[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24354]
[[Page Unknown]]
[Federal Register: September 30, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 900
[Docket No. 93N-0351]
Quality Standards and Certification Requirements for Mammography
Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim rule; opportunity for public comment.
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SUMMARY: The Food and Drug Administration (FDA) is issuing regulations
to implement the Mammography Quality Standards Act of 1992 (MQSA). The
MQSA requires the establishment of a Federal certification and
inspection program for mammography facilities; regulations and
standards for accrediting bodies for mammography facilities; and
standards for mammography equipment, personnel, and practices,
including quality assurance. This regulation, which amends two
previously published interim rules, modifies and adds to the
definitions previously set forth. In addition, the interim rule
provides a mechanism to request permission to meet alternative
requirements, other than those previously set forth, if the proposed
alternative requirement is at least as effective as the existing
quality standards in achieving quality mammography services for women.
DATES: The interim regulation is effective October 1, 1994; written
comments by December 29, 1994. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication in 21
CFR 900.12(d)(1)(i), effective on September 30, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
The MQSA (Pub. L. 102-539) was enacted to establish minimum,
national quality standards for mammography. The MQSA requires that, to
provide mammography services legally after October 1, 1994, all
facilities, except facilities of the Department of Veterans Affairs,
must be both accredited by an approved accrediting body and certified
by the Secretary of Health and Human Services (HHS) (the Secretary).
The authority to approve accreditation bodies and to certify facilities
has been delegated by the Secretary to FDA.
The MQSA was passed on October 27, 1992, in response to statistics
on the prevalence of breast cancer across the United States. Breast
cancer is now the most common cancer, and the second leading cause of
cancer deaths among women. According to the 1992 projections by the
American Cancer Society, there would be 180,000 new cases of breast
cancer among women in the United States in just that year. Of these new
cases, it was estimated that approximately 46,000 of these women would
die from the disease. The lifetime risk of developing breast cancer is
increasing. In 1992, breast cancer affected 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.
Early detection of breast cancer, typically involving physical
breast examination and mammography, is the best means of preventing
deaths that result from breast cancer detected at an advanced stage.
The value of undergoing mammography screening is that mammography can
detect cancers that are too small to be felt through physical
examination (palpation). Mammograms can detect breast cancer up to 2
years before a woman or her doctor can feel a lump. In addition, these
early stage cancers can be 90 to 100 percent curable (Ref. 1).
However, according to the General Accounting Office (GAO), a
mammogram is one of the most difficult radiographic images to read. It
must have optimal clarity for the image to be interpreted correctly. If
the image quality is poor or the interpretation is faulty, the
interpreter may miss an incipient cancerous lesion. This could delay
treatment and result in an avoidable death or mastectomy. Further, it
is equally true that poor images or faulty interpretations can lead to
a false positive diagnosis, which produces needless patient anxiety,
costly additional testing, and painful biopsies when normal tissue is
misread as abnormal.
The Senate Committee on Labor and Human Resources held hearings on
the breast cancer issue and found a wide range of problems with the
current mammography system: Poor quality equipment, the lack of quality
assurance procedures, poorly trained technologists and physicians,
false representation of accreditation by some mammography facilities,
and the lack of inspections or consistent governmental oversight. The
MQSA addresses these specific concerns by establishing national minimum
standards for all mammography facilities, except the Department of
Veterans Affairs, in the areas of radiation dose, equipment, personnel,
and practices, such as quality control and quality assurance. The MQSA
replaces a patchwork of Federal, State, and private standards and
guarantees sufficient oversight and enforcement to ensure that women
will receive high quality mammography services.
II. Comments
To date, FDA has received 97 comments on the 2 interim rules that
were published in the Federal Register of December 21, 1993 (58 FR
67558 and 58 FR 67565). These comments, which have been carefully
reviewed and summarized, are under consideration as the final
regulations are being developed. FDA will publish its response to the
various comments in the Federal Register when the final rules are
published.
III. Effective Date
The effective date of this regulation is October 1, 1994. Although
the effective date of a final regulation ordinarily may not be less
than 30 days after date of publication in the Federal Register, the
Administrative Procedures Act and FDA's regulations permit exceptions
to this timeframe when: (1) The regulation grants an exemption or
relieves a restriction; (2) the regulation interprets rules and policy
statements; or, (3) good cause exists and is published for the earlier
date. This interim rule satisfies any one or all of the exemption
criteria that permit an earlier effective date. (See 5 U.S.C. 553(d)
and 21 CFR 10.40(c)(4).)
First, this interim rule exempts certain mammography devices and
procedures from quality standards established under the MQSA. Second,
the interim rule provides a means for proposing alternative standards
that may relieve restrictions for certain mammography facilities.
Third, the interim rule provides interpretive definitions and FDA
policy statements to clarify essential terms in rules previously issued
under the MQSA. Finally, failure to implement this interim rule by
October 1, 1994, could inadvertently render critical mammography
devices and procedures illegal that are not currently intended to be
covered under the MQSA. Therefore, the agency finds good cause for an
effective date fewer than 30 days after publication of this regulation.
Accordingly, for all these reasons, this interim rule is made effective
as of October 1, 1994.
IV. Legislative Authority
December 14, 1993, the President signed legislation (H. Rept. 2202)
granting interim rule authority to the Secretary for promulgation of
standards required by the MQSA. This authorization was provided in
recognition of the fact that the certification deadline of October 1,
1994, could not be met without streamlining the process for initial
promulgation of standards. Because of the perceived urgent public
health need for Federal standards for mammography, it was decided that
interim rule authority should be granted, rather than an extension of
the deadline to develop standards.
Under the interim rule legislation, the Secretary is authorized to
issue temporary, interim regulations setting forth standards for
approving accrediting bodies and for quality standards for mammography,
under section 354(e) and 354(f) of the Public Health Service Act (the
PHS Act) (42 U.S.C. 263b(e) and 354(f)). Under the abbreviated process,
the Secretary is required to adopt existing standards to the maximum
extent feasible, such as those established by the Health Care Financing
Administration (HCFA), private voluntary accreditation bodies, e.g.,
the American College of Radiology (ACR), and some States. Also, in
developing the interim regulations, the Secretary is not required to
consult with the National Mammography Quality Assurance Advisory
Committee (Advisory Committee). However, after the interim standards
are issued, Congress intended that the Secretary proceed with the more
extensive rulemaking procedures envisioned by the original enactment of
the MQSA, including the statutorily required consultation with the
Advisory Committee.
FDA used this authority to issue interim requirements for
accrediting bodies, quality standards, and certification on December
21, 1993. Those interim standards have been used to approve
accreditation bodies and certify facilities before the October 1, 1994,
deadline. However, since the interim regulations were published on
December 1993, FDA's experience in applying those interim standards has
convinced the agency that certain amendments to those interim rules are
necessary in order to clarify the obligation that facilities have to
meet under MQSA by the October 1, 1994, deadline. The regulations
implemented by this interim rule add to and modify the interim rules
issued on December 21, 1993, and will remain in effect until final
regulations are proposed and promulgated in 1995.
V. Provisions of the Rule
A. Amended Definition
FDA's experience in developing standards and planning for
implementation of the MQSA over the past year has made the agency aware
that certain changes to its previously published interim definitions
are necessary.
Section 900.2 (21 CFR 900.2) of the December 21, 1993, interim rule
(58 FR 67558 at 67563) defines essential terms used throughout the
interim rules. These definitions are intended to inform mammography
facilities and consumers of the meaning of terminology used throughout
the MQSA regulations. This interim rule amends and modifies certain
terms defined in Sec. 900.2.
In determining which facilities would be subject to the standards
under the MQSA, Congress defined the term ``facility'' to include a
hospital, outpatient department, clinic, radiology practice, or mobile
unit, an office of a physician, or other facility, as determined by the
Secretary, and, by delegation, FDA, that conducts breast cancer
screening or diagnosis through mammography activities. The term does
not include a facility of the Department of Veterans Affairs.
Congress further defined mammography ``activities'' to include the
operation of equipment to produce a mammogram, the processing of film,
the initial interpretation of the mammogram, and the (maintenance of)
viewing conditions for that interpretation. However, Congress
recognized that a mammogram may be performed in a place that is
different from the facility that processes or interprets the x-ray
film. In such a case, the MQSA requires the facility performing the
mammogram to be responsible for meeting the MQSA quality standards.
Under this interim rule, FDA is amending the definition of
``facility'' under Sec. 900.2 to clarify that it is the facility
performing the mammogram that is responsible for obtaining
accreditation by an FDA-approved accrediting body and certification by
FDA to provide mammography services legally after October 1, 1994. The
facility performing the mammogram must substantiate that the additional
mammography activities of processing the x-ray film, interpreting the
image, and maintaining viewing conditions, wherever performed, meet all
quality standards required under the MQSA. Facilities that provide only
partial services (e.g., film processing companies or interpreting
radiologists) are not required at this time to apply for accreditation
or certification under MQSA, although these partial providers will have
to meet MQSA standards in order to be employed by any facility that
performs mammograms. In the future, FDA may require facilities that
perform any portion of the process required for a mammography
evaluation to be directly subject to the accreditation and
certification process.
In addition, although the MQSA excludes facilities of the
Department of Veterans Affairs (VA) from the scope of the legislation,
VA is working to establish standards consistent with this legislation.
All other facilities that conduct the following screening or diagnostic
mammography activities are subject to the standards issued under the
MQSA.
B. New Definitions
This interim rule is adding the new terms ``screening mammography''
and ``diagnostic mammography'' to Sec. 900.2 in order to clarify which
breast cancer screening or diagnostic mammography activities conducted
by a facility will render that facility subject to the provisions of
and regulations issued under the MQSA, and which activities are
excluded from regulation. Under the MQSA, Congress defined the term
``mammography'' as radiography of the breast, but provided no statutory
definition for the terms ``screening mammography'' and ``diagnostic
mammography.'' This interim rule is adding the terms ``screening
mammography'' and ``diagnostic mammography'' to the definition portion
of the regulations in order to clarify the scope of the regulated
mammography activities. These definitions are based on definitions
developed by the Agency for Health Care Policy and Research (AHCPR) and
the ACR, and have been modified as necessary for purposes of MQSA
implementation.
The term ``screening mammography'' is being defined as mammography
performed on an asymptomatic patient to detect the presence of breast
cancer at an early stage. In screening mammography, the patient
typically has not manifested any clinical signs, symptoms, or physical
findings of breast cancer. The screening mammogram is performed to
detect the presence of a breast abnormality in its incipient stage and
to serve as a baseline film to which future screening or diagnostic
mammograms may be compared.
The term ``diagnostic mammography'' is being defined as mammography
performed on a patient with clinical signs, symptoms, or physical
findings suggestive of breast cancer; an abnormal or questionable
screening mammogram; a history of breast cancer with breast
conservation surgery regardless of absence of clinical breast signs,
symptoms, or physical findings; or, augmented breasts regardless of
absence of clinical breast signs, symptoms, or physical findings.
Diagnostic mammography is also called problem-solving mammography or
consultative mammography. A diagnostic mammogram is performed because
there is a reasonable articulable suspicion that an abnormality may
exist in the breast. The diagnostic mammogram may confirm or deny the
presence of an abnormality and, if confirmed, may assist in determining
the nature of the problem.
FDA has further defined the terms screening and diagnostic
mammography to exclude breast imaging performed in a research setting
as part of a scientific study to evaluate experimental mammography
devices conducted in accordance with FDA's investigational device
exemption regulations in 21 CFR part 812. Science has not progressed to
the point where effective quality standards may be written for every
category of experimental mammography device. Therefore, at this time
these investigational devices for breast radiography will not be
subject to the quality standards issued under the MQSA. However, any
conventional mammography device used as part of the scientific study to
provide baseline data from which to evaluate the safety and efficacy of
the experimental device would be subject to MQSA quality standards.
In addition, invasive interventions which employ breast radiography
devices to produce radiographic images of the breast in association
with localization or biopsy (e.g., stereotactic x-ray) procedures have
also been excluded from the definitions of screening and diagnostic
mammography activities.
In the future, when the science has advanced to a point where
effective, national quality standards may be developed, FDA may
regulate facilities that employ these invasive interventions or
facilities that employ experimental devices for breast radiography to
ensure their compliance under the act.
C. Alternative Standards
FDA recognizes that there may be alternative standards to the
standards issued in Sec. 900.12 (21 CFR 900.12) of the Federal Register
of December 12, 1993 (58 FR 67565), that are at least as effective in
delivering high quality mammography services to women. In the interest
of improving the overall quality of mammography, FDA wants to provide
an avenue by which safe and effective alternative standards may be
implemented. Accordingly, the agency has created a mechanism for
qualified applicants to request permission to meet an alternative
standard rather than an existing quality standard. The request must be
supported by such evidence as required by the agency to render a
determination that the suggested alternative is at least as effective
as the agency mandated standard in helping to achieve high quality
mammography.
If the agency determines that the proposed alternative is
acceptable, the agency will grant the request. The applicant will
receive written notice of the approval of the alternative standard,
including any limitations on use of the alternative, and the period of
time that the alternative may be employed. The decision will be placed
in the public docket file in the Dockets Management Branch (address
above), after deletion of any patient identifiers or confidential
commercial information, and may also be published in the form of a
notice in the Federal Register.
Other entities that desire to use the alternative standard must
also submit an application and receive approval by the agency before
they may substitute the alternative for the agency mandated standard.
FDA anticipates that ``me-too'' entities filing an application in
accordance with the regulations typically would receive a prompt
response to the request. This process is necessary to ensure that those
other entities wishing to avail themselves of the alternative fully
understand and appreciate the alternative procedure and its
applicability so that the overall quality of mammography services is
maintained. However, if a manufacturer of mammography equipment applies
to the agency for approval of an alternative standard based on
particular characteristics of that manufacturers's equipment, FDA
approval of that alternative standard would apply to all facilities
using that manufacturer's equipment.
VI. Quality Assurance Standards: Screen-Film
FDA is amending the quality assurance (QA) standard for screen-film
systems. Section 900.12(d)(1)(i) (58 FR 67565 at 67572) requires the
screen-film QA program for a mammography facility to be substantially
the same as that described in the 1992 edition of ``Mammography Quality
Control: Radiologist's Manual, Radiologic Technologists Manual and
Medical Physicist's Manual.'' Recently, the 1994 edition of the manual
has been published. FDA has evaluated the revised QA screen-film
program in this latest edition and determined that either the 1992
version or the 1994 version of the program can serve as the basis for a
facility's screen-film QA program. FDA is amending Sec. 900.12(d)(1)(i)
to reflect this change.
VII. Paperwork Reduction Act of 1980
This interim rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1980 (44 U.S.C. Chapter 35). The title,
description, and respondent description of the information collection
are shown below with an estimate of the annual reporting and
recordkeeping burden. 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: Quality Standards and Certification Requirements for
Mammography Facilities.
Description: FDA is issuing an interim rule to implement the
certification and quality standards provisions of the MQSA. This
regulation, which amends two previously published interim rules,
modifies and adds to the definitions previously set forth. In addition,
the interim rule provides a mechanism to request permission to meet
alternative requirements, other than those previously set forth, if the
proposed alternative requirement is at least as effective as the
existing quality standards in achieving quality mammography services
for women.
As required by section 3504(h) of the Paperwork Reduction Act of
1980, FDA is submitting a copy of this interim rule to OMB for its
review of these information collection requirements. Other
organizations and individuals desiring to submit comments regarding
this burden estimate or any aspects of these information collection
requirements, including suggestions for reducing the burden, should
direct them to FDA's Dockets Management Branch (address above) and to
the Office of Information and Regulatory Affairs, OMB, rm. 3208, New
Executive Office Bldg., Washington, D.C. 20503, Attention: Desk Officer
for FDA.
Estimated Annual Burden for Reporting
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No. of
CFR section No. of responses per Total annual Hours per Total
respondents respondent responses response hours
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21 CFR 900.11(b)(2), 21 CFR 900.18\1\... 25 1 25 2 50
---------
Total............................... ............... ............... ............ ............ 50
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1FDA is unable to estimate the burden imposed by 21 CFR 900.18 at this time because there is insufficient
information to determine how many requests for approval of an alternative standard will be submitted. This
estimate will be provided when FDA has sufficient information on which to base an estimate.
Estimated Annual Burden for Recordkeeping
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No. of Annual hours per Total annual
CFR section recordkeepers recordkeeping burden hours
----------------------------------------------------------------------------------------------------------------
21 CFR 900.11(c)(1)....................................... 1,000 1 1,000
21 CFR 900.12(e)(1), 21 CFR 900.18\1\..................... 10,000 1 10,000
-----------------------------------
Total Annual Burden................................... ................ ................ 11,050
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1FDA is unable to estimate the burden imposed by 21 CFR 900.18 at this time because there is insufficient
information to determine how many requests for approval of an alternative standard will be submitted. This
estimate will be provided when FDA has sufficient information on which to base an estimate.
VIII. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
IX. Economic Impact
FDA has examined the impacts of the interim rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this interim rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the interim
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because a request for an alternative requirement is
a voluntary action by the applicant and the amended definitions limit
the current applicability of these requirements, the agency certifies
that the interim rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
X. References
The following reference has 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. Report on the Mammography Quality Standards Act of 1992, U.S.
Senate, Report 102-448, October 1, 1992.
XI. Request for Comments
Interested persons may, on or before December 29, 1994, submit to
the Dockets Management Branch (address above) written comments
regarding this interim rule. 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. Although these
amendments to the interim regulations become effective October 1, 1994,
FDA will consider and evaluate all comments it receives as part of its
ongoing work on the final rules.
List of Subjects in 21 CFR Part 900
Electronic products, Incorporation by reference, Mammography,
Medical devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 900 is amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: 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. Section 900.2 is amended by revising paragraph (e) and by adding
new paragraphs (r) and (s) to read as follows:
Sec. 900.2 Definitions.
* * * * *
(e) Facility means a hospital, outpatient department, clinic,
radiology practice, or mobile unit, office of a physician, or other
facility that conducts breast cancer screening mammography activities
or conducts diagnostic mammography activities, including the following:
The operation of equipment to produce a mammogram, processing of film,
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.
* * * * *
(r) Diagnostic mammography means mammography performed on a patient
with: clinical signs, symptoms, physical findings suggestive of breast
cancer; an abnormal or questionable screening mammogram; a history of
breast cancer with breast conservation surgery regardless of absence of
clinical breast signs, symptoms, or physical findings; or, augmented
breasts regardless of absence of clinical breast signs, symptoms, or
physical findings. Diagnostic mammography is also called problem-
solving mammography or consultative mammography. This definition
excludes mammography performed during invasive interventions for
localization or biopsy procedures. The definition further excludes
mammography performed as part of a scientific study to evaluate an
experimental mammography device conducted in accordance with FDA's
investigational device exemption regulations in part 812 of this
chapter.
(s) Screening mammography means mammography performed on an
asymptomatic patient to detect the presence of breast cancer at an
early stage. This definition excludes mammography performed as part of
a scientific study to evaluate an experimental mammography device
conducted in accordance with FDA's investigational device exemption
regulations in part 812 of this chapter.
3. Section 900.12(d)(1)(i) is revised to read as follows:
Sec. 900.12 Quality standards.
* * * * *
(d) * * *
(1) * * *
(i) For film-screen systems, be substantially the same as that
described in the 1992 or 1994 edition of ``Mammography Quality Control:
Radiologist's Manual, Radiologic Technologist's Manual, and Medical
Physicist's Manual,'' prepared by the American College of Radiology,
Committee on Quality Assurance in Mammography, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American College of Radiology, Mammography
Accreditation Program, 1891 Preston White Dr., Reston, VA 22091-5431;
and may be inspected at the Center for Devices and Radiological Health,
Division of Mammography and Radiation Programs (HFZ-200), 5600 Fishers
Lane, Rockville, MD 20857; or may be examined at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
* * * * *
4. Section 900.18 is added to subpart B to read as follows:
Sec. 900.18 Alternative requirements for MQSA quality standards.
(a) Criteria for approval of alternative standards. Upon
application by a qualified party as defined under paragraph (b) of this
section, the Director, Division of Mammography Quality and Radiation
Programs (the Director), may approve an alternative to a quality
standard under Sec. 900.12, when the Director determines that:
(1) The proposed alternative standard will be at least as effective
in assuring quality mammography as the standard it proposes to replace,
and
(2) The proposed alternative:
(i) Is too limited in its applicability to justify amending the
standard, or
(ii) Offers an expected benefit to public health which is so great
that the time required for the processing of an amendment to the
standard would present an unjustifiable risk to public health, and
(3) The granting of the alternative is in keeping with the purposes
of the Mammography Quality Standards Act of 1992.
(b) Applicants for alternatives. (1) Mammography facilities and
accreditation bodies may apply for alternatives to the quality
standards of Sec. 900.12.
(2) State governments that are not accrediting bodies may apply for
alternatives to the standards of Sec. 900.12(a).
(3) Manufacturers and assemblers of equipment used for mammography
may apply for alternatives to the standards of Sec. 900.12 (b), (c),
and (d).
(c) Application for approval of an alternative standard. An
application for approval of an alternative standard or for an amendment
or extension of the alternative standard shall be submitted in an
original and two copies to the Director, Division of Mammography
Quality and Radiation Programs, Center for Devices and Radiological
Health (HFZ-240), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. The application for approval of an alternative
standard shall include the following information:
(1) Identification of the original standard for which the
alternative standard is being proposed and an explanation of why it is
believed necessary to propose the alternative;
(2) A description of the manner in which the alternative is
proposed to deviate from the original standard;
(3) A description, supported by data, of the advantages to be
derived from such deviation;
(4) An explanation, supported by data, of how such a deviation
would assure equal or greater quality of production, processing, or
interpretation of mammograms than the original standard;
(5) The suggested period of time that the proposed alternative
standard would be in effect; and
(6) Such other information required by the Director to evaluate and
act on the application.
(d) Ruling on applications. (1) The Director may approve or deny,
in whole or in part, a request for approval of an alternative standard
or any amendment or extension thereof, and shall inform the applicant
in writing of this action. The written notice will state the manner in
which the requested alternative standard differs from the agency
standard and a summary of the reasons for approval or denial of the
request. If the request is approved, the written notice will also
include the effective date and the termination date of the approval, a
summary of the limitations and conditions attached to the approval, and
any other information that may be relevant to the approved request.
Each approved alternative standard will be assigned an identifying
number.
(2) Notice of an approved request for an alternative standard or
any amendment or extension thereof will be placed in the public docket
file in the office of the Dockets Management Branch and may also be in
the form of a notice published in the Federal Register. The notice will
state the name of the applicant, a description of the published agency
standard, and a description of the approved alternative standard,
including limitations and conditions attached to approval of the
alternative standard.
(3) Summaries of approved alternative standards, including
information on their nature and number, will be provided to the
National Mammography Quality Assurance Advisory Committee.
(4) All applications for approval of alternative standards and for
amendments and extensions thereof and all correspondence (including
written notices of approval) on these applications will be available
for public disclosure in the Dockets Management Branch, excluding
patient identifiers and confidential commercial information.
(e) Amendment or extension of an alternative standard. An
application for amending or extending approval of an alternative
standard shall include the following information:
(1) The approval number and the expiration date of the alternative
standard;
(2) The amendment or extension requested and the basis for the
amendment or extension; and
(3) An explanation, supported by data, of how such an amendment or
extension would assure equal or greater quality of production,
processing, or interpretation of mammograms than the original standard.
(f) Applicability of the alternative standards. Any approval of an
alternative standard, amendment, or extension may be implemented only
by the entity to which it was granted and under the terms under which
it was granted, except that when an alternative standard is approved
for a manufacturer of equipment, any facility using that equipment will
also be covered by the alternative standard. Other entities interested
in similar or identical approvals must file their own application by
following the provisions of Sec. 900.18(c).
(g) Withdrawal of approval of alternative standards. The Director
shall amend or withdraw approval of an alternative standard whenever
the Director determines that this action is necessary to protect the
public health or otherwise is justified by Sec. 900.12. Such action
will become effective on the date specified in the written notice of
the action sent to the applicant, except that it will become effective
immediately upon notification of the applicant when the Director
determines that such action is necessary to prevent an imminent health
hazard.
Dated: September 26, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-24354 Filed 9-28-94; 12:40 pm]
BILLING CODE 4160-01-P