[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