[Federal Register: October 22, 1998 (Volume 63, Number 204)]
[Rules and Regulations]
[Page 56555-56559]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc98-17]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 95N-0192]
RIN 0910-AA24

Quality Mammography Standards; Correcting Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting its
regulations governing mammography, published in a document entitled
``Quality Mammography Standards'' that appeared in the Federal Register
of October 28, 1997. The regulations are effective April 28, 1999;
except Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which
become effective October 28, 2002. The October 28, 1997, document was
published with some inadvertent typographical errors. Some of those
errors were corrected in a document entitled ``Quality Mammography
Standards; Correction'' that appeared in the Federal Register of
November 10, 1997, but additional typographical errors occurred in the
publication of this document. In addition, since November 10, 1997,
certain other problems with the text of the regulations have been
identified that, if uncorrected, would lead to unforeseen and
undesirable consequences. This document corrects those errors.

EFFECTIVE DATE: The corrections are effective April 28, 1999, except
corrections to Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B),
which become effective October 28, 2002.

FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, 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

    The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539)
was signed on October 27, 1992, to establish national quality standards
for mammography. The MQSA required that, to provide mammography
services legally after October 1, 1994, all facilities, except
facilities of the Department of Veterans Affairs, be accredited by an
approved accreditation

[[Page 56556]]

body and certified by the Secretary of Health and Human Services (the
Secretary). The authority to approve accreditation bodies and to
certify facilities was delegated by the Secretary to FDA.
    A specific requirement of the MQSA was that quality standards be
established for mammographic equipment and practices, including quality
assurance and quality control programs. Mammography facilities had to
meet these standards to become accredited and certified. The standards
were intended to replace the patchwork of Federal, State, and private
standards existing in 1992 to ensure that all women nationwide receive
high quality mammography services.
    On December 14, 1993, the President signed legislation granting
interim rule authority to the Secretary (and by delegation to FDA) to
issue interim quality standards under the MQSA. In the Federal Register
of December 21, 1993 (58 FR 67558 and 67565), FDA issued rules
establishing interim standards for the approval of accreditation bodies
and for the certification of mammography facilities. These standards
were amended by another interim rule published in the Federal Register
of September 30, 1994 (59 FR 49808). Since October 1, 1994, the
effective date of the MQSA requirements, these interim standards have
governed the approval of accreditation bodies and the accreditation and
certification of mammography facilities.
    On April 3, 1996, FDA proposed final regulations to replace the
interim regulations (61 FR 14856, 14870, 14884, 14898, and 14908).
Developed with strong congressional encouragement, these proposed final
regulations reflected FDA's belief that more comprehensive quality
standards would further optimize facility performance. After analysis
of the extensive public comments received on the proposed regulations,
revisions were made and a final rule was published on October 28, 1997
(62 FR 55852). The effective date for most of the final rule is April
28, 1999. A few equipment and equipment quality assurance requirements
do not become effective until October 28, 2002.
    During the preparation of the final rule for publication, a number
of typographical errors, some with a significant impact, occurred. Some
of these errors were corrected in a republication of November 10, 1997
(62 FR 60614), but in the process additional errors occurred. In the
subsequent months, further errors have been discovered and certain
other problems, with unforeseen significant consequences, have been
identified. The purpose of the amendments is to correct these remaining
problems in part 900 (21 CFR part 900).

II. Need for Amendments

A. Section 900.2(d)--Air Kerma

    In the definition of ``air kerma,'' an editorial error in the
November 10, 1997, republication led to the radiation dose unit, the
rad, being identified as an abbreviation for the angular measurement
unit of the radian. The amendment eliminates mention of the radian. The
opportunity to amend this definition was also used to more precisely
state the relationship between the several radiation quantities and
units. The equal sign between 1 Gray and 114 roentgens was replaced
with the statement that ``In air, 1 Gy of absorbed dose is delivered by
114 roentgens (R) of exposure.''

B. Section 900.12(a)(2)(ii)--Mammography Requirements

    This paragraph provides alternative ways for the technologist to
meet the requirement to have adequate initial training in the
performance of mammography examinations. The technologist must complete
at least 40 hours of training specific to mammography, including
training and experience in certain identified areas, or ``* * * prior
to April 28, 1999 must have qualified as a radiologic technologist
under paragraph (a)(2) of this section * *  *.'' Under the second
option, qualification as a radiologic technologist would have to have
been achieved under the interim regulations, as they are effective
until April 28, 1999. A reader could, however, misinterpret this
reference to paragraph (a)(2) as meaning (a)(2) of the final
regulations. To avoid such a misinterpretation, FDA is clarifying this
requirement by adding the words ``of FDA's interim regulations'' after
the word ``section.'' This would make the wording of this
``grandparenting'' provision identical with that used in defining a
similar grandparenting provision for interpreting physicians.

C. Section 900.12(a)(2)(iv) and (a)(3)(iii)(B)--Continuing Experience
Requirements of the Radiologic Technologist and the Medical Physicist

    The present wording of the final rule requires that these
requirements be met ``following the second anniversary date of the end
of the calender quarter'' during which the technologist or physicist's
initial requirements were met ``or of October 28, 1997, whichever is
later.'' For most radiologic technologists and medical physicists, this
wording means that they would be checked during inspections for
compliance with this requirement beginning after January 1, 2000. This
date is well after the effective date of the regulations; however, for
some time after this date, the 24-month averaging period, during which
compliance would be assessed, begins before the effective date of the
final rule. To avoid such a retroactive effect of the regulation, the
date in these two provisions is changed from October 28, 1997 (the date
of publication of the final rule), to April 28, 1999 (the effective
date of the final rule). This means that checking for compliance with
these requirements during inspections will begin after June 30, 2001,
and in all cases, the 24-month averaging period will fall completely
after April 28, 1999.
    The phrase ``preceding the inspection,'' which should have modified
the calendar quarter by the end of which a radiologic technologist or
medical physicist must meet certain requirements, was also erroneously
omitted in these two sections. FDA is amending these sections to
include this phrase. The options for the continuing experience
requirement, thus would read ``* * * the 24 months immediately
preceding the date of the facility's annual MQSA inspection or the last
day of the calendar quarter preceding the inspection or any date in
between * * *.'' This will eliminate any confusion over what calendar
quarter is referred to. It will also make the wording of the end point
options identical to those for the continuing experience requirement of
the interpreting physician and to those of the continuing education
requirement for interpreting physicians, radiologic technologists, and
medical physicists, as was intended.

D. Section 900.12(a)(3)(iii)(B)--Continuing Experience of the Medical
Physicist

    A typographical error led to the word ``or'' in ``* * * within a
10-month period or a specific unit * * *'' being changed to ``on,''
significantly confusing the meaning of the requirement. Similarly the
phrase ``the total mammography unit survey,'' preceding the word
``requirement,'' was not replaced with ``this'' as intended, again
leading to confusion over the exact requirement. The amendments replace
``on'' with ``or'' and replace ``the total mammography units survey''
with ``this.''

[[Page 56557]]

E. Section 900.12(c)(4)(i)--Maintenance of Records

    A typographic error of serious consequences was made in the
citation in this provision to ``paragraph (c)(3)(ii) of this section.''
The citation should be to ``paragraph (c)(4)(ii).''

F. Section 900.12(c)(4)(ii)--Transfer of Records

    The editor's note to move the word ``by'' from this requirement
from after to before the words ``on behalf of'' was not accomplished
during the final production of the document. The amendment moves this
word, thus making the requirement clearer.

G. Section 900.12(d)(2)--Quality Assurance Records

    As discussed in the preamble to the final regulations (62 FR 55852
at 55936 and 55937), the recordkeeping requirements for the quality
assurance program contained in the proposed final regulations,
published April 3, 1996, were simplified in the final regulations. The
rewording unfortunately created two possible interpretations of the
list of records that must be kept. The intended interpretation is that
the records ``concerning employee qualifications to meet assigned
quality assurance tasks'' would be the first on the list of categories
of required records that continues with the categories of ``mammography
techniques and procedures, quality control * * *.'' However, it is also
possible to interpret this as saying that the required records are of
employee qualifications to meet assigned quality assurance tasks,
employee qualifications for mammography techniques and procedures,
employee qualifications for quality control, and so forth. Two changes
were made in order to leave only the interpretation that the preamble
discussion shows was intended. First, the words ``employee
qualifications to meet assigned quality assurance tasks'' was moved
from first to last in the list of records that must be kept. Second,
the word ``these'' beginning the second sentence of the requirement was
changed to ``the.''

H. Section 900.12(e)(1)--Daily Quality Control Tests

    The preamble to the final regulations (62 FR 55852 at 55938) stated
that the agency would replace the word ``examinations'' with ``films''
and the word ``performed'' with ``processed.'' Each word appeared twice
in the paragraph, but only one set of words was replaced. FDA is now
amending the rule to change the remaining set of words.

I. Section 900.12(e)(4)(iii)(B)--Compression Force After October 28,
2002

     The proposed final regulations, published April 3, 1996, required
that 5 years after publication, the compression device shall provide a
maximum compression from the power drive of between 111 newtons (25
pounds) and 200 newtons (45 pounds). As pointed out at two places ( 62
FR 55852 at 55942) of the preamble to the final regulations, after a
review of the comments received on this portion of the proposal, it was
decided to retain this requirement in the final rule. In the
regulations themselves, however, the upper limit was mistakenly stated
as 209 newtons (47 pounds). FDA is changing this figure to the intended
value of 200 newtons (45 pounds).

J. Section 900.12(e)(8)(ii)(A)--Tests Whose Failure Means That
Corrective Actions Must be Carried Out Before Use of the Failed
Component in Clinical Examinations

    The proposed final regulations of April 3, 1996, in
Sec. 900.12(e)(8)(ii) had required that corrective action be carried
out before further clinical use of the failed component, no matter
which of the quality control tests required in other parts of
Sec. 900.12(e) was failed. As discussed in (62 FR 55852 at 55942 and
55947) the preamble to the final rule, numerous comments were made on
this requirement, which also received significant attention from the
National Mammography Quality Assurance Advisory Committee (NMQAAC).
After consideration of the information provided to it, FDA concluded
that failure of only some tests was serious enough to require
corrective action before further use and that to apply this requirement
to all tests would disrupt facility operations without achieving a
compensating benefit. In the final regulations, the agency divided the
quality control tests into two groups. Section 900.12(e)(8)(ii)(A)
lists those tests whose failure is considered serious enough that the
corrective actions must be carried out before the failed component of
the mammography system is used for further patient examinations.
Section 900.12(e)(8)(ii)(B) lists those tests for which it was believed
the corrective action could be delayed for up to 30 days without
presenting a serious threat to the public health.
    Some errors were made in the editing of the regulations, however,
that caused them to depart from the division of the tests into the two
groups described in the preamble. The test required by
Sec. 900.12(e)(4)(i) was mistakingly listed in Sec. 900.12(e)(8)(ii)(A)
as Sec. 900.12(e)(5)(ii) and the tests in Sec. 900.12(e)(5)(iii) and
Sec. 900.12(e)(5)(v) were also mistakenly included in this group. FDA
is amending Sec. 900.12(e)(8)(ii)(A) so that it correctly reflects the
division of the tests into the two groups described in the preamble.

K. Section 900.12(e)(10)--Mammography Equipment Evaluations

    A typographical error will be corrected in the first sentence of
this paragraph by changing the word ``dissembled'' to ``disassembled.''

L. Section 900.12(f)(3)--Reviewing Interpreting Physician for the
Medical Outcome Audit

    An edit in the sequence of words ``for documenting the results and
for notifying other interpreting physicians'' in this provision was
overlooked in the final preparation of the regulations for publication.
As a result, a comma appeared instead of the words ``and for'' making
the sentence in which these words occur appear to be incomplete. FDA is
amending the regulation to eliminate this error.

III. Environmental Impact

    The agency has previously determined under 21 CFR 25.30(i) that
this final rule 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 was
required. The changes in these amendments do not alter this conclusion.

IV. Analysis of Impacts

    FDA has examined the impact of this rule under Executive Order
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended
by subtitle D of the Small Business Regulatory Fairness Act of 1996
(Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (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 agency believes that this rule is consistent with the regulatory
philosophy and principles identified in the Executive Order. In
addition, this rule is not a significant regulatory action as defined
by the Executive Order and so is not

[[Page 56558]]

subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The agency certifies that this final rule will not
have a significant negative economic impact on a substantial number of
small entities. This rule also does not trigger the requirement for a
written statement under section 202(a) of the Unfunded Mandates Reform
Act because it does not impose a mandate that results in an expenditure
of $100 million or more by State, local, or tribal governments in the
aggregate, or by the private sector, in any 1 year.
    FDA had previously estimated (62 FR 55852 at 55968) that the
expected average annual benefits from the final regulations would range
between $181.7 to $262.7 million. Average annual compliance costs were
estimated at $38.2 million.
    The amendment to Sec. 900.12(e)(4)(iii)(B) may act to reduce costs
somewhat from the changes estimated as presumably a compression limit
of 200 newtons can be achieved at less cost than the present limit of
209 newtons. However, the change in the requirement is relatively minor
and so the costs savings are not likely to be significant. None of the
other amendments will change the estimates of compliance costs.
    In summary, the effect of the amendments, if any, would be to
reduce very slightly the estimated average annual compliance level of
$38.2 million.

V. Paperwork Reduction Act of 1995

    FDA has determined that this final rule contains no additional
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

List of Subjects in 21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
900 is amended as follows:

PART 900--MAMMOGRAPHY

    1. The authority citation for 21 CFR 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 revising paragraph (d) to read as
follows:

Sec. 900.2   Definitions.

* * * * *
    (d)  Air kerma means kerma in a given mass of air. The unit used to
measure the quantity of air kerma is the Gray (Gy). For X-rays with
energies less than 300 kiloelectron volts (keV), 1 Gy = 100 rad. In
air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of
exposure.
* * * * *
     3. Section 900.12 is amended by revising the first sentence of
paragraph (a)(2)(ii), paragraphs (a)(2)(iv)(A) and (a)(3)(iii)(B); by
removing ``(c)(3)(ii)'' from paragraph (c)(4)(i) and adding in its
place ``(c)(4)(ii)''; by revising paragraphs (c)(4)(ii), the first
sentence of paragraph (d)(2), the introductory text of paragraph
(e)(1), paragraphs (e)(4)(iii)(B), and (e)(8)(ii)(A), the first
sentence of paragraph (e)(10), and paragraph (f)(3) to read as follows:

Sec. 900.12  Quality standards.

    (a) * * *
    (2) * * *
    (ii) Mammography requirements. Have, prior to April 28, 1999,
qualified as a radiologic technologist under paragraph (a)(2) of this
section of FDA's interim regulations of December 21, 1993, or completed
at least 40 contact hours of documented training specific to
mammography under the supervision of a qualified instructor. * * *
* * * * *
    (iv) Continuing experience requirements. (A) Following the second
anniversary date of the end of the calendar quarter in which the
requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section
were completed or of April 28, 1999, whichever is later, the radiologic
technologist shall have performed a minimum of 200 mammography
examinations during the 24 months immediately preceding the date of the
facility's annual inspection or the last day of the calendar quarter
preceding the inspection or any date in between the two. The facility
will choose one of these dates to determine the 24-month period.
* * * * *
    (3) * * *
    (iii) * * *
    (B) Continuing experience. Following the second anniversary date of
the end of the calendar quarter in which the requirements of paragraphs
(a)(3)(i) and (a)(3)(ii) of this section were completed or of April 28,
1999, whichever is later, the medical physicist shall have surveyed at
least two mammography facilities and a total of at least six
mammography units during the 24 months immediately preceding the date
of the facility's annual MQSA inspection or the last day of the
calender quarter preceding the inspection or any date in between the
two. The facility shall choose one of these dates to determine the 24-
month period. No more than one survey of a specific facility within a
10-month period or a specific unit within a period of 60 days can be
counted towards this requirement.
* * * * *
    (c) * * *
    (4) * * *
    (ii) Shall upon request by, or on behalf of, the patient,
permanently or temporarily transfer the original mammograms and copies
of the patient's reports to a medical institution, or to a physician or
health care provider of the patient, or to the patient directly;
* * * * *
    (d) * * *
    (2) Quality assurance records. The lead interpreting physician,
quality control technologist, and medical physicist shall ensure that
records concerning mammography technique and procedures, quality
control (including monitoring data, problems detected by analysis of
that data, corrective actions, and the effectiveness of the correction
actions), safety, protection, and employee qualifications to meet
assigned quality assurance tasks are properly maintained and updated. *
* *
* * * * *
    (e) Quality assurance--equipment--(1) Daily quality control tests.
Film processors used to develop mammograms shall be adjusted and
maintained to meet the technical development specifications for the
mammography film in use. A processor performance test shall be
performed on each day that clinical films are processed before any
clinical films are processed that day. The test shall include an
assessment of base plus fog density, mid-density, and density
difference, using the mammography film used clinically at the facility.
* * * * *
    (4) * * *
    (iii) * * *
    (B) Effective October 28, 2002, the maximum compression force for
the initial power drive shall be between 111 newtons (25 pounds) and
200 newtons (45 pounds).
* * * * *
    (8) * * *

[[Page 56559]]

    (ii) * * *
    (A) Before any further examinations are performed or any films are
processed using a component of the mammography system that failed any
of the tests described in paragraphs (e)(1), (e)(2), (e)(4)(i),
(e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;
* * * * *
    (10) Mammography equipment evaluations. Additional evaluations of
mammography units or image processors shall be conducted whenever a new
unit or processor is installed, a unit or processor is disassembled and
reassembled at the same or a new location, or major components of a
mammography unit or processor equipment are changed or repaired. * * *
* * * * *
    (f) * * *
    (3)  Reviewing 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 for notifying other
interpreting physicians of their results and the facility aggregate
results. If followup actions are taken the reviewing interpreting
physician shall also be responsible for documenting the nature of the
followup.
* * * * *

    Dated: October 6, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-28148 Filed 10-21-98; 8:45 am]
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