[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14856-14870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7829]




[[Page 14855]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 900



Mammography Quality Standards; Proposed Rules

  Federal Register / Vol. 61, No. 65 / Wednesday, April 3, 1996 / 
Proposed Rules  

[[Page 14856]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 95N-0192]
RIN 0910-AA24


Quality Mammography Standards; General Preamble and Proposed 
Alternative Approaches

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

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

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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