[Federal Register Volume 63, Number 204 (Thursday, October 22, 1998)]
[Rules and Regulations]
[Pages 56555-56559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28148]


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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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