Quality Mammography Standards; Companion Document to Direct Final Rule

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 99N-1502]

Quality Mammography Standards; Companion Document to Direct Final

Rule

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. The purpose of the amendments is

to incorporate changes required by the Mammography Quality Standards

Reauthorization Act (MQSRA). This proposed rule is a companion document

to the direct final rule published elsewhere in this issue of the

Federal Register.

DATES: Comments on this proposal must be received by August 31, 1999.

If FDA receives no significant adverse comment on the provisions of

these regulations within the specified comment period, the agency

intends to publish a document confirming the effective date of the

final rule in the Federal Register within 30 days after the comment

period on the direct final rule ends. The direct final rule will be

effective November 1, 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 20857, 301-594-3332.

SUPPLEMENTARY INFORMATION: This proposed rule is a companion to the

direct final rule published in the final rules section of this issue of

the Federal Register. This companion proposed rule is identical to the

direct final rule. This proposed rule will provide a procedural

framework to finalize the rule in the event the agency receives a

significant adverse comment and the direct final rule is withdrawn. FDA

is publishing the direct final rule because the rule contains direct

incorporations of statutory mandates, and FDA anticipates that it will

receive no significant adverse comments. If no significant comment is

received in response to the direct final rule, no further action will

be taken related to this proposed rule. Instead, FDA will publish a

confirmation document within 30 days after the comment period ends

confirming that the direct final rule will go into effect no later than

135 days after publication. Additional information about FDA's direct

final rulemaking procedures is set forth in a guidance published in the

Federal Register of November 21, 1997 (62 FR 62466).

If FDA receives significant adverse comments regarding this rule,

the agency will publish a document withdrawing the direct final rule

within 30 days after the comment period ends and will proceed to

respond to the comments under this rule using usual notice-and-comment

procedures. The comment period for this companion proposed rule runs

concurrently with the direct final rule's comment period. Any comments

received under this companion proposed rule will also be considered as

comments regarding the direct final rule. A significant adverse comment

is defined as a comment that explains why the rule would be

inappropriate, including challenges to the rule's underlying premise or

approach, or would be ineffective or unacceptable without a change. It

should be remembered, however, that the requirements themselves were

established by the MQSRA. FDA must implement these new statutory

provisions.

In determining whether a significant adverse comment is sufficient

to terminate a direct final rulemaking, FDA will consider whether the

comment raises an issue serious enough to warrant a substantive

response in a note-and-comment process. Comments that are frivolous,

insubstantial, or outside the scope of the rule will not be considered

a significant adverse comment under this procedure. For example, a

comment recommending a rule change in addition to the rule will not be

considered a significant adverse comment, unless the comment shows how

the rule would be ineffective without the additional change. In

addition, if a significant adverse comment applies to an amendment,

paragraph, or section of this rule and that provision can be severed

from the remainder of the rule, FDA may adopt as final those provisions

of the rule that are not the subject of a significant adverse comment.

I. Background

The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539)

was passed on October 27, 1992, to establish national quality standards

for mammography. The MQSA required that, to lawfully provide

mammography services after October 1, 1994, all facilities, except

facilities of the Department of Veterans Affairs, shall be accredited

by an approved accreditation body and certified by the Secretary of

Health and Human Services (the Secretary). To become accredited and

certified, a facility had to meet national quality standards to be

established by the Secretary. The authority to establish these

standards, to approve accreditation bodies, and to certify facilities

was delegated by the Secretary to FDA.

Facilities were initially accredited and certified if they met the

standards contained within the interim rules issued by FDA in the

Federal Register of December 21, 1993 (58 FR 67558 and 58 FR 67565),

and amended by another interim rule published in the Federal Register

of September 30, 1994 (59 FR 49808). More comprehensive standards were

proposed by FDA in the Federal Register of April 3, 1996 (61 FR 14856,

[[Page 32444]]

61 FR 14870, 61 FR 14884, 61 FR 14898, and 61 FR 14908). After some

revision in response to the approximately 8,000 comments received on

the proposed rule, a final rule was published in the Federal Register

of October 28, 1997 (62 FR 55852) (hereinafter referred to as the

October 1997 final rule). The effective date of most of the new

standards contained within the October 1997 final rule is April 28,

1999, but a few will not become effective until October 28, 2002.

On October 9, 1998, the MQSRA (Pub. L. 105-248) became law. The

basic purpose of the MQSRA was to extend the authorities established by

the MQSA until September 30, 2002. However, the MQSRA also contained a

requirement that was significantly different from the corresponding

requirement in the October 1997 final rule. Although this MQSRA

requirement will become effective on April 28, 1999, with or without

the amendment of the final rule, FDA is proposing to amend the final

rule to incorporate the change. The purpose of this proposed amendment

is to provide to the mammography facilities the convenience of being

able to find all of the quality standards within a single document

instead of having to consult both the October 1997 final rule and the

MQSRA and to avoid confusion as to the applicable reporting

requirement.

Other provisions of the MQSRA clarify the basis for some of the

requirements contained within the October 1997 final rule. FDA is also

amending the October 1997 final rule to conform its wording of those

requirements to that of the statute.

II. Changes in the Regulations

A. Reporting Requirements

Section 900.12(c)(2) (21 CFR 900.12(c)(2)) of the October 1997

final rule describes the requirements for communicating mammography

results to the patients. As published in the October 1997 final rule,

these requirements mandated that each mammography facility have a

system to ensure that the results of each examination are communicated

to the patient in a timely manner. Patients without a referring health

care provider were to be sent the report of the examination (as

described in Sec. 900.12(c)(1)) directly by the mammography facility,

along with a written notification or summary of the results in lay

terms. It was further required by the October 1997 final rule that such

self-referred patients should be referred to a health care provider

when clinically indicated.

In the case of patients with a referring health care provider,

Sec. 900.12(c)(3) required that the health care provider receive the

report of the examination. The facility's system for ensuring that

results reached the patient could utilize the services of that health

care provider to achieve that goal. There was no specific requirement

that a summary in lay terms be provided to the patient with a referring

health care provider.

The MQSRA amended the MQSA to specifically require that all

patients, not just self-referred patients, receive directly from the

mammography facility, a summary of the written report in terms easily

understood by a lay person. As previously noted, this MQSRA requirement

will go into effect on April 28, 1999. FDA is proposing to amend

Sec. 900.12(c)(2) to incorporate this new requirement.

B. Clarifications

The MQSRA at several points clarified the provisions of the MQSA

upon which certain requirements of the interim and final rules were

based. In contrast to the change in the patient reporting requirements,

these clarifications became effective on October 9, 1998, the date on

which the MQSRA became law. FDA is proposing to amend the regulations

to similarly clarify the wording of the October 1997 final rule on

these points.

1. Review Physicians

The most important function of the accreditation bodies approved by

FDA is to conduct a quality review of clinical images submitted by

facilities seeking accreditation. This review is the key factor in

determining if the facility should be accredited and then certified. It

has been recognized from the start of the MQSA program that the

physicians used by the accreditation bodies to review the clinical

images submitted by the facilities should meet qualifications beyond

those needed to serve as interpreting physicians in mammography

facilities. All accreditation bodies applying to FDA for approval must

demonstrate that their reviewing physicians have the high

qualifications necessary to perform such reviews before approval is

given.

In section 4, the MQSRA emphasized these points by defining the

physicians reviewing clinical images for the accreditation bodies as

``review physicians.'' In the MQSRA definition, it is further

recognized that the accreditation bodies can establish, with FDA

approval, additional qualifications for these review physicians beyond

the qualifications applicable to interpreting physicians in mammography

facilities.

FDA is proposing to add Sec. 900.2(yy) to incorporate the MQSRA

definition of ``review physician'' into the final rule. FDA is further

proposing to amend Sec. 900.4 in order to use the term review physician

at the appropriate points. In addition, since this term could be

confused with the term ``reviewing interpreting physician,'' presently

used in connection with the requirements for the mammography audit, FDA

is proposing to change the term, ``reviewing interpreting physician''

to ``audit interpreting physician'' in Sec. 900.12(f).

2. Patient Notification

The October 1997 final rule at Sec. 900.12(j) states that if FDA

determines that any activity related to the provision of mammography at

a facility presents a sufficiently serious risk to human health, the

agency may require the facility to notify the patients, their

physicians, and/or the public of actions that may be taken to minimize

this risk. This provision was established to aid FDA in fulfilling its

general responsibility under the MQSA to inform the public about

facilities against which the agency has been required to take action

for failure to meet the quality standards. In section 10(a), the MQSRA

provided a specific statement of the agency's authority to require

patient notification. FDA is proposing to amend the wording of

Sec. 900.12(j) to bring it into conformance with the wording of the

MQSRA on this point.

III. Environmental Impact

The agency has determined under 21 CFR 25.34(c) 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 impacts of these proposed amendments under

Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C.

601-612), 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 the impact of a rule on

small entities. The Unfunded

[[Page 32445]]

Mandates Reform Act requires (in section 201) that agencies prepare an

assessment of anticipated costs and benefits before enacting any rule

that may result in an expenditure in any one year by State, local, and

tribal governments, in the aggregate, or by the private sector of $100

million (adjusted annually for inflation).

As previously noted, the proposed amendments explained under

section II.B of this document merely clarify provisions already

contained within the October 1997 final rule. The impacts of the

provisions of that final rule were discussed in the preamble of the

final rule (62 FR 55852 at 55961), and are unchanged by the

clarifications. Any economic impact of the proposed amendments is

related solely to the change in the patient reporting requirement

mandated by the MQSRA. Given the statutory basis for extending this

requirement to all mammography facilities effective April 28, 1999, FDA

did not consider alternatives to implementing the requirements.

In the October 1997 final rule, FDA estimated that there were 9,800

mammography facilities that would be considered small. Moreover, FDA

previously estimated the impact of a requirement for sending a lay

summary of results to all patients during the development of its

proposed rule of April 3, 1996 (61 FR 14856), although that requirement

was removed from the October 1997 final rule in response to public

comments (Ref. 1). FDA believes that these estimates remain accurate.

The earlier estimate concerning the impact of required lay

summaries was based upon the assumption that an adequate lay summary of

results could be provided in the great majority of cases in a brief,

standardized format. Using this assumption, it was estimated that the

compliance cost per examination would be $0.94, including the labor of

the office worker and the cost of postage.

To convert this per examination cost to a national total, it was

necessary to make several other assumptions. Using the best data and

expert opinion available at the time, it was estimated that

approximately 25 million mammography examinations were conducted

annually in this country. Of this, it was estimated that 7.7 percent or

1,925,000 were examinations of self-referred patients. Because

facilities were already required by the MQSA (and by the interim rule)

to provide a lay summary of results to self-referred patients, that

portion of the cost of sending lay summaries had already been included

in the impact estimates made in association with the development of the

interim rule of October 27, 1993.

There remained then approximately 23,075,000 patients for which

this was potentially a new requirement. However, it was further

estimated that 40 percent of the patients were already receiving a lay

summary in some form from the facility at which they received their

examinations. Thus, the new requirement would lead to additional lay

summaries in only 60 percent of the referred examinations or

approximately 13,845,000. At $0.94 a lay summary, the added cost would

be slightly over $13 million a year.

Two major changes have occurred since the information upon which

these estimates were based was collected in late 1995. Most

significantly, through FDA's activities and those of other private and

government groups, public awareness of the need for regular mammography

examinations and public confidence that a high quality examination will

be received have both increased. As a result, the number of

examinations given per year has increased to an estimated 40 million.

This requires increasing the costs estimated previously by 60 percent.

Postage rates have also gone up $0.01 per letter thus the cost per lay

summary would increase from $0.94 to $0.95. The combined impact of

these two changes is to increase the estimate of the annual incremental

costs to meet this proposed new requirement to approximately $21

million.

For the great majority of cases, the assumption that the lay

summaries can be provided in brief, standardized format is valid.

However, in approximately 10 percent of the cases, the overall

assessment of the findings is expected to be ``suspicious'' or ``highly

suggestive of malignancy.'' In such cases, the facility is required to

``make reasonable attempts to ensure that the results are communicated

to the patients as soon as possible.''

Facilities that accept self-referred patients are already required

by the final rule to make such attempts for cases with an overall

assessment of ``suspicious'' or ``highly suggestive of malignancy.''

Based upon the assumption that the attempt would involve a 5 minute

telephone conversation of the interpreting physician with the patient,

a cost of $8.93 per examination was estimated. This cost would be in

addition to the $0.95 estimated cost for the written lay summary which

would still need to be sent. Assuming that this would be a new cost for

10 percent of the 60 percent of the referred patients among the 40

million receiving examinations annually, the incremental cost for these

contacts is approximately $21.4 million.

The total annual incremental cost due to this proposed new

requirement, therefore, would be approximately $42.4 million.

Previously, the annual cost for compliance with the interim and final

MQSA rules was estimated at $61.5 million (Ref. 2). Adding the cost of

compliance with this proposed new requirement brings the total annual

cost of compliance with the final rule as amended to approximately

$103.9 million.

Compliance with the proposed new requirement would also be expected

to increase the benefits from mammography. Mammography is the most

effective technique presently available for the early detection of

breast cancer. Early detection of breast cancer followed by prompt

treatment can avert mortalities that can result if treatment is delayed

until the cancer reaches a more advanced stage. In addition, the cost

and severity of the treatment methods will in general be less when the

cancer is treated at an early stage. Even in cases where the assessment

is negative, there will be an expected benefit arising from relieving

the anxiety of the patient about the possible results of the

examination through prompt reporting of results to her. But for these

benefits to be gained, the patient must be informed of the results of

her examination so that necessary followup actions can be promptly

taken. Unfortunately, although it is not possible to make a

quantitative estimate of the number of such cases, there have been

frequent complaints about patients receiving the results of their

examinations after an undue delay or not at all. Studies have also

shown that direct communication of results to the patient by the

mammography facility (as compared to traditional communication

procedures where the facility communicates only with the referring

provider), produces an improvement in compliance with followup

recommendations (Ref. 3). The new requirement should thus add to the

benefits expected from interim and final rules, which were previously

estimated to range from $284 to $408 million (61 FR 55986), primarily

due to a gain in averted mortalities (Ref. 2).

Based on these analyses, FDA has determined that the rule is

consistent with the principles set forth in the Executive Order, the

Regulatory Flexibility Act, and the Unfunded Mandates Reform Act. The

wording of the requirement related to sending lay summaries to referred

patients directly parallels that of the MQSRA and so, in accordance

with the Executive Order, maximizes the net benefits to the extent

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allowed by that statute. Similarly, in accordance with the Regulatory

Flexibility Act, the impact of the rule on small entities has been

analyzed. Finally, as noted previously, the incremental annual

expenditures (beyond those already incurred from the previous interim

and final rules) required by the rule are estimated at $42.4 million

and thus do not exceed $100 million in 1 year so the rule does not come

under the requirements of the Unfunded Mandates Reform Act.

V. Paperwork Reduction Act of 1995

This proposed rule contains information collection provisions that

are subject to review by the Office of Management and Budget (OMB)

under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-

3520). The title, description, and respondent description of the

information collection provisions are shown below with an estimate of

the annual reporting and recordkeeping burden. Included in the estimate

are the times for reviewing the instructions, searching existing data

sources, gathering and maintaining the data needed, and completing and

reviewing each collection of information.

FDA invites comments on: (1) Whether the proposed collection of

information is necessary for the proper performance of FDA's functions,

including whether the information will have practical utility; (2) the

accuracy of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

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

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

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Title: Lay Summary of Examination Results to Patients

Description: This proposed rule would merely implement a statutory

information collection requirement; there is no additional burden

attributable to the regulation. The proposed rule would conform the

requirements of this section with the requirement of section 6 of Pub.

L. 105-248 that states: ``(IV) whether or not such a physician is

available or there is no such physician, a summary of the written

report shall be sent directly to the patient in terms easily understood

by a lay person.'' To produce the required lay summary, the mammography

facilities will review the medical report of each patient's examination

and collect from it the necessary information.

Respondent Description: Businesses and other for-profit

organizations, nonprofit organizations.

For consistency with the direct final rule to which this proposed

rule is a companion, FDA is following the PRA comment procedures for

direct final rules in this proposed rule. As provided in 5 CFR

1320.5(c)(1), collections of information in a direct final rule are

subject to the procedures set forth in 5 CFR 1320.10. Interested

persons and organizations may submit comments on the information

collection provisions of this proposed rule by August 31, 1999, to the

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630

Fishers Lane, rm. 1061, Rockville, MD 20852. At the close of the 75-day

comment period, FDA will review the comments received, revise the

information collection provisions as necessary, and submit these

provisions to OMB for review. FDA will publish a notice in the Federal

Register when the information collection provisions are submitted to

OMB, and an opportunity for public comment to OMB will be provided at

that time. Prior to the effective date of the direct final rule, FDA

will publish a notice in the Federal Register of OMB's decision to

approve, modify, or disapprove the information collection provisions.

An agency may not conduct or sponsor, and a person is not required to

respond to, a collection of information unless it displays a currently

valid OMB control number.

VI. References

The following references have been placed on display at 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. Eastern Research Group, ``Cost and Benefit Analysis of

Regulations Under the Mammography Quality Standards Act of 1992-

Preliminary Final,'' March 14, 1996.

2. Eastern Research Group, ``Economic Impact Analysis of

Regulations Under the Mammography Quality Standards Act of 1992-

Final,'' October 7, 1997.

3. Agency for Health Care Policy and Research (AHCPR), ``Quality

Determinants of Mammography,'' AHCPR Pub. No. 95-0632, October 1994.

List of Subjects in 21 CFR Part 900

Electronic products, Health facilities, Medical devices, Radiation

protection, Reporting and recordkeeping requirements, X-rays.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and

under authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 900 be amended as follows:

PART 900--MAMMOGRAPHY

1. The authority citation for part 900 continues to read as

follows:

Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

2. Section 900.2 is amended by adding paragraph (yy) to read as

follows:

Sec. 900.2 Definitions.

* * * * *

(yy) Review physician means a physician who, by meeting the

requirements set out in Sec. 900.4(c)(5), is qualified to review

clinical images on behalf of the accreditation body.

3. Section 900.4 is amended by revising the last sentence of

paragraph (a)(4); and by revising paragraphs (c)(3)(ii), (c)(5)

introductory text, (c)(5)(i), (c)(5)(ii), and (c)(6)(ii) to read as

follows:

Sec. 900.4 Standards for accreditation bodies.

(a) * * *

(4) * * * Such individuals who review clinical or phantom images

under the provisions of paragraphs (c) and (d) of this section or who

visit facilities under the provisions of paragraph (f) of this section

shall not review clinical or phantom images from or visit a facility

with which such individuals maintain a relationship, or when it would

otherwise be a conflict of interest for them to do so, or when they

have a bias in favor of or against the facility.

* * * * *

(c) * * *

(3) * * *

(ii) All clinical images submitted by a facility to the

accreditation body shall be reviewed independently by two or more

review physicians.

* * * * *

(5) Review physicians. Accreditation bodies shall ensure that all

of their review physicians:

(i) Meet the interpreting physician requirements specified in

Sec. 900.12(a)(1) and meet such additional requirements as have been

established by the accreditation body and approved by FDA;

(ii) Are trained and evaluated in the clinical image review

process, for the types of clinical images to be evaluated by a review

physician, by the accreditation body before designation as review

physicians and periodically thereafter; and

* * * * *

(6) * * *

(ii) If a review physician identifies a suspicious abnormality on

an image

[[Page 32447]]

submitted for clinical image review, the accreditation body shall

ensure that this information is provided to the facility and that the

clinical images are returned to the facility. Both shall occur no later

than 10-business days after identification of the suspected

abnormality.

* * * * *

4. Section 900.12 is amended by revising paragraphs (c)(2) and

(f)(3) and the first sentence of paragraph (j)(2) to read as follows:

Sec. 900.12 Quality standards.

* * * * *

(c) * * *

(2) Communication of mammography results to the patients. Each

facility shall send each patient a summary of the mammography report

written in lay terms within 30 days of the mammographic examination. If

assessments are ``Suspicious'' or ``Highly suggestive of malignancy,''

the facility shall make reasonable attempts to ensure that the results

are communicated to the patient as soon as possible.

(i) Patients who do not name a health care provider to receive the

mammography report shall be sent the report described in paragraph

(c)(1) of this section within 30 days, in addition to the written

notification of results in lay terms.

(ii) Each facility that accepts patients who do not have a health

care provider shall maintain a system for referring such patients to a

health care provider when clinically indicated.

* * * * *

(f) * * *

(3) Audit interpreting physician. Each facility shall designate at

least one interpreting physician to review the medical outcomes audit

data at least once every 12 months. This individual shall record the

dates of the audit period(s) and shall be responsible for analyzing

results based on this audit. This individual shall also be responsible

for documenting the results and notifying other interpreting physicians

of their results and the facility aggregate results. If followup

actions are taken, the audit interpreting physician shall also be

responsible for documenting the nature of the followup.

* * * * *

(j) * * *

(2) If FDA determines that the quality of mammography performed by

a facility, whether or not certified under Sec. 900.11, was so

inconsistent with the quality standards established in this section as

to present a significant risk to individual or public health, FDA may

require such facility to notify patients who received mammograms at

such facility, and their referring physicians, of the deficiencies

presenting such risk, the potential harm resulting, appropriate

remedial measures, and such other relevant information as FDA may

require. * * *

Dated: June 9, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy Coordination.

[FR Doc. 99-15293 Filed 6-16-99; 8:45 am]

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