Quality Mammography Standards; General Preamble and Proposed Alternative Approaches

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its interim regulations issued under the Mammography Quality Standards

Act of 1992 (the MQSA). In addition, FDA is also setting forth ideas

for the application of alternative performance and outcome-based

standards to ensure quality mammography. FDA is soliciting comments on

these alternatives as possible ways of meeting the objectives of

Executive Order 12866, which requires Federal agencies to, where

feasible, specify performance objectives, rather than specifying the

behavior and manner of compliance and to avoid duplicative regulations.

Elsewhere in this issue of the Federal Register, FDA is proposing

amendments to the requirements for accreditation bodies, procedures for

facility certification and quality standards for mammography personnel,

equipment and practices, including quality assurance. These actions are

being taken to ensure adequate and consistent evaluation of mammography

facilities on a nationwide basis.

DATES: Written comments on the proposed rule by July 2, 1996. Written

comments on the information collections should be submitted by May 3,

1996.

ADDRESSES: Submit written comments on the proposed rule to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact

Study (RIS) is available at the Dockets Management Branch for review

between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies

of the RIS should be submitted to the Freedom of Information Staff

(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,

Rockville, MD 20857.

Submit written comments on the information collections to the

Office of Information and Regulatory Affairs, Office of Management and

Budget (OMB), New Executive Office Building, 725 17th St. NW., rm.

10235, Washington DC 20503, ATTN: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for

Devices and Radiological Health (HFZ-240), Food and Drug

Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. General Preamble

The MQSA (Pub. L. 102-539) was passed 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.

The MQSA was enacted in response to the growing incidence of breast

cancer and its associated mortality rate. Breast cancer is now the most

common nonskin cancer and is the second leading cause of cancer deaths

among women, after lung cancer. The American Cancer Society projects

that in 1995 there will be 180,000 new cases of breast cancer among

women in the United States (Ref. 1). Of these new cases, it is

estimated that approximately 46,000 of these women will die from the

disease. The lifetime risk of developing breast cancer is increasing.

In 1993, breast cancer was projected to affect 1 in 8 women in their

lifetime, as compared to 1 in 11 in 1980, 1 in 14 in 1960, and 1 in 20

in 1940 (Ref. 2).

Early detection of breast cancer, typically involving breast

physical examination and mammography, is the best means of preventing

deaths that can result when the diagnosis is delayed until the onset of

more advanced symptoms. The value of undergoing screening mammography

is that it can detect cancers that are asymptomatic. Mammograms can

reveal breast cancer up to 2 years before a woman or her doctor can

feel a lump. In addition, over 90 percent of these early stage cancers

can be cured (Ref. 3).

However, according to the General Accounting Office, a mammogram is

among the most difficult radiographic images to read. It must be of

high quality for the image to be interpreted correctly. If the image

quality is poor, the interpreter may miss an incipient cancerous

lesion. This false negative diagnosis could delay early treatment and

result in an avoidable death or mastectomy. Further, it is equally true

that poor quality images or faulty interpretations can lead to a false

positive diagnosis when normal tissue is misread as abnormal. This can

lead to needless anxiety for the examinee, costly additional testing,

and painful biopsies.

The Senate Committee on Labor and Human Resources held hearings on

breast cancer in 1992 and found a wide range of problems with

mammography practice in the United States: (1) Poor quality equipment,

(2) a lack of quality assurance procedures, (3) poorly trained

radiologic technologists and interpreting physicians, and (4) a lack of

facility inspections or consistent governmental oversight.

A. Provisions of the MQSA

The MQSA legislation was enacted to address these deficiencies in

mammography practice. Under the MQSA, Congress established a

comprehensive statutory scheme for the certification and inspection of

mammography facilities to ensure that, after October 1, 1994, only

those facilities that comply with minimum Federal standards for safe,

high-quality mammography services may lawfully continue to operate.

Operation after that date is contingent on receipt of an FDA

certificate attesting that the facility meets the minimum mammography

quality standards issued under section 354(f) of the Public Health

Service Act (the PHS Act)(42 U.S.C. 263b(f)). These standards are

intended to apply equally to screening and diagnostic mammography.

Specifically, the MQSA required the following:

(1) Accreditation of mammography facilities by private, nonprofit

organizations or State agencies that have met the standards established

by FDA for accreditation bodies and have been approved by FDA. The MQSA

requires a direct Federal audit of the accreditation bodies through

facility inspections by Federal inspectors. It also requires that, as

part of the overall accreditation process, actual clinical mammograms

from each facility be evaluated for quality by the accreditation body.

(2) An annual mammography facility physics survey, consultation,

and evaluation performed by a qualified medical physicist.

(3) Annual inspection of mammography facilities, to be performed by

FDA-certified Federal or

[[Page 14857]]

State inspectors. If State inspectors are used, the MQSA requires a

Federal audit of the State inspection program by direct Federal

inspections of a sample of State-inspected facilities.

(4) Establishment of initial and continuing qualification standards

for interpreting physicians, radiologic technologists, medical

physicists, and mammography facility inspectors.

(5) Specification of boards or organizations eligible to certify

the adequacy of training and experience of mammography personnel.

(6) Establishment of quality standards for mammography equipment

and practices, including quality assurance and quality control

programs.

(7) Establishment by the Secretary of a National Mammography

Quality Assurance Advisory Committee (NMQAAC). Among other things, the

NMQAAC is required to advise FDA on appropriate quality standards for

mammography facilities and accreditation bodies.

(8) Standards governing recordkeeping for examinee files and

requirements for mammography reporting and examinee notification by

physicians.

The MQSA replaced a patchwork of Federal, State, and private

standards in order to guarantee sufficient oversight of mammography

facilities to ensure that all women nationwide will receive high

quality mammography services.

B. Interim Regulations

On December 14, 1993, the President signed legislation (H. Rept.

2202) granting interim rule authority to the Secretary (and by

delegation, to FDA) to issue interim quality standards under MQSA. This

authorization was provided in recognition of the fact that FDA

certification of the over 10,000 mammography facilities in the United

States could not be accomplished by the October 1, 1994, statutory

deadline without streamlining the rulemaking process for issuing the

initial standards. Because of the urgent public health need for

national mammography standards, Congress decided to grant this interim

rule authority rather than extend the deadline to develop standards.

Under the interim rule legislation, FDA was authorized to issue

temporary interim regulations setting forth standards for approving

accreditation bodies and quality standards for mammography facilities.

Under the abbreviated process, Congress expected FDA to adopt

existing standards to the maximum extent feasible, such as those

established by the Health Care Financing Administration (HCFA), private

voluntary accreditation bodies such as the American College of

Radiology (ACR), and some States. The Secretary was not required to

consult with the NMQAAC in developing the interim regulations. However,

following issuance of the interim standards, Congress intended that FDA

proceed with the more extensive rulemaking procedures envisioned under

the MQSA, including consultation with the NMQAAC.

In the Federal Register of December 21, 1993 (58 FR 67558 and 58 FR

67565), FDA issued interim rules establishing requirements for entities

applying to serve as accreditation bodies and for facilities applying

to obtain FDA certification in order to continue legally providing

mammography services after October 1, 1994. These interim rules became

effective on February 22, 1994. They were amended by another interim

rule published in the Federal Register on September 30, 1994 (59 FR

49808).

There are several reasons why it is important to replace the

existing interim regulations on quality mammography standards with more

comprehensive final regulations, apart from strong congressional

encouragement for such action when the agency was granted interim

regulation authority. In a 1995 report by the Physician Insurers

Association of America, misdiagnosis of breast cancer remains the most

common charge against radiologists in malpractice situations. In

addition, there was considerable variation in clinical performance of

mammography facilities in 1992 and 1993 despite compliance with

existing voluntary accreditation standards that were similar to the

interim regulations published by FDA (Ref. 4). FDA believes that more

comprehensive final regulations would optimize facility performance.

The interim regulations, for reasons stated above, were based

primarily upon the voluntary standards of the American College of

Radiology (ACR) Mammography Accreditation Program (MAP). Applying these

standards to all facilities has had a significant impact on mammography

nationwide but evaluations of the ACR program (Ref. 5) have shown that

further improvement is possible through more comprehensive standards

than those of MAP.

This is especially true in the equipment area where the MAP

standards were minimal and where the FDA's authority under the Medical

Device Amendments to the Food, Drug, and Cosmetic Act is limited

because presently used mammography systems are pre-amendment devices.

To provide greater assurances of quality equipment performance (and to

meet a priority identified in ``The National Strategic Plan for the

Early Detection of Breast and Cervical Cancers'' (Ref. 7), the ACR,

with the Centers for Disease Control and Prevention had convened expert

committees to develop specifications for mammography equipment. The

reports of these expert committees were an important basis for the

equipment provisions in the proposed regulations.

Other portions of the proposed regulations, such as those providing

standards for imaging patients with breast implants, are required by

the MQSA. In addition, some of the details contained in the proposed

regulations, such as requirements to ensure that personnel have

practical training on equipment they use, reflect areas of concern that

were inadvertently neglected in the interim regulations.

For all of these reasons, therefore, it is necessary to replace the

interim regulations with more comprehensive final regulations if the

highest quality mammography that is reasonably achievable is to be

obtained.

In issuing the interim regulations, FDA attempted to balance the

pressing need to put national mammography standards into effect with

the agency's concern that facilities be provided a reasonable amount of

time to comply with these standards. The interim regulations were

drafted and implemented to maximize lawful operation by facilities

under existing quality standards, and to ensure adequate examinee

access to quality mammography during the transition to more

comprehensive national standards.

For example, the ACR, a private, nonprofit association of

radiologists, began a voluntary Mammography Accreditation Program (MAP)

in 1987 to provide assurance of quality to examinees seeking services

at ACR-accredited facilities. Many of the requirements under the

interim rules were derived from the ACR's MAP program, as well as from

HCFA regulations and some State programs. The MAP included a number of

procedural and image quality requirements for facilities applying for

ACR accreditation, including an evaluation of actual clinical images

produced by each facility. In the absence of a national regulatory

requirement, only those facilities that voluntarily sought

accreditation pursued the ACR accreditation process. Nevertheless, many

mammography facilities applied for and obtained ACR accreditation.

Historically, approximately 30 percent of the facilities that applied

for ACR

[[Page 14858]]

accreditation failed to become accredited on their first attempt,

although many of these were subsequently able to improve their services

and gain accreditation on a second attempt.

C. Accreditation and Certification

Before the October 1, 1994, statutory deadline, FDA approved the

ACR and the State of Iowa as accreditation bodies and issued

certificates to the more than 6,000 facilities (out of an estimated

total of 10,666 facilities in the United States) accredited by these

bodies. The States of Arkansas and California were also approved by FDA

as accreditation bodies and began accrediting mammography facilities

within their States after the statutory deadline. These facilities were

subsequently certified by FDA.

In addition, the MQSA permitted FDA to issue 6-month provisional

certificates to facilities whose applications for accreditation had not

been approved by the statutory deadline but were sufficiently complete

to be accepted for review by an FDA-approved accreditation body. The

statute also allowed FDA to extend a facility's provisional certificate

once, for up to 90 days, if: (1) The owner, lessor, or agent of the

facility could demonstrate that, without such an extension, access to

mammography in the geographic area served by the facility would be

significantly reduced; and (2) the owner, lessor, or agent described in

a report the steps that would be taken to qualify for full

certification (42 U.S.C. 263b(c)(2)).

In recognition of the fact that a large number of facilities were

working to meet accreditation standards at the same time, and cognizant

of the increased demands placed on accreditation bodies during the

initial implementation of the MQSA, FDA issued 6-month provisional

certificates on October 1, 1994, to facilities whose applications for

accreditation were sufficiently complete for review and which, on

preliminary examination, appeared reasonably likely to receive

accreditation. These 6-month provisional certificates were extendable

for an additional 90 days for those facilities that satisfied the

extension criteria under the statute (42 U.S.C. 263b(c)(2)) and had

diligently pursued accreditation, but had not yet completed all aspects

of the accreditation process before expiration of their provisional

certificate.

Of the more than 10,000 facilities that provide mammography

services in the United States, the vast majority have received full

accreditation and certification. By October 1, 1994, FDA had issued

approximately 6,000 certificates and 4,800 provisional certificates.

Moreover, over 50 percent of those facilities issued provisional

certificates on October 1, 1994, subsequently became accredited and

FDA-certified by March 31, 1994, which was the closing date for the 6-

month provisional period. The remainder of the provisionally certified

facilities satisfied the extension criteria and were granted a 90-day

extension to obtain accreditation and certification.

The agency estimates that 427 mammography facilities closed between

October 1993 and October 1994. These closings were due to a number of

reasons, including failure to apply for certification, voluntary

closure, and failure to successfully complete the accreditation

process. By April 26, 1995, 4 weeks after the end of the 6-month

provisional period, 153 additional facilities had to close either

because they did not pursue accreditation (57 facilities) or they

failed accreditation (96 facilities). Sometime during the 6-month

provisional certification period, 187 facilities voluntarily withdrew

from the accreditation process.

D. Onsite Inspection of Facilities

In accordance with the MQSA, FDA established an annual onsite

inspection program to monitor facility compliance with MQSA standards.

FDA has trained and certified inspectors from most States, and

inspection of mammography facilities began in January 1995. As of

February 21, 1996, 7,265 inspections had been conducted and the results

have been reported to the agency.

E. Role of the States

The MQSA explicitly states that nothing in the statute is intended

to limit the authority of any State to enact State laws relating to

mammography that are at least as stringent as the MQSA or regulations

under the MQSA (42 U.S.C. 263b(m)). In addition to ensuring that States

retain their authority to pass laws that raise mammography standards

even higher, Congress provided a significant role for States to play in

implementing the regulatory scheme and nationwide standards required by

the MQSA.

A State may apply to FDA to become an accreditation body to

accredit mammography facilities operating within the State. As earlier

described, three States--Iowa, California, and Arkansas--have been

approved to accredit the facilities operating within their respective

jurisdictions. A State also may apply to the agency to become the

certifying authority for mammography facilities operating within its

borders (42 U.S.C 263b(q)). The agency currently is conducting research

into various alternatives that would allow States to fulfill this role.

The statute also permits States to perform annual onsite facility

inspections to ensure that facilities operating within the State are

performing quality mammography (42 U.S.C 263b(g)). To date, the

District of Columbia, Puerto Rico, New York City, and all of the

States, except New Mexico, have negotiated contracts with the agency to

perform these annual inspections.

Facilities located in States that elect to serve as accreditation

bodies may elect to be accredited either by the State or the ACR, a

private national approved accreditation body. Both types of

accreditation bodies are audited by FDA to ensure that MQSA standards

are being satisfied.

As mentioned above, most States contract with FDA to perform the

annual inspection required under MQSA. These inspections are subject to

audit by FDA. In those cases where States do not do the inspection,

Federal personnel conduct the required annual inspection.

States' participation and implementation of MQSA is funded in a

variety of ways. Because the MQSA provides for but does not mandate a

particular level of State involvement in the mammography program, a

State can choose to participate at a level that does not require the

appropriation or expenditure of State funds. States acting as

accreditation bodies may charge and collect a reasonable fee from the

facilities which seek the States' accreditation. States that currently

participate in the annual onsite inspection of facilities are paid by

FDA through contract. The agency charges the facilities a reasonable

inspection fee for this service in accordance with 42 U.S.C 263b(r).

Once the agency issues provisions to permit States to serve as

certifiers of mammography facilities, MQSA requires States that elect

voluntarily to serve in this capacity to devote adequate funds to the

administration and enforcement of MQSA requirements.

F. Development of Proposed Regulations

Coincident with the implementation of the interim rules, work was

proceeding on the development of proposed regulations to replace the

interim rules. As discussed previously, the MQSA established an

advisory committee (NMQAAC) to advise FDA in this effort. By statute,

the NMQAAC is to consist of 13 to 19 members, including health

professionals whose work focused significantly on

[[Page 14859]]

mammography, as well as representatives of consumer groups. The NMQAAC

was chartered on July 7, 1993. Nominations for members were accepted

until September 7, 1993. The first meeting of the NMQAAC was held

February 17 through 18, 1994. At that meeting, and in subsequent

meetings in April, July, and September 1994, the NMQAAC reviewed and

commented on drafts of portions of the proposed regulations developed

by FDA. At its January, 1995 meeting, the NMQAAC reviewed the entire

body of proposed regulations as then drafted. Many of the requirements

in the proposed regulations are based on advice obtained from the

NMQAAC during these meetings.

G. Framework of Proposed Regulations

FDA is issuing five separate proposed rules to amend the interim

regulations. All of these proposals are published in this issue of the

Federal Register. The first proposed rule as set forth below, contains

background information (given above), a summary of the preliminary

analysis of the costs and benefits of the proposed amendments to 21 CFR

part 900, a description of the information collection requirements,

proposed revisions to Secs. 900.1 Scope (21 CFR 900.1) and 900.2

Definitions (21 CFR 900.2), and proposed alternative approaches to

mammography quality standards and a request for comments on the

proposed alternatives. The other four proposals set forth requirements

related to: (1) Accreditation bodies; (2) general facility

requirements, including requirements for a medical reporting and

recordkeeping program, a medical outcomes audit program, special

methods for examining individuals with breast implants, a consumer

complaint mechanism, and a variance procedure for requesting FDA

approval of alternative standards; (3) personnel requirements for

interpreting physicians, radiologic technologists, and medical

physicists; and (4) definitions, mammography equipment standards, and

quality assurance requirements for mammography equipment.

The agency believes that the proposed amendments, when implemented,

will increase the quality of mammography nationwide and facilitate the

early diagnosis and treatment of breast cancer or other diseases of the

breast.

In drafting the proposed regulations, and in consultation with the

NMQAAC, FDA has established specific requirements for those areas that

the agency believes are essential to the practice of quality

mammography. Conversely, in those areas where the agency is aware of

multiple methods or procedures for effectively accomplishing the same

task, the proposed requirements have been drafted in more general

terms, to give facilities more flexibility to accomplish a particular

quality practice. In some cases, FDA will provide guidance documents

that explain methods and practices that the agency recommends, based on

its current thinking, but does not require by regulation.

The rules that are developed and finalized as a result of this

rulemaking will replace the interim rules issued on December 21, 1993.

The interim rules will continue to apply until final rules become

effective.

II. Alternative Approaches for Quality Mammography

Executive Order 12866 requires Federal agencies to identify and

assess alternative forms of regulation and, where feasible, specify

performance objectives, rather than specifying the behavior and manner

of compliance that regulated entities must adopt (E.O. 12866, Section

1(b)(8)). In addition, Executive Order 12866 (Section 1(b)(10))

requires each agency to avoid regulations that duplicate other

regulations. In proposing final standards, FDA is aware that there can

be alternative means for ensuring quality mammography other than

through those presented in these proposals. FDA notes that the MQSA

itself establishes many overlapping requirements relating to quality

mammography which are reflected in the proposed final regulations. FDA

also recognizes that many of the proposed final regulations contain

design specifications, training and educational requirements, and

process requirements, rather than performance or outcomes standards. In

order to meet objectives established by the Executive Order 12866, FDA

is soliciting comments on the following alternative approaches to

achieve quality mammography under the MQSA. FDA encourages comments on

these alternative approaches to be as detailed as possible. Comments

that address and describe the application of specific performance or

outcomes standards will be most useful in the event the agency is

persuaded that this alternative is the more desirable approach.

Overlapping functions for facilities, accreditation bodies, and FDA

have advantages and disadvantages. As an example, under section

354(e)(1)(B)(v) of the Public Health Service Act (PHS Act) (42 U.S.C.

263b(e)(1)(B)(v)), as amended by the MQSA, the accreditation body is

required to perform monitoring and evaluation of medical physicists'

annual surveys. At the same time, under section 354(g)(1)(B)(v) of the

PHS Act, the MQSA requires FDA to annually inspect facility compliance

with quality standards, including compliance with the section of the

MQSA that requires each facility to have a qualified medical physicist

annually survey mammography equipment (42 U.S.C. 263b(f)(1)(F)). In

this instance, therefore, annual physicist surveys are being reviewed

by both the accreditation body and the inspector. FDA's experience

under the interim final regulations is that of 7,431 MQSA inspections

in 1995, only 5 accredited facilities were without annual physicist

surveys. This suggests that duplicative review serves a compliance

purpose. However, it may be possible under a different approach for the

accreditation body to accept inspection reviews of surveys, or, for

inspectors to accept an accreditation body's review of a facility's

survey. While there are strengths in a program that has multiple checks

and overlapping areas of responsibility to ensure compliance, there are

also cost and resource considerations that may favor alternative

approaches to satisfy statutory mandates. Such alternative approaches

will need to adequately ensure integrity of the evaluation if oversight

mechanisms are decreased. FDA is soliciting comments on approaches that

would reduce the overlapping nature of many quality assurance

provisions proposed, while maintaining assurances for integrity of the

evaluation.

Advantages and disadvantages exist in adopting an approach that

utilizes detailed design and qualification-based standards versus an

approach based on performance standards and outcomes measures. For

example, detailed design and behavior-based standards may be clear and

precise; they can provide an objective evaluation of compliance during

an inspection and make clear to facilities what is expected of them.

However, these standards can limit flexibility and innovation and do

not ensure that everyone who meets the established criteria is indeed

competent. On the other hand, performance standards and outcome

measures may allow greater variability in behavior and methods of

compliance. However, while outcome measures may reflect the true nature

of performance in a population and be an incentive to good performance,

they may also be subject to adjustments to circumvent low performance.

FDA is soliciting comments on the possibility of pursuing

[[Page 14860]]

quality mammography through more performance and outcome-based

standards. FDA would also like comments on the anticipated economic

consequences of this approach compared to the approach of the proposed

regulations. FDA hopes the comments will provide more information

regarding the short and long-term viability of this alternative

approach for purposes of mammography regulation.

The following sections discuss ideas for the application of

performance and outcome-based standards to mammography facility

operations:

A. Mammography Equipment and Quality Control

Under current proposals, FDA has specified mammography equipment

performance and design requirements. While design specifications are

clear, they may inadvertently impede technical innovation. An

alternative proposal would be to use phantom image testing as a

complete equipment system test, thereby eliminating the need for other

specific quality control tests, or, permitting those other tests to be

conducted less frequently. The phantom image test is currently being

proposed to be done weekly as a part of the facility's ongoing quality

assurance program. The current phantom used, however, is not the

optimal design if phantom image testing were to serve as a single

system performance evaluation criterion. A recent article (Ref. 8)

suggested that the current phantom has limitations in simulating the

average breast. Research may be necessary to design a phantom whose

image will be significantly affected by enough characteristics of the

system so that other tests could be eliminated.

Another issue associated with the use of phantom image testing as a

single system evaluation test is that there is inadequate information

available on how phantom images correlate with actual clinical images.

There is concern that no phantom image evaluation will adequately

predict the clarity and characteristics of the entire biologic spectrum

of breast tissue.

FDA believes it is theoretically possible to substitute phantom

image testing for some equipment requirements and some quality control

tests if some other standards were made more stringent and the phantom

were suitable. For example, the frequency of phantom image testing

might be increased to daily if the backing material could be changed to

be more tissue equivalent, if different thicknesses could be developed

to represent the range of actual breast thicknesses encountered in

daily practice, and if research established appropriate performance

parameters based on these changes. A step wedge might be included in

the design of the phantom so that, after a trial period, daily

sensitometry could be eliminated. It may be necessary to record the mAs

value daily, so that when deviations occur, it would be possible to

determine if it was an x-ray machine variation or film processor

variation. Ideally, this image test would be combined with a dose

measurement, at least periodically, so that an even more complete

system test would be conducted.

Another possible performance measure for equipment and substitute

for equipment specifications and quality control tests is an ongoing

analysis of a facility's repeat rate. Under both the interim final

regulations and the proposed final regulations set forth elsewhere in

this issue of the Federal Register, the repeat rate is to be analyzed

every 3 months, and up to 250 exams are used. Ongoing repeat analysis

might substitute for some quality control tests, equipment

requirements, and technologist requirements. Using the repeat rate as a

performance outcome might be appropriate if repeat analysis were

conducted continuously, rather than periodically, if personnel were

trained to evaluate the films according to the criteria currently used

by accreditation bodies for clinical image review, and if trends or

problems were identified and corrected immediately. One potential

problem with this approach is that the repeat rate is easily altered by

a facility through the acceptance of all examinations of any quality

performed. Thus, a facility could conceivably have a zero repeat rate,

but many problems. Adopting use of repeat rates as a performance

measure would require the development of mechanisms to minimize this

type of manipulation.

B. Mammography Personnel: The Interpreting Physician and the Medical

Audit

Under the current proposal for final standards, interpreting

physicians would be required to meet initial qualifications through

board certification or training, mammography-specific training and

experience, and continuing education and experience requirements. While

these requirements for training and experience guarantee familiarity

with mammography and interpretation issues, it is possible that

interpretation performance can be less than optimal despite meeting

these requirements. An alternative means to ensuring the MQSA's mandate

of ``* * * quality assurance * * * at each facility that is adequate

and appropriate to ensure the reliability, clarity, and accuracy of

interpretation of mammograms * * *'' (42 U.S.C. 263b(A)(1)(A)) may be

to use performance-based standards.

The use of specific medical outcomes measures is discussed in the

proposal entitled ``Quality Standards and Certification Requirements

for Mammography Facilities; General Facility Requirements'', published

elsewhere in this issue of the Federal Register. FDA recognizes the

significant cost and effort associated with tracking examinations

interpreted as nonmalignant. While the absence of cancer registries in

many locales limits the feasibility of collecting many outcomes

measures, those locales with cancer registries may be able to collect

data on sensitivity and specificity. These locales might be able to

forego compliance with all or some of the proposed personnel

qualifications so long as sensitivity and specificity for screening

mammography, or other measures such as minimal cancer detection rates,

were within an acceptable range, e.g., the Agency for Health Care and

Policy Research guidelines. These ranges may have to be refined using

other data from recently published practice patterns, clinical trials,

and information from the National Cancer Institute's Breast Cancer

Consortium studies. In order to be valid, facilities would have to

track other variables of the screening clientele that could affect

sensitivity and specificity such as age and other parameters that are

currently being identified through research. This data collection,

while time-consuming, would enhance the validity of calculated

statistics.

In areas without cancer registries, positive predictive value may

be calculated to assist in ensuring appropriateness and accuracy of

physician recommendations. FDA notes that there is not yet a consensus

on what ranges of the positive predictive value are acceptable, and

that this value is subject to intentional adjustment by practices in

the facility. However, use of the positive predictive value coupled

with indices of early detection, such as sizes of cancers detected,

could reduce concerns about intentional manipulation of data and

provide a useful measure of an individual physician's comparative

performance from year to year.

FDA recognizes concerns raised by the NMQAAC about public

disclosure of statistics, including issues of legal liability and

public confusion over the meaning and limitations of statistics.

[[Page 14861]]

The agency believes that data generated and reviewed for mammography

audits should be used internally by each facility to improve individual

and group performance. The agency further recognizes that State laws

with respect to medical audit information vary and may not prevent

disclosure in State courts through discovery or other procedures

established by State law. However, concerns raised about public

disclosure of statistics and consumers not understanding their

limitations could be addressed through active consumer education to

assist consumers in analyzing information and making health care

decisions. A recent summary of the New York State experience with

public reporting of cardiovascular surgery mortality outcomes showed

improved risk-adjusted operative mortality beyond what was expected

using nationwide trends for adjustment. The summary states that the

collection data on mortality and reporting risk-adjusted mortality

rates to hospitals and physicians contributed to improved outcomes

(Ref. 9).

Finally, FDA is aware that substantial differences in statistics

can arise from differences in definitions of screening mammography.

Under an outcomes measurement approach, it might be necessary for the

agency to define the precise situations that would constitute

screening. For example, a woman with implants might have a diagnostic

mammogram, meaning the procedure was under the direct supervision of an

interpreting physician and consisted of more than standard mediolateral

oblique/craniocaudal views. However, this woman's mammogram

interpretation and her medical outcome might be classified by FDA as

screening for statistical calculations if she was asymptomatic at the

time of the examination. Thus, choosing to use outcomes measures could

require the agency to establish certain definitions of medical

practice.

Another alternative to proposed training and experience regulations

is to have interpreting physicians undergo proficiency testing on

mammogram interpretation. While the establishment of such tests and

their periodic administration would be challenging, this testing,

perhaps administered through the accreditation bodies, would allow for

direct assessment of mammography interpretive skills. Remedial programs

and reassessments would have to be established as well. FDA is aware of

the ACR's Committee on Mammography Interpretive Skills Assessment

(COMISA), created in 1992. COMISA is charged with development of an

educational examination tool. Experiences gained through this project

could be used for development of a proficiency test.

It is possible that regulations for interpreting physician

qualifications could include all three options: Training and experience

requirements, medical outcomes audit statistics and acceptable ranges,

and an option for periodic proficiency testing, or some combination

allowing for choice of compliance option. Again, FDA solicits comments

on the utility and advisability of this approach.

C. Mammography Personnel: The Radiologic Technologist

Under the current proposal for final standards, radiologic

technologists would be required to meet initial qualifications through

board certification or training, mammography-specific training and

experience, and continuing education and experience requirements. While

these requirements for training and experience guarantee familiarity

with the performance of mammograms and mammography issues, it is

possible that the technologist's own performance can be less than

optimal despite meeting these requirements. An alternative means to

ensure proper mammography performance is to consider using clinical

image review as a performance assessment tool. Clinical image review of

a sufficient number of mammograms performed by the radiologic

technologist would provide information on compression, positioning,

selection of adequate technique factors, and production of clear and

reliable mammograms. This assessment would have to control for

equipment performance and processing in order for it to be a true

measure of technologist performance. This could perhaps be accomplished

through appropriate daily phantom imaging as discussed above. In

addition, the method for selection of mammograms would have to be

carefully defined to allow for representative sampling of technologist

performance given differences in patients' habitus, breast morphology,

and cooperativeness with the procedure. The assessment would also have

to be correlated with repeat rate. It would be undesirable for the

technologist to achieve a high level of clinical image quality at the

cost of a high repeat rate.

As with interpreting physicians, the development of a technologist

proficiency test that would include a practical examination could also

be viewed as a performance-based measure. Currently, the ARRT's

certification in mammography only includes a written examination.

Expansion of this to include a practical examination along with

periodic recertification examinations would increase the viability of

ensuring competency in mammographic procedures.

D. Mammography Personnel: The Mammography Medical Physicist

Under the current proposal for final standards, medical physicists

must be either board certified in an appropriate specialty or State

approved, and, in addition, meet education and experience requirements.

While these requirements are meant to ensure knowledge and experience

in surveying and overseeing mammography machines and quality control,

they do not necessarily ensure good performance. Alternative

performance measures would include the development of a written

examination along with a practical survey test. The survey test, while

most reflective of actual practice, still could not test for all

possible situations a medical physicist is called upon to deal with at

facilities. It would be necessary to have this proficiency test

repeated periodically, requiring the development of new logistic and

administrative procedures. If this approach were adopted, the

practicing medical physicist's actual performance outside of the

testing environment still must be correlated to test performance.

Development of an accurate and predictive tool would require adequate

resources.

E. Request for Comments

FDA is interested in comments on the desirability of any of the

approaches described above, and on any other possible approaches that

would address the issue of performance-based standards. If performance-

based standards are considered desirable, there may be need for

additional research to provide information to make scientifically sound

and cost effective performance based standards. There are several

options as to how the agency could proceed while such research is being

performed. The agency could leave the interim final standards in place,

or, the agency could make minor amendments to the interim final

standards to clarify points but not add any new requirements, or, the

agency could proceed with final implementation of the set of standards

contained in this proposal as modified after consideration of the

comments. FDA invites comment on the pursuit of any of these or other

options.

[[Page 14862]]

III. Scope and Definitions

A. Scope

Proposed Sec. 900.1 summarizes the scope of part 900 (21 CFR part

900), which contains two subparts implementing different sections of 42

U.S.C. 263b. Subpart A of part 900 establishes application procedures

and requirements for accreditation bodies. Subpart B of part 900

establishes procedures for mammography facility certification and

quality standards for mammography facilities. The proposed requirements

for subpart B of part 900 are published elsewhere in this issue of the

Federal Register.

B. Definitions

FDA is proposing amendments and additions to the definitions

established in Sec. 900.2 of the interim regulations. These proposed

definitions apply to the regulations in this proposal and in the other

MQSA proposals published elsewhere in this issue of the Federal

Register.

1. Amendments

a. Mammography. The amendments to the interim regulations published

in the Federal Register of September 30, 1994 (59 FR 49808), added

definitions of ``screening mammography'' and ``diagnostic mammography''

to clarify the applicability of the interim regulations to various

types of facilities. However, differences of opinion within the

professional community regarding the distinction between these two

types of mammography became apparent in discussions between NMQAAC

members and consultants at the January 1995 NMQAAC meeting. In

addition, proposed changes to the interim regulations have made it

unnecessary to define screening and diagnostic mammography for the

purpose of these regulations. Therefore, FDA is proposing to delete

these two definitions. The reference to screening and diagnostic

mammography previously included in the interim definition of

``interpreting physician'' also would be deleted.

The definitions of screening and diagnostic mammography were

intended to clarify which breast cancer screening or diagnostic

mammography activities conducted by a facility were exempt from the

MQSA regulations. Such exempted activities included any breast imaging

conducted in a research setting as part of a scientific study to

evaluate experimental mammography devices, in accordance with FDA's

investigational device exemption regulations (21 CFR part 812). This

exclusion did not apply to mammography conducted using any conventional

mammography device as part of the scientific study to provide baseline

data for evaluating the safety and efficacy of the experimental device.

An exemption was also made for interventional mammography, which

involves the use of breast radiography devices to produce radiographic

images of the breast in association with localization or biopsy

procedures.

These exemptions were based on FDA's belief that science had not

advanced to the point where effective national quality standards could

be developed for these devices. Because FDA still believes this to be

the case, the agency is proposing to retain these exemptions, but to

incorporate them into the proposed definition of ``mammography.''

Eventually, FDA does expect to develop standards for interventional

mammography devices and for research devices that come into standard

use.

b. Interpreting physician. Throughout the MQSA regulations, FDA is

proposing to use only the term ``interpreting physician'' to refer to

persons who interpret mammograms or perform clinical image reviews.

Therefore, the agency is deleting the interim definition for

``qualified practicing physician.'' Also, as discussed previously, the

term ``interpreting physician'' would be modified to refer to

mammography, rather than screening and diagnostic mammography.

c. Patient. In the interim regulations, the term ``patient'' is

used to mean any individual who undergoes clinical evaluation in a

mammography facility, regardless of whether the person is referred by a

physician or self-referred. However, most individuals who undergo

mammography are not ill and do not have a condition requiring medical

care. Therefore, FDA is proposing to substitute the term ``examinee''

for the term ``patient.''

2. New Definitions

a. Personnel qualifications. During implementation of the interim

regulations, questions were raised concerning how physicians,

technologists, or physicists in training, who had not satisfied the

personnel requirements by October 1, 1994, or who failed to maintain

them after October 1, 1994, might establish or reestablish their

credentials. In response to these concerns, FDA is proposing amendments

(published elsewhere in this issue of the Federal Register) to the

personnel requirements in Sec. 900.12(a) (21 CFR 900.12(a)). For the

purpose of implementing these provisions, FDA is proposing to add

definitions of ``contact hour,'' ``direct instruction,'' and ``direct

supervision.'' The intent of these definitions is to clarify that: (1)

The individuals providing training to mammography personnel must be in

contact with the trainees, at least to the extent of evaluating their

work; and (2) those who are supervising the trainees must be available

to review, and, if necessary, correct the trainees' work.

The proposed revisions to Sec. 900.12(a) also would ensure that

individuals trained in the use, survey, or interpretation of images

produced using one modality do not begin work using another modality

without first receiving training related to that modality. The addition

of this requirement made it necessary to define the term ``modality.''

FDA is proposing to define this as a form of technology, within the

scope of the MQSA, for performing radiography of the breast. The

technologies considered to be modalities under this proposed definition

would include existing technologies, such as screen-film systems and

xeromammography, and any future technologies within the scope of the

MQSA. Technologies such as ultrasound that are used to image breast

tissue but do not fall within the scope of the MQSA would not be

considered modalities for the purpose of this proposed rule.

Under the interim regulations, interpreting physicians are allowed

to use double reading to meet the initial and continuing experience

requirements for physicians. The proposed requirements would permit

this practice to continue. However, because there was some confusion

over the meaning of the term, FDA is proposing to add a definition of

``double reading.''

A major concern of the NMQAAC was to make sure that the initial

experience requirement for interpreting physicians did not cause

problems for diagnostic residency programs that schedule the

mammography rotations in the first 6 months of the final year. At the

same time, it was considered important that interpreting physicians

meet this requirement in a relatively short time before beginning to

interpret mammograms independently. To meet both goals, FDA is

proposing (elsewhere in this issue of the Federal Register) to require

residents to become certified at the ``first allowable time'' if they

want to use residency training to meet the initial experience

requirement. Therefore, a definition of the term ``first allowable

time'' has been added to the proposed regulations.

The interim requirements in Sec. 900.12(a)(3) deal specifically

with the qualifications of the medical physicist.

[[Page 14863]]

The interim regulation refers to requirements for degree programs in

``physical science.'' This term can cover a broad spectrum of

scientific disciplines, some of which are unrelated to the knowledge

and skills needed for mammography. For this reason, a narrower

definition of physical science is needed (with respect to both

bachelor's and advanced degrees). FDA is proposing that only physics,

chemistry, radiation science (including medical physics and health

physics), and engineering be considered as physical sciences for the

purpose of this regulation.

b. Equipment. Standards for equipment used in mammography were

established in Sec. 900.12(b) of the interim regulations. Because of

additional proposed equipment requirements, FDA is adding a definition

for the term ``mean optical density,'' defined as the average of

optical densities measured for specified phantom thicknesses at

clinically appropriate peak kilovoltage (kVp) levels. A definition of

the term ``mammography unit'' is being added to clarify that when this

term is used, the reference is to the x-ray generator and associated

components.

c. Quality assurance. Proposed Sec. 900.12(d) would specify new

requirements for the individuals responsible for various aspects of the

facility quality assurance program. These proposed changes have made it

necessary to define the terms ``lead interpreting physician'' and

``quality control technologist.'' The lead interpreting physician would

be the interpreting physician with primary responsibility for ensuring

that the facility quality assurance program meets the requirements of

paragraphs (d) through (f) of Sec. 900.12. It would be left to the

discretion of the facility whether this individual would also have

other supervisory duties. The quality control technologist(s) would be

responsible for those aspects of the quality assurance program not

carried out by the lead interpreting physician or medical physicist.

Several definitions are being added to proposed Sec. 900.2 on

quality assurance requirements for equipment. These include a

definition for ``time cycle,'' which means the film development time,

and for ``traceability,'' which relates to calibration of radiation

measuring instruments.

d. Mammography medical outcomes audit. Discussions with the NMQAAC

regarding the medical auditing requirements in proposed Sec. 900.12(f)

indicated a need to define medical audit. Therefore, FDA is proposing

to define the ``mammography medical outcomes audit'' as a systematic

collection of mammography results and the comparison of these results

with outcome data (e.g., results of subsequent biopsy followup

procedures).

For use with the mammography medical outcomes audit, FDA is also

defining a ``positive mammogram'' as one with an overall assessment of

findings that are either ``suspicious'' or ``highly suggestive of

malignancy.'' This definition incorporates two of the assessment

categories described in Sec. 900.12(c)(1)(iii) (published elsewhere in

this issue of the Federal Register) for use in mammography records and

reports.

e. Breast implant. Proposed Sec. 900.12(g), published elsewhere in

this issue of the Federal Register, contains new standards for

mammography of examinees with breast implants. Establishment of such

standards is required by the MQSA. FDA is proposing to define a

``breast implant'' as a prosthetic device implanted in the breast.

f. Consumer complaint mechanism. FDA is proposing new requirements

in Secs. 900.4(g) and 900.12(h), published elsewhere in this issue of

this Federal Register, for consumer complaint mechanisms to be

established by facilities and accreditation bodies. The purpose of

these new requirements is to ensure that serious complaints about the

quality of the MQSA-related mammography services are adequately

addressed without unduly burdening facilities and accreditation bodies

with Federal regulations requiring extensive consideration of

relatively minor complaints (e.g., complaints about facility air

temperature). Therefore, FDA is proposing to add definitions of

``adverse event,'' ``serious adverse event,'' and ``serious complaint''

to clarify the kinds of situations that would require full

investigation and correction under the statute. These definitions also

would clarify that any substantive complaints that warrant attention,

but are not within the scope of the MQSA (e.g., discrimination or

harassment), must be handled through other mechanisms.

FDA is proposing to add a definition of ``consumer'' to clarify

that the consumer complaint process also can be used by interested

parties other than the examinee (e.g., family members or referring

physicians).

IV. Environmental Impact

The agency has determined under 21 CFR 25.24(e)(3) 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.

V. Analysis of Impacts

This proposed rule sets forth preliminary ideas for the application

of alternative performance and outcome-based standards to ensure

quality mammography. FDA requests that comments submitted on this

proposal also address the estimated costs and benefits of such

alternatives.

FDA has examined together the impacts of the remaining four

proposed rules to implement the MQSA requirements, published

concurrently in this issue of the Federal Register, under Executive

Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354), 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 regulatory options that

would minimize any significant impact of a rule on small entities. The

Unfunded Mandates Reform Act requires (in section 202) that agencies

prepare an assessment of anticipated costs and benefits before

proposing any rule that may result in an annual expenditure by State,

local, and tribal governments, in the aggregate, or by the private

sector, of $100 million (adjusted annually for inflation). The agency

has conducted preliminary analyses of the proposed rules, and has

determined that the proposed rules are consistent with the principles

set forth in the Executive Order and in these two statutes. The

Regulatory Impact Study that details the agency's calculation of these

economic impacts is available at the Dockets Management Branch for

review. A brief summary of the cost and benefit determination follows.

Incremental annual costs were estimated for each section of the

proposed regulations. Actions expected to be taken by mammography

facilities to come into compliance with the proposal were identified

and current compliance levels were estimated in conjunction with agency

experts and industry consultants. Costs were determined for a 10-year

analysis period. Yearly costs of compliance for mammography facilities

were estimated to range from a high of $203.2 million during the first

year of implementation

[[Page 14864]]

to $25.2 million during the 10th year (2005). These yearly costs

differed due to the phased implementation dates for some of the

proposed requirements. Overall, average annualized costs of this

proposal (at a 7-percent discount rate) are preliminarily estimated to

equal $61.4 million.

Over the full 10-year analysis period, expenditures for the largest

cost element (replacement of mammography units and film processors with

units meeting standards required in proposed Sec. 900.12(b)) could

total more than $270 million and contribute approximately $35 million

in average annual costs (57 percent of total average annual costs).

Other major cost components include proposed Sec. 900.12(c)(2)(i)

(written notification of patient) which accounts for average annual

costs of $14 million (23 percent of total average annual costs),

proposed Sec. 900.12(c)(3)(ii) (telephone contact with referring

physicians) which accounts for over $4 million in annual costs (7

percent of total average annual costs), and proposed Sec. 900.12(e)(2)

(requiring weekly image quality tests) which accounts for average

annual costs of almost $2 million (3 percent of total average annual

costs).

The benefits of the proposed rule were estimated as illustrations

of the expected health outcomes for given levels of quality

improvement. FDA believes that the proposed rules are complementary,

and that quality improvements are limited by the ``weakest link'' in

the process of conducting or interpreting a mammographic examination.

Thus, benefits were estimated assuming compliance with all of the

proposed requirements at the same level of overall quality.

Benefit scenarios were based on an outcome prediction model that

forecast breast cancer survival based on stage-determination at the

time of identification. In addition, FDA estimated the reduction in

costs attributable to the avoidance of followup procedures for those

patients correctly diagnosed as not having cancer due to a range of

quality gains that may occur as a result of the proposed rule. The

calculated benefits are illustrative of the magnitude of health gains

that would be expected to follow heightened quality levels of

sensitivity and specificity. For example, a 5-percent gain in a

sensitivity measurement of 80 percent would indicate a revised

sensitivity level of 81 percent (a reduction of the rate of false

positives from 20 percent to 19 percent).

Overall, the agency could not predict precise quality improvement

gains. FDA estimates, however, those 5-year survival rates of all

patients identified with breast cancer would increase by 0.006 percent

if quality improves by 1 percent, 0.028 percent if the proposed rules

result in a 5-percent gain in quality, and 0.084 percent if the quality

improvements induce a 20-percent gain in sensitivity. (These are equal

to increased survival rates of 0.02, 0.1, and 0.3 percent for all

screened patients at the estimated levels of improvement.) Based on

current disease prevalence rates, these results project that a 1-

percent quality improvement would avert 10 breast cancer fatalities

annually (based on 5-year survival rates), whereas quality improvement

levels of 5 and 20 percent, respectively, would prevent 50 and 150

cancer fatalities.

Several analyses have estimated that society has indicated a

willingness to pay to avoid a statistical death of approximately $5

million. Therefore, a 1-percent improvement in sensitivity as a result

of this proposal would have monetized benefits of $50 million.

Likewise, 5 and 20 percent improvements would bring annual benefits of

$250 million and $750 million, respectively.

In addition, the proposed rules are anticipated to result in

corresponding percent improvements in specificity, which would reduce

the number of followup procedures in nondiseased patients. An

improvement of 1 percent would reduce current annual medical

expenditures by approximately $14 million. If the improvement in

specificity were as high as 5 percent, the annual reduction in medical

costs would equal $72 million. A 20-percent improvement in quality

would reduce current annual medical costs by $287 million.

FDA recognizes that the nature of these proposed regulations may

have a disproportionate effect on small volume mammography facilities

as fixed costs of compliance for equipment improvements are likely to

increase the cost per mammogram for low-volume facilities relatively

more than for high-volume facilities. FDA is currently collecting

additional information on the potential impact on this industry sector,

and requests comments that will assist it in accounting for this

impact.

The agency also notes that average annual compliance costs of $61.4

million could increase the cost per screening mammogram at certain

clinics by from 2 to 6 percent. FDA has estimated that if these costs

are passed on to consumers, the demand for mammograms could be reduced

by approximately 200,000 per year (or 0.9 percent of current demand).

However, the agency believes that quality improvement savings may more

than balance these expected price effects.

[[Page 14865]]

FDA also examined the effect of alternative implementation

schedules for this proposal. An alternative requiring even more

elaborate equipment upgrade immediately upon issuance of the

regulations was rejected as putting an unnecessary burden on the

industry, with estimated average annual costs of more than $120

million. By eliminating some specifications that were considered

marginal to ensuring mammography quality, and phasing in some

requirements to allow for normal replacement of current equipment, the

agency reduced the cost of compliance. FDA also found that delaying the

implementation of the proposed equipment requirements by an additional

year, while reducing the average annual compliance costs by $7.1

million, would mitigate the expected impact of the proposed rule on

quality improvements. Therefore, the proposed implementation schedule

was selected as a reasonable balance between compliance costs and

quality improvements.

MQSA includes a separate reimbursement mechanism to repay State,

local, or tribal governments for the costs of inspections required by

these proposed regulations. Consequently, no unfunded mandate is placed

on local governments as a result of these proposals.

In summary, FDA expects that the proposal would lead to mammography

quality increases. Average annual costs of compliance with this

proposal are estimated to be $61.4 million. The estimated benefits

accrue as a result of fewer breast cancer mortalities as well as the

avoidance of unnecessary surgery. While the magnitude of the expected

quality increases are currently under investigation, an improvement of

only 1 percent would result in monetized annual benefits of $64 million

including 10 fewer cancer mortalities, which slightly exceed the

estimated compliance costs. If the quality improvements range to 5 or

20 percent, the benefits would increase proportionately. A 5-percent

improvement projects average annual monetized benefits of $322 million.

At this level of quality improvement, the cost savings of avoiding

surgery are, by themselves, greater than compliance costs. This would

occur in addition to 50 fewer breast cancer mortalities per year. A 20-

percent quality improvement would result in average annual monetized

benefits of $1,037 million, with 150 fewer annual breast cancer deaths

due to earlier detection.

Because of the preliminary nature of these estimates, FDA requests

comments on all of the methodology and projections included in this

analysis. Comments may be submitted to the Dockets Management Branch

(address above).

IV. Paperwork Reduction Act of 1995

The information collections contained in the December 21, 1993,

interim regulations implementing the MQSA were approved by the Office

of Management and Budget (OMB) under the Paperwork Reduction Act of

1995 (Pub. L. 104-13) under control number 0910-0309, which includes

OMB approval for Form FD-3422. The approval will expire July 31, 1998.

Three of the five proposed rules to amend 21 CFR part 900, published

together in this issue of the Federal Register, contain amendments to

the approved information collections, and these revisions are subject

to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L.

104-13). The title, description, and respondent description of the

revised information collections to 21 CFR part 900 are shown below with

an estimate for any annual reporting and recordkeeping burdens which

will be changed by these proposed rules. Included in the estimate is

the time for reviewing instructions, searching existing data sources,

gathering and maintaining the data needed, and completing and reviewing

the collection of information.

Title: Mammography Facilities.

Description: These information collection requirements apply to

accreditation bodies and to mammography facilities. In order to be an

approved accreditation body, private nonprofit organizations or State

agencies must submit an application to FDA and establish procedures and

a quality assurance program. Mammography facilities must obtain and

prominently display an FDA-issued certificate or provisional

certificate; have a medical reporting and recordkeeping program, a

medical outcomes audit program, a consumer complaint mechanism; and

maintain records documenting personnel qualifications. These actions

are being taken to ensure safe, accurate, and reliable mammography on a

nationwide basis.

Respondent Description: Businesses and other for-profit

organizations, nonprofit organizations, Federal, State, and local

governments.

Therefore, the agency solicits public comments on the revised

information collection requirements in order to: (1) Evaluate whether

the proposed collection of information is necessary for the proper

performance of the functions of the agency, including whether the

information will have practical utility; (2) evaluate the accuracy of

the agency's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) enhance the quality, utility, and clarity of the information

to be collected; and (4) minimize the burden of the collection of

information on those who are to respond, including through the use of

appropriate automated, electronic, mechanical, or other technological

collection techniques or other forms of information technology, e.g.,

permitting electronic submission of responses.

[[Page 14866]]

Proposed Requirements for Accreditation Bodies of Mammography Facilities

[Table 1a.--Estimated Annual Reporting Burden]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total

Number of Annual Total annual Hours per Total capital operating and

CFR Section respondents frequency per responses response Total hours costs maintenance

response costs

--------------------------------------------------------------------------------------------------------------------------------------------------------

900.3(b)(3)................................ 10.0 1.0 10.0 60 600 $50

900.4(a)(7) \1\............................

900.4(b)(2) \1\............................

900.4(c) \1\...............................

900.4(d) \1\...............................

900.4(e)(1) \1\............................

900.4(e)(2) \1\............................

900.4(h)(1) \1\............................

900.4(h)(3) \1\............................

900.4(i)(1)\1\.............................

900.4(i)(2)\1\.............................

------------------------------------------------------------------------------------------------------------

Total.................................. .............. .............. .............. .............. 600 $50 0

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ There is no additional burden.

Proposed Requirements for Accreditation Bodies of Mammography Facilities

[Table 1b.--Estimated Annual Recordkeeping Burden]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total

Number of Annual Total annual Hours per Total capital operating and

CFR section recordkeeepers frequency of records recordkeeper Total hours costs maintenance

recordkeeping costs

--------------------------------------------------------------------------------------------------------------------------------------------------------

900.3(f)(1)................................ 10 130 1,300 200 2,000

900.4(c) \1\...............................

900.4(c)(2)(viii) \1\......................

900.4(c)(5)(iii) \1\.......................

900.4(d) \1\...............................

900.4(d)(5)(iii) \1\.......................

900.4(e)(1) \1\............................

900.4(e)(2) \1\............................

900.4(f)(2) \1\............................

900.4(g) \1\...............................

900.4(h)(1) \1\............................

------------------------------------------------------------------------------------------------------------

Total.................................. .............. .............. .............. .............. 2,000 0 0

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ There is no additional burden.

[[Page 14867]]

Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements

[Table 2a.--Estimated Annual Reporting Burden]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total

Number of Annual Total annual Hours per Total capital operating and

CFR section respondents frequency per responses response Total hours costs maintenance

response costs

--------------------------------------------------------------------------------------------------------------------------------------------------------

900.11(b)(1) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.11(b)(2) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.11(b)(3) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.11(c).................................. 10,000 0.005 50 20 1,000 .............. $1,000

900.12(c)(1) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.12(c)(2)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............

900.12(c)(3)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............

900.15(d)(3)(ii)........................... 10,000 0.002 20 2 40 .............. 100

900.18(c).................................. 10,000 0.0005 6 2 12 .............. 60

900.18(e) \1\.............................. 10 0.1 1 1 1 .............. 10

------------------------------------------------------------------------------------------------------------

Total.................................. .............. .............. .............. .............. 1,053 0 $1,170

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ There is no additional burden.

Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements

[Table 2b.--Estimated Annual Recordkeeping Burden]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total

Number of Annual Total annual Hours per Total capital operating and

CFR section recordkeeepers frequency of records recordkeeper Total hours costs maintenance

recordkeeping costs

--------------------------------------------------------------------------------------------------------------------------------------------------------

900.12(c)(4) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.12(d)(2)(i) \1\........................ .............. .............. .............. .............. ........... .............. ..............

900.12(d)(2)(ii)........................... 10,000 1 10,000 0.25 2,500

900.12(d)(2)(iii).......................... 10,000 1 10,000 1 10,000

900.12(d)(2)(iv) \1\....................... .............. .............. .............. .............. ........... .............. ..............

900.12(f)(2) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.12(f)(4) \1\........................... .............. .............. .............. .............. ........... .............. ..............

900.12(h)(2)............................... 10,000 2 20,000 0.5 10,000 .............. $20,000

------------------------------------------------------------------------------------------------------------

Total.................................. .............. .............. .............. .............. 22,500 0 $20,000

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ There is no additional burden.

[[Page 14868]]

Quality Standards and Certification Requirements for Mammography Facilities; Personnel Requirements

[Table 3.--Estimated Annual Recordkeeping Burden]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Total

Number of Annual Total annual Hours per Total capital operating and

CFR Section recordkeeepers frequency of records recordkeeper Total hours costs maintenance

recordkeeping costs

--------------------------------------------------------------------------------------------------------------------------------------------------------

900.12(a)(4)\1\............................ .............. .............. .............. .............. ........... .............. ..............

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ There is no additional burden.

Under OMB information collection no. 0910-0309, 82,810 burden hours

were approved for information collection currently contained in 21 CFR

part 900. The additional requirements contained in these proposed rules

will add 26,153 burden hours to this estimate, resulting in a total

annual burden of 108,963.

As required by section 3507(d) of the Paperwork Reduction Act of

1995, FDA has submitted a copy of the five proposed rules amending 21

CFR part 900 to OMB for its review of the revised information

collection requirements; these five proposed rules are published

together in this issue of the Federal Register. Other organizations and

individuals interested in submitting comments regarding this burden

estimate or any aspect of these information collection requirements,

including suggestions for reducing the burden, should direct them to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN:

Desk Officer for FDA. Written comments on the information collections

should be submitted by May 3, 1996.

VII. Comments

The agency will consider any comments submitted in response to this

proposed rule in its evaluation of the proposed alternative approaches

for quality mammography and the four proposed amendments to the interim

regulations published elsewhere in this issue of the Federal Register.

FDA advises that, under 21 CFR 10.30(d), any comments submitted in

response to this notice will be included under the docket number found

in brackets in the heading of this document.

Interested persons may, on or before July 2, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this NPRM. Two copies of any comments are to be submitted, except that

individuals may submit one copy. Comments are to be identified with the

docket number found in brackets in the heading of this document.

Received comments may be seen in the office above between 9 a.m. and 4

p.m., Monday through Friday.

VIII. References

The following references have been placed on display in 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. Wingo, P. A., T. Tong, and S. Bolden, ``Cancer Statistics

1995,'' CA: A Cancer Journal for Clinicians, 45:8-30, 1995.

2. Feuer, E. J., L. M. Wun, and C. C. Boring, et al., ``The

Lifetime Risk of Developing Breast Cancer,'' Journal of the National

Cancer Institute, 85:892-897, 1993.

3. Ries, L. A. G., B. A. Miller, and B.F. Hankey, et al. (eds.),

``SEER Cancer Statistics Review, 1973-1991,'' National Cancer

Institute, NIH Pub. No. 94-2789, Bethesda, MD, 1994.

4. Brown, M. L., F. Houn, E. A. Sickles, L.G. Kessler,

``Screening Mammography in Community Practice: Positive Predictive

Value of Abnormal Findings and Yield of Follow-Up Diagnostic

Procedures,'' American Journal of Radiology, 165:1373-1377; 1995.

5. Kuester, G. F., S. M. Wolfe, ``HRG Report on Screening

Mammography, Public Citizen Health Research Group,'' July 1991.

6. Conway, B. J., O. H. Suleiman, F. G. Rueter, R. G. Antonsen,

R. J. Slayton, J. L. McCrohan, ``Does Credentialing Make a

Difference in Mammography?,'' U.S. Food and Drug Administration,

Center for Devices and Radiological Health, Rockville, MD, Presented

to the Radiological Society of North America, November 19, 1992.

7. ``The National Strategic Plan for the Early Detection and

Control of Breast and Cervical Cancers,'' U.S. Department of Health

and Human Services, Public Health Service.

8. Geise, R. A., A. Palchevsky. Composition of Mammographic

Phantom Materials. Radiology 198:347-350, 1996.

9. Chassin, M. R., E. L. Hannan, B. A. DeBuono. Benefits and

Hazards of Reporting Medical Outcomes Publicly. The New England

Journal of Medicine, pp. 394-398 February 8, 1996.

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, the

Public Health Service 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 21 CFR part 900 continues to read as

follows:

Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of

the Public Health Service Act (42 U.S.C. 263b).

2. Sections 900.1 and 900.2 are revised to read as follows:

Sec. 900.1 Scope.

The regulations set forth in this part implement the Mammography

Quality Standards Act (42 U.S.C. 263b). The intent of subpart A of this

part is to establish procedures whereby an entity can apply to become

an FDA-approved accreditation body to accredit facilities to be

eligible to perform screening or diagnostic mammography services.

Subpart A further establishes requirements and standards for

accreditation bodies to ensure that all mammography facilities under

the jurisdiction of the United States are adequately and consistently

evaluated for compliance with national quality standards for

mammography. The intent of subpart B of this part is to establish

minimum national quality standards for mammography facilities to ensure

safe, reliable, and accurate mammography. The regulations set forth in

this part do not apply to facilities of the Department of Veterans

Affairs.

Sec. 900.2 Definitions.

The following definitions apply to subparts A and B of this part:

(a) Accreditation body or body means an entity that has been

approved by FDA under 42 U.S.C. 263b(e)(1)(A) to accredit mammography

facilities.

(b) Action limits or action levels means the minimum and maximum

values of a quality assurance measurement that can be interpreted as

representing acceptable performance of the equipment being tested.

Values less than the minimum or greater than the maximum action limit

or level indicate that corrective action must be taken by the facility.

Action limits or levels are also sometimes called control limits or

levels.

[[Page 14869]]

(c) Adverse event means an undesirable experience associated with

mammography activities within the scope of 42 U.S.C. 263b. Adverse

events include, but are not limited to:

(1) Poor image quality;

(2) Failure to send mammography reports within 30 days to the

referring physician or the self-referred examinee (as specified in

Sec. 900.12(c)(2) and (c)(3)(i)); and

(3) Use of personnel that do not meet the applicable requirements

of Sec. 900.12(a).

(d) Breast implant means a prosthetic device implanted in the

breast.

(e) Certificate means the certificate described in 42 U.S.C.

263b(b)(1).

(f) Certification means the process of approval of a facility by

FDA to provide mammography services.

(g) Clinical image means a mammogram.

(h) Consumer means an individual who chooses to comment or complain

in reference to a mammography examination, including the examinee or

representatives of the examinee (e.g., family members or referring

physicians).

(i) Contact hour means an hour of training received through direct

instruction.

(j) Direct instruction means:

(1) Face-to-face interaction between instructor(s) and student(s),

as when the instructor provides a lecture, conducts demonstrations, or

reviews student performance; or

(2) The administration and correction of student examinations by an

instructor(s) with subsequent feedback to the student(s).

(k) Direct supervision means that:

(1) During joint interpretation of mammograms, the supervising

physician reviews, discusses, and confirms the diagnosis of the

physician being supervised and signs the resulting report before it is

entered into the examinee's records; and

(2) During the performance of a mammography examination or survey

of the facility's equipment and quality assurance program, the

supervisor is present to observe and correct, as needed, the

performance of the individual being supervised who is performing the

examination or conducting the survey.

(l) Double reading means two or more interpreting physicians

interpreting the same clinical image.

(m) Examinee means any individual who undergoes a mammography

evaluation in a facility, regardless of whether the person is referred

by a physician or is self-referred.

(n) Facility means a hospital, outpatient department, clinic,

radiology practice, mobile unit, office of a physician, or other

facility that conducts mammography activities, including the following:

Operation of equipment to produce a mammogram, processing of the

mammogram, initial interpretation of the mammogram, and maintaining

viewing conditions for that interpretation. This term does not include

a facility of the Department of Veterans Affairs.

(o) First allowable time means the earliest time a resident is

eligible to take the diagnostic radiology boards from an FDA-approved

certifying body. The ``first allowable time'' may vary with the

certifying body.

(p) Interpreting physician means a physician who interprets

mammograms and who meets the requirements set forth in

Sec. 900.12(a)(1).

(q) Lead interpreting physician means the interpreting physician

assigned the general responsibility for ensuring that a facility's

quality assurance program meets all of the requirements of

Sec. 900.12(d) through (f). The administrative title and other

supervisory responsibilities of this individual, if any, are left to

the discretion of the facility.

(r) Mammogram means a radiographic image produced through

mammography.

(s) Mammography means radiography of the breast, but does not

include:

(1) Radiography of the breast performed during invasive

interventions for localization or biopsy procedures; or

(2) Radiography of the breast performed as part of a scientific

study to evaluate an investigational mammography device conducted in

accordance with FDA's investigational device exemption regulations in

part 812 of this chapter.

(t) Mammography equipment evaluation means an onsite assessment of

a mammography unit or image processor for the purpose of making a

preliminary determination as to whether the equipment meets all of the

applicable standards in Sec. 900.12(b) and (e).

(u) Mammography medical outcomes audit means a systematic

collection of mammography results and the comparison of those results

with outcomes data.

(v) Mammography unit or unit means an assemblage of components for

the production of x-rays for use during mammography, including, at a

minimum: An x-ray generator, an x-ray control, a tube housing assembly,

a beam limiting device, and the necessary supporting structures for

these components.

(w) Mean optical density means the average of the optical densities

measured for phantom thicknesses of 2 centimeters to 6 centimeters

using values of kilovolt peak (kVp) clinically appropriate for those

thicknesses.

(x) Medical physicist means a person trained in evaluating the

performance of mammography equipment and facility quality assurance

programs and who meets the qualifications for a medical physicist set

forth in Sec. 900.12(a)(3).

(y) Modality means a technology, within the scope of 42 U.S.C.

263b, for radiography of the breast. Examples are screen-film

mammography and xeromammography.

(z) Phantom means a test object used to simulate radiographic

characteristics of compressed breast tissue and containing components

that radiographically model aspects of breast disease and cancer.

(aa) Phantom image means a radiographic image of a phantom.

(bb) Physical science means physics, chemistry, radiation science

(including medical physics and health physics), and engineering.

(cc) Positive mammogram means a mammogram that has an overall

assessment of findings that are either ``suspicious'' or ``highly

suggestive of malignancy.''

(dd) Provisional certificate means the provisional certificate

described in 42 U.S.C. 263b(c)(2).

(ee) Quality control technologist means an individual meeting the

requirements of Sec. 900.12(a)(2)(i) who is responsible for those

quality assurance responsibilities not assigned to the lead

interpreting physician or to the medical physicist.

(ff) Radiographic equipment means x-ray equipment used for the

production of static x-ray images.

(gg) Radiologic technologist means an individual specifically

trained in the use of radiographic equipment and the positioning of

examinees for radiographic examinations and who meets the requirements

set forth in Sec. 900.12(a)(2).

(hh) Serious adverse event means an adverse event that may

significantly compromise clinical outcomes, or an adverse event for

which a facility fails to take appropriate corrective action in a

timely manner.

(ii) Serious complaint means a report of a serious adverse event.

(jj) Survey means an onsite physics consultation and evaluation of

a facility performed by a medical physicist.

(kk) Time cycle means the film development time.

(ll) Traceability means the ability to show that an instrument has

been

[[Page 14870]]

calibrated at least annually through an unbroken chain of comparisons

starting with either an appropriate national standard established by

the National Institute of Science and Technology (NIST), Gaithersburg,

MD, or with a transfer standard calibrated by NIST.

Dated: March 22, 1996.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 96-7829 Filed 3-29-96; 8:45 am]

BILLING CODE 4160-01-P