[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.

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

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                                      
----------------------------------------------------------------------------------------------------------------
                                                                No. of                                          
              CFR section                      No. of       responses per   Total annual    Hours per     Total 
                                            respondents      respondent      responses      response     hours  
----------------------------------------------------------------------------------------------------------------
21 CFR 900.11(b)(2), 21 CFR 900.18\1\...              25                1            25             2       50  
                                                                                                       ---------
    Total...............................  ...............  ...............  ............  ............      50  
----------------------------------------------------------------------------------------------------------------
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                                    
----------------------------------------------------------------------------------------------------------------
                                                                 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 
----------------------------------------------------------------------------------------------------------------
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