. In Sec.  900.2, revise paragraphs (c)(2), (k), (z), and (aa)(1) and 
(2), add paragraph (aa)(3), and revise paragraph (ii) to read as 
follows:


Sec.  900.2   Definitions.

* * * * *
    (c) * * *
    (2) Failure to send mammography reports within 30 days to the 
referring healthcare provider or in a timely manner to the self-
referred patient; and
* * * * *
    (k) Consumer means an individual who chooses to comment or complain 
in reference to a mammography examination, including the patient or 
representative of the patient (e.g., family member or referring 
healthcare provider).
* * * * *
    (z) Mammographic modality means a technology, within the scope of 
42 U.S.C. 263b, for radiography of the breast. Examples are screen-film 
mammography, full field digital mammography, and digital breast 
tomosynthesis.
    (aa) * * *
    (1) Radiography of the breast performed during invasive 
interventions for localization or biopsy procedures;
    (2) Radiography of the breast performed with an investigational 
mammography device as part of a scientific study conducted in 
accordance with FDA's investigational device exemption regulations in 
part 812 of this chapter; or
    (3) Computed tomography of the breast.
* * * * *
    (ii) Patient means any individual who undergoes a mammography 
evaluation in a facility, regardless of whether the person is referred 
by a healthcare provider or is self-referred.
* * * * *

0
3. In Sec.  900.4 revise paragraphs (a)(6) and (f)(1)(ii)(B) to read as 
follows:


Sec.  900.4   Standards for accreditation bodies.

    (a) * * *
    (6)(i) When an accreditation body denies accreditation to a 
facility, the accreditation body shall notify the facility in writing 
and explain the bases for its decision. The notification shall also 
describe the appeals process available from the accreditation body for 
the facility to contest the decision.
    (ii) If a facility has failed to become accredited after three 
consecutive attempts, no accreditation body shall accept an application 
for accreditation from the facility for a period of 1 year from the 
date of the most recent accreditation failure.
* * * * *
    (f) * * *
    (1) * * *
    (ii) * * *
    (B) Review of facility documentation to determine if appropriate 
mammography reports are sent to patients and providers as required;
* * * * *

0
4. In Sec.  900.11 revise paragraph (c)(4) to read as follows:


Sec.  900.11   Requirements for certification.

* * * * *
    (c) * * *
    (4) If a facility's certificate was revoked on the basis of an act 
described in 42 U.S.C. 263b(i)(1), as implemented by Sec.  900.14(a), 
no person who owned or operated that facility at the time the act 
occurred may own or operate a mammography facility within 2 years of 
the date of revocation.

0
5. In Sec.  900.12:
0
a. Revise paragraph (a)(4);
0
b. Add paragraphs (b)(2)(i) and (ii);
0
c. Revise paragraph (b)(11);
0
d. Add paragraph (b)(16);
0
e. Revise paragraphs (c)(1) and (2), (c)(3)(ii), (c)(4), and (f)(1);
0
f. Add paragraph (f)(4); and
0
g. Revise paragraph (j).

    The additions and revisions read as follows:


Sec.  900.12   Quality standards.

    (a) * * *
    (4) Retention of personnel records. Facilities shall maintain 
records of training and experience relevant to their qualification 
under MQSA for personnel who work or have worked at the facility as 
interpreting physicians, radiologic technologists, or medical 
physicists. These records must be available for review by the MQSA 
inspectors. Records of personnel no longer employed by the facility 
must be maintained for no less than 24 months from the date of the 
departure of an employee, and these records must be available for 
review at the time of any annual inspection occurring during those 24 
months. The facility shall provide copies of these personnel records to 
current interpreting physicians, radiologic technologists, and medical 
physicists upon their request. Facilities must provide personnel 
records to former employees if the former employees communicate their 
request within 24 months of the date of their departure. If it has been 
greater than 24 months and the facility has maintained those records, 
the facility must provide those records to former employees upon 
request. Before a facility closes or ceases to provide mammography 
services, it must make arrangements for access by current and former 
personnel to their MQSA personnel records. This access may be provided 
by the permanent transfer of these records to the personnel or the 
transfer of the records to a facility or other entity that will provide 
access to these records for no less than 24 months from the date of 
facility closure or cessation of mammography services.
    (b) * * *
    (2) * * *
    (i) All devices used in mammography must have met the applicable 
FDA premarket authorization requirements for medical devices of that 
type with that intended use.
    (ii) A mammography unit that is converted from one mammographic 
modality to another is considered a new unit at the facility under this 
part and must, prior to clinical use, undergo a mammography equipment 
evaluation demonstrating compliance with applicable requirements. The 
facility must also follow its accreditation body's procedures for 
applying for accreditation of that unit.
* * * * *
    (11) Film. For facilities using screen-film units, the facility 
shall use x-ray film for mammography that has been designated by the 
film manufacturer as appropriate for mammography. For facilities using 
hardcopy prints of digital images for transfer, retention, or final 
interpretation purposes, the facility shall use a type of film 
designated by the film manufacturer as appropriate for

[[Page 15169]]

these purposes and compatible with the printer being used.
* * * * *
    (16) Equipment--other modalities. Systems with image receptor 
modalities other than screen-film shall demonstrate compliance with 
quality standards by successful results of quality assurance testing as 
specified under paragraph (e)(6) of this section.
    (c) Medical records and mammography reports--(1) Contents and 
terminology. Each facility shall prepare a written report of the 
results of each mammographic examination performed under its 
certificate. The mammographic examination presented for interpretation 
must be in the original mammographic modality in which it was 
performed, and must not consist of digital images produced through 
copying or digitizing hardcopy original images. The mammography report 
shall include the following information:
    (i) The name of the patient and an additional patient identifier;
    (ii) Date of examination, facility name, and location. At a 
minimum, the location shall include the city, State, ZIP code, and 
telephone number of the facility;
    (iii) The name of the interpreting physician who interpreted the 
mammogram;
    (iv) Overall final assessment of findings, classified in one of the 
following categories (the assessment statement is only the word or 
phrase within the quotation marks):
    (A) ``Negative.'' Nothing to comment upon (if the interpreting 
physician is aware of clinical findings or symptoms, despite the 
negative assessment, these shall be documented and addressed);
    (B) ``Benign.'' Also a normal result, with benign findings present, 
but no evidence of malignancy (if the interpreting physician is aware 
of clinical findings or symptoms, despite the benign assessment, these 
shall be documented and addressed);
    (C) ``Probably Benign.'' Finding(s) has a high probability of being 
benign;
    (D) ``Suspicious.'' Finding(s) without all the characteristic 
morphology of breast cancer but indicating a definite probability of 
being malignant;
    (E) ``Highly Suggestive of Malignancy.'' Finding(s) has a high 
probability of being malignant;
    (F) ``Known Biopsy-Proven Malignancy.'' Reserved for known 
malignancies being mammographically evaluated for definitive therapy; 
and
    (G) ``Post-Procedure Mammogram for Marker Placement.'' Reserved for 
a post-procedure mammogram used to confirm the deployment and position 
of a breast tissue marker.
    (v) In cases where no final assessment category can be assigned due 
to incomplete work-up, one of the following classification statements 
shall be assigned as an assessment and reasons why no final assessment 
can be made shall be stated by the interpreting physician.
    (A) ``Incomplete: Need additional imaging evaluation.'' Reserved 
for examinations where additional imaging needs to be performed before 
an assessment category identified in paragraphs (c)(1)(iv)(A) through 
(G) of this section can be given; or
    (B) ``Incomplete: Need prior mammograms for comparison.'' Reserved 
for examinations where comparison with prior mammograms should be 
performed before an assessment category identified in paragraphs 
(c)(1)(iv)(A) through (G) of this section can be given. If this 
assessment category is used, a followup report with an assessment 
category identified in paragraphs (c)(1)(iv)(A) through (E) of this 
section must be issued within 30 calendar days of the initial report 
whether or not comparison views can be obtained.
    (vi) Overall assessment of breast density, classified in one of the 
following categories:
    (A) ``The breasts are almost entirely fatty.''
    (B) ``There are scattered areas of fibroglandular density.''
    (C) ``The breasts are heterogeneously dense, which may obscure 
small masses.''
    (D) ``The breasts are extremely dense, which lowers the sensitivity 
of mammography.''
    (vii) Recommendations made to the healthcare provider about what 
additional actions, if any, should be taken. All clinical questions 
raised by the referring healthcare provider shall be addressed in the 
report to the extent possible, even if the assessment is negative or 
benign.
    (2) Communication of mammography results to the patients. Each 
facility shall provide each patient a summary of the mammography report 
written in lay terms within 30 calendar days of the mammographic 
examination which shall, at a minimum, include the name of the patient; 
the name, address, and telephone number of the facility performing the 
mammographic examination; and an assessment of breast density as 
described in paragraphs (c)(2)(iii) and (iv) of this section. If the 
assessment of the mammography report is ``Suspicious'' or ``Highly 
Suggestive of Malignancy,'' the facility shall provide the patient a 
summary of the mammography report written in lay language within 7 
calendar days of the final interpretation of the mammograms.
    (i) Patients who do not name a healthcare provider to receive the 
mammography report shall be sent the report described in paragraph 
(c)(1) of this section within 30 days, in addition to the written 
notification of results in lay terms. If the assessment of the 
mammography report is ``Suspicious'' or ``Highly Suggestive of 
Malignancy,'' the facility shall send this report to the patient within 
7 calendar days of the final interpretation of the mammograms.
    (ii) Each facility that accepts patients who do not have a 
healthcare provider shall maintain a system for referring such patients 
to a healthcare provider when clinically indicated, which shall include 
when such patients' mammogram assessment is either probably benign, 
suspicious, or highly suggestive of malignancy.
    (iii) If the mammography report identifies the patient's breast 
density as ``The breasts are almost entirely fatty'' or ``There are 
scattered areas of fibroglandular density,'' the lay summary shall 
include the statement ``Breast tissue can be either dense or not dense. 
Dense tissue makes it harder to find breast cancer on a mammogram and 
also raises the risk of developing breast cancer. Your breast tissue is 
not dense. Talk to your healthcare provider about breast density, risks 
for breast cancer, and your individual situation.''
    (iv) If the mammography report identifies the breast density as 
``The breasts are heterogeneously dense, which may obscure small 
masses'' or ``The breasts are extremely dense, which lowers the 
sensitivity of mammography,'' the lay summary shall include the 
statement ``Breast tissue can be either dense or not dense. Dense 
tissue makes it harder to find breast cancer on a mammogram and also 
raises the risk of developing breast cancer. Your breast tissue is 
dense. In some people with dense tissue, other imaging tests in 
addition to a mammogram may help find cancers. Talk to your healthcare 
provider about breast density, risks for breast cancer, and your 
individual situation.''
    (3) * * *
    (ii) If the assessment is ``Suspicious'' or ``Highly Suggestive of 
Malignancy,'' the facility shall provide a written report of the 
mammographic examination, including the items listed in paragraph 
(c)(1) of this section, to the referring healthcare provider, or if the 
referring healthcare provider is unavailable, to a responsible designee 
of the referring healthcare provider within

[[Page 15170]]

7 calendar days of the final interpretation of the mammograms.
    (4) Recordkeeping. Each facility that performs mammograms:
    (i) Shall (except as provided in paragraph (c)(4)(ii) of this 
section) maintain the original mammograms and mammography reports in a 
permanent medical record of the patient for the longest of the 
following: a period of not less than 5 years, a period of not less than 
10 years if no additional mammograms of the patient are performed at 
the facility, or a period, if any, mandated by State or local law. 
Facilities shall implement policies and procedures to minimize the 
possibility of loss of these records. The original mammograms must be 
retained in retrievable form in the mammographic modality in which they 
were produced. They cannot be produced by copying or digitizing 
hardcopy originals.
    (ii) Shall upon request by, or on behalf of, the patient, 
permanently or temporarily transfer the original mammograms and copies 
of the patient's reports to a medical institution, a physician or 
healthcare provider of the patient, or to the patient directly during 
the time specified in paragraph (c)(4)(i) of this section. Transfer of 
the mammograms and mammography reports must take place within 15 
calendar days of the facility receiving such request. The transferred 
mammograms must be in the mammographic modality in which they were 
produced, and cannot be produced by copying or digitizing hardcopy 
originals. For digital mammograms or digital breast tomosynthesis, if 
the examination is being transferred for final interpretation purposes, 
the facility must be able to provide the recipient with original 
digital images electronically;
    (iii) Shall upon request by, or on behalf of, the patient, provide 
copies of mammograms and copies of mammogram reports to a medical 
institution, a physician or healthcare provider of the patient, or to 
the patient directly during the time specified in paragraph (c)(4)(i) 
of this section. Release of the copies must take place within 15 
calendar days of the facility receiving such request. For digital 
mammograms or digital breast tomosynthesis, if the copies are being 
released for final interpretation purposes, the facility must be able 
to provide the recipient with digital images electronically;
    (iv) Any fee charged to the patients for providing the services in 
paragraphs (c)(4)(ii) or (iii) of this section shall not exceed the 
documented costs associated with this service; and
    (v) Before a facility closes or ceases to provide mammography 
services, it must make arrangements for access by patients and 
healthcare providers to their mammographic records. This access may be 
provided by the permanent transfer of mammographic records to the 
patient or the patient's healthcare provider or the transfer of the 
mammographic records to a facility or other entity that will provide 
access to patients and healthcare providers. Access to the records must 
be provided by such other facility or entity for the remainder of the 
time periods specified in paragraph (c)(4)(i) of this section. If a 
facility ceases to perform mammography but continues to operate as a 
medical entity, and is able to satisfy the recordkeeping requirements 
of paragraphs (c)(4)(i) through (iv) of this section, it may choose to 
continue to retain the medical records rather than transfer them to 
another facility, unless such a transfer is requested by, or on behalf 
of, the patient. The facility must notify its accreditation body and 
certification agency in writing of the arrangements it has made and 
must make reasonable efforts to notify all affected patients.
* * * * *
    (f) * * *
    (1) General requirements. For the purposes of these audit 
requirements, a mammographic examination consisting of routine views of 
an asymptomatic patient shall be termed a screening mammogram, while a 
mammographic examination consisting of individualized views of a 
patient with breast symptoms, physical signs of breast disease, or 
abnormal findings on a screening mammogram shall be termed a diagnostic 
mammogram. Each facility shall establish a system to collect and review 
outcome data for all mammographic examinations performed, including 
followup on the disposition of all positive mammograms and correlation 
of pathology results with the interpreting physician's mammography 
report. In addition, for cases of breast cancer among patients imaged 
at the facility that subsequently become known to the facility, the 
facility shall promptly initiate followup on surgical and/or pathology 
results and review of the mammographic examinations taken prior to the 
diagnosis of a malignancy. Analysis of these outcome data shall be made 
individually and collectively for all interpreting physicians and, at a 
minimum, shall consist of a determination of the following:
    (i) Positive predictive value--percent of patients with positive 
mammograms who are diagnosed with breast cancer within 1 year of the 
date of the mammographic examination.
    (ii) Cancer detection rate--of the patients initially examined with 
screening mammograms who receive an assessment of ``Incomplete: Need 
additional imaging evaluation,'' ``Suspicious,'' or ``Highly Suggestive 
of Malignancy'' on the screening mammogram or on a subsequent 
diagnostic mammogram, the number of patients who are diagnosed with 
breast cancer within 1 year of the date of the initial screening 
mammogram, expressed arithmetically as a ratio per 1,000 patients.
    (iii) Recall rate--percentage of screening mammograms given an 
assessment of ``Incomplete: Need additional imaging evaluation.''
* * * * *
    (4) The records and data required to demonstrate compliance with 
the requirements in paragraphs (f)(1) through (3) of this section must 
be retained until the annual inspection that follows the facility's 
analysis of that information.
* * * * *
    (j) Additional mammography review and patient and referring 
provider notification. (1) If FDA or the State certification agency 
believes that mammographic quality at a facility has been compromised 
and may present a significant risk to human health, the facility shall 
provide clinical images and other relevant information, as specified by 
FDA or the State certification agency, for review by the accreditation 
body or the State certification agency. This additional mammography 
review will help FDA or the State certification agency determine 
whether the facility is in compliance with this section and whether 
there is a need to notify affected patients, their referring physicians 
or other healthcare providers, and/or the public that there is a 
significant risk to human health.
    (2) Based on the results of the additional mammography review, the 
facility's failure to comply with the terms of the additional 
mammography review, or other information, FDA or the State 
certification agency may determine that the quality of mammography 
performed by a facility, whether or not certified under Sec.  900.11, 
was so inconsistent with the quality standards established in this part 
as to present a significant risk to human health. FDA or the State 
certification agency may require such a facility to notify all patients 
who received mammograms at the facility or those patients who are 
determined to be at

[[Page 15171]]

risk due to the quality of their mammography, and their referring 
physicians or other healthcare providers, of the deficiencies and 
resulting potential harm, appropriate remedial measures, and such other 
relevant information as FDA or the State certification agency may 
require. Such notification shall occur within a timeframe and in a 
manner specified by FDA or the State certification agency. If the 
facility is unable or unwilling to perform such notification, FDA or 
the State certification agency may notify patients and their referring 
physicians or other healthcare providers individually or through the 
mass media.

0
6. In Sec.  900.14 revise paragraphs (a) introductory text and (a)(3), 
(5), and (6) and add paragraph (a)(7) to read as follows:


Sec.  900.14   Suspension or revocation of certificates.

    (a) Except as provided in paragraph (b) of this section, FDA may 
suspend or revoke a certificate if FDA finds, after providing the owner 
or operator of the facility with notice and opportunity for a hearing 
in accordance with part 16 of this chapter, that the facility, owner, 
operator, or any employee of the facility:
* * * * *
    (3) Has failed to comply with reasonable requests of FDA, the State 
certification agency, or the accreditation body for records, 
information, reports, or materials, including clinical images for an 
additional mammography review under Sec.  900.12(j), that FDA or the 
State certification agency believes are necessary to determine the 
continued eligibility of the facility for a certificate or continued 
compliance with the standards of Sec.  900.12;
* * * * *
    (5) Has violated or aided and abetted in the violation of any 
provision of or regulation issued pursuant to 42 U.S.C. 263b;
    (6) Has failed to comply with prior sanctions imposed by FDA or the 
State certification agency under 42 U.S.C. 263b(h), including a 
directed plan of correction or a patient and referring physician 
notification; or
    (7) Has failed to comply with requests of current or former 
facility personnel for records of their training or experience relevant 
to their qualification under MQSA, in violation of Sec.  900.12(a)(4).
* * * * *

0
7. In Sec.  900.15 revise paragraph (d)(1) to read as follows:


Sec.  900.15   Appeals of adverse accreditation or reaccreditation 
decisions that preclude certification or recertification.

* * * * *
    (d) * * *
    (1) References to the Centers for Medicare and Medicaid Services in 
42 CFR part 498 should be read as the Division of Mammography Quality 
Standards (DMQS), Center for Devices and Radiological Health, Food and 
Drug Administration.
* * * * *

    Dated: February 27, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-04550 Filed 3-9-23; 8:45 am]
BILLING CODE 4164-01-P