[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Proposed Rules]
[Pages 59750-59751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29563]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 98N-0728]
Quality Mammography Standards
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 that published in a document
entitled ``Quality Mammography Standards.'' The purpose of these
amendments is to eliminate a conflict between the mammography
regulations, which must be followed by all facilities performing
mammography, and FDA's Electronic Product Radiation Control (EPRC)
performance standards, which establish radiation safety performance
requirements for x-ray units, including mammographic systems.
DATES: Submit written comments on the proposed rule by January 4, 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 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 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
uniformly high quality mammography services. Since October 1, 1994,
these standards have been provided by interim rules published in the
Federal Register of December 21, 1993 (58 FR 67558 and 58 FR 67565) and
amended in the Federal Register of September 30, 1994 (59 FR 49808).
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.
FDA has subsequently discovered that some mammographic x-ray
systems will have difficulty meeting certain of the new requirements
because of design features that were used by the manufacturers in order
to ensure that their units met the agency's EPRC performance standards
for diagnostic x-ray systems. The purpose of these amendments is to
resolve this conflict.
II. Need for Proposed Amendments
The source of the conflict lies in the requirements for the
collimation of the x-ray field and the alignment of that field with the
image receptor found in Sec. 900.12(b)(5) and (e)(5)(vii)(A) (21 CFR
900.12(b)(5) and (e)(5)(vii)(A)) of the MQSA final regulations. Two
problems exist with these provisions as they appeared in the Federal
Register of October 28, 1997.
First, both of these provisions permit the x-ray field ``to extend
to or beyond the edges of the image receptor.'' This allowance was made
in response to the expressed desire of some mammography facilities to
have the capacity to ``blacken'' the film to the edges, a capacity that
is particularly useful when automated viewing devices are used. Masking
clear borders of mammography films is difficult to accomplish with such
devices. However, the manufacturers of all diagnostic x-ray systems,
including mammography systems, must comply with applicable performance
standards established by FDA. These performance standards currently
require that mammography systems be manufactured with collimation to
ensure that the x-ray field does not extend beyond the nonchest wall
edges of the image receptor.
It is possible for a mammography system to meet both of these sets
of standards as they are currently written. However, FDA has been
informed by one manufacturer that in the past, in order to be sure to
meet the EPRC standards, their systems were designed so that the x-ray
field does not reach the nonchest wall edges of the image receptor.
Such systems would not meet the final MQSA regulations as presently
written. Units of other manufacturers may have the same problem.
Without an amendment to the MQSA regulations, in order to be in
compliance, some facilities would have to choose among three courses of
action. The first would be to apply for and receive approval of an
alternative requirement for alignment under 21 CFR 900.18 of the MQSA
regulations that would allow the facility to continue using its system
unchanged. The second would be to purchase a retrofit of their system
under a variance to the performance standards that has already been
approved by FDA for one manufacturer. The third would be to purchase a
new system that meets both sets of existing requirements.
FDA is proposing to solve this first problem by changing
Sec. 900.12(e)(5)(vii)(A) so that the x-ray field will be allowed, but
not required as at present, to extend to or beyond the nonchest wall
sides of the image receptor. This would permit facilities whose systems
are not presently capable of ``blackening'' the films to these edges to
continue to use those systems without the need of either applying for
an alternative requirement or purchasing an expensive retrofit.
The second problem is that the limit on the extension of the x-ray
field
[[Page 59751]]
beyond all edges of the image receptor to ``within 2 percent of the
SID'', discussed at 62 FR 55852 at 55945 of the regulation preamble was
erroneously applied in the regulations only to the chest-wall side of
the image receptor. This omission raises the possibility of an
unnecessary radiation hazard to the patient if the x-ray field extends
an excessive amount beyond the nonchest wall edges of the image
receptor. The agency is proposing to remove the radiation hazard
concern by amending Sec. 900.12(e)(5)(vii)(A) to apply the 2 percent of
the source-image receptor distance (SID) extension limit to all edges
of the image receptor, in accordance with the intentions expressed in
the preamble.
Finally, FDA is also proposing to simplify the regulations by
dropping all mention of alignment from Sec. 900.12(b)(5), thus
consolidating all alignment requirements at one location in
Sec. 900.12(e)(5)(vii)(A). The portion of Sec. 900.12(b)(5) dealing
with the light field remains unchanged.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(i) 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 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 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 rule, if finalized,
will not have a significant 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 compliance cost estimate did not
include the possible added costs related to the alignment requirement
discussed previously, as the difficulty noted by the one manufacturer
was not foreseen during the development of the regulations. These added
costs would be minimal if an alternative requirement was applied for
and received but would be more significant if retrofitting or
purchasing of a new unit was carried out to meet the requirement.
However, amending the regulations as proposed by FDA would eliminate
the requirement leading to the possible extra costs and thus eliminate
any possible extra cost.
V. Paperwork Reduction Act of 1995
The agency has tentatively determined that this proposed 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, Mammography, 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 900.12 is amended by removing paragraph (b)(5)(i) and by
redesignating paragraph (b)(5)(ii) as paragraph (b)(5), by revising
newly redesignated paragraph (b)(5), and by revising paragraph
(e)(5)(vii)(A) to read as follows:
Sec. 900.12 Quality standards.
* * * * *
(b) * * *
(5) Light fields. For any mammography system with a light beam that
passes through the X-ray beam-limiting device, the light shall provide
an average illumination of not less than 160 lux (15 foot candles) at
100 cm or the maximum source-image receptor distance (SID), whichever
is less.
* * * * *
(e) * * *
(5) * * *
(vii) * * *
(A) All systems shall have beam-limiting devices that allow the
entire chest wall edge of the X-ray field to extend to the chest wall
edge of the image receptor and provide means to assure that the X-ray
field does not extend beyond any edge of the image receptor by more
than two percent of the SID.
* * * * *
Dated: September 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-29563 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F
