[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Proposed Rules]
[Pages 11669-11686]
[FR Doc No: 2019-05803]

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
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 proposing updates to
modernize the regulations by incorporating current science and
mammography best practices. These updates would 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: Submit either electronic or written comments on the proposed
rule by June 26, 2019. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by April 29, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified as
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0134 for ``Mammography Quality Standards Act; Amendments to
Part 900 Regulations.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
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should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 to the Office of Management and Budget
(OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title, Mammography Quality Standards Act; Amendments to Part 900
Regulations.

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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Legal Authority
    C. Summary of the Major Provisions of the Proposed Rule
    D. Costs and Benefits of the Proposed Rule
II. Table of Abbreviations and Acronyms Commonly Used in This
Document
III. Background
    A. FDA's Current Regulatory Framework for Mammography
    B. History of FDA's Mammography Regulations (21 CFR Part 900)
    C. Need for New and Amended Regulations
IV. Legal Authority
V. Description of the Proposed Rule
    A. Definitions of Mammography and Mammographic Modality
    B. Repeated Failure of Accreditation
    C. Retention and Provision of Personnel Records
    D. Equipment and Quality Control
    E. Mammography Reporting
    F. Recordkeeping
    G. Mammography Medical Outcomes Audit
    H. Additional Mammography Review and Patient and Referring
Physician Notification
    I. Additional Bases for Suspension or Revocation of a
Certificate, and Ineligibility To Own or Operate After Revocation
VI. Proposed Effective Date
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

    Mammography is an x-ray imaging examination used to identify signs
of breast cancer. For women 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 that all women nationwide have
access to quality mammography services, and its implementing
regulations address standards for accreditation bodies and certifying
agencies, qualifications of personnel at mammography facilities,
standards for mammography equipment, quality assurance testing,
recordkeeping, and communication of results. Based on technology
changes in mammography and our experience with the administration of
the MQSA program, FDA is proposing to modernize and improve the
regulations as well as improve the information, including breast
density information, provided by mammography facilities to patients and
their healthcare providers. The proposed changes would require that the
lay summary provided to patients identify whether the patient has low
or high density breasts and include a prescribed paragraph on the
significance of breast density. They would also establish 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 (Pub. L. 102-539) was enacted on October 27, 1992, and is
codified under the Public Health Service (PHS) Act (42 U.S.C. 263b;
section 354 of the PHS Act). Under the MQSA, all mammography
facilities, except facilities of the Department of Veteran Affairs
(VA), must be accredited by an approved accreditation body and
certified by FDA (or an approved State certification agency) to provide
mammography services (42 U.S.C. 263b(b)(1), (d)(1)(iv)). FDA is
proposing these amendments to the mammography regulations (set forth in
part 900 (21 CFR part 900)) under section 354 of the PHS Act (42 U.S.C.
263b), and sections of the FD&C Act (sections 519, 537, and 704(e); 21
U.S.C. 360i, 360nn, and 374(e)).

C. Summary of the Major Provisions of the Proposed Rule

    FDA is proposing 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.
     New and amended proposed provisions related to technology
would, among other things, update several equipment and quality control
provisions in the regulations to address current technology, including
digital mammography.
     Improvements that enhance enforcement would, 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, 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 reasonable
requests by FDA, the State certification agency, or the accreditation
body for records, including clinical images for an additional
mammography review (AMR), or with reasonable 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 would, among other things:
    [cir] Require that the mammographic examination report include the
facility name and location (at a minimum, the city, State, and ZIP code
of the facility), in order to help to ensure that healthcare providers
can obtain the necessary information to enable them to assist women 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 would
allow mammography facilities to more precisely classify and communicate
findings;
    [cir] Add a specific, required timeframe for facilities to deliver
medical reports to healthcare providers and the summary written in lay
language 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 they and their healthcare
providers can make informed healthcare decisions;
    [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 Proposed Rule

    The primary public health benefits of the proposed rule come from
the potential for earlier breast cancer detection, improved morbidity
and mortality, resulting in reductions in cancer treatment costs.
    The quantified benefits 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 $16.27 million to $466.75 million at a 7 percent
discount rate and $16.27 million to $534.03 million at a 3 percent
discount rate. The costs of the proposed rule include costs to
mammography facilities to comply with the proposed 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 $34.96 million to $60.50 million at a 7 percent
discount rate with a primary value of $47.03 million. Using a 3 percent
discount rate, the annualized costs range from $33.86 million to $59.40
million with a primary value of $45.92 million. The primary estimate of
the present value of costs over 10 years is $330.29 million at a 7
percent discount rate and $391.74 million at a 3 percent discount rate.

 II. Table of Abbreviations and Acronyms Commonly Used in This Document
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American College of Radiology............  ACR.
Centers for Disease Control and            CDC.
 Prevention.
Conference of Radiation Control Program    CRCPD.
 Directors, Inc.
Division of Mammography Quality Standards  DMQS.
Food and Drug Administration.............  FDA or we.
Federal Food, Drug, and Cosmetic Act.....  FD&C Act.
Institute of Medicine....................  IOM.
Mammography Quality Standards Act of 1992  MQSA.
Mammography Quality Standards              MQSRA.
 Reauthorization Acts of 1998 and 2004.
National Mammography Quality Assurance     NMQAAC.
 Advisory Committee.
Public Health Service Act................  PHS Act.
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III. Background

    According to the Centers for Disease Control and Prevention (CDC),
in 2014, the most recent year for which numbers are available, over
235,000 women were diagnosed with breast cancer, and more than 41,000
women died of the disease (Ref. 1). According to the National Cancer
Institute of the National Institutes of Health, in 2017, over 250,000
women were projected to be diagnosed with breast cancer, and over
40,000 women were projected to die of the disease (Ref. 2). Among
women, breast cancer is now the most common non-skin cancer and the
second leading cause of cancer deaths after lung cancer (Ref. 3). Early
detection of breast cancer, typically involving breast physical
examination and mammography, is the best means of preventing deaths
that can result if the diagnosis is delayed until the onset of more
advanced symptoms (Ref. 4). 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 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 work station, and can, for example, be digitally magnified.
Digital breast tomosynthesis also uses an electronic image receptor and
a computer work station, 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. 5).
    However, as noted by the Government Accountability Office (GAO), a
mammogram is among the most difficult radiographic images to interpret
(Ref. 6). 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. FDA's Current Regulatory Framework for Mammography

    The MQSA was enacted on October 27, 1992. The passage of the MQSA
came after the Senate Committee on Labor and Human Resources held
hearings on breast cancer and found a wide range of problems with
mammography practice in the United States, including poor quality
equipment, a lack of quality assurance (QA) procedures, poorly trained
radiologic technologists and interpreting physicians, and a lack of
facility inspections and consistent governmental oversight (Refs. 7 and
8). Under the MQSA, a comprehensive statutory scheme for the
certification and inspection of mammography facilities was established
to ensure that only those facilities that comply with Federal standards
of safety and quality could continue to operate after October 1, 1994.
Operation after that date is contingent on receipt of an FDA
certificate attesting that the facility meets the mammography quality
standards. All mammography facilities are subject to the MQSA, except
for those under the jurisdiction of the VA. All covered facilities have
to meet baseline standards in the areas of radiation dose, equipment,
and personnel, and other general practices, such as quality control and
quality assurance, are required to be accredited by an approved
accreditation body and certified by the Secretary of Health and Human
Services (the Secretary) (42 U.S.C. 263b(b)(1) and (d)(1)(A)(iv)).
Facilities must also undergo annual inspections to ensure compliance
with the MQSA requirements (42 U.S.C 263b(g)(1)). The MQSA also
provides for oversight and enforcement to help to ensure that
mammography services meet these Federal quality standards (42 U.S.C.
263b(h), (i), and (j)).
    The Mammography Quality Standards Reauthorization Acts of 1998 and
2004 (MQSRA) (Pub. L. 105-248 and 108-365) amended the MQSA by, among
other things, enhancing patient notification concerning health risks
and clarifying the types of certificates that could be issued under the
MQSA.
    Specifically, the MQSA requires the following:
    1. Accreditation of mammography facilities by private, nonprofit
organizations or State agencies that have been approved by FDA as
meeting the standards established by FDA for accreditation bodies and
that continue to pass annual FDA reviews of their activities (see 42
U.S.C. 263b(e)(1) and (3)). The MQSA also requires that, as part of the
overall accreditation process, actual clinical mammograms from each
facility be evaluated for quality by the accreditation body (see 42
U.S.C. 263b(e)(1)(B)(i)).
    2. An annual mammography facility physics survey, consultation, and
evaluation performed by a qualified medical physicist (see 42 U.S.C.
263b(e)(1)(B)(iv)).
    3. Annual inspection of mammography facilities, to be performed by
FDA-certified Federal or State inspectors (see 42 U.S.C.
263b(g)(1)(E)). If State inspectors are used, the MQSA requires a
Federal audit of the State inspection program by direct Federal
inspections of a sample of State-inspected facilities (see 42 U.S.C.
263b(g)(3)).
    4. Establishment of initial and continuing qualification standards
for interpreting physicians, radiologic technologists, medical
physicists, and mammography facility inspectors (see 42 U.S.C.
263b(f)(1)(C)-(E) and (g)(1)(D)).
    5. Specification of boards or organizations eligible to certify the
adequacy of training and experience of mammography personnel (see 42
U.S.C. 263b(f)(2)).
    6. Establishment of quality standards for mammography equipment and
practices, including QA and quality control programs (see 42 U.S.C.
263b(f)(1)(A)).
    7. Standards governing recordkeeping for patient files and
requirements for mammography reporting and patient notification by
physicians (see 42 U.S.C. 263b(f)(1)(G)).
    8. Establishment of the National Mammography Quality Assurance
Advisory Committee (NMQAAC or Committee) (see 42 U.S.C. 263b(n)(1)).
Among other things, NMQAAC is required to advise FDA on appropriate
quality standards for mammography facilities and accreditation bodies
(see 42 U.S.C. 263b(n)(3)).

B. History of FDA's Mammography Regulations (21 CFR Part 900)

    FDA published interim mammography regulations on December 21, 1993
(58 FR 67558 and 58 FR 67565; see also 59 FR 49808). These interim
regulations established requirements for entities applying to serve as
accreditation bodies and for facilities applying to obtain FDA
certification to provide mammography services after October 1, 1994.
FDA published comprehensive mammography quality standards in a final
rule published on October 28, 1997 (62 FR 55852). Most of

these regulations became effective on April 28, 1999; the remainder
became effective on October 28, 2002. FDA also published a final rule
on the MQSA and State certification agencies on February 6, 2002 (67 FR
5446).

C. Need for New and Amended Regulations

    Most of the requirements in our mammography regulations are over 20
years old. As described below, 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 proposing to
update our mammography regulations in response to several gaps that we
have identified as we have implemented the current regulations. For
example, FDA is proposing to require that both the mammography report
and lay summary include basic mammography facility identification
information. Technology has also advanced since the regulations were
promulgated, so the proposed regulations would make changes to reflect
current mammography best practices and technologies.
1. Additional Information in Mammography Reporting: Breast Density
    Breast density refers to the proportion of fibroglandular tissue in
the breast, as seen on a mammogram. Mammograms of breasts with higher
density are harder to interpret than those of less dense breasts,
because the dense tissue can obscure cancers (Ref. 9). In 2005, the
Institute of Medicine (IOM) noted that breast density is a
characteristic of some patients that affects the quality of
mammographic interpretation (Ref. 10). In addition, since the
publication of the current MQSA regulations, peer reviewed scientific
research has confirmed that dense breast tissue is one of the factors
that increases the chances that a woman will develop breast cancer
(Refs. 11 to 15). The CDC accordingly lists dense breast tissue as one
of the risk factors for breast cancer (Ref. 16). Because dense breast
tissue can obscure small cancers and is also a risk factor for breast
cancer, some women with dense breasts may choose, after consulting with
their healthcare provider, to undergo additional screening. Additional
screening of women with dense breasts can detect some additional
cancers and reduce delays in treatment (Refs. 17 to 19).
    On November 4, 2011, FDA convened an open public meeting of the
NMQAAC to consider possible changes to the MQSA regulations. At the
meeting, FDA sought input from the Committee on the potential inclusion
of breast tissue density information in facility mammography reports.
The Committee advised that FDA require breast density reporting in
mammography reports provided to healthcare providers as well as in lay-
language summaries provided to patients (Ref. 20).
    The MQSA and current regulations require a mammography facility to
provide a written report on each mammographic examination to the
patient's healthcare provider (see 42 U.S.C. 263b(f)(1)(G)(ii)(II);
Sec.  900.12(c)(3) (21 CFR 900.12(c)(3)). The mammography facility is
also required to provide a summary of the report in lay language to the
patient (see 42 U.S.C. 263b(f)(1)(G)(ii)(IV); Sec.  900.12(c)(2)).
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 May 2018, 34 States have passed laws mandating
notification of breast density (Ref. 21). These State laws impose
requirements that vary from State to State. To ensure all women receive
consistent breast density information from their mammograms, FDA is
proposing to amend the mammography reporting requirements in Sec.
900.12(c) 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.
2. Classifications of Mammography Assessment
    Additionally, the current categories do not account for some
important clinical and mammographic scenarios, which could lead to
confusing communication between interpreting physicians and referring
healthcare providers, and may also lessen the usefulness of the
required medical outcomes audit if these cases are incorrectly
classified. Classification of the assessment of the mammogram is part
of the information that a mammography facility currently is required to
include in the mammography report (see Sec.  900.12(c)(1)(iv)).
Mammography facilities classify their findings regarding a mammogram
using the following assessment categories: Negative, benign, probably
benign, suspicious, and highly suggestive of malignancy (see Sec.
900.12(c)(1)(iv)(A)-(E)), or the assessment ``incomplete: need
additional imaging evaluation'' (see Sec.  900.12(c)(1)(v)). FDA is
proposing to add to the current categories two new categories of final
assessment (known biopsy proven malignancy and post-procedure
mammograms for marker placement), and one new assessment category of
incomplete (need prior mammograms for comparison). The addition of
these categories would allow the mammography facility to more precisely
classify its findings (see section V.E.3 of this proposed rule and
proposed Sec.  900.12(c)(1)). In September 2006, the NMQAAC recommended
adding these categories to the assessment categories used in the
referring healthcare provider report (Ref. 22).

IV. Legal Authority

    The MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is
codified at 42 U.S.C. 263b (section 354 of the PHS Act). Under the
MQSA, all mammography facilities, except facilities of the VA, must be
accredited by an approved accreditation body 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 proposing these
amendments to the mammography regulations (set forth in part 900) under
section 354 of the PHS Act (42 U.S.C. 263b), and sections 519, 537, and
704(e) of the FD&C Act (21 U.S.C. 360i, 360nn, and 374(e)).

V. Description of the Proposed Rule

A. Definitions of Mammography and Mammographic Modality

    FDA is proposing to amend the definition of ``mammography'' to
exclude computed tomography (CT) of the breast as the requirements in
part 900 relating to mammography personnel qualifications and image
quality are not applicable to breast CT (Sec.  900.2(aa)). FDA is also
proposing to amend the definition of ``mammographic modality'' to
replace ``xeromammography'' as an example of a modality with ``full
field digital mammography,'' as the former is an obsolete technology
(see Sec.  900.2(z)).

B. Repeated Failure of Accreditation

    FDA is proposing to add a new subsection to the code of conduct and
general responsibilities requirements for accreditation bodies, which
would prohibit an accreditation body 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 failed attempt
(proposed Sec.  900.4(a)(6)(ii)).
    Upon receipt of an accreditation body's decision that a facility
has submitted the necessary information, FDA may issue a provisional
certificate to the facility so that it can perform mammography and
obtain clinical images for the purposes of ultimately meeting the
requirements necessary for accreditation (and later certification).
FDA's experience with MQSA program administration has shown that some
facilities repeatedly receive a provisional certificate--and continue
to perform mammography--but repeatedly resubmit and fail to achieve
accreditation. This new subsection would prohibit an accreditation body
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 (proposed Sec.
900.4(a)(6)(ii)). This would help to ensure that facilities that have
repeatedly failed to meet the required quality standards will not
continue to offer mammography services while in an unaccredited and
provisionally certified status. FDA believes that three consecutive
failures signify that a facility is not capable of performing
mammography that meets the required quality standards.

C. Retention and Provision of Personnel Records

    Mammography personnel in all categories (interpreting physicians,
radiologic technologists, and medical physicists) may work in more than
one mammography facility. Each facility is required to maintain records
of the training and experience supporting the qualification of each of
its personnel (see Sec.  900.12(a)(4)). If a facility worker loses his
or her personal copy of these records, he or she may attempt to obtain
copies from a facility where he or she works. Experience with MQSA
program administration has shown that facilities have refused
reasonable requests by personnel for copies of these records. When
personnel cannot obtain copies of their records to document their
qualifications, they may not be able to work at additional or new
facilities, which can lead to reduced public access to mammography
services. FDA is proposing to amend the retention of personnel records
section to require that facilities provide copies of these records to
personnel upon their reasonable request (proposed Sec.  900.12(a)(4)).
It would further require that facilities that close or cease to provide
mammography services make arrangements for access by personnel to these
records.

D. Equipment and Quality Control

    The proposed rule would amend parts of the equipment section to
address digital mammography and other changes in technology that have
occurred since publication of the current regulations (Sec.
900.12(b)).
1. Digital Accessories and Unit Conversion
    FDA is proposing to add a new provision that would require that
facilities use only digital accessory components that were either
approved or cleared by FDA specifically for mammography or approved or
cleared by FDA for a use that could include mammography and that have
the same equipment specifications as those approved or cleared for
mammography (Sec.  900.12(b)(2)). All equipment must be designed for
mammography. The mechanism by which it is known that equipment is
designed for mammography is that it was approved or cleared by FDA for
that use. This proposal clarifies that this is applicable to all
equipment, including things such as monitors. This change would ensure
that only those components appropriate for mammography would be used
clinically.
    The proposed rule would also add a provision establishing that a
mammography unit that is converted from one mammographic modality to
another is considered a new unit at the facility under this part and,
prior to clinical use, must undergo a mammography equipment evaluation
demonstrating compliance with applicable requirements. The facility
would also have to follow its accreditation body's procedures for
applying for accreditation of that unit.
2. X-Ray Film/Printer Film
    FDA is proposing to rename ``X-Ray film'' to ``Film'' and insert
the phrase ``For facilities using screen-film units'' regarding the use
of x-ray film (Sec.  900.12(b)(11)). The revised section also would
contain an additional provision that would require that facilities
using hardcopy prints of digital images for transfer, retention, or
final interpretation purposes use a type of printer film designated by
the film manufacturer as appropriate for this purpose and compatible
with the printer being used to maintain image quality.
3. Quality Assurance Testing for Equipment Other Than Screen-Film
    To ensure compliance with image quality standards, FDA is proposing
to amend the equipment section to add a new paragraph for equipment of
other modalities (proposed Sec.  900.12(b)(16)) that would require that
systems with image receptor modalities other than screen-film
demonstrate compliance with quality standards by successful results of
QA testing as specified in the section for quality control testing--
other modalities (Sec.  900.12(e)(6)).

E. Mammography Reporting

    FDA also is proposing to amend section ``Medical records and
mammography reports'' (Sec.  900.12(c)). The proposed rule would amend
the mammography reporting requirements as described below (see Sec.
900.12(c)). Our goal is to revise the mammography reporting regulations
to increase the clarity of communication among mammography facilities,
healthcare providers, and patients, facilitate the retrieval of
mammography images, and help ensure that healthcare providers and
patients are obtaining the necessary information from the report of the
results of a mammographic examination to enable a woman and her
healthcare provider to make informed healthcare decisions.
1. Contents and Terminology
    Image quality contributes to accurate interpretation of mammograms.
The MQSA and implementing regulations are intended to ensure that
quality images are produced. However, FDA's experience has shown that
some facilities copy or digitize clinical images, and submit these
copies, of lesser quality than the original images, to the interpreting
physician for interpretation. This can adversely affect accuracy of
interpretation. Therefore, to ensure that the interpreting physician
interprets the actual images, which were performed in compliance with
MQSA quality standards, FDA is proposing to change this section on
content and terminology of medical records and mammography reports to
require that the mammograms submitted for interpretation be presented
in the mammographic modality in which they were originally produced,
and not be copied or digitized (Sec.  900.12(c)(1)).
2. Facility Identification and Other Information
    The existing section on content and terminology requires that a
mammography facility prepare a written report of each mammographic
examination performed under its certificate (Sec.  900.12(c)(1)). The
proposed rule would add a requirement that the report include the
facility name and location (at a minimum, the city, State,

and ZIP code of the facility) (proposed Sec.  900.12(c)(1)(ii)). This
proposed addition would help to ensure that healthcare providers know
which facility is providing the report of the results of a mammographic
examination so they can follow up with the reporting facility as
necessary in order to assist their patients in making informed
healthcare decisions.
    The existing section on communication of mammography results to the
patients requires that the facility provide each patient with a summary
of the report in lay language within 30 calendar days of the
mammographic examination (Sec.  900.12(c)(2)). The proposed rule would
revise this subsection to require that the lay summary include the name
of the patient, and the name, address, and telephone number of the
facility performing the mammographic examination. This proposed
addition would help to ensure that appropriate mammography facility
identification information is included in the lay summary sent to the
patient. Experience has shown that inadequate facility identification
information in mammography reports and lay summaries can impede
communication among healthcare providers and patients and hamper the
timely provision of medical care.
3. Mammographic Assessment Categories
    Mammography facilities classify their findings regarding a
mammogram using the categories listed in current categories for final
assessment of findings (Sec.  900.12(c)(1)(iv)), and they report that
classification in the written report of the results of each mammography
examination sent to the healthcare provider. For each final assessment
category in the current regulations, the words in quotation marks are
required to be included in the medical report, while the remaining
language is intended to provide explanations of the categories to
promote their consistent use but is not required to be included in the
medical report.
    FDA is proposing to change the explanatory language associated with
the ``benign'' assessment category to more accurately reflect and
communicate the intent of this category (Sec.  900.12(c)(1)(iv)(B)).
Currently the prescribed wording associated with this assessment is ``
`Benign:' Also a negative assessment.'' FDA is proposing to change the
wording of this category to `` `Benign:' Also a normal assessment, 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 explained).'' The
mammogram assigned this category is not truly ``negative,'' as it has
one or more findings. However, these findings are benign, and no
further evaluation or follow up is recommended. This change would
promote greater consistency and accuracy in the use of the ``benign''
final assessment category.
    These proposed changes to the reporting requirements would add
three new categories (listed below) of mammographic assessment to the
existing categories in the regulations (proposed Sec.  900.12(c)(1)(iv)
through (c)(1)(vi)). The addition of these categories would allow the
mammography facility to more precisely classify its findings.
    One proposed new category is `` `Known Biopsy Proven Malignancy.'
Reserved for known malignancies being evaluated by mammography for
definitive therapy'' (see proposed Sec.  900.12(c)(1)(iv)(F)). The
addition of this final assessment was recommended in the IOM report of
2005 (Ref. 10), which was commissioned by Congress to address concerns
about the quality of mammography image interpretation. This
recommendation was also supported by the NMQAAC in 2006 (Ref. 22). This
assessment would be used when breast imaging is performed after a
tissue diagnosis of cancer, but before complete surgical removal of the
cancer. The category would alert providers who receive the report that
the mammographic finding has already received additional evaluation,
including tissue diagnosis, and is not a new finding that requires
further evaluation. Additionally, the category would be relevant to the
mammography medical outcomes audit, which is required under the MQSA
regulations (see Sec.  900.12(f)). For this required audit, each
facility must have a system to track a mammogram that is found to be
either ``suspicious'' or ``highly suggestive of malignancy'' and a
process to correlate the mammographic findings with biopsy results. The
``Known Biopsy Proven Malignancy'' final assessment could be used to
exclude such cases from the mammography medical outcomes audit, in
order to avoid counting the same cancer case more than once in an
audit. FDA determined that this proposed category could be used as an
alternative quality standard (see Sec.  900.18) (Ref. 23).
    The second proposed new category is ``Post-Procedure Mammograms for
Marker Placement'' (proposed Sec.  900.12(c)(1)(iv)(G)). The addition
of this final assessment category was also supported by the NMQAAC in
2006 (Ref. 20). This category has two roles in current clinical
practice. It is primarily used for a mammogram performed following a
biopsy to confirm the deployment and position of a breast tissue
marker. During a biopsy using a needle to withdraw tissue from a
suspicious breast lesion, a marker may be placed at the site, and
mammographic images are obtained to assess and document the position of
the marker. If this mammogram demonstrates that the marker has not
deployed or has migrated, placement of another marker may be necessary
before concluding the procedure. Also, if the tissue biopsy result,
when it becomes available, shows cancer and further surgery is
necessary, the marker identifies the site for further surgical
planning. The breast abnormality has already been found to be
mammographically suspicious and warranting biopsy, and it will be
definitively diagnosed by the tissue biopsy result when available, so
this post-procedure mammogram does not contribute to lesion
characterization, and other final assessments are not appropriate for
this mammogram. The other use of this final assessment category is for
a mammogram performed to document the position of a localization
needle. During needle localization, a needle is positioned as a
temporary marker 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 marker needle. FDA
determined that this proposed category could be used as an alternative
quality standard (see Sec.  900.18) (Ref. 24).
    FDA proposes to add a third new category, ``Incomplete: Need prior
mammograms for comparison,'' for those examinations where no final
assessment category can be assigned (proposed Sec.
900.12(c)(1)(v)(B)). This assessment category would be reserved for
examinations where comparison with prior mammograms should be performed
before one of the other assessment categories is given. If this
assessment category is used, a follow up report with one of the other
assessment categories must be issued within 30 calendar days of the
initial report whether or not comparison views can be obtained. The
addition of this assessment category was also supported by the NMQAAC
in 2006 (Ref. 22). Comparison to previous examinations is sometimes
required to make a final

assessment. Assigning this ``Incomplete: need prior mammograms''
assessment as an assessment category would allow tracking of these
examinations to ensure either that prior examinations are obtained and
compared in a timely fashion, or, if they remain unavailable, that the
current examination is given a definitive final assessment in a timely
fashion. This proposed category is part of an assessment that FDA
determined could be used as an alternative quality standard (see Sec.
900.18) (Ref. 23).
4. Deadlines for Provision of Lay Summary to Patient and Report to
Provider
    Current regulations require that if the final assessment in a
mammography report is ``Suspicious'' or ``Highly suggestive of
malignancy,'' the facility should make reasonable attempts to ensure
that the results are communicated to the patient and healthcare
provider as soon as possible (Sec.  900.12(c)(2) and (c)(3)(ii)). FDA
proposes adding a specific timeframe for delivery of medical reports to
healthcare providers and the summary written in lay language to
patients whose mammograms have either of these two final assessment
categories.
    The proposed rule would amend communication of mammography results
to patients and healthcare providers to require that, if the assessment
of the mammography report is ``Suspicious'' or ``Highly suggestive of
malignancy,'' the facility must communicate the results to the
referring healthcare provider or a healthcare provider named by the
patient, within 7 calendar days of the final interpretation of the
mammographic examination but in no case later than 14 calendar days
from the date of the mammographic examination, and to the patient in
the summary written in lay language, within 7 calendar days of the
final interpretation of the mammographic examination but in no case
later than 21 calendar days from the date of the mammographic
examination (Sec.  900.12(c)(2) and (c)(3)). FDA would require such
action by the facility for these two final assessment categories
because they both suggest a high possibility of malignancy. We believe
that specifying a timeframe for communicating these results, instead of
the open-ended ``as soon as possible,'' which is currently required,
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.
5. Breast Density Notification
    Clinical practice guidelines already recommend that the
interpreting physician provide breast density information in the
mammography report to the referring healthcare provider (Ref. 25).
Moreover, as of May 2018, facilities in 34 States are also required by
State law to provide breast density information to patients (Ref. 21).
Proposed Sec.  900.12(c)(1)(vi) would require that the patient's breast
density be included in the mammography report that must be provided to
the patient's referring or named healthcare provider. Proposed Sec.
900.12(c)(1)(vi) would establish four categories for reporting breast
tissue density in the mammography report: ``The breasts are almost
entirely fatty.'', ``There are scattered areas of fibroglandular
density.'', ``The breasts are heterogeneously dense, which may obscure
small masses.'', and ``The breasts are extremely dense, which lowers
the sensitivity of mammography.'' These four categories are consistent
with current clinical practice guidelines (Ref. 25).
    Based on discussion with the NMQAAC in 2011 (Ref. 20), and
consistent with current clinical practice (Ref. 26) as well as most
State density notification laws (Ref. 27), for notification to
patients, FDA has grouped these four categories of breast density into
two broader groups: Low density and high density. Proposed Sec.
900.12(c)(2)(iii) and (c)(2)(iv) would require that the lay summary
provided to patients identify whether the patient has low or high
density breasts and include a prescribed paragraph on the significance
of breast density.
    FDA developed two patient density paragraphs, one intended for
patients with low breast density and one for patients with high breast
density with input from FDA's Risk Communication Advisory Committee.
The paragraphs contain an explanation of high breast tissue density, as
well as specific topics for women to discuss with their healthcare
providers.
    The purpose of these proposed breast density notification
requirements is to provide women and their healthcare providers with
additional information regarding their mammography results and the
potential limitations of those results to enable women and their
healthcare providers to make informed healthcare decisions. As
discussed previously, dense breast tissue increases the risk of
developing breast cancer (Refs. 11 to 13). Dense breast tissue can also
obscure mammographic signs of breast cancer and thus result in a
delayed cancer diagnosis (Ref. 9). Women with dense breasts who receive
the notification would have additional information about their own
anatomy and be positioned to discuss this and make more informed
healthcare choices with their healthcare providers. With knowledge of
their breast density, some women may choose additional screening using
technology approved by FDA, either with indications for use
specifically for dense breasts, or known to be effective for evaluating
dense breasts, which could result in additional cancers detected and
reduce delays in treatment. For example, a device for automated breast
ultrasound has been FDA-approved for use in combination with a
screening mammogram for additional breast cancer screening in women
with dense breasts and a negative mammogram. One study showed that
supplemental ultrasound screening in high-risk women with dense breasts
resulted in the detection of 1.1 to 7.2 additional cancers per 1,000
women (Ref. 19). The detection of additional cancers has to be weighed
against any increase in false positive results (Ref. 28).
6. Mammography Self-Referrals
    Current Sec.  900.12(c)(2)(ii) requires 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
clinically indicated,'' i.e., when necessitated by the presence of
signs or symptoms of disease. However, many cases of breast cancer are
identified due to an abnormality on a mammogram, in the absence of any
clinical signs or symptoms. Proposed Sec.  900.12(c)(2)(ii) adds the
term ``mammographically'' as another indication for which facilities
must maintain a system for referral to a healthcare provider. This
addition would help to ensure that patients without healthcare
providers and receiving mammographic examinations from a mammography
facility are referred to healthcare providers when mammographically
appropriate, i.e., when appropriate based on the results of the
mammogram, as well as when clinically appropriate.

F. Recordkeeping

1. Policies To Minimize Loss of Records
    Current Sec.  900.12(c)(4)(i) requires facilities to maintain
mammography films and reports in a permanent medical record of the
patient for a period of not less than 5 years, or not less than 10
years if no additional mammograms of the patient are performed at the
facility, or a longer

period if mandated by State or local law. FDA's experience has shown
that, with the widespread use of electronic media for the storage of
soft copy images, facilities face new technical challenges regarding
maintaining the availability of current and recent mammograms. Since
the loss of these images can have a significant impact on patient care,
facilities must address these challenges. The proposed rule (proposed
Sec.  900.12(c)(4)(i)) would amend this section to require each
facility to implement policies and procedures to minimize the
possibility of loss of these records. In addition, since copying or
digitizing a mammographic image can degrade the quality of the image
and potentially lead to incorrect diagnoses, the proposed rule would
also require that, to preserve image quality, the mammograms must be
retained in retrievable form in the mammographic modality in which they
were produced and cannot be produced by copying or digitizing hardcopy
originals.
2. Transfer of Mammograms and Mammography Reports
    Current Sec.  900.12(c)(4)(ii) requires facilities, upon request
by, or on behalf of, the patient, to 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. Since delays in the transfer of
these records can lead to delays in diagnosis or treatment, the FDA's
proposed rule (proposed Sec.  900.12(c)(4)(ii)) would amend this
section to require facilities to release records within 15 calendar
days of the facility receiving the transfer request in order to
facilitate prompt patient care. Also, copying or digitizing a
mammographic image can degrade the quality of the image and potentially
lead to incorrect diagnoses. Therefore, to preserve image quality, the
proposed rule would also require that the transferred mammograms be in
the mammographic modality in which they were produced, and cannot be
produced by copying or digitizing hardcopy originals. Additionally, 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.
3. Provision of Copies of Mammograms and Mammography Reports
    With the widespread use of digital mammography, facilities often
retain the original mammogram even when releasing a copy upon the
patient's request. Delays in release of these copies can lead to delays
in diagnosis or treatment, so FDA is proposing to add Sec.
900.12(c)(4)(iii), which would require that each facility that performs
mammograms, 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, and that the release of the copies must take
place within 15 calendar days of the facility receiving such a request
in order to facilitate prompt patient care.
4. Facility Closure and Record Access
    FDA is proposing to add Sec.  900.12(c)(4)(v), which would provide
that, before a facility closes or no longer provides mammography
services, it must make arrangements for the continued access by
patients and healthcare providers to mammograms and reports. This
access may be provided by the permanent transfer of mammograms and
reports to the patient or her healthcare provider or transfer of the
mammograms and reports to a facility or other entity that will continue
to provide access to patients and healthcare providers within the time
periods specified in Sec.  900.12(c)(4)(i). The facility must notify
its accreditation body and certifying agency in writing of the
arrangements it has made and must make reasonable efforts to notify all
affected patients as to how to obtain their records.

G. Mammography Medical Outcomes Audit

    As part of recordkeeping requirements, the existing MQSA
regulations, Sec.  900.12(f), require facilities to perform an audit of
medical outcomes of its mammography patients, but do not specify the
information to be collected or evaluated during this audit. Recently,
the clinical practice community recognized that specific audit metrics
are particularly relevant to continuous quality improvement at
mammography facilities (Refs. 29 and 30).
    Based on this industry best practice, FDA is proposing to clarify
the minimum required components of the medical outcomes audit,
including the calculation of three clinically significant metrics known
as positive predictive value, cancer detection rate, and recall rate
(see proposed Sec.  900.12(f)(1)). The latter two metrics incorporate
the accepted clinical distinction between a screening mammogram
(consisting of routine views for the earlier detection of cancer in an
asymptomatic woman) and a diagnostic mammogram (consisting of
individualized views for the evaluation of a woman with breast
symptoms, physical signs of breast disease, or abnormal findings on a
screening mammogram) (Ref. 31). Calculating and tracking these three
audit metrics would allow facilities and interpreting physicians to
review their performance, evaluate their accuracy in detecting breast
cancer, and enact quality improvement measures as necessary. As a
result, FDA is proposing to revise Sec.  900.12(f)(1) and add
subparagraphs Sec.  900.12(f)(1)(i) through (f)(1)(iii) to clarify the
minimum information that must be collected during the audit, including
a determination of three of the most clinically significant metrics:
Positive predictive value, cancer detection rate, and recall rate.

H. Additional Mammography Review and Patient and Referring Physician
Notification

    Existing Sec.  900.12(j) addresses AMR and PPN. It sets forth the
AMR procedures, whereby FDA may require the facility to provide
clinical images and other relevant information to the accreditation
body or other entity designated by FDA if FDA believes that mammography
quality at the facility has been compromised and may present a serious
risk to human health (Sec.  900.12(j)(1)). If FDA determines that the
quality of mammography performed by a facility was so inconsistent with
the quality standard established in Sec.  900.12 as to present a
significant risk to individual or public health, FDA may require such
facility to issue a PPN to notify patients who received mammography at
such facility and their referring physicians of the deficiencies and
resulting potential harm, appropriate remedial measures, and other
relevant information (Sec.  900.12(j)(2)).
    Proposed revised Sec.  900.12(j)(1) adds the State certification
agency as an entity that may initiate an AMR. Proposed revised Sec.
900.12(j)(2) would require that referring non-physician healthcare
providers receive notification along with referring physicians (many
patients are referred for mammography by non-physician healthcare
providers), and expressly state 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 the
required notification. This proposed subsection also would make clear
that a PPN could be based on information discovered during the AMR or
it could be based on other information. These proposals would

help to assure that quality mammography services are provided and that
patients and providers are informed of significant risk to individual
or public health resulting from mammography that fails to meet quality
standards.

I. Additional Bases for Suspension or Revocation of a Certificate, and
Ineligibility To Own or Operate After Revocation

    Revisions to Sec.  900.14(a)(3) would expressly state that FDA and
State certification agencies can suspend or revoke the certificate of a
facility that fails to comply with reasonable requests by FDA, the
State certification agency, or the accreditation body for records,
including clinical images for an AMR under Sec.  900.12(j). Experience
with MQSA program administration has shown that some facilities are
unable or unwilling to cooperate with submissions for such requested
materials. The refusal to provide records can delay identification of
serious risks to human health or delay notification of significant risk
to individual or public health to affected patients and their
healthcare providers.
    In addition, proposed Sec.  900.14(a)(7) would state that FDA may
suspend or revoke the certificate of a facility that fails to comply
with reasonable requests by current or former facility personnel for
records documenting their qualifications. Experience with MQSA program
administration has also shown that facilities have refused reasonable
requests to give copies of their records to the personnel named in the
records. When personnel cannot obtain copies of their records to
document their qualifications under MQSA, they may be prevented from
working at additional or new facilities, which can lead to reduced
public access to mammography services.
    The MQSA (42 U.S.C. 263b(i)) states that upon the finding of
certain acts, such as misrepresentation in obtaining a certificate,
failure to comply with quality standard requirements, failure to
provide certain information to FDA in response to reasonable requests,
failure to permit inspection, violation of any provision of the MQSA or
regulation promulgated under the MQSA, and failure to comply with a
sanction, a facility's certificate may be revoked. If a facility's
certificate is revoked, persons who owned or operated the facility at
the time of revocation are ineligible to own or operate a mammography
facility for 2 years.
    FDA is also revising Sec.  900.11(c) to correct a citation error to
the MQSA and make clear that Sec.  900.14(c) implements 42 U.S.C.
263b(i) and not 41 U.S.C. 263b(i).

VI. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this
proposal become effective 18 months after the date of publication of
the final rule in the Federal Register. Facilities need time to become
familiar with new requirements and to add breast density reporting to
their reporting systems.

VII. Preliminary Economic Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, 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). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed 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 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 proposed 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 proposing ``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 $150 million, using the most current (2017) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
result in an expenditure in any year that meets or exceeds this amount.

B. Summary of Benefits and Costs

    The proposed rule would modernize mammography regulations by
incorporating current science and mammography best practices to improve
the delivery of mammography services. The proposed updates include
requirements on recordkeeping, reporting, and communication of results.
This proposed rule also addresses procedural requirements in several
areas related to quality control and management of mammography
facilities.
    The benefits and costs associated with this proposed 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. In this analysis, 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 quality-
adjusted life years (QALY). Under the VSL approach, the estimate of
annualized benefits over 10 years ranges from $73.24 million to $466.75
million at a 7 percent discount rate. Using a 3 percent discount rate,
the annualized benefits range from $85.33 million to $534.03 million.
Under the QALY approach, the estimate of annualized benefits over 10
years ranges from $16.27 million to $77.23 million at a 7 percent
discount rate. Using a 3 percent discount rate, the annualized benefits
range from $16.27 million to $ 61.77. Because there is uncertainty in
the literature about the most appropriate method for analyzing reduced
mortality for the population affected by this proposed 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 QALY approach, which yields
the lower bound estimate of the two methods. Other benefits that we are
not able to quantify include improvements in the accuracy of
mammography by improving quality control and records management, and
effects on morbidity.
    The costs of the proposed rule include costs to mammography
facilities to comply with the proposed 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 $34.96 million to

$60.50 million at a 7 percent discount rate with a primary value of
$47.03 million. Using a 3 percent discount rate, the annualized costs
range from $33.86 million to $59.40 million with a primary value of
$45.92 million. The primary estimate of the present value of costs over
10 years is $330.29 million at a 7 percent discount rate and $391.74
million at a 3 percent discount rate.

                               Table 1--Summary of Benefits and Costs in Millions 2017 Dollars Over a 10-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                   Primary                                    -----------------------------------------------
           Category               estimate      Low estimate    High estimate                   Discount rate      Period                Notes
                                                                                Year dollars         (%)          covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized...............  ..............          $16.27         $466.75            2017              7%  10 years       ..........................
    Monetized $/year.........  ..............           16.27          534.03            2017               3  10 years       ..........................
    Annualized Quantified....  ..............  ..............  ..............  ..............               7
                                                                                3
                              ------------------------------------------------
    Qualitative..............    Improvements in the accuracy of mammography
                                    and better management of mammography
                                                 facilities.
                              ------------------------------------------------
Costs:
    Annualized Monetized $/             47.03           34.96           60.50            2017               7  10 years       ..........................
     year.                              45.92           33.86           59.40            2017               3  10 years.....
    Annualized Quantified....  ..............  ..............  ..............  ..............               7
                                                                                3
    Qualitative..............
Transfers:
    Federal..................  ..............  ..............  ..............  ..............               7
    Annualized Monetized $/    ..............  ..............  ..............  ..............               3
     year.
                              -----------------------------------------------------------------------------------------------
    From/To..................                       From:
                                                     To:
                              -----------------------------------------------------------------------------------------------
    Other....................  ..............  ..............  ..............  ..............               7
    Annualized Monetized $/    ..............  ..............  ..............  ..............               3
     year.
                              -----------------------------------------------------------------------------------------------
    From/To..................                       From:
                                                     To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business: Annual cost per affected small entity estimated as 357-623, which would represent a maximum of 2.7 percent of annual receipts.......
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these costs this proposed rule would be considered a
regulatory action under E.O. 13771.

                                 Table 2--EO 13771 Summary Tables in Millions 2016 Dollars Over an Infinite Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................         $615.44         $446.14         $804.56       $1,378.67         $983.65       $1,819.96
Present Value of Cost Savings...........................               0               0               0               0               0               0
Present Value of Net Costs..............................          615.44          446.14          804.56        1,378.67          983.65        1,819.96
Annualized Costs........................................           43.08           31.23           56.32           41.36           29.51           54.60
Annualized Cost Savings.................................               0               0               0               0               0               0
Annualized Net Costs....................................           43.08           31.23           56.32           41.36           29.51           54.60
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    We estimate that there are 4,585 non-hospital facilities and 4,106
hospitals that perform mammography. A minimum of 3,865 of the
mammography facilities in operation for the entire year, or 95 percent
of the total, would be small. At least 382 of all hospitals with less
than $10 million in annual receipts, or 9 percent of the total, are
small. The estimated one-time cost is $4,100 to $6,474 per facility.
The estimated annual cost is $357 to $623 per facility. One-time costs
are 26.7 percent of receipts and annual costs are 4.1 percent of
receipts for the smallest diagnostic imaging centers. Based on this, we
conclude that the proposed rule, if finalized, would have a significant
impact on a substantial number of small entities. The proposed
regulation would have smaller effects on hospitals because they provide
more diversified services and tend to be larger. We have developed a
comprehensive Economic Analysis of Impacts that assesses the impacts of
the proposed rule.
    The full analysis of economic impacts is available in the docket
for this proposed rule (Ref. 32) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. We solicit
comment about the analysis of economic impacts.

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 proposed rule refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). The collections of information in part 900 have been
approved under OMB control number 0910-0309. The proposed amendments to
part 900 in this document necessitate revisions to OMB control number
0910-0309. A description of the proposed amendments that necessitate
revisions to the annual third-party disclosure burden is given in the
Description section below. 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.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's information collection provisions that are subject to review
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Mammography Facilities, Standards, and Lay Summaries for
Patients.
    Description: FDA is proposing to amend its mammography reporting
requirements to require that the mammography report provided to the
healthcare provider and the lay summary report provided to the patient
include basic mammography facility identification information and
information concerning patient breast density. This action is intended
to facilitate communication between 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
woman and her healthcare provider to make informed healthcare
decisions. FDA also is proposing additional categories be added to the
list of assessments that facilities are required to use in the
mammography report. In addition, FDA is proposing to amend 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 provide mammographic examinations and
State certification.
    Agencies: As of May 1, 2018, FDA internal data on facilities showed
that there were 8,691 facilities certified to perform mammography. In
addition to mammography-performing facilities, the regulation would
also affect four State certification agencies (Ref. 33).
    FDA estimates the burden of this collection of information as
follows:

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity/21 CFR section                Number of      disclosures    Total annual         Average burden per disclosure          Total hours
                                                 respondents   per respondent    disclosures                                                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provision of personnel records--900.12(a)(4).             608               1             608  0.08 (5 minutes).........................              49
Transfer of personnel records by closing                   87               1              87  5........................................             435
 facilities--900.12(a)(4).
New assessment categories and breast density            8,691               1           8,691  23.......................................         199,893
 reporting in mammography report (one-time
 burden)--900.12(c)(1)(iv)-(c)(1)(vi).
Breast density reporting in lay summary (one-           8,691               1           8,691  11.......................................          95,601
 time burden)--900.12(c)(2).
Transfer/provision of copies of mammograms              8,691           1,508      13,109,566  0.08 (5 minutes).........................       1,048,765
 and records upon patient's request--
 900.12(c)(4)(ii) and (c)(4)(iii).
Facility closure; notification and records                 87               1              87  32.......................................           2,784
 access--900.12(c)(4)(v).
Patient notification of significant risk (by                5               1               5  100......................................             500
 State certification agency)--900.12(j)(2).
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       1,348,027
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Columns may not sum due to rounding.

    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
interpreting physicians, radiologic technologists, or medical
physicists. Facilities must maintain records of personnel no longer
employed by the facility at least until the next annual inspection and
until FDA has determined that the facility is in compliance with the
MQSA personnel requirements. FDA is not proposing any changes to these
requirements. The information collection (recordkeeping) burden for
this provision is currently approved under OMB control number 0910-
0309.
    Also under proposed Sec.  900.12(a)(4), facilities would have to
provide copies of personnel records to current or former interpreting
personnel (physician, radiological technologist and medical physicist)
upon their reasonable request. We estimate that there are, on average,
seven interpreting personnel per facility (approximately 60,837 total).
We estimate that 1 percent

of these personnel (608 personnel annually) would request the records
and that it would take approximately 5 minutes to provide the copies
for each request.
    Additionally, under proposed Sec.  900.12(a)(4), before a facility
closes or ceases to provide mammography services, it would 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 would provide access to these records. We estimate that
annually 1 percent of the total facilities would close or cease to
provide mammography services and that it would take each of the
facilities approximately 5 hours to transfer the records.
    Medical records and mammography reports--Sec.  900.12(c)(1) through
(c)(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 interpreting physician,
and recommendations to the healthcare provider.
    This proposed rule would include two additional final assessment
categories and an additional classification in the mammography report
and would also require an assessment of breast density in the report
(proposed Sec.  900.12(c)(1)(iv) through (c)(1)(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 would take 23 hours per facility
(Ref. 34).
    Under the proposed rule, if the final assessment is ``Suspicious''
or ``Highly suggestive of malignancy,'' the facility would have to
provide the report to the healthcare provider, or if the referring
healthcare provider is unavailable, to a responsible designee (proposed
Sec.  900.12(c)(3)(ii)) within a specified timeframe; the current
regulation states that facilities must make reasonable attempts to
provide the report in such situations ``as soon as possible.'' 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. Therefore, these changes would not result in additional
burden.
    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. Under the proposed rule, if the final assessment
is ``Suspicious'' or ``Highly suggestive of malignancy,'' the facility
would have to provide the patient a summary of the mammography report
within a specified timeframe (proposed Sec.  900.12(c)(2)); the current
regulation states that facilities must make reasonable attempts to
provide the report in such situations ``as soon as possible.'' Under
the proposed rule, this summary would need to include the name of the
patient and name, address, and telephone number of the facility. We
estimate that the proposed requirements for the lay summary to include
this information would not result in a change to the currently approved
information collection burden for Sec.  900.12(c)(2).
    Proposed Sec.  900.12(c)(2) also would require facilities to
provide an assessment of breast density in the lay summary. We estimate
a one-time burden for facilities to update their existing lay summary
reports with the breast density assessments. Based on the ERG report,
we believe this would take 11 hours per facility (Ref. 34).
    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 proposed rule would also require that the system provide
referrals when ``mammographically'' indicated. We estimate this
proposed addition would not result in a change to the currently
approved information collection burden.
    The proposed requirements in Sec.  900.12(c)(2)(iii) and (c)(2)(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 proposed Sec.  900.12(c)(4)(i), facilities that perform
mammograms must maintain mammographic records. The proposed rule would
require that facilities implement policies and procedures to minimize
the possibility of record loss and would require that records be
maintained in the modality in which they were produced. We estimate
these proposed additions would not result in a change to the currently
approved information collection burden.
    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
proposed Sec.  900.12(c)(4)(ii) and (c)(4)(iii), facilities would need
to 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 would need to be in
the same modality in which they were produced. Moreover, for digital
mammograms or digital breast tomosynthesis, the facility would have to
be able to provide the recipient with original digital images
electronically if the examination is being transferred for final
interpretation. While the burden of maintaining records under Sec.
900.12(c)(4) is included in the currently approved burden estimate, the
currently approved burden estimate does not include the third-party
disclosure burden of transferring the records. We estimate that
approximately one third of patients would request transfer or release
of the records (this equals an average of approximately 1,508 requests
per facility) and it would take approximately 5 minutes per request.
    Under proposed Sec.  900.12(c)(4)(v), before a facility closes or
ceases to provide mammography services, it would have to make
arrangements for access by patients and healthcare providers to their
mammographic records. Additionally, the facility would have to 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. We estimate that 1 percent of facilities would close
on an annual basis and that it would 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 follow up on the disposition of all positive mammograms and
correlation of pathology results with the interpreting physician's
mammography report. The proposed rule would clarify that positive
predictive value, cancer detection rate, and recall rate would have to
be collected during this audit. We estimate that the proposed
clarifications would not result in a change to the currently approved
information collection burden.
    Additional mammography review and patient and referring physician
notification--Sec.  900.12(j): Under Sec.  900.12(j)(1), if FDA
believes that mammographic quality at a facility has been compromised
and may present a serious risk to human health, the facility must
provide clinical images and other relevant information for review by
the accreditation body or other entity designated by FDA. Under the
proposed rule, the State certification agency may request and then
review such information. We estimate these proposed revisions would not
result in a change to the currently approved information collection
burden.
    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 of the deficiencies and resulting potential
harm, appropriate remedial measures, and other relevant information.
Under the proposed rule, facilities would need to notify referring non-
physician healthcare providers (along with referring physicians). We
estimate this proposed revision would not result in a change to the
currently approved information collection burden. Also under the
proposed rule, State certification agencies (along with FDA) would have
the authority to notify patients and their providers if a facility is
unable or unwilling to do so. We estimate that the burden to State
certification agencies would be similar to the approved burden estimate
for facilities; approximately five notifications per year will take 100
hours per notification.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title, ``Mammography Facilities, Standards, and Lay
Summaries for Patients (OMB control number 0910-0309)''.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has
submitted the information collection provisions of this proposed rule
(revisions of collections approved under OMB control number 0910-0309)
to OMB for review. These requirements will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these requirements in the Federal Register.

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 women 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.
    The proposed amendments to the MQSA regulations, among other
things, are intended to amend the requirements for reporting to
healthcare providers and patients to assure that patients receive all
necessary information after their mammograms, including an assessment
of breast density, while not unduly burdening the mammography facility.
    Although certain proposed 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 would not change if the
proposed regulations were finalized, as these proposals would 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. 18). 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, 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
proposed rule is consistent with the federalism principles expressed in
Executive Order 13132.

XI. References

    The following references 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. 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. Centers for Disease Control and Prevention, ``Breast Cancer
Statistics.'' Available at 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. Centers for Disease Control and Prevention, ``Cancer Among
Women.'' Available at http://www.cdc.gov/cancer/dcpc/data/women.htm.
4. 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[hyphen]723.
5. American Cancer Society, ``Can Breast Cancer Be Found Early?''
Available at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-detection.
6. Government Accountability Office, ``GAO-06-724 Mammography:
Current Nationwide Capacity Is Adequate, but Access Problems May
Exist in Certain

Locations (July 2006).'' Available at http://www.gao.gov/new.items/d06724.pdf.
7. Improving the Quality of Mammography: How Current Practice Fails.
Hearing before the Subcommittee on Aging of the Committee on Labor
and Human Resources, United States Senate, 102d Congress, 1992.
8. The Failure and Success of Current Mammography Practice: The Need
for Strong Federal Quality Standards. Hearing before the
Subcommittee on Aging of the Committee on Labor and Human Resources,
United States Senate, 102d Congress, 1992.
9. American College of Radiology/Society of Breast Imaging, ``Breast
Density: Breast Cancer Screening.'' Available at https://www.acr.org/-/media/ACR/Files/Breast-Imaging-Resources/Breast-Density-bro_ACR_SBI.pdf.
10. Institute of Medicine, ``Improving Breast Imaging Quality
Standards.'' May 23, 2005. Available at https://www.nap.edu/read/11308/chapter/1.
11. McCormack, V.A. and I. dos Santos Silva, ``Breast Density and
Parenchymal Patterns as Markers of Breast Cancer Risk: A Meta-
Analysis,'' Cancer Epidemiology, Biomarkers, and Prevention, 2006;
15: 1159-1169.
12. 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.
13. Vachon, C.M., C.H. van Gils, T.A. Sellers, et al.,
``Mammographic Density, Breast Cancer Risk and Risk Prediction,''
Breast Cancer Research, 2007; 9: 217.
14. Gastounioti, A., E.F. Conant, and D. Kontos, ``Beyond Breast
Density: A Review on the Advancing Role of Parenchymal Texture
Analysis in Breast Cancer Risk Assessment,'' Breast Cancer Research,
2016; 18: 19. Available at https://doi.org/10.1186/s13058-016-0755-8.
15. Guterbock, T., W.F. Cohn, D.L. Rexrode, et al. ``What Do Women
Know About Breast Density? Results From a Population Survey of
Virginia Women,'' Journal of the American College of Radiology.
2017; 14: 34-44. Available at https://doi.org/10.1016/j.jacr.2016.07.003.
16. Centers for Disease Control and Prevention, ``What Are the Risk
Factors for Breast Cancer?'' Available at http://www.cdc.gov/cancer/breast/basic_info/risk_factors.htm.
17. Kolb, T.M., J. Lichy, and J.H. Newhouse, ``Comparison of the
Performance of Screening Mammography, Physical Examination, and
Breast US and Evaluation of Factors That Influence Them: An Analysis
of 27,825 Patient Evaluations,'' Radiology, 2002; 225: 165-175.
18. Leconte, I., C. Feger, C. Galant, et al., ``Mammography and
Subsequent Whole-Breast Sonography of Nonpalpable Breast Cancers:
The Importance of Radiologic Breast Density,'' American Journal of
Roentgenology, 2003; 180: 1675-1679.
19. Berg, W.A., J.D. Blume, J.B. Cormack, et al., ``Combined
Screening With Ultrasound and Mammography Compared to Mammography
Alone in Women at Elevated Risk of Breast Cancer of the First-Year
Screen in ACRIN 6666,'' Journal of the American Medical Association,
2008; 299(18); 2151-2163. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2718688/pdf/nihms73151.pdf.
20. U.S. Food and Drug Administration, Public Meeting Materials,
National Mammography Quality Assurance Advisory Committee (NMQAAC)
meeting, 24-Hour Summary, November 4, 2011. Available at https://wayback.archive-it.org/7993/20170404143639/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/NationalMammographyQualityAssuranceAdvisoryCommittee/UCM279484.pdf.
21. Dense Breast Info website. Available at http://densebreast-info.org/legislation.aspx.
22. Transcript of the National Mammography Quality Assurance
Advisory Committee (NMQAAC) meeting, September 28-29, 2006.
Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=636.
23. MQSA Alternative Standard #11, approved on August 29, 2003.
Available at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm259289.htm.
24. MQSA Alternative Standard #12, approved on September 17, 2003.
Available at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm259290.htm.
25. Sickles, E.A., C.J. D'Orsi, L.W. Bassett, et al., ``ACR BI-RADS
Mammography.'' In: ACR BI-RADS Atlas: Breast Imaging Reporting and
Data System, 5th ed., Reston, VA: American College of Radiology, pp.
123-126, 2013.
26. American Cancer Society, ``Breast Density and Your Mammogram
Report.'' Available at https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/mammograms/breast-density-and-your-mammogram-report.html.
27. Ho, J.M., N. Jafferjee, G.M. Covarrubias, et al., ``Dense
Breasts: A Review of Reporting Legislation and Available
Supplemental Screening Options,'' American Journal of Roentgenology,
2014; 203: 449-456.
28. Melnikow, J., J.J. Fenton, E.P. Whitlock, et al., ``Supplemental
Screening for Breast Cancer in Women With Dense Breasts: A
Systematic Review for the U.S. Preventive Services Task Force,''
Annals of Internal Medicine 2016; 164(4): 268-278. Available at
http://annals.org/article.aspx?articleid=2480756.
29. 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.
30. Sickles, E.A. and C.J. D'Orsi, ``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.
31. Sickles, E.A., C.J. D'Orsi, L.W. Bassett, et al., ``ACR BI-RADS
Mammography.'' In: ACR BI-RADS Atlas: Breast Imaging Reporting and
Data System, 5th ed., Reston, VA: American College of Radiology, pp.
7-8, 2013.
32. Analysis of Economic Impacts. Available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
33. U.S. Food and Drug Administration, MQSA National Statistics,
2018. Available at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityScorecard/ucm113858.htm.
34. Eastern Research Group, Inc., ``Baseline Quality Measures of
Screening Mammography and the Impacts of Proposed Revisions to
Regulations Implementing the Mammography Quality Standards Act.''
Final Report, July 19, 2012. (ERG, 2012a).

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. Amend Sec.  900.2 by revising paragraphs (z), (aa)(1) and (2), and
by adding new paragraph (aa)(3) to read as follows:

Sec.  900.2  Definitions.

* * * * *
    (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 and full field digital mammography.
    (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.
* * * * *
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3. Amend Sec.  900.4 by redesignating paragraph (a)(6) as (a)(6)(i) and
by adding new paragraph (a)(6)(ii).
    The addition reads as follows:

Sec.  900.4  Standards for accreditation bodies.

    (a) * * *
    (6)(i) * * *
    (ii) If a facility has failed to become accredited after three
consecutive attempts, an accreditation body shall not accept an
application for accreditation from the facility for a period of 1 year
from the date of the most recent accreditation failure.
* * * * *
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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.
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5. Amend Sec.  900.12 by:
0
a. Revising paragraph (a)(4);
0
b. Adding paragraphs (b)(2)(i) and (ii);
0
c. Revising paragraph (b)(11);
0
d. Adding paragraph (b)(16); and
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e. Revising paragraphs (c)(1) and (2), (c)(3)(ii), (c)(4), (f)(1), and
(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 at least until the next annual inspection has been
completed and FDA has determined that the facility is in compliance
with the MQSA personnel requirements. The facility shall provide copies
of these personnel records to current or former interpreting
physicians, radiologic technologists, and medical physicists upon their
reasonable request. Before a facility closes or ceases to provide
mammography services, it must make arrangements for access by 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.
    (b) * * *
    (2) * * *
    (i) All digital accessory components shall be approved or cleared
by FDA,
    (A) Specifically for mammography or,
    (B) For a use that could include mammography and have the same
equipment specifications as those approved or cleared by FDA
specifically for mammography.
    (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 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:
    (A) ``Negative:'' Nothing to comment upon (if the interpreting
physician is aware of clinical findings or symptoms, despite the
negative assessment, these shall be explained);
    (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 explained);
    (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 Mammograms 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 classifications shall be
assigned as an assessment and reasons why no 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 paragraph (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 paragraph
(c)(1)(iv)(A) through (G) of this section can be given. If this
assessment category is used, a follow up report with an assessment
category identified in paragraph (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 paragraph (c)(1)(vi) 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 but in no case later than 21
calendar days from the date of the mammographic examination.
    (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.
    (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 mammographically or clinically indicated.
    (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 ``Some patients have high breast tissue density (more glands
than fat in the breasts), which makes it harder to find breast cancer
on a mammogram. Your breast tissue density is low, not high. Follow the
recommendations in this letter, and 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 ``Some
patients have high breast tissue density (more glands than fat in the
breasts), which makes it harder to find breast cancer on a mammogram.
Your breast tissue density is high. Some patients with high breast
density may need other imaging tests in addition to mammograms. Follow
the recommendations in this letter, and talk to your healthcare
provider about high breast density and how it relates to breast cancer
risk, 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 7 calendar days of the
final interpretation of the mammograms but in no case later than 14
calendar days from the date of the mammographic examination.
    (4) Recordkeeping. Each facility that performs mammograms:
    (i) Shall (except as provided in paragraph (c)(4)(ii) of this
section) maintain the mammograms and mammography reports in a permanent
medical record of the patient for a period of not less than 5 years, or
not less than 10 years if no additional mammograms of the patient are
performed at the facility, or a longer period if mandated by State or
local law. Facilities shall implement policies and procedures to
minimize the possibility of loss of these records. The 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;
    (iv) Any fee charged to the patients for providing the services in
paragraphs (c)(4)(ii) or (c)(4)(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 her healthcare provider or the transfer of the mammographic
records to a facility or other entity that will provide access to
patients and healthcare providers for the time periods specified in
paragraph (c)(4)(i) of this section. 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 requirements, a
mammographic examination consisting of routine views of an asymptomatic
woman shall be termed a screening mammogram, while a mammographic
examination consisting of individualized views of a woman 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 follow up 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 follow up 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.''
* * * * *
    (j) Additional mammography review and patient and referring
physician 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 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 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 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.
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6. In Sec.  900.14, revise paragraph (a) introductory text and
paragraphs (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 promulgated 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 reasonable 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).
* * * * *

    Dated: March 21, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-05803 Filed 3-27-19; 8:45 am]
 BILLING CODE 4164-01-P