[Federal Register Volume 64, Number 116 (Thursday, June 17, 1999)]
[Proposed Rules]
[Pages 32443-32447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15293]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 99N-1502]
Quality Mammography Standards; Companion Document to Direct Final
Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing mammography. The purpose of the amendments is
to incorporate changes required by the Mammography Quality Standards
Reauthorization Act (MQSRA). This proposed rule is a companion document
to the direct final rule published elsewhere in this issue of the
Federal Register.
DATES: Comments on this proposal must be received by August 31, 1999.
If FDA receives no significant adverse comment on the provisions of
these regulations within the specified comment period, the agency
intends to publish a document confirming the effective date of the
final rule in the Federal Register within 30 days after the comment
period on the direct final rule ends. The direct final rule will be
effective November 1, 1999.
ADDRESSES: Submit written comments on the proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, Center for Devices
and Radiological Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20857, 301-594-3332.
SUPPLEMENTARY INFORMATION: This proposed rule is a companion to the
direct final rule published in the final rules section of this issue of
the Federal Register. This companion proposed rule is identical to the
direct final rule. This proposed rule will provide a procedural
framework to finalize the rule in the event the agency receives a
significant adverse comment and the direct final rule is withdrawn. FDA
is publishing the direct final rule because the rule contains direct
incorporations of statutory mandates, and FDA anticipates that it will
receive no significant adverse comments. If no significant comment is
received in response to the direct final rule, no further action will
be taken related to this proposed rule. Instead, FDA will publish a
confirmation document within 30 days after the comment period ends
confirming that the direct final rule will go into effect no later than
135 days after publication. Additional information about FDA's direct
final rulemaking procedures is set forth in a guidance published in the
Federal Register of November 21, 1997 (62 FR 62466).
If FDA receives significant adverse comments regarding this rule,
the agency will publish a document withdrawing the direct final rule
within 30 days after the comment period ends and will proceed to
respond to the comments under this rule using usual notice-and-comment
procedures. The comment period for this companion proposed rule runs
concurrently with the direct final rule's comment period. Any comments
received under this companion proposed rule will also be considered as
comments regarding the direct final rule. A significant adverse comment
is defined as a comment that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. It
should be remembered, however, that the requirements themselves were
established by the MQSRA. FDA must implement these new statutory
provisions.
In determining whether a significant adverse comment is sufficient
to terminate a direct final rulemaking, FDA will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a note-and-comment process. Comments that are frivolous,
insubstantial, or outside the scope of the rule will not be considered
a significant adverse comment under this procedure. For example, a
comment recommending a rule change in addition to the rule will not be
considered a significant adverse comment, unless the comment shows how
the rule would be ineffective without the additional change. In
addition, if a significant adverse comment applies to an amendment,
paragraph, or section of this rule and that provision can be severed
from the remainder of the rule, FDA may adopt as final those provisions
of the rule that are not the subject of a significant adverse comment.
I. Background
The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539)
was passed on October 27, 1992, to establish national quality standards
for mammography. The MQSA required that, to lawfully provide
mammography services after October 1, 1994, all facilities, except
facilities of the Department of Veterans Affairs, shall be accredited
by an approved accreditation body and certified by the Secretary of
Health and Human Services (the Secretary). To become accredited and
certified, a facility had to meet national quality standards to be
established by the Secretary. The authority to establish these
standards, to approve accreditation bodies, and to certify facilities
was delegated by the Secretary to FDA.
Facilities were initially accredited and certified if they met the
standards contained within the interim rules issued by FDA in the
Federal Register of December 21, 1993 (58 FR 67558 and 58 FR 67565),
and amended by another interim rule published in the Federal Register
of September 30, 1994 (59 FR 49808). More comprehensive standards were
proposed by FDA in the Federal Register of April 3, 1996 (61 FR 14856,
[[Page 32444]]
61 FR 14870, 61 FR 14884, 61 FR 14898, and 61 FR 14908). After some
revision in response to the approximately 8,000 comments received on
the proposed rule, a final rule was published in the Federal Register
of October 28, 1997 (62 FR 55852) (hereinafter referred to as the
October 1997 final rule). The effective date of most of the new
standards contained within the October 1997 final rule is April 28,
1999, but a few will not become effective until October 28, 2002.
On October 9, 1998, the MQSRA (Pub. L. 105-248) became law. The
basic purpose of the MQSRA was to extend the authorities established by
the MQSA until September 30, 2002. However, the MQSRA also contained a
requirement that was significantly different from the corresponding
requirement in the October 1997 final rule. Although this MQSRA
requirement will become effective on April 28, 1999, with or without
the amendment of the final rule, FDA is proposing to amend the final
rule to incorporate the change. The purpose of this proposed amendment
is to provide to the mammography facilities the convenience of being
able to find all of the quality standards within a single document
instead of having to consult both the October 1997 final rule and the
MQSRA and to avoid confusion as to the applicable reporting
requirement.
Other provisions of the MQSRA clarify the basis for some of the
requirements contained within the October 1997 final rule. FDA is also
amending the October 1997 final rule to conform its wording of those
requirements to that of the statute.
II. Changes in the Regulations
A. Reporting Requirements
Section 900.12(c)(2) (21 CFR 900.12(c)(2)) of the October 1997
final rule describes the requirements for communicating mammography
results to the patients. As published in the October 1997 final rule,
these requirements mandated that each mammography facility have a
system to ensure that the results of each examination are communicated
to the patient in a timely manner. Patients without a referring health
care provider were to be sent the report of the examination (as
described in Sec. 900.12(c)(1)) directly by the mammography facility,
along with a written notification or summary of the results in lay
terms. It was further required by the October 1997 final rule that such
self-referred patients should be referred to a health care provider
when clinically indicated.
In the case of patients with a referring health care provider,
Sec. 900.12(c)(3) required that the health care provider receive the
report of the examination. The facility's system for ensuring that
results reached the patient could utilize the services of that health
care provider to achieve that goal. There was no specific requirement
that a summary in lay terms be provided to the patient with a referring
health care provider.
The MQSRA amended the MQSA to specifically require that all
patients, not just self-referred patients, receive directly from the
mammography facility, a summary of the written report in terms easily
understood by a lay person. As previously noted, this MQSRA requirement
will go into effect on April 28, 1999. FDA is proposing to amend
Sec. 900.12(c)(2) to incorporate this new requirement.
B. Clarifications
The MQSRA at several points clarified the provisions of the MQSA
upon which certain requirements of the interim and final rules were
based. In contrast to the change in the patient reporting requirements,
these clarifications became effective on October 9, 1998, the date on
which the MQSRA became law. FDA is proposing to amend the regulations
to similarly clarify the wording of the October 1997 final rule on
these points.
1. Review Physicians
The most important function of the accreditation bodies approved by
FDA is to conduct a quality review of clinical images submitted by
facilities seeking accreditation. This review is the key factor in
determining if the facility should be accredited and then certified. It
has been recognized from the start of the MQSA program that the
physicians used by the accreditation bodies to review the clinical
images submitted by the facilities should meet qualifications beyond
those needed to serve as interpreting physicians in mammography
facilities. All accreditation bodies applying to FDA for approval must
demonstrate that their reviewing physicians have the high
qualifications necessary to perform such reviews before approval is
given.
In section 4, the MQSRA emphasized these points by defining the
physicians reviewing clinical images for the accreditation bodies as
``review physicians.'' In the MQSRA definition, it is further
recognized that the accreditation bodies can establish, with FDA
approval, additional qualifications for these review physicians beyond
the qualifications applicable to interpreting physicians in mammography
facilities.
FDA is proposing to add Sec. 900.2(yy) to incorporate the MQSRA
definition of ``review physician'' into the final rule. FDA is further
proposing to amend Sec. 900.4 in order to use the term review physician
at the appropriate points. In addition, since this term could be
confused with the term ``reviewing interpreting physician,'' presently
used in connection with the requirements for the mammography audit, FDA
is proposing to change the term, ``reviewing interpreting physician''
to ``audit interpreting physician'' in Sec. 900.12(f).
2. Patient Notification
The October 1997 final rule at Sec. 900.12(j) states that if FDA
determines that any activity related to the provision of mammography at
a facility presents a sufficiently serious risk to human health, the
agency may require the facility to notify the patients, their
physicians, and/or the public of actions that may be taken to minimize
this risk. This provision was established to aid FDA in fulfilling its
general responsibility under the MQSA to inform the public about
facilities against which the agency has been required to take action
for failure to meet the quality standards. In section 10(a), the MQSRA
provided a specific statement of the agency's authority to require
patient notification. FDA is proposing to amend the wording of
Sec. 900.12(j) to bring it into conformance with the wording of the
MQSRA on this point.
III. Environmental Impact
The agency has determined under 21 CFR 25.34(c) 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 the impacts of these proposed amendments under
Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C.
601-612), and under the Unfunded Mandates Reform Act (Pub. L. 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Regulatory
Flexibility Act requires agencies to analyze the impact of a rule on
small entities. The Unfunded
[[Page 32445]]
Mandates Reform Act requires (in section 201) that agencies prepare an
assessment of anticipated costs and benefits before enacting any rule
that may result in an expenditure in any one year by State, local, and
tribal governments, in the aggregate, or by the private sector of $100
million (adjusted annually for inflation).
As previously noted, the proposed amendments explained under
section II.B of this document merely clarify provisions already
contained within the October 1997 final rule. The impacts of the
provisions of that final rule were discussed in the preamble of the
final rule (62 FR 55852 at 55961), and are unchanged by the
clarifications. Any economic impact of the proposed amendments is
related solely to the change in the patient reporting requirement
mandated by the MQSRA. Given the statutory basis for extending this
requirement to all mammography facilities effective April 28, 1999, FDA
did not consider alternatives to implementing the requirements.
In the October 1997 final rule, FDA estimated that there were 9,800
mammography facilities that would be considered small. Moreover, FDA
previously estimated the impact of a requirement for sending a lay
summary of results to all patients during the development of its
proposed rule of April 3, 1996 (61 FR 14856), although that requirement
was removed from the October 1997 final rule in response to public
comments (Ref. 1). FDA believes that these estimates remain accurate.
The earlier estimate concerning the impact of required lay
summaries was based upon the assumption that an adequate lay summary of
results could be provided in the great majority of cases in a brief,
standardized format. Using this assumption, it was estimated that the
compliance cost per examination would be $0.94, including the labor of
the office worker and the cost of postage.
To convert this per examination cost to a national total, it was
necessary to make several other assumptions. Using the best data and
expert opinion available at the time, it was estimated that
approximately 25 million mammography examinations were conducted
annually in this country. Of this, it was estimated that 7.7 percent or
1,925,000 were examinations of self-referred patients. Because
facilities were already required by the MQSA (and by the interim rule)
to provide a lay summary of results to self-referred patients, that
portion of the cost of sending lay summaries had already been included
in the impact estimates made in association with the development of the
interim rule of October 27, 1993.
There remained then approximately 23,075,000 patients for which
this was potentially a new requirement. However, it was further
estimated that 40 percent of the patients were already receiving a lay
summary in some form from the facility at which they received their
examinations. Thus, the new requirement would lead to additional lay
summaries in only 60 percent of the referred examinations or
approximately 13,845,000. At $0.94 a lay summary, the added cost would
be slightly over $13 million a year.
Two major changes have occurred since the information upon which
these estimates were based was collected in late 1995. Most
significantly, through FDA's activities and those of other private and
government groups, public awareness of the need for regular mammography
examinations and public confidence that a high quality examination will
be received have both increased. As a result, the number of
examinations given per year has increased to an estimated 40 million.
This requires increasing the costs estimated previously by 60 percent.
Postage rates have also gone up $0.01 per letter thus the cost per lay
summary would increase from $0.94 to $0.95. The combined impact of
these two changes is to increase the estimate of the annual incremental
costs to meet this proposed new requirement to approximately $21
million.
For the great majority of cases, the assumption that the lay
summaries can be provided in brief, standardized format is valid.
However, in approximately 10 percent of the cases, the overall
assessment of the findings is expected to be ``suspicious'' or ``highly
suggestive of malignancy.'' In such cases, the facility is required to
``make reasonable attempts to ensure that the results are communicated
to the patients as soon as possible.''
Facilities that accept self-referred patients are already required
by the final rule to make such attempts for cases with an overall
assessment of ``suspicious'' or ``highly suggestive of malignancy.''
Based upon the assumption that the attempt would involve a 5 minute
telephone conversation of the interpreting physician with the patient,
a cost of $8.93 per examination was estimated. This cost would be in
addition to the $0.95 estimated cost for the written lay summary which
would still need to be sent. Assuming that this would be a new cost for
10 percent of the 60 percent of the referred patients among the 40
million receiving examinations annually, the incremental cost for these
contacts is approximately $21.4 million.
The total annual incremental cost due to this proposed new
requirement, therefore, would be approximately $42.4 million.
Previously, the annual cost for compliance with the interim and final
MQSA rules was estimated at $61.5 million (Ref. 2). Adding the cost of
compliance with this proposed new requirement brings the total annual
cost of compliance with the final rule as amended to approximately
$103.9 million.
Compliance with the proposed new requirement would also be expected
to increase the benefits from mammography. Mammography is the most
effective technique presently available for the early detection of
breast cancer. Early detection of breast cancer followed by prompt
treatment can avert mortalities that can result if treatment is delayed
until the cancer reaches a more advanced stage. In addition, the cost
and severity of the treatment methods will in general be less when the
cancer is treated at an early stage. Even in cases where the assessment
is negative, there will be an expected benefit arising from relieving
the anxiety of the patient about the possible results of the
examination through prompt reporting of results to her. But for these
benefits to be gained, the patient must be informed of the results of
her examination so that necessary followup actions can be promptly
taken. Unfortunately, although it is not possible to make a
quantitative estimate of the number of such cases, there have been
frequent complaints about patients receiving the results of their
examinations after an undue delay or not at all. Studies have also
shown that direct communication of results to the patient by the
mammography facility (as compared to traditional communication
procedures where the facility communicates only with the referring
provider), produces an improvement in compliance with followup
recommendations (Ref. 3). The new requirement should thus add to the
benefits expected from interim and final rules, which were previously
estimated to range from $284 to $408 million (61 FR 55986), primarily
due to a gain in averted mortalities (Ref. 2).
Based on these analyses, FDA has determined that the rule is
consistent with the principles set forth in the Executive Order, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act. The
wording of the requirement related to sending lay summaries to referred
patients directly parallels that of the MQSRA and so, in accordance
with the Executive Order, maximizes the net benefits to the extent
[[Page 32446]]
allowed by that statute. Similarly, in accordance with the Regulatory
Flexibility Act, the impact of the rule on small entities has been
analyzed. Finally, as noted previously, the incremental annual
expenditures (beyond those already incurred from the previous interim
and final rules) required by the rule are estimated at $42.4 million
and thus do not exceed $100 million in 1 year so the rule does not come
under the requirements of the Unfunded Mandates Reform Act.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the
information collection provisions are shown below with an estimate of
the annual reporting and recordkeeping burden. Included in the estimate
are the times for reviewing the instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Lay Summary of Examination Results to Patients
Description: This proposed rule would merely implement a statutory
information collection requirement; there is no additional burden
attributable to the regulation. The proposed rule would conform the
requirements of this section with the requirement of section 6 of Pub.
L. 105-248 that states: ``(IV) whether or not such a physician is
available or there is no such physician, a summary of the written
report shall be sent directly to the patient in terms easily understood
by a lay person.'' To produce the required lay summary, the mammography
facilities will review the medical report of each patient's examination
and collect from it the necessary information.
Respondent Description: Businesses and other for-profit
organizations, nonprofit organizations.
For consistency with the direct final rule to which this proposed
rule is a companion, FDA is following the PRA comment procedures for
direct final rules in this proposed rule. As provided in 5 CFR
1320.5(c)(1), collections of information in a direct final rule are
subject to the procedures set forth in 5 CFR 1320.10. Interested
persons and organizations may submit comments on the information
collection provisions of this proposed rule by August 31, 1999, to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. At the close of the 75-day
comment period, FDA will review the comments received, revise the
information collection provisions as necessary, and submit these
provisions to OMB for review. FDA will publish a notice in the Federal
Register when the information collection provisions are submitted to
OMB, and an opportunity for public comment to OMB will be provided at
that time. Prior to the effective date of the direct final rule, FDA
will publish a notice in the Federal Register of OMB's decision to
approve, modify, or disapprove the information collection provisions.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
VI. References
The following references have been placed on display at 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. Eastern Research Group, ``Cost and Benefit Analysis of
Regulations Under the Mammography Quality Standards Act of 1992-
Preliminary Final,'' March 14, 1996.
2. Eastern Research Group, ``Economic Impact Analysis of
Regulations Under the Mammography Quality Standards Act of 1992-
Final,'' October 7, 1997.
3. Agency for Health Care Policy and Research (AHCPR), ``Quality
Determinants of Mammography,'' AHCPR Pub. No. 95-0632, October 1994.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 900 be amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for part 900 continues to read as
follows:
Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
2. Section 900.2 is amended by adding paragraph (yy) to read as
follows:
Sec. 900.2 Definitions.
* * * * *
(yy) Review physician means a physician who, by meeting the
requirements set out in Sec. 900.4(c)(5), is qualified to review
clinical images on behalf of the accreditation body.
3. Section 900.4 is amended by revising the last sentence of
paragraph (a)(4); and by revising paragraphs (c)(3)(ii), (c)(5)
introductory text, (c)(5)(i), (c)(5)(ii), and (c)(6)(ii) to read as
follows:
Sec. 900.4 Standards for accreditation bodies.
(a) * * *
(4) * * * Such individuals who review clinical or phantom images
under the provisions of paragraphs (c) and (d) of this section or who
visit facilities under the provisions of paragraph (f) of this section
shall not review clinical or phantom images from or visit a facility
with which such individuals maintain a relationship, or when it would
otherwise be a conflict of interest for them to do so, or when they
have a bias in favor of or against the facility.
* * * * *
(c) * * *
(3) * * *
(ii) All clinical images submitted by a facility to the
accreditation body shall be reviewed independently by two or more
review physicians.
* * * * *
(5) Review physicians. Accreditation bodies shall ensure that all
of their review physicians:
(i) Meet the interpreting physician requirements specified in
Sec. 900.12(a)(1) and meet such additional requirements as have been
established by the accreditation body and approved by FDA;
(ii) Are trained and evaluated in the clinical image review
process, for the types of clinical images to be evaluated by a review
physician, by the accreditation body before designation as review
physicians and periodically thereafter; and
* * * * *
(6) * * *
(ii) If a review physician identifies a suspicious abnormality on
an image
[[Page 32447]]
submitted for clinical image review, the accreditation body shall
ensure that this information is provided to the facility and that the
clinical images are returned to the facility. Both shall occur no later
than 10-business days after identification of the suspected
abnormality.
* * * * *
4. Section 900.12 is amended by revising paragraphs (c)(2) and
(f)(3) and the first sentence of paragraph (j)(2) to read as follows:
Sec. 900.12 Quality standards.
* * * * *
(c) * * *
(2) Communication of mammography results to the patients. Each
facility shall send each patient a summary of the mammography report
written in lay terms within 30 days of the mammographic examination. If
assessments are ``Suspicious'' or ``Highly suggestive of malignancy,''
the facility shall make reasonable attempts to ensure that the results
are communicated to the patient as soon as possible.
(i) Patients 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 within 30 days, in addition to the written
notification of results in lay terms.
(ii) Each facility that accepts patients who do not have a health
care provider shall maintain a system for referring such patients to a
health care provider when clinically indicated.
* * * * *
(f) * * *
(3) Audit interpreting physician. Each facility shall designate at
least one interpreting physician to review the medical outcomes audit
data at least once every 12 months. This individual shall record the
dates of the audit period(s) and shall be responsible for analyzing
results based on this audit. This individual shall also be responsible
for documenting the results and notifying other interpreting physicians
of their results and the facility aggregate results. If followup
actions are taken, the audit interpreting physician shall also be
responsible for documenting the nature of the followup.
* * * * *
(j) * * *
(2) If FDA determines that the quality of mammography performed by
a facility, whether or not certified under Sec. 900.11, was so
inconsistent with the quality standards established in this section as
to present a significant risk to individual or public health, FDA may
require such facility to notify patients who received mammograms at
such facility, and their referring physicians, of the deficiencies
presenting such risk, the potential harm resulting, appropriate
remedial measures, and such other relevant information as FDA may
require. * * *
Dated: June 9, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15293 Filed 6-16-99; 8:45 am]
BILLING CODE 4160-01-F
