[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Proposed Rules]
[Pages 11669-11686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:

[[Page 11670]]

     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 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on 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: 202-395-7285, or email to 
[email protected]. 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, 301-796-5911.

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)).

[[Page 11671]]

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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[[Page 11672]]

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

[[Page 11673]]

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

[[Page 11674]]

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,

[[Page 11675]]

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

[[Page 11676]]

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

[[Page 11677]]

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

[[Page 11678]]

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

[[Page 11679]]

$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,

[[Page 11680]]

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

[[Page 11681]]

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

[[Page 11682]]

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: 202-395-7285, 
or emailed to [email protected]. 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

[[Page 11683]]

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

[[Page 11684]]

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


Sec.  900.11  Requirements for certification.

* * * * *
    (c) * * *
    (4) If a facility's certificate was revoked on the basis of an act 
described in 42 U.S.C. 263b(i)(1), as implemented by Sec.  900.14(a), 
no person who owned or operated that facility at the time the act 
occurred may own or operate a mammography facility within 2 years of 
the date of revocation.
0
5. 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
0
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

[[Page 11685]]

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

[[Page 11686]]

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.
0
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