[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14856-14870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7829]
[[Page 14855]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 900
Mammography Quality Standards; Proposed Rules
Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 /
Proposed Rules
[[Page 14856]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0192]
RIN 0910-AA24
Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its interim regulations issued under the Mammography Quality Standards
Act of 1992 (the MQSA). In addition, FDA is also setting forth ideas
for the application of alternative performance and outcome-based
standards to ensure quality mammography. FDA is soliciting comments on
these alternatives as possible ways of meeting the objectives of
Executive Order 12866, which requires Federal agencies to, where
feasible, specify performance objectives, rather than specifying the
behavior and manner of compliance and to avoid duplicative regulations.
Elsewhere in this issue of the Federal Register, FDA is proposing
amendments to the requirements for accreditation bodies, procedures for
facility certification and quality standards for mammography personnel,
equipment and practices, including quality assurance. These actions are
being taken to ensure adequate and consistent evaluation of mammography
facilities on a nationwide basis.
DATES: Written comments on the proposed rule by July 2, 1996. Written
comments on the information collections should be submitted by May 3,
1996.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collections to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), New Executive Office Building, 725 17th St. NW., rm.
10235, Washington DC 20503, ATTN: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. General Preamble
The MQSA (Pub. L. 102-539) was passed on October 27, 1992, to
establish national quality standards for mammography. The MQSA required
that, to provide mammography services legally after October 1, 1994,
all facilities, except facilities of the Department of Veterans
Affairs, be accredited by an approved accreditation body and certified
by the Secretary of Health and Human Services (the Secretary). The
authority to approve accreditation bodies and to certify facilities was
delegated by the Secretary to FDA.
The MQSA was enacted in response to the growing incidence of breast
cancer and its associated mortality rate. Breast cancer is now the most
common nonskin cancer and is the second leading cause of cancer deaths
among women, after lung cancer. The American Cancer Society projects
that in 1995 there will be 180,000 new cases of breast cancer among
women in the United States (Ref. 1). Of these new cases, it is
estimated that approximately 46,000 of these women will die from the
disease. The lifetime risk of developing breast cancer is increasing.
In 1993, breast cancer was projected to affect 1 in 8 women in their
lifetime, as compared to 1 in 11 in 1980, 1 in 14 in 1960, and 1 in 20
in 1940 (Ref. 2).
Early detection of breast cancer, typically involving breast
physical examination and mammography, is the best means of preventing
deaths that can result when the diagnosis is delayed until the onset of
more advanced symptoms. The value of undergoing screening mammography
is that it can detect cancers that are asymptomatic. Mammograms can
reveal breast cancer up to 2 years before a woman or her doctor can
feel a lump. In addition, over 90 percent of these early stage cancers
can be cured (Ref. 3).
However, according to the General Accounting Office, a mammogram is
among the most difficult radiographic images to read. It must be of
high quality for the image to be interpreted correctly. If the image
quality is poor, the interpreter may miss an incipient cancerous
lesion. This false negative diagnosis could delay early treatment and
result in an avoidable death or mastectomy. Further, it is equally true
that poor quality images or faulty interpretations can lead to a false
positive diagnosis when normal tissue is misread as abnormal. This can
lead to needless anxiety for the examinee, costly additional testing,
and painful biopsies.
The Senate Committee on Labor and Human Resources held hearings on
breast cancer in 1992 and found a wide range of problems with
mammography practice in the United States: (1) Poor quality equipment,
(2) a lack of quality assurance procedures, (3) poorly trained
radiologic technologists and interpreting physicians, and (4) a lack of
facility inspections or consistent governmental oversight.
A. Provisions of the MQSA
The MQSA legislation was enacted to address these deficiencies in
mammography practice. Under the MQSA, Congress established a
comprehensive statutory scheme for the certification and inspection of
mammography facilities to ensure that, after October 1, 1994, only
those facilities that comply with minimum Federal standards for safe,
high-quality mammography services may lawfully continue to operate.
Operation after that date is contingent on receipt of an FDA
certificate attesting that the facility meets the minimum mammography
quality standards issued under section 354(f) of the Public Health
Service Act (the PHS Act)(42 U.S.C. 263b(f)). These standards are
intended to apply equally to screening and diagnostic mammography.
Specifically, the MQSA required the following:
(1) Accreditation of mammography facilities by private, nonprofit
organizations or State agencies that have met the standards established
by FDA for accreditation bodies and have been approved by FDA. The MQSA
requires a direct Federal audit of the accreditation bodies through
facility inspections by Federal inspectors. It also requires that, as
part of the overall accreditation process, actual clinical mammograms
from each facility be evaluated for quality by the accreditation body.
(2) An annual mammography facility physics survey, consultation,
and evaluation performed by a qualified medical physicist.
(3) Annual inspection of mammography facilities, to be performed by
FDA-certified Federal or
[[Page 14857]]
State inspectors. 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.
(4) Establishment of initial and continuing qualification standards
for interpreting physicians, radiologic technologists, medical
physicists, and mammography facility inspectors.
(5) Specification of boards or organizations eligible to certify
the adequacy of training and experience of mammography personnel.
(6) Establishment of quality standards for mammography equipment
and practices, including quality assurance and quality control
programs.
(7) Establishment by the Secretary of a National Mammography
Quality Assurance Advisory Committee (NMQAAC). Among other things, the
NMQAAC is required to advise FDA on appropriate quality standards for
mammography facilities and accreditation bodies.
(8) Standards governing recordkeeping for examinee files and
requirements for mammography reporting and examinee notification by
physicians.
The MQSA replaced a patchwork of Federal, State, and private
standards in order to guarantee sufficient oversight of mammography
facilities to ensure that all women nationwide will receive high
quality mammography services.
B. Interim Regulations
On December 14, 1993, the President signed legislation (H. Rept.
2202) granting interim rule authority to the Secretary (and by
delegation, to FDA) to issue interim quality standards under MQSA. This
authorization was provided in recognition of the fact that FDA
certification of the over 10,000 mammography facilities in the United
States could not be accomplished by the October 1, 1994, statutory
deadline without streamlining the rulemaking process for issuing the
initial standards. Because of the urgent public health need for
national mammography standards, Congress decided to grant this interim
rule authority rather than extend the deadline to develop standards.
Under the interim rule legislation, FDA was authorized to issue
temporary interim regulations setting forth standards for approving
accreditation bodies and quality standards for mammography facilities.
Under the abbreviated process, Congress expected FDA to adopt
existing standards to the maximum extent feasible, such as those
established by the Health Care Financing Administration (HCFA), private
voluntary accreditation bodies such as the American College of
Radiology (ACR), and some States. The Secretary was not required to
consult with the NMQAAC in developing the interim regulations. However,
following issuance of the interim standards, Congress intended that FDA
proceed with the more extensive rulemaking procedures envisioned under
the MQSA, including consultation with the NMQAAC.
In the Federal Register of December 21, 1993 (58 FR 67558 and 58 FR
67565), FDA issued interim rules establishing requirements for entities
applying to serve as accreditation bodies and for facilities applying
to obtain FDA certification in order to continue legally providing
mammography services after October 1, 1994. These interim rules became
effective on February 22, 1994. They were amended by another interim
rule published in the Federal Register on September 30, 1994 (59 FR
49808).
There are several reasons why it is important to replace the
existing interim regulations on quality mammography standards with more
comprehensive final regulations, apart from strong congressional
encouragement for such action when the agency was granted interim
regulation authority. In a 1995 report by the Physician Insurers
Association of America, misdiagnosis of breast cancer remains the most
common charge against radiologists in malpractice situations. In
addition, there was considerable variation in clinical performance of
mammography facilities in 1992 and 1993 despite compliance with
existing voluntary accreditation standards that were similar to the
interim regulations published by FDA (Ref. 4). FDA believes that more
comprehensive final regulations would optimize facility performance.
The interim regulations, for reasons stated above, were based
primarily upon the voluntary standards of the American College of
Radiology (ACR) Mammography Accreditation Program (MAP). Applying these
standards to all facilities has had a significant impact on mammography
nationwide but evaluations of the ACR program (Ref. 5) have shown that
further improvement is possible through more comprehensive standards
than those of MAP.
This is especially true in the equipment area where the MAP
standards were minimal and where the FDA's authority under the Medical
Device Amendments to the Food, Drug, and Cosmetic Act is limited
because presently used mammography systems are pre-amendment devices.
To provide greater assurances of quality equipment performance (and to
meet a priority identified in ``The National Strategic Plan for the
Early Detection of Breast and Cervical Cancers'' (Ref. 7), the ACR,
with the Centers for Disease Control and Prevention had convened expert
committees to develop specifications for mammography equipment. The
reports of these expert committees were an important basis for the
equipment provisions in the proposed regulations.
Other portions of the proposed regulations, such as those providing
standards for imaging patients with breast implants, are required by
the MQSA. In addition, some of the details contained in the proposed
regulations, such as requirements to ensure that personnel have
practical training on equipment they use, reflect areas of concern that
were inadvertently neglected in the interim regulations.
For all of these reasons, therefore, it is necessary to replace the
interim regulations with more comprehensive final regulations if the
highest quality mammography that is reasonably achievable is to be
obtained.
In issuing the interim regulations, FDA attempted to balance the
pressing need to put national mammography standards into effect with
the agency's concern that facilities be provided a reasonable amount of
time to comply with these standards. The interim regulations were
drafted and implemented to maximize lawful operation by facilities
under existing quality standards, and to ensure adequate examinee
access to quality mammography during the transition to more
comprehensive national standards.
For example, the ACR, a private, nonprofit association of
radiologists, began a voluntary Mammography Accreditation Program (MAP)
in 1987 to provide assurance of quality to examinees seeking services
at ACR-accredited facilities. Many of the requirements under the
interim rules were derived from the ACR's MAP program, as well as from
HCFA regulations and some State programs. The MAP included a number of
procedural and image quality requirements for facilities applying for
ACR accreditation, including an evaluation of actual clinical images
produced by each facility. In the absence of a national regulatory
requirement, only those facilities that voluntarily sought
accreditation pursued the ACR accreditation process. Nevertheless, many
mammography facilities applied for and obtained ACR accreditation.
Historically, approximately 30 percent of the facilities that applied
for ACR
[[Page 14858]]
accreditation failed to become accredited on their first attempt,
although many of these were subsequently able to improve their services
and gain accreditation on a second attempt.
C. Accreditation and Certification
Before the October 1, 1994, statutory deadline, FDA approved the
ACR and the State of Iowa as accreditation bodies and issued
certificates to the more than 6,000 facilities (out of an estimated
total of 10,666 facilities in the United States) accredited by these
bodies. The States of Arkansas and California were also approved by FDA
as accreditation bodies and began accrediting mammography facilities
within their States after the statutory deadline. These facilities were
subsequently certified by FDA.
In addition, the MQSA permitted FDA to issue 6-month provisional
certificates to facilities whose applications for accreditation had not
been approved by the statutory deadline but were sufficiently complete
to be accepted for review by an FDA-approved accreditation body. The
statute also allowed FDA to extend a facility's provisional certificate
once, for up to 90 days, if: (1) The owner, lessor, or agent of the
facility could demonstrate that, without such an extension, access to
mammography in the geographic area served by the facility would be
significantly reduced; and (2) the owner, lessor, or agent described in
a report the steps that would be taken to qualify for full
certification (42 U.S.C. 263b(c)(2)).
In recognition of the fact that a large number of facilities were
working to meet accreditation standards at the same time, and cognizant
of the increased demands placed on accreditation bodies during the
initial implementation of the MQSA, FDA issued 6-month provisional
certificates on October 1, 1994, to facilities whose applications for
accreditation were sufficiently complete for review and which, on
preliminary examination, appeared reasonably likely to receive
accreditation. These 6-month provisional certificates were extendable
for an additional 90 days for those facilities that satisfied the
extension criteria under the statute (42 U.S.C. 263b(c)(2)) and had
diligently pursued accreditation, but had not yet completed all aspects
of the accreditation process before expiration of their provisional
certificate.
Of the more than 10,000 facilities that provide mammography
services in the United States, the vast majority have received full
accreditation and certification. By October 1, 1994, FDA had issued
approximately 6,000 certificates and 4,800 provisional certificates.
Moreover, over 50 percent of those facilities issued provisional
certificates on October 1, 1994, subsequently became accredited and
FDA-certified by March 31, 1994, which was the closing date for the 6-
month provisional period. The remainder of the provisionally certified
facilities satisfied the extension criteria and were granted a 90-day
extension to obtain accreditation and certification.
The agency estimates that 427 mammography facilities closed between
October 1993 and October 1994. These closings were due to a number of
reasons, including failure to apply for certification, voluntary
closure, and failure to successfully complete the accreditation
process. By April 26, 1995, 4 weeks after the end of the 6-month
provisional period, 153 additional facilities had to close either
because they did not pursue accreditation (57 facilities) or they
failed accreditation (96 facilities). Sometime during the 6-month
provisional certification period, 187 facilities voluntarily withdrew
from the accreditation process.
D. Onsite Inspection of Facilities
In accordance with the MQSA, FDA established an annual onsite
inspection program to monitor facility compliance with MQSA standards.
FDA has trained and certified inspectors from most States, and
inspection of mammography facilities began in January 1995. As of
February 21, 1996, 7,265 inspections had been conducted and the results
have been reported to the agency.
E. Role of the States
The MQSA explicitly states that nothing in the statute is intended
to limit the authority of any State to enact State laws relating to
mammography that are at least as stringent as the MQSA or regulations
under the MQSA (42 U.S.C. 263b(m)). In addition to ensuring that States
retain their authority to pass laws that raise mammography standards
even higher, Congress provided a significant role for States to play in
implementing the regulatory scheme and nationwide standards required by
the MQSA.
A State may apply to FDA to become an accreditation body to
accredit mammography facilities operating within the State. As earlier
described, three States--Iowa, California, and Arkansas--have been
approved to accredit the facilities operating within their respective
jurisdictions. A State also may apply to the agency to become the
certifying authority for mammography facilities operating within its
borders (42 U.S.C 263b(q)). The agency currently is conducting research
into various alternatives that would allow States to fulfill this role.
The statute also permits States to perform annual onsite facility
inspections to ensure that facilities operating within the State are
performing quality mammography (42 U.S.C 263b(g)). To date, the
District of Columbia, Puerto Rico, New York City, and all of the
States, except New Mexico, have negotiated contracts with the agency to
perform these annual inspections.
Facilities located in States that elect to serve as accreditation
bodies may elect to be accredited either by the State or the ACR, a
private national approved accreditation body. Both types of
accreditation bodies are audited by FDA to ensure that MQSA standards
are being satisfied.
As mentioned above, most States contract with FDA to perform the
annual inspection required under MQSA. These inspections are subject to
audit by FDA. In those cases where States do not do the inspection,
Federal personnel conduct the required annual inspection.
States' participation and implementation of MQSA is funded in a
variety of ways. Because the MQSA provides for but does not mandate a
particular level of State involvement in the mammography program, a
State can choose to participate at a level that does not require the
appropriation or expenditure of State funds. States acting as
accreditation bodies may charge and collect a reasonable fee from the
facilities which seek the States' accreditation. States that currently
participate in the annual onsite inspection of facilities are paid by
FDA through contract. The agency charges the facilities a reasonable
inspection fee for this service in accordance with 42 U.S.C 263b(r).
Once the agency issues provisions to permit States to serve as
certifiers of mammography facilities, MQSA requires States that elect
voluntarily to serve in this capacity to devote adequate funds to the
administration and enforcement of MQSA requirements.
F. Development of Proposed Regulations
Coincident with the implementation of the interim rules, work was
proceeding on the development of proposed regulations to replace the
interim rules. As discussed previously, the MQSA established an
advisory committee (NMQAAC) to advise FDA in this effort. By statute,
the NMQAAC is to consist of 13 to 19 members, including health
professionals whose work focused significantly on
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mammography, as well as representatives of consumer groups. The NMQAAC
was chartered on July 7, 1993. Nominations for members were accepted
until September 7, 1993. The first meeting of the NMQAAC was held
February 17 through 18, 1994. At that meeting, and in subsequent
meetings in April, July, and September 1994, the NMQAAC reviewed and
commented on drafts of portions of the proposed regulations developed
by FDA. At its January, 1995 meeting, the NMQAAC reviewed the entire
body of proposed regulations as then drafted. Many of the requirements
in the proposed regulations are based on advice obtained from the
NMQAAC during these meetings.
G. Framework of Proposed Regulations
FDA is issuing five separate proposed rules to amend the interim
regulations. All of these proposals are published in this issue of the
Federal Register. The first proposed rule as set forth below, contains
background information (given above), a summary of the preliminary
analysis of the costs and benefits of the proposed amendments to 21 CFR
part 900, a description of the information collection requirements,
proposed revisions to Secs. 900.1 Scope (21 CFR 900.1) and 900.2
Definitions (21 CFR 900.2), and proposed alternative approaches to
mammography quality standards and a request for comments on the
proposed alternatives. The other four proposals set forth requirements
related to: (1) Accreditation bodies; (2) general facility
requirements, including requirements for a medical reporting and
recordkeeping program, a medical outcomes audit program, special
methods for examining individuals with breast implants, a consumer
complaint mechanism, and a variance procedure for requesting FDA
approval of alternative standards; (3) personnel requirements for
interpreting physicians, radiologic technologists, and medical
physicists; and (4) definitions, mammography equipment standards, and
quality assurance requirements for mammography equipment.
The agency believes that the proposed amendments, when implemented,
will increase the quality of mammography nationwide and facilitate the
early diagnosis and treatment of breast cancer or other diseases of the
breast.
In drafting the proposed regulations, and in consultation with the
NMQAAC, FDA has established specific requirements for those areas that
the agency believes are essential to the practice of quality
mammography. Conversely, in those areas where the agency is aware of
multiple methods or procedures for effectively accomplishing the same
task, the proposed requirements have been drafted in more general
terms, to give facilities more flexibility to accomplish a particular
quality practice. In some cases, FDA will provide guidance documents
that explain methods and practices that the agency recommends, based on
its current thinking, but does not require by regulation.
The rules that are developed and finalized as a result of this
rulemaking will replace the interim rules issued on December 21, 1993.
The interim rules will continue to apply until final rules become
effective.
II. Alternative Approaches for Quality Mammography
Executive Order 12866 requires Federal agencies to identify and
assess alternative forms of regulation and, where feasible, specify
performance objectives, rather than specifying the behavior and manner
of compliance that regulated entities must adopt (E.O. 12866, Section
1(b)(8)). In addition, Executive Order 12866 (Section 1(b)(10))
requires each agency to avoid regulations that duplicate other
regulations. In proposing final standards, FDA is aware that there can
be alternative means for ensuring quality mammography other than
through those presented in these proposals. FDA notes that the MQSA
itself establishes many overlapping requirements relating to quality
mammography which are reflected in the proposed final regulations. FDA
also recognizes that many of the proposed final regulations contain
design specifications, training and educational requirements, and
process requirements, rather than performance or outcomes standards. In
order to meet objectives established by the Executive Order 12866, FDA
is soliciting comments on the following alternative approaches to
achieve quality mammography under the MQSA. FDA encourages comments on
these alternative approaches to be as detailed as possible. Comments
that address and describe the application of specific performance or
outcomes standards will be most useful in the event the agency is
persuaded that this alternative is the more desirable approach.
Overlapping functions for facilities, accreditation bodies, and FDA
have advantages and disadvantages. As an example, under section
354(e)(1)(B)(v) of the Public Health Service Act (PHS Act) (42 U.S.C.
263b(e)(1)(B)(v)), as amended by the MQSA, the accreditation body is
required to perform monitoring and evaluation of medical physicists'
annual surveys. At the same time, under section 354(g)(1)(B)(v) of the
PHS Act, the MQSA requires FDA to annually inspect facility compliance
with quality standards, including compliance with the section of the
MQSA that requires each facility to have a qualified medical physicist
annually survey mammography equipment (42 U.S.C. 263b(f)(1)(F)). In
this instance, therefore, annual physicist surveys are being reviewed
by both the accreditation body and the inspector. FDA's experience
under the interim final regulations is that of 7,431 MQSA inspections
in 1995, only 5 accredited facilities were without annual physicist
surveys. This suggests that duplicative review serves a compliance
purpose. However, it may be possible under a different approach for the
accreditation body to accept inspection reviews of surveys, or, for
inspectors to accept an accreditation body's review of a facility's
survey. While there are strengths in a program that has multiple checks
and overlapping areas of responsibility to ensure compliance, there are
also cost and resource considerations that may favor alternative
approaches to satisfy statutory mandates. Such alternative approaches
will need to adequately ensure integrity of the evaluation if oversight
mechanisms are decreased. FDA is soliciting comments on approaches that
would reduce the overlapping nature of many quality assurance
provisions proposed, while maintaining assurances for integrity of the
evaluation.
Advantages and disadvantages exist in adopting an approach that
utilizes detailed design and qualification-based standards versus an
approach based on performance standards and outcomes measures. For
example, detailed design and behavior-based standards may be clear and
precise; they can provide an objective evaluation of compliance during
an inspection and make clear to facilities what is expected of them.
However, these standards can limit flexibility and innovation and do
not ensure that everyone who meets the established criteria is indeed
competent. On the other hand, performance standards and outcome
measures may allow greater variability in behavior and methods of
compliance. However, while outcome measures may reflect the true nature
of performance in a population and be an incentive to good performance,
they may also be subject to adjustments to circumvent low performance.
FDA is soliciting comments on the possibility of pursuing
[[Page 14860]]
quality mammography through more performance and outcome-based
standards. FDA would also like comments on the anticipated economic
consequences of this approach compared to the approach of the proposed
regulations. FDA hopes the comments will provide more information
regarding the short and long-term viability of this alternative
approach for purposes of mammography regulation.
The following sections discuss ideas for the application of
performance and outcome-based standards to mammography facility
operations:
A. Mammography Equipment and Quality Control
Under current proposals, FDA has specified mammography equipment
performance and design requirements. While design specifications are
clear, they may inadvertently impede technical innovation. An
alternative proposal would be to use phantom image testing as a
complete equipment system test, thereby eliminating the need for other
specific quality control tests, or, permitting those other tests to be
conducted less frequently. The phantom image test is currently being
proposed to be done weekly as a part of the facility's ongoing quality
assurance program. The current phantom used, however, is not the
optimal design if phantom image testing were to serve as a single
system performance evaluation criterion. A recent article (Ref. 8)
suggested that the current phantom has limitations in simulating the
average breast. Research may be necessary to design a phantom whose
image will be significantly affected by enough characteristics of the
system so that other tests could be eliminated.
Another issue associated with the use of phantom image testing as a
single system evaluation test is that there is inadequate information
available on how phantom images correlate with actual clinical images.
There is concern that no phantom image evaluation will adequately
predict the clarity and characteristics of the entire biologic spectrum
of breast tissue.
FDA believes it is theoretically possible to substitute phantom
image testing for some equipment requirements and some quality control
tests if some other standards were made more stringent and the phantom
were suitable. For example, the frequency of phantom image testing
might be increased to daily if the backing material could be changed to
be more tissue equivalent, if different thicknesses could be developed
to represent the range of actual breast thicknesses encountered in
daily practice, and if research established appropriate performance
parameters based on these changes. A step wedge might be included in
the design of the phantom so that, after a trial period, daily
sensitometry could be eliminated. It may be necessary to record the mAs
value daily, so that when deviations occur, it would be possible to
determine if it was an x-ray machine variation or film processor
variation. Ideally, this image test would be combined with a dose
measurement, at least periodically, so that an even more complete
system test would be conducted.
Another possible performance measure for equipment and substitute
for equipment specifications and quality control tests is an ongoing
analysis of a facility's repeat rate. Under both the interim final
regulations and the proposed final regulations set forth elsewhere in
this issue of the Federal Register, the repeat rate is to be analyzed
every 3 months, and up to 250 exams are used. Ongoing repeat analysis
might substitute for some quality control tests, equipment
requirements, and technologist requirements. Using the repeat rate as a
performance outcome might be appropriate if repeat analysis were
conducted continuously, rather than periodically, if personnel were
trained to evaluate the films according to the criteria currently used
by accreditation bodies for clinical image review, and if trends or
problems were identified and corrected immediately. One potential
problem with this approach is that the repeat rate is easily altered by
a facility through the acceptance of all examinations of any quality
performed. Thus, a facility could conceivably have a zero repeat rate,
but many problems. Adopting use of repeat rates as a performance
measure would require the development of mechanisms to minimize this
type of manipulation.
B. Mammography Personnel: The Interpreting Physician and the Medical
Audit
Under the current proposal for final standards, interpreting
physicians would be required to meet initial qualifications through
board certification or training, mammography-specific training and
experience, and continuing education and experience requirements. While
these requirements for training and experience guarantee familiarity
with mammography and interpretation issues, it is possible that
interpretation performance can be less than optimal despite meeting
these requirements. An alternative means to ensuring the MQSA's mandate
of ``* * * quality assurance * * * at each facility that is adequate
and appropriate to ensure the reliability, clarity, and accuracy of
interpretation of mammograms * * *'' (42 U.S.C. 263b(A)(1)(A)) may be
to use performance-based standards.
The use of specific medical outcomes measures is discussed in the
proposal entitled ``Quality Standards and Certification Requirements
for Mammography Facilities; General Facility Requirements'', published
elsewhere in this issue of the Federal Register. FDA recognizes the
significant cost and effort associated with tracking examinations
interpreted as nonmalignant. While the absence of cancer registries in
many locales limits the feasibility of collecting many outcomes
measures, those locales with cancer registries may be able to collect
data on sensitivity and specificity. These locales might be able to
forego compliance with all or some of the proposed personnel
qualifications so long as sensitivity and specificity for screening
mammography, or other measures such as minimal cancer detection rates,
were within an acceptable range, e.g., the Agency for Health Care and
Policy Research guidelines. These ranges may have to be refined using
other data from recently published practice patterns, clinical trials,
and information from the National Cancer Institute's Breast Cancer
Consortium studies. In order to be valid, facilities would have to
track other variables of the screening clientele that could affect
sensitivity and specificity such as age and other parameters that are
currently being identified through research. This data collection,
while time-consuming, would enhance the validity of calculated
statistics.
In areas without cancer registries, positive predictive value may
be calculated to assist in ensuring appropriateness and accuracy of
physician recommendations. FDA notes that there is not yet a consensus
on what ranges of the positive predictive value are acceptable, and
that this value is subject to intentional adjustment by practices in
the facility. However, use of the positive predictive value coupled
with indices of early detection, such as sizes of cancers detected,
could reduce concerns about intentional manipulation of data and
provide a useful measure of an individual physician's comparative
performance from year to year.
FDA recognizes concerns raised by the NMQAAC about public
disclosure of statistics, including issues of legal liability and
public confusion over the meaning and limitations of statistics.
[[Page 14861]]
The agency believes that data generated and reviewed for mammography
audits should be used internally by each facility to improve individual
and group performance. The agency further recognizes that State laws
with respect to medical audit information vary and may not prevent
disclosure in State courts through discovery or other procedures
established by State law. However, concerns raised about public
disclosure of statistics and consumers not understanding their
limitations could be addressed through active consumer education to
assist consumers in analyzing information and making health care
decisions. A recent summary of the New York State experience with
public reporting of cardiovascular surgery mortality outcomes showed
improved risk-adjusted operative mortality beyond what was expected
using nationwide trends for adjustment. The summary states that the
collection data on mortality and reporting risk-adjusted mortality
rates to hospitals and physicians contributed to improved outcomes
(Ref. 9).
Finally, FDA is aware that substantial differences in statistics
can arise from differences in definitions of screening mammography.
Under an outcomes measurement approach, it might be necessary for the
agency to define the precise situations that would constitute
screening. For example, a woman with implants might have a diagnostic
mammogram, meaning the procedure was under the direct supervision of an
interpreting physician and consisted of more than standard mediolateral
oblique/craniocaudal views. However, this woman's mammogram
interpretation and her medical outcome might be classified by FDA as
screening for statistical calculations if she was asymptomatic at the
time of the examination. Thus, choosing to use outcomes measures could
require the agency to establish certain definitions of medical
practice.
Another alternative to proposed training and experience regulations
is to have interpreting physicians undergo proficiency testing on
mammogram interpretation. While the establishment of such tests and
their periodic administration would be challenging, this testing,
perhaps administered through the accreditation bodies, would allow for
direct assessment of mammography interpretive skills. Remedial programs
and reassessments would have to be established as well. FDA is aware of
the ACR's Committee on Mammography Interpretive Skills Assessment
(COMISA), created in 1992. COMISA is charged with development of an
educational examination tool. Experiences gained through this project
could be used for development of a proficiency test.
It is possible that regulations for interpreting physician
qualifications could include all three options: Training and experience
requirements, medical outcomes audit statistics and acceptable ranges,
and an option for periodic proficiency testing, or some combination
allowing for choice of compliance option. Again, FDA solicits comments
on the utility and advisability of this approach.
C. Mammography Personnel: The Radiologic Technologist
Under the current proposal for final standards, radiologic
technologists would be required to meet initial qualifications through
board certification or training, mammography-specific training and
experience, and continuing education and experience requirements. While
these requirements for training and experience guarantee familiarity
with the performance of mammograms and mammography issues, it is
possible that the technologist's own performance can be less than
optimal despite meeting these requirements. An alternative means to
ensure proper mammography performance is to consider using clinical
image review as a performance assessment tool. Clinical image review of
a sufficient number of mammograms performed by the radiologic
technologist would provide information on compression, positioning,
selection of adequate technique factors, and production of clear and
reliable mammograms. This assessment would have to control for
equipment performance and processing in order for it to be a true
measure of technologist performance. This could perhaps be accomplished
through appropriate daily phantom imaging as discussed above. In
addition, the method for selection of mammograms would have to be
carefully defined to allow for representative sampling of technologist
performance given differences in patients' habitus, breast morphology,
and cooperativeness with the procedure. The assessment would also have
to be correlated with repeat rate. It would be undesirable for the
technologist to achieve a high level of clinical image quality at the
cost of a high repeat rate.
As with interpreting physicians, the development of a technologist
proficiency test that would include a practical examination could also
be viewed as a performance-based measure. Currently, the ARRT's
certification in mammography only includes a written examination.
Expansion of this to include a practical examination along with
periodic recertification examinations would increase the viability of
ensuring competency in mammographic procedures.
D. Mammography Personnel: The Mammography Medical Physicist
Under the current proposal for final standards, medical physicists
must be either board certified in an appropriate specialty or State
approved, and, in addition, meet education and experience requirements.
While these requirements are meant to ensure knowledge and experience
in surveying and overseeing mammography machines and quality control,
they do not necessarily ensure good performance. Alternative
performance measures would include the development of a written
examination along with a practical survey test. The survey test, while
most reflective of actual practice, still could not test for all
possible situations a medical physicist is called upon to deal with at
facilities. It would be necessary to have this proficiency test
repeated periodically, requiring the development of new logistic and
administrative procedures. If this approach were adopted, the
practicing medical physicist's actual performance outside of the
testing environment still must be correlated to test performance.
Development of an accurate and predictive tool would require adequate
resources.
E. Request for Comments
FDA is interested in comments on the desirability of any of the
approaches described above, and on any other possible approaches that
would address the issue of performance-based standards. If performance-
based standards are considered desirable, there may be need for
additional research to provide information to make scientifically sound
and cost effective performance based standards. There are several
options as to how the agency could proceed while such research is being
performed. The agency could leave the interim final standards in place,
or, the agency could make minor amendments to the interim final
standards to clarify points but not add any new requirements, or, the
agency could proceed with final implementation of the set of standards
contained in this proposal as modified after consideration of the
comments. FDA invites comment on the pursuit of any of these or other
options.
[[Page 14862]]
III. Scope and Definitions
A. Scope
Proposed Sec. 900.1 summarizes the scope of part 900 (21 CFR part
900), which contains two subparts implementing different sections of 42
U.S.C. 263b. Subpart A of part 900 establishes application procedures
and requirements for accreditation bodies. Subpart B of part 900
establishes procedures for mammography facility certification and
quality standards for mammography facilities. The proposed requirements
for subpart B of part 900 are published elsewhere in this issue of the
Federal Register.
B. Definitions
FDA is proposing amendments and additions to the definitions
established in Sec. 900.2 of the interim regulations. These proposed
definitions apply to the regulations in this proposal and in the other
MQSA proposals published elsewhere in this issue of the Federal
Register.
1. Amendments
a. Mammography. The amendments to the interim regulations published
in the Federal Register of September 30, 1994 (59 FR 49808), added
definitions of ``screening mammography'' and ``diagnostic mammography''
to clarify the applicability of the interim regulations to various
types of facilities. However, differences of opinion within the
professional community regarding the distinction between these two
types of mammography became apparent in discussions between NMQAAC
members and consultants at the January 1995 NMQAAC meeting. In
addition, proposed changes to the interim regulations have made it
unnecessary to define screening and diagnostic mammography for the
purpose of these regulations. Therefore, FDA is proposing to delete
these two definitions. The reference to screening and diagnostic
mammography previously included in the interim definition of
``interpreting physician'' also would be deleted.
The definitions of screening and diagnostic mammography were
intended to clarify which breast cancer screening or diagnostic
mammography activities conducted by a facility were exempt from the
MQSA regulations. Such exempted activities included any breast imaging
conducted in a research setting as part of a scientific study to
evaluate experimental mammography devices, in accordance with FDA's
investigational device exemption regulations (21 CFR part 812). This
exclusion did not apply to mammography conducted using any conventional
mammography device as part of the scientific study to provide baseline
data for evaluating the safety and efficacy of the experimental device.
An exemption was also made for interventional mammography, which
involves the use of breast radiography devices to produce radiographic
images of the breast in association with localization or biopsy
procedures.
These exemptions were based on FDA's belief that science had not
advanced to the point where effective national quality standards could
be developed for these devices. Because FDA still believes this to be
the case, the agency is proposing to retain these exemptions, but to
incorporate them into the proposed definition of ``mammography.''
Eventually, FDA does expect to develop standards for interventional
mammography devices and for research devices that come into standard
use.
b. Interpreting physician. Throughout the MQSA regulations, FDA is
proposing to use only the term ``interpreting physician'' to refer to
persons who interpret mammograms or perform clinical image reviews.
Therefore, the agency is deleting the interim definition for
``qualified practicing physician.'' Also, as discussed previously, the
term ``interpreting physician'' would be modified to refer to
mammography, rather than screening and diagnostic mammography.
c. Patient. In the interim regulations, the term ``patient'' is
used to mean any individual who undergoes clinical evaluation in a
mammography facility, regardless of whether the person is referred by a
physician or self-referred. However, most individuals who undergo
mammography are not ill and do not have a condition requiring medical
care. Therefore, FDA is proposing to substitute the term ``examinee''
for the term ``patient.''
2. New Definitions
a. Personnel qualifications. During implementation of the interim
regulations, questions were raised concerning how physicians,
technologists, or physicists in training, who had not satisfied the
personnel requirements by October 1, 1994, or who failed to maintain
them after October 1, 1994, might establish or reestablish their
credentials. In response to these concerns, FDA is proposing amendments
(published elsewhere in this issue of the Federal Register) to the
personnel requirements in Sec. 900.12(a) (21 CFR 900.12(a)). For the
purpose of implementing these provisions, FDA is proposing to add
definitions of ``contact hour,'' ``direct instruction,'' and ``direct
supervision.'' The intent of these definitions is to clarify that: (1)
The individuals providing training to mammography personnel must be in
contact with the trainees, at least to the extent of evaluating their
work; and (2) those who are supervising the trainees must be available
to review, and, if necessary, correct the trainees' work.
The proposed revisions to Sec. 900.12(a) also would ensure that
individuals trained in the use, survey, or interpretation of images
produced using one modality do not begin work using another modality
without first receiving training related to that modality. The addition
of this requirement made it necessary to define the term ``modality.''
FDA is proposing to define this as a form of technology, within the
scope of the MQSA, for performing radiography of the breast. The
technologies considered to be modalities under this proposed definition
would include existing technologies, such as screen-film systems and
xeromammography, and any future technologies within the scope of the
MQSA. Technologies such as ultrasound that are used to image breast
tissue but do not fall within the scope of the MQSA would not be
considered modalities for the purpose of this proposed rule.
Under the interim regulations, interpreting physicians are allowed
to use double reading to meet the initial and continuing experience
requirements for physicians. The proposed requirements would permit
this practice to continue. However, because there was some confusion
over the meaning of the term, FDA is proposing to add a definition of
``double reading.''
A major concern of the NMQAAC was to make sure that the initial
experience requirement for interpreting physicians did not cause
problems for diagnostic residency programs that schedule the
mammography rotations in the first 6 months of the final year. At the
same time, it was considered important that interpreting physicians
meet this requirement in a relatively short time before beginning to
interpret mammograms independently. To meet both goals, FDA is
proposing (elsewhere in this issue of the Federal Register) to require
residents to become certified at the ``first allowable time'' if they
want to use residency training to meet the initial experience
requirement. Therefore, a definition of the term ``first allowable
time'' has been added to the proposed regulations.
The interim requirements in Sec. 900.12(a)(3) deal specifically
with the qualifications of the medical physicist.
[[Page 14863]]
The interim regulation refers to requirements for degree programs in
``physical science.'' This term can cover a broad spectrum of
scientific disciplines, some of which are unrelated to the knowledge
and skills needed for mammography. For this reason, a narrower
definition of physical science is needed (with respect to both
bachelor's and advanced degrees). FDA is proposing that only physics,
chemistry, radiation science (including medical physics and health
physics), and engineering be considered as physical sciences for the
purpose of this regulation.
b. Equipment. Standards for equipment used in mammography were
established in Sec. 900.12(b) of the interim regulations. Because of
additional proposed equipment requirements, FDA is adding a definition
for the term ``mean optical density,'' defined as the average of
optical densities measured for specified phantom thicknesses at
clinically appropriate peak kilovoltage (kVp) levels. A definition of
the term ``mammography unit'' is being added to clarify that when this
term is used, the reference is to the x-ray generator and associated
components.
c. Quality assurance. Proposed Sec. 900.12(d) would specify new
requirements for the individuals responsible for various aspects of the
facility quality assurance program. These proposed changes have made it
necessary to define the terms ``lead interpreting physician'' and
``quality control technologist.'' The lead interpreting physician would
be the interpreting physician with primary responsibility for ensuring
that the facility quality assurance program meets the requirements of
paragraphs (d) through (f) of Sec. 900.12. It would be left to the
discretion of the facility whether this individual would also have
other supervisory duties. The quality control technologist(s) would be
responsible for those aspects of the quality assurance program not
carried out by the lead interpreting physician or medical physicist.
Several definitions are being added to proposed Sec. 900.2 on
quality assurance requirements for equipment. These include a
definition for ``time cycle,'' which means the film development time,
and for ``traceability,'' which relates to calibration of radiation
measuring instruments.
d. Mammography medical outcomes audit. Discussions with the NMQAAC
regarding the medical auditing requirements in proposed Sec. 900.12(f)
indicated a need to define medical audit. Therefore, FDA is proposing
to define the ``mammography medical outcomes audit'' as a systematic
collection of mammography results and the comparison of these results
with outcome data (e.g., results of subsequent biopsy followup
procedures).
For use with the mammography medical outcomes audit, FDA is also
defining a ``positive mammogram'' as one with an overall assessment of
findings that are either ``suspicious'' or ``highly suggestive of
malignancy.'' This definition incorporates two of the assessment
categories described in Sec. 900.12(c)(1)(iii) (published elsewhere in
this issue of the Federal Register) for use in mammography records and
reports.
e. Breast implant. Proposed Sec. 900.12(g), published elsewhere in
this issue of the Federal Register, contains new standards for
mammography of examinees with breast implants. Establishment of such
standards is required by the MQSA. FDA is proposing to define a
``breast implant'' as a prosthetic device implanted in the breast.
f. Consumer complaint mechanism. FDA is proposing new requirements
in Secs. 900.4(g) and 900.12(h), published elsewhere in this issue of
this Federal Register, for consumer complaint mechanisms to be
established by facilities and accreditation bodies. The purpose of
these new requirements is to ensure that serious complaints about the
quality of the MQSA-related mammography services are adequately
addressed without unduly burdening facilities and accreditation bodies
with Federal regulations requiring extensive consideration of
relatively minor complaints (e.g., complaints about facility air
temperature). Therefore, FDA is proposing to add definitions of
``adverse event,'' ``serious adverse event,'' and ``serious complaint''
to clarify the kinds of situations that would require full
investigation and correction under the statute. These definitions also
would clarify that any substantive complaints that warrant attention,
but are not within the scope of the MQSA (e.g., discrimination or
harassment), must be handled through other mechanisms.
FDA is proposing to add a definition of ``consumer'' to clarify
that the consumer complaint process also can be used by interested
parties other than the examinee (e.g., family members or referring
physicians).
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
V. Analysis of Impacts
This proposed rule sets forth preliminary ideas for the application
of alternative performance and outcome-based standards to ensure
quality mammography. FDA requests that comments submitted on this
proposal also address the estimated costs and benefits of such
alternatives.
FDA has examined together the impacts of the remaining four
proposed rules to implement the MQSA requirements, published
concurrently in this issue of the Federal Register, under Executive
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354), and
under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages, distributive impacts, and equity). The Regulatory
Flexibility Act requires agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. The
Unfunded Mandates Reform Act requires (in section 202) that agencies
prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an annual expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100 million (adjusted annually for inflation). The agency
has conducted preliminary analyses of the proposed rules, and has
determined that the proposed rules are consistent with the principles
set forth in the Executive Order and in these two statutes. The
Regulatory Impact Study that details the agency's calculation of these
economic impacts is available at the Dockets Management Branch for
review. A brief summary of the cost and benefit determination follows.
Incremental annual costs were estimated for each section of the
proposed regulations. Actions expected to be taken by mammography
facilities to come into compliance with the proposal were identified
and current compliance levels were estimated in conjunction with agency
experts and industry consultants. Costs were determined for a 10-year
analysis period. Yearly costs of compliance for mammography facilities
were estimated to range from a high of $203.2 million during the first
year of implementation
[[Page 14864]]
to $25.2 million during the 10th year (2005). These yearly costs
differed due to the phased implementation dates for some of the
proposed requirements. Overall, average annualized costs of this
proposal (at a 7-percent discount rate) are preliminarily estimated to
equal $61.4 million.
Over the full 10-year analysis period, expenditures for the largest
cost element (replacement of mammography units and film processors with
units meeting standards required in proposed Sec. 900.12(b)) could
total more than $270 million and contribute approximately $35 million
in average annual costs (57 percent of total average annual costs).
Other major cost components include proposed Sec. 900.12(c)(2)(i)
(written notification of patient) which accounts for average annual
costs of $14 million (23 percent of total average annual costs),
proposed Sec. 900.12(c)(3)(ii) (telephone contact with referring
physicians) which accounts for over $4 million in annual costs (7
percent of total average annual costs), and proposed Sec. 900.12(e)(2)
(requiring weekly image quality tests) which accounts for average
annual costs of almost $2 million (3 percent of total average annual
costs).
The benefits of the proposed rule were estimated as illustrations
of the expected health outcomes for given levels of quality
improvement. FDA believes that the proposed rules are complementary,
and that quality improvements are limited by the ``weakest link'' in
the process of conducting or interpreting a mammographic examination.
Thus, benefits were estimated assuming compliance with all of the
proposed requirements at the same level of overall quality.
Benefit scenarios were based on an outcome prediction model that
forecast breast cancer survival based on stage-determination at the
time of identification. In addition, FDA estimated the reduction in
costs attributable to the avoidance of followup procedures for those
patients correctly diagnosed as not having cancer due to a range of
quality gains that may occur as a result of the proposed rule. The
calculated benefits are illustrative of the magnitude of health gains
that would be expected to follow heightened quality levels of
sensitivity and specificity. For example, a 5-percent gain in a
sensitivity measurement of 80 percent would indicate a revised
sensitivity level of 81 percent (a reduction of the rate of false
positives from 20 percent to 19 percent).
Overall, the agency could not predict precise quality improvement
gains. FDA estimates, however, those 5-year survival rates of all
patients identified with breast cancer would increase by 0.006 percent
if quality improves by 1 percent, 0.028 percent if the proposed rules
result in a 5-percent gain in quality, and 0.084 percent if the quality
improvements induce a 20-percent gain in sensitivity. (These are equal
to increased survival rates of 0.02, 0.1, and 0.3 percent for all
screened patients at the estimated levels of improvement.) Based on
current disease prevalence rates, these results project that a 1-
percent quality improvement would avert 10 breast cancer fatalities
annually (based on 5-year survival rates), whereas quality improvement
levels of 5 and 20 percent, respectively, would prevent 50 and 150
cancer fatalities.
Several analyses have estimated that society has indicated a
willingness to pay to avoid a statistical death of approximately $5
million. Therefore, a 1-percent improvement in sensitivity as a result
of this proposal would have monetized benefits of $50 million.
Likewise, 5 and 20 percent improvements would bring annual benefits of
$250 million and $750 million, respectively.
In addition, the proposed rules are anticipated to result in
corresponding percent improvements in specificity, which would reduce
the number of followup procedures in nondiseased patients. An
improvement of 1 percent would reduce current annual medical
expenditures by approximately $14 million. If the improvement in
specificity were as high as 5 percent, the annual reduction in medical
costs would equal $72 million. A 20-percent improvement in quality
would reduce current annual medical costs by $287 million.
FDA recognizes that the nature of these proposed regulations may
have a disproportionate effect on small volume mammography facilities
as fixed costs of compliance for equipment improvements are likely to
increase the cost per mammogram for low-volume facilities relatively
more than for high-volume facilities. FDA is currently collecting
additional information on the potential impact on this industry sector,
and requests comments that will assist it in accounting for this
impact.
The agency also notes that average annual compliance costs of $61.4
million could increase the cost per screening mammogram at certain
clinics by from 2 to 6 percent. FDA has estimated that if these costs
are passed on to consumers, the demand for mammograms could be reduced
by approximately 200,000 per year (or 0.9 percent of current demand).
However, the agency believes that quality improvement savings may more
than balance these expected price effects.
[[Page 14865]]
FDA also examined the effect of alternative implementation
schedules for this proposal. An alternative requiring even more
elaborate equipment upgrade immediately upon issuance of the
regulations was rejected as putting an unnecessary burden on the
industry, with estimated average annual costs of more than $120
million. By eliminating some specifications that were considered
marginal to ensuring mammography quality, and phasing in some
requirements to allow for normal replacement of current equipment, the
agency reduced the cost of compliance. FDA also found that delaying the
implementation of the proposed equipment requirements by an additional
year, while reducing the average annual compliance costs by $7.1
million, would mitigate the expected impact of the proposed rule on
quality improvements. Therefore, the proposed implementation schedule
was selected as a reasonable balance between compliance costs and
quality improvements.
MQSA includes a separate reimbursement mechanism to repay State,
local, or tribal governments for the costs of inspections required by
these proposed regulations. Consequently, no unfunded mandate is placed
on local governments as a result of these proposals.
In summary, FDA expects that the proposal would lead to mammography
quality increases. Average annual costs of compliance with this
proposal are estimated to be $61.4 million. The estimated benefits
accrue as a result of fewer breast cancer mortalities as well as the
avoidance of unnecessary surgery. While the magnitude of the expected
quality increases are currently under investigation, an improvement of
only 1 percent would result in monetized annual benefits of $64 million
including 10 fewer cancer mortalities, which slightly exceed the
estimated compliance costs. If the quality improvements range to 5 or
20 percent, the benefits would increase proportionately. A 5-percent
improvement projects average annual monetized benefits of $322 million.
At this level of quality improvement, the cost savings of avoiding
surgery are, by themselves, greater than compliance costs. This would
occur in addition to 50 fewer breast cancer mortalities per year. A 20-
percent quality improvement would result in average annual monetized
benefits of $1,037 million, with 150 fewer annual breast cancer deaths
due to earlier detection.
Because of the preliminary nature of these estimates, FDA requests
comments on all of the methodology and projections included in this
analysis. Comments may be submitted to the Dockets Management Branch
(address above).
IV. Paperwork Reduction Act of 1995
The information collections contained in the December 21, 1993,
interim regulations implementing the MQSA were approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995 (Pub. L. 104-13) under control number 0910-0309, which includes
OMB approval for Form FD-3422. The approval will expire July 31, 1998.
Three of the five proposed rules to amend 21 CFR part 900, published
together in this issue of the Federal Register, contain amendments to
the approved information collections, and these revisions are subject
to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L.
104-13). The title, description, and respondent description of the
revised information collections to 21 CFR part 900 are shown below with
an estimate for any annual reporting and recordkeeping burdens which
will be changed by these proposed rules. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
Title: Mammography Facilities.
Description: These information collection requirements apply to
accreditation bodies and to mammography facilities. In order to be an
approved accreditation body, private nonprofit organizations or State
agencies must submit an application to FDA and establish procedures and
a quality assurance program. Mammography facilities must obtain and
prominently display an FDA-issued certificate or provisional
certificate; have a medical reporting and recordkeeping program, a
medical outcomes audit program, a consumer complaint mechanism; and
maintain records documenting personnel qualifications. These actions
are being taken to ensure safe, accurate, and reliable mammography on a
nationwide basis.
Respondent Description: Businesses and other for-profit
organizations, nonprofit organizations, Federal, State, and local
governments.
Therefore, the agency solicits public comments on the revised
information collection requirements in order to: (1) Evaluate whether
the proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (2) evaluate the accuracy of
the agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) enhance the quality, utility, and clarity of the information
to be collected; and (4) minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses.
[[Page 14866]]
Proposed Requirements for Accreditation Bodies of Mammography Facilities
[Table 1a.--Estimated Annual Reporting Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR Section respondents frequency per responses response Total hours costs maintenance
response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3(b)(3)................................ 10.0 1.0 10.0 60 600 $50
900.4(a)(7) \1\............................
900.4(b)(2) \1\............................
900.4(c) \1\...............................
900.4(d) \1\...............................
900.4(e)(1) \1\............................
900.4(e)(2) \1\............................
900.4(h)(1) \1\............................
900.4(h)(3) \1\............................
900.4(i)(1)\1\.............................
900.4(i)(2)\1\.............................
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 600 $50 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
Proposed Requirements for Accreditation Bodies of Mammography Facilities
[Table 1b.--Estimated Annual Recordkeeping Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR section recordkeeepers frequency of records recordkeeper Total hours costs maintenance
recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3(f)(1)................................ 10 130 1,300 200 2,000
900.4(c) \1\...............................
900.4(c)(2)(viii) \1\......................
900.4(c)(5)(iii) \1\.......................
900.4(d) \1\...............................
900.4(d)(5)(iii) \1\.......................
900.4(e)(1) \1\............................
900.4(e)(2) \1\............................
900.4(f)(2) \1\............................
900.4(g) \1\...............................
900.4(h)(1) \1\............................
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 2,000 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
[[Page 14867]]
Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
[Table 2a.--Estimated Annual Reporting Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR section respondents frequency per responses response Total hours costs maintenance
response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.11(b)(1) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.11(b)(2) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.11(b)(3) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.11(c).................................. 10,000 0.005 50 20 1,000 .............. $1,000
900.12(c)(1) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(c)(2)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............
900.12(c)(3)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............
900.15(d)(3)(ii)........................... 10,000 0.002 20 2 40 .............. 100
900.18(c).................................. 10,000 0.0005 6 2 12 .............. 60
900.18(e) \1\.............................. 10 0.1 1 1 1 .............. 10
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 1,053 0 $1,170
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
[Table 2b.--Estimated Annual Recordkeeping Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR section recordkeeepers frequency of records recordkeeper Total hours costs maintenance
recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(c)(4) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(d)(2)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............
900.12(d)(2)(ii)........................... 10,000 1 10,000 0.25 2,500
900.12(d)(2)(iii).......................... 10,000 1 10,000 1 10,000
900.12(d)(2)(iv) \1\....................... .............. .............. .............. .............. ........... .............. ..............
900.12(f)(2) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(f)(4) \1\........................... .............. .............. .............. .............. ........... .............. ..............
900.12(h)(2)............................... 10,000 2 20,000 0.5 10,000 .............. $20,000
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. 22,500 0 $20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
[[Page 14868]]
Quality Standards and Certification Requirements for Mammography Facilities; Personnel Requirements
[Table 3.--Estimated Annual Recordkeeping Burden]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Annual Total annual Hours per Total capital operating and
CFR Section recordkeeepers frequency of records recordkeeper Total hours costs maintenance
recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(a)(4)\1\............................ .............. .............. .............. .............. ........... .............. ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There is no additional burden.
Under OMB information collection no. 0910-0309, 82,810 burden hours
were approved for information collection currently contained in 21 CFR
part 900. The additional requirements contained in these proposed rules
will add 26,153 burden hours to this estimate, resulting in a total
annual burden of 108,963.
As required by section 3507(d) of the Paperwork Reduction Act of
1995, FDA has submitted a copy of the five proposed rules amending 21
CFR part 900 to OMB for its review of the revised information
collection requirements; these five proposed rules are published
together in this issue of the Federal Register. Other organizations and
individuals interested in submitting comments regarding this burden
estimate or any aspect of these information collection requirements,
including suggestions for reducing the burden, should direct them to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN:
Desk Officer for FDA. Written comments on the information collections
should be submitted by May 3, 1996.
VII. Comments
The agency will consider any comments submitted in response to this
proposed rule in its evaluation of the proposed alternative approaches
for quality mammography and the four proposed amendments to the interim
regulations published elsewhere in this issue of the Federal Register.
FDA advises that, under 21 CFR 10.30(d), any comments submitted in
response to this notice will be included under the docket number found
in brackets in the heading of this document.
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this NPRM. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
VIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Wingo, P. A., T. Tong, and S. Bolden, ``Cancer Statistics
1995,'' CA: A Cancer Journal for Clinicians, 45:8-30, 1995.
2. Feuer, E. J., L. M. Wun, and C. C. Boring, et al., ``The
Lifetime Risk of Developing Breast Cancer,'' Journal of the National
Cancer Institute, 85:892-897, 1993.
3. Ries, L. A. G., B. A. Miller, and B.F. Hankey, et al. (eds.),
``SEER Cancer Statistics Review, 1973-1991,'' National Cancer
Institute, NIH Pub. No. 94-2789, Bethesda, MD, 1994.
4. Brown, M. L., F. Houn, E. A. Sickles, L.G. Kessler,
``Screening Mammography in Community Practice: Positive Predictive
Value of Abnormal Findings and Yield of Follow-Up Diagnostic
Procedures,'' American Journal of Radiology, 165:1373-1377; 1995.
5. Kuester, G. F., S. M. Wolfe, ``HRG Report on Screening
Mammography, Public Citizen Health Research Group,'' July 1991.
6. Conway, B. J., O. H. Suleiman, F. G. Rueter, R. G. Antonsen,
R. J. Slayton, J. L. McCrohan, ``Does Credentialing Make a
Difference in Mammography?,'' U.S. Food and Drug Administration,
Center for Devices and Radiological Health, Rockville, MD, Presented
to the Radiological Society of North America, November 19, 1992.
7. ``The National Strategic Plan for the Early Detection and
Control of Breast and Cervical Cancers,'' U.S. Department of Health
and Human Services, Public Health Service.
8. Geise, R. A., A. Palchevsky. Composition of Mammographic
Phantom Materials. Radiology 198:347-350, 1996.
9. Chassin, M. R., E. L. Hannan, B. A. DeBuono. Benefits and
Hazards of Reporting Medical Outcomes Publicly. The New England
Journal of Medicine, pp. 394-398 February 8, 1996.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Mammography, Medical
devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Sections 900.1 and 900.2 are revised to read as follows:
Sec. 900.1 Scope.
The regulations set forth in this part implement the Mammography
Quality Standards Act (42 U.S.C. 263b). The intent of subpart A of this
part is to establish procedures whereby an entity can apply to become
an FDA-approved accreditation body to accredit facilities to be
eligible to perform screening or diagnostic mammography services.
Subpart A further establishes requirements and standards for
accreditation bodies to ensure that all mammography facilities under
the jurisdiction of the United States are adequately and consistently
evaluated for compliance with national quality standards for
mammography. The intent of subpart B of this part is to establish
minimum national quality standards for mammography facilities to ensure
safe, reliable, and accurate mammography. The regulations set forth in
this part do not apply to facilities of the Department of Veterans
Affairs.
Sec. 900.2 Definitions.
The following definitions apply to subparts A and B of this part:
(a) Accreditation body or body means an entity that has been
approved by FDA under 42 U.S.C. 263b(e)(1)(A) to accredit mammography
facilities.
(b) Action limits or action levels means the minimum and maximum
values of a quality assurance measurement that can be interpreted as
representing acceptable performance of the equipment being tested.
Values less than the minimum or greater than the maximum action limit
or level indicate that corrective action must be taken by the facility.
Action limits or levels are also sometimes called control limits or
levels.
[[Page 14869]]
(c) Adverse event means an undesirable experience associated with
mammography activities within the scope of 42 U.S.C. 263b. Adverse
events include, but are not limited to:
(1) Poor image quality;
(2) Failure to send mammography reports within 30 days to the
referring physician or the self-referred examinee (as specified in
Sec. 900.12(c)(2) and (c)(3)(i)); and
(3) Use of personnel that do not meet the applicable requirements
of Sec. 900.12(a).
(d) Breast implant means a prosthetic device implanted in the
breast.
(e) Certificate means the certificate described in 42 U.S.C.
263b(b)(1).
(f) Certification means the process of approval of a facility by
FDA to provide mammography services.
(g) Clinical image means a mammogram.
(h) Consumer means an individual who chooses to comment or complain
in reference to a mammography examination, including the examinee or
representatives of the examinee (e.g., family members or referring
physicians).
(i) Contact hour means an hour of training received through direct
instruction.
(j) Direct instruction means:
(1) Face-to-face interaction between instructor(s) and student(s),
as when the instructor provides a lecture, conducts demonstrations, or
reviews student performance; or
(2) The administration and correction of student examinations by an
instructor(s) with subsequent feedback to the student(s).
(k) Direct supervision means that:
(1) During joint interpretation of mammograms, the supervising
physician reviews, discusses, and confirms the diagnosis of the
physician being supervised and signs the resulting report before it is
entered into the examinee's records; and
(2) During the performance of a mammography examination or survey
of the facility's equipment and quality assurance program, the
supervisor is present to observe and correct, as needed, the
performance of the individual being supervised who is performing the
examination or conducting the survey.
(l) Double reading means two or more interpreting physicians
interpreting the same clinical image.
(m) Examinee means any individual who undergoes a mammography
evaluation in a facility, regardless of whether the person is referred
by a physician or is self-referred.
(n) Facility means a hospital, outpatient department, clinic,
radiology practice, mobile unit, office of a physician, or other
facility that conducts mammography activities, including the following:
Operation of equipment to produce a mammogram, processing of the
mammogram, initial interpretation of the mammogram, and maintaining
viewing conditions for that interpretation. This term does not include
a facility of the Department of Veterans Affairs.
(o) First allowable time means the earliest time a resident is
eligible to take the diagnostic radiology boards from an FDA-approved
certifying body. The ``first allowable time'' may vary with the
certifying body.
(p) Interpreting physician means a physician who interprets
mammograms and who meets the requirements set forth in
Sec. 900.12(a)(1).
(q) Lead interpreting physician means the interpreting physician
assigned the general responsibility for ensuring that a facility's
quality assurance program meets all of the requirements of
Sec. 900.12(d) through (f). The administrative title and other
supervisory responsibilities of this individual, if any, are left to
the discretion of the facility.
(r) Mammogram means a radiographic image produced through
mammography.
(s) Mammography means radiography of the breast, but does not
include:
(1) Radiography of the breast performed during invasive
interventions for localization or biopsy procedures; or
(2) Radiography of the breast performed as part of a scientific
study to evaluate an investigational mammography device conducted in
accordance with FDA's investigational device exemption regulations in
part 812 of this chapter.
(t) Mammography equipment evaluation means an onsite assessment of
a mammography unit or image processor for the purpose of making a
preliminary determination as to whether the equipment meets all of the
applicable standards in Sec. 900.12(b) and (e).
(u) Mammography medical outcomes audit means a systematic
collection of mammography results and the comparison of those results
with outcomes data.
(v) Mammography unit or unit means an assemblage of components for
the production of x-rays for use during mammography, including, at a
minimum: An x-ray generator, an x-ray control, a tube housing assembly,
a beam limiting device, and the necessary supporting structures for
these components.
(w) Mean optical density means the average of the optical densities
measured for phantom thicknesses of 2 centimeters to 6 centimeters
using values of kilovolt peak (kVp) clinically appropriate for those
thicknesses.
(x) Medical physicist means a person trained in evaluating the
performance of mammography equipment and facility quality assurance
programs and who meets the qualifications for a medical physicist set
forth in Sec. 900.12(a)(3).
(y) Modality means a technology, within the scope of 42 U.S.C.
263b, for radiography of the breast. Examples are screen-film
mammography and xeromammography.
(z) Phantom means a test object used to simulate radiographic
characteristics of compressed breast tissue and containing components
that radiographically model aspects of breast disease and cancer.
(aa) Phantom image means a radiographic image of a phantom.
(bb) Physical science means physics, chemistry, radiation science
(including medical physics and health physics), and engineering.
(cc) Positive mammogram means a mammogram that has an overall
assessment of findings that are either ``suspicious'' or ``highly
suggestive of malignancy.''
(dd) Provisional certificate means the provisional certificate
described in 42 U.S.C. 263b(c)(2).
(ee) Quality control technologist means an individual meeting the
requirements of Sec. 900.12(a)(2)(i) who is responsible for those
quality assurance responsibilities not assigned to the lead
interpreting physician or to the medical physicist.
(ff) Radiographic equipment means x-ray equipment used for the
production of static x-ray images.
(gg) Radiologic technologist means an individual specifically
trained in the use of radiographic equipment and the positioning of
examinees for radiographic examinations and who meets the requirements
set forth in Sec. 900.12(a)(2).
(hh) Serious adverse event means an adverse event that may
significantly compromise clinical outcomes, or an adverse event for
which a facility fails to take appropriate corrective action in a
timely manner.
(ii) Serious complaint means a report of a serious adverse event.
(jj) Survey means an onsite physics consultation and evaluation of
a facility performed by a medical physicist.
(kk) Time cycle means the film development time.
(ll) Traceability means the ability to show that an instrument has
been
[[Page 14870]]
calibrated at least annually through an unbroken chain of comparisons
starting with either an appropriate national standard established by
the National Institute of Science and Technology (NIST), Gaithersburg,
MD, or with a transfer standard calibrated by NIST.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7829 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P