[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14884-14898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7831]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0192]
RIN 0910-AA24

Proposed Requirements for Accreditation Bodies of Mammography 
Facilities
AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its interim regulations for application procedures for FDA approval as 
an accreditation body under the Mammography Quality Standards Act of 
1992 (the MQSA). FDA is proposing these amendments based on experience 
gained in administering the interim regulations, advice from the 
National Mammography Quality Assurance Advisory Committee (NMQAAC), and 
public comments received in response to the interim regulations. This 
proposal would also establish new requirements and responsibilities for 
accreditation bodies. This proposal is the second of five proposed 
rules published in this issue of the Federal Register regarding MQSA 
requirements applicable to mammography facilities. These proposed rules 
are being issued to ensure adequate and consistent evaluation of 
mammography facilities on a nationwide basis.

DATES: Written comments on this proposed rule by July 2, 1996. Written 
comments on the information collection requirements should be submitted 
by May 3, 1996. The agency is proposing that any final rule based on 
this proposed rule become effective 1 year after its date of 
publication in the Federal Register.

ADDRESSES: Submit written comments on this 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 collection requirements 
to the Office of Information and Regulatory Affairs, Office of 
Management and Budget, New Executive Office Bldg., 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. Background

    This proposal is the second of five related proposed rules 
published in this issue of the Federal Register to amend interim 
regulations published on December 21, 1993 (58 FR 67558 and 58 FR 
67565) implementing the MQSA (Pub. L. 102-539). The first proposed 
rule, ``Quality Mammography Standards; General Preamble and Proposed 
Alternative Approaches'' contains background information and a summary 
of the preliminary analysis of the costs and benefits of the proposed 
rules, 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.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulation

    This proposed rule covers procedures for application to FDA for 
approval as an accreditation body and the requirements and 
responsibilities of such bodies. As with the interim regulations, FDA 
was guided in the development of this proposed rule by the intent of 
the legislation to guarantee access to safe and effective mammography 
services for all women in the United States (Ref. 1). FDA also relied 
upon three major sources of information, in addition to the expertise 
and research of FDA personnel.

    First, the agency considered public comments received on the 
interim regulations. The agency received 103 comments from individuals 
and organizations, including professional organizations, medical 
facilities, State agencies, consumer groups, manufacturers, and 
individual physicians, medical physicists, and radiologic 
technologists. The proposed regulations were also discussed in a series 
of quarterly meetings with the NMQAAC. Members of the NMQAAC include 
interpreting physicians, medical physicists, radiologic technologists, 
representatives of State agencies, and consumer representatives. 
Consultants to the NMQAAC and guests invited to attend the committee 
meetings in recognition of their expertise in mammography also 
participated in these discussions of the proposed regulations. Finally, 
the agency's experience over the last year with the four accreditation 
bodies approved under the interim regulations also influenced the 
development of the proposed regulations. A discussion of the proposed 
amendments and a summary and analysis of both NMQAAC input and public 
comments regarding the regulations are provided below.
B. Application for Approval as an Accreditation Body
    In Sec. 900.3 (21 CFR 900.3) of the interim regulations, FDA 
established standards for approving the applications of prospective 
accreditation bodies. These standards are expanded in proposed 
Sec. 900.3 to provide FDA with more thorough criteria for assessing a

[[Page 14885]]

prospective body's capabilities. FDA is also proposing regulations to 
establish renewable terms of authority and the scope of authority of 
accreditation bodies.
1. Accreditation Body Assessment Criteria
    To identify more comprehensive criteria for evaluating prospective 
accreditation bodies, FDA researched Federal oversight of other 
accreditation organizations in the health care field. This included 
review of HCFA regulations and of an assessment of those regulations by 
GAO.
    In the Federal Register of December 14, 1990 (55 FR 51434), HCFA 
published a proposed regulation entitled ``Medicare Program: Granting 
and Withdrawal of Deeming Authority to National Accreditation 
Organizations.'' GAO reviewed that proposed regulation and stated in a 
1991 report that, with only one exception, the proposed regulation met 
all of the criteria that GAO considers important in the evaluation of 
an accreditation organization (Ref. 2). This regulation was finalized 
in the Federal Register of November 23, 1993 (58 FR 61816).
    Based on GAO's review of the proposed HCFA regulation, and FDA's 
experience with accreditation bodies under the interim regulations, FDA 
considers it essential to require a complete description of a 
prospective accreditation body's review and decisionmaking processes, 
including policies and procedures used to notify facilities of 
deficiencies and to monitor the correction of deficiencies. In 
addition, FDA considers the following criteria to be important in 
evaluating a prospective accreditation body's application: (1) 
Qualifications of the body's professional staff; (2) adequacy of the 
body's staffing level, finances, and other resources; (3) the body's 
ability to provide data and reports in an electronic format compatible 
with FDA data systems; and (4) adequacy of the body's consumer 
complaint mechanism. These additional criteria, together with the 
interim criteria, are reflected in proposed Sec. 900.3(b)(3).
    Several comments on the interim regulations as well as members of 
the NMQAAC noted the importance of timely processing of accreditation 
applications. These comments requested that accreditation body 
applications include satisfactory assurances that the applicant will be 
able to complete the accreditation process for a given facility within 
6 months if the facility submits the required information in a timely 
manner.
    FDA agrees that timely processing of accreditation materials is 
necessary in order to: (1) Meet statutory requirements, that, in most 
cases, allow new facilities to be provisionally certified for only 6 
months, and (2) ensure that reaccreditation applications will be 
processed before expiration of a facility's accreditation. Therefore, 
FDA is proposing to add a requirement in Sec. 900.3(b)(3)(iii)(J) for 
prospective accreditation bodies to submit such assurances with their 
application for approval, along with a description of their policies 
and procedures for ensuring timely processing of accreditation 
materials.
    To gain further insight regarding appropriate criteria for 
evaluating prospective accreditation bodies, FDA reviewed a regulation 
entitled ``Secretary's Procedures and Criteria for Recognition of 
Accrediting Agencies,'' which was finalized by the U.S. Department of 
Education in the Federal Register of April 29, 1994 (59 FR 22250). 
Based on FDA's review of that regulation, along with the agency's 
experience under the interim regulations and comments by NMQAAC 
members, FDA is proposing to add new Sec. 900.3 (b)(3)(iii)(K), 
(b)(3)(viii), and (b)(3)(ix). These sections would require each 
prospective accreditation body to submit with its accreditation 
application: (1) A description of the body's appeals process for 
facilities contesting accreditation decisions; (2) a description of the 
body's mechanism for ensuring against conflicts of interest; and (3) 
information disclosing any commercial products used in mammography that 
the body develops, sells, or distributes.
2. Term Limits and Scope of Authority
    In Sec. 900.3(g), FDA is proposing to establish renewable 5-year 
terms of approval for accreditation bodies. The agency believes that a 
body should not be approved for an indefinite amount of time without 
undergoing periodic comprehensive reviews. Although the interim 
regulations addressed the possibility of withdrawing the approval of an 
accreditation body for unsatisfactory performance, the interim 
regulations did not establish a regular term limit for accreditation 
body approval.
    FDA is proposing in Sec. 900.3(c) a schedule and requirements for 
application for renewal of an accreditation body's approval. These 
schedule and renewal requirements would also apply to accreditation 
bodies approved under the interim regulations that seek to continue 
serving as accreditation bodies under the final regulations. FDA's 
intention in establishing such a schedule is to ensure sufficient time 
for the review and processing of applications in order to avoid 
interruption in the availability of the services of the accreditation 
body. The agency solicits comments on whether the 90-day timeframe for 
application is appropriate.
    Proposed Sec. 900.3(d) describes the process the agency would use 
for reviewing accreditation body applications and renewals. The 
proposed process includes a provision for extending an accreditation 
body's previous approval if FDA has not reached a final decision on 
renewal before the previous approval expires.
    FDA is proposing new provisions in Sec. 900.3 (e) and (f) requiring 
the accreditation body to notify facilities and FDA, and to transfer 
records in instances where the body: (1) Voluntarily ceases its 
accreditation functions before expiration of its 5-year term, (2) 
decides not to reapply for an additional term of approval, or (3) fails 
to become reapproved by FDA.
    In addition to limiting the term of approval of accreditation 
bodies, FDA believes that the agency should be permitted to limit the 
scope of authority of an accreditation body (for example, 
geographically, for State agencies). This is proposed in Sec. 900.3(g).
    FDA plans to issue application guidance to prospective 
accreditation bodies to assist them in preparing materials and 
supporting documentation required by the revised accreditation 
regulations, when finalized. It is expected that for accreditation 
bodies applying for renewal, the supporting documentation will consist 
primarily of updates of information previously provided to FDA.

C. Standards for Accreditation Bodies

    In Sec. 900.4 (21 CFR 900.4), FDA is proposing expanded 
requirements and responsibilities for accreditation bodies. These 
standards are intended to ensure that accreditation bodies work 
together with FDA and mammography facilities to achieve and maintain 
high quality mammography at all facilities.
    Proposed Sec. 900.4(a) establishes a code of conduct and general 
responsibilities for accreditation bodies to assure the integrity and 
impartiality of accreditation body actions and appropriate oversight of 
the quality of mammography at all accredited facilities. Other proposed 
paragraphs in Sec. 900.4 and the accreditation body requirements they 
address include: Sec. 900.4(b)--standards that the accreditation body 
must apply to

[[Page 14886]]
accredit facilities; Sec. 900.4 (c) and (d)--accreditation body review 
of facility clinical and phantom images; paragraph (e)--accreditation 
body review of reports of mammography equipment evaluation, physics 
surveys, quality control records, and personnel updates at facilities; 
Sec. 900.4(f)--accreditation body onsite visits to facilities and 
performance of random clinical image reviews; Sec. 900.4(g)--consumer 
complaint mechanisms; Sec. 900.4(h)--other reporting and recordkeeping 
requirements; and Sec. 900.4(i)--fees that accreditation bodies may 
charge facilities for accreditation. While most of these requirements 
were addressed by the interim regulations, FDA is proposing additions 
and modifications that are described in this preamble.
1. Code of Conduct and General Responsibilities
    In Sec. 900.4(a)(1), FDA is proposing to require an accreditation 
body to take certain actions if the agency believes that the clinical 
image quality or other aspects of a facility's practice are seriously 
compromised and would pose an unreasonable risk of substantial harm to 
the public. The agency's intention is that this authority would only be 
used in those situations, hopefully rare, where the mammography-
specific health hazard is serious enough to warrant actions beyond the 
scope of those normally used to meet the facility quality standards. It 
is not intended to replace the normal interaction between accreditation 
bodies and facilities as they seek to meet the quality standards.
    This section was added in response to discussions with the NMQAAC 
and public comments requesting additional measures to ensure timely 
compliance with regulatory requirements by facilities. For example, one 
comment questioned whether the loss of a facility's certification would 
assure termination of a facility's ability to provide mammography 
services. Another comment stated that accreditation bodies should have 
the authority to take action against miscreant facilities.
    FDA advises that there are a number of mechanisms in place to 
ensure that decertified facilities no longer provide mammography 
services. When facilities lose their certification, they can no longer 
provide mammography services lawfully and are required to return their 
certificate to the agency. Consumers have been advised through various 
publicity campaigns to check for the presence of an FDA certificate 
when they go for a mammogram, so many consumers will be aware that they 
should not have a mammogram performed at a facility that does not 
display an FDA certificate. In addition, the statute provides for civil 
money penalty and injunctive sanctions against facilities that practice 
mammography without a certificate. Nonetheless, for circumstances where 
FDA believes there is a risk of substantial harm to the public, 
proposed Sec. 900.4(a)(1) would provide an additional means of 
monitoring facility compliance with MQSA requirements and would allow 
FDA to require accreditation bodies to assist the agency in taking 
actions or requiring facilities to take actions that the agency deems 
necessary to prevent harm to consumers. FDA solicits comments on the 
nature and appropriateness of this proposed additional monitoring.
    Similarly, Sec. 900.4(a)(2) and (a)(3) propose additional steps to 
be taken by accreditation bodies in circumstances where a facility's 
operations may compromise the quality of mammography or otherwise pose 
a health or safety hazard that is within the scope of the MQSA but not 
as severe as situations addressed by Sec. 900.4(a)(1). In accordance 
with these proposed paragraphs, accreditation bodies would be required 
to notify FDA any time the accreditation body becomes aware that there 
has been actual loss of life or serious injury or illness associated 
with facility noncompliance with MQSA requirements. Such notification 
would have to be provided to FDA within 5 business days of the 
accreditation body's learning of the event. The 5-business day interval 
was chosen as a compromise between the agency's need to be informed as 
soon as possible of serious mammography-specific health hazards and the 
need for the accreditation body to have sufficient time to identify and 
report the event. Comments are specifically invited upon the 
appropriateness of the allowed length of time. Accreditation bodies 
would also be required to obtain, review, and monitor plans of 
correction from facilities not in compliance with the facility 
standards. These provisions should further address the concerns of the 
comments mentioned above.
    One comment requested that all time period designations related to 
requirements for action by accreditation bodies be specified in 
``business'' days rather than ``calendar'' days.
    FDA agrees that some time period designations should be specified 
as business days and has proposed changes to the interim regulations 
accordingly. Where proposed time periods are not explicitly specified 
as business days, they should be interpreted as calendar days. In 
addition, in order to afford accreditation bodies and facilities 
increased flexibility, FDA is proposing to eliminate some of the 
mandatory schedules specified under the interim regulations. For 
example, FDA is eliminating the interim requirement that accreditation 
bodies with minor deficiencies submit a plan of corrective action 
within 90 days. Thus, under the proposed regulations, certain schedule 
requirements would be left to the discretion of the accreditation body 
or FDA or would be subject to FDA approval during the accreditation 
body application process.
    In Sec. 900.4(a)(4), FDA is proposing that accreditation bodies be 
required to establish a quality assurance (QA) program that includes 
clinical and phantom image review. This QA program would establish 
policies and procedures to ensure consistent and accurate evaluation of 
facility images with respect to both methods of review. The QA program 
would also address training and evaluation of staff performing the 
reviews.
    In proposed Sec. 900.4(a)(5), FDA calls for new measures to reduce 
the possibility of conflict of interest or bias on the part of an 
accreditation body or anyone acting on an accreditation body's behalf 
with regard to specific facilities. NMQAAC members and consultants 
expressed concern about conflicts of interest or bias with regard to 
clinical image reviewers evaluating images from their own States or 
from geographically limited areas where the reviewers may know the 
facilities and their interpreting physicians. Also, various comments 
expressed concern that: (1) ``Innumerable `non-profit' health care 
corporations'' could be approved as accreditation bodies and accredit 
their own facilities as long as clinical image reviewers had no 
financial interest in the facilities; (2) a professional organization 
serving as an accreditation body has members with ``vested interests in 
the outcome of the body's decisions;'' (3) individuals employed by a 
professional organization that is an accreditation body have a conflict 
of interest with regard to the establishment of standards by which 
their facilities would be evaluated under the MQSA; and (4) members of 
a professional organization that was an approved accreditation body 
would be prevented from conducting clinical image reviews.
    The proposed code of conduct in Sec. 900.4(a) is intended to 
address the various concerns raised regarding conflict of interest 
considerations for accreditation bodies. In addition, FDA notes that 
all standards used by accreditation bodies to accredit facilities

[[Page 14887]]
are subject to review and approval by the agency. However, neither the 
interim requirements nor the proposed code of conduct would preclude 
members of a professional organization that is designated as an 
accreditation body from conducting clinical image reviews for that 
organization solely on the basis of membership in that organization. In 
addition, the proposed standards include conflict of interest 
provisions that would preclude other situations suggested by the 
comments.
    Several comments and presentations at the NMQAAC meetings, on 
behalf of a trade association of software vendors, expressed concern 
that a currently approved accreditation body that markets mammography 
reporting software might have a sales advantage because of its MQSA 
accreditation functions and a perceived ``imprimatur of government 
approval'' for its products. In particular, this trade association 
proposed that the following language be incorporated into FDA's 
standards for approval of an accreditation body:

    Satisfactory assurances that the body does not have any interest 
in the development, sale, promotion, or distribution of any product 
(including computer software) under circumstances where the product 
will be the subject of inspection or review by the accreditation 
body in facility quality assurance or quality control or other 
aspects of the accreditation process. This restriction does not 
apply to educational programs or educational material typically 
prepared or disseminated by an accreditation body.

    Although FDA has not proposed the standard suggested by this 
comment, the agency specifically solicits public comment on this 
alternative. This issue has been raised repeatedly during the open 
public sessions of the NMQAAC meetings, and FDA wants to be certain 
that there is full opportunity for the public to comment on the 
underlying question: Is there an inherent conflict in an accreditation 
body also being a product vendor for a mammography- related product? As 
currently proposed, the requirements in Sec. 900.4(a)(6) minimize the 
possibility of accreditation body conflict of interest with regard to 
the marketing of commercial products by prohibiting an accreditation 
body from representing in any way that the purchase of a particular 
product is a condition of accreditation. However, proposed 
Sec. 900.4(a)(6) would not require accreditation bodies to divest all 
interests in commercial products. Moreover, the proposed regulation 
would permit an accreditation body to require the use of a product by 
facilities it accredits, even when there is the possibility of a 
conflict of interest, if FDA determines that such use is in the best 
interest of public health. As noted previously, FDA encourages further 
public comment on the conflict of interest issue, including comment on 
whether the outcome of any conflict of interest issue would be affected 
by: (1) The cost of the product sold by an accreditation body, i.e., by 
the magnitude of the financial interest; or (2) the number of 
accreditation bodies available to choose from.
    Proposed Sec. 900.4(a)(6) would require an accreditation body to 
state the bases for denying accreditation in a written notification to 
the affected facility. In accordance with proposed 
Sec. 900.3(b)(3)(iii)(K), each accreditation body will establish 
procedures for appeal of adverse accreditation decisions to the 
accreditation body. The accreditation body's notification of denial of 
accreditation also would be required to describe the appeals process 
available from the body if the facility wishes to contest the adverse 
decision.
    Proposed Sec. 900.4(a)(8) would explicitly prohibit any State that 
has been approved as an accreditation body from precluding any other 
FDA-approved accreditation bodies from operating in that State. This 
amendment is intended to codify what has been FDA policy and practice 
under the interim regulations.
    Several comments stated that FDA should allow only one 
accreditation body to operate in a given State or should allow only 
States to serve as accreditation bodies.
    FDA disagrees with these comments. The statute itself does not 
provide for such exclusivity. The MQSA allows FDA to approve either 
State agencies or private nonprofit organizations to serve as 
accreditation bodies, as long as they meet the standards established by 
FDA. The agency believes that facilities, consumers, and the 
professional community can benefit from the existence of more than one 
accreditation body.
    Consistent with the interim regulations, the proposed regulations 
would require that accreditation bodies obtain FDA authorization before 
changing accreditation body standards previously approved by FDA 
(Sec. 900.4(a)(9)). Several comments expressed concern that this 
requirement would preempt section 354(m) of the PHS Act, which permits 
States to enact and enforce laws that are more stringent than those 
mandated by the MQSA. There was also discussion during the January 1995 
NMQAAC meeting as to whether accreditation bodies could have more 
stringent requirements than those mandated under MQSA.
    FDA requires State agencies and private nonprofit organizations 
approved as accreditation bodies by FDA to establish and implement 
facility standards that have been approved by FDA. FDA will approve 
such standards only if FDA determines that they are substantially the 
same as the standards required under MQSA. In addition, all 
accreditation bodies, whether State agencies or private nonprofit 
organizations, must determine the MQSA accreditation status of a 
facility using only FDA-approved standards. However, accreditation 
bodies may use more stringent standards under other (non-MQSA) 
authorities for purposes other than that of determining the MQSA 
accreditation status of facilities. For example, a State public health 
agency approved as an MQSA accreditation body by FDA may require 
facilities in the State to meet additional standards (beyond those 
required by MQSA) under the body's authority as a State accreditation 
agency. However, the body may not require facilities to meet these 
additional standards in order to obtain MQSA accreditation. Similarly, 
a private nonprofit organization approved as an accreditation body may 
recommend compliance with more stringent standards than those mandated 
under MQSA, but may not use such standards in determining the MQSA 
accreditation status of a facility.
    Proposed Sec. 900.4(a)(10) states the accreditation body's 
obligation to protect the confidentiality of nonpublic information 
acquired in connection with carrying out accreditation body 
responsibilities. The accreditation body may not use or disclose 
information it receives from facilities, other than to FDA or its 
designated representatives, without the consent of the facility. The 
accreditation body must also protect the confidentiality of nonpublic 
information it receives from FDA or its duly designated 
representatives.
2. Facility Standards
    In proposed Sec. 900.4(b), FDA outlines the quality standards for 
mammography that accreditation bodies would have to apply to facilities 
they accredit (facility standards). The details of the facility 
standards required under the MQSA are being proposed elsewhere in this 
issue of the Federal Register. FDA is also proposing in Sec. 900.4(b) 
actions to be required by the accreditation body with respect to 
facilities not in compliance with the quality standards, such as 
reviewing and monitoring the implementation of facility plans of 
correction and revoking a facility's accreditation.

[[Page 14888]]

    One comment recommended that a single quality standard be 
implemented nationwide by all accreditation bodies.
    FDA intends to ensure that each accreditation body's standards are 
substantially the same as those promulgated by the agency, in 
accordance with the requirements of section 354(e)(1) of the PHS Act 
(42 U.S.C. 263b(e)). However, FDA notes that mammography standards are 
unlikely to be identical across the country because the MQSA allows for 
both private nonprofit organizations and State agencies to serve as 
accreditation bodies, and also permits States to establish more 
stringent mammography standards under their own authority. In addition, 
FDA believes it is necessary to allow some flexibility in accreditation 
body operations in order to provide for efficient accreditation 
services for the more than 10,000 mammography facilities nationwide. 
Nonetheless, the statute and proposed regulations are intended to 
establish minimum nationwide facility standards, and proposed 
Sec. 900.4(b) would require all accreditation bodies to adopt and apply 
these standards.
3. Clinical Image Review
    FDA believes that effective clinical image review is essential to 
ensure high quality mammograms. A primary purpose of the MQSA is to 
ensure that all mammography facilities have the benefit of such review 
and that accreditation bodies be qualified to perform that function. 
Accordingly, FDA is proposing to establish more specific requirements 
with respect to clinical image review than were established under the 
interim regulations. The requirements proposed are based on advice from 
the NMQAAC and public comments.
    The areas covered by the proposed standards in Sec. 900.4 for 
clinical image review are as follows: Sec. 900.4(c)(1)--requirements 
for the minimum frequency of review; Sec. 900.4(c)(2)--clinical image 
attributes to be evaluated (with a provision for FDA approval of 
alternatives, including ones that may be appropriate for new 
technology); Sec. 900.4(c)(3)--scoring of clinical images; 
Sec. 900.4(c)(4)--selection of clinical images for review; 
Sec. 900.4(c)(5)--qualifications and procedures for clinical image 
reviewers; Sec. 900.4(c)(6)--management of clinical images to ensure 
their timely return to facilities and the reporting of unsuspected 
abnormalities; and Sec. 900.4(c)(7)--corrective measures for 
unsatisfactory image quality. With respect to this last paragraph, it 
is FDA's intent that the accreditation process be a constructive one 
that helps facilities improve mammography quality. Therefore, FDA is 
proposing that clinical image reviewers be required to provide 
information to facilities that can help them correct deficiencies 
identified from their clinical images.
    Several comments as well as NMQAAC discussions concerned the 
interim requirements for clinical image review. Some NMQAAC members and 
consultants expressed uncertainty about whether States would have the 
expertise to perform clinical image reviews, because States had no 
prior experience with such reviews. Some comments called for increased 
standardization and the establishment of minimum requirements for 
clinical image review. One comment believed that all clinical images 
should be selected randomly in order to prevent facilities from merely 
selecting their best images for accreditation body review. Two comments 
questioned the need for clinical image review requirements at all. 
These two comments believed that other requirements in the interim 
regulations adequately addressed image quality. Another comment 
believed that clinical images should be independently reviewed by more 
than one radiologist.
    In response to these comments, FDA notes first that the MQSA 
mandates clinical image reviews and FDA fully supports the need for 
such reviews. FDA does not intend to approve any entity as an 
accreditation body, including a State agency, without first determining 
that the prospective body will be capable of performing or providing 
satisfactory clinical image reviews. The proposed regulations 
concerning clinical image review add specific details and requirements 
that are in addition to those set forth in the interim regulations. FDA 
believes that these additions in the proposed regulations, as well as 
anticipated agency guidance, will ensure that prospective accreditation 
bodies understand what FDA expects of them regarding such reviews and 
will be prepared to establish their ability to perform or provide these 
reviews as part of their application to become accreditation bodies. In 
addition, FDA will monitor accreditation bodies' compliance with the 
agency's standards and expectations, including their clinical image 
review functions. This will be done through annual performance 
evaluations and other oversight mechanisms.
    FDA agrees with the comment that clinical images should be 
independently reviewed by more than one radiologist. Although such a 
requirement was not explicitly established in the interim regulations, 
it has been the practice established by FDA and the accreditation 
bodies under those regulations. FDA is proposing to codify this policy 
in Sec. 900.4(c)(3)(ii).
    FDA disagrees with the comment that all clinical images submitted 
by facilities should be selected completely at random. For example, it 
is important in assessing the quality of a facility's mammography that 
accreditation bodies evaluate, for each mammography unit in a facility, 
mammograms for women with different types of breast composition (e.g., 
with predominantly glandular versus adipose tissue). FDA believes that 
systems for clinical image review under the MQSA can be implemented 
using random or nonrandom methods of image selection. FDA also notes 
that nonrandom methods for clinical image review were used by the ACR 
as part of its voluntary accreditation program before the passage of 
the MQSA.
4. Phantom Image Review
    FDA is proposing a new requirement in Sec. 900.4(d) for review of 
phantom images by the accreditation body. This is being done on the 
recommendation of the NMQAAC. To the extent that issues in the review 
of phantom images parallel issues in the review of clinical images, the 
requirements of this paragraph parallel those of Sec. 900.4(c). 
However, a unique issue with respect to phantom images is determining 
what constitutes acceptable phantom characteristics for 
radiographically modeling aspects of breast disease and cancer.
    FDA recognizes that a variety of phantoms may be useful for this 
purpose, and that the desirable phantom characteristics may change over 
time, particularly with the introduction of new technology. 
Consequently, FDA is not proposing that any specific attributes, such 
as specks, fibers, or masses, or their dimensions, be required by 
regulation. However, to assure the adequacy of phantoms used, FDA is 
proposing to require that accreditation bodies obtain FDA approval for 
the phantoms and methods of use that the bodies specify for facilities 
they accredit. This approach will provide needed flexibility for 
accreditation bodies and facilities and will enable FDA to respond in a 
timely manner to technological advances in this area.
5. Reports of Mammography Equipment Evaluation, Surveys, and Quality 
Control
    Consistent with the interim regulations and statutory requirements, 
FDA is proposing to require in Sec. 900.4(e) that accreditation bodies 
mandate submission of a survey by facilities in

[[Page 14889]]
order to obtain accreditation. ``Survey'' is defined in Sec. 900.2 
(published elsewhere in this issue of the Federal Register) as an 
onsite physics consultation and evaluation of a facility performed by a 
medical physicist. This survey would have to demonstrate the facility's 
compliance with the MQSA standards adopted by the accreditation body.
    The statute does not require new facilities to submit a survey in 
order to qualify for provisional certification from FDA. Therefore, new 
facilities may perform mammography for up to 6 months without 
undergoing a survey. Both the agency and the NMQAAC believe that 
postponement of the survey required for full accreditation under MQSA 
should not be interpreted as permitting the clinical use of equipment 
that has not been evaluated for safety. Accordingly, FDA is proposing 
that all facilities, whether seeking full or provisional certification, 
be required to submit with their initial accreditation application a 
mammography equipment evaluation demonstrating that the facility's 
equipment is in compliance with the requirements in Sec. 900.12(e) (21 
CFR 900.12)(e)) for equipment quality assurance (published elsewhere in 
this issue of the Federal Register). This requirement would ensure that 
provisionally certified facilities verify the proper functioning of 
their mammography equipment prior to clinical use.
    FDA will be developing a guidance document outlining the criteria 
for an adequate equipment evaluation. The agency invites comments on 
possible criteria for inclusion within this guidance document. A 
complete survey, which includes reviews and information in addition to 
equipment QA, would still have to be submitted in order for a 
provisionally certified facility to obtain accreditation and full 
certification.
    There was some discussion with the NMQAAC regarding who should 
perform the mammography equipment evaluation that is part of the 
initial application for accreditation. In deference to comments from 
rural health care providers, FDA has decided against requiring that 
this evaluation be performed by a medical physicist. Rural health care 
providers have indicated that, because of the limited availability of 
medical physicists in rural areas, it might be difficult for a 
physicist to visit a rural facility twice over a short time period in 
order to perform the mammography equipment evaluation and, later, the 
survey required for accreditation and full certification. In addition, 
the agency's experience under the Radiation Control for Health and 
Safety Act (Pub. L. 90-602) shows that the types of measurements being 
requested for the mammography equipment evaluation can be performed 
effectively by nonphysicists. Therefore, FDA believes it would not be 
cost-effective or practical to require performance of the mammography 
equipment evaluation by a medical physicist.
    FDA is proposing specific time periods for facility submission and 
accreditation body review of mammography equipment evaluations and 
surveys. These requirements are being recommended as a result of FDA's 
experience with MQSA over the last year and advice from the NMQAAC. In 
particular, both the agency and the NMQAAC believe it is important that 
facilities be required to submit survey and evaluation data that 
reflects current practice in the facility at the time of application 
for accreditation.
    FDA is proposing to require in Sec. 900.4(e) that accreditation 
bodies mandate annual submission of certain materials by the facility 
to the accreditation body for review. These materials would include the 
annual survey and quality control records, personnel updates, and other 
information that the body may require. This requirement is intended to 
assure continued compliance with the facility standards and to provide 
continued accreditation body oversight of facilities' quality control 
programs as they relate to such standards.
    Several comments addressed issues related to accreditation and 
certification of facilities with more than one mammography unit 
(consisting of the x-ray generator and associated image receptor and 
auxiliary equipment). In particular, clarification was requested 
regarding the status of multiple-unit facilities that had not undergone 
all tests to assure compliance with standards or that had failed to 
meet all requirements. Some comments favored requiring the complete 
evaluation of all units in a facility, with measures to ensure that 
only equipment meeting the necessary requirements is used to perform 
mammography.
    FDA agrees that only equipment meeting necessary requirements 
should be used to perform mammography. Under both the interim and 
proposed regulations, all units that are used for mammography in a 
facility must be reported to the accreditation body and meet applicable 
standards. As discussed previously, FDA is proposing to require that 
facilities submit the results of mammography equipment evaluations with 
their initial application for accreditation. Those evaluations will 
establish compliance with equipment QA standards under Sec. 900.12(e) 
for every unit in the facility. In addition, surveys (Sec. 900.4(e)), 
as well as clinical (Sec. 900.4(c)(4)(i)) and phantom images 
(Sec. 900.4(d)(4)), would have to be submitted for each mammography 
unit at a facility during specified time periods. FDA is also proposing 
in Sec. 900.4(c)(2)(viii)(G) that facilities with multiple units have a 
mechanism for identifying the unit used to produce each mammography 
image. This would enable inspectors and accreditation body visitors to 
check facility images against the compliance status of facility 
equipment and would facilitate problem identification and corrective 
measures, if necessary.
    It is FDA's policy that similar requirements apply to new and 
repaired equipment, i.e., such equipment may be used clinically after 
the mammography equipment evaluation has demonstrated compliance of the 
equipment with the requirements in Sec. 900.12(e). A survey and 
clinical and phantom image reviews may be required after the initiation 
of clinical use. Such image reviews and a survey are now, and would 
continue to be, necessary for new equipment; however, the accreditation 
body will specify, with FDA's approval, the circumstances under which 
repaired equipment will require a survey or image reviews by the 
accreditation body. Any facility that performs mammography with 
equipment the facility has reason to believe does not meet MQSA 
standards will be subject to sanctions under section 354(h)(2) of the 
PHS Act, including civil money penalties.
    One comment questioned the value of requiring annual submission of 
all facility quality control records to both the accreditation body and 
FDA. The comment also suggested that quality control records may be 
useful for internal evaluations, but that documents that are to be 
submitted to the accreditation body may be screened or amended by the 
facility in order to avoid negative publicity or regulatory action.
    FDA advises that no routine requirement exists to submit all 
quality control records to FDA. In addition, the use of the phrase 
``quality control records'' in Sec. 900.4(e)(2)(iii) of the interim 
regulations is not intended to mandate submission of all quality 
control records to the accreditation body every year. The records to be 
submitted will depend on the specific requirements established by the 
accreditation body, subject to FDA approval. FDA agrees that quality 
control records can serve as an

[[Page 14890]]
important internal source of information for helping facilities 
identify problems and appropriate solutions. However, FDA would regard 
any purposeful alterations of records to be acts of fraud.
6. Accreditation Body Onsite Visits and Random Clinical Image Reviews
    The MQSA requires that accreditation bodies make a ``sufficient 
number'' of onsite visits to facilities they accredit ``to allow a 
reasonable estimate of the performance'' of the body (42 U.S.C. 
263b(e)(4)). The MQSA also requires the accreditation body to conduct 
random reviews of clinical images from the facilities it accredits, in 
addition to the clinical image reviews required for accreditation (42 
U.S.C. 263b(e)(1)(B)). These requirements are listed in Sec. 900.4(f) 
of the proposed regulations (corresponding to Sec. 900.4(e) in the 
interim regulations). In the proposed regulations, the word ``visits'' 
is substituted for the previously used word ``inspections'' in order to 
reduce any confusion between onsite visits by accreditation bodies and 
annual inspections by State or FDA inspectors.
    One comment disputed the need for onsite visits by accreditation 
bodies and another comment questioned the need for the interim 
requirement that the accreditation body submit a copy of the visit 
report to FDA.
    FDA disagrees with both of these comments. The need for onsite 
visits is established by the statute. The purpose of the visits is to 
provide a mechanism by which an accreditation body can both ensure 
facility compliance with quality standards and monitor its own 
performance of accreditation functions. The accreditation body would be 
able to compare the results from visits for consistency with 
information obtained through other accreditation body functions. Also, 
because FDA is required to evaluate annually the performance of each 
accreditation body, the reports of onsite visits would provide valuable 
information on which to base such evaluations. Therefore, although the 
agency is proposing to delete the requirement that a full copy of each 
onsite visit report be provided to FDA at the conclusion of the 
accreditation body's onsite visit, FDA would continue to require that a 
summary of findings obtained as a result of accreditation body visits 
to facilities be included in the accreditation body's annual report to 
FDA. As discussed previously, notification about situations involving 
health hazards and death or serious injury or illness cannot wait for 
annual reports.
    Several comments addressed the selection process, number, and need 
for advance notification of facilities for accreditation body onsite 
visits. Some comments stated that the percentage of visits performed by 
accreditation bodies should be established by FDA (at perhaps 5 or 10 
percent of accredited facilities). One comment suggested that a means 
be established to ensure proportionate distribution of visits to 
facilities with regard to facility size and geographic distribution. 
Several comments believed that accreditation bodies should be required 
to give facilities advance notice of a visit, although one comment 
believed that FDA should specify certain circumstances for which 
unannounced visits might be appropriate.
    In response to these comments, FDA is proposing in Sec. 900.4(f)(1) 
that accreditation bodies select some facilities for onsite visits on a 
random basis and select other facilities based on specific reasons for 
concern with those facilities, such as previous history of 
noncompliance with quality standards. In general, each accreditation 
body would have to visit annually at least 5 percent of facilities it 
accredits, up to a maximum of 50 facilities, but no less than 5. The 
number could exceed 50 if many facilities need to be visited because of 
previously identified concerns.
    Regarding advance notification of facilities by accreditation 
bodies, FDA believes that accreditation bodies will need flexibility in 
scheduling onsite visits. In some cases, particularly if an 
accreditation body has serious concerns about a facility's ability to 
meet quality standards, significant advance notice would not be 
appropriate. In general, however, for facilities selected randomly for 
onsite visits, FDA will encourage accreditation bodies to work with 
facilities to schedule visits so as to minimize examinee inconvenience 
and disruption to facility operations.
    For random clinical image reviews, FDA is proposing that, on an 
annual basis, 3 percent of facilities (but no less than five 
facilities) accredited by an accreditation body would have to be chosen 
randomly to submit clinical images for review. These clinical images 
would be in addition to those submitted every 3 years as part of the 
accreditation process. As the requirements have been proposed, the 
accreditation body would be able to count toward this 3 percent 
requirement all facilities that have undergone an additional clinical 
image review because of random selection for the onsite visits in 
Sec. 900.4(f)(1)(i)(A).
    The requirement for selecting a 3 percent random sample of 
facilities is changed from that in the interim regulations, which 
required random clinical image review for each facility accredited by a 
body. The change in the sampling requirement is based on FDA experience 
with implementing the interim regulations. The agency believes that 
annual random clinical image review for every facility in addition to 
the clinical image reviews required for initial accreditation and 
renewal is not an effective use of accreditation body resources. In 
addition, accreditation bodies should not schedule random clinical 
image reviews at facilities that have received their notification of 
their need to begin the accreditation renewal process or at facilities 
that have completed the accreditation renewal process within the 
previous 6 months.
7. Consumer Complaint Mechanism
    The interim regulations required accreditation bodies to establish 
processes for receipt, investigation, and records maintenance of 
consumer complaints about facilities they accredit. In accordance with 
42 U.S.C. 263(n)(3)(E), FDA has worked with the NMQAAC to develop 
mechanisms to investigate consumer complaints. The committee and FDA 
agree that the investigation of ``serious complaints'' and the 
correction of underlying problems that may have precipitated them can 
help improve the practice of mammography. The proposed role of 
accreditation bodies in this process is specified in Sec. 900.4(g).
    A ``serious'' complaint is defined in proposed Sec. 900.2 
(published elsewhere in this issue of the Federal Register) as a report 
by a consumer of: (1) A ``serious adverse event'' that significantly 
compromises, or has the potential to significantly compromise, clinical 
outcomes, or (2) an ``adverse event'' for which the facility fails to 
take appropriate corrective action. ``Consumer'' is defined in proposed 
Sec. 900.2 as an individual who chooses to comment or complain in 
reference to a mammography exam. Consumers, therefore, may include the 
examinee or representatives of the examinee (e.g., family members or 
referring physicians).
    In the proposed regulations, the consumer complaint mechanism 
focuses on serious complaints related to incidents over which FDA has 
regulatory authority under MQSA. FDA acknowledges that there may be 
additional kinds of serious complaints that are legitimate and worthy 
of investigation, but that do not fall under the agency's regulatory 
authority under MQSA (e.g., sexual harassment or discrimination). FDA 
encourages the channeling and resolution of such complaints through 
appropriate existing mechanisms, such as State oversight

[[Page 14891]]
organizations and professional licensing boards.
    The proposed consumer complaint mechanism would set minimum 
requirements for facilities and accreditation bodies. FDA has worked 
extensively with NMQAAC in developing this mechanism and believes that 
the proposed requirements meet the important needs of the consumer 
without imposing undue burden on mammography facilities. The proposed 
regulations would allow facilities flexibility in instituting their own 
complaint resolution procedures. FDA encourages facilities to design 
their complaint mechanisms to be responsive to language, ethnic, and 
literacy differences among consumers served by the facility.
    FDA believes that all comments and complaints should be directed 
first to the facility, where there is the greatest opportunity for 
resolution. FDA is proposing that facilities be required to establish 
and administer a documented consumer complaint mechanism that complies 
with standards in proposed Sec. 900.12(h), published elsewhere in this 
issue of the Federal Register. However, FDA also recognizes that, under 
certain circumstances, consumers may want to report serious complaints 
that they have been unable to resolve with the facility to a more 
impartial organization. FDA believes that a facility's accreditation 
body should receive these complaints because the accreditation body has 
the responsibility for assuring that facilities meet quality standards. 
To fulfill this responsibility, accreditation bodies need data on 
serious complaints related to mammography quality. Therefore, FDA is 
proposing that the accreditation body be the second level in the 
complaint process to receive, investigate, and resolve serious consumer 
complaints.
    The third level of the complaint process, should the complaint go 
unresolved at the accreditation body level, would be FDA. The 
accreditation body could recommend that FDA take regulatory action, 
including inspections, sanctions, or revocation of the facility's 
certificate. Some consumers might want to address complaints about 
facilities directly to FDA, and this option is also open to them.
    FDA is proposing to require accreditation bodies to review and 
evaluate each facility's plan for handling consumer complaints. The 
agency is also proposing that the accreditation body be required to 
maintain a record of each serious complaint it receives regarding 
facilities it accredits, whether or not the accreditation body is able 
to resolve the complaint. All records of serious complaints would have 
to be retained for at least 3 years after the date of receipt of the 
complaint by the accreditation body. Accreditation bodies would also be 
required to submit to FDA an annual report summarizing serious 
complaints.
    One comment on the interim regulations requested that complaint 
information be shared with States and the public.
    The MQSA does not include a provision requiring public disclosure 
of individual consumer complaints or release of such information by 
individual facilities to State authorities. However, the MQSA does 
require in 42 U.S.C. 263b(l)(1) that information FDA determines to be 
useful in evaluating the performance of mammography facilities be made 
available to the general public no later than October 1, 1996, and 
annually thereafter. This information must include a list of facilities 
that have been convicted under Federal or State laws relating to fraud 
and abuse, false billings, or kickbacks, have been subject to 
sanctions, have had certificates revoked or suspended, or have had 
accreditation revoked.
    One comment on the interim regulations noted that the mechanism for 
handling complaint information contains no provision for protecting 
confidentiality and that unsubstantiated allegations should not be made 
publicly available.
    As discussed above, FDA does not believe the MQSA is intended to 
authorize public disclosure of details concerning specific complaints 
or allegations. FDA encourages all individuals involved in resolution 
of complaints to protect the confidentiality of consumers and health 
professionals to the full extent required by State law and professional 
ethics. However, knowledge of the identity of individuals involved in 
the complaint process may be necessary in order for the accreditation 
body or FDA to investigate the complaint. The agency's own regulations 
prohibit disclosure of information that would be an unwarranted 
invasion of personal privacy and FDA will not release names or personal 
identifiers without consent of the individuals involved (21 CFR 20.63 
and 20.111).
8. Reporting and Recordkeeping
    In Sec. 900.4(h), FDA is proposing to require that accreditation 
body reports to FDA be submitted in the format and medium prescribed by 
the agency. This requirement would facilitate the use of uniform 
methods for efficient data management and analysis, including the use 
of computer-based systems by FDA.
    One comment stated that the timeframes specified in the interim 
regulations (Sec. 900.4(g)) for accreditation body reporting were 
unreasonable.
    FDA agrees that changes in this area are needed and the proposed 
regulations have been designed to allow greater flexibility in 
specifying timeframes for reports to FDA, based on FDA and 
accreditation body needs.
    One comment expressed concern that the wording of the interim 
requirement in Sec. 900.4(g)(6) might result in a request for 
proprietary information not specifically required by or relevant to the 
MQSA. Another comment indicated concern that the interim requirement in 
Sec. 900.4(d)(1) for a facility to provide its accreditation body with, 
``any other information the body may require, as a part of the annual 
report about the facility'', was excessively broad.
    FDA believes that the MQSA provides the agency with the authority 
to determine the information that is necessary to meet the agency's 
statutory responsibilities under MQSA (e.g., 42 U.S.C. 
263b(d)(1)(B)(iii) and (e)(1)(C)(vi)). In addition, FDA has 
considerable experience with receiving and protecting proprietary 
information. However, in response to the comments, FDA has modified the 
regulatory language to specify that any information collected by an 
accreditation body from a facility should be relevant to the MQSA. In 
addition, as part of FDA's approval and oversight responsibilities, the 
agency will review the information required by accreditation bodies 
with regard to its relevance to such bodies' responsibilities under 
MQSA.
    As discussed earlier, FDA has also addressed the issue of 
confidentiality in the accreditation body code of conduct and general 
responsibilities. Proposed Sec. 900.4(a)(9) states the obligation of 
the accreditation body to keep confidential all nonpublic information 
it acquires in connection with carrying out its accreditation body 
responsibilities.
9. Fees
     In proposed Sec. 900.4(i), FDA is continuing to require that 
accreditation body fees charged to facilities be reasonable, as in 
Sec. 900.4(c) of the interim regulations.
    Several comments regarding accreditation fees mentioned the 
relatively small amounts of various third party reimbursements for 
screening mammography and hoped that FDA would consider this 
information when establishing requirements for fees. Two comments 
disagreed with the interim requirements for limiting fee increases to 
adjustments in the consumer price index (CPI). A

[[Page 14892]]
few other comments raised additional issues related to determining the 
reasonableness of fees, including expansion costs and accreditation 
body activities specifically attributable to MQSA responsibilities. The 
latter issue was raised with respect to State agencies with multiple 
responsibilities in addition to those associated with MQSA.
    FDA is proposing certain changes in the fee provisions in response 
to comments. The proposed regulations would permit variation in 
accreditation body fees, and adjustments would no longer be limited to 
changes in the CPI. However, FDA is proposing that accreditation bodies 
only be allowed to recover costs that are a result of MQSA-attributable 
functions. Consequently, fee changes might be appropriate for changes 
in accreditation body activities that have been approved by FDA. 
However, accreditation body activities that are not FDA-approved 
activities could not be considered in determining fees charged for MQSA 
accreditation functions. Consequently, the relationship of fees to 
costs incurred because of accreditation body responsibilities under 
these regulations would be an important factor in determining the 
reasonableness of fees.
    One comment questioned whether providers would have an opportunity 
to question the reasonableness of fees before they are approved by FDA.
    Although there is no official provision for public comment on 
accreditation fees, anyone who feels that fee increases are excessive 
may raise these concerns with FDA at any time.

D. Evaluation of Accreditation Bodies

    In proposed Sec. 900.5, FDA states that the agency will evaluate 
all accreditation bodies at least annually and at other times if 
specific circumstances warrant.
    Two comments suggested the following additions to the factors 
specified in the interim regulations for evaluating accreditation 
bodies: (1) Responsiveness of the body to FDA and to complaints from 
other sources, and (2) compliance of the body with requirements for 
approval as an accreditation body. One of these comments also suggested 
that more detail be added related to the sample size of facilities and 
clinical images to be assessed by FDA as part of FDA's evaluation of 
accreditation bodies.
    In response to these comments, FDA advises that the proposed 
regulations contain more extensive requirements (in Sec. 900.3) for 
approval as an accreditation body than did the interim regulations. As 
part of its annual evaluation of accreditation bodies, FDA will 
consider compliance with these requirements, including the 
responsiveness and timeliness with which accreditation bodies meet 
their various responsibilities. In order to perform these evaluations, 
FDA will have access to the results of annual inspections of facilities 
by FDA or State inspectors, information from annual and other reports 
from accreditation bodies, and visits to facilities or accreditation 
bodies to evaluate their compliance with the standards specified under 
subparts A and B of part 900 (21 CFR part 900). FDA also will be able 
to request more data, such as additional clinical images, at any time 
the agency determines that it needs further information to complete its 
evaluation.

E. Withdrawal of Approval

    In Sec. 900.6, FDA has proposed certain changes to the interim 
criteria for withdrawal of approval of an accreditation body and the 
addition of certain other actions the agency may take against 
accreditation bodies, when warranted.
    Under the interim regulations, FDA was precluded from reinstating 
approval of an accreditation body if withdrawal of approval was based 
on fraud or material false statements. FDA has reconsidered these 
criteria in drafting these proposed rules and in light of the agency's 
experience implementing the interim regulations.
    FDA continues to believe that certain actions are so egregious that 
they should automatically preclude an accreditation body from 
continuing or ever resuming service as an accreditation body. The 
agency believes that, in addition to the commission of fraud, willful 
disregard of the public health constitutes an action by an 
accreditation body that should permanently disqualify that body from 
future approval. Accordingly, FDA has added willful disregard of the 
public health as a bar to reinstatement as an accreditation body.
    However, FDA is proposing to review on a case-by-case basis 
applications from former accreditation bodies whose approval was 
withdrawn due to the submission of material false statements. The 
agency is persuaded that there may be instances where the submission of 
material false statements was unintentional or had limited 
consequences. FDA has drafted the proposed regulations to retain 
discretion to reinstate accreditation bodies if the agency determines 
there is evidence to demonstrate that such conduct will not recur.
    The proposed regulations also clarify that FDA reserves the right 
to withdraw approval or place an accreditation body on probationary 
status, depending on the specific deficiencies involved. Unlike the 
interim regulations, the proposal gives FDA discretion about how to 
proceed, even with respect to accreditation bodies that have 
demonstrated major deficiencies. FDA would make these determinations on 
a case-by-case basis. In addition, FDA would have discretion to specify 
particular corrective actions that the accreditation body must take or 
to offer the accreditation body an opportunity to submit its own plan 
of corrective action (including timetables) for FDA approval.
    Two comments stated that the specification in the interim 
regulations of a 90-day time period for submitting a corrective action 
plan to FDA for minor deficiencies should be shortened from 30 to 60 
days, and that FDA should respond to the proposed plan within the same 
timeframe.
    FDA has concluded that establishing fixed time periods for 
submission or implementation of corrective action plans does not allow 
the agency or accreditation bodies sufficient flexibility. Timeframes 
for correction of minor deficiencies should be based on the specific 
deficiencies that must be addressed. Therefore, the agency has not set 
forth specific timeframes in proposed Sec. 900.6(b)(2). Instead, FDA 
will determine the necessary implementation schedules on a case-by-case 
basis.

F. Hearings

    Under proposed Sec. 900.7 on hearings, a facility that has been 
denied accreditation would be entitled to an appeals process from the 
accreditation body (Sec. 900.7(b)). The facility could then appeal the 
results of this process to FDA and the Department of Health and Human 
Services in accordance with proposed Sec. 900.15, published elsewhere 
in this issue of the Federal Register.

III. 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.

IV. Analysis of Impacts

    FDA has examined together the impacts of this proposed rule and the 
proposed rules on general facility requirements, personnel 
requirements, and quality standards for mammography equipment and 
quality assurance, published elsewhere in this issue of the

[[Page 14893]]
Federal Register, under Executive Order 12866, the Regulatory 
Flexibility Act (Pub. L. 96-354), and under the Unfunded Mandates 
Reform Act. The analysis has addressed the proposed requirements of 
these four rules as one unit for purposes of determining their economic 
impact. The preamble to the proposed rule ``Quality Mammography 
Standards; General Preamble and Proposed Alternative Approaches,'' 
published elsewhere in this issue of the Federal Register, contains a 
brief summary of the cost and benefit determination and the Regulatory 
Impact Study that details the agency's calculation of these economic 
impacts and is available at the Dockets Management Branch (address 
above) for review. FDA recognized that these proposed regulations may 
have a disproportionate effect on small volume mammography facilities 
and is currently collecting additional information on the potential 
impact on this industry sector. The agency requests comments that will 
assist it in accounting for this impact.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collections which are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title, 
description, and respondent description of the information collection 
are contained in the proposed rule ``Quality Mammography Standards; 
General Preamble and Proposed Alternative Approaches,'' published 
elsewhere in this issue of the Federal Register, with an estimate of 
the annual reporting and recordkeeping burden.
    The agency has submitted a copy of this proposed rule to OMB for 
its review and approval of these information collection requirements. 
Other organizations and individuals desiring to submit 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, rm. 10235, New Executive Office Bldg., Washington, DC 20503, Attn: 
Desk Officer for FDA. Written comments on the information collection 
requirements should be submitted by May 3, 1996.

VI. Comments

     Interested persons may, on or before July 2, 1996, submit to the 
Dockets Management Branch (address above) written commentsregarding 
this proposed 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.

VII. References

    The following information 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.
    2. ``Health Care: Hospitals with Quality-of-Care Problems Need 
Closer Monitoring,'' U.S. GAO, GAO/HRD-91-40, May 1991.

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 Sec. 900.3 through 900.7 are revised to read as 
follows:


Sec. 900.3  Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State agencies 
capable of meeting the requirements of this subpart may apply for 
approval as accreditation bodies.
    (b) Application for initial approval. (1) An applicant seeking 
initial FDA approval as an accreditation body shall inform the Division 
of Mammography Quality and Radiation Programs, Center for Devices and 
Radiology Health (HFZ-240), Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850, marked Attn: Mammography Standards Branch, of 
its requested scope of authority.
    (2) Following receipt of the request, FDA will send application 
guidance to the applicant.
    (3) In accordance with the guidance provided, the applicant shall 
furnish to FDA at the address in paragraph (b)(1) of this section three 
copies of an application containing the following information, 
materials, and supporting documentation:
    (i) Name, address, and phone number of the applicant and evidence 
of nonprofit status (i.e., of fulfilling Internal Revenue Service 
requirements as a nonprofit organization) if the applicant is not a 
State agency;
    (ii) Detailed description of the accreditation standards the 
applicant will require facilities to meet and a discussion 
substantiating their equivalence to FDA standards required under 42 
U.S.C. 263b(e)(3);
    (iii) Detailed description of the applicant's accreditation review 
and decisionmaking process, including:
    (A) Procedures for performing clinical image review;
    (B) Procedures for performing phantom image review;
    (C) Procedures for assessing mammography equipment evaluations and 
surveys;
    (D) Procedures for performing onsite visits to facilities;
    (E) Procedures for assessing facility personnel qualifications;
    (F) Copies of the accreditation application forms, guidelines, 
instructions, and other materials the applicant will send to facilities 
during the accreditation process;
    (G) Policies and procedures for notifying facilities of 
deficiencies;
    (H) Procedures for monitoring corrections of deficiencies by 
facilities;
    (I) Policies and procedures for revoking a facility's 
accreditation;
    (J) Policies and procedures that will assure processing of 
accreditation applications and renewals within a timeframe approved by 
FDA and assurances that the body will adhere to such policies and 
procedures; and
    (K) A description of the applicant's appeals process for facilities 
contesting adverse accreditation status decisions.
    (iv) Education, experience, and training requirements for the 
applicant's professional staff, including reviewers of clinical or 
phantom images;
    (v) Description of the applicant's electronic data management and 
analysis system with respect to accreditation review and decision 
processes and the applicant's ability to provide electronic data in a 
format compatible with FDA data systems;
    (vi) Resource analysis that demonstrates that the applicant's 
staffing, funding, and other resources are adequate to perform the 
required accreditation activities;
    (vii) Fee schedules with supporting cost data;
    
[[Page 14894]]

    (viii) Statement of policies and procedures established to avoid 
conflicts of interest or the appearance of conflicts of interest by the 
applicant's board members, commissioners, professional personnel 
(including reviewers of clinical and phantom images), consultants, 
administrative personnel, and other representatives of the applicant;
    (ix) Disclosure of any specific brand of imaging system or 
component, measuring device, software package, or other commercial 
product used in mammography that the applicant develops, sells, or 
distributes;
    (x) Description of the body's documented consumer complaint 
mechanism;
    (xi) Satisfactory assurances that the applicant shall comply with 
the requirements of Sec. 900.4; and
    (xii) Any other information as may be required by FDA.
    (c) Application for renewal of approval. An approved accreditation 
body that intends to continue to serve as an accreditation body beyond 
its current term shall apply to FDA for renewal or notify FDA of its 
plans not to apply for renewal in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of a body's 
approval, an applicant for renewal shall inform FDA at the address 
given in paragraph (b)(1) of this section.
    (2) FDA will notify the applicant of the applicable information, 
materials, and supporting documentation from paragraph (b)(3) of this 
section that the applicant shall submit as part of the renewal 
procedure.
    (3) At least 6 months before the date of expiration of a body's 
approval, the applicant shall furnish to FDA at the address in 
paragraph (b)(1) of this section three copies of a renewal application 
containing the information, materials, and supporting documentation 
requested by FDA in accordance with paragraph (c)(2) of this section.
    (4) No later than July 2, 1996, any accreditation body approved 
under the interim regulations published in the Federal Register of 
December 21, 1993 (58 FR 67558) that intends to continue to serve as an 
accreditation body under the final regulations shall apply for renewal 
of approval in accordance with the procedures set forth in paragraphs 
(c)(1) through (c)(3) of this section.
    (5) Any accreditation body that does not plan to renew its approval 
shall so notify FDA at the address given in paragraph (b)(1) of this 
section at least 90 days before the expiration of the body's term of 
approval.
    (d) Rulings on applications for initial and renewed approval. (1) 
FDA will conduct a review and evaluation to determine whether the 
applicant substantially meets the applicable requirements of this 
subpart and whether the accreditation standards the applicant will 
require facilities to meet are substantially the same as the quality 
standards published under subpart B of this part.
     (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be rectified within a 
specified time period. If the deficiencies are not rectified to FDA's 
satisfaction within the specified time period, the application for 
approval as an accreditation body will be rejected.
    (3) The applicant will receive a formal notice from FDA stating 
whether the application has been approved or denied and a statement of 
the bases for any denial.
    (4) The review of any application may include a meeting between FDA 
and representatives of the applicant at a time and location mutually 
acceptable to FDA and the applicant.
    (5) FDA will advise the accreditation body of the circumstances 
under which a denied application may be resubmitted.
    (6) If FDA does not reach a final decision on a renewal application 
in accordance with this paragraph before the expiration of an 
accreditation body's approval, the approval will be deemed extended 
until the agency reaches a final decision on the application, unless an 
accreditation body does not rectify deficiencies in the application 
within the specified time period, as required in paragraph (d)(2) of 
this section.
    (e) Relinquishment of authority. An accreditation body that decides 
to relinquish its accreditation authority before expiration of the 
body's term of approval shall submit a letter of such intent to FDA at 
the address in paragraph (b)(1) of this section at least 90 days before 
relinquishing such authority.
    (f) Transfer of records. An accreditation body that does not apply 
for renewal of accreditation body approval, is denied such approval by 
FDA, or relinquishes its accreditation authority and duties before 
expiration of its term of approval, shall:
    (1) Transfer facility records and other related information as 
required by FDA to a location and according to a schedule approved by 
FDA.
    (2) Notify, in a manner and time period approved by FDA in 
accordance with Secs. 900.3(d) or 900.4(a)(9), all facilities 
accredited or seeking accreditation by the body that the body will no 
longer have accreditation authority.
    (g) Scope of authority. The accreditation body's term of approval 
is for a period of 5 years. FDA may limit the scope of accreditation 
authority.


Sec. 900.4  Standards for accreditation bodies.

    (a) Code of conduct and general responsibilities. The accreditation 
body shall accept the following responsibilities in order to ensure 
safe and accurate mammography at the facilities it accredits and shall 
perform these responsibilities in a manner that ensures the integrity 
and impartiality of accreditation body actions.
    (1) Upon request by FDA, the accreditation body shall review a 
facility's clinical images or other aspects of a facility's practice to 
assist FDA in determining whether or not the facility's practice poses 
an unreasonable risk of substantial harm to the public. Such reviews 
would be in addition to the evaluation an accreditation body performs 
as part of the initial accreditation or renewal process for facilities. 
If FDA determines that a facility's practice poses an unreasonable risk 
of substantial harm to the public:
    (i) The accreditation body shall require the facility to take 
appropriate corrective actions as determined by the accreditation body 
or FDA, including, but not limited to, notifying examinees or referring 
physicians; and
    (ii) The accreditation body shall monitor the facility's 
implementation of corrective actions in accordance with a schedule 
specified by FDA.
    (2) The accreditation body shall provide guidance to facilities 
regarding reporting requirements for conditions within the scope of 42 
U.S.C. 263b that arise at the facility and that pose a health hazard to 
examinees, personnel, or others in the facility.
    (i) The accreditation body shall require that such information and 
a plan of correction addressing the conditions be submitted by the 
facility in a manner and time period specified by the accreditation 
body.
    (ii) The accreditation body shall require the facility to cease use 
of any equipment or to eliminate any practices that may contribute to 
such potentially harmful conditions as soon as possible. In those 
circumstances where the accreditation body has reason to believe a 
hazard exists, the accreditation body shall notify the facility that 
use of the equipment or continuation of the practice shall stop 
immediately.
    (iii) The accreditation body shall monitor the facility's 
compliance with the plan of correction and progress

[[Page 14895]]
toward meeting applicable standards and minimizing health hazards.
    (3) The accreditation body shall inform FDA within 5 business days 
of becoming aware of equipment or practices that pose an unreasonable 
risk of substantial harm to the public.
    (4) The accreditation body shall establish and administer a quality 
assurance (QA) program that has been approved by FDA in accordance with 
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality 
assurance program shall:
    (i) Include requirements for clinical image review and phantom 
image review;
    (ii) Ensure that clinical and phantom images are evaluated 
consistently and accurately; and
    (iii) Specify the methods and frequency of training, evaluation, 
and performance improvement for clinical and phantom image reviewers, 
and the bases and procedures for removal of such reviewers.
    (5) The accreditation body shall establish measures that FDA has 
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this 
section to reduce the possibility of conflict of interest or facility 
bias on the part of individuals acting on the body's behalf. Such 
individuals who review clinical or phantom images under the provisions 
of paragraphs (c) and (d) of this section or who visit facilities under 
the provisions of paragraph (f) of this section shall not review 
clinical or phantom images from or visit a facility with which such 
individuals maintain a financial relationship, or when it would 
otherwise be a conflict of interest for them to do so, or when they 
have a bias in favor of or against the facility.
    (6) The accreditation body may require specific equipment 
performance or design characteristics that FDA has approved. However, 
no accreditation body shall require, either explicitly or implicitly, 
the use of any specific brand of imaging system or component, measuring 
device, software package, or other commercial product as a condition 
for accreditation by the body, unless FDA determines that it is in the 
best interest of public health to do so.
    (i) Any representation, actual or implied, either orally, in sales 
literature, or in any other form of representation, that the purchase 
or use of a particular product brand is required in order for any 
facility to be accredited or certified under 42 U.S.C. 263b, is 
prohibited, unless FDA approves such representation.
    (ii) Unless FDA has approved the exclusive use and promotion of a 
particular commercial product in accordance with this section, all 
products produced, distributed, or sold by an accreditation body or an 
organization that has a financial or other relationship with the 
accreditation body that may be a conflict of interest or have the 
appearance of a conflict of interest with the body's accreditation 
functions, shall bear a disclaimer stating that the purchase or use of 
such products is not required for accreditation or certification of any 
facility under 42 U.S.C. 263b. Any representations about such products 
shall include a similar disclaimer.
    (7) When an accreditation body denies accreditation to a facility, 
the accreditation body shall notify the facility in writing and explain 
the bases for its decision. The notification shall also describe the 
appeals process available from the accreditation body for the facility 
to contest the decision.
    (8) No State agency that is approved as an accreditation body may 
require facilities in the State to be accredited under 42 U.S.C. 263b 
only by the State agency and not by other FDA- approved accreditation 
bodies.
    (9) The accreditation body shall obtain FDA authorization for any 
changes it proposes to make in any standards that FDA has previously 
accepted under Sec. 900.3(d).
    (10) An accreditation body shall protect confidential information 
it collects or receives in its role as an accreditation body.
    (i) Nonpublic information collected from facilities for the purpose 
of carrying out accreditation body responsibilities shall not be used 
for any other purpose or disclosed, other than to FDA or its duly 
designated representatives, without the consent of the facility;
    (ii) Nonpublic information that FDA or its duly designated 
representatives share with the accreditation body concerning a facility 
that is accredited or undergoing accreditation by that body shall not 
be further disclosed except with the written permission of FDA.
    (b) Facility standards. (1) The accreditation body shall require 
that each facility it accredits meet standards for the performance of 
quality mammography that are substantially the same as those in this 
subpart and in subpart B of this part.
    (2) The accreditation body shall notify a facility regarding 
equipment, personnel, and other aspects of the facility's practice that 
do not meet such standards and take reasonable steps to ensure that 
such equipment, personnel, or other aspects of the practice are not 
used by the facility for activities covered by 42 U.S.C. 263b.
    (3) The accreditation body shall specify the actions that 
facilities must take to correct deficiencies in equipment, personnel, 
and other aspects of the practice to ensure facility compliance with 
applicable standards.
    (4) If deficiencies cannot be corrected to ensure compliance with 
standards or if a facility is unwilling to take corrective actions, the 
accreditation body shall revoke the facility's accreditation in 
accordance with the policies and procedures in 
Sec. 900.3((b)(3)(iii)(I).
    (c) Clinical image review. (1) Frequency of review. The 
accreditation body shall review clinical images from each facility 
accredited by the body at least once every 3 years.
    (2) Requirements for clinical image attributes. The accreditation 
body shall use the following attributes for all clinical image reviews, 
unless FDA has approved other attributes.
    (i) Positioning. Sufficient breast tissue shall be imaged to ensure 
that cancers are not likely to be missed because of inadequate 
positioning.
    (ii) Compression. Compression shall be applied in a manner that 
minimizes the potential obscuring effect of overlying breast tissue and 
motion artifact.
    (iii) Tissue exposure. Tissue exposure shall be adequate to 
visualize breast structures. Images shall be neither underexposed nor 
overexposed.
    (iv) Contrast. Image contrast shall permit differentiation of 
subtle tissue density differences.
    (v) Sharpness. Margins of normal breast structures shall be 
distinct and not blurred.
    (vi) Noise. Noise in the image shall not significantly obscure 
breast structures or suggest the appearance of structures not actually 
present.
    (vii) Artifacts. Artifacts due to lint, scratches, and other 
factors external to the breast shall not obscure breast structures or 
suggest the appearance of structures not actually present.
    (viii) Examination identification. Each image shall have the 
following information indicated on it in a permanent and unambiguous 
manner and placed so as not to obscure anatomic structures:
    (A) Examinee identification.
    (B) Date of examination.
    (C) View and laterality. This information shall be placed on the 
image in a position near the axilla. Standardized codes specified by 
the accreditation body and approved by FDA in accordance with 
Sec. 900.3(d) or

[[Page 14896]]
paragraph (a)(9) of this section shall be used to identify view and 
laterality.
    (D) Facility name and location. At a minimum, the location shall 
include the city, state, and zip code number of the facility.
    (E) Technologist identification.
    (F) Cassette/screen identification.
    (G) Mammography unit identification, if there is more than one unit 
in the facility.
    (3) Scoring of clinical images. Accreditation bodies shall 
establish and administer a system for scoring clinical images using all 
attributes specified in paragraphs(c)(2)(i) through (c)(2)(viii) of 
this section or an alternative system that FDA has approved in 
accordance with Sec. 900.3(d) or paragraph (a)(9) of this section. The 
scoring system shall include an individual scoring scale for each 
attribute. Each scoring scale shall cover the range from unacceptable 
deficiencies that markedly reduce the clinical value of an image to no 
significant deficiencies. Each clinical image submitted shall be scored 
for each attribute.
    (i) The accreditation body shall establish and employ criteria for 
a pass-fail system for clinical image review that has been approved by 
FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
    (ii) All clinical images submitted by a facility to the 
accreditation body shall be reviewed independently by two or more 
clinical image reviewers.
    (4) Selection of clinical images for review. Unless otherwise 
specified by FDA, the accreditation body shall require that for each 
mammography unit in the facility:
    (i) The facility shall submit craniocaudal (CC) and mediolateral 
oblique (MLO) views from two mammographic examinations that the 
facility produced during a time period specified by the accreditation 
body;
    (ii) Clinical images submitted from one such mammographic 
examination for each unit shall be of dense breasts (predominance of 
glandular tissue) and the other shall be of fat-replaced breasts 
(predominance of adipose tissue);
    (iii) All clinical images submitted shall be images that the 
facility's interpreting physician(s) interpreted as normal.
    (iv) If the facility has no clinical images meeting the 
requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this 
section, it shall so notify the accreditation body, which shall specify 
alternative clinical image selection methods that do not compromise 
care of the examinee.
    (5) Clinical image reviewers. Accreditation bodies shall ensure 
that all of their clinical image reviewers:
    (i) Meet the interpreting physician requirements specified in 
Sec. 900.12(a)(1);
    (ii) Are trained and evaluated in the clinical image review 
process, for the types of clinical images to be evaluated by a clinical 
image reviewer, by the accreditation body before designation as 
clinical image reviewers and periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any clinical image and provide information to the 
facility for use in improving the attributes for which significant 
deficiencies were identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to assure the security and return to the 
facility of all clinical images received and to assure completion of 
all clinical image reviews by the body in a timely manner. The 
accreditation body shall return all clinical images to the facility 
within 60 days of their receipt by the body, with the following 
exceptions:
    (i) If the clinical images are needed earlier by the facility for 
clinical purposes, the accreditation body shall work with the facility 
to accommodate such needs.
    (ii) If a clinical image reviewer identifies an abnormality on a 
clinical image that the facility interpreted as normal, and this 
finding is not clearly specified on mammography reports submitted with 
the clinical images, the accreditation body shall ensure that this 
information is provided and the clinical images returned to the 
facility no later than 10 business days after identification of the 
suspected abnormality.
    (7) Corrective measures for unsatisfactory image quality. If the 
accreditation body determines that the clinical images from a facility 
it accredits are of insufficient quality, the body shall notify the 
facility of the nature of the problem and its possible causes. The 
accreditation body shall monitor facility progress in correcting the 
problem and take appropriate action if the necessary corrective 
measures are not implemented in a manner and time period satisfactory 
to the body.
    (d) Phantom image review. (1) Frequency of review. The 
accreditation body shall review phantom images from each facility 
accredited by the body at least once every 3 years.
    (2) Requirements for the phantom used. The accreditation body shall 
require that each facility submit for review phantom images that the 
facility produced using a phantom and methods of use specified by the 
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph 
(a)(9) of this section.
    (3) Scoring phantom images. The accreditation body shall use a 
system for scoring phantom images that has been approved by FDA in 
accordance with Sec. 900.3(d) or paragraph (a)(9) of this section.
    (4) Phantom images selected for review. For each mammography unit 
in the facility, the accreditation body shall require the facility to 
submit phantom images that the facility produced during a time period 
specified by the body.
    (5) Phantom image reviewers. Accreditation bodies shall ensure that 
all of their phantom image reviewers:
    (i) Meet the requirements specified in Sec. 900.12(a)(3) or 
alternative requirements established by the accreditation body and 
approved by FDA in accordance with Sec. 900.3(d) or paragraph (a)(9) of 
this section;
    (ii) Are trained and evaluated in the phantom image review process, 
for the types of phantom images to be evaluated by a phantom image 
reviewer, by the accreditation body before designation as phantom image 
reviewers and periodically thereafter; and
    (iii) Clearly document their findings and reasons for assigning a 
particular score to any phantom image and provide information to the 
facility for use in improving its phantom image quality with regard to 
the significant deficiencies identified.
    (6) Image management. The accreditation body's QA program shall 
include a tracking system to assure the security and return to the 
facility of all phantom images received and to ensure completion of all 
phantom image reviews by the body in a timely manner.
    (7) Corrective measures for unsatisfactory image quality. If the 
accreditation body determines that any phantom images are of 
insufficient quality, the body shall notify the facility of the nature 
of the problem and its possible causes. The accreditation body shall 
monitor facility progress in correcting the problem and take 
appropriate action if the necessary corrective measures are not 
implemented in a manner and time period satisfactory to the body.
    (e) Reports of mammography equipment evaluation, surveys, and 
quality control. The following requirements apply to all facility 
equipment covered by the provisions of subparts A and B:
    (1) The accreditation body shall require every facility applying 
for accreditation to submit:

[[Page 14897]]

    (i) With its initial accreditation application, a mammography 
equipment evaluation performed no earlier than 6 months before the date 
of application for accreditation by the facility. Such evaluation shall 
demonstrate compliance of the facility's equipment with the 
requirements in Sec. 900.12(e).
    (ii) A survey which was performed no earlier than 6 months before 
the date of application for accreditation by the facility. Such survey 
shall assess the facility's compliance with the facility standards 
referenced in paragraph (b) of this section.
    (2) The accreditation body shall require that all facilities 
undergo an annual survey to assure continued compliance with the 
standards referenced in paragraph (b) of this section and to provide 
continued oversight of facilities' quality control programs as they 
relate to such standards. The accreditation body shall require for all 
facilities that:
    (i) Such annual surveys be conducted no later than 14 months after 
the most recent prior survey;
    (ii) Facilities take reasonable steps to ensure that they receive 
reports of such surveys within 30 days of survey completion; and
    (iii) Facilities submit the results of such surveys, together with 
quality control records, personnel updates, and other information that 
the body may require, to the body at least annually.
    (3) The accreditation body shall review and analyze the information 
required in this section and use it to determine the accreditation 
status of a facility and to identify necessary corrective measures for 
facilities.
    (f) Onsite visits to facilities and random clinical image reviews. 
The accreditation body shall conduct onsite visits and random clinical 
image reviews of a sample of facilities to monitor and assess their 
compliance with the facility standards imposed under Sec. 900.3. The 
accreditation body shall submit annually to FDA, at the address given 
in Sec. 900.3(b)(1), 3 copies of a summary report describing all 
facility assessments the body conducted under the provisions of this 
section for the year being reported.
    (1) Onsite visits. (i) Sample size. Annually, each accreditation 
body shall visit at least 5 percent of the facilities it accredits. 
However, a minimum of 5 facilities shall be visited, and visits to no 
more than 50 facilities are required, unless problems identified in 
paragraph (f)(1)(i)(B) of this section indicate a need to visit more 
than 50 facilities.
    (A) At least 50 percent of the facilities visited shall be selected 
randomly.
    (B) Other facilities visited shall be selected based on problems 
identified through State or FDA inspections, complaints received from 
consumers or others, a previous history of noncompliance, or any other 
information in the possession of the accreditation body, inspectors, or 
FDA.
    (C) Before, during, or after any facility visit, the accreditation 
body may require that the facility submit to the body for review 
clinical images, phantom images, or any other information relevant to 
applicable standards in this subpart and in subpart B of this part.
    (ii) Visit plan. The accreditation body shall conduct visits 
according to a visit plan that has been approved by FDA in accordance 
with Sec. 900.3(d) or paragraph (a)(9) of this section. At a minimum, 
such plan shall address review of the following elements during visits 
to facilities selected randomly and facilities selected because of 
previously identified concerns:
    (A) Assessment of overall clinical image QA activities of the 
facility;
    (B) Review of facility documentation to determine if appropriate 
mammography reports are sent to examinees and physicians as required;
    (C) Selection of a sample of clinical images for clinical image 
review by the accreditation body. Clinical images shall be selected in 
a manner that does not compromise care of the examinee as a result of 
the absence of the selected images from the facility;
    (D) Review of the facility's medical audit system and assessment of 
correlation between film and pathology reports for positive cases;
    (E) Verification that personnel specified by the facility are the 
ones actually performing designated personnel functions;
    (F) Verification that equipment specified by the facility is the 
equipment that is actually being used to perform designated equipment 
functions;
    (G) Verification of facility compliance with its consumer complaint 
mechanism; and
    (H) Review of all factors related to previously identified concerns 
or concerns identified during that visit.
    (2) Clinical image review for random sample of facilities. (i) 
Sample size. In addition to conducting clinical image reviews for 
initial and renewed accreditation for all facilities, the accreditation 
body shall conduct clinical image reviews annually for a randomly 
selected sample of 3 percent of the facilities the body accredits. 
However, a minimum of five facilities shall be selected for such random 
clinical image review. Accreditation bodies may count toward this 3 
percent requirement all facilities selected randomly for the onsite 
visits described in paragraph (f)(1)(i)(A) of this section. 
Accreditation bodies shall not count toward the 3 percent random sample 
requirement any facilities selected for a visit because of previously 
identified concerns described in paragraph (f)(1)(i)(B) of this 
section.
    (ii) Clinical image review. In performing clinical image reviews of 
the 3 percent random sample of facilities, accreditation bodies shall 
apply the same standards as those in paragraph (c) of this section for 
review of clinical images for initial and renewed accreditation.
    (iii) Accreditation bodies should not schedule random clinical 
image reviews at facilities that have received notification of need to 
begin the accreditation renewal process or that have completed the 
accreditation renewal process within the previous 6 months.
    (g) Consumer complaint mechanism. The accreditation body shall 
develop and administer a written and documented system, including 
timeframes, for collecting and resolving serious consumer complaints 
that could not be resolved at a facility. Such system shall have been 
approved by FDA in accordance with Sec. 900.3(d) or paragraph (a)(9) of 
this section. Accordingly, all accreditation bodies shall:
    (1) Provide a mechanism for filing a serious complaint with the 
accreditation body if the complaint has not been resolved at the 
facility;
    (2) Maintain a record of every serious complaint received by the 
body on all facilities it accredits for a period of at least 3 years 
from the date of receipt of each such complaint;
    (3) Submit to FDA, at the address in paragraph (b)(1) of this 
section, in a manner and time period specified by FDA, an annual report 
summarizing all serious complaints received during the previous 
calendar year, their resolution status, and any actions taken in 
response to them.
    (h) Reporting and recordkeeping. All reports to FDA specified in 
paragraphs (h)(1) through (h)(4) of this section shall be prepared and 
submitted in a format and medium prescribed by FDA and shall be 
submitted to a location and according to a schedule specified by FDA. 
The accreditation body shall:
    (1) Collect and submit to FDA the information required by 42 U.S.C. 
263b(d) for each facility when the facility is initially accredited and 
at least annually when updated, in a manner and at a time specified by 
FDA.

[[Page 14898]]

    (2) Accept applications containing the information required in 42 
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.12(b)(2) 
for extension of provisional certificates, on behalf of FDA, and notify 
FDA of the receipt of such information;
    (3) Submit to FDA the name, identifying information, and other 
information relevant to 42 U.S.C. 263b and specified by FDA for any 
facility for which the accreditation body denies or revokes 
accreditation, or for which the accreditation body denies submission to 
FDA of information required from facilities for provisional 
certification or for extension of provisional certification, as 
described in paragraph (h)(3) of this section, and the reason(s) for 
such action;
    (4) Provide to FDA other information relevant to 42 U.S.C. 263b and 
required by FDA about any facility accredited or undergoing 
accreditation by the body.
    (i) Fees. Fees charged to facilities for accreditation shall be 
reasonable. Costs of accreditation body activities that are not related 
to accreditation functions under 42 U.S.C. 263b are not recoverable 
through fees established for accreditation.
    (1) The accreditation body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different facilities.
    (2) At FDA's request, accreditation bodies shall provide financial 
records or other material to assist FDA in assessing the reasonableness 
of accreditation body fees. Such material shall be provided to FDA in a 
manner and time period specified by the agency.


Sec. 900.5  Evaluation.

    FDA will evaluate annually the performance of each accreditation 
body. Such evaluation shall include an assessment of the reports of FDA 
or State inspections of facilities accredited by the body as well as 
any additional information deemed relevant by FDA that has been 
provided by the accreditation body or other sources or has been 
required by FDA as part of its oversight initiatives.


Sec. 900.6  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 900.5, 
or through other means, that an accreditation body is not in 
substantial compliance with this subpart, FDA shall initiate 
enforcement actions as follows:
    (a) Major deficiencies. If FDA determines that an accreditation 
body has failed to perform a major accreditation function 
satisfactorily, has demonstrated willful disregard for public health, 
has violated the code of conduct, has committed fraud, or has submitted 
material false statements to the agency, FDA may withdraw its approval 
of that accreditation body.
    (1) FDA will notify the accreditation body of the agency's action 
and the grounds on which the approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
facilities accredited or seeking accreditation by it that its approval 
has been withdrawn. Such notification shall be made within a time 
period and in a manner approved by FDA.
    (b) Minor deficiencies. If FDA determines that an accreditation 
body has demonstrated deficiencies in performing accreditation 
functions and responsibilities that are less serious or more limited 
than the deficiencies in paragraph (a) of this section, FDA shall 
notify the body that it has a specified period of time to take 
particular corrective measures directed by FDA or to submit to FDA for 
approval the body's own plan of corrective action addressing the minor 
deficiencies. FDA may place the body on probationary status for a 
period of time determined by FDA, or may withdraw approval of the body 
as an accreditation body if corrective action is not taken.
    (1) If FDA places an accreditation body on probationary status, the 
body shall notify all facilities accredited or seeking accreditation by 
it of its probationary status within a time period and in a manner 
approved by FDA.
    (2) Probationary status will remain in effect until such time as 
the body can demonstrate to the satisfaction of FDA that it has 
successfully implemented or is implementing the corrective action plan 
within the established schedule, and that the corrective actions have 
substantially eliminated all identified problems.
    (3) If FDA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all facilities accredited or seeking accreditation by it of its loss of 
approval authority, within a time period and in a manner approved by 
FDA.
    (c) Reapplication by accreditation bodies that have had their 
approval withdrawn. (1) A former accreditation body that has had its 
approval withdrawn may submit a new application for approval if the 
body can provide information to FDA to establish that the problems that 
were grounds for withdrawal of approval have been resolved.
    (2) If FDA determines that the new application demonstrates that 
the body satisfactorily has addressed the causes of its previous 
unacceptable performance, FDA may reinstate approval of the 
accreditation body.
    (3) FDA may request additional information or establish additional 
conditions that must be met by a former accreditation body before FDA 
approves the reapplication.
    (4) FDA will not accept an application from a former accreditation 
body whose approval was withdrawn because of fraud or willful disregard 
of public health.


Sec. 900.7  Hearings.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval or reapproval of accreditation bodies, withdrawal of 
approval of accreditation bodies, or rejection of a proposed fee shall 
be communicated through notices of opportunity for informal hearings in 
accordance with part 16 of this chapter.
    (b) A facility that has been denied accreditation is entitled to an 
appeals process from the accreditation body. The appeals process shall 
be specified in writing by the accreditation body and shall have been 
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
    (c) A facility that cannot achieve satisfactory resolution of an 
adverse accreditation decision through the accreditation body's appeals 
process may appeal to FDA for reconsideration in accordance with 
Sec. 900.15.

    Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7831 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P