[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14870-14884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7830]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 93N-0351]
RIN 0910-AA24
Quality Standards and Certification Requirements for Mammography
Facilities; General Facility Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the facility standards established in the interim regulations
implementing the Mammography Quality Standards Act of 1992 (the MQSA).
This proposed rule would modify and add to the general requirements for
mammography facilities, 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. In addition to the statutory
framework and the expertise and research of FDA personnel, the agency
is proposing this rule based on advice from the National Mammography
Quality Assurance Advisory Committee (NMQAAC) and public comments
received in response to the interim regulations. This action is being
taken to ensure safe, accurate, and reliable mammography on a
nationwide basis. This is the third of five related proposed rules
being published concurrently.
DATES: Written comments on this proposed rule by July 2, 1996.
Written comments on the information collection requirements should
be submitted by May 3, 1996. The agency is proposing that any final
rule based on this proposed rule become effective 1 year after its date
of publication in the Federal Register.
ADDRESSES: Submit written comments on this 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 collection requirements
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.
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. Background
This proposal is the third of five related proposed rules published
in this issue of the Federal Register to amend interim regulations
published on December 21, 1993 (58 FR 67558 and 58 FR 67565)
implementing the MQSA (Pub. L. 102-539). The first proposed rule,
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' contains background information and a summary
of the preliminary analysis of the costs and benefits of all of these
proposed rules, a description of the information collection
requirements, proposed revisions to Sec. 900.1 Scope and Sec. 900.2
Definitions, and proposed alternative approaches to mammography
standards and a request for comments on the proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulations
This proposed rule establishes mammography facility standards for
recordkeeping and reporting, medical outcomes audit, quality assurance,
imaging of examinees with breast implants, and addressing consumer
complaints. The proposal also establishes general certification
requirements, and a procedure for any entity regulated under this rule
to request FDA approval of alternative standards. As in the development
of the interim regulations, FDA has been guided by the requirements of
the MQSA and its stated legislative intent to guarantee access to safe
and effective mammography services for all women in the United States
(Ref. 1).
In addition to the statutory framework and the expertise and
research of FDA personnel, the agency relied upon two major sources of
information in developing this proposed rule. The first source was the
written comments received on the interim regulations. FDA received 103
comments from individuals and organizations on the interim regulations.
Included among the written comments were responses from professional
organizations, medical facilities, State agencies, consumer groups,
manufacturers, and individual physicians, medical physicists, and
radiologic technologists.
The second outside source of information used to develop the
proposed regulations was the advice and recommendations of the NMQAAC.
Sections of these proposed regulations were discussed at the NMQAAC
meetings in February, May, July, and September 1994. All of these
proposed regulations, as then drafted, were reviewed again at the
January 1995 meeting of the NMQAAC. The members of the NMQAAC include
interpreting physicians, medical physicists, radiologic technologists,
representatives of State agencies, and consumer representatives.
Consultants to the NMQAAC and guests invited to attend the meetings in
recognition of their expertise in mammography also participated in the
discussions.
B. Applicability
Proposed Sec. 900.10 states that the provisions of subpart B apply
to all facilities under the jurisdiction of the United States that
provide mammography services, with the exception of the facilities of
the Department of Veterans Affairs (DVA).
Several comments objected to the exemption of DVA facilities from
the interim regulations. In response to these comments, the agency
notes that the DVA facilities are excluded from the requirements of the
MQSA by the statute itself (42 U.S.C. 263b(a)(3)(A)). However, since
the publication of the interim regulations, DVA has voluntarily
committed its facilities to a program consistent with the standards
issued under the MQSA.
C. Certification Requirements
Proposed Sec. 900.11 defines the two types of certificates,
provisional and
[[Page 14871]]
full, that permit a mammography facility to operate lawfully after
October 1, 1994. This section states the length of time the
certificates will be valid and the circumstances under which the
certificates may be renewed or extended. In addition, proposed
Sec. 900.11(c) outlines reinstatement procedures for a facility that
has allowed its certificate to expire, has been refused a renewal of
its certificate, or has had its certificate revoked by FDA. It also
states that the owner or operator of a facility that has had its
certificate revoked by FDA may not apply for reinstatement until at
least 2 years have passed from the time of the revocation. This
additional restriction is required by the statute (42 U.S.C.
263b(i)(3)).
One comment on the interim regulations requested that FDA state
clearly that a provisional certificate can only be issued once.
FDA reviewed this issue in connection with implementation of the
interim regulations and concluded that the statute does not limit any
particular facility to receiving a provisional certificate only once.
Situations in which a subsequent provisional certificate might be
issued to a facility include cases where a facility was denied an
initial full certificate or renewal of its full certificate or has had
its certificate revoked by FDA but subsequently has made substantial
progress in correcting the problems that led to denial or revocation of
the certificate. In the case of a facility that failed to achieve
accreditation and certification during its initial 6-month provisional
time period, the regulations permit FDA to issue a second provisional
certificate if the facility applies for one after a corrective action
plan has been effectively implemented. At that point, a new 6-month
provisional certificate may be provided to the facility while the
accreditation process is underway. In the case of a revoked
certificate, as described previously, at least 2 years must pass before
the owner or operator of the facility can apply for a new provisional
certificate. A subsequent provisional certificate also might be issued
to a facility that allowed its previous certificate to expire but later
wishes to resume providing mammography services.
However, the comment is correct to the extent that FDA may not
issue two sequential, uninterrupted 6-month provisional certificates to
the same facility. The agency invites comments on whether its policy of
permitting a facility to obtain a subsequent 6-month provisional
certificate once the facility has effectively corrected its
deficiencies should be included in the final regulations and, if so,
what if any, conditions should be placed in the process.
The same comment expressed the opinion that provisional
certificates were only intended to aid facilities in meeting the
October 1, 1994, deadline.
Although it is true that the provisional certificates were valuable
in helping existing facilities meet the October 1, 1994, deadline, they
are also intended to provide a way for new facilities to commence
operation after the date became effective. To become accredited and
certified, a facility must pass clinical image review. However, without
provisional certification, a new facility would be unable to perform
the necessary mammographic examinations for presentation to the
accreditation body for review after October 1, 1994. The provisional
certificate allows such facilities lawfully to produce the images they
need to achieve full accreditation and certification.
Two comments suggested that other justifications, in addition to
avoiding an adverse impact on the availability of mammography, should
be considered in making a determination to grant a 90-day extension of
the provisional certificate.
Congress limited the possibility of a 90-day extension of a
provisional certificate under the MQSA to cases in which there would be
a significant reduction of access to mammography in the geographic area
served by the facility (42 U.S.C. 263b(c)(2)). Provisionally certified
facilities should make every effort to obtain full certification no
later than 6 months from the date the provisional certificate is
issued.
Other comments asked that the time periods for the provisional
certificates and the 90-day extensions be increased, primarily because
of the difficulty accreditation bodies experienced in meeting the
timeframes.
Again, the agency notes that the MQSA established these timeframes
and FDA cannot amend them. Although the number of applications for
accreditation submitted to meet the October 1, 1994, deadline did cause
some difficulties for accreditation bodies meeting the timeframes, the
accreditation bodies have increased their staffs to match the workload.
The agency believes that once the initial implementation period is
over, the accreditation bodies will be fully staffed to meet these
timeframes effectively and efficiently, provided that facilities
promptly submit the required information for evaluation. In addition,
accreditation bodies are taking steps to adjust the timeframes for
renewal of accreditation so that the workload is more evenly
distributed.
One comment suggested that some additional time be allowed for FDA
and facilities to gain experience with the interim standards before any
major changes are proposed. The comment stated that experience could
then serve as a guide in determining what revisions were needed.
When Congress gave FDA interim regulation authority, it intended
that FDA take prompt action to promulgate final regulations through
notice and comment rulemaking. Accordingly, FDA began work on the final
standards almost immediately after the interim regulations were
published. Because of the deliberative nature of the rulemaking
process, however, the agency will have had some experience with the
interim regulations before the final regulations are published. The
lessons learned during this interim period have been and will continue
to be applied in the development of the final regulations.
In addition, the passage of time has helped FDA identify concerns
that were not immediately apparent when the interim regulations were
drafted. For example, FDA has realized that there is a possibility
that, at some future time, particular facilities may not have access to
an accreditation body. If this event were to occur, FDA would have to
provide an alternative for accreditation or the facilities could not
lawfully operate. To be prepared for this possibility, the agency has
added the words ``or other entity as designated by FDA'' at every point
in Sec. 900.11, and elsewhere in the regulations, where facilities are
required to take some action with respect to their accreditation body.
D. Medical Records and Mammography Reports
Proposed Sec. 900.12(c) establishes certain requirements for the
content and terminology of the mammography examination report, the
manner of communicating results of the mammography examination to the
examinee and to health care providers, and the duties of the facility
for maintaining records of examinees.
1. Mammography Reporting
The information and assessment categories listed in proposed
Sec. 900.12(c)(1) are intended to establish a minimum national standard
that will permit the results of mammography examinations to be more
easily compared. This standardized format for presenting the results of
the
[[Page 14872]]
examination will assist in preparation of the medical outcomes audit
that each facility is required to perform. The standard will also
facilitate communication about the risk of breast cancer from the
interpreting physician to the referring health care providers. The
categories proposed in the regulation are recommended by the American
College of Radiology and also recommended by the Agency for Health Care
Policy and Research (AHCPR) mammography practice guidelines, ``Quality
Determinants of Mammography.''
During discussions with NMQAAC, certain advisory committee members
suggested that FDA establish standard operating procedures that
facilities should follow for the production of mammography reports. FDA
believes that regulating a facility's internal procedures for
generating mammography reports would be overly intrusive. Interested
parties can find suggested guidelines for optimal facility operating
procedures for production and dissemination of mammography results in
the AHCPR's ``Quality Determinants of Mammography.''
FDA and NMQAAC discussed the collection of racial and ethnic data
as part of the recordkeeping requirements. Opinions of individual
committee members varied with respect to collection of such data. FDA
recognizes the value of these data in addressing such important issues
as the utilization and efficacy of mammography, as well as other
pertinent public health research questions. However, after consultation
with other Public Health Service agencies that have experience in
attempting to collect racial and ethnic data from mammography
facilities, FDA determined that there is currently no effective
established method for collecting this information. Therefore, FDA is
not at this time proposing a requirement for facilities to collect
racial and ethnic data. FDA does encourage facilities to collect all
information, including racial and ethnic data, that will allow
facilities to better understand and serve their particular communities.
The items listed in proposed Sec. 900.12 (c)(1) and (c)(2)(i) are
minimum requirements and do not preclude the facility from including
additional information in mammography reports or in notifications to
examinees, including relevant public health messages to the health care
provider or to the examinee.
2. Signatures
Proposed Sec. 900.12(c)(1) would require the written mammography
report to be signed by the interpreting physician. FDA views the
signature on the report as an attestation of the signatory as the
individual who has read the mammogram and has rendered the
interpretation in the report. Therefore, in addition to handwritten
signatures on the mammography reports, FDA will accept other
``signatures,'' including those that are generated from computer
systems, typewritten, or name stamped, on the condition that these
signatures were personally authorized by the interpreting physician.
NMQAAC advised FDA to adopt regulations to mandate that all
facilities have a written policy that ensures the integrity of the
signature on the mammography report as coming from the interpreting
physician, or a designated interpreting physician, if the interpreting
physician is unavailable. NMQAAC also encouraged FDA to mandate that
facilities assure that all personnel signatures, and other legally
binding equivalents in the medical record, include professional titles.
FDA encourages these practices but believes that it is unnecessary to
require them through regulation.
3. Communication With the Examinee and Health Care Providers
Communication responsibilities have long been a frustrating area in
mammography practice. All women who have mammography need to know the
results. Examinees without any health care providers need to have the
actual reports to show to subsequent health care providers, especially
in the case of abnormal findings. Many examinees believe no news is
good news. This fallacy contributes to delays in treatment when,
through communication problems, the significance of a finding is not
properly communicated to the examinee.
Currently, interim regulations provide that only women who have no
health care provider receive the actual medical report and a summary of
the mammography results in lay language. Two comments on the interim
regulations recommended that the final regulations be amended to ensure
that every examinee receives a written report signed by the
interpreting physician and presented in lay language. One comment on
the interim regulations suggested requiring the report to include all
elements previously required by the Health Care Financing
Administration's (HCFA's) screening mammography program.
Proposed Sec. 900.12(c)(2) would require that all examinees receive
notification of results expressed in lay terms. Examinees without
health care providers would receive the actual mammography report along
with the lay notification. If there is a health care provider, the lay
notification would go to the examinee and the actual report would go to
the health care provider, who, in turn, could communicate with the
examinee again or in greater detail, if necessary.
This proposal is in response to consumer complaints of failure to
communicate abnormal and normal results to examinees. The proposed
standard intends to maintain the examinee-provider relationship while
ensuring that results get communicated to the examinee. The lay
notification of results and recommendations vary in length and detail,
but may be as simple as ``Your mammogram reveals you need further
tests. Please contact your physician.'' FDA also believes that
notifications to examinees should be written in a way that is not
overly alarming. In addition, FDA believes that in those cases in which
an examination reveals the need for followup, notification directly to
the examinee is essential.
FDA recognizes there are some referring health care providers who
feel that they may be placed in an uncomfortable position if an
examinee is notified of results before the health care provider is
notified. There is also a concern that the examinee may be unduly
alarmed by the facility's notification.
In response to these concerns, the agency notes that the main
purposes of the lay notification requirements are to provide another
safety mechanism to help to ensure that abnormal results are followed
up and to ensure that all examinees know their mammography results. If
facilities notify physicians and examinees simultaneously, the
referring doctor will have access to the results of the mammogram at
the time an examinee calls for clarification or followup. Those
physicians who prefer to handle all communication with their examinees
may continue that practice if procedures are properly coordinated with
the facility generating the reports. The proposed requirements would
not prohibit the mammography facility from providing standard lay
notifications, along with the mammography report, to a referring health
care provider who has agreed to issue these notices to his or her
examinees. This agreement should be documented by attestation
statements from the referring provider and should be on file at the
mammography facility for inspection purposes.
During discussions with NMQAAC, FDA heard diverse opinions
concerning the form and content of the notification that all examinees
will receive.
[[Page 14873]]
However, NMQAAC did favor some form of written notification to all
examinees, and that recommendation has been incorporated into the
proposal.
Section 900.12(e)(2)(ii)(A) of the interim regulations establishes
that the written report of any mammography examination shall be sent
directly to the patient if the patient's physician is not ``available''
or if the patient does not have a physician. Two comments stated that
the word ``available'' in this provision is ambiguous and could be
interpreted to mean that the physician will not be notified if he or
she is on vacation, at a meeting, or absent. One comment suggested
deleting this word. Another comment asked how one is to ascertain the
availability of the examinee's physician at the time a report is
generated.
FDA advises that, in the proposed regulation, communication of
mammography results to examinees and communication of results to health
care providers are addressed in separate sections. As with the interim
regulations, the proposed regulations require a facility to provide the
mammography report directly to the examinee if she does not have a
health care provider (Sec. 900.12(c)(2)(ii)). The issue of the
``availability'' of a physician is addressed in the section of the
proposed regulation that covers communications of results to health
care providers, Sec. 900.12(c)(3).
Proposed Sec. 900.12(c)(3)(ii) is intended to address the specific
concern that arises when a mammography report reveals possible
malignancy. The proposed regulations would require the mammography
facility immediately to make reasonable attempts to communicate a
finding of possible malignancy directly to the health care provider or
a responsible designee, if the health care provider is not available.
``Not available'' is intended to mean ``not on call,'' ``not able to be
reached at this time,'' or other similar situations. Health care
providers normally have means of handling unexpected important health
matters concerning their examinees through coverage systems and the
proposed regulation recognizes this practice. The regulations are
intended to require reasonable attempts to notify the health care
provider or the entity designated by the referring health care provider
as responsible for patient care while the referring health care
provider is not available.
Questions were raised by the NMQAAC about retention of lay
notifications. Although the regulations do not require a facility to
keep a copy of the notification in the medical record, each facility
should have a system to monitor and verify that such a notice was sent
out for each examinee. In addition, samples of the lay notifications
which go to all examinees must be available for inspectors during
annual the MQSA inspections.
The results given in the lay notification are purposely labeled as
``results'' and not as ``assessment'' to avoid facilities having to use
one of the six assessment categories in proposed Sec. 900.12(c)(1)(iii)
and (c)(1)(iv). FDA encourages facilities to tailor these lay
notification letters of results to their clientele's literacy level,
and ethnic, cultural, and social sensibilities in order to maximize the
likelihood that these examinees will understand and appropriately
followup results.
Proposed Sec. 900.12(c)(2) recognizes that assessments indicating a
high probability of cancer need to be communicated with special care to
examinees, especially to those examinees without health care providers.
Examinees without a health care provider should receive person-to-
person communication, such as a telephone call, if it is at all
possible, when immediate followup is needed. In addition, in these and
other circumstances, such as when there are physical findings in the
absence of mammographic findings, when there are symptoms of breast
disease, or when a mammography report recommends further testing, the
proposed regulation requires each facility to have a formal system that
can refer an examinee who is without a health care provider. FDA
believes this proposed regulation codifies the role many radiologists
now assume with self-referred examinees.
The interim regulations require each facility to prepare a written
report of the results of each mammographic examination as soon as
possible. Two comments on the interim regulations stated that it is not
clear how a time limit of ``as soon as reasonably possible'' for
completing a report can be enforced. The comments suggested inclusion
of an actual time limit or replacing the word ``shall'' with
``should.''
FDA agrees that a timeframe should be specified. Proposed
Sec. 900.12(c)(3)(i) requires every mammography report to be prepared
and communicated to the health care provider as soon as possible, but
no later than 30 days from the date of the examination. Proposed
Sec. 900.12(c)(2) establishes the same timeframe for communication of
results to examinees. If the facility is gathering comparison films, an
initial report or notification can be sent to the examinee or health
care provider indicating preliminary results with an addendum to
follow.
4. Recordkeeping
One comment stated that the mammograms should be kept indefinitely,
noting particularly the need for retention of baseline mammograms.
FDA believes that the 10-year time period, which is set forth in
the statute itself, 42 U.S.C. 263b(f)(1)(G)(i), allows for adequate
prior information to be stored and used. The proposed regulations thus
adopt, in Sec. 900.12(c)(4)(i), the same retention periods required by
the interim regulations, which establish a minimum of 10 years in
situations where no additional mammography examinations are done for an
examinee. The time period may be longer, if required by State law.
One comment stated that the retention requirement in Sec. 900.12(e)
of the interim regulations requires facilities to retain all mammograms
for 10 years, because costs of determining after 5 years whether an
examinee has had additional mammograms will exceed storage costs.
FDA does not agree with this comment. One way to determine if
mammograms can be discarded is during filing of each new mammogram. At
that time, prior mammograms over 5 years old can be discarded if
clinically appropriate and if permitted by State law. This policy
allows for a case by case determination of record retention for
individual examinees. A facility can keep images longer than the
minimum set forth in the proposed regulations.
The same comment further requested that FDA revise the interim
regulations to require that mammography records be retained for the
same time periods that are otherwise required by State law, or if any
State lacks such a requirement, for a period of 7 years, which is the
time period specified by California.
Because the MQSA specifies minimum retention periods, the proposed
change would be inconsistent with the statute. The MQSA permits States
to have more stringent regulations, including requirements relating to
record retention. However, the 7-year California requirement for
retention of a single mammography examination would not be a more
stringent requirement, because it is less than the 10 years required by
the MQSA.
One comment noted that two mammography studies taken on consecutive
days would allow a facility to circumvent the requirement for 10-year
record retention.
[[Page 14874]]
FDA does not believe this comment raises a valid concern. Although
the first mammograms would be exempt from the 10-year retention period,
the second study would not be. It is doubtful that a facility would
discard the first study while maintaining the second and highly
improbable that any facility would do double studies simply to avoid
retaining a set of images.
One comment suggested that examinees should only have a right to
copies of mammograms, not to the originals, because of the increased
risk of loss or misplacement associated with examinees permanently
taking possession of their original films and reports. Another comment
from an interpreting physician noted great difficulty in obtaining
original mammograms for comparison purposes. This comment stated that
copied films are of inadequate quality when assessing the need for
surgery.
The issue of whether to require copies or originals to be sent to
facilities for clinical use or for comparison studies was discussed
with NMQAAC. Although NMQAAC members did acknowledge problems with loss
or misplacement of original films, there was general concern that many
copies were of such poor quality that they did not provide adequate
information. Sometimes only original films can provide the information
that will prevent a woman from undergoing unnecessary invasive
procedures, or confirm the need for such procedures. Thus, the NMQAAC
agreed that FDA should require that originals be sent for comparison
studies, as proposed in Sec. 900.12(c)(4)(ii). Under the proposed
regulations, examinees would need to request any transfer of their
films. Facilities could ask examinees to sign releases as part of the
request for the transfer of originals. A copy of the film could be kept
at the original facility until the original films are returned.
FDA and NMQAAC discussed the issue of facility closure and
disposition of the films and mammography reports. Members of the NMQAAC
advised FDA to require that facilities give the public notice of their
impending closure to allow a reasonable opportunity for examinees to
obtain or transfer films and reports; that facilities be required to
make financial plans to fulfill this notification requirement and to
transfer medical records in the event of cessation of mammography
activities; that facilities be required to notify the accreditation
bodies and FDA of the disposition of films and records; and that
facilities establish contingency locations for the transfer of
examinees' films and records.
The issue of medical record and film disposition in the event of a
closure is generic to the health care system. Facilities are required
under the interim and proposed regulations to report all changes in
status to their accreditation bodies, including plans to close. FDA
would encourage facilities to plan for an orderly transfer of records
in case of closure and to comply with applicable State laws concerning
record retention. However, FDA believes that additional Federal
regulations on this issue would be problematic with respect to
compliance and enforcement.
E. Quality Assurance--General
The MQSA requires each facility to establish and maintain a quality
assurance and quality control program to ensure the reliability,
clarity, and accuracy of interpretation of mammograms.
Proposed Sec. 900.12(d) establishes general requirements for
quality assurance (QA) programs.
Proposed Sec. 900.12(d)(1) requires the facility to assign
responsibility for various components of its QA program to individuals
who are qualified for their assignments and who shall be given adequate
time to perform their duties. Proposed Sec. 900.12(d)(1) also
establishes QA responsibilities for the lead interpreting physician,
interpreting physician, medical physicist, and quality control
technologist.
The agency developed these regulations in response to several
comments that objected to the medical physicist having primary
responsibility for the QA program under the interim regulations. The
comments noted that, especially if the medical physicist is a contract
employee, he or she may not have the authority to ensure that all the
actions necessary for proper implementation of the QA program are
carried out. In addition, NMQAAC members advised FDA that some aspects
of the QA program fall outside the medical physicist's area of
expertise.
The agency believes that the division of responsibility under the
proposed regulations addresses these concerns and satisfies the
requirements under the MQSA that certain responsibilities be assigned
to the physicist.
Proposed Sec. 900.12(d)(1)(i) states that the lead interpreting
physician shall have general responsibility for assuring that all of
the QA requirements are met. The regulation is intended to recognize
that, in order to carry out this responsibility effectively, the lead
interpreting physician must have authority to ensure that the
individuals involved with the QA program are qualified for their duties
and that they perform them properly.
The proposed regulation requires each facility to designate a
qualified individual as lead interpreting physician for purposes of the
QA program. However, the actual administrative title of the individual
is left to the facility. Decisions to assign other supervisory duties,
unrelated to the QA program, to the lead interpreting physician are
left to the discretion of each facility.
NMQAAC felt strongly that the individual assigned overall
responsibility for the QA program should be an interpreting physician.
NMQAAC recognized that this may cause some difficulty for a facility
whose interpreting physician is not normally at the facility. However,
the committee believed, and FDA agrees, that the benefits to be gained
when the individual overseeing the QA program has the skills of an
interpreting physician outweighed the difficulties.
Proposed Sec. 900.12(d)(1)(ii) establishes that all interpreting
physicians have a responsibility to assist and participate in the QA
program.
Proposed Sec. 900.12(d)(1)(iii) establishes that the primary
responsibility of the medical physicist in the QA program is related to
mammography equipment.
Proposed Sec. 900.12(d)(1)(iv) is intended to recognize that many
aspects of the QA program should be assigned to quality control
technologists. NMQAAC believed that it was essential that quality
control technologists be qualified to perform diagnostic radiology
examinations in order to be able to carry out adequately the
responsibilities normally assigned to them, including, for example,
responsibility for darkroom cleanliness, darkroom fog tests, processor
quality control, analysis of fixer retention in film, and retake
analysis. After some discussion, NMQAAC also concluded that the quality
control technologists need not be qualified to perform mammography
examinations specifically.
NMQAAC's position is reflected in the definition of quality control
technologist in proposed Sec. 900.2, published elsewhere in this issue
of the Federal Register. The definition would bar biomedical engineers,
manufacturer's service personnel, darkroom personnel, or individuals in
other positions from serving as quality control technologists unless
they were also qualified to perform diagnostic radiology examinations.
NMQAAC discussed the advisability of limiting performance of
certain QA
[[Page 14875]]
tasks exclusively to quality control technologists. NMQAAC concluded
that there might be certain situations where the absence of the
technologist might require a medical physicist or interpreting
physician to step in and perform these tasks in order to avoid the
temporary closure of a facility. The proposed regulations, therefore,
do not assign specific QA duties to particular individuals, as do the
ACR manuals.
Proposed Sec. 900.12(d)(2) outlines the necessary QA records the
facility will be required to keep. These records include: A QA manual;
a list assigning responsibility for the various aspects of the QA
program; records to show the qualifications of the individuals involved
in the program; and records that monitor the facility's implementation
of its QA program and resolution of any problems that occur. FDA
believes that such records are necessary to ensure that all employees
are aware of their QA responsibilities and trained to perform them and
that appropriate actions are taken to meet the goal of providing high
quality mammography.
F. Medical Outcomes Audit
Proposed Sec. 900.12(f) requires a mammography medical outcomes
audit program to be part of each facility's QA program. A mammography
medical outcomes audit is a systematic collection and analysis of
mammography results and the comparison of those results with data from
biopsy results.
The intent of the mammography medical audit is to provide an
objective measure of the interpretive ability of the interpreting
physician. This information can be useful for determining how the
interpreting physician performs from year to year and in comparison
with other interpreting physicians in the same facility and serving the
same examinee population.
As the medical outcomes audit data are collected and analyzed, a
facility should acquire information that can improve the interpretive
skills of the physicians. Some examples of this type of information
include: positive predictive value (PPV), cancer detection rate, and
percent of minimal cancers found. The medical literature describes
these and other outcome data that may prove useful in assisting the
interpreting physician in assessing and continuing to develop and
improve his or her interpretive skills. If one interpreting physician
is not ``doing as well'' as his/her colleagues in the same practice,
he/she may obtain additional training.
Although audits can be as detailed as necessary, the proposed
requirements in Sec. 900.12(f) for the medical outcomes audit program
are general in nature. There are several reasons for this. In drafting
the MQSA, Congress recognized that there is not consensus on the most
desirable methodologies for such audit programs and provided
authorization in 42 U.S.C. 263b(p) for research grants to study the
most desirable methods for the collection and use of outcomes data.
These research grants are administered by the National Cancer Institute
(NCI). FDA believes it would be premature to require specific
methodologies in the regulations before these studies are complete. In
addition, some facilities may not be able to collect data that are
meaningful if specific methodologies are mandated. The agency also
believes that each facility should have flexibility to design an audit
program that best serves its needs.
There was also concern expressed during discussion with NMQAAC that
facilities may be reluctant to collect medical audit data because of
concerns relating to legal liability and malpractice litigation.
In response to these concerns, FDA advises that the MQSA requires
the agency to establish standards for a quality assurance and quality
control program at each facility (42 U.S.C. 263b(f)(1)(A)). The agency
believes that data generated and reviewed for mammography audits are to
be used internally by each facility to improve individual and group
performance and should not necessarily be viewed as information that is
accessible to third parties.
The MQSA inspectors are trained to verify that a facility has a
medical audits system that tracks positive mammograms, seeks followup
results of surgical procedures, correlates those results with the
mammogram, and interprets and evaluates the resulting data at least
yearly for both the facility as a whole and for individual interpreting
physicians. Inspectors ordinarily will not copy the data as part of the
inspection and FDA has no current plans to ask facilities to provide
the agency with the results of their medical audits. Accordingly, it is
unlikely that the agency will have records in its possession that would
be responsive to requests from the public for medical audit data.
If it does become necessary for an MQSA inspector to collect
specific medical audit data, or if FDA should wish to obtain such data
in the future, the agency would protect audit results from public
disclosure in accordance with the Freedom of Information Act, the Trade
Secrets Act, and the agency's implementing public information
regulations. Aggregate data that does not identify the medical audit
outcomes of any particular facility would be available to the public.
The agency recognizes that State laws with respect to medical audit
information vary considerably. The 1993 ACHPR guidelines on ``Quality
Determinants of Mammography'' noted that very few broadly drawn
statutes protecting audit information from discovery are in place at
this time. Accordingly, the agency's commitment to protect such data
may not prevent disclosure in state courts through discovery or other
procedures established by State law. The agency believes, however, that
the medical audit requirements that are proposed in this rule are
general requirements that will not increase third-party requests for
medical audit data.
Proposed Sec. 900.12(f) requires each facility to establish and
maintain a mammography medical outcomes audit program that correlates
the results of biopsy and cytology examinations with the interpreting
physician's recommendations. A facility must correlate the biopsy or
cytology results of its positive mammograms with the interpreting
physician's recommendations and mammographic report. A positive
mammogram includes one that has an overall assessment of findings that
are suspicious or highly suggestive of malignancy, as set forth in
proposed Sec. 900.12(c)(1)(iii). The pathologist examines the tissue
sample and its cellular structure to determine whether or not the
tissue is cancerous.
Proposed Sec. 900.12(f)(4) requires each facility to designate at
least one interpreting physician to review the audit data at least
annually. This individual shall record the dates of the audit period(s)
and be responsible for identifying issues and analyzing results based
on this audit. This physician will notify other interpreting physicians
of these issues and results, and ensure that necessary corrective
actions are taken and documented. The proposal requires evaluations to
be made individually and collectively for all interpreting physicians
at the facility.
One comment noted that the preamble to the interim regulations
discussed preventing false negative results, but the only quality
assurance issue actually addressed in the interim regulations was the
tracking of positive readings.
FDA believes that it would be too burdensome to require facilities
to identify all false negative exams because, at the current time,
adequate methods are not available to track all negative readings. The
research studies funded by NCI grants may prove helpful
[[Page 14876]]
in future development of adequate methods for tracking false negative
results.
A related comment expressed the belief that it was imperative that
FDA spell out specific audit standards in the regulations. Another
comment suggested that the final regulations should include a
requirement for keeping statistics on additional procedures ordered by
each radiologist.
Again, NCI's research program may aid in determining whether the
collection and analysis of specific statistics should be mandated.
However, FDA believes that currently there is inadequate data to
justify making these suggestions regulatory requirements. NMQAAC
supported the agency's position at its January 1995 meeting.
One comment suggested that, instead of correlating surgical biopsy
results with mammography reports, a similar result can be achieved by
requiring documentation of all erroneous or indistinguishable
mammography results through a complaint program.
FDA believes the complaint mechanism and audit are substantially
different in intent; therefore, one cannot replace the other.
One comment did not understand how the radiology department could
use outcomes data, such as pathology reports, to improve the quality of
mammography or the performance of technologists.
FDA believes that an audit program helps to provide quality
assurance for the interpretation component of mammography by reviewing
outcome data for each interpreting physician and monitoring how that
physician is performing over time with respect to other interpreting
physicians in the same facility and serving the same patient
population. This review and analysis provides physicians with an
opportunity to evaluate and improve performance. As mentioned
previously, a physician may learn from an audit that he or she needs
additional training in particular skills. Technologists' performance
may be better evaluated through the repeat analysis process.
One comment mistakenly perceived a deficiency in the interim audit
regulations because the comment believed that the interim regulations
did not require followup of positive screening examinations. In fact,
the interim regulations do require the facility's medical audit to
track all positive mammograms and this requirement has been maintained
in the proposed regulations at Sec. 900.12(f)(1).
One comment suggested that all mammograms should be read a second
time by a second qualified physician to avoid unnecessary surgery and
emotional distress that can be associated with a false positive
reading, and to avoid lack of appropriate followup and treatment in the
case of a false negative reading.
Although the proposed regulations do not preclude this practice,
FDA has not required it due to a lack of consensus within the medical
community as to whether the benefits of double reading outweigh the
costs. FDA solicits further comments on this issue.
G. Mammography of Examinees With Breast Implants
The MQSA specifically requires that standards be established
relating to special techniques for mammography of examinees with breast
implants (42 U.S.C. 263b(f)(1)(H)). FDA interprets this requirement to
mean mammography of the breast for the early detection of breast
cancer, and not for imaging of the implant for rupture, leakage, or
other problems. The agency recommends that women who have had breast
surgery for cancer, including reconstruction with breast implants,
consult with their physician as to the appropriateness of mammography
for their particular situation.
Proposed Sec. 900.12(g) requires facilities to establish
procedure(s) to identify examinees with breast implants. The regulation
also sets forth general techniques facilities should follow for
mammographic examinations of women with breast implants. The proposed
requirements are flexible enough to allow efficient adoption of newer
imaging techniques as they become available.
One comment suggested that facilities should simply establish an
intake procedure to identify examinees with implants and to indicate
that special techniques are necessary. Another comment expressed
concern that, if an examinee does not notify the technician that she
has an implant, the mammogram may have to be redone.
FDA agrees with these comments and has proposed in
Sec. 900.12(g)(1) that facilities have a procedure to inquire if an
examinee has a breast implant at the time of mammogram scheduling.
Another comment suggested that there be a requirement for
``Eklund'' views (four views per breast). A similar comment stated
that, in order to obtain an adequate image of a breast with an implant,
both the breast and implant should be carefully manipulated so that the
maximum amount of breast tissue is imaged. A third comment, however,
stated that FDA should not mandate medical procedures in regulations.
FDA and NMQAAC agree that currently the Eklund procedures,
including appropriate individualized views, provide the best
mammographic means to visualize breast tissue for most women with
implants. There was also recognition, however, that other methods may
exist that would be preferable in particular cases.
In addition, breast implant imaging is evolving, and the agency
believes that it would be premature to limit this imaging by regulation
to only one technique.
However, in response to the comment that stated FDA should not
require medical procedures in regulations, the agency notes that the
MQSA does require FDA to establish standards and that the codification
of certain procedures in regulations may be appropriate when there is
consensus that such procedures are necessary to protect women and
assure accurate and safe mammography.
Another comment suggested that mammography facilities provide an
excellent opportunity for further data collection and health assessment
of examinees with implants.
In response to this comment, FDA notes that proposed Sec. 900.12(f)
requires mammography facilities to perform mammography medical outcomes
audits, and that these audits would include examinees with breast
implants.
Two comments were concerned about possible harm from the
compression of the implant.
To minimize this possibility, FDA has proposed in
Sec. 900.12(a)(2)(ii)(C) (published elsewhere in this issue of the
Federal Register) that the technologist have at least 5 hours of
training in imaging examinees with breast implants and in
Sec. 900.12(g)(3) that the supervising interpreting physician be
required to have training in mammography of examinees with breast
implants, including specialized mammographic techniques.
H. Facility Complaint Mechanism
In accordance with section 354(n)(3)(E) of the Public Health
Service Act (the PHS Act) as amended by the MQSA (42 U.S.C.
263b(n)(3)(E)), FDA has worked with the NMQAAC to develop mechanisms to
investigate consumer complaints about mammography services provided by
facilities. The preamble for proposed Sec. 900.4(g), published
elsewhere in this issue of the Federal Register, provides a thorough
discussion of the complaint mechanism, including the role of the
accreditation body in the process. In addition, FDA received a number
of written comments on the complaint
[[Page 14877]]
mechanism following the publication of the interim rules (58 FR 67558
and 58 FR 67565). These comments are also addressed in the preamble to
proposed Sec. 900.4(g).
While proposed Sec. 900.4(g) focuses on the responsibility of
accreditation bodies for consumer complaint processes, proposed
Sec. 900.12(h) establishes corresponding requirements for facilities to
develop a system to evaluate and resolve consumer complaints about the
mammography services that they provide. FDA believes that consumer
complaints can be resolved most easily at the individual facilities
providing the mammography services. Therefore, FDA encourages the
facilities to work diligently to resolve these complaints. However, in
the event that a facility is unable to resolve a complaint to the
consumer's satisfaction, proposed Sec. 900.12(h) requires the facility
to provide the consumer with adequate directions to file the complaint
with the facility's accreditation body.
Some members of the NMQAAC suggested that FDA require facilities to
post a sign that explains how to file consumer complaints or provide a
toll free telephone number for making such reports to the accreditation
body.
At this time, FDA is proposing not to mandate such requirements.
Instead, FDA believes facilities should have the flexibility to promote
their own consumer complaint mechanism to their clientele in a manner
that is most appropriate. The agency notes that the name of the
accreditation body is listed on the facility certificate, which the
facility is required by statute to post prominently within view of the
examinees.
Proposed Sec. 900.12(h) is intended to ensure that ``serious''
complaints within the purview of the MQSA are adequately addressed.
``Serious'' complaints are defined in proposed Sec. 900.2. FDA has
worked extensively with the NMQAAC in developing the proposed consumer
complaint mechanism and believes the proposed requirements meet
important consumer needs without imposing an undue burden on
facilities. Proposed Sec. 900.12(h) establishes minimum requirements
for facilities and provides them with the flexibility to institute
their own complaint mechanism procedures. FDA encourages facilities to
design their complaint mechanism procedures to be responsive to the
language, ethnic, and literacy differences among consumers served by
the facility.
I. Additional Clinical Image Review and Examinee Notification
Proposed Sec. 900.12(i) requires a facility to cooperate with FDA
in the investigation of concerns about the quality of the images
produced by that facility and in notification of examinees or the
public, should the investigation justify such notification.
Proposed Sec. 900.12(i)(1) complements the requirements in proposed
Sec. 900.4(f) of the accreditation body regulations, which are
published elsewhere in this issue of the Federal Register. Proposed
Sec. 900.4(f), among other things, would require accreditation bodies,
or other entities as specified by FDA, to perform additional clinical
image reviews when there are concerns or complaints about the quality
of images produced at a facility. Proposed Sec. 900.12(i)(1) requires
the facility to provide the clinical images for this review.
If FDA determines that any activity related to the provision of
mammography at a facility presents a serious risk to human health,
proposed Sec. 900.12(i)(2) would require a facility to notify
examinees, their designees, or the public of actions that may be
necessary to minimize the risk. Such notification may be used in cases
where diagnoses of possible malignancy may have been missed due to the
grossly inadequate performance of the facility. Examinees, their
designees, health professionals, or the public may have to be notified
so that they may take appropriate remedial action. For example,
affected examinees may wish to repeat examinations at another facility
or a member of the public may be able to contact an otherwise
unreachable examinee.
J. Revocation of a Facility's Accreditation and Revocation of FDA
Approval of a Facility's Accreditation Body
Proposed Sec. 900.13 establishes procedures for revocation of
facility accreditation and accreditation body approval. No comments
were received on these requirements as promulgated under the interim
regulations. The agency is proposing to retain these procedures with
the exception of the following changes and additions:
Proposed Sec. 900.13(a) gives FDA the discretion to revoke or
suspend the certificate of a facility whose accreditation has been
revoked by its accreditation body while the agency investigates what
actions to take with respect to the facility as a result of the
revocation.
Proposed Sec. 900.13(b)(1) gives the agency greater flexibility
with respect to facilities when FDA has revoked approval of the
accreditation body that accredited the facilities. Under the proposed
regulation, the certificates of the facilities would normally remain in
effect for up to 1 year after the accreditation body approval was
revoked. The change from the interim regulations, however, would allow
the agency to shorten this period if FDA determined that a facility had
been accredited fraudulently or posed a serious threat to public health
or safety.
Proposed Sec. 900.13(b)(2) incorporates the additional language the
agency has proposed in Sec. 900.11 in order to provide alternative
means of accreditation if the accreditation body cannot or will not
perform this function at some future date.
K. Suspension and Revocation of Certificates
FDA has revised Sec. 900.14 to set forth the bases for agency
action to suspend or revoke certificates and the procedural rights
available to facilities in these circumstances.
Proposed Sec. 900.14 tracks 42 U.S.C. 263b(i), the section of the
PHS Act that establishes provisions for suspension and revocation of
certificates. Proposed Sec. 900.14(a) provides that the agency may
suspend or revoke a certificate, following notice and opportunity for a
hearing in accordance with part 16 (21 CFR part 16), if FDA finds that
the owner, operator, or any employee of the facility: (1) Has been
guilty of misrepresentation in obtaining the certificate; (2) has
failed to comply with standards under Sec. 900.12; (3) has failed to
comply with reasonable requests for records or information; (4) has
refused to permit duly authorized inspections; (5) has violated or
aided and abetted violations of the MQSA or implementing regulations;
or (6) has failed to comply with prior sanctions imposed under 42
U.S.C. 263b(h).
Proposed Sec. 900.14(b) sets forth the bases for FDA to suspend a
certificate prior to holding a hearing. Here, too, the regulation
tracks the statutory provision. FDA may dispense with a hearing if, in
addition to making one of the findings listed above, the agency also
determines that: (1) Failure to comply with the required standards
presents a serious risk to human health; (2) the refusal to permit
inspection makes immediate suspension necessary; or (3) there is reason
to believe that the violative acts were intentional or otherwise rise
to a level that presents a threat to the public. These three
aggravating factors create circumstances in which the need to protect
the public health outweighs the harm to the affected facility, which
will have to wait a period of time for an
[[Page 14878]]
opportunity to demonstrate that the agency's determinations are
erroneous.
As set forth in the statute and in the proposed regulation at
Sec. 900.14(b)(1), FDA may take action before a hearing if the agency
determines that a facility's failure to comply with promulgated
standards presents a serious risk to human health.
FDA may also take such action following a determination that a
facility has refused reasonable requests for inspection. The agency
believes this provision is intended to provide discretion for the
agency to suspend a certificate in circumstances where recalcitrant
actions by a facility make it impossible for the agency to inspect and
investigate violations in order to determine whether the public is at
risk if the facility continues operation. Proposed Sec. 900.14(b)(2)
sets forth this basis for suspension prior to hearing.
The agency may also take action prior to hearing upon a
determination that a facility has violated or aided and abetted in the
violation of any provision of the statute or an implementing
regulation. FDA has interpreted this statutory provision to mean that
the agency may suspend prior to hearing when the compliance record of
the facility or other evidence demonstrates that responsible persons at
that facility are not disposed to comply with established standards or
with representations that were made during the certifying process.
Proposed Sec. 900.14(b)(3) states that the agency may suspend a
certificate prior to hearing when the agency determines that there is
reason to believe that the violation, or aiding and abetting of the
violation, was intentional or associated with fraud. Such behavior
cannot be tolerated without undermining the entire regulatory system
and is sufficiently egregious to warrant immediate action by the
agency.
As required by the MQSA and proposed in Sec. 900.14(c)(1),
facilities whose certificates are suspended prior to hearing will have
an opportunity for a hearing within 60 days of the suspension.
As a matter of general policy, FDA will not suspend certificates
without a hearing unless the agency believes that violations at the
facility or misconduct by responsible persons present a serious risk to
human health. Furthermore, suspension of a certificate, with or without
a hearing, is not a regulatory action FDA intends to initiate as a
matter of course. The MQSA favors voluntary compliance over regulatory
sanctions, and FDA is committed to working with facilities to correct
deficiencies rather than eliminating services. Suspension will be
necessary only in those cases where voluntary action or lesser
sanctions have proven ineffective.
L. Appeals of Adverse Accreditation Decisions
The MQSA includes a provision that requires the Secretary of DHHS
(the Secretary) to provide particular appeal procedures to a facility
that has been denied certification. Section 263b(d)(2) of the PHS Act
requires the Secretary (FDA, by delegation) to provide the facility
with a statement of the grounds upon which the denial is based, and
``an opportunity for an appeal in accordance with procedures set forth
in regulations published at 42 CFR 498 and in effect on the date of the
enactment of [the MQSA].'' (42 U.S.C. 263b(d)(2).)
Because FDA may not certify a facility that has failed to become
accredited, appeal of an FDA decision not to certify a facility will
become, in actuality, a review of the accreditation body's
determination that the facility did not meet necessary standards. For
this reason, FDA believes that the procedural rights that are
referenced in the statute should be available to the facility at the
time it receives an adverse accreditation decision from the
accreditation body to which it has applied.
FDA also believes that accreditation bodies should establish and
implement impartial procedures for review and reconsideration of
adverse accreditation decisions. As discussed elsewhere in this issue
of the Federal Register, FDA is requiring each accreditation body to
establish such reconsideration procedures and to inform any facility
that receives an adverse accreditation decision of the opportunity to
seek reconsideration by the accreditation body. Because it is the
accreditation body that has the most detailed knowledge of the facts
and alleged deficiencies of the facility's mammography practice, it is
the accreditation body that is in the best position to make suggestions
or review additional information that may result in accreditation.
FDA is proposing to require mammography facilities to seek
reconsideration by the accreditation body before appealing the adverse
decision to FDA. The agency believes this practice is in the best
interest of the facility, the agency, and the public. As discussed
above, the accreditation body will be in the best position to evaluate
any additional information the facility presents for reconsideration.
In addition, in order to perform an adequate evaluation of the adverse
accreditation decision, FDA will request and review materials provided
by the accreditation body as well as the facility. The internal
reconsideration process at the accreditation body level will permit the
areas of dispute to be clarified for FDA review and conserve the
limited resources of agency personnel.
A facility that is not satisfied with the result of the
accreditation body's reconsideration may appeal that determination to
the government. The regulations set forth at 42 CFR part 498, which are
referenced in the MQSA, are Health Care Financing Administration (HCFA)
regulations that were promulgated for appeals of decisions that among
other things deny providers of medical services the opportunity to
participate in Medicare. In order to implement a certification appeals
process that is in accordance with those provisions and appropriate to
the review of mammography accreditation decisions, FDA has consulted
with other agencies of the Department of Health and Human Services
(DHHS) that utilize and apply those procedures on a regular basis. As a
result of those cooperative efforts, FDA and other agencies of DHHS
have agreed that FDA's Division of Mammography Quality and Radiation
Programs (DMQRP) will handle all appeals for reconsideration of an
accreditation body's decision to deny accreditation. Hearing officers
of the DHHS' Departmental Appeals Board (DAB) will conduct formal
hearings for facilities that wish to appeal the FDA's reconsideration
decision, and the DAB itself will hear appeals of the hearing officer's
decision.
The procedures to be followed for these various appeals are
detailed in 42 CFR part 498. However, as discussed above, because those
are HCFA regulations, references to HCFA should be read as FDA for
purposes of the MQSA program. In addition, references to the Social
Security Appeals Council in 42 CFR part 498 should be read as the DAB;
although 42 CFR part 498 has not been amended to reflect the delegation
of authority, administrative law judges of the DAB have been handling
adversarial HCFA hearings since 1992 and the DAB itself has been
handling appeals of those hearing decisions.
Although 42 CFR part 498 is referenced in the MQSA and in FDA's
implementing regulations, FDA is also proposing that its MQSA
regulations broadly summarize the way these HCFA regulations will be
applied by FDA. The agency believes that summary of the various appeal
levels will make the procedures more accessible to facilities that wish
to challenge adverse
[[Page 14879]]
decisions. Applicable details about the various appeal procedures that
are not codified in FDA's proposed regulations can be found at 42 CFR
part 498.
A facility that is appealing an adverse accreditation decision,
regardless of the level of appeal, may not perform mammography services
until the decision has been reversed and the facility has been
certified by FDA.
M. Alternative Requirements
In the interim rule published in the Federal Register of September
30, 1994 (59 FR 49808), FDA established procedures for approval of
alternatives to the quality standards of Sec. 900.12. Such alternatives
can be approved if, among other things, the alternatives provide at
least as great an assurance of quality mammography as the original
standards. These procedures were developed to permit flexibility in
appropriate individual circumstances and to encourage further
improvement in the practice of mammography. The alternative requirement
procedures will allow the agency to permit the practice of mammography
to benefit rapidly from improvements and advancements without the need
first to amend regulations, which is often a lengthy process. Approved
alternative requirements will be made available for review in the
public docket file in FDA's Dockets Management Branch (address above).
In addition, notices of approved alternative requirements with wide
applicability will be published in the Federal Register.
The comment period on the interim regulations ended on December 29,
1994. No comments were received on the alternative requirements or, for
that matter, on any of the amendments. The agency has interpreted this
lack of response to indicate that members of the public did not object
to the content of the amendments.
NMQAAC discussed the alternative requirement regulation
(Sec. 900.18) at its February 1994 meeting. The regulation was
discussed again at NMQAAC's January 1995 meeting. The only suggestion
for change at the latter meeting came from a Federal liaison to NMQAAC
who recommended that Federal agencies be given the same opportunity as
State Governments to apply for approval of alternative requirements.
NMQAAC endorsed this suggestion and FDA has revised Sec. 900.18(b)(2)
accordingly.
III. 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.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on accreditation bodies, personnel requirements, and
quality standards for mammography equipment and quality assurance,
published elsewhere in this issue of the Federal Register, under
Executive Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354),
and under the Unfunded Mandates Reform Act. The analysis has addressed
the proposed requirements of these four rules as one unit for purposes
of determining their economic impact. The preamble to the proposed rule
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' published elsewhere in this issue of the
Federal Register, contains a brief summary of the cost and benefit
determination and the Regulatory Impact Study that details the agency's
calculation of these economic impacts and is available at the Dockets
Management Branch (address above) for review. FDA recognized that these
proposed regulations may have a disproportionate effect on small volume
mammography facilities and is currently collecting additional
information on the potential impact on this industry sector. The agency
requests comments that will assist it in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collection
are contained in the proposed rule ``Quality Mammography Standards;
General Preamble and Alternative Approaches'' published elsewhere in
this issue of the Federal Register with an estimate of the annual
reporting and recordkeeping burden.
The agency has submitted a copy of this proposed rule to OMB for
its review and approval of these information collections. Other
organizations and individuals desiring to submit 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
collection should be submitted by May 3, 1996.
VI. Request for Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. 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.
VII. Reference
The following reference has 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. ``Report on the Mammography Quality Standards Act of 1992,'' S.
Rept. 102-448, October 1, 1992.
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. Section 900.10 is revised to read as follows:
Sec. 900.10 Applicability.
The provisions of subpart B are applicable to all facilities under
the regulatory jurisdiction of the United States that provide screening
or diagnostic mammography services, with the exception of the
facilities of the Department of Veterans Affairs.
3. Section 900.11 is revised to read as follows:
Sec. 900.11 Requirements for certification.
(a) General. After October 1, 1994, a certificate issued by FDA is
required for
[[Page 14880]]
lawful operation of all mammography facilities subject to the
provisions of subpart B of this part. To obtain a certificate from FDA,
facilities are required to meet the quality standards in Sec. 900.12
and to be accredited by an approved accreditation body or other entity
as designated by FDA.
(b) Application--(1) Certificates. (i) In order to qualify for a
certificate, a facility must apply to an FDA-approved accreditation
body, or to another entity as designated by FDA. The facility shall
submit to such body or entity the information required in 42 U.S.C.
263b(d)(1).
(ii) Following the agency's receipt of the accreditation body's
decision to accredit a facility, or an equivalent decision by another
entity as designated by FDA, the agency will issue a certificate to the
facility, or renew an existing certificate, if the agency determines
that the facility has satisfied the requirements for certification or
recertification.
(2) Provisional certificates. (i) New facilities beginning
operation after October 1, 1994, are eligible to apply for provisional
certificates. The provisional certificate will enable the facility to
perform mammography and to obtain the clinical images needed to
complete the accreditation process. To apply for and receive a
provisional certificate, a facility must meet the requirements of 42
U.S.C. 263b(c)(2) and submit the necessary information to an approved
accreditation body or other entity designated by FDA.
(ii) FDA will issue a provisional certificate to a facility upon
determination that the facility has satisfied the requirements of
paragraph (b)(2)(i) of this section. A provisional certificate shall be
effective for up to 6 months from the date of issuance. A provisional
certificate cannot be renewed, but a facility may apply for a 90-day
extension of the provisional certificate.
(3) Extension of provisional certificate. (i) To apply for a 90-day
extension to a provisional certificate, a facility shall submit to its
accreditation body, or other entity as designated by FDA, a statement
of what the facility is doing to obtain certification and evidence that
there would be a significant adverse impact on access to mammography in
the geographic area served if such facility did not obtain an
extension.
(ii) FDA will issue a 90-day extension for a provisional
certificate upon determination that the extension meets the criteria
set forth in 42 U.S.C. 263b(c)(2).
(iii) There can be no renewal of a provisional certificate beyond
the 90-day extension.
(c) Reinstatement policy. A previously certified facility that has
allowed its certificate to expire, that has been refused a renewal of
its certificate by FDA, or that has had its certificate revoked by FDA,
may apply to have the certificate reinstated.
(1) Unless prohibited from reinstatement under paragraph (c)(4) of
this section, a facility applying for reinstatement shall:
(i) Contact an FDA-approved accreditation body or other entity as
designated by FDA to determine the requirements for reapplication for
accreditation;
(ii) Fully document its history as a previously provisionally or
fully certified mammography facility, including the following
information:
(A) Name and address of the facility under which it was previously
provisionally or fully certified;
(B) Name of previous owner/lessor;
(C) FDA facility identification number assigned the facility under
its previous certification; and
(D) Expiration date of the most recent FDA provisional or full
certificate; and
(iii) Justify application for reinstatement of accreditation by
submitting to the accreditation body or other entity as designated by
FDA, a corrective action plan that details how the facility has
corrected deficiencies that contributed to the lapse of, denial of
renewal, or revocation of its certificate.
(2) FDA will issue a provisional certificate to the facility if:
(i) The accreditation body or other entity as designated by FDA
notifies the agency that the facility has adequately corrected, or is
in the process of correcting, pertinent deficiencies; and
(ii) FDA determines that the facility has taken sufficient
corrective action since the lapse of, denial of renewal, or revocation
of its previous certificate.
(3) After receiving the provisional certificate, the facility may
lawfully resume performing mammography services while completing the
requirements for full certification.
(4) If a facility's certificate was revoked, that facility is not
eligible for reinstatement until at least 2 years from the date the
certificate was revoked if the facility is owned or operated by any
person who owned or operated the facility at the time of revocation.
4. Section 900.12 is amended by revising paragraphs (c) and (d) and
by adding new paragraphs (f), (g), (h), and (i) to read as follows:
Sec. 900.12 Quality standards.
* * * * *
(c) Medical records and mammography reports. (1) Contents and
terminology. Each facility shall prepare a written report signed by the
interpreting physician for each mammography examination performed under
its certificate. The mammography report shall include the following
information:
(i) The name of the examinee;
(ii) Date of examination;
(iii) 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 negative assessment, but benign finding(s)
can be described at the discretion of the interpreter;
(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;
(iv) In cases where no final assessment category can be assigned
due to incomplete work-up, ``Needs additional imaging evaluation''
shall be assigned as an assessment and reasons why no assessment can be
made shall be stated by the interpreting physician; and
(v) Recommendations made to the health care provider about what
additional actions, if any, should be taken. All clinical questions
raised by the referring health care provider shall be addressed in the
report to the extent possible.
(2) Communication of mammography results to the examinee. Each
facility shall maintain a system for providing written notification of
results of each mammographic examination to the examinee. The written
notification issued by the facility or by its designee shall be
communicated to the examinee as soon as possible, but no later than 30
days from the date of the mammography examination. If assessments are
``Suspicious'' or ``Highly suggestive of malignancy'' and if the
examinee has not named a referring health care provider, the facility
shall make reasonable attempts to communicate results to the examinee
immediately.
(i) The written notification of results provided to the examinee
shall include:
(A) The date of the examination;
[[Page 14881]]
(B) The results of the examination in lay terms; and
(C) A recommendation to the examinee on followup actions.
(ii) Examinees who do not name a health care provider to receive
the mammography report shall be sent the report described in paragraph
(c)(1) of this section, in addition to the written notification
described in paragraph (c)(2)(i) of this section.
(iii) Each facility that accepts examinees who do not have a
primary care provider shall maintain a system for referring such
examinees to a health care provider when clinically indicated.
(3) Communication of mammography results to health care providers.
When the examinee has a referring health care provider or the examinee
has named a health care provider, the facility shall:
(i) Provide a written report of the mammography examination,
including the items listed in paragraph (c)(1) of this section, to that
health care provider as soon as possible, but no later than 30 days
from the date of the mammography examination; and
(ii) If the assessment is ``Suspicious'' or ``Highly suggestive of
malignancy,'' make reasonable attempts to communicate with the health
care provider immediately, or if the health care provider is
unavailable, to a responsible designee of the health care provider.
(4) Recordkeeping. Each facility shall maintain mammography films
and reports in a permanent medical record of the examinee as follows:
(i) For a period of not less than 5 years, or of not less than 10
years if no additional mammograms of the examinee are performed at the
facility, or a longer period if mandated by State or local law; or
(ii) Until requested by an examinee to transfer the original
mammograms and copies of the examinee's reports to a medical
institution, or to a physician or health care provider designated by
the examinee, or to the examinee directly, and the records are so
transferred.
(iii) Any fee charged to examinees for providing the services in
paragraphs (c)(4)(ii) of this section shall not exceed the actual
documented costs associated with this service.
(d) Quality assurance--general. Each facility shall establish and
maintain a quality assurance program to ensure the safety, reliability,
clarity, and accuracy of mammography services performed at the
facility.
(1) Responsible individuals. Responsibility for the quality
assurance program and for each of its elements shall be assigned to
individuals who are qualified for their assignments and who shall be
given adequate time to perform these duties.
(i) Lead interpreting physician. The facility shall identify a lead
interpreting physician who shall have the general responsibility of
ensuring that the quality assurance program meets all requirements of
paragraphs (d) through (f) of this section. No other individual shall
be assigned or shall retain responsibility for quality assurance tasks
unless the lead interpreting physician has determined that the
individual's qualifications for, and performance of, the assignment are
adequate.
(ii) Interpreting physicians. All interpreting physicians
interpreting mammograms for the facility shall provide feedback on the
quality of the mammograms they interpret to the radiologic
technologists producing those mammograms and shall participate in the
facility's medical outcomes audit program.
(iii) Medical physicist. Each facility shall have available the
services of an individual or individuals, who meet the qualifications
of paragraph (a)(3) of this section, to survey mammography equipment
and oversee the equipment-related quality assurance practices of the
facility.
(iv) Quality control technologist. Responsibility for all
individual tasks within the quality assurance program not assigned to
the lead interpreting physician or the medical physicist shall be
assigned to quality control technologists.
(2) Quality assurance records. The facility shall maintain the
following documents related to its quality assurance program:
(i) A quality assurance manual describing the procedures that are
to be followed in meeting the requirements of paragraphs (e) and (f) of
this section, including ``action levels'' for corrective actions, as
defined in Sec. 900.2. The manual shall be readily available to all
staff members. It shall contain a sign-off page documenting that it has
been read and approved by the lead interpreting physician and the
medical physicist.
(ii) A current list of the individuals to whom quality assurance
responsibilities have been assigned and the duties assigned to them.
This list shall be readily available to all staff members.
(iii) Records to show that all staff members assigned
responsibilities in the quality assurance program are qualified to
conduct their assigned duties.
(iv) Records to show the data obtained during monitoring of the
facility's performance, the analysis of the monitoring data, the
problems detected and corrective actions carried out, and the
effectiveness of the corrective actions in resolving the problems.
These records shall be kept for each test specified in paragraphs (e)
and (f) of this section for a minimum of 1 year or until the test has
been performed two additional times at the required frequency,
whichever is longer.
* * * * *
(f) Quality assurance--mammography medical outcomes audit. Each
facility shall establish and maintain a mammography medical outcomes
audit program for followup based on mammographic assessments and to
correlate biopsy or cytology results with interpreting physicians'
recommendations. This program shall be designed to ensure the
reliability, clarity, and accuracy of the interpretation of mammograms.
(1) General requirements. Each facility shall establish a system
for reviewing outcome data from all mammography performed, in order to
followup on the disposition of positive mammograms and to correlate
biopsy or cytology results with interpreting physician's mammography
report.
(2) Data collection. Data shall be collected on an ongoing basis
for all examinees with positive mammograms.
(3) Frequency of audit analysis. An initial audit analysis shall be
conducted no later than 12 months after the date the facility became
fully certified. Subsequent audit analyses shall be conducted at least
once every 12 months from the date of the initial analysis.
(4) Reviewing interpreting physician. The facility shall designate
at least one interpreting physician to review the audit data at least
once every 12 months. This individual shall record the dates of the
audit period(s) and shall be responsible for identifying issues and
analyzing results based on this audit, notifying the other interpreting
physicians of these issues and results, and ensuring that necessary
corrective actions are taken and documented. Evaluations shall be made
individually and collectively for all interpreting physicians at the
facility.
(g) Mammographic procedure and techniques for mammography of
examinees with breast implants. (1) Each facility shall have a
procedure to inquire whether an examinee has a breast implant at the
time of mammogram scheduling.
(2) Except where contraindicated, or unless modified by a
physician's directions, examinees with breast implants undergoing
mammography shall have mammographic views to maximize the visualization
of breast tissue and optimize breast cancer detection.
[[Page 14882]]
(3) These mammographic examinations shall be supervised by an
onsite interpreting physician who is trained in mammography of
examinees with breast implants, including training in specialized
mammographic techniques of these examinees and training in interpreting
the mammograms of these examinees.
(h) Consumer complaint mechanism. Each facility shall:
(1) Establish a written and documented system for collecting and
resolving consumer complaints;
(2) Maintain a record of each serious complaint received by the
facility for at least 3 years from the date the complaint was received;
(3) Provide the consumer with adequate directions for filing the
complaint with the facility's accreditation body, if the facility is
unable to resolve a serious complaint to the consumer's satisfaction;
(4) Report unresolved serious complaints to the accreditation body
in a manner and timeframe specified by the accreditation body.
(i) Additional clinical image review and examinee notification.
(1) If FDA believes that image quality at a facility has been
severely compromised and presents a serious risk to human health, the
facility shall provide clinical images, as specified by FDA, for review
by the accreditation body or other entity designated by FDA. This
additional clinical image review will help the agency to determine
whether there is a need to notify affected examinees and the public.
(2) If FDA determines that any activity related to the provision of
mammography at a facility presents a serious risk to human health such
that examinee notification is necessary, the facility shall notify
examinees, their designees, or the public of action that may be taken
to minimize the effects of the risk. Such notification shall occur
within a timeframe specified by FDA.
5. Section 900.13 is revised to read as follows:
Sec. 900.13 Revocation of accreditation, and revocation of
accreditation body approval.
(a) FDA action following revocation of accreditation. If a
facility's accreditation is revoked by an accreditation body, the
agency may conduct an investigation into the reasons for the
revocation. If FDA determines that the revocation was justified, FDA
may take action, revoke or suspend the facility's certificate, or
require the submission and implementation of a corrective action plan,
whichever action or combination of actions will best protect the public
health.
(b) Revocation of FDA approval of an accreditation body.
(1) If FDA revokes approval of an accreditation body under
Sec. 900.6, the certificates of facilities previously accredited by
such body shall remain in effect for up to 1 year from the date of
revocation, unless FDA determines, in order to protect human health or
because the accreditation body fraudulently accredited facilities, that
the certificates of some or all of the facilities should be revoked or
suspended or that a shorter time period should be established for the
certificates to remain in effect.
(2) After 1 year from the date of revocation of approval of an
accreditation body, or within any shorter period of time established by
the agency, the affected facilities must obtain accreditation from
another accreditation body, or from another entity designated by FDA.
6. Section 900.14 is revised to read as follows:
Sec. 900.14 Suspension or revocation of certificates.
(a) FDA may suspend or revoke a certificate if FDA finds, after
providing the owner or operator of the facility with notice and
opportunity for an informal hearing in accordance with part 16 of this
chapter, that the owner, operator, or any employee of the facility:
(1) Has been guilty of misrepresentation in obtaining the
certificate;
(2) Has failed to comply with the standards of Sec. 900.12;
(3) Has failed to comply with reasonable requests of the agency for
records, information, reports, or materials that FDA believes are
necessary to determine the continued eligibility of the facility for a
certificate or continued compliance with the standards of Sec. 900.12;
(4) Has refused a reasonable request of a duly designated FDA
inspector, State inspector, or accreditation body representative for
permission to inspect the facility or the operations and pertinent
records of the facility;
(5) Has violated or aided and abetted in the violation of any
provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or
(6) Has failed to comply with prior sanctions imposed by the agency
under 42 U.S.C. 263b(h).
(b) FDA may suspend the certificate of a facility before holding a
hearing if FDA makes a finding described in paragraph (a) of this
section and also determines that:
(1) The failure to comply with required standards presents a
serious risk to human health;
(2) The refusal to permit inspection makes immediate suspension
necessary; or
(3) There is reason to believe that the violation or aiding and
abetting of the violation was intentional or associated with fraud.
(c) If FDA suspends a certificate in accordance with paragraph (b)
of this section:
(1) The agency shall provide the facility with an opportunity for
an informal hearing under part 16 of this chapter not later than 60
days from the effective date of the suspension;
(2) The suspension shall remain in effect until the agency
determines that:
(i) Allegations of violations or misconduct were not substantiated;
(ii) Violations of required standards have been corrected to the
agency's satisfaction; or
(iii) The facility's certificate is revoked in accordance with
Sec. 900.14(d).
(d) After providing a hearing in accordance with paragraph (c)(1)
of this section, the agency may revoke the facility's certificate if
the agency determines that the facility:
(1) Is unwilling or unable to correct violations that were the
basis for suspension; or
(2) Has engaged in fraudulent activity to obtain or continue
certification.
7. New Sec. 900.15 is added to subpart B to read as follows:
Sec. 900.15 Appeals of adverse accreditation and certification
decisions.
(a) The appeals procedures described in this section are available
only for adverse accreditation decisions that preclude certification or
recertification by FDA. Agency decisions to suspend or revoke
certificates that are already in effect will be handled in accordance
with Sec. 900.14.
(b) Upon learning that a facility has failed to become accredited,
FDA will notify the facility that the agency is unable to certify that
facility without proof of accreditation.
(c) A facility that has been denied accreditation is entitled to an
appeals process from the accreditation body, in accordance with
Sec. 900.7. A facility must avail itself of the accreditation body's
appeal process before requesting reconsideration from FDA.
(d) A facility that cannot achieve satisfactory resolution of an
adverse accreditation decision through the accreditation body's appeal
process is entitled to further appeal in accordance with procedures set
forth in this section and in regulations published at 42 CFR part 498.
(1) References to the Health Care Financing Administration (HCFA)
in 42
[[Page 14883]]
CFR part 498 should be read as the Division of Mammography Quality and
Radiation Programs, Center for Devices and Radiological Health, Food
and Drug Administration.
(2) References to the Appeals Council of the Social Security
Administration in 42 CFR part 498 should be read as references to the
Departmental Appeals Board.
(3) In accordance with the procedures set forth in subpart B of 42
CFR part 498, a facility that has been denied accreditation following
appeal to the accreditation body may request reconsideration of that
adverse decision from DMQRP.
(i) A facility must make its request for reconsideration to DMQRP,
within 60 days of the accreditation body's adverse appeals decision, at
the following address: Division of Mammography Quality and Radiation
Programs (HFZ-240), Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn:
Facility Accreditation Review Committee.
(ii) The request for reconsideration shall include 3 copies of the
following records:
(A) The accreditation body's original denial of accreditation;
(B) All information the facility submitted to the accreditation
body as part of the appeals process;
(C) A copy of the accreditation body's adverse appeals decision;
and
(D) A statement of the bases for the facility's disagreement with
the accreditation body's decision.
(iii) DMQRP will conduct its reconsideration in accordance with the
procedures set forth in subpart B of 42 CFR part 498.
(4) A facility that is dissatisfied with DMQRP's decision following
reconsideration is entitled to a formal hearing in accordance with
procedures set forth in subpart D of 42 CFR part 498.
(5) Either the facility or FDA may request review of the hearing
officer's decision. Such review will be conducted by the Departmental
Appeals Board in accordance with subpart E of 42 CFR part 498.
(6) A facility cannot perform mammography services while an adverse
accreditation decision is being appealed.
8. Section 900.18 is revised to read as follows:
Sec. 900.18 Alternative requirements for 42 U.S.C. 263b quality
standards.
(a) Criteria for approval of alternative standards. Upon
application by a qualified party as defined under paragraph (b) of this
section, the Director, Division of Mammography Quality and Radiation
Programs (the Director), may approve an alternative to a quality
standard under Sec. 900.12, when the Director determines that:
(1) The proposed alternative standard will be at least as effective
in assuring quality mammography as the standard it proposes to replace,
and
(2) The proposed alternative:
(i) Is too limited in its applicability to justify an amendment to
the standard; or
(ii) Offers an expected benefit to human health that is so great
that the time required for amending the standard would present an
unjustifiable risk to the human health; and
(3) The granting of the alternative is in keeping with the purposes
of 42 U.S.C. 263b.
(b) Applicants for alternatives. (1) Mammography facilities and
accreditation bodies may apply for alternatives to the quality
standards of Sec. 900.12.
(2) Federal agencies and State governments that are not
accreditation bodies may apply for alternatives to the standards of
Sec. 900.12(a).
(3) Manufacturers and assemblers of equipment used for mammography
may apply for alternatives to the standards of Sec. 900.12 (b) and (e).
(c) Applications for approval of an alternative standard. An
application for approval of an alternative standard or for an amendment
or extension of the alternative standard shall be submitted in an
original and two copies to the Director, Division of Mammography
Quality and Radiation Programs, Center for Devices and Radiological
Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850. The application for approval of an alternative
standard shall include the following information:
(1) Identification of the original standard for which the
alternative standard is being proposed and an explanation of why the
applicant is proposing the alternative;
(2) A description of the manner in which the alternative is
proposed to deviate from the original standard;
(3) A description, supported by data, of the advantages to be
derived from such deviation.
(4) An explanation, supported by data, of how such a deviation
would assure equal or greater quality of production, processing, or
interpretation of mammograms than the original standard;
(5) The suggested period of time that the proposed alternative
standard would be in effect; and
(6) Such other information required by the Director to evaluate and
act on the application.
(d) Ruling on applications. (1) The Director may approve or deny,
in whole or in part, a request for approval of an alternative standard
or any amendment or extension thereof, and shall inform the applicant
in writing of this action. The written notice will state the manner in
which the requested alternative standard differs from the agency
standard and a summary of the reasons for approval or denial of the
request. If the request is approved, the written notice will also
include the effective date and the termination date of the approval and
a summary of the limitations and conditions attached to the approval
and any other information that may be relevant to the approved request.
Each approved alternative standard will be assigned an identifying
number.
(2) Notice of an approved request for an alternative standard or
any amendment or extension thereof will be placed in the public docket
file in the Dockets Management Branch and may also be in the form of a
notice published in the Federal Register. The notice will state the
name of the applicant, a description of the published agency standard,
and a description of the approved alternative standard, including
limitations and conditions attached to the approval of the alternative
standard.
(3) Summaries of the approval of alternative standards, including
information on their nature and number, will be provided to the
National Mammography Quality Assurance Advisory Committee.
(4) All applications for approval of alternative standards and for
amendments and extensions thereof and all correspondence (including
written notices of approval) on these applications will be available
for public disclosure in the Dockets Management Branch, excluding
examinee identifiers and confidential commercial information.
(e) Amendment or extension of an alternative standard. An
application for amending or extending approval of an alternative
standard shall include the following information:
(1) The approval number and the expiration date of the alternative
standard;
(2) The amendment or extension requested and the basis for the
amendment or extension; and
(3) An explanation, supported by data, of how such an amendment or
extension would assure equal or greater quality of production,
processing, or
[[Page 14884]]
interpretation of mammograms than the original standard.
(f) Applicability of the alternative standards. Any approval of an
alternative standard, amendment, or extension may be implemented only
by the entity to which it was granted and under the terms under which
it was granted, except that when an alternative standard is approved
for a manufacturer of equipment, any facility using that equipment will
also be covered by the alternative standard. Other entities interested
in similar or identical approvals must file their own application
following the procedures of paragraph (c) of this section.
(g) Withdrawal of approval of alternative requirements. The
Director shall amend or withdraw approval of an alternative standard
whenever the Director determines that this action is necessary to
protect the human health or otherwise is justified by Sec. 900.12. Such
action will become effective on the date specified in the written
notice of the action sent to the applicant, except that it will become
effective immediately upon notification of the applicant when the
Director determines that such action is necessary to prevent an
imminent health hazard.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7830 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P